NEULASTIM Solution for injection (2015)
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Περιεχόμενα
1. Name of the medicinal product
NEULASTIM Injection.
2. Qualitative and quantitative composition
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0,6 ml (10 mg/ ml) in solution for injection. Pegfilgrastim is composed of filgrastim (recombinant methionyl human granulocyte colony stimulating ...
3. Pharmaceutical form
Pre-filled syringe. A clear and colourless liquid, practically free from particles.
4.1. Therapeutic indications
To reduce the duration of neutropenia and the incidence of febrile neutropenia and the incidence of infection as manifested by febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy ...
4.2. Posology and method of administration
<u>Adults (≥18 years):</u> One 6 mg dose (a single pre-filled syringe) of NEULASTIM is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following ...
4.3. Contraindications
Hypersensitivity to pegfilgrastim, filgrastim, E. coli derived proteins, or to any excipients.
4.4. Special warnings and precautions for use
Cases of splenic rupture, in some cases fatal, have been reported following administration of pegfilgrastim. Spleen size should be carefully monitored. Patients receiving pegfilgrastim who report left ...
4.5. Interaction with other medicinal products and other forms of interaction
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ NEULASTIM should be administered approximately 24 hours after administration of cytotoxic chemotherapy. In ...
4.6. Pregnancy and lactation
Safety in pregnancy has not been established. Studies in animals have shown reproductive toxicity. The potential risk to the human embryo or foetus is unknown. NEULASTIM should not be used during pregnancy. ...
4.8. Undesirable effects
In randomised clinical studies in patients with malignancy receiving NEULASTIM after cytotoxic chemotherapy, most adverse events were caused by the underlying malignancy or cytotoxic chemotherapy. The ...
4.9. Overdose
Single doses of 300 µg/kg have been administered to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse effects. The adverse events were similar ...
5.1. Pharmacodynamic properties
A 8.5 Medicines acting on blood and haemopoietic system others. Pharmacodynamic properties Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release ...
5.2. Pharmacokinetic properties
Absorption After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing. Distribution Serum concentrations of pegfilgrastim are ...
6.1. List of excipients
Sodium acetate, sorbitol, polysorbate 20, water for injections.
6.4. Special precautions for storage
Store at 2-8°C (in a refrigerator). Do not freeze. Keep the container in the outer carton, in order to protect from light. Keep out of reach and sight of children. Accidental exposure to freezing temperatures ...
6.5. Nature and contents of container
1 ml clear colourless Type I glass pre-filled syringe (containing 0,6 ml) with a stainless steel needle, for single use only. Cartons with 1 or 5 syringes.
7. Marketing authorization holder
Amgen South Africa (Pty) Ltd. Building D, Ballyoaks Office Park, 35 Ballyclare Drive, Bryanston Ext. 7, South Africa
8. Marketing authorization number(s)
42/8.5/0598
10. Date of revision of the text
12 June 2015
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