DOLAMVIR TABLET

Država: Južnoafriška republika

Jezik: angleščina

Source: South African Health Products Regulatory Authority (SAHPRA)

Dostopno od:

Novagen Pharma (Pty) Ltd

Odmerek:

50,0 mg 300,0 mg 245,0 mg

Farmacevtska oblika:

TABLET

Sestava:

EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE EQUIVALENT TO TENOFIVIR DISOPROXIL 245,0 mg

Status dovoljenje:

Registered

Navodilo za uporabo

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Page 1 of 15
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
DOLAMVIR 50 MG/300 MG/300 MG FILM-COATED TABLETS
DOLUTEGRAVIR /LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE
CONTAINS SUGAR (145,37 MG MANNITOL PER TABLET)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE DOLAMVIR
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
DOLAMVIR 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.
WHAT IS IN THIS LEAFLET
1. What DOLAMVIR is and what it is used for
2. What you need to know before you take DOLAMVIR
3. How to take DOLAMVIR
4. Possible side effects
5. How to store DOLAMVIR
6. Contents of the pack and other information
1. WHAT DOLAMVIR IS AND WHAT IT IS USED FOR
The active ingredients in DOLAMVIR are dolutegravir (as dolutegravir
sodium), lamivudine and tenofovir
disoproxil fumarate.
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DOLAMVIR is used to treat HIV (human immunodeficiency virus) infection
in adults and adolescents over 18
years old.
WARNING:
TOO MUCH ACID IN THE BODY DUE TO LACTIC ACID AND SERIOUS ENLARGED,
FATTY
LIVER, INCLUDING CASES RESULTING IN DEATH, HAVE BEEN REPORTED WITH THE
USE
OF NUCLEOSIDE ANALOGUES (MEDICINES USED FOR THE TREATMENT OF HIV)
ALONE
OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE “TAKE SPECIAL CARE
WITH DOLAMVIR”). DOLAMVIR IS NOT INDICATED FOR TREATMENT OF CHRONIC
HEPATITIS B VIRUS (HBV) INFECTION. THE SAFETY AND EFFICACY OF DOLAMVIR
HAS
NOT BEEN ESTABLISHED IN PATIENTS INFECTED WITH BOTH HBV AND HIV.
SEVERE
ACUTE WORSENING OF HEPATITIS B HAS BEEN REPORTED IN PATIENTS WHO ARE
INFECTED WITH BOTH HBV AND HIV AND HAVE STOPPED TAKING THE COMBINATION
TABLET. LIVER FUNCTION SHOULD BE MONITORED CLOSELY BY A HEALTHCARE
PRACTITIONER FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO ARE INFECTED
WITH BOTH HIV AND HBV AND WHO STOPPED TAKING THE COMBINATION TABLET.
IF
APPROPRIATE, MEDICINE TO TR

Lastnosti izdelka

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Page 1 of 51
SCHEDULING STATUS
1. NAME OF THE MEDICINE
DOLAMVIR 50 mg/300 mg /300 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg dolutegravir (as sodium), 300
mg lamivudine and 300 mg tenofovir disoproxil
fumarate which is equivalent to 245 mg of tenofovir disoproxil.
_Excipient with known effect:_ Contains sugar: 145,37 mg mannitol.
For the full list of excipients, see section 6.1.
WARNING
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL
CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE
OR IN
COMBINATION WITH OTHER ANTIRETROVIRALS (SEE SECTION 4.4).
DOLAMVIR IS NOT INDICATED FOR THE TREATMENT OF CHRONIC HEPATITIS B
VIRUS
(HBV) INFECTION. THE SAFETY AND EFFICACY OF DOLMVIR HAS NOT BEEN
ESTABLISHED
IN PATIENTS CO-INFECTED WITH HBV AND HIV. SEVERE ACUTE EXACERBATIONS
OF
HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO ARE COINFECTED WITH HBV
AND
HIV AND HAVE DISCONTINUED THE COMBINATION TABLET.
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Page 2 of 51
HEPATIC
FUNCTION
SHOULD
BE
MONITORED
CLOSELY
WITH
BOTH
CLINICAL
AND
LABORATORY
FOLLOW-UP
FOR
AT
LEAST
SEVERAL
MONTHS
IN
PATIENTS
WHO
DISCONTINUE DOLMVIR AND ARE CO-INFECTED WITH HIV AND HBV. IF
APPROPRIATE,
INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED (SEE SECTION
4.4).
3. PHARMACEUTICAL FORM
Film-coated tablets.
Pink coloured, oval, biconvex, film coated tablet debossed with
‘N33’ on one side and plain on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DOLAMVIR is a triple combination therapy which is indicated for the
treatment of human immunodeficiency virus
(HIV) infection in adults aged 18 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOLAMVIR therapy should be initiated by a medical practitioner
experienced in the management of HIV infection.
_ADULTS: _
The dose of DOLAMVIR is one tablet taken orally, once daily, without
regard to food.
Special Populations:
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_RENAL IMPAIRMENT: _
Significantly increased expo