NITYR ( NITISINONE) 5 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

NITISINONE

متاح من:

TRUEMED LTD, ISRAEL

ATC رمز:

A16AX04

الشكل الصيدلاني:

TABLETS

تركيب:

NITISINONE 5 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CYCLE PHARMACEUTICALS LTD, UK

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 phenylalanine.

تاريخ الترخيص:

2020-09-24

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986
THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
NITYR NITISINONE 2 MG
NITYR NITISINONE 5 MG
NITYR NITISINONE 10 MG
TABLETS
COMPOSITION:
ACTIVE INGREDIENT:
EACH TABLET OF NITYR 2 MG CONTAINS NITISINONE 2 MG
EACH TABLET OF NITYR 5 MG CONTAINS NITISINONE 5 MG
EACH TABLET OF NITYR 10 MG CONTAINS NITISINONE 10 MG
FOR A LIST OF INACTIVE AND ALLERGENIC INGREDIENTS IN THE
PREPARATION, see section 6 ”Further Information“.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them even if
it seems to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Nityr tablets is given to treat a hereditary disease called
tyrosinemia type 1. In this disease, your body is unable to
completely break down the amino acid tyrosine )amino acids
are building blocks that build the proteins in our body(, resulting
in the body accumulating a substance that is harmful to it. Nityr
tablets prevent the breakdown of the amino acid tyrosine in
the first place, and as a result, the harmful substance does not
accumulate in your body.
Because tyrosine remains in the body, a special dietary regimen
based on foods with low amounts of tyrosine and phenylalanine
should be maintained during treatment with Nityr tablets.
THERAPEUTIC GROUP: treatment of essential metabolic system
defects.
2. BEFORE USING THE MEDICINE:
DO NOT USE THE PREPARATION IF:
• You are sensitive )allergic( to the active ingredient
nitisinone or to any of the other ingredients contained in
the medicine )please see section 6 ”Further Information“(.
• You are breastfeeding.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE AND DURING TREATMENT WITH NITYR TABLETS, TELL THE
DOCTOR:
• If redness

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NITYR 2mg, 5mg, 10mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg, 5mg, 10mg nitisinone.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
White to beige, round, flat tablet, which may display light yellow to
brown speckles, debossed
with “L” on one side and the strength (“2”mg,
“5”mg,”10”mg) on the other side.
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
NITYR tablets 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 NITYR tablets 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 pediatric and adult population is
1mg/kg body weight
administered orally. The dose of NITYR tablets 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 NITYR tablets treatment, the NITYR
tablets dose should be
increased to 1.5 mg/kg body weight/day divided in 2 doses. A dose of 2
mg/kg body weight/day
may be needed based on the evalua