Examples of using Novothirteen in English and their translations into Polish
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Computer
NovoThirteen(A-subunit) binds to free human FXIII B-subunit resulting in a heterotetramer[rA2B2]
NovoThirteen is used for the long-term prevention of bleeding in patients with a condition called‘congenital factor XIII A-subunit deficiency.
NovoThirteen may not be effective in patients with hepatic impairment if the hepatic impairment is severe enough to result in decreased levels of FXIII B-subunits.
One healthy subject developed low-titer, transient non-neutralising antibodies after receiving the first dose of NovoThirteen.
Animal studies are insufficient with respect to reproductive toxicity(see section 5.3) as NovoThirteen has not been studied in pregnant animals.
During the long-term study, no bleeding episodes were observed in children below 6 years of age treated with NovoThirteen.
Patients known to have neutralising antibodies to FXIII should not be treated with NovoThirteen without close monitoring.
effectiveness of NovoThirteen in children below 6 years of age was supported by preliminary data from an ongoing long-term study during which the patients were given NovoThirteen to prevent bleeding episodes.
Considering that the posology and the FXIII concentration in NovoThirteen are different from those of the other FXIII containing products,
If NovoThirteen is injected into a child weighing less than 24 kg the reconstituted NovoThirteen should be diluted with 6.0 ml of sodium chloride 0.9%,
Additionally, the company that markets NovoThirteen will provide all doctors who are expected to prescribe it with an information pack for doctors
NovoThirteen was investigated in a main study involving 41 adults
six children less than 6 years old have been treated with NovoThirteen for a total of 393 exposures.
ml sodium chloride 0.9%, solution for injection see section 3‘How to use NovoThirteen- Use in small children.
since the factor XIII concentration in NovoThirteen is different from other factor XIII- containing medicines.
The most common side effects with NovoThirteen(seen in between 1 and 10 patients in 100)
As NovoThirteen contains a recombinant protein it may cause allergic reactions including anaphylactic reactions.
Contact your doctor if you have injected more NovoThirteen than you have been instructed.
There is limited clinical experience in administering NovoThirteen to elderly patients with congenital FXIII deficiency.
NovoThirteen works by providing the factor XIII A-subunit,