দেশ: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
CABOTEGRAVIR
GLAXO SMITH KLINE (ISRAEL) LTD
PROLONGED RELEASE SUSPENSION FOR INJECTION
CABOTEGRAVIR 200 MG / 1 ML
I.M
Required
VIIV HEALTHCARE UK LIMITED, UK
Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class
2022-06-06
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician’s prescription only Vocabria Injection Prolonged-release suspension for injection Each vial contains: cabotegravir 200 mg/mL The 2 mL vial contains - 400 mg cabotegravir The 3 mL vial contains - 600 mg cabotegravir For the list of the inactive and allergenic ingredients in the medicine, see section 6 - “Additional information”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Vocabria Injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. Therapeutic group: Vocabria Injection contains the active ingredient cabotegravir. Cabotegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs) . Vocabria Injection does not cure HIV infection; it keeps the amount of virus in your body at a low level. This helps maintain the number of CD4 cells in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. Vocabria Injection is always given in combination with another injection of an anti- retroviral medicine called rilpivirine injection. Refer to the rilpivirine patient leaflet for information on that medicine. 2. BEFORE USING THE MEDICINE Do not use the medicine If: • you are hypersensitive (allergic) to the active ingredient (cabotegra সম্পূর্ণ নথি পড়ুন
1 1. NAME OF THE MEDICINAL PRODUCT Vocabria Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 400 mg Each vial contains 400 mg cabotegravir in 2 mL (200mg/ml). 600 mg Each vial contains 600 mg cabotegravir in 3 mL (200mg/ml). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release suspension for injection. White to light pink suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vocabria_ _injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class (see sections 4.2, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vocabria should be prescribed by physicians experienced in the management of HIV infection. Each injection should be administered by a healthcare professional. Vocabria injection is indicated for the treatment of HIV-1 in combination with rilpivirine injection, therefore, the prescribing information for rilpivirine injection should be consulted for recommended dosing. PRIOR TO STARTING VOCABRIA INJECTION, HEALTHCARE PROFESSIONALS SHOULD HAVE CAREFULLY SELECTED PATIENTS WHO AGREE TO THE REQUIRED INJECTION SCHEDULE AND COUNSEL PATIENTS ABOUT THE IMPORTANCE OF ADHERENCE TO SCHEDULED DOSING VISITS TO HELP MAINTAIN VIRAL SUPPRESSION AND REDUCE THE RISK OF VIRAL REBOUND AND POTENTIAL DEVELOPMENT OF RESISTANCE WITH MISSED DOSES. FOLLOWING DISCONTINUATION OF VOCABRIA AND RILPIVIRINE INJECTION, IT IS ESSENTIAL TO ADOPT AN ALTERNATIVE, FULLY SUPPRESSIVE ANTIRETROVIRAL REGIMEN NO LATER THAN ONE MONTH AFTER THE FINAL INJECTION OF VOCABRIA WHEN DOSED MONTHLY AND NO LATER THAN TWO MONTHS AFTER THE FINAL INJECTION OF VOCABRIA WHEN DOSED EVERY 2 MONTHS (SEE SECTION 4.4). The healthcare provider and patient may decide to use cabotegravir tablets as an ora সম্পূর্ণ নথি পড়ুন