KALYDECO 50 MG GRANULES

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

IVACAFTOR

Tilgjengelig fra:

VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL

ATC-kode:

R07AX02

Legemiddelform:

GRANULES

Sammensetning:

IVACAFTOR 50 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

VERTEX PHARMACEUTICALS (IRELAND) LIMITED, IRELAND

Terapeutisk område:

IVACAFTOR

Indikasjoner:

Kalydeco granules are indicated for the treatment of children with cystic fibrosis (CF) aged 2 years and older and weighing less than 25 kg who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data. Limitations of use:Kalydeco is not effective in patients with CF who are homozygous for the F508del mutation in the CFTR gene.

Autorisasjon dato:

2022-07-31

Informasjon til brukeren

KALY_50_75_150-PIL-1023-V1 Page 1 of 7
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) 1986
This medicine is
dispensed with a doctor’s
prescription only
KALYDECO 50 MG GRANULES
KALYDECO 75 MG GRANULES
KALYDECO 150 MG FILM COATED TABLETS
ACTIVE INGREDIENTS AND THEIR QUANTITIES
Kalydeco 50 mg granules
Each sachet of granules contains ivacaftor 50 mg
Kalydeco 75 mg granules
Each sachet of granules contains ivacaftor 75 mg
Kalydeco 150 mg film coated tablets
Each tablet contains ivacaftor 150 mg
Inactive ingredients and allergens - see section 6
“
ADDITIONAL INFORMATION
”
. See also
“
IMPORTANT INFORMATION ABOUT SOME OF THIS
MEDICINE’S INGREDIENTS”
in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU/YOUR CHILD START USING
THIS MEDICINE. This leaflet
contains concise information about this medicine. If you have further
questions, consult your
doctor or pharmacist.
This medicine has been prescribed to treat you/your
child’s
illness. Do not pass it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Kalydeco tablets are indicated for the treatment of patients with
cystic fibrosis (CF) aged 6 years
and older and weighing 25 kg or more who have one mutation in the
_CFTR_ gene that is
responsive to treatment with Kalydeco._ _
Kalydeco granules are indicated for the treatment of children with
cystic fibrosis (CF) aged 2
years and older and weighing less than 25 kg who have one mutation in
the _CFTR_ gene that is
responsive to treatment with Kalydeco.
Kalydeco is not effective in patients with CF who are homozygous for
the _F508del _mutation in the
_CFTR_ gene.
Kalydeco contains the active ingredient ivacaftor. Ivacaftor acts at
the level of the cystic fibrosis
transmembrane conductance regulator (_CFTR_), a protein that forms a
channel at the cell surface
that allows the movement of particles such as chloride ions in and out
of the cell. Due to
mutations in the _CFTR_ gene (see below), chlor

Preparatomtale

KALY_50_75_150-SPC-1023-V1 Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Kalydeco 50 mg granules
Kalydeco 75 mg granules
Kalydeco 150 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film-coated tablets
Each film-coated tablet contains 150 mg of ivacaftor.
Excipient with known effect: each film-coated tablet contains 167.2 mg
of lactose monohydrate.
Granules in sachet
Kalydeco 50 mg granules in sachet: each sachet contains 50 mg of
ivacaftor.
Excipient with known effect: each sachet contains 73.2 mg of lactose
monohydrate.
Kalydeco 75 mg granules in sachet: each sachet contains 75 mg of
ivacaftor.
Excipient with known effect: each sachet contains 109.8 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet
Light blue, capsule-
shaped tablets, printed with “V
150” in black ink on one side and plain on the other
.
Granules in sachet
White to off-white granules approximately 2 mm in diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kalydeco tablets are indicated for the treatment of patients with
cystic fibrosis (CF) aged 6 years and older
and weighing 25 kg or more who have one mutation in the _CFTR_ gene
that is responsive to ivacaftor
potentiation based on clinical and/or _in vitro_ assay data (see
sections 4.4 and 5.1).
Kalydeco granules are indicated for the treatment of children with
cystic fibrosis (CF) aged 2 years and
older and weighing less than 25 kg who have one mutation in the _CFTR_
gene that is responsive to
ivacaftor potentiation based on clinical and/or _in vitro _assay data_
_(see sections 4.4 and 5.1).
Limitations of use:
Kalydeco is not effective in patients with CF who are homozygous for
the _F508del_ mutation in the _CFTR_
gene.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Kalydeco should only be prescribed by physicians with experience in
the treatment of cystic fibrosis. If
the patient's genotype is unknown, an accurate and validated
genotyping method should be per