Dutrebis 150 mg film-coated tablets lamivudine, raltegravir
Country: European Union
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
Lamivudine, raltegravir potassium
Available from:
Merck Sharp & Dohme Limited
ATC code:
J05AR16
INN (International Name):
Lamivudine, raltegravir potassium
Dosage:
150 mg of lamivudine and 300 mg of raltegravir
Pharmaceutical form:
Film-coated tablets
Administration route:
Oral
Units in package:
60 film-coated tablets
Prescription type:
Subject to restricted medical prescription
Therapeutic group:
Antivirals for systemic use
Therapeutic area:
HIV Infections
Therapeutic indications:
Indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes
Authorization status:
Authorized
Authorization date:
2015-03-26
Patient Information leaflet
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTREBIS 150 MG/300 MG FILM-COATED TABLETS
lamivudine/raltegravir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
IF YOU ARE THE PARENT OF A CHILD TAKING DUTREBIS, PLEASE READ THIS
INFORMATION CAREFULLY WITH
YOUR CHILD.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or
nurse.
This medicine has been prescribed for you or your child 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, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What DUTREBIS is and what it is used for
2.
What you need to know before you take DUTREBIS
3.
How to take DUTREBIS
4.
Possible side effects
5.
How to store DUTREBIS
6.
Contents of the pack and other information
1.
WHAT DUTREBIS IS AND WHAT IT IS USED FOR
WHAT DUTREBIS IS
DUTREBIS is an antiretroviral medicine used to treat infection with
human immunodeficiency virus
(HIV). It contains the active substances lamivudine and raltegravir:
Lamivudine belongs to a group of medicines called nucleoside
analogue reverse transcriptase
inhibitors (NRTIs)
Raltegravir belongs to a group of medicines called HIV integrase
strand transfer inhibitors
WHAT DUTREBIS IS USED FOR
DUTREBIS is used to treat HIV (Human Immunodeficiency Virus). HIV is
the virus that causes
Acquired Immune Deficiency Syndrome (AIDS).
DUTREBIS is used in combination with other medicines to treat
adults, adolescents, and children
6 years of age and older and weighing at least 30 kg who are
infected by HIV. Your doctor has
prescribed DUTREBIS to help control your HIV infection.
HOW DUTREBIS WORKS
When used with other medicines, DUTREBIS may:
reduce the amount of HIV in your bl
Read the complete document
Summary of Product characteristics
2
1.
NAME OF THE MEDICINAL PRODUCT
DUTREBIS 150 mg/300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of lamivudine and 300 mg of
raltegravir (as potassium).
Excipient with known effect: Each tablet contains 39.70 mg lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Green, oval tablet, marked with "144" on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DUTREBIS is indicated in combination with other anti-retroviral
medicinal products for the treatment
of human immunodeficiency virus (HIV-1) infection in adults,
adolescents, and children from the age
of 6 years and weighing at least 30 kg without present or past
evidence of viral resistance to antiviral
agents of the InSTI (Integrase Strand Transfer Inhibitor) and
NRTI (
Nucleoside Reverse Transcriptase
Inhibitor
) classes (see sections 4.2, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
DUTREBIS should be used in combination with other active
anti-retroviral therapy (ART) (see
sections 4.4 and 5.1).
_Adults, adolescents, and children (6 through 11 years of age
weighing at least 30 kg)_
The recommended dosage is one tablet (150 mg lamivudine/300 mg
raltegravir) twice daily.
Raltegravir is also available in a chewable tablet formulation for
children weighing at least 11 kg and
in granules for oral suspension formulation for infants and toddlers
from 4 weeks of age and weighing
at least 3 kg to less than 20 kg. Refer to the chewable tablet and
granules for oral suspension SmPCs
for additional dosing information.
Lamivudine is also available as an oral solution for children over
three months of age and who weigh
less than 14 kg or for patients who are unable to swallow tablets.
The maximum dose is one tablet twice daily.
_Advice on missed doses_
If DUTRE
Read the complete document
