Isentress 100mg granules sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Raltegravir

Available from:

Merck Sharp & Dohme Ltd

ATC code:

J05AX08

INN (International Name):

Raltegravir

Dosage:

100mg

Pharmaceutical form:

Granules

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5013945301441

Patient Information leaflet

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

Summary of Product characteristics

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