SYMDEKO 100 MG150 MG & 150 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

IVACAFTOR; TEZACAFTOR

متاح من:

VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL

ATC رمز:

R07AX31

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

IVACAFTOR 150 MG; TEZACAFTOR 100 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

VERTEX PHARMACEUTICALS (EUROPE) LIMITED, UK

المجال العلاجي:

IVACAFTOR AND TEZACAFTOR

الخصائص العلاجية:

SYMDEKO is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.If the patient’s genotype is unknown, a health authority cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

تاريخ الترخيص:

2019-09-23

نشرة المعلومات

SYMD-PIL-0923-V1
Page 1 of 6
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with
a doctor’s prescription only
SYMDEKO 50 MG/ 75 MG & 75 MG
SYMDEKO 100 MG/150 MG & 150 MG
FILM-COATED TABLETS
ACTIVE INGREDIENTS AND THEIR QUANTITIES
SYMDEKO 50 MG/ 75 MG & 75 MG
White film-coated tablets
Each film coated tablet contains tezacaftor 50 mg and ivacaftor 75 mg
Light blue film-coated tablets
Each film coated tablet contains ivacaftor 75 mg
SYMDEKO 100 MG/150 MG & 150 MG
Yellow film-coated tablets
Each film coated tablet contains tezacaftor 100 mg and ivacaftor 150
mg
Light blue film-coated tablets
Each film coated 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 THE ENTIRE LEAFLET CAREFULLY BEFORE YOU 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 your 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?
Symdeko contains a combination of tezacaftor and ivacaftor and is used
for the treatment of
cystic fibrosis (CF) in patients ages 6 years and older who have
inherited the _F508del _mutation
(change) from both parents and therefore have the mutation in two
copies of the CFTR gene, or
who have at least one mutation in the CFTR gene that is responsive to
treatment with Symdeko.
THERAPEUTIC GROUP:
Tezacaftor
–
CFTR corrector
Ivacaftor
–
Potentiator of the CFTR protein
Symdeko contains two active substances, tezacaftor and ivacaftor that
work together to improve
the function of the abnormal CFTR protein. Tezacaftor increases the
amount of CFTR available
and ivacaftor helps the abnormal protein to work more properly.
2.
BEFORE USING THE MED

خصائص المنتج

SYMD-SPC-0923-V1
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SYMDEKO 50 mg/75 mg & 75 mg
SYMDEKO 100 mg/150 mg & 150 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SYMDEKO 50 MG/75 MG & 75 MG
TEZACAFTOR/IVACAFTOR TABLET:
Each film-coated tablet contains 75 mg ivacaftor and 50 mg tezacaftor.
IVACAFTOR TABLET:
Each film-coated tablet contains 75 mg ivacaftor.
EXCIPIENTS WITH KNOWN EFFECT:
Each Ivacaftor film-coated tablet contains 83.6 mg of lactose.
SYMDEKO 100 MG/150 MG & 150 MG
TEZACAFTOR/IVACAFTOR TABLET:
Each film-coated tablet contains 150 mg ivacaftor and 100 mg
tezacaftor.
IVACAFTOR TABLET:
Each film-coated tablet contains 150 mg ivacaftor.
EXCIPIENTS WITH KNOWN EFFECT:
Each Ivacaftor film-coated tablet contains 167.2 mg of lactose.
For the full list of excipients, _see Description (12)_.
3 PHARMACEUTICAL FORM
Film-coated tablets
SYMDEKO 50 MG/75 MG & 75 MG
TEZACAFTOR/IVACAFTOR TABLET:
White film-coated tablet,
debossed with “V
50” on one
face.
IVACAFTOR TABLET:
Light blue capsule-
shaped tablet printed with “V 75” in black ink on one
face.
SYMDEKO 100 MG/150 MG & 150 MG
TEZACAFTOR/IVACAFTOR TABLET:
Yellow film-coated tablet,
debossed with “V
100” on one
face.
IVACAFTOR TABLET:
Light blue capsule-shaped tablet printed with
“
V 150
”
in black ink on one face.
4 THERAPEUTIC INDICATION
SYMDEKO is a combination of tezacaftor and ivacaftor, indicated for
the treatment of patients with cystic fibrosis (CF) aged 6 years and
older who are homozygous
for the _F508del_ mutation or who have at least one mutation in the
cystic fibrosis transmembrane conductance regulator (CFTR) gene that
is responsive to
tezacaftor/ivacaftor based on _in vitro_ data and/or clinical evidence
[_see Clinical Pharmacology (13.1)]._
If the patient’s genotype is unknown,
a health authority cleared CF mutation test should be used to detect
the presence of a CFTR mutation followed by verification
with bi-directional sequencing when recommended by the mutation test
instructions for use.
5 DOS