Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα
®
 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

FULPHILA Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: