parabolan side effects

International nonproprietary name:

clopidogrel

 

Dosage Form : parabolan side effects, film-coated

Ingredients :

1 parabolan side effects contains

Active substance:

Clopidogrel hydrogen sulfate – 0.098 g (in terms of clopidogrel – 0,075 g) Excipients:

potato starch, lactose (milk sugar), microcrystalline cellulose. HIPRO-melloza (hydroxypropyl methylcellulose). Macrogol 6000 (polyethylene glycol 6000). stearic acid, magnesium stearate.

Cover structure:

hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 6000 (polietileng-glycol 6000), iron oxide red.

Description : film-coated parabolan side effectss pink – cream color, round, biconcave. The cross section shows two layers.

 

Pharmacotherapeutic group:

antiplatelet agent.

 

ATC code: V01AS04

 

Pharmacological properties:

 

Pharmacodynamics:

It inhibits platelet aggregation by binding of the selective blockade of adenosine diphosphate (ADP) to its receptor on platelets and activation of the complex GPIIb / IIIa. Inhibits aggregation grombotsitov caused by other agonists by avoiding platelet adenosine diphosphate released, does not affect the activity of phosphodiesterase. Changes of platelet ADP receptors caused by clopidogrel is irreversible, methasterone and therefore non-functional platelets remain throughout the period of the life of platelets, antiplatelet agents, and the effect is maintained throughout this period. Restoration of normal function is as an update of platelets (approximately 7 days). In the presence of atherosclerotic vascular lesions, clopidogrel prevents the development of atherothrombosis regardless of the localization process of vascular (cerebrovascular, cardiovascular or peripheral lesions).

Pharmacokinetics:

After ingestion of 75 mg clopidogrel drug it is quickly absorbed from the gastrointestinal
tract, however, the low plasma concentration after 2 h after administration does not reach the measurement limit (0.025 mg / l), and inhibition of platelet aggregation reached at
40%. The maximum effect (60% inhibition of aggregation) develops within 4-7 days of continuous use of the drug at a dose 98 mg / day (based on kdopidogrel -75 mg / day). The drug is metabolized in the liver. The major metabolite – inactive derivative of a carboxylic acid, the maximum concentration in plasma (TStah) which after repeated Clopidogrel 75 mg, about 3 mg / l and observed after about 1 hour after ingestion. Clopidogrel and its major metabolite are bound to plasma proteins (98-94%, respectively)

Excretion: after oral administration around 50% of the dose excreted in urine and approximately 46% through the intestine to feces (in section 120 hours after administration). The half-life (T 1/2) of the main metabolite after single and repeated administration – 8 hours.

Farmakokinetia in special clinical situations:

– The concentration of the main metabolite in plasma after administration of clopidogrel 75 mg / d lower in patients with severe renal disease (creatinine clearance of endogenous (CC) 5-15 ml / min) compared with patients with moderately severe renal disease (creatinine clearance from 30 endogenous 60 ml / min) and HEALTHCENTER persons;

– Maximum drug concentration in plasma (Cmax) was higher in patients with cirrhosis, after a single dose and at steady state. At the same time the safety and tolerability of the drug in such patients does not change when taking clopidogrel 75 mg / day for 10 days.

 

Indications for use:

 

Prophylaxis of ischemic disorders (myocardial infarction, stroke, peripheral arterial thrombosis, vascular sudden death) in patients with atherosclerosis, including:

– After myocardial infarction and ischemic stroke
– with peripheral artery disease;
– in acute coronary syndrome without ST segment elevation (unstable angina or myocardial infarction without tooth Q), in combination with acetylsalicylic acid;
– during the operation of percutaneous coronary angioplasty;

 

Contraindications:

 

• hypersensitivity to the drug:
• severe hepatic insufficiency;
• acute bleeding (eg, peptic ulcer or intracranial hemorrhage),
• pregnancy, lactation;
• children’s age.

Pregnancy and lactation: Contraindicated due to the lack of safety data

Carefully:

The drug should be used with caution in patients with an increased risk of bleeding (injuries, before surgery) and with moderate hepatic and / or renal insufficiency (may develop hemorrhagic diathesis).Patients should be warned that they must tell your doctor about every case of bleeding.

 

Dosage and administration:

 

Inside – 1 parabolan side effects 1 time per day, regardless of the write.

Treatment should begin within the period of a few days up to 35 days in patients after myocardial infarction and from 7 days to 6 months. – In patients after ischemic stroke.

In acute coronary syndrome without ST elevation the ST (unstable angina or myocardial infarction without tooth the Q ) treatment should be started with the appointment of a single loading dose of 4 parabolan side effectss of the drug Agregal (300 mg clopidogrel), and then continued at 1 parabolan side effects Agregal drug per day (75 mg clopidogrel) with simultaneous appointment of acetylsalicylic acid at a dose of 75-375mt / day) The maximum rate of co-use of the drug Agregal and acetylsalicylic acid – 1 year (for more prolonged use of safety has not been studied).

Selecting the scheme and the duration of treatment Agregal during percutaneous coronary angioplasty is determined by the doctor depending on the type of stent and the timing of the operation.

 

Side effects:

From the blood coagulation system : gastrointestinal bleeding (2% to 0.7% of the cases requiring hospitalization); less frequently – hematoma, hematuria and hemorrhage in the conjunctiva.

From hemopoiesis system: severe neutropenia (number of granulocytes <450 / l) was observed in 0.04%; severe thrombocytopenia (platelet counts <80,000 / ul) – 0.2%.

From the digestive system: abdominal pain, dyspepsia (constipation, diarrhea, nausea), gastritis; rarely – changes in liver samples.

On the part of the central nervous system and peripheral nervous system: headache, dizziness, paresthesia.

Dermatological reactions: skin rash, pruritus.

Allergic reactions: rarely – bronchospasm, angioedema, anaphylactic reactions.

Other: thrombocytopenic purpura (1/200 000).

Other clinically significant side effects noted in a number of major international research with a frequency> 0.1%, and any serious side effects are presented below in accordance with the WHO classification.Their frequency is defined as follows: common (> 1/100 but <1/10.); sometimes (> 1/1000, but <1/100); rare (> 1/10000. at <1/1000).

On the part of the central nervous system and peripheral nervous system: often – headache, dizziness, paresthesia; rare – vertigo.

From the digestive system: often – diarrhea, abdominal pain: sometimes – nausea, gastritis, flatulence, constipation, vomiting, gastric ulcer and duodenal ulcer.

From the blood coagulation system: sometimes – prolongation of bleeding time.

From hemopoiesis system: sometimes – leukopenia, a reduction in the number of neutrophils and eosinophils, decreased platelet count.

Dermatological reactions: sometimes, rash and pruritus.

 

Overdose:

 

No cases of overdose were observed.

A echenie: transfusion of platelets. There is no specific antidote.

 

Interaction with other drugs:

 

Warfarin : the topical application of the drug is not recommended Agregal with warfarin, as this combination can enhance the intensity of bleeding.

Inhibitors of glycoprotein IIb / IIIa :. Appointment of inhibitors of glycoprotein IIb / IIIa in conjunction with the preparation Agregal requires caution.

Acetylsalicylic acid: acetylsalicylic acid does not alter the formulation Agregal ingibiruyushego effect on ADP-induced platelet aggregation, but enhances Agregal drug acetylsalicylic acid on collagen-induced platelet aggregation. The combined use of these drugs requires caution.

Heparin: according to clinical trials conducted in healthy persons, not izenyaet clopidogrel or heparin requirements nor the action of heparin on blood clotting. The simultaneous use of heparin did not alter the inhibitory effect of clopidogrel on platelet aggregation. However, the safety of such combinations has not been established and the simultaneous use of these drugs requires caution.

Fibrinolitiki : safety of combined use of clopidogrel, recombinant tissue plasminogen activator (rt-PA) and heparin was studied in patients with a recent myocardial infarction. The incidence of clinically significant bleeding was similar to that

I observed in the case of joint use of rt-PA and heparin. Security co-application of clopidogrel with other fibrinolytics is not yet established, and the simultaneous use of these drugs requires caution.

Nonsteroidal anti-inflammatory agents : Assignment NSAIDs together with the drug Agregal requires caution (may increase the risk of bleeding).

The combined use with other medicinal products : there were no observed clinically significant pharmacodynamic interaction with clopidogrel in conjunction with atenolol, nifedipine, phenobarbital, cimetidine, estrogens, digoxin, theophylline, phenytoin, tolbutamide and antacid, however, there is evidence that clopidogrel inhibits the activity of one of cytochrome CYP2C9 enzyme and may alter the concentration of medicines metabolized by CYP2C9 (phenytoin, tolbutamide, and others).

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parabolan steroid

International nonproprietary name:

parabolan steroid

Dosage Form:

injection

Composition:

1 ml of solution contains active compound parabolan steroid – 20 mg Excipients: sodium chloride, water for injection

Description:
Clear colorless solution

Pharmacotherapeutic group:

vasodilating agent.

ATC code: [C04AD03]

Pharmacological properties
Pharmacodynamics

antispasmodic group of purines. It improves the microcirculation and blood rheology. The mechanism of action is associated with inhibition of phosphodiesterase and increase the content of cyclic AMP in platelets and ATP in erythrocytes with simultaneous saturation of energy potential, which in turn leads to vasodilatation, decreased total peripheral vascular resistance, increase in stroke and cardiac output without significant changes in heart rate ( . HR)
Expanding the coronary arteries, increases the delivery of oxygen to the myocardium (antianginal effect), pulmonary vessels – improves blood oxygenation.
increases tone of respiratory muscles (intercostal muscles and the diaphragm). When administered intravenously, it leads to increased collateral circulation, increase volume of blood flowing through a unit cross section. It leads to an increase in ATP content in the brain, a positive effect on the bioelectric activity of the central nervous system.
Reduces blood viscosity, increases the elasticity of erythrocyte membranes (due to the impact on pathologically altered deformability of red blood cells). It improves the microcirculation in the areas of impaired circulation.
In peripheral arterial occlusive disease ( “intermittent” claudication) leads to a lengthening of the distance away, elimination of night leg cramps and pain at rest.

Pharmacokinetics
The drug is rapidly metabolized in the liver. During metabolism several active metabolites are formed, which are of major metabolite metabolite 1 and 5. Their blood plasma concentrations of 5 and 8 times (respectively) above concentration of the starting material.
Displayed as metabolites (94%) and in the intestine (4% ), the first output chasa 4 to 90% of the dose. The unchanged output 2% of the drug. parabolan steroid and its metabolites do not bind to plasma proteins.
Excretion slowed metabolites In severe renal dysfunction. If abnormal liver function observed lengthening half-life and increased bioavailability.

Indications

  • the peripheral blood circulation against the background of atherosclerosis, diabetes and inflammatory processes (including in the “intermittent” claudication due to atherosclerosis, diabetic angiopathy, obliterative endarteritis);
  • trophic disorders of tissues as a result of violations of arterial or venous microcirculation (varicose ulcers, gangrene, frostbite);
  • angioneyropatii (paresthesia, akrotsianoz, Raynaud’s disease);
  • acute and chronic cerebrovascular disease of ischemic origin (including the cerebral arteriosclerosis);
  • state after hemorrhagic or ischemic stroke;
  • disorders of blood circulation in the vessels of the eyes (acute and chronic circulatory insufficiency and vascular mesh eye membranes);
  • middle ear dysfunction of vascular origin, accompanied by hearing loss.

    Contraindications

  • Hypersensitivity to parabolan steroid and substances from the group of xanthine derivatives;
  • pronounced coronary or cerebral arteriosclerosis;
  • acute myocardial infarction;
  • The expressed disturbances of heart rhythm;
  • uncontrolled arterial hypotension;
  • porphyria;
  • massive bleeding;
  • retinal hemorrhage;
  • acute hemorrhagic stroke;
  • pregnancy, lactation;
  • age of 18 years (effectiveness and safety have been established).

    With care – patients with labile blood pressure, prone to hypotension, congestive heart failure, a tendency to hemorrhage, state after recently transferred surgical intervention, liver and / or kidney failure.

    Dosing and Administration
    The drug can be administered intravenously, intraarterially, intramuscularly.
    During the infusion the patient should be in a prone position. Intravenously – 100 mg (1 ampoule) in 250-500 mL of 0.9% sodium chloride solution or 5% dextrose solution ( glucose) infusion over 1.5-3 hours.With good tolerance dose can be increased to 100 mg per day. The maximum daily dose of -300 mg. Intraarterially – 100 mg of the drug initially in 20-50 ml of 0.9% sodium chloride solution in the following days – 200-300 30-50 mg per ml of solvent. Administered at 100 mg (5 ml of a 2% solution of the drug) over 10 minutes. When atherosclerosis of cerebral vessels can not enter into the carotid artery. Patients with chronic renal insufficiency (creatinine clearance less than 10 mL / min) was administered to 50-70% of the usual dose. Intramuscular: 1-2 times a day with 100 mg (1 ampoule ).

    Side effect On the part of the central nervous system: headache, dizziness; anxiety, sleep disorders, convulsions. Cardio-vascular system: tachycardia, arrhythmia, cardialgia rarely -progressirovanie angina, lower blood pressure. For the skin: facial flushing, “tides” of blood to the skin of the face and upper chest cell swelling, increased fragility of nails. On the part of the digestive tract: nausea, vomiting, feeling of heaviness in the stomach, loss of appetite, intestinal atony, aggravation cholecystitis, cholestatic hepatitis, bleeding from the mucous membranes of the stomach membranes tren side effects, the intestines. from the senses: blurred vision, scotoma. On the part of the hemostatic system and of hematopoiesis: thrombocytopenia, leukopenia, pancytopenia, gipofibrinogenemia; bleeding from vessels in the skin. Allergic reactions: rarely – itching, skin flushing, urticaria, angioedema, anaphylactic shock. Laboratory findings: increased activity of “liver” enzymes: alanine aminotransferase (ALT), aspartate aminotransferase (the ACT), lactate dehydrogenase (LDH) and alkaline phosphatase .

    Overdose symptoms: weakness, dizziness, marked reduction in blood pressure, fainting, tachycardia, drowsiness, loss of consciousness, tonic-clonic seizures, increased nervous irritability, pyrexia, areflexia, signs of gastrointestinal bleeding (vomiting-type “coffee grounds”). Treatment : symptomatic aimed at maintaining respiratory function and blood pressure.

    Interaction with other drugs
    parabolan steroid may increase the effects of drugs that affect blood clotting (indirect and direct anticoagulants, thrombolytics) anitibiotikov (including cephalosporins – tsefamandola, cefoperazone, tsefotetan)., Valproic acid
    increases the effectiveness of antihypertensive drugs, insulin and oral hypoglycemic agents.
    Cimetidine increases the concentration of parabolan steroid in plasma (the risk of side effects).
    Co-administration with other xanthines can lead to excessive nervous excitement.

    Specific guidance
    Treatment should be under the control of blood pressure. In patients with chronic heart failure should be to achieve compensation of blood circulation.
    In patients with diabetes, taking hypoglycemic agents, the appointment of large doses can cause pronounced hypoglycemia (dose correction is required).
    When assigning simultaneously with anticoagulants should be carefully monitored for indicators of blood coagulation. In patients who have undergone recent surgery, requires systematic monitoring of hemoglobin concentration and hematocrit.
    The dose should be reduced in patients with low and unstable blood pressure. Older people may require dose reduction (decreased clearance rate).
    Smoking may reduce the therapeutic efficacy of the drug. Compatibility parabolan steroid solution with another infusion solution should be checked in each case.

    Product form
    Injectable solution 20 mg / ml (ampoules) 5 ml.
    In a 5 ml glass ampoules of hydrolytic. 5 ampoules in a cardboard box with instructions for use.

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parabolan dosage

International nonproprietary name:

parabolan dosage.

 

 

Dosage Form:

pills.

 

Composition
1 tablet contains: active substance parabolan dosage 0.5 mg Excipients: lactose, L-leucine, magnesium stearate (E572)

Description: white flat oval tablets with a facet and Valium on one side, engraved with “0.5” on one side of the risks and “CBG” – on the other.

 

Pharmacotherapeutic group:

dopamine receptor agonist

 

ATX code: G02CB03.

pharmacological properties

Pharmacodynamics
parabolan dosage – synthetic ergot alkaloid derivative ergoline dopamine agonist is a long acting inhibiting prolactin secretion. The mechanism of action of parabolan dosage includes stimulation of central dopamine receptors of the hypothalamus. At doses higher than those required for suppression of prolactin secretion, the drug is a central dopaminergic effect due to stimulation of the dopamine D2-receptor. The drug has a dose-dependent manner. Decreasing the amount of prolactin in blood is usually observed after 3 hours and maintained for 2-3 weeks, and therefore to suppress the secretion of milk is usually sufficient single dose of the drug. In the treatment of hyperprolactinemia blood prolactin normalized after 2-4 weeks of application in the effective drug dose. Normal prolactin levels may persist for several months after discontinuation of the drug.
parabolan dosage has a highly selective effect and no effect on basal secretion of other pituitary hormones and cortisol. The only pharmacodynamic effect is not related to mibolerone the therapeutic effect is the reduction of blood pressure (BP). The maximum antihypertensive effect usually develops within 6 hours after a single dose of the drug; the degree of decrease in blood pressure and the incidence of dose-dependent hypotensive effect.

Pharmacokinetics Absorption After oral administration parabolan dosage is rapidly absorbed from the gastrointestinal tract (GIT). Maximum plasma concentration is achieved within 0.5-4 hours. Food does not affect the absorption or distribution of parabolan dosage. Distribution Binding of parabolan dosage (at a concentration of 0.1-10 ng / ml) to plasma proteins is 41-42%. Metabolism In urinary metabolites detected parabolan dosage:. b-allyl-8p-carboxy-ergoline in an amount of 4-6% of the dose, and three other metabolite with a total content of less than 3% of all metabolites in a much lesser degree (compared with parabolan dosage) inhibit secretion prolactin.Excretion

parabolan dosage has a long half-life: T ½ was 63-68 hours in healthy volunteers and 79-115 hours in patients with hyperprolactinemia.

In this half-life equilibrium state is reached after 4 weeks. The urine and feces revealed respectively, 18% and 72% of the dose. Contents parabolan dosage unchanged in urine is 3.2%.
The pharmacokinetics is linear up to a dose of 7 mg / day. Pre-clinical safety data , as shown in preclinical studies, parabolan dosage secure a considerable range of doses and has no teratogenic, mutagenic or carcinogenic effects.

 

Indications

    • Suppression physiological postpartum lactation (only for medical reasons).
    • Suppression already established lactation (only for medical reasons).
    • Disturbances associated with hyperprolactinemia (including functional disorders like amenorrhea, oligomenorrhea, anovulation, galactorrhoea).
    • Prolactin pituitary adenomas (micro- and macroprolactinoma).

Idiopathic hyperprolactinemia.

 

Contraindications

  • Postpartum or uncontrolled hypertension.
  • Hypersensitivity to parabolan dosage, other ergot alkaloids or to any component of the drug.
  • Severe liver dysfunction.
  • Adverse events in the lungs, such as pleurisy or fibrosis (including history) associated with the intake of dopamine agonists.
  • Psychoses (including history) or the risk of development.
  • Pregnancy and develop its pre-eclampsia and eclampsia.
  • Breast-feeding.

Efficacy and safety of parabolan dosage in children under 16 years of age has not been studied.

 

Precautions: in patients with cardiovascular disease, hypotension, Raynaud’s syndrome, peptic ulcer or gastrointestinal bleeding, in patients with end-stage renal disease on hemodialysis, or in elderly patients.

Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation.
To exclude pregnancy before you start taking the drug. It is recommended to avoid pregnancy for at least 1 month after cessation of treatment. . Limited data are available for receiving the drug during pregnancy, obtained during the first 8 weeks after conception. The use of parabolan dosage has not been accompanied by an increased risk of abortion, premature delivery, multiple pregnancy or congenital abnormalities. Other data has not yet been received.
In animal studies, direct or indirect adverse effects of parabolan dosage on pregnancy, embryo / fetal, parturition or postnatal development were found.
Given the limited experience with the use of parabolan dosage in pregnancy, when it is planning drug should be discontinued. In case of pregnancy during treatment with parabolan dosage immediately overturned. In connection with the expansion of pre-existing tumors should be monitored signs of increased pituitary gland in pregnant women.
Because parabolan dosage inhibits lactation, the drug should not be administered to mothers who choose to breast-feeding infants. During treatment with parabolan dosage should stop breastfeeding.

Dosage and administration
parabolan dosage is taken orally, preferably during meals. Adults Treatment of disorders associated with hyperprolactinemia recommended initial dose – 0.5 mg per week in one or two divided doses (eg on Monday and Thursday). The dosage is gradually increased, usually 0.5 mg / week at intervals of 1 month to achieve optimum therapeutic effect. Maintenance dose – 1 mg / week (0.25 – 2 mg / week); . in some cases, patients with hyperprolactinemia to 4,5 mg / week when using the drug in doses greater than 1 mg / week, it is recommended to divide the weekly dose by 2 or more receptions depending on tolerability. For the suppression of lactation: the recommended dose – 1 mg once daily within the first 24 hours after birth. use in patients with impaired hepatic or renal function The information presented in the “contraindications” and “special instructions”. use in the elderly Given the indications for use, experience with parabolan dosage in elderly patients is limited. Available data show no specific risks.

Side effects
Unwanted effects are usually dose-dependent and decreases with its gradual decline. Suppression of lactation: adverse events develop in approximately 14% of patients. The most common: reduction in blood pressure (12%), dizziness (6%) and headache (5%). Long-term treatment increases the frequency of these effects up to 70%. Frequent (more than 1/100, less than 1/10) of the nervous system: . Depression, headache and dizziness, paresthesia, fatigue, somnolence From the cardiovascular system (CVS ): low blood pressure, palpitations and chest pain. On the part of the digestive tract: nausea, vomiting, gastralgia, gastritis, constipation. Skin and subcutaneous tissue:. Hyperemia skin Uncommon (more than 1/1000, less than 1/100) From the side view: hemianopsia. From the CCC: . Epistaxis Rare (more than 1/10000, less than 1/1000) : Allergic reaction : skin rash. From the CCC: fainting. From the musculoskeletal system: cramps in the fingers and calves. on the part of the digestive tract: abnormal liver function. blood pressure reduction (systolic over 20 mm Hg and diastolic by more than.. 10 mm Hg. Art.) noted 3-4 days after a single dose of parabolan dosage at a dose of 1 mg in women after childbirth.Adverse events usually occur within the first two weeks, then decrease or disappear. Cancel the drug due to side effects was required in 3% of cases. Post-marketing surveillance parabolan dosage treatment was accompanied by excessive daytime sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’s disease. There are reports of increasing libido in patients with Parkinson’s disease with dopamine agonists in the treatment including parabolan dosage, especially at high doses. Also observed in the treatment of parabolan dosage pleural effusions, pleural fibrosis, valvulopatiya, respiratory disorders (including respiratory failure).

Overdose

Data on overdose are not present. Based on the results of animal experiments, we can expect the appearance of symptoms caused by hyperstimulation of dopamine receptors: nausea, vomiting, decreased blood pressure, impaired consciousness / psychosis or hallucinations. If shown, it should take steps to restore blood pressure. Furthermore, in severe CNS symptoms (hallucinations) may require the use of dopamine antagonists.

Interaction with other drugs
Effect of macrolide antibiotics on parabolan dosage plasma levels when used together has not been studied. Given the possibility of increasing the level of parabolan dosage, the drug is not recommended for use in combination with macrolides.
The mechanism of action of parabolan dosage is associated with the direct stimulation of dopamine receptors, so it should not be used in combination with antagonists of dopamine receptors (phenothiazines, butyrophenones, thioxanthenes, metoclopramide).
No information is available about the interaction parabolan dosage with other ergot alkaloids, however, not recommended for long-term use of such a combination.
Given the pharmacodynamics of parabolan dosage (hypotensive effect), it is necessary to take into account the interaction with drugs that reduce blood pressure.
In clinical studies in patients with Parkinson’s disease pharmacokinetic interaction with levodopa, or selegiline were found. Pharmacokinetic interactions with other drugs on the basis of the available information about the metabolism of parabolan dosage is impossible to predict.

Cautions
To open the bottle, first click on the cover, and then turn it as shown on the cover. The capsule with the bottle of silica is not removed and not eat inside.
The data on the efficacy and safety of parabolan dosage in patients with impaired hepatic or renal function is limited. The pharmacokinetics of parabolan dosage has not changed significantly in moderate or severe renal insufficiency. It has not been studied in patients with end-stage renal failure or dialysis. Therefore, in these patients the drug should be used with caution. The effects of alcohol on overall tolerability of parabolan dosage has not been established.
parabolan dosage can cause symptomatic hypotension, especially when co-administered with drugs that reduce blood pressure. It is recommended to regularly measure blood pressure in the first 3-4 days after initiation of treatment.
Hyperprolactinemia in conjunction with amenorrhea and infertility may be associated with pituitary tumors, so before treatment with parabolan dosage is necessary to find out the cause of hyperprolactinemia.
We recommend checking the content of prolactin in the blood serum of each month, as after achieving an effective therapeutic regimen normal prolactin level is maintained for 2-4 weeks.
after the cancellation of hyperprolactinemia drug usually occurs again. However, some patients experience a persistent decline in prolactin concentrations in a few months.
parabolan dosage restores ovulation and fertility in women with hyperprolactinemic hypogonadism. Because pregnancy can occur before the resumption of menstruation, pregnancy tests are recommended during the period of amenorrhea, and after the restoration of the menstrual cycle – in all cases of delays of more than 3 days. Women who do not want to get pregnant, it is recommended to use effective non-hormonal contraception during treatment with parabolan dosage and after its completion. Women planning a pregnancy, it is recommended to conceive not earlier than 1 month after discontinuation of the drug. A number of patients ovulatory cycle was maintained for 6 months after discontinuation of the drug.
With prolonged use of parabolan dosage, as well as other ergot derivatives, pleural effusions may appear / pulmonary fibrosis and valvular heart disease. Sometimes these events occurred in patients previously treated with dopamine agonists of the ergot group. Cancel parabolan dosage in the case of the development of this pathology leads to an improvement of signs and symptoms.
In case of new clinical symptoms of the respiratory system is recommended X-ray light. Patients with pleural effusion / fibrosis was an increase in erythrocyte sedimentation rate (ESR), in this regard, at an elevated ESR, without overt clinical signs should also conduct X-ray examination. When using parabolan dosage and drowsiness may occur sudden episodes of sleep, especially in patients with Parkinson’s disease. Sudden falling asleep during daily activities, in some cases develops without warning, is rare.
The drug contains lactose. Patients with rare hereditary form of galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not take parabolan dosage.
Effects on ability to drive a car, and management mechanisms parabolan dosage reduces blood pressure, which may interfere with the reaction rate in some patients. This must be taken into account in situations requiring concentration, such as driving a car or operating machinery. Patients should be informed of the need to observe caution when driving or operating machinery.
Patients have been observed drowsiness and / or episodes of sudden sleep with parabolan dosage treatment, have to give up the car or other driving-related risk of the activity, when disturbances of the reaction rate can be for them and others at risk of serious injury or death. Sometimes it is advisable to decrease the dosage or withdrawal of the drug.

Product form tablets 0.5 mg. At 2 and 8 tablets in dark glass vials (type III) with a neck sealed by a membrane of aluminum foil and film (polyester / polyethylene), HDPE with a lid equipped with a system of opening against children vial contains cylindrically shaped capsule with silica gel and seal of cotton. 1 bottle with instruction for use in a cardboard box.

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parabolan cycle

PURPOSE
Specific prophylaxis of viral hepatitis A in children aged 12 months to 15 years inclusive.

CONTRA
-Allergiya to the active component parabolan cycle, one of the excipients included in the vaccine, neomycin, polysorbate; severe allergic reaction to previous administration Avaksima 80.
-Zabolevanie accompanied by fever, acute infectious or chronic disease in the acute stage. Vaccination is carried out 2-4 weeks after recovery, or in the period of convalescence, or remission. In non-severe acute respiratory viral infection, acute intestinal diseases and others. Vaccinations carried out immediately after the normalization of temperature.

USE DURING PREGNANCY AND BREASTFEEDING
Due to the lack of adequate data on the use of the vaccine in pregnant women, its use during pregnancy is not recommended.
The decision is only based on the evaluation of real risk should be taken of the vaccination of pregnant women infected with hepatitis A.
The vaccine can be used in lactation.

DOSAGE AND ADMINISTRATION
The vaccine is injected intramuscularly in the deltoid muscle in the shoulder of a single dose of 0.5 ml twice with an interval of 6-18 months. In violation of the vaccination scheme the second administration must be carried out in the shortest possible time.
Children under 2 years of age the vaccine is administered into the upper outer thigh area.
Prior to injection, the syringe should be shaken until a homogeneous suspension. Prior to administration, make sure that the needle does not hit a blood vessel.
Patients with thrombocytopenia and other diseases of the blood coagulation system of the vaccine should be administered subcutaneously.

Do not use the vaccine in the event of a change in its color or the presence of foreign particles.

ADVERSE REACTIONS
In clinical studies noted:
Frequently (1-10%):
reactions in the injection site: pain, redness, swelling or induration
-General reactions such as headache, from the parabolan cycle gastrointestinal tract disorders (abdominal pain, diarrhea, nausea , vomiting), pain in the muscles or joints, transient behavior disorders (loss of appetite, insomnia, irritability), fever, and weakness.
in rare cases (0.1-1%) were observed cutaneous manifestations (rash, urticaria).
All adverse reactions were mild, occurred in the first few days after vaccination and were on their own.
The patient should be informed of the need to inform your doctor of the occurrence of severe reactions or any other adverse effects not mentioned in this manual.

Cautions
Immunosuppressive therapy, or immune deficiency may be the cause of a weak immune response to the vaccine.
The vaccine should never be administered in the intravascular direction or intradermally.

INTERACTION WITH OTHER DRUGS
AWACS 80 may be administered simultaneously (in one day), in different parts of the body, with the national calendar of preventive vaccinations vaccines containing one or more of the following components: diphtheria toxoid, tetanus; pertussis vaccines (acellular or whole cell), Haemophilus influenzae type b, polio (live or inactivated).
The doctor should be informed about the recently held either coincides with the introduction of vaccination the child of any other drug, including – OTC.

PACKAGING
One dose (0.5 ml) in 1 ml capacity syringe of glass type 1, hlorobrombutila of piston parabolan cycle, with a fixed stainless steel needle and a needle protection cap, placed in a transparent closed cell package.
In one syringe in a closed cellular packaging in the paper cartons, together with instructions for use.

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parabolan

Pharmacodynamics
Parabolan (paclitaxel) is an anticancer drug of natural origin, derived semisynthetic route from the plant Taxus Baccata.
The mechanism of action is associated with the ability to stimulate the “assembly” of microtubules of the dimeric molecules of tubulin and stabilize their structure and inhibit the dynamic reorganization in interphase, which violates the mitotic cell function.
It is dose-dependent suppression of bone marrow hematopoiesis. According to experimental data, mutagenic and embryotoxic properties, causes a decrease in reproductive function.

Pharmacokinetics
For intravenous (i / v) administration for 3 hours in a dose of 135 mg / m² maximum concentration (Cmax) was 2170 ng / ml, area under “concentration-time” curve (AUC) – 7952 ng / h / ml; when administered in the same dose for 24 hours – 195 ng / mL and 6300 ng / h / ml, respectively. Cmax AUC and dose-dependent: 3 hour infusion at increasing doses up to 175 mg / m results in an increase of these parameters by 68% and 89%, respectively, with 24 hour – 87% and 26%, respectively.
Communication with plasma proteins – 88- 98%. The average volume of distribution – 198-688 l / m². Poluraspredeleniya time of blood in the tissue – 30 min. Easily penetrates and is adsorbed tissue accumulates primarily in the liver, spleen, pancreas, stomach, intestine, heart, the muscles.
It is metabolized in the liver by hydroxylation with cytochrome P450 isoenzymes CYP2D8 (to form a metabolite – 6-alpha gidroksipaklitaksel) and CYP3CA4 (with 3-metabolites form the vapor-gidroksipaklitaksel and 6-alpha, 3-p-digidroksipaklitaksel). Write mainly in the bile – 90%. Repeated infusions are not accumulates.
The half-life and the total clearance is variable and depends on the dose and duration of the on / in: 13.1-52.7 and 12.2-23.8 h l / h / m², respectively. After the on / in infusion (1-24 hours) the total excretion by the kidneys is 1.3-12.6% of the dose (15-275 mg / m²), which indicates the presence of intensive extrarenal clearance.

Indications

• ovarian cancer (first-line treatment of patients with the common form of the disease or a residual tumor (more than 1 cm) after surgery (in combination with cisplatin) and second-line therapy for metastases after standard therapy has not yielded a positive result).
• Breast cancer ( the presence of the affected lymph nodes after standard combination therapy (adjuvant treatment) after relapse within 6 months after initiation of adjuvant therapy – first-line therapy, metastatic breast cancer after failure of standard therapy – second line therapy).
• Non-small cell lung cancer (therapy first-line patients who had not planned surgery and / or radiation therapy (in combination with cisplatin).
• Kaposi’s sarcoma in AIDS patients (second line therapy).

Contraindications

• Hypersensitivity to paclitaxel or other components of the formulation (including polyoxyethylated castor oil)
• Original content neutrophils less than 1500 / ml in patients with solid tumors.
• Original (or registered in the course of treatment) neutrophils less than 1000 / microliter patients Kaposi’s sarcoma in AIDS patients.
• Pregnancy and lactation.

Precautions : inhibition of bone marrow hematopoiesis (including after chemotherapy or radiation therapy), hepatic failure, acute infectious diseases (including herpes zoster, chickenpox, herpes), severe coronary heart disease, myocardial infarction (in history ), arrhythmias.
The safety and efficacy Parabolan drug in children has not been established.

Dosing and Administration

In order to prevent severe hypersensitivity reactions, all patients must be carried out with the use of premedication glkzhokortikosteroidov, antihistamines and H2 histamine receptor antagonists. For example, 20 mg dexamethasone (or its equivalent) into approximately 12 and 6 hours prior to drug administration Parabolan 50 mg diphenhydramine (or its equivalent) intravenously and cimetidine 300 mg or ranitidine 50 mg intravenously 30-60 minutes prior to drug administration Parabolan.
When you select and dose in each individual case should be guided by the data of literature.
Parabolan administered intravenously as a 3-hour or 24-hour infusion at a dose of 175 mg / m or 135 mg / m with an interval between doses for 3 weeks. The drug is used alone or in combination with cisplatin (ovarian cancer and non-small cell lung cancer), and doxorubicin (breast cancer).
The recommended dose Parabolan preparation for the treatment of Kaposi’s sarcoma in AIDS patients is 100 mg / m 2 as a 3-hour infusion every 2 weeks.
Introduction Parabolan drug need not be repeated for as long as neutrophil not be at least 1500 / ml blood, and platelet count of at least 100,000 / microliter blood. Patients who have after the introduction Parabolana observed severe neutropenia (neutrophil count <500 / ml of blood for 7 days or longer period of time) or severe peripheral neuropathy during subsequent treatments, Parabolana dose should be reduced by 20%.
The solution for infusion prepared immediately prior to administration by diluting a concentrate of 0.9% sodium chloride or 5% dextrose, or 5% dextrose in 0.9% sodium chloride solution for injection or 5% dextrose in Ringer’s solution to a final concentration of 0 3 to 1.2 mg / ml. Opalescent solutions may be prepared for the composition present in the dosage form of the carrier bases, and after filtration the solution opalescence persists.

In the preparation, storage and administration of drug Parabolan equipment should be used which does not contain parts of PVC.
Parabolan be administered through the system with a built-membrane filter (pore size less than 0.22 micron).

Side effect

The frequency and severity of side effects are dose-dependent. From the side of hematopoiesis: neutropenia, thrombocytopenia, anemia. Myelosuppression, primarily granulocytic germ was the major toxic effects, the dose limiting. The maximum decrease in neutrophil levels is usually observed on the day of 8-11, the normalization occurs on day 22. On the part of the immune system: in the first hours after administration Parabolana may experience hypersensitivity reactions manifested by bronchospasm, decreased blood pressure, pain in the chest, flushing to-face, skin rash, generalized urticaria, angioedema.Described isolated cases of fever and back pain. Cardio-vascular system: decrease in blood pressure (BP), rarely – increased blood pressure, bradycardia, may be tachycardia, dysrhythmia, atrioventricular block, ventricular bigemini, ECG changes, thrombosis of the veins. The respiratory system: interstitial pneumonia, lung fibrosis, pulmonary embolism, as well as more frequent development of radiation pneumonitis in patients while undergoing radiation therapy. from the nervous system: mainly paresthesia. Rarely – seizures type grand mal, visual disturbances, ataxia, encephalopathy, autonomic neuropathy, manifested paralytic ileus and orthostatic hypotension. From the Musculoskeletal System: arthralgia, myalgia. From the digestive system: nausea, vomiting, diarrhea, mucositis, anorexia, constipation. There are few reports of acute intestinal obstruction, intestinal perforation, mesenteric artery thrombosis, ischemic colitis. Liver function: increased activity of “liver” transaminases (often ACT), alkaline phosphatase, and bilirubin in blood serum. Cases of gepatonekroz and hepatic encephalopathy. Skin and skin appendages: alopecia, rarely violation of pigmentation or discoloration of the nail bed.Very rarely – exudative erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, onycholysis. From the senses: blurred vision, conjunctivitis, increased lacrimation. Local reactions: thrombophlebitis, pain, swelling, erythema, induration and pigmentation of the skin at the injection site; extravasation can cause inflammation and necrosis of the subcutaneous tissue. Other: asthenia and malaise, reduced tolerance to infections (any cause).

Overdose

Symptoms: bone marrow aplasia, peripheral neuropathy, mucositis.
Treatment: symptomatic. Antidote paclitaxel is not known.

Interaction with other medicinal products and other forms of interaction

Cisplatin reduces total clearance of paclitaxel by 20% (the more severe myelosuppression observed when paclitaxel is administered after cisplatin).
Co-administration with cimetidine, ranitidine, dexamethasone or diphenhydramine does not affect the relationship of paclitaxel to plasma proteins.
The inhibitors of microsomal oxidation ( including ketoconazole, cimetidine, verapamil, diazepam, quinidine, cyclosporin, etc.) inhibit the metabolism of paclitaxel.
The polyoxyethylated castor oil, which is part of paclitaxel can cause extraction DEGP [di- (2-hexyl) phthalate] from plasticized polyvinylchloride ( PVC) containers, where the degree of leaching DEGP increases with increasing solution concentration and with time.

special instructions

Application Parabolana should be administered under the supervision of a physician who has experience with anticancer chemotherapeutic agents.
In case of severe hypersensitivity reactions, infusion Parabolan drug should be discontinued immediately and start a symptomatic treatment, and inject the drug again should not be.
During the treatment should be regularly monitored picture peripheral blood, blood pressure, heart rate and the number of breaths (particularly during the first hour of infusion), ECG monitoring (and prior to treatment).
In cases of violations of atrioventricular conduction, after repeated administration necessary to carry out continuous cardiac monitoring.
Patients during treatment Parabolanom and at least 3 months after completion of therapy should use reliable methods of contraception.
in the period of treatment must be careful when driving lesson potentially dangerous activities which require high concentration and psychomotor speed reactions.
Parabolan is a cytotoxic agent, at work with which you must be careful to use gloves and avoid contact with the skin or mucous membranes, which in these cases should be thoroughly washed with soap and water or (eye) with plenty of water.

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