Nazione: Singapore
Lingua: inglese
Fonte: HSA (Health Sciences Authority)
Raltegravir Potassium 108.6 mg eqv Raltegravir
MSD PHARMA (SINGAPORE) PTE. LTD.
J05AX08
100 mg
TABLET, CHEWABLE
Raltegravir Potassium 108.6 mg eqv Raltegravir 100 mg
ORAL
Prescription Only
Patheon Pharmaceuticals Inc.
ACTIVE
2014-03-07
PRODUCT CIRCULAR SG-MK0518-T-102013 ISENTRESS® Tablets (raltegravir 400 mg) ISENTRESS® Chewable Tablets (raltegravir 25 mg and 100 mg) I. THERAPEUTIC CLASS ISENTRESS (raltegravir) is an HIV integrase strand transfer inhibitor active against the Human Immunodeficiency Virus (HIV-1). II. CHEMISTRY The chemical name for raltegravir potassium is N -[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1- methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4- pyrimidinecarboxamide monopotassium salt. The empirical formula is C 20 H 20 FKN 6 O 5 and the molecular weight is 482.51. The structural formula is: N N H N O H N O O H 3 C CH 3 H 3 C O N N O H 3 C F K Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol. III. COMPOSITION IIIa. Active Ingredients 2 Each film-coated tablet of ISENTRESS contains 434.4 mg of raltegravir (as potassium salt), equivalent to 400 mg of raltegravir free phenol. Each 100 mg chewable tablet of ISENTRESS contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol. Each 25 mg chewable tablet of ISENTRESS contains 27.16 mg of raltegravir (as potassium salt), equivalent to 25 mg of raltegravir free phenol. IIIb. Inactive Ingredients - 400 mg Tablet Each film-coated tablet of ISENTRESS contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (co Leggi il documento completo
PRODUCT CIRCULAR SG-MK0518-T-112020 ISENTRESS®-G Tablets (raltegravir 400 mg) ISENTRESS® Chewable Tablets (raltegravir 25 mg and 100 mg) I. THERAPEUTIC CLASS ISENTRESS-G (raltegravir) is an HIV integrase strand transfer inhibitor active against the Human Immunodeficiency Virus (HIV-1). II. CHEMISTRY The chemical name for raltegravir potassium is N -[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1- methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4- pyrimidinecarboxamide monopotassium salt. The empirical formula is C 20 H 20 FKN 6 O 5 and the molecular weight is 482.51. The structural formula is: N N H N O H N O O H 3 C CH 3 H 3 C O N N O H 3 C F K Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol. III. COMPOSITION IIIa. Active Ingredients Each film-coated tablet of ISENTRESS-G contains 434.4 mg of raltegravir (as potassium salt), equivalent to 400 mg of raltegravir free phenol. Each 100 mg chewable tablet of ISENTRESS contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol. Each 25 mg chewable tablet of ISENTRESS contains 27.16 mg of raltegravir (as potassium salt), equivalent to 25 mg of raltegravir free phenol. IIIb. Inactive Ingredients – 400 mg Tablet Each film-coated tablet of ISENTRESS-G contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, and black iron oxide. IIIc. Inactive Ingredients – Chewable Tablets Each 100 mg chewable tablet of ISENTRESS contains the following inactive ingredients: hydroxypropyl cellulose, sucralose, saccharin so Leggi il documento completo