Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Maraviroc 300mg;
GlaxoSmithKline NZ Limited
Maraviroc 300 mg
300 mg
Film coated tablet
Active: Maraviroc 300mg Excipient: Calcium hydrogen phosphate Magnesium stearate Microcrystalline cellulose Opadry blue 85G20583 Sodium starch glycolate
Blister pack, PVC/Al, 60 tablets
Prescription
Prescription
Ajinomoto OmniChem SA
Celsentri, in combination with other antiretroviral medicinal products, is indicated for adult patients infected with only CCR5-tropic HIV-1. The use of other active agents with Celsentri is associated with a greater likelihood of treatment response.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 60 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with PP closure - 180 tablets - 24 months from date of manufacture stored at or below 30°C
2008-01-04
Celsentri ® 1 CELSENTRI ® _maraviroc _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Celsentri. This leaflet answers some common questions about Celsentri. 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 Celsentri against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CELSENTRI IS USED FOR Celsentri is used in combination with other anti-HIV medicines in the treatment of HIV-1 infection. Its active ingredient, maraviroc, belongs to a group of medicines called CCR5 blockers. Celsentri prevents the entry of HIV-1 into the cells in your blood that are attacked by the HIV virus (called CD4 or T-cells). Celsentri works by blocking the CCR5 receptor which is the most common gateway the HIV virus uses to gain entry into these cells. Celsentri reduces the amount of HIV in your body and enhances your immune system. You should be aware that Celsentri is not a cure for HIV or AIDS and that appropriate precautions should be taken to prevent transmission. Celsentri should be taken in combination with other medicines used to treat HIV. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CELSENTRI HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Celsentri for another reason. This medicine is only available with a doctor’s prescription. BEFORE YOU TAKE CELSENTRI _WHEN YOU MUST NOT USE IT _ Do not take CELSENTRI if you have an allergy to: any medicine containing mara Đọc toàn bộ tài liệu
_THE MEDICINE IS NOT CURRENTLY MARKETED IN NEW ZEALAND_ _ _ Page 1 of 23 DATA SHEET CELSENTRI (MARAVIROC) NAME OF THE MEDICINE CELSENTRI 150 mg and 300 mg film-coated tablets. DESCRIPTION Maraviroc is a white to pale coloured powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5). Maraviroc is chemically described as 4,4-difluoro-_N_-{(1_S_)-3_-_[_exo_-3-(3-isopropyl-5-methyl-4_H_-1,2,4-triazol-4-yl)-8- azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide. The molecular formula is C 29 H 41 F 2 N 5 O and the structural formula is: N H O F F N N N N C H 3 C H 3 C H 3 CAS no.: 376348-65-1 CELSENTRI is supplied for oral administration in two strengths: 150 and 300 mg blue, biconvex, oval film-coated tablets debossed with “MVC 150” or “MVC 300” on one side. Each film-coated tablet contains either 150 or 300 mg of maraviroc and the following inactive ingredients: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium starch glycollate, magnesium stearate. The film-coat [Opadry II Blue (85G20583)] contains indigo carmine CI73015, soya lecithin, macrogol 3350, polyvinyl alcohol, talc and titanium dioxide. PHARMACOLOGY PHARMACOLOGICAL ACTIONS Pharmacotherapeutic group: Antivirals for systemic use, Other Antivirals ATC code: J05AX09 Mechanism of action: Maraviroc is a member of a therapeutic class called CCR5 antagonists. Maraviroc selectively binds to the human chemokine receptor CCR5, preventing CCR5-tropic HIV-1 from entering cells. _THE MEDICINE IS NOT CURRENTLY MARKETED IN NEW ZEALAND_ _ _ Page 2 of 23 Antiviral activity in vitro: Maraviroc inhibits the entry and replication of CCR5-tropic laboratory strains and clinical isolates of HIV-1 in models of acute T-cell infection. The in vitro IC 50 (50% inhibitory concentration) for maraviroc against the replication of HIV-1 group M isolates (subtypes A to J and Đọc toàn bộ tài liệu