Orkambi
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
27-07-2023
Karatteristiċi tal-prodott
(SPC)
27-07-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
27-07-2023
Ingredjent attiv:
Lumacaftor, ivacaftor
Disponibbli minn:
Vertex Pharmaceuticals (Ireland) Limited
Kodiċi ATC:
R07AX30
INN (Isem Internazzjonali):
lumacaftor, ivacaftor
Grupp terapewtiku:
Other respiratory system products
Żona terapewtika:
Cystic Fibrosis
Indikazzjonijiet terapewtiċi:
Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene.Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.
Sommarju tal-prodott:
Revision: 32
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2015-11-19
Fuljett ta 'informazzjoni
90
B. PACKAGE LEAFLET
91
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ORKAMBI 100
MG/125
MG FILM-COATED TABLETS
ORKAMBI 200
MG/125
MG FILM-COATED TABLETS
lumacaftor/ivacaftor
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
•
WHAT IS IN THIS LEAFLET
1.
What Orkambi is and what it is used for
2.
What you need to know before you take Orkambi
3.
How to take Orkambi
4.
Possible side effects
5.
How to store Orkambi
6.
Contents of the pack and other information
1.
WHAT ORKAMBI IS AND WHAT IT IS USED FOR
Orkambi contains two active substances, lumacaftor and ivacaftor. It
is a medicine used for long-term
treatment of cystic fibrosis (CF) in patients aged 6 years and older
who have a specific change (called
_F508del _
mutation) affecting the gene for a protein called cystic fibrosis
transmembrane conductance
regulator (CFTR), which plays an important role in regulating the flow
of mucus in the lungs. People
with the mutation will produce an abnormal CFTR protein. Cells contain
two copies of the
_CFTR_
gene; Orkambi is used in patients in whom both copies are affected by
the
_F508del_
mutation
(homozygotes).
Lumacaftor and ivacaftor work together to improve the function of the
abnormal CFTR protein.
Lumacaftor increases the amount of CFTR available and ivacaftor helps
the abnormal protein to work
more normally.
Orkambi may help your breathing by improving your lung function. You
may also notice that it is
easier to gain weight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORKAMBI
DO NOT TAKE ORKAMBI
•
if you are allergic to lumac
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Orkambi 100 mg/125 mg film-coated tablets
Orkambi 200 mg/125 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Orkambi 100 mg/125 mg film-coated tablets
Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of
ivacaftor.
Orkambi 200 mg/125 mg film-coated tablets
Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of
ivacaftor.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film
-
coated tablet (tablet)
Orkambi
100 mg/125 mg film-coated tablets
Pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed
with “1V125” in black ink on one
side.
Orkambi
200 mg/125 mg film-coated tablets
Pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed
with “2V125” in black ink on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Orkambi tablets are indicated for the treatment of cystic fibrosis
(CF) in patients aged 6 years and
older who are homozygous for the
_F508del_
mutation in the cystic fibrosis transmembrane conductance
regulator (
_CFTR_
) gene (see sections 4.2, 4.4, and 5.1).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Orkambi should only be prescribed by physicians with experience in the
treatment of CF. If the
patient’s genotype is unknown, an accurate and validated genotyping
method should be performed to
confirm the presence of the
_F508del_
mutation on both alleles of the
_CFTR_
gene.
Posology
TABLE 1: DOSING RECOMMENDATIONS IN PATIENTS AGED 6 YEARS AND OLDER
AGE
STRENGTH
DOSE (EVERY 12 HOURS)
MORNING
EVENING
6 to < 12 years
lumacaftor 100 mg/ivacaftor 125 mg
2 tablets
2 tablets
12 years and older
lumacaftor 200 mg/ivacaftor 125 mg
2 tablets
2 tablets
Patients may start treatment on any day of the week.
This medicinal product should be taken with fat-containing food. A
fat-containing meal or snack
should be consumed just before or just after dosing (see section 5.2).
_Missed dose _
_ _
If less than 6 hours have passed since the m
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