Emtriva
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
18-04-2023
Produktets egenskaber
(SPC)
18-04-2023
Offentlige vurderingsrapport
(PAR)
22-12-2016
Aktiv bestanddel:
emtricitabine
Tilgængelig fra:
Gilead Sciences Ireland UC
ATC-kode:
J05AF09
INN (International Name):
emtricitabine
Terapeutisk gruppe:
Antivirals for systemic use
Terapeutisk område:
HIV Infections
Terapeutiske indikationer:
Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.
Produkt oversigt:
Revision: 33
Autorisation status:
Authorised
Autorisation dato:
2003-10-24
Indlægsseddel
38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
EMTRIVA 200 MG HARD CAPSULES
emtricitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Emtriva is and what it is used for
2.
What you need to know before you take Emtriva
3.
How to take Emtriva
4.
Possible side effects
5.
How to store Emtriva
6.
Contents of the pack and other information
1.
WHAT EMTRIVA IS AND WHAT IT IS USED FOR
EMTRIVA IS A TREATMENT FOR HUMAN IMMUNODEFICIENCY VIRUS
(HIV) infection in adults, children and
infants aged 4 months and over. Emtriva 200 mg hard capsules are
ONLY SUITABLE FOR PATIENTS WHO
WEIGH AT LEAST 33 KG.
Emtriva oral solution is available for people who have difficulty in
swallowing
Emtriva hard capsules.
EMTRIVA CONTAINS THE ACTIVE SUBSTANCE _EMTRICITABINE._
This active substance is an
_antiretroviral_
medicine which is used to treat HIV infection. Emtricitabine is a
_nucleoside reverse transcriptase _
_inhibitor_
(NRTI) which works by interfering with the normal working of an enzyme
(reverse
transcriptase) that is essential for the HIV virus to reproduce
itself. Emtriva may lower the amount of
HIV in the blood (viral load). It may also help to increase the number
of T cells called CD4 cells.
Emtriva should always be combined with other medicines to treat HIV
infection.
THIS MEDICINE IS NOT A CURE FOR HIV INFECTION.
While taking Emtriva you may still develop
infections or other illnesses associated with HIV infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMTRIVA
DO NOT TAKE EMTRIVA
•
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Emtriva 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 200 mg of emtricitabine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Each capsule has a white opaque body with a light blue opaque cap, of
dimensions 19.4 mm x 6.9 mm.
Each capsule is printed with “200 mg” on the cap and “GILEAD”
and [Gilead logo] on the body in
black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emtriva is indicated in combination with other antiretroviral
medicinal products for the treatment of
human immunodeficiency virus-1 (HIV-1) infected adults and children
aged 4 months and over.
This indication is based on studies in treatment-naïve patients and
treatment-experienced patients with
stable virological control. There is no experience of the use of
Emtriva in patients who are failing
their current regimen or who have failed multiple regimens (see
section 5.1).
When deciding on a new regimen for patients who have failed an
antiretroviral regimen, careful
consideration should be given to the patterns of mutations associated
with different medicinal products
and the treatment history of the individual patient. Where available,
resistance testing may be
appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
Emtriva 200 mg hard capsules may be taken with or without food.
_Adults:_
The recommended dose of Emtriva is one 200 mg hard capsule, taken
orally, once daily.
If a patient misses a dose of Emtriva within 12 hours of the time it
is usually taken, the patient should
take Emtriva with or without food as soon as possible and resume their
normal dosing schedule. If a
patient misses a dose of Emtriva by more than 12 hours and it is
almost time for their next dose, the
patient should not take the missed dose and simply resume the usual
dosing schedule.
If the pat
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