ISENTRESS TABLET

Kraj: Republika Południowej Afryki

Język: angielski

Źródło: South African Health Products Regulatory Authority (SAHPRA)

Dostępny od:

MSD (Pty) Ltd

Dawkowanie:

See ingredients

Forma farmaceutyczna:

TABLET

Skład:

EACH TABLET CONTAINS RALTEGRAVIR POTASSIUM EQUIVALENT TO RALTEGRAVIR 400,0 mg

Status autoryzacji:

Registered

Data autoryzacji:

2011-04-03

Ulotka dla pacjenta

PRODUCT NAME: ISENTRESS TABLETS & ISENTRESS
CHEWABLE TABLETS
COMPONENT: ENGLISH PATIENT INFORMATION
LEAFLET
UPDATE APPROVED: 02 JUNE 2020
TP20200605
Page 1 of 11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
ISENTRESS
®
Tablets
Raltegravir 400 mg
ISENTRESS
®
CHEWABLE 25 mg and 100 mg Tablets
Raltegravir 25 mg or 100 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ISENTRESS
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
ISENTRESS has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
1.
WHAT ISENTRESS IS AND WHAT IS IT USED FOR
ISENTRESS works against the Human Immunodeficiency Virus (HIV), the
virus that causes
AIDS (Acquired Immune Deficiency Syndrome). ISENTRESS blocks HIV
integrase, an
enzyme that is needed for HIV to make more viruses.
S4
PRODUCT NAME: ISENTRESS TABLETS & ISENTRESS
CHEWABLE TABLETS
COMPONENT: ENGLISH PATIENT INFORMATION
LEAFLET
UPDATE APPROVED: 02 JUNE 2020
TP20200605
Page 2 of 11
ISENTRESS is used in combination with other antiretroviral medicinal
products for the
treatment of human immunodeficiency virus (HIV-1) infection in
patients 2 years of age and
older.
ISENTRESS DOES NOT CURE HIV INFECTION OR AIDS.
Your doctor has prescribed ISENTRESS to help control your HIV
infection.
It is very important that you stay under the care of your doctor
during treatment of your HIV
infection.
DOES ISENTRESS DECREASE THE CHANCE OF PASSING HIV TO OTHER PEOPLE?
ISENTRESS does not reduce the chance of passing HIV to others through
sexual contact,
sharing needles, or being exposed to your blood. Continue to practice
safe sex. Use latex or
polyurethane condoms or other barrier methods of contraception to
lower the chance of
sexual contact with any, body fluid such as semen, vaginal secretions
or blood. Never re-use
or share needles.
Ask your doctor if

Charakterystyka produktu

PRODUCT NAME: ISENTRESS TABLETS &
CHEWABLE TABLETS
COMPONENT: ENGLISH PROFESSIONAL
INFORMATION
UPDATE APPROVED: 02 JUNE 2020
TP20200609
Page 1 of 38
SCHEDULING STATUS
1
NAME OF MEDICINE
ISENTRESS
®
Tablets (400 mg)
ISENTRESS
®
CHEWABLE 25 mg and 100 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains raltegravir potassium equivalent to
400 mg of raltegravir.
Each chewable tablet contains raltegravir potassium equivalent to 25
mg or 100 mg of
raltegravir.
3
PHARMCEUTICAL FORM
A.20.2.8 Antiviral agents
Raltegravir is an HIV integrase strand transfer inhibitor active
against the Human
Immunodeficiency Virus (HIV-1).
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ISENTRESS is indicated in combination with other antiretroviral
medicines for the treatment of
human immunodeficiency virus (HIV-1) infection in patients 2 years of
age and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
S4
PRODUCT NAME: ISENTRESS TABLETS &
CHEWABLE TABLETS
COMPONENT: ENGLISH PROFESSIONAL
INFORMATION
UPDATE APPROVED: 02 JUNE 2020
TP20200609
Page 2 of 38
ISENTRESS is available as a 400 mg tablet formulation and as a
chewable tablet
formulation in 100 mg (scored) and 25 mg strengths.
Because the formulations are not bioequivalent, do not substitute
chewable tablets for the
400 mg tablet. The maximum dose of the chewable tablet is 300 mg twice
daily.
ISENTRESS can be administered with or without food.
ISENTRESS is to be given in a combination regimen with other
antiretroviral medicines. For
the treatment of patients with HIV-1 infection, the dosage of
ISENTRESS is as follows:
ADULTS: One 400 mg tablet twice daily, orally.
CHILDREN AND ADOLESCENTS:

At least 25 kg: One 400 mg tablet twice daily, orally

2 to less than 6 years of age:
Chewable tablets: Weight based to maximum dose 300 mg, twice daily, as
specified in
TABLE 1.
TABLE 1: RECOMMENDED DOSE
* FOR ISENTRESS CHEWABLE TABLETS IN PAEDIATRIC
PATIENTS
BODY WEIGHT (KG)
DOSE
NUMBER OF CHEWABLE TABLETS
7 to < 10
50 mg twice daily
0,5 x 100 mg
†