Примери за използване на Nityr на Английски и техните преводи на Български
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How to take Nityr.
Nityr contains lactose.
How is Nityr used?
How to store Nityr.
How has Nityr been studied?
Other medicines and Nityr.
Why is Nityr authorised in the EU?
If you stop taking Nityr.
Nityr is intended for long-term use.
Other information about Nityr.
What is Nityr and what is it used for?
If you forget to take Nityr.
Nityr contains the active substance nitisinone and is a‘generic medicine'.
The active ingredient of Nityr is nitisinone.
Nityr is a medicine used to treat hereditary tyrosinaemia type 1(HT-1).
However, as the unconverted tyrosine remains in the body during Nityr treatment, patients need to eat.
Nityr with food Nityr can be taken with or without food throughout your course of treatment.
Therefore, the Agency's view was that, as for Orfadin,the benefit of Nityr outweighs the identified risk and it can be authorised for use in the EU.
Nityr is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
The European Medicines Agency concluded that, in accordance with EU requirements, Nityr has been shown to have comparable quality and to be bioequivalent to Orfadin.
Nityr should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
The active substance in Nityr, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Nityr can only be obtained with a prescription and treatment should be started and monitored by doctors who have experience in the treatment of patients with HT-1.
The study demonstrated that Nityr can be administered with or without food without affecting its bioavailability.
Because Nityr is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
After administration of a single dose of Nityr tablets(10 mg) the terminal half-life(median) of nitisinone in plasma was 59 hours(ranging from 41 to 74 hours).
This means that Nityr contains the same active substance and works in the same way as a‘reference medicine' already authorised in the EU called Orfadin.