Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Raltegravir
Merck Sharp & Dohme Ltd
J05AX08
Raltegravir
100mg
Granules
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5013945301441
USER MANUAL BRING THIS BOOKLET TO YOUR CHILD’S APPOINTMENTS. ISENTRESS® 100 MG GRANULES FOR ORAL SUSPENSION raltegravir INSTRUCTIONS FOR USE _for babies _ _ _ THIS KIT HAS CHANGED AND MAY BE DIFFERENT THAN THE ONE YOU HAVE USED BEFORE. NEW DIRECTIONS FOR DOSE PREPARATION NEW AMOUNT OF WATER FOR MIXING THE PRODUCT NEW SYRINGE SIZES TO MEASURE THE DOSE BE SURE YOU READ AND UNDERSTAND THESE INSTRUCTIONS FOR USE. BEFORE YOU START _NOTE: _Make sure your doctor shows you how to prepare and give Isentress for oral suspension. Be sure you understand these instructions before you start. If you are not sure, call your doctor. It is very important that you measure the water and Isentress carefully using the correct syringe. Before you give Isentress to your child, check the expiration date. The expiry date is printed on the carton and the Isentress sachets. The amount of Isentress depends on your child’s age and weight, so it will change over time. Your doctor will tell you the right dose at each check-up after weighing your child. Be sure to keep your doctor’s appointments so you get new dosing information as your child grows. During your child’s first week of life, you will give Isentress 1 time a day. After that, you will give it 2 times a day. This booklet tells you how to: º Mix Isentress into a liquid form º Measure the right dose using a syringe º Give Isentress to your child º Clean up KIT CONTENTS Outer carton Instructions (this booklet) Prescribing leaflet 2 mixing cups • 60 sachets of Isentress granules • 6 syringes 2 BLUE (10 mL) syringes 2 GREEN (3 mL) syringes 2 WHITE (1 mL) syringes THE KIT HAS AN EXTRA CUP AND SET OF SYRINGES IN CASE ONE IS LOST OR DAMAGED. DO NOT USE ANY DAMAGED CUPS OR SYRINGES. STEP 1. GET READY Put your child in a safe place. You will need both hands to prepare Isentress. Wash your hands with soap and water. Take out what you need to make 1 dose and place on a clean surface: 1 mixing cup (Using the tab on the mi Soma hati kamili
OBJECT 1 ISENTRESS 100 MG GRANULES FOR ORAL SUSPENSION Summary of Product Characteristics Updated 12-Apr-2018 | Merck Sharp & Dohme Limited 1. Name of the medicinal product ISENTRESS® 100 mg granules for oral suspension 2. Qualitative and quantitative composition Each sachet contains 100 mg of raltegravir (as potassium). Following reconstitution the oral suspension has a concentration of 10 mg per mL. Excipients with known effect Each sachet contains approximately: 0.5 mg fructose, 1.5 mg sorbitol and 4.7 mg sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Granules for oral suspension. White to off-white, granular powder that may contain yellow or beige to tan particles, in a single-use sachet. 4. Clinical particulars 4.1 Therapeutic indications ISENTRESS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection (see sections 4.2, 4.4, 5.1 and 5.2). 4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of HIV infection. Posology ISENTRESS should be used in combination with other active anti-retroviral therapies (ARTs) (see sections 4.4 and 5.1). Because the formulations have different pharmacokinetic profiles neither the granules for oral suspension nor the chewable tablets should be substituted for the 400 mg tablet or 600 mg tablet (see section 5.2). The granules for oral suspension and the chewable tablets have not been studied in HIV-infected adolescents (12 to 18 years) or adults. _Neonates, Infants and Toddlers _ Dosing is weight based from birth as specified in Table 1 and Table 2. Patients can remain on the granules for oral suspension as long as their weight is below 20 kg. For patients weighing between 11 and 20 kg, either the granules for oral suspension or the chewable tablet can be used as specified in Table 1 (see section 5.2). Refer to the chewable tablet SmPC for additional dosing information. The safety and efficacy of r Soma hati kamili