VOLIBRIS 10 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

AMBRISENTAN

Beschikbaar vanaf:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-code:

C02KX02

farmaceutische vorm:

FILM COATED TABLETS

Samenstelling:

AMBRISENTAN 10 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

PATHEON INC., CANADA

Therapeutisch gebied:

AMBRISENTAN

therapeutische indicaties:

Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment with tadalafil.Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.

Autorisatie datum:

2024-01-31

Bijsluiter

PATIENT LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed
according to a physician’s prescription only
VOLIBRIS 5 MG
FILM-COATED TABLETS
EACH TABLET CONTAINS:
AMBRISENTAN 5 MG
VOLIBRIS 10 MG
FILM-COATED TABLETS
EACH TABLET CONTAINS:
AMBRISENTAN 10 MG
For a list of inactive and allergenic ingredients in the
medicine, see section 2 – “Important information
about some of the ingredients of the medicine”
and section 6 – “Additional information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have any
other 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.
Volibris patient safety information card
IN ADDITION TO THE LEAFLET, VOLIBRIS HAS A PATIENT
SAFETY INFORMATION CARD REGARDING POTENTIAL
HARM TO THE FETUS AND POTENTIAL LIVER INJURY.
THIS CARD CONTAINS IMPORTANT SAFETY INFORMATION
THAT YOU MUST KNOW AND ACT UPON BEFORE
STARTING AND DURING TREATMENT WITH VOLIBRIS.
READ THE PATIENT SAFETY INFORMATION CARD AND
THE PATIENT LEAFLET BEFORE STARTING TO USE THE
PREPARATION. KEEP THE CARD AND THE LEAFLET FOR
FURTHER READING IF NECESSARY.
Do not take Volibris if you are pregnant since
the use of this medicine may harm the fetus
)see section 2 “Do not use the medicine”,
section 2 “Pregnancy” and “Breast-feeding”).
If you are a woman of child-bearing age who may
become pregnant, a pregnancy test should be
performed before starting treatment with Volibris
and routinely each month while you are taking
this medicine, and a month after stopping the
treatment. Ensure a negative result at each
pregnancy test.
You must use a reliable form of birth control
)contraception) during the treatment with Volibris,
and for an additional one month after stopping
the treatment )see section 2
“Pregnancy”).
1. WHAT IS

Productkenmerken

Page 1 of 18
VOLIBRIS 5 MG
VOLIBRIS 10 MG
1.
NAME OF THE MEDICINAL PRODUCT
Volibris 5 mg
Volibris 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VOLIBRIS 5 MG:
Each tablet contains 5 mg of ambrisentan.
Excipient(s) with known effect:
Each tablet contains approximately 90.3 mg of lactose (as
monohydrate), approximately 0.25 mg of
lecithin (soya) (E322) and approximately 0.11 mg of allura red AC
aluminium lake (E129).
VOLIBRIS 10 MG
Each tablet contains 10 mg of ambrisentan.
Excipient(s) with known effect:
Each tablet contains approximately 85.5mg lactose (as monohydrate),
approximately 0.25 mg of
lecithin (soya) (E322) and approximately 0.45 mg of allura red AC
aluminium lake (E129).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Volibris 5 mg
:
Pale-pink, 6.6 mm square, convex, film-coated tablet with “GS”
debossed on one side and “K2C” on
the other side.
Volibris 10
mg:
Deep-pink, 9.8 mm × 4.9 mm oval, convex, film-coated tablet with
“GS” debossed on one side and
“KE3” on the other side.
Page 2 of 18
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Volibris is indicated for treatment of pulmonary arterial hypertension
(PAH) in adult patients of WHO
Functional Class (FC) II to III, including use in combination
treatment with tadalafil
.
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated
with connective tissue
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated by a physician experienced in the
treatment of PAH.
Posology
_Ambrisentan monotherapy _
Volibris is to be taken orally to begin at a dose of 5 mg once daily
and may be increased to 10 mg
daily depending upon clinical response and tolerability.
_ _
_Ambrisentan in combination with tadalafil _
When used in combination with tadalafil, Volibris should be titrated
to 10 mg once daily.
In the AMBITION study, patients received 5
mg ambrisentan daily for the first 8 weeks before up
titrating to 10
mg, dependent on tolerability (see section 5.1). When u