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
Συνδρομές 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

LONQUEX Solution for injection in pre-filled syringe (2019)

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

Lonquex 6 mg solution for injection in pre-filled syringe.

Qualitative and quantitative composition

Each pre-filled syringe contains 6 mg of lipegfilgrastim* in 0.6 ml solution. Each ml of solution for injection contains 10 mg of lipegfilgrastim. The active substance is a covalent conjugate of filgrastim** ...

Pharmaceutical form

Solution for injection in pre-filled syringe (injection). Clear, colourless solution.

Therapeutic indications

Lonquex is indicated in adults for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of ...

Posology and method of administration

Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology. Posology One 6 mg dose of lipegfilgrastim (a single pre-filled syringe of Lonquex) is recommended ...

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 trade name and batch number of the administered medicinal product should be clearly recorded in the patient file. ...

Interaction with other medicinal products and other forms of interaction

Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, Lonquex should be administered approximately 24 hours after administration of cytotoxic chemotherapy. Concomitant ...

Fertility, pregnancy and lactation

Pregnancy There are very limited data (less than 300 pregnancy outcomes) on the use of lipegfilgrastim in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary ...

Effects on ability to drive and use machines

Lonquex has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most frequent undesirable effects are musculoskeletal pain and nausea. Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported ...

Overdose

There is no experience with overdose of lipegfilgrastim. In the case of overdose, WBC and platelet count should be performed regularly and spleen size should be carefully monitored (e.g. clinical examination, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Immunostimulants, colony stimulating factors ATC code: L03AA14 Mechanism of action Lipegfilgrastim is a covalent conjugate of filgrastim with a single methoxy polyethylene glycol ...

Pharmacokinetic properties

General Healthy volunteers In 3 studies (XM22-01, XM22-05, XM22-06) in healthy volunteers, the maximum blood concentration was reached after a median of 30 to 36 hours and the average terminal half-life ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and local tolerance. In a study of toxicity to reproduction ...

List of excipients

Glacial acetic acid Sodium hydroxide (for pH-adjustment) Sorbitol (E420) Polysorbate 20 Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

2 years.

Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. Lonquex may be removed from the refrigerator and stored below 25°C for ...

Nature and contents of container

Pre-filled syringe (type I glass) with a plunger stopper [poly(ethylene-co-tetrafluoroethylene)-coated bromobutyl rubber] and a fixed injection needle (stainless steel, 29G [0.34 mm] or 27G [0.4 mm] x ...

Special precautions for disposal and other handling

The solution should be visually inspected before use. Only clear, colourless solutions without particles should be used. The solution should be allowed to reach a comfortable temperature (15°C-25°C) for ...

Marketing authorization holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Marketing authorization number(s)

EU/1/13/856/001 EU/1/13/856/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 25 July 2013 Date of latest renewal: 08 May 2018

Πηγαίο έγγραφο

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

Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.