Примери за използване на Pegaspargase на Английски и техните преводи на Български
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The active substance is pegaspargase.
Pegaspargase was not mutagenic in the Ames test using Salmonella typhimurium strains.
One ml of solution contains 750 units pegaspargase.
Pegaspargase was well tolerated both in rats and dogs when administered intravenously in single dose up to 500 U/kg body weight.
Each pack contains 1 glass vial with 3,750 U pegaspargase.
The decrease in serum proteins caused by pegaspargase can increase the toxicity of other medicinal products that are protein bound.
After reconstitution, 1 ml of solution contains 750 U pegaspargase(750 U/ml).
The active substance(pegaspargase) contains the enzyme asparaginase which works by breaking up and reducing the blood levels of the amino acid asparagine.
Reproductive toxicity No studies of reproductive toxicity were conducted with pegaspargase.
Fertility No studies investigating the effect of pegaspargase on fertility have been performed.
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection/infusion 1 vial with 3,750 U pegaspargase.
If these substances are given subsequently,the effect of pegaspargase can be weakened antagonistically.
NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml powder for solution for injection/infusion pegaspargase.
Although they have not been specifically associated with the use of pegaspargase, they may occur with the use of Oncaspar.
Immediately preceding orsimultaneous treatment with vincristine can increase the toxicity of pegaspargase.
Children with a body surface area< 0.6 m2 should receive 82.5 U of pegaspargase(equivalent to 0.1 ml Oncaspar)/kg body weight every 14 days.
Long-term investigations of carcinogenicity orstudies of the effect on fertility in animals were not conducted with pegaspargase.
No reproduction studies in animals with pegaspargase were performed but studies in animals with L-asparaginase have shown teratogenicity(see section 5.3).
Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving pegaspargase(see section 4.8).
Pegaspargase may cause myelosuppression, either directly or indirectly(by altering myelosuppressive effects of other agents such as methotrexate or 6-mercaptopurine).
Treatment may be monitored based on the trough serum asparaginase activity measured before the next administration of pegaspargase.
As pegaspargase is a protein with a high molecular weight, it is not excreted renally, and no dose adjustment is necessary in patients with renal impairment.
Type I flint glass vial with chlorobutyl elastomer stopper, capped with a 20 mm aluminium flip-off seal,containing 3,750 U pegaspargase.
Only very high doses of pegaspargase given to mice intraperitoneally as a single dose(25,000100,000 U/kg body weight) caused the death of 14% of all treated mice.
Methotrexate and cytarabine can interact differently with Oncaspar: their prior administration can increase the action of pegaspargase synergistically.
Oncaspar contains pegaspargase, which is an enzyme(asparaginase) that breaks down asparagine, an important building block of proteins without which cells cannot survive.
Therefore and due to its pharmacological properties,Oncaspar should not be used during pregnancy unless the clinical conditions of the woman require treatment with pegaspargase.
Unless otherwise prescribed, the recommended posology in adults aged>21 years is 2,000 U of pegaspargase(equivalent to 2.67 ml Oncaspar)/m2 body surface area every 14 days.
As pegaspargase is a protein with a high molecular weight, it is not excreted renally, and no change of pharmacokinetic of Oncaspar in patients with renal impairment is foreseen.
In addition, by inhibiting protein synthesis andcell division, pegaspargase can disturb the mechanism of action of other substances which require cell division for their effect, e.g., methotrexate.