Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
Etravirine
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
J05AG04
200mg/tablet
TABLET
Etravirine 200mg/tablet
ORAL
Prescription Only
Janssen Pharmaceutica NV (Spray Dried Powder)
ACTIVE
2014-04-03
- 1 - NAME OF THE MEDICINAL PRODUCT INTELENCE TM 100 mg tablets INTELENCE TM 200 mg tablets DOSAGE FORMS AND STRENGTHS 100 mg tablet: Contains 100mg of etravirine. White to off-white, oval tablet, debossed with “T125” on one side and “100” on the other side. Contains 160mg lactose. 200 mg tablet: Contains 200mg of etravirine. White to off-white, biconvex, oblong tablet debossed with “T200” on one side For excipients, see ‘_List of Excipients’. _ CLINICAL INFORMATION INDICATIONS INTELENCE, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents. This indication is based on week 48 analyses from 2 randomised, double-blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults. The following points should be considered when initiating therapy with INTELENCE: - Treatment history, and, when available, resistance testing, should guide the use of INTELENCE. - The use of other active antiretroviral agents with INTELENCE is associated with an increased likelihood of treatment response. - In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs (see Pharmacodynamic Prope read_full_document
- 1 - PRODUCT NAME INTELENCE TM 200 mg tablets DOSAGE FORM AND STRENGTH Contains 200mg of etravirine. White to off-white, biconvex, oblong tablet debossed with “T200” on one side For excipients, see ‘ _List of Excipients’. _ CLINICAL INFORMATION INDICATIONS INTELENCE TM , in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents. This indication is based on week 48 analyses from 2 randomised, double-blind, placebo-controlled trials of INTELENCE TM . Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults. The following points should be considered when initiating therapy with INTELENCE TM : - Treatment history, and, when available, resistance testing, should guide the use of INTELENCE TM . - The use of other active antiretroviral agents with INTELENCE TM is associated with an increased likelihood of treatment response. - In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE TM in combination with only N[t]RTIs (see Pharmacodynamic Properties). - The risks and benefits of INTELENCE TM have not been established in pediatric patients or in treatment naïve adult patients. DOSAGE AND ADMINISTRATION INTELENCE TM must always be given in combination with other antiretroviral medicinal products. _ _ _ _ ADULTS The recommended dose of INTELENCE TM is 200 mg (one 200mg tablet) taken orally twice daily (b.i.d.), following a meal (see _Pharmacokinetic _ _Properties_ ). Patients should be instructed to swallow the tablets as a whole with a liquid such as water. Patients who are unable to swallow the INTELENCE TM tablets whole may disperse the tablets in a glass of water. Once the tablets are dispersed, read_full_document