FULPHILA Solution for injection (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Fulphila 6 mg solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**. * Produced in Escherichia coli cells by recombinant DNA ...
Pharmaceutical form
Solution for injection (injection). Clear, colourless solution for injection.
Therapeutic indications
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and ...
Posology and method of administration
Pegfilgrastim therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. Posology One 6 mg dose (a single pre-filled syringe) of pegfilgrastim is recommended for ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients with myeloid leukaemia ...
Interaction with other medicinal products and other forms of interaction
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy. In clinical ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of pegfilgrastim in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Pegfilgrastim is not recommended ...
Effects on ability to drive and use machines
Pegfilgrastim has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions were bone pain (very common [≥1/10]) and musculoskeletal pain (common [≥1/100 to <1/10]). Bone pain was generally of mild to ...
Overdose
Single doses of 300 mcg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions. The adverse events ...
Pharmacodynamic properties
Pharmacotherapeutic group: immunostimulants, colony stimulating factor ATC Code: L03AA13 Fulphila is a biosimilar medicinal product. Detailed information is available on the website of the European Medicines ...
Pharmacokinetic properties
After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the ...
Preclinical safety data
Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary ...
List of excipients
Sodium acetate* Sorbitol (E420) Polysorbate 20 Water for injections * Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Incompatibilities
This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Shelf life
3 years.
Special precautions for storage
Store in a refrigerator (2°C–8°C). Fulphila may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours. Fulphila left at room temperature for more than 72 hours should ...
Nature and contents of container
Pre-filled syringe (Type I glass), with a fluorotec-coated bromobutyl rubber stopper and a stainless steel needle with or without an automatic needle guard. Pack size of one pre-filled syringe, in blistered ...
Special precautions for disposal and other handling
Before administration, Fulphila solution should be inspected visually for particulate matter. Only a solution that is clear and colourless should be injected. Excessive shaking may aggregate pegfilgrastim, ...
Marketing authorization holder
Mylan S.A.S., 117 allée des Parcs, 69800, Saint-Priest, France
Marketing authorization number(s)
EU/1/18/1329/001 1 pre-filled syringe EU/1/18/1329/002 1 pre-filled syringe with needle guard
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 November 2018
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