ORFADIN 2 MG HARD CAPSULES

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

NITISINONE

متاح من:

MEGAPHARM LTD

ATC رمز:

A16AX04

الشكل الصيدلاني:

HARD CAPSULE

تركيب:

NITISINONE 2 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

APOTEK PRODUKTION & LABORATORIER AB, SWEDEN

المجموعة العلاجية:

NITISINONE

المجال العلاجي:

NITISINONE

الخصائص العلاجية:

Treatment of patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine05/06/2018 בקשה לשינוי משטר מינון Once Daily

تاريخ الترخيص:

2016-12-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS - 1986
This medicine is dispensed
with a physician’s prescription only
ORFADIN
™ 2 MG
HARD CAPSULES
ORFADIN
™ 5 MG
HARD CAPSULES
ORFADIN
™ 10 MG
HARD CAPSULES
COMPOSITION:
ACTIVE INGREDIENT:
EACH CAPSULE OF ORFADIN 2 MG HARD CAPSULES
CONTAINS NITISINONE 2 MG
EACH CAPSULE OF ORFADIN 5 MG HARD CAPSULES
CONTAINS NITISINONE 5 MG
EACH CAPSULE OF
ORFADIN 10 MG HARD CAPSULES
CONTAINS NITISINONE 10 MG
For the list of inactive ingredients and allergens in the
medicine, see section 6,
“Additional information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, consult
your
physician 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.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Treatment of patients with confirmed diagnosis of
hereditary tyrosinemia type 1 )HT-1( in combination with
dietary restriction of tyrosine and phenylalanine.
In this disease your body is unable to completely break
down the amino acid tyrosine )amino acids are the building
blocks that build the proteins in our body(, and as a result,
a harmful substance accumulates in the body. ORFADIN
HARD CAPSULES prevent the breakdown of the amino acid
tyrosine from the outset, and as a result, the harmful
substance does not accumulate in your body.
Since tyrosine remains in the body, a special dietary
regime based on foods with low quantities of tyrosine and
phenylalanine should be maintained during treatment with
ORFADIN HARD CAPSULES.
THERAPEUTIC GROUP: Treatment of defects in an essential
metabolic system.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You are sensitive )allergic( to the active ingredient nitisinone
or to any of the additional ingredients that the medicine
contains )please see section 6, “Additional information”(.
�

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Orfadin 2 mg, 5mg, 10mg Hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2 mg, 5mg, 10mg Nitisinone.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
White, opaque capsules imprinted “NTBC 2mg”/ “NTBC 5mg”/
“NTBC 10mg” in black on the
body of the capsule.
The capsules contain a white to off white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients with confirmed diagnosis of hereditary
tyrosinemia type 1 (HT-1) in
combination with dietary restriction of tyrosine and phenylalanine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Orfadin hard capsules treatment should be initiated and supervised by
a physician experienced
in the treatment of HT-1 patients.
Posology
Treatment of all genotypes of the disease should be initiated as early
as possible to
increase overall survival and avoid complications such as liver
failure, liver cancer and
renal disease. Adjunct to the Orfadin hard capsules treatment, a diet
deficient in
phenylalanine and tyrosine is required and should be followed by
monitoring of plasma
amino acids (see sections 4.4 and 4.8).
The recommended initial dose in the paediatric and adult population is
1 mg/kg body weight_ _
administered orally. The dose of Orfadin hard capsules should be
adjusted individually. It is
recommended to administer the dose once daily. However, due to the
limited data in
patients with body weight <20 kg, it is recommended to divide the
total daily dose into two
daily administrations in this patient population.
_Dose adjustment_
During regular monitoring, it is appropriate to follow urine
succinylacetone, liver function test
values and alpha-fetoprotein levels (see section 4.4). If urine
succinylacetone is still
detectable one month after the start of Orfadin hard capsules
treatment, the Orfadin hard
capsules dose should be increased to 1.5 mg/kg body weight/day divided
in 2 doses. A dose
of 2 mg/kg body weight