KALYDECO 150 MG FILM COATED TABLETS

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

IVACAFTOR

Disponibil de la:

VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL

Codul ATC:

R07AX02

Forma farmaceutică:

FILM COATED TABLETS

Compoziție:

IVACAFTOR 150 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

VERTEX PHARMACEUTICALS (EUROPE) LIMITED, UK

Zonă Terapeutică:

IVACAFTOR

Indicații terapeutice:

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 of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.Limitations of use:Kalydeco is not effective in patients with CF who are homozygous for the F508del mutation in the CFTR gene

Data de autorizare:

2020-04-30

Prospect

KALY_50_75_150-PIL-0320-V1 Page 1 of 7
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) 1986
This medicine is marketed upon physician’s prescription only
KALYDECO 150MG FILM COATED TABLETS
Film-
coated tablets
Each film-coated tablet contains: 150 mg ivacaftor
KALYDECO 50MG GRANULES, KALYDECO 75MG GRANULES
Granules in sachet
Each 50 mg granules in sachet contains: 50 mg ivacaftor
Each 75 mg granules in sachet contains: 75 mg ivacaftor
The list of the inactive ingredients in the product is shown in
section 6 (“other information”) in this leaflet.
READ THIS LEAFLET CAREFULLY BEFORE YOU/YOUR CHILD START USING THE
MEDICINE. This leaflet contains
concise information about the medicine. If you have any further
questions ask the doctor or the 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.
Kalydeco tablets are intended to treat adults and children age 6 years
and older weighing 25 kg or more.
Kalydeco granules are intended to treat children aged 2 years and
older and weighing less than 25 kg.
1.
WHAT IS THIS MEDICINE USED 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 of the following gating (class
III) mutations in the _CFTR_ gene:
_G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
_
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 of the following
gating (class III) mutations in the CFTR
gene: _G551D_, _G1244E_, _G1349D_, _G178R_, _G551S_, _S1251N_,
_S1255P_, _S549N_ or _S549R_.
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 regulat

Caracteristicilor produsului

KALY_50_75_150-SPC-0320-V1 Page 1 of 19
PHYSICIAN PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Kalydeco 50mg Granules (granules in sachet)
Kalydeco 75mg Granules (granules in sachet)
Kalydeco 150mg Film Coated Tablets (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 (as 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
(as 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
(as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Light blue, capsule-shaped tablets, printed with “V 150” in black
ink on one side and plain on the other
(16.5 mm x 8.4 mm in modified tablet shape).
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 of the following gating (class
III) mutations in the
_CFTR_
gene:
_G551D_
,
_G1244E_
,
_G1349D_
,
_G178R_
,
_G551S_
,
_S1251N_
,
_S1255P_
,
_S549N_
or
_ S549R_
(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 of the following
gating (class III) mutations in the
_CFTR_
gene:
_G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N _
or
_ S549R_
(see sections 4.4 and
5.1).
Limitations of use:
KALY_50_75_150-SPC-0320-V1 Page 2 of 19
Kalydeco is not effective in patients with CF who are homozygous for
the
_F508del_
mutation in the
_CFTR_
gene.
4.2
POSOLOGY AND