Dutrebis
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-04-2017
Charakterystyka produktu
(SPC)
27-04-2017
Sprawozdanie z oceny publicznego
(PAR)
27-04-2017
Składnik aktywny:
lamivudine, raltegravir potassium
Dostępny od:
Merck Sharp Dohme Limited
Kod ATC:
J05AR16
INN (International Nazwa):
lamivudine, raltegravir potassium
Grupa terapeutyczna:
Antivirals for systemic use, Antivirals for treatment of HIV infections, combinations
Dziedzina terapeutyczna:
HIV Infections
Wskazania:
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).
Status autoryzacji:
Withdrawn
Data autoryzacji:
2015-03-26
Ulotka dla pacjenta
38
B. PACKAGE LEAFLET
Medicinal product no longer authorised
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 blood
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
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
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