Nitisinone MDK (previously Nitisinone MendeliKABS)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

nitisinone

Available from:

MendeliKABS Europe Ltd

ATC code:

A16AX04

INN (International Name):

nitisinone

Therapeutic group:

Other alimentary tract and metabolism products,

Therapeutic area:

Tyrosinemias

Therapeutic indications:

Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.

Product summary:

Revision: 6

Authorization status:

Withdrawn

Authorization date:

2017-08-24

Patient Information leaflet

27
B. PACKAGE LEAFLET
Medicinal product no longer authorised
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
NITISINONE MDK 2 MG HARD CAPSULES
NITISINONE MDK 5 MG HARD CAPSULES
NITISINONE MDK 10 MG HARD CAPSULES
NITISINONE MDK 20 MG HARD CAPSULES
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nitisinone MDK is and what it is used for
2.
What you need to know before you take Nitisinone MDK
3.
How to take Nitisinone MDK
4.
Possible side effects
5.
How to store Nitisinone MDK
6.
Contents of the pack and other information
1.
WHAT NITISINONE MDK IS AND WHAT IT IS USED FOR
Nitisinone MDK contains the active
substance
nitisinone. This medicine is used for treatment of a
rare disease called hereditary tyrosinemia type 1 in adults,
adolescents and children (in any age range).
In this disease 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. Nitisinone MDK blocks the breakdown of tyrosine and the
harmful substances are not
formed.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITISINONE MDK
DO NOT TAKE NITISINONE MDK:
-
if you are allergic to nitisinone or any of the other ingredients of
this medicine (listed in
section 6).
˗
Do not breast-feed while tak

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Nitisinone MDK 2 mg hard capsules
Nitisinone MDK 5 mg hard capsules
Nitisinone MDK 10 mg hard capsules
Nitisinone MDK 20 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitisinone MDK 2 mg hard capsule
Each hard capsule contains 2 mg nitisinone.
Nitisinone MDK 5 mg hard capsule
Each hard capsule contains 5 mg nitisinone.
Nitisinone MDK 10 mg hard capsule
Each hard capsule contains 10 mg nitisinone.
Nitisinone MDK 20 mg hard capsule
Each hard capsule contains 20 mg nitisinone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
The capsules contain a white to off white powder.
Nitisinone MDK 2 mg hard capsule
White, opaque capsules of 15.7 mm imprinted with black ink “2 mg”
on the cap and “Nitisinone” on the
body.
Nitisinone MDK 5 mg hard capsule
White, opaque capsules of 15.7 mm imprinted with black ink “5 mg”
on the cap and “Nitisinone” on the
body.
Nitisinone MDK 10 mg hard capsule
White, opaque capsules of 15.7 mm imprinted with black ink “10 mg”
on the cap and “Nitisinone” on
the body.
Nitisinone MDK 20 mg hard capsule
White, opaque capsules of 15.7 mm imprinted with black ink “20 mg”
on the cap and “Nitisinone” on
the body.
Medicinal product no longer authorised
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adult and paediatric (in any age range) 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
Nitisinone 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
nitisinone treatment, a diet deficie