BELKYRA Solution for injection (2019)
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
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
Belkyra 10mg/ml solution for injection.
Qualitative and quantitative composition
1 ml solution for injection contains 10 mg deoxycholic acid. Each vial contains 20 mg of deoxycholic acid in 2 ml solution. Excipient(s) with known effect: Each mL contains 184 µmol (or 4.23 mg) of sodium ...
Pharmaceutical form
Solution for injection (injection). A clear, colourless solution, free from visible particles. The formulation is adjusted to pH 8.3 with hydrochloric acid or sodium hydroxide and has a tonicity compatible ...
Therapeutic indications
Belkyra is indicated for the treatment of moderate to severe convexity or fullness associated with submental fat in adults when the presence of submental fat has an important psychological impact for the ...
Posology and method of administration
Posology The total volume injected and the number of treatment sessions should be tailored to the individual patients submental fat distribution and treatment goals. Inject 0.2 ml (2 mg) per injection ...
Contraindications
Hypersensitivity to deoxycholic acid or to any of the excipients listed in section 6.1. Presence of infection at the proposed injection sites.
Special warnings and precautions for use
To be administered only by subcutaneous route. Injections in or near vulnerable areas Do not inject within 1 to 1.5 cm of vulnerable anatomic structures. Belkyra should not be injected into or in close ...
Interaction with other medicinal products and other forms of interaction
No clinical drug interaction studies have been conducted with Belkyra.
Fertility, pregnancy and lactation
Pregnancy Reproduction studies have been performed in rats and rabbits at exposures up to 1.8 times (rat) and 12 times (rabbit) the exposure at maximum recommended human dose. While they do not indicate ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
The data described in the underlying table reflect undesirable effects reported for Belkyra treated patients who were evaluated in the clinical studies that assessed the use of Belkyra for the treatment ...
Overdose
No overdosing with Belkyra in humans has been reported. Injection of increased volume or decreasing the spacing between injections of Belkyra may be expected to increase risk of local adverse effects. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other dermatological preparations ATC code: D11AX24 Mechanism of action Deoxycholic acid is a cytolytic drug, which when injected into localized subcutaneous fat, physically ...
Pharmacokinetic properties
Endogenous deoxycholic acid plasma levels are highly variable within and between individuals; most of this natural secondary bile acid is sequestered in the enterohepatic circulation system. Pharmacokinetics ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction and development. Carcinogenicity ...
List of excipients
Water for injection Sodium chloride Sodium hydroxide (for dissolution and pH adjustment) Disodium phosphate anhydrous Hydrochloric acid (for pH adjustment)
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
30 months. The product should be used immediately once the vial stopper has been penetrated. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions after first opening of the medicinal product, see section 6.3.
Nature and contents of container
Solution for injection in a vial (Type I glass), fitted with a stopper (chlorobutyl rubber) and a seal (aluminium) with flip-top lid (polypropylene). One carton contains 4 vials. Each vial contains 2 ml ...
Special precautions for disposal and other handling
Each vial is for single patient use only. After use, discard any unused product. Belkyra shall be prepared for injections in the following way: Remove the flip-off cap from the vial and clean the penetrable ...
Marketing authorization holder
Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology park, Dublin 17, D17 E400, Ireland
Marketing authorization number(s)
PA2103/003/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 2<sup>nd</sup> June 2017
Date of revision of the text
April 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
