Nityr
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
15-06-2023
Vara einkenni
(SPC)
15-06-2023
Opinber matsskýrsla
(PAR)
09-08-2018
Virkt innihaldsefni:
nitisinone
Fáanlegur frá:
Cycle Pharmaceuticals (Europe) Ltd
ATC númer:
A16AX04
INN (Alþjóðlegt nafn):
nitisinone
Meðferðarhópur:
Other alimentary tract and metabolism products,
Lækningarsvæði:
Tyrosinemias
Ábendingar:
Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Vörulýsing:
Revision: 5
Leyfisstaða:
Authorised
Leyfisdagur:
2018-07-26
Upplýsingar fylgiseðill
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
NITYR
10 MG TABLETS
nitisinone
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nityr is and what it is used for
2.
What you need to know before you take Nityr
3.
How to take Nityr
4.
Possible side effects
5.
How to store Nityr
6.
Contents of the pack and other information
1.
WHAT NITYR IS AND WHAT IT IS USED FOR
Nityr contains the active substance nitisinone.
Nityr is used to treat:
-
A rare disease called hereditary tyrosinemia type 1 in adults,
adolescents and children.
-
A rare disease called alkaptonuria (AKU) in adults.
In these diseases your body is unable to completely break down the
amino acid tyrosine (amino acids
are building blocks of our proteins), forming harmful substances.
These substances are accumulated in
your body. Nityr blocks the breakdown of tyrosine and the harmful
substances are not formed.
For the treatment of hereditary tyrosinemia type 1,
you must follow a special diet while you are
taking this medicine, because tyrosine will remain in your body. This
special diet is based on low
tyrosine and phenylalanine (another amino acid) content.
For the treatment of AKU, your doctor may advise you to follow a
special diet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITYR
_ _
DO NOT TAKE NITYR
-
if you are allergic to nitisinone or any of the other ingredients of
this medicine (listed in section
6).
Do not breast-feed while taking this medicine, see section
“Pregnancy and breast-feeding”.
WARNINGS
Lestu allt skjalið
Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nityr 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg nitisinone.
Excipient with known effect
Each tablet contains 102.99 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to beige, round (7 mm), flat tablet, which may display light
yellow to brown speckles, marked
“10” on one side and “L” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hereditary tyrosinemia type 1 (HT-1)
Nityr is indicated for the treatment of adult and paediatric patients
with confirmed diagnosis of
hereditary tyrosinemia type 1 (HT-1) in combination with dietary
restriction of tyrosine and
phenylalanine.
Alkaptonuria (AKU)
Nityr is indicated for the treatment of adult patients with
alkaptonuria (AKU).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_HT-1_
Nitisinone treatment should be initiated and supervised by a physician
experienced in the treatment of
HT-1 patients.
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
nitisinone 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).
_Starting dose HT-1 _
The recommended initial daily dose in the paediatric and adult
population is 1 mg/kg body weight
administered orally. The dose of nitisinone 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,
3
it is recommended to divide the total daily dose into two daily
administrations in this patient
population.
_Dose adjustment HT-1 _
During regular monitoring, it is appropriate to follow urine
succinylacetone, liver function test values
and alpha-fetoprotein levels (see section 4.
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