Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Didanosine 400mg;
Bristol-Myers Squibb (NZ) Limited
Didanosine 400 mg
400 mg
Capsule
Active: Didanosine 400mg Excipient: Carmellose sodium Diethyl phthalate Gelatin Methacrylic acid copolymer Opacode red S-1-15094 Opacode red S-1-15095 Purified talc Sodium starch glycolate Titanium dioxide
Blister pack, 30 capsules
Prescription
Prescription
Bristol-Myers Squibb Barceloneta Inc
Videx EC in combination with other antiretroviral drugs, is indicated for the treatment of HIV infected adults.
Package - Contents - Shelf Life: Blister pack, - 30 capsules - 18 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 30 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 60 capsules - 36 months from date of manufacture stored at or below 25°C
2000-08-10
Videx EC vs 4 page 1 of 15 DATA SHEET 1. PRODUCT NAME VIDEX EC 400 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Videx 400 mg hard capsules Each hard capsule contains 400 mg of didanosine. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Hard capsule 400 mg: capsules are opaque white and embossed in red with "6674" on one half, and "BMS 400 mg" on the other half. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Videx EC in combination with other antiretroviral medicines, is indicated for the treatment of HIV infected adults. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE: ADULTS Videx EC capsules should be administered on an empty stomach. Videx EC capsules should be swallowed intact. The recommended daily dose is dependent on body weight and is administered as one capsule given on a once daily schedule as outlined in Table 1. Videx EC vs 4 page 2 of 15 TABLE 1: PATIENT BASELINE WEIGHT VIDEX EC CAPSULES < 60kg 250mg OD 60kg 400mg OD ADULT PATIENTS WITH RENAL IMPAIRMENT: In adult patients with impaired renal function, the dose of Videx EC should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of Videx E C in adult patients with renal insufficiency are presented in Table 2. TABLE 2. RECOMMENDED DOSAGE IN PATIENTS WITH RENAL IMPAIRMENT BY BODY WEIGHT A CREATININE CLEARANCE (ML/MIN) DOSAGE (MG) AT LEAST 60KG LESS THAN 60KG at least 60 400 once daily 250 once daily 30-59 200 once daily 125 once daily 10-29 125 once daily 125 once daily Videx EC vs 4 page 3 of 15 Less than 10 125 once daily b a Based on studies using buffered formulation of didanosine b Not suitable for use in patients less than 60kg with CL cr less then 10mL/min. For patients requiring CAPD or haemodialysis, follow dosing recommendations for patients with creatinine clearance less than 10mL/min, shown in Table 2. It is not necessary to administer a supplemental dose of didanosine following haemodialysis. 4.3 CONTRAINDICATIONS Videx EC is contraindic Prečítajte si celý dokument