TIVICAY 50 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

DOLUTEGRAVIR AS SODIUM

Tilgjengelig fra:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kode:

J05AX12

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

DOLUTEGRAVIR AS SODIUM 50 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

GLAXO WELLCOME SA, SPAIN

Terapeutisk område:

DOLUTEGRAVIR

Indikasjoner:

Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age.

Autorisasjon dato:

2019-01-31

Informasjon til brukeren

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a physician’s prescription only
TIVICAY 10 MG
TIVICAY 25 MG
TIVICAY 50 MG
FILM-COATED TABLETS.
Each tablet contains:
Tivicay 10 mg: DOLUTEGRAVIR (AS SODIUM) 10 MG
Tivicay 25 mg: DOLUTEGRAVIR (AS SODIUM) 25 MG
Tivicay 50 mg: DOLUTEGRAVIR (AS SODIUM) 50 MG
The list of the additional ingredients is detailed in section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the physician
or the pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if it seems to you that their
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Tivicay is used to treat HIV (HUMAN IMMUNODEFICIENCY VIRUS)
INFECTION in adults, adolescents and children over 6 years old
and weighing at least 15 kg.
Tivicay does not cure HIV infection; it reduces the amount of
virus in your body, and keeps it at a low level. As a result, it also
increases the CD4 cell count in your blood. CD4 cells are a type
of white blood cells that are important in helping your body to
fight infection.
Not everyone responds to treatment with Tivicay in the same way.
Your physician will monitor the effectiveness of your treatment.
Tivicay treatment is always in combination with other antiretroviral
medicines (_combination therapy_). To control your HIV infection,
and to prevent your illness from getting worse, you must continue
taking all your medicines, unless your physician tells you to stop
taking any of them.
THERAPEUTIC GROUP
Tivicay contains the active ingredient dolutegravir. This medicine
belongs to a group of antiretroviral medicines called _integrase _
_inhibitors (INIs)_.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
• if you (or your child, if they are the patient) are sensitive
(allergic) to the active ingredient or to any of the
other
ingred

Preparatomtale

1
1.
NAME OF THE MEDICINAL PRODUCT
Tivicay 10 mg film-coated tablets
Tivicay 25 mg film-coated tablets
Tivicay 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tivicay 10 mg film-coated tablets
Each film-coated tablet contains dolutegravir sodium equivalent to 10
mg dolutegravir.
Tivicay 25 mg film-coated tablets
Each film-coated tablet contains dolutegravir sodium equivalent to 25
mg dolutegravir.
Tivicay 50 mg film-coated tablets
Each film-coated tablet contains dolutegravir sodium equivalent to 50
mg dolutegravir.
_ _
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet (tablet).
Tivicay 10 mg film-coated tablets
White, round, biconvex tablets approximately 6 mm in diameter debossed
with ‘SV 572’ on
one side and ‘10’ on the other side.
Tivicay 25 mg film-coated tablets
Pale yellow, round, biconvex tablets approximately 7 mm in diameter
debossed with ‘SV
572’ on one side and ‘25’ on the other side.
Tivicay 50 mg film-coated tablets
Yellow, round, biconvex tablets approximately 9 mm in diameter
debossed with ‘SV 572’ on
one side and ‘50’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
2
Tivicay is indicated in combination with other anti-retroviral
medicinal products for the
treatment of Human Immunodeficiency Virus (HIV) infected adults,
adolescents and children
above 6 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tivicay should be prescribed by physicians experienced in the
management of HIV infection.
_ _
Posology
_Adults _
_ _
_Patients infected with HIV-1 without documented or clinically
suspected resistance to the _
_integrase class _
The recommended dose of dolutegravir is 50 mg (one tablet) orally once
daily.
Dolutegravir should be administered twice daily in this population
when co-administered with
some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or
rifampicin). Please refer
to section 4.5.
_Patients infected with HIV-1 with resistance to the integrase class
(docume