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The drug is intended for adults only. Administered as an intravenous infusion lasting at least 30 minutes and no more than 90 minutes.
When choosing the dose and buy parabolan mode of administration in each individual case should be referred to the literature.
In a dose of combination chemotherapy is Kamptotekana:with 5-fluorouracil and folinic acid administered weekly at – 80 mg / m 2 ,when administered by continuous infusion of 1 every 2 weeks – 180 mg / m 2 ;in combination with the introduction of the jet 5 – fluorouracil and calcium folinate – 125 mg / m 2 weekly.

Dose and mode of administration of 5-fluorouracil and calcium folinate described in detail in the literature.
Introduction Kamptotekana should not be performed as long as the number of neutrophils in the peripheral blood exceeds 1500 cells / ml, and yet are fully cropped complications such as nausea, vomiting and especially diarrhea. The introduction of the drug to the resolution of all side effects can be delayed for 1-2 weeks.
With the development during treatment pronounced inhibition of bone marrow hematopoiesis (neutrophil count less than 500 / ml, and / or white blood cell count less than 1000 / mm, and / or platelet count of less than 100,000 / ul), febrile neutropenia (neutrophil count 1000 / ml of blood or less in combination with fever over 38 ° C), infectious complications, severe diarrhea, or other hematological toxicity grade 3-4 Kamptotekana subsequent doses, and if necessary 5 -ftoruratsila should be reduced by 15-20%. Patients with impaired liver function. When the bilirubin level in blood serum higher than the upper normal limit of no more than 1.5 times, due to the increased risk of severe neutropenia should be carefully monitored blood parameters of the patient . When the bilirubin level more than 1.5 times – Kamptotekanom treatment should be discontinued. Patients with impaired renal function. Is not recommended for treatment Kamptotekanom as data on the use of irinotecan in this category there are no patients. Patients with advanced age. There are no special instructions Usage irinotecan absent in older people. Dose in each case should be selected with care.

Instructions for preparation of infusion solution
required amount of drug diluted in 250 ml of 0.5% dextrose or 0.9% sodium chloride solution and stir the resulting solution by rotating the vial. Before the introduction of the solution should be visually inspected for clarity. In the case of sludge, the drug must be discarded.
The solution should be used immediately after dilution.
If dilution performed under aseptic conditions (for example, to install the laminar air flow) Kamptotekana solution can be used in the case of storage at room temperature, within 12 hours (including infusion time) and, in the case of storage at 2-8 ° C for 24 hours after opening the vial with the concentrate.

Side effect

From the side of hematopoiesis: neutropenia is observed on average 80% of patients, including half of them there is a decrease of neutrophils less than 1,000 cells in 1 mm. Recovery of neutrophils usually occurs 7-20 days after the start of treatment. Anemia varying severity occurs on average 60% ??of patients, and thrombocytopenia – 7% of patients. We describe a case of thrombocytopenia with the formation of anti-platelet antibodies. On the part of the digestive system: Late diarrhea occurring more than 24 hours (on average 5 days) after administration of the drug is a dose-limiting toxicities observed in approximately 87% of patients with severe – at 38%. Nausea and vomiting is usually occurs on the first day of administration or after 24 hours in 85% of patients. It reported the development of dewatering on the background of vomiting and diarrhea, rarely with the development of renal insufficiency, hypotension and cardiac insufficiency. There may be abdominal pain, anorexia, mucositis, constipation. Acute cholinergic syndrome observed in 9% of patients during the first 24 hours after administration of the drug and is manifested by diarrhea, abdominal pain, sweating, cramps, disorder of vision, lacrimation, salivation, decrease in blood pressure , dizziness, fever and general malaise. On buy parabolan the part of the central nervous system: involuntary muscle twitching or convulsions, paraesthesia, asthenia. Allergic reactions: seldom – skin rash, very rarely – anaphylactic shock. Other: dyspnea, alopecia, fever, local reaction.

Overdose

The main expected manifestations of overdose – neutropenia and diarrhea.
The specific antidote for irinotecan unknown. Treatment is symptomatic. In the case of an overdose the patient should be hospitalized and carefully monitor the function of vital organs.

Interaction with other drugs

Since irinotecan has anticholinesterase activity may increase the duration of neuromuscular blockade when combined with suxamethonium and antagonize the interaction against neuromuscular blockade when combined with non-depolarizing muscle relaxants.
Kamptotekan should not be mixed with other medications in the same bottle.

Precautionary measures

Should be carried out in specialized chemotherapy wards under the supervision of a physician who has experience with anticancer drugs.
Patients receiving , you must make weekly detailed clinical analysis of blood and monitor liver function.
Diarrhea that arises as a consequence of the cytotoxic action of the drug, usually marked not earlier than 24 hours after administration Kamptotekana (the majority of patients after an average of 5 days).When the first episode of loose stools assignment must abundant drink containing electrolytes and the immediate holding antidiarrheal therapy comprising loperamide receiving high doses (4 mg and the first reception then 2 mg every 2 hours). This therapy is continued for at least 12 hours after the last episode of loose stools, no more than 48 hours because of the possibility of intestinal paresis. If diarrhea is regarded as severe (more than 6 episodes of loose stools within a day or severe tenesmus), and if it is accompanied by vomiting or fever, the patient should be urgently hospitalized in the intensive care unit for the comprehensive treatment, including the introduction of broad-spectrum antibiotics. In moderate or mild diarrhea (less than 6 episodes of loose stools during the day and moderate tenesmus), which is not stopped during the first 48 hours you need to start taking broad-spectrum antibiotics inside. With the simultaneous occurrence of diarrhea and neutropenia (white blood cell count less than 500 / ml) in addition to the antidiarrheal therapy prophylactically inside appointed broad-spectrum antibiotics.
Loperamide should not be given prophylactically, including patients who have diarrhea was observed during previous administrations  .
The patient should be forewarned about the possibility of his delayed diarrhea. Patients should inform their doctor immediately about the occurrence of diarrhea and start appropriate therapy immediately.
With inadequate treatment of diarrhea may develop a condition that threatens the life of the patient, especially if diarrhea developed against the backdrop of neutropenia.
Patients with febrile neutropenia (body temperature ≥38 ° C and neutrophil count ≤1000 / l) should be launched without delay introduction of broad-spectrum antibiotics in the hospital.
Acute cholinergic syndrome usually occurs during administration of the drug or in the first 24 hours after administration to quickly and effectively stopped by subcutaneous administration of 0.25 mg of atropine (caution in patients bronchial asthma).
The dosage form of the preparation as an adjuvant contains sorbitol, and therefore buy parabolan can not be used in patients with hereditary fructose intolerance.
during treatment  and at least three months after discontinuation of therapy should be applied reliable contraceptive measures.
If you get a solution Campto or infusion solution to the skin or mucous membranes of the skin, immediately wash with soap and water, mucous membranes just water.
Patients should be warned of the possibility of occurrence during treatment Kamptotekanom dizziness and visual disturbances that develop within 24 hours after administration. If you have these symptoms, patients are advised to refrain from driving and other activities potentially hazardous activities that require high concentration and psychomotor speed reactions.

release Form

Concentrate for solution for infusion 100 mg / 5 ml in dark glass bottles, sealed with bromobutyl stopper and crimped aluminum cap with a plastic insert. 1 bottle with the attached instructions for use in a carton box.

Storage conditions

List B. The temperature is between 15 ° C to + 30 ° C, protected from light and out of reach of children.

Shelf life

2 years

Conditions of supply of pharmacies

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