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GENERIC TAMIFLU 75 MG
Purchase Generic Tamiflu 75 mg Here
Tamiflu 75 mg
International nonproprietary name: oseltamivir (Oseltamivir)
Registration numbers
Kaps. - P № 012090/01, 15.07.2005
Por. d / сусп. for oral administration - № LS-000550, 29/07/2005
Composition
Tamiflu capsules
One capsule contains 75 mg of oseltamivir;
Other ingredients: pregelatinized starch, povidone K30, croscarmellose sodium, talc, sodium stearate fumarate.
Tamiflu Powder for suspension for oral administration
1 ml suspension contains 12 mg of oseltamivir;
Other ingredients: sorbitol, titanium dioxide, sodium benzoate, xanthan
resin, monosodium citrate, sodium saccharin, permasil 11900-31 Tutti Frutti.
Description
Tamiflu capsule. Hard gelatin capsules, size 2. Housing - gray, opaque; lid - light yellow, opaque. The contents of capsules - powder from white to yellowish color. The main body of the capsule inflicted «Roche», on the lid - "75 mg».
Tamiflu Powder for suspension for oral administration. Granular, from white to light yellow color with a fruity odor; allowed balling. After the restoration of an opaque suspension was formed from white to light yellow (the vial is added about 52 ml of water and vigorously shaken for 15 seconds).
Pharmacotherapeutic group
Antiviral
ATC code [J05AH02]
Pharmacological action
Mechanism of
Tamiflu - the antiviral drug. Oseltamivir phosphate is a pro-drug, its active metabolite (oseltamivir carboxylate), competitive and selective inhibition of neuraminidase of influenza viruses type A and B - an enzyme that catalyzes the process of releasing newly formed virus particles from infected cells and their penetration into the epithelial cells of the respiratory tract and the virus continues to spread in the body.
Oseltamivir carboxylate acts outside the cells. Inhibits the growth of influenza virus in vitro and inhibits the replication of the virus and its pathogenicity in vivo, reduces the allocation of influenza viruses A and B of the body. His concentration required to suppress the activity of the enzyme by 50% (IC50), are at the lower boundary nanomolyarnogo range.
Efficiency
Shown that Tamiflu is effective in preventing and treating influenza in adolescents (over 12 years), adults, elderly and senile, as well as treatment for influenza in children older than 1 year. At the beginning of treatment, no later than 40 hours after the first symptoms of influenza, Tamiflu significantly reduces the period of clinical manifestations of influenza infection, reduce the severity and reduces the incidence of complications of influenza, requiring the use of antibiotics (bronchitis, pneumonia, sinusitis, otitis media), shortens the time of viral shedding from the body and reduces the area under the curve "viral titers-time."
When you receive for prevention, Tamiflu significantly (92%) and significantly reduces the incidence of influenza among Exposed persons reduces the incidence of viral shedding and prevent transmission of the virus from one family member to another.
Tamiflu does not affect the formation of influenza antibodies, including antibody production in response to the introduction of inactivated influenza vaccine.
During the circulation of influenza virus among the population, was conducted one double-blind, placebo-controlled trial among children aged 1-12 years (mean age 5.3) who have fever, accompanied by a respiratory symptom (cough or coryza). In this study, 67% of patients were infected with A and 33% of patients were infected with B. Treatment of Tamiflu, which started within 48 hours after onset of symptoms, significantly reduced the duration of the disease at 35.8 hours compared with placebo. Duration of disease was defined as the time needed to reduce cough, runny nose, fever, and permission to return to normal and to normal activity. The proportion of patients, children who developed acute otitis media and who took Tamiflu, decreased by 40% compared with placebo. Children who received Tamiflu, returned to normal and to normal activity almost 2 days earlier than children who received placebo.
Resistant virus
According to today's data, while taking
Tamiflu 75 mg to post-exposure (7 days) and seasonal (42 days) prevention of influenza resistance to the drug is not indicated.
The frequency of transient selection of influenza virus neuraminidase with reduced sensitivity to oseltamivir carboxylate in adult patients with influenza was 0.4% resistant Eliminating the virus from the body of patients receiving Tamiflu, there is no deterioration in clinical status of patients. The frequency of resistance in clinical isolates of influenza virus type A does not exceed 1,5%. Among clinical isolates of influenza virus in drug resistance strains were found.
Pharmacokinetics
Suction
After oral administration of oseltamivir phosphate is readily absorbed in the gastrointestinal tract and is highly converted to the active metabolite under the action of liver esterases. Concentrations of the active metabolite in plasma
determined within 30 minutes, reaching nearly the maximum level after 2-3 hours after administration and significantly (more than 20 times) higher than the concentration of pro-drugs. Not less than 75% of an oral dose reaches the systemic circulation in the form of the active metabolite, less than 5% - as a source of the drug. Plasma concentrations of pro-drug and active metabolite are proportional to dose and do not depend on the meal.
Distribution
In humans, the average volume of distribution (Vss) of the active metabolite is about 23 liters.
In the experiments after oral administration of oseltamivir phosphate, its active metabolite was detected in the lungs, flushing waters of the bronchi, the mucous membrane of the nasal cavity, middle ear and trachea in concentrations that provide antiviral effect.
The binding of the active metabolite in human plasma proteins only slightly (about 3%). Binding pro-drugs with human plasma proteins is 42%, which is not enough to cause significant drug interactions.
Metabolism
Oseltamivir phosphate to a large extent converted into an active metabolite under the action of esterases, located predominantly in the liver and intestine. Neither oseltamivir phosphate, or an active metabolite are not substrates or inhibitors of cytochrome P450 isozymes.
Withdrawal
Grown deep oseltamivir appears mainly (> 90%), by becoming an active metabolite. The active metabolite is not subject to further transformation and is excreted in the urine (> 99%). In most patients, elimination half-life of the active metabolite from plasma is 6-10 hours.
The active metabolite is derived entirely (> 99%) by renal excretion. Renal clearance (18.8 l / h) exceeds glomerular filtration rate (7.5 l / h), which indicates that the drug appears more and by tubular secretion. Since feces derived less than 20% taken orally radioactively labeled drug.
Pharmacokinetics in special groups
Patients with renal
In the appointment of Tamiflu to 100 mg 2 times a day for 5 days to patients with varying degrees of kidney damage area under the curve "concentration of the active metabolite in plasma - time» (AUC) are inversely proportional decrease in kidney function.
Patients with liver
Experiments in vitro have shown that patients with liver pathology magnitude AUC of oseltamivir phosphate is not significantly increased, and the AUC of active metabolite is not reduced.
Patients Senile
In patients with old age (65 - 78 years) AUC of active metabolite at steady state was 25-35% higher than in younger patients in the appointment of similar doses of Tamiflu. The half-life drugs in the elderly did not differ from that of younger patients adulthood. Given the data on the AUC and drug tolerability, patients with senile patients dose adjustment in the treatment and prevention of influenza is not required.
Children
Pharmacokinetics of Tamiflu was studied in children from 1 year and up to 16 years in the pharmacokinetic study with a single dose in a clinical study of a small number of children aged 3-12 years. Young children breeding pro-drug and active metabolite was going faster than adults, resulting in a lower AUC in relation to a particular dose.
Receiving the drug in a dose of 2 mg / kg provides the same AUC of oseltamivir carboxylate, which is achieved in adults after a single dose capsules with 75 mg (equivalent to approximately 1 mg / kg). Pharmacokinetics of oseltamivir in children older than 12
years is the same as in adults.
Indications
- Treatment of influenza caused by viruses types A and B in adults and children older than 1 year.
Typical flu symptoms appear suddenly and include fever, cough, headache, marked weakness, muscle aches and pains in the throat.
- Prevention of influenza in adults and adolescents over the age of 12 years who are at increased risk of the virus (in the military units and large industrial groups, in debilitated patients).
Contraindications
- Increased sensitivity to oseltamivir phosphate or any component of the drug.
- Chronic renal failure (permanent hemodialysis, chronic peritoneal dialysis, creatinine clearance <10 mL / min).
Dosing and Administration
Tamiflu is taken orally, during a meal or with or without food. Admission Tamiflu during a meal or with a small amount of milk reduces the possibility of gastric discomfort.
Treatment should begin in the first or second day of onset of symptoms of influenza.
Adults and children over 12 years: 75 mg 2 times a day inside for 5 days. Increasing the dose of 150 mg / day does not lead to greater effect.
Children over 40 kg or older than 8 years of age who can swallow capsules, can also be treated by taking one capsule 75 mg 2 times a day, as an alternative to the recommended dose of Tamiflu suspension (see below).
Children older than 1 year is recommended suspension for oral administration in 5 days:
children weighing less than 15 kg each appoint 30 mg 2 times a day;
children weighing 15-23 kg - 45 mg 2 times a day;
children weighing 23-40 kg - 60 mg 2 times a day;
children over 40 kg - 75 mg 2 times a day.
Prevention
The recommended dose of Tamiflu for preventing influenza after contact with an infected person - 75 mg 1 time a day into a period of not less than 7 days. The compound is necessary to begin no later than the first 2 days after exposure.
The recommended dose for prophylaxis during flu season, 75 mg 1 time a day, shows the effectiveness and safety of the drug while taking it for 6 weeks. Preventive effect lasts as long as it lasts for receiving the drug.
Preparation of suspension:
1. Gently tap your finger a few times on the closed bottle so that the powder was assigned to the bottom of the vial.
2. Measure 52 ml of water using a measuring cup (if applicable), filling it to the specified level.
3. Add the 52 ml of water in a bottle, close the cap well and shake for 15 seconds.
4. Remove the cap and insert the neck of the bottle adapter.
5. Tightly screw the bottle cap to ensure correct positioning adapter.
It is recommended on the bottle to write the date of the expiration date of preparation of the suspension. Before using a bottle with preparation of the suspension must be shaken. For the suspension dosage dosing syringe enclosed with labels indicating the levels of doses of 30 mg, 45 mg and 60 mg.
For dosing of the suspension to use the attached syringe (calibrated in mg), the required number of suspension is taken from the vial dosing syringe, transferred into the measuring cup and taken inside.
Cautions
In addition to Tamiflu, perhaps symptomatic of the appointment in order to facilitate certain forms of influenza, such as antipyretics.
Even if you already feel much better, treatment should be brought to a conclusion, that is to take all 10 capsules of Tamiflu within 5 days.
If you forget to take Tamiflu, take the missed dose as soon as you remember about it, but no later than 2 hours before the next appointment. Then continue to take Tamiflu at the usual time. A double dose of Tamiflu should not be accepted. If you have missed several doses in a row, consult your doctor.
Patients with impaired renal function and the spacecraft is above 30 ml / min to adjust the dose is not necessary. In patients with CC less than 30 ml / min is recommended to reduce the dose of Tamiflu 75 mg 1 time / day for 5 days. In patients with renal insufficiency (CC less than 10 ml / min) application of the drug was not studied, so when his appointment to be careful.
Patients with hepatic impairment dose adjustment is required.
Patients Senile dosage adjustment is required.
Side effects
Typically, Tamiflu is well tolerated. The most common adverse reactions are nausea and vomiting. Their probability can be reduced if we take the drug during meals. When you see others not mentioned here side effects, consult your doctor.
Pregnancy and lactation
Currently, data on the use of the drug during pregnancy is insufficient to assess the teratogenic effects or fetotoxicity oseltamivir phosphate, so it is usually during pregnancy and lactation take Tamiflu is not recommended.
If you are pregnant or could become pregnant during treatment with Tamiflu, before starting treatment talk to your doctor.
Overdose
At present, cases of overdose is not described.
Estimated symptoms of acute overdose: nausea with vomiting or without her.
Single doses of Tamiflu to 1000 mg was well tolerated, with the exception of nausea and vomiting.
Drug Interactions
Information obtained in the pharmacological and pharmacokinetic studies of oseltamivir phosphate, can be considered clinically significant drug interactions unlikely.
Drug interactions due to competition for active centers of esterases, transforming oseltamivir phosphate in the active substance in the literature not covered in detail. Low binding of oseltamivir and the active metabolite of proteins do not suggest the existence of interactions associated with the displacement of drugs from its association with proteins.
Experiments in vitro have demonstrated that neither oseltamivir phosphate, or an active metabolite is not the preferred substrate for multifunctional cytochrome P450 oxidase system or glyukuroniltransferaz. The formal basis for interaction with hormonal oral contraceptives no.
Cimetidine, a nonspecific inhibitor of cytochrome P450 isozymes, competing in the process of tubular secretion of alkaline drugs such as having the properties of cations does not affect the concentrations of oseltamivir and its active metabolite in plasma.
Clinically significant drug interactions based on competition in the renal tubular secretion are unlikely, because of the peculiarities of elimination of active metabolite (glomerular filtration and anionic tubular secretion), and removes the ability of these two paths, as well as a large pool of safety of Tamiflu. Concurrent administration of probenecid increases the AUC of active metabolite of approximately 2-fold due to inhibition of active tubular secretion in the kidneys. However, dose adjustment, while the application of probenecid is not required.
Simultaneous treatment with Tamiflu with paracetamol has no effect on plasma concentrations of oseltamivir, its active metabolite, and paracetamol.
In Phase III clinical Tamiflu prescribed with ACE inhibitors (enalapril, captopril), thiazide diuretics, penicillin, cephalosporins, azithromycin, erythromycin, doxycycline, blocking histamine H2 receptors (ranitidine, cimetidine), beta-blockers (propranolol), xanthine ( theophylline), sympathomimetics (pseudoephedrine), codeine, GKS, inhaled bronchodilators, analgesics, antipyretics and NSAIDs (acetylsalicylic acid, ibuprofen and paracetamol). Changes in the nature or frequency of adverse events while not observed.
Product
Capsules: 10 capsules in blister PVC / Al.
1 blister card with instructions for the application is placed in a cardboard box.
Powder for suspension for oral administration: 30 grams of powder for suspension for oral administration in a bottle of brown glass, screw-cap ukuporennoy, obospechivayuschey control the opening and the protection of children from opening.
1 bottle with a dosing syringe, measuring cup, and instructions for use is placed in a cardboard box.
Storage
Capsules should be stored at temperatures not above 30 ° C.
Powder for suspension for oral administration to keep at a temperature not exceeding 25 ° C.
After preparing the suspension stored at 2 - 8 ° C for 10 days.
Do not use the suspension after 10 days from the date of preparation.
Keep out of reach of children.
Expiration
Capsules - 5 years
Powder for suspension for oral administration - 2 years.
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