País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Maraviroc
ViiV Healthcare UK Ltd
J05AX09
Maraviroc
300mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030100; GTIN: 5013457019797
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CELSENTRI 25 MG FILM-COATED TABLETS CELSENTRI 75 MG FILM-COATED TABLETS CELSENTRI 150 MG FILM-COATED TABLETS CELSENTRI 300 MG FILM-COATED TABLETS maraviroc READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET: 1. What CELSENTRI is and what it is used for 2. What you need to know before you take CELSENTRI 3. How to take CELSENTRI 4. Possible side effects 5. How to store CELSENTRI 6. Contents of the pack and other information 1. WHAT CELSENTRI IS AND WHAT IT IS USED FOR CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a group of medicines called _CCR5 antagonists_ . CELSENTRI works by blocking a receptor called CCR5 which HIV uses to enter and infect your blood cells. CELSENTRI IS USED TO TREAT HUMAN IMMUNODEFICIENCY VIRUS TYPE-1 (HIV-1) IN ADULTS, ADOLESCENTS AND CHILDREN OF 2 YEARS AND OLDER, AND WEIGHING AT LEAST 10 KG. CELSENTRI must be taken in combination with other medicines which are also used to treat the HIV infection. These medicines are all called _anti-HIV medicines _ or _ antiretrovirals_ . CELSENTRI, as part of combination therapy, reduces the amount of virus in your body, and keeps it at a low level. This helps your body to increase the CD4 cell count in your blood. CD4 cells are a type of white blood cell that are important in helping your body to fight infection. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELSENTRI DO NOT TAKE CELSENTRI: if you (or your child, if they are the patient) are ALLERGIC to maraviroc or to peanut or so Leer el documento completo
OBJECT 1 CELSENTRI FILM-COATED TABLETS Summary of Product Characteristics Updated 18-Apr-2018 | ViiV Healthcare UK Ltd 1. Name of the medicinal product CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets 2. Qualitative and quantitative composition CELSENTRI 25 mg film-coated tablets Each film-coated tablet contains 25 mg of maraviroc. Excipient with known effect: each 25 mg film-coated tablet contains 0.14 mg of soya lecithin. CELSENTRI 75 mg film-coated tablets Each film-coated tablet contains 75 mg of maraviroc. Excipient with known effect: each 75 mg film-coated tablet contains 0.42 mg of soya lecithin. CELSENTRI 150 mg film-coated tablets Each film-coated tablet contains 150 mg of maraviroc. Excipient with known effect: each 150 mg film-coated tablet contains 0.84 mg of soya lecithin. CELSENTRI 300 mg film-coated tablets Each film-coated tablet contains 300 mg of maraviroc. Excipient with known effect: each 300 mg film-coated tablet contains 1.68 mg of soya lecithin. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. CELSENTRI 25 mg film-coated tablets Blue, biconvex, oval film-coated tablets, approximate dimensions 4.6 mm x 8.0 mm and debossed with “MVC 25”. CELSENTRI 75 mg film-coated tablets Blue, biconvex, oval film-coated tablets, approximate dimensions 6.74 mm x 12.2 mm and debossed with “MVC 75”. CELSENTRI 150 mg film-coated tablets Blue, biconvex, oval film-coated tablets, approximate dimensions 8.56 mm x 15.5 mm and debossed with “MVC 150”. CELSENTRI 300 mg film-coated tablets Blue, biconvex, oval film-coated tablets, approximate dimensions 10.5 mm x 19.0 mm and debossed with “MVC 300”. 4. Clinical particulars 4.1 Therapeutic indications CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment- experienced adults, adolescents and children of 2 years of age, and older and weighing at least 10 kg infected with o Leer el documento completo