Country: Armenía
Tungumál: enska
Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
rifampicin, isoniazid
Lupin Limited
J04AM02
rifampicin, isoniazid
150mg+ 75mg
tablets film-coated
(672/24x28) in blister
Prescription
Registered
2016-12-08
LUPIN LIMITED ANNEX 5 PRODUCT: AKURIT (RIFAMPIN AND ISONIAZID TABLETS) PAGE 1 OF 10 TITLE: SUMMARY OF PRODUCT CHARACTERISTICS D:\regestration\FC registrac\Nist 368 25-11-16 24dex\Rifampicin Isoniazid\Orig PIl mock 3 vida, SPC by mail Anaida gr\Rifampin Isoniazid_SmPC.doc STRICTLY CONFIDENTIAL 1. NAME OF THE FINISHED PHARMACEUTICAL PRODUCT Rifampin and Isoniazid Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains; Rifampin USP 150mg Isoniazid USP 75mg 3. PHARMACEUTICAL FORM Tablets Brick red coloured, capsule shaped, biconvex, film coated tablets with breakline on one side and plain on the other side. The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses or the tablet should not be divided. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS It is indicated for the continuation phase of short course treatment of patients with pulmonary or extra-pulmonary tuberculosis. During this phase, it should be administered on a daily continuous basis. This fixed-dosage combination drug is not recommended for initial therapy of tuberculosis or for prevention therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Akurit is administered to patients on the basis of body weight. Patient Body Weight Continuation Phase (Kg) Four Months Akurit Tablets Daily 30-37 2 LUPIN LIMITED ANNEX 5 PRODUCT: AKURIT (RIFAMPIN AND ISONIAZID TABLETS) PAGE 2 OF 10 TITLE: SUMMARY OF PRODUCT CHARACTERISTICS D:\regestration\FC registrac\Nist 368 25-11-16 24dex\Rifampicin Isoniazid\Orig PIl mock 3 vida, SPC by mail Anaida gr\Rifampin Isoniazid_SmPC.doc STRICTLY CONFIDENTIAL 38-54 3 55-70 4 >70 5 4.3 CONTRAINDICATIONS It is contraindicated in patients with a history of hypersensitivity to Rifampin, Isoniazid or the any of the excipients. Other contraindications include patients with severe hepatic damage, patients who develop severe adverse reactions to Isoniazid like drug fever, chills and arthritis. Patients with acute liver disease with any aetiology and patients suffering f Lestu allt skjalið