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SCHEDULING STATUS:
PROPRIETARY NAME AND DOSAGE FORM:
COMPOSITION:
Each Intas Finasteride 5 mg film-coated tablet contains: PHARMACOLOGICAL CLASSIFICATION:
PHARMACOLOGICAL ACTION:
Finasteride is a synthetic 4-azasteroid compound, that is an inhibitor of Type II 5-alpha reductase, an intracellular enzyme which metabolizes testosterone into the more potent androgen dihydrotestosterone (DHT). In benign prostatic hyperplasia (BPH), enlargement of the prostate gland is dependent upon the conversion of testosterone to DHT within the prostate. Intas Finasteride 5 mg reduces circulating and intraprostatic DHT. Finasteride has no affinity for the androgen receptor. Pharmacokinetics
Following an oral dose of 14C-finasteride in man, 39 % of the dose was excreted in the urine in the form of metabolites (virtually no unchanged agent was excreted in the urine) and 57 % of the total dose was excreted in the faeces. Two metabolites of finasteride have been identified which possess only a small fraction of the 5-alpha reductase inhibitory activity of finasteride. Relative to an intravenous reference dose, the oral bioavailability of finasteride is approximately 80 %. The bioavailability is not affected by food. Maximum finasteride plasma concentrations are reached approximately two hours after dosing and the absorption is complete after six to eight hours. Finasteride displays a mean plasma elimination half-life of approximately 6 hours (4-12 hours) in subjects 46-60 years of age and approximately 8 hours in men 70 years of age and older. Protein binding is approximately 93 %. Plasma clearance and the volume of distribution of finasteride are approximately 165 ml/min and 76 litres, respectively. INDICATIONS:
Intas Finasteride 5 mg is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in Improve urinary flow and improve the symptoms associated with BPH by causing regression of the Reduce the incidence of acute urinary retention Reduce the incidence of surgery including transurethral resection of the prostate (TURP) and CONTRA-INDICATIONS:
Hypersensitivity to any component of this product. Pregnancy – Use in women when they are or may potentially be pregnant (see Pregnancy and Lactation). Intas Finasteride 5 mg is not indicated for use in women. Intas Finasteride 5 mg is not indicated for paediatric use. WARNINGS:
Intas Finasteride 5 mg is contra-indicated in women when they are or may potentially be pregnant as it may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman. It is not known whether Intas Finasteride 5 mg is excreted in breast milk. Serum Prostate Specific Antigen (S-PSA) levels decrease in patients treated with Intas Finasteride 5 mg. INTERACTIONS:
No medicinal interactions of clinical importance have been identified. Intas Finasteride 5 mg does not appear to affect significantly the cytochrome P450-linked medicine metabolizing enzyme system. Compounds which have been tested in man have included propranolol, digoxin, glibenclamide, warfarin, theophylline and antipyrine and no clinically meaningful interactions were found. Other Concomitant Therapy
Although specific interaction studies were not performed in clinical studies Intas Finasteride 5 mg was used concomitantly with ACE-inhibitors, paracetamol, acetylsalicylic acid, alpha-blockers, beta-blockers, calcium channel blockers, cardiac nitrates, diuretics, H2 antagonists, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory medicines (NSAIDs), quinolones and benzodiazepines without evidence of clinically PREGNANCY AND LACTATION:
Intas Finasteride 5 mg is contra-indicated for use in women when they are or may potentially be pregnant (see CONTRA-INDICATIONS). Because of the ability of Type II 5-alpha reductase inhibitors to inhibit
conversion of testosterone to dihydrotestosterone, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant women. Exposure to Intas Finasteride 5 mg – Risk To Male Foetus
Women should not handle crushed or broken Intas Finasteride 5 mg tablets when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus (see Use in Pregnancy). Intas Finasteride 5 mg tablets are coated and will prevent
contact with the active ingredient during normal handling, provided that the tablets have not been broken or It is not known whether finasteride is excreted in human milk. DOSAGE AND DIRECTIONS FOR USE:
The recommended dosage is one 5 mg tablet daily with or without food. Although early improvement in symptoms may be seen, a therapeutic trial of 6 -12 months may be necessary to assess whether a Dosage in Renal Insufficiency
No adjustments in dosage are required in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 ml/min) as pharmacokinetic studies did not indicate any change in the disposition of Dosage in the Elderly
No adjustment in dosage is required although pharmacokinetic studies indicated the elimination of Intas Finasteride is decreased in patients more than 70 years of age. SIDE EFFECTS AND SPECIAL PRECAUTIONS
SIDE EFFECTS

Reproductive system and breast disorders:
Frequent: Impotence, decreased libido, decreased volume of ejaculate, ejaculation disorder, and testicular Less frequent: Breast enlargement and breast tenderness Cardiac disorders:
Hepato-biliary disorders:
Frequency unknown: Increased liver enzymes Skin and subcutaneous tissue disorders:
Less frequent: Skin rash, pruritus and urticaria General disorders and administration site conditions:
Less frequent: Hypersensitivity reactions, swelling of the lips and face SPECIAL PRECAUTIONS
Patients with a large residual urine volume and/or severely diminished urinary flow should be carefully Effects on PSA and prostate cancer detection
No clinical benefit has been demonstrated in patients with prostate cancer treated with Intas Finasteride 5 mg. Digital rectal examinations as well as other evaluations for prostate cancer are recommended prior to initiating therapy with Intas Finasteride 5 mg and periodically thereafter. Serum prostate-specific antigen (S-PSA) is also used for prostate cancer detection. Generally a baseline S-PSA greater than 10 ng/ml (Hybritech) prompts further evaluation and consideration of biopsy; for S-PSA levels between 4 and 10 ng/ml, further evaluation is advisable. There is considerable overlap in S-PSA levels among men with and without prostate cancer. Therefore, in men with BPH, S-PSA values within the normal reference range do not rule out prostate cancer, regardless of treatment with Intas Finasteride 5 mg. A baseline S-PSA less than 4 ng/ml does not exclude prostate cancer. Intas Finasteride 5 mg causes a decrease in serum S-PSA concentrations by approximately 50 % in patients with BPH, even in the presence of prostate cancer. This decrease in S-PSA levels in patients with BPH treated with Intas Finasteride 5 mg should be considered when evaluating S-PSA data and does not rule out concomitant prostate cancer. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. DRUG/LABORATORY TEST INTERACTIONS
Effect on levels of S-PSA
S-PSA concentration is correlated with patient age and prostatic volume, and prostatic volume is correlated with patient age. When S-PSA laboratory determinations are evaluated, consideration should be given to the fact that S-PSA levels decrease in patients treated with Intas Finasteride 5 mg. In most patients, a rapid decrease in S-PSA is seen within the first months of therapy, after which time S-PSA levels stabilize to a new baseline. The post-treatment baseline approximates half of the pre-treatment value. Therefore, in typical patients treated with Intas Finasteride 5 mg for six months or more, S-PSA values should be doubled for comparison to normal ranges in untreated men. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
No specific treatment of overdosage with Intas Finasteride 5 mg is recommended. Treatment is symptomatic and supportive. IDENTIFICATION
Intas Finasteride 5 mg tablets are blue, 7 mm, round, biconvex, film coated tablets marked ‘F5’ on one side PRESENTATION
Intas Finasteride 5 mg film coated tablets are packaged in a plain 0,025 mm thick, hard aluminium
blister foil with a matt finish, consisting of an opaque white 250 micron PVC film coated with PVDC (90 GSM). The blisters are packaged in an outer unit cardboard carton and marketed as 30’s. STORAGE INSTRUCTIONS
Store at or below 25 0C and protect from light. Women should not handle crushed or broken tablets of Intas Finasteride 5 mg when they are or may potentially be pregnant (see CONTRA-INDICATIONS, Use in: Pregnancy and Exposure to Intas
Finasteride 5 mg – Risk To Male Foetus).
KEEP OUT OF REACH OF CHILDREN
REGISTRATION NUMBER
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
DATE OF PUBLICATION OF THE PACKAGE INSERT

Source: http://www.tripharm.co.za/images/packageinserts/Intas-Finasteride.pdf

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