Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
raltegravir potassium, Quantity: 108.6 mg (Equivalent: raltegravir, Qty 100 mg)
Merck Sharp & Dohme (Australia) Pty Ltd
Raltegravir potassium
Tablet, chewable
Excipient Ingredients: hyprolose; sucralose; saccharin sodium; sodium citrate dihydrate; mannitol; sodium stearylfumarate; magnesium stearate; iron oxide yellow; crospovidone; iron oxide red; purified water; strong ammonia solution; ethylcellulose; oleic acid; medium chain triglycerides; sorbitol; ammonium glycyrrhizinate; fructose; Flavour; hypromellose; macrogol 400
Oral
60 chewable tablets
(S4) Prescription Only Medicine
ISENTRESS or ISENTRESS HD, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents and children from the age of 2 years.,This indication is based on analyses of plasma HIV-1 RNA levels in controlled studies of ISENTRESS (see Section 5.1).,The indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24 weeks in a multicentre, open label, noncomparative study in HIV-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,The use of other active antiretroviral agents in combination with ISENTRESS is associated with a greater likelihood of treatment response (see Section 5.1).,There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.
Visual Identification: Pale orange, oval shaped tablet scored on both sides: one side is imprinted with the MSD logo and '477' on either side of the score.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-02-06
ISENTRESS ® AND ISENTRESS HD ® _raltegravir_ CONSUMER MEDICINE INFORMATION THE FOLLOWING INFORMATION IS APPLICABLE TO ISENTRESS (400 MG TABLET, 25 MG AND 100 MG CHEWABLE TABLET) AND ISENTRESS HD (600 MG TABLET) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about the ISENTRESS product range. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ISENTRESS against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR, PHARMACIST OR TREATMENTS OFFICER AT YOUR LOCAL AIDS COUNCIL. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ISENTRESS IS USED FOR ISENTRESS is used in combination with other anti-HIV medicines to treat adults, adolescents and children 2 years of age and older who are infected with HIV. The children and adolescents (2 - 18 years of age) who participated in the ISENTRESS studies had previously taken HIV medicines. ISENTRESS belongs to a group of medicines called integrase inhibitors. It works by blocking HIV integrase, one of the enzymes that is needed during the replication process for HIV to make more virus. When integrase is blocked by ISENTRESS, the virus is not able to reproduce normally. This helps reduce the amount of virus in the blood. When used with other anti-HIV medicines, ISENTRESS helps reduce the amount of HIV virus in your blood (called "viral load") and increase the number of CD4 (T) cells. ISENTRESS may not have these effects in all patients. ISENTRESS DOES NOT CURE HIV INFECTION OR AIDS. It is very important that you stay under the care of your doctor during treatment with ISENTRESS. BEFORE YOU TAKE ISENTRESS _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ISENTRESS IF YOU HAVE AN ALLERGY TO: • any medicine containing raltegravir • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reactio Read the complete document
WPC-MK0518-MF-012018 AUS-2018-017933 AUSTRALIAN PRODUCT INFORMATION ISENTRESS ® and ISENTRESS HD ® (raltegravir potassium) tablets 1 NAME OF THE MEDICINE ISENTRESS (raltegravir) 400 mg tablet, 25 mg chewable tablet and 100 mg chewable tablet. ISENTRESS HD (raltegravir) 600 mg tablet. 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM 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. The pKa is 6.6 in water. The octanol/water partition at pH 7.4 is 2.80. ISENTRESS HD 600 MG TABLET Each film-coated tablet of ISENTRESS HD contains 600 mg of raltegravir (as potassium salt). ISENTRESS 400 MG TABLET Each film-coated tablet of ISENTRESS contains 400 mg of raltegravir (as potassium salt). ISENTRESS 100 MG CHEWABLE TABLET Each chewable tablet contains 100 mg of raltegravir (as potassium salt). ISENTRESS 25 MG CHEWABLE TABLET Each chewable tablet contains 25 mg of raltegravir (as potassium salt). For the full list of excipients, see Section 6.1 List of excipients. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ISENTRESS or ISENTRESS HD, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents and children from the age of 2 years. This indication is based on analyses of plasma HIV-1 RNA levels in controlled studies of ISENTRESS (see Section 5.1). The indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24 weeks in a multicentre, open label, non- comparative study in HIV-1 infected, treatment-experienced children and adolescents 2 to 18 years of age. The use of other active antiretroviral agents in combination with ISENTRESS is associated with a greater likelihood of treatment response (see Section 5.1). WPC-MK0518-MF-012018 AUS-2018-017933 There are no study results Read the complete document