NPLATE Powder for solution for injection (2020)
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Περιεχόμενα
Name of the medicinal product
Nplate 125 micrograms powder for solution for injection. Nplate 250 micrograms powder for solution for injection. Nplate 500 micrograms powder for solution for injection.
Qualitative and quantitative composition
Nplate 125 micrograms powder for solution for injection: Each vial contains 125 mcg of romiplostim. After reconstitution, a deliverable volume of 0.25 mL solution contains 125 mcg of romiplostim (500 mcg/mL). ...
Pharmaceutical form
Powder for solution for injection (powder for injection). The powder is white.
Therapeutic indications
Nplate is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see ...
Posology and method of administration
Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases. Posology Nplate should be administered once weekly as a subcutaneous injection. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to E. coli derived proteins.
Special warnings and precautions for use
Reoccurrence of thrombocytopenia and bleeding after cessation of treatment Thrombocytopenia is likely to reoccur upon discontinuation of treatment with romiplostim. There is an increased risk of bleeding ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown. Medicinal products used in ...
Pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of romiplostim in pregnant women. Studies in animals have shown that romiplostim crossed the placenta and increased foetal platelet counts. ...
Effects on ability to drive and use machines
Nplate has moderate influence on the ability to drive and use machines. In clinical trials, mild to moderate, transient bouts of dizziness were experienced by some patients.
Undesirable effects
Summary of the safety profile Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, the overall subject incidence of all adverse reactions ...
Overdose
No adverse effects were seen in rats given a single dose of 1,000 mcg/kg or in monkeys after repeated administration of romiplostim at 500 mcg/kg (100 or 50 times the maximum clinical dose of 10 mcg/kg, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antihaemorrhagics, other systemic haemostatics ATC code: B02BX04 Mechanism of action Romiplostim is an Fc-peptide fusion protein (peptibody) that signals and activates intracellular ...
Pharmacokinetic properties
The pharmacokinetics of romiplostim involved target-mediated disposition, which is presumably mediated by TPO receptors on platelets and other cells of the thrombopoietic lineage such as megakaryocytes. ...
Preclinical safety data
Multiple dose romiplostim toxicology studies were conducted in rats for 4 weeks and in monkeys for up to 6 months. In general, effects observed during these studies were related to the thrombopoietic activity ...
List of excipients
Mannitol (E421) Sucrose L-histidine Hydrochloric acid (for pH adjustment) Polysorbate 20
Incompatibilities
This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Shelf life
Shelf life: 5 years. After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and for 24 hours at 2°C–8°C, when protected from light and kept in the original ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Store in the original carton in order to protect from light. May be removed from the refrigerator for a period of 30 days at room temperature (up to 25°C) ...
Nature and contents of container
Single-dose vial (type 1 clear glass) with a stopper (chlorobutyl rubber), seal (aluminium) and a flip-off cap (polypropylene). The 125 mcg vial cap is beige, the 250 mcg vial cap is red and the 500 mcg ...
Special precautions for disposal and other handling
Reconstitution Nplate is a sterile but unpreserved medicinal product and is intended for single use only. Nplate should be reconstituted in accordance with good aseptic practice. Nplate 125 micrograms ...
Marketing authorization holder
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Marketing authorization number(s)
EU/1/08/497/009 EU/1/08/497/010 EU/1/08/497/001 EU/1/08/497/003 EU/1/08/497/002 EU/1/08/497/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 4 February 2009 Date of latest renewal: 20 December 2013
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