Примери за използване на Obizur на Английски и техните преводи на Български
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How is Obizur used?
OBIZUR contains sodium.
Why is Obizur approved?
Medication name Obizur.
What OBIZUR contains.
Other information about Obizur.
OBIZUR is indicated in adults.
Solvent for Obizur water for injections.
What are the risks associated with Obizur?
Obizur was not compared with any other medicine.
This is because it has not been possible to obtain complete information about Obizur due to the rarity of the disease.
What is Obizur and what is it used for?
The European Commission granted a marketing authorisation valid throughout the European Union for Obizur on 11 November 2015.
OBIZUR 500 U powder for solution for injection.
If you are allergic to hamster proteins(trace amounts may be present in Obizur arising from the manufacturing process).
Obizur contains the active substance susoctocog alfa.
The results of the main study showed that Obizur was effective in treating serious bleeding episodes in adults with the disorder.
Obizur(susoctocog alfa)- Summary of product characteristics- B02.
To collect and analyse immediate and long-term data on clinical efficacy and safety of all patientswith acquired haemophilia and who are treated with Obizur, the MAH must conduct a surveillance programme/ registry according to an agreed protocol and for an indefinite time.
OBIZUR 500 U powder and solvent for solution for injection susoctocog alfa.
The MAH shall ensure that in each Member State where Obizur is marketed, all healthcare professionals who are expected to prescribe and dispense Obizur have access to/are provided with the following educational package.
Obizur(susoctocog alfa)- Conditions or restrictions regarding supply and use- B02.
Further to the assessment of the totality of the responses submitted by the MAH for susoctocog alfa(Obizur), the PRAC is of the opinion that the outcome of this article 31 referral procedure does not apply to this product in view of the indication of Obizur(acquired haemophilia A due to inhibitory antibodies to endogenous FVIII) and the different target population.
Obizur contains the active substance susoctocog alfa. How is Obizur used?
Therefore, OBIZUR must only be administered when considered clinically necessary.
Obizur is a recombinant, B-domain deleted, porcine sequence Factor VIII(susoctocog alfa).
The response to Obizur was considered positive if bleeding stopped or was reduced, while a negative response meant that the bleeding continued or worsened.
Obizur is a recombinant, B-domain deleted, porcine sequence Factor VIII(susoctocog alfa). It is a glycoprotein.
Additionally, the company that markets Obizur will provide healthcare professionals who are expected to use Obizur with educational material containing information on how to calculate the dose.
Obizur can only be obtained with a prescription and treatment should be supervised by a doctor with experience in the treatment of haemophilia.