Belkyra 10 mg/ml solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Available from:

AbbVie Limited Citywest Business Campus, Dublin 24, Ireland

ATC code:

D11AX24

INN (International Name):

DEOXYCHOLIC ACID 10 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

DEOXYCHOLIC ACID 10 mg/ml

Prescription type:

POM

Therapeutic area:

OTHER DERMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2016-10-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BELKYRA 10
MG/ML SOLUTION FOR INJECTION
deoxycholic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BELKYRA is and what it is used for
2.
What you need to know before you use BELKYRA
3.
How to use BELKYRA
4.
Possible side effects
5.
How to store BELKYRA
6.
Contents of the pack and other information
1.
WHAT BELKYRA IS AND WHAT IT IS USED FOR
Belkyra contains the active substance deoxycholic acid. Deoxycholic
acid is produced naturally in your body
to aid in the digestion of fats.
The medicine is used in adults for the treatment of submental fat
(unwanted fat under the chin) when its
presence has an important psychological impact for the patient.
Belkyra contains a non-human, non-animal version of deoxycholic acid
which is identical to naturally-
occuring deoxycholic acid. Belkyra is an injectable medicine given by
your doctor or nurse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BELKYRA
DO NOT USE BELKYRA:
•
if you are allergic to deoxycholic acid or any of the other
ingredients of this medicine (listed in
section 6).
•
if you have an infection in your chin or neck area where the product
will be injected.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Belkyra. Your
doctor or nurse will check how well you
are before each treatment. Make sure you tell your doctor or nurse
about any illness you have before each
treatment.
Your doctor or nurse will pay particular attention to the area around
your neck because caution is necessary
in the case of any diseases or previous surgery (e.g. scarring,
liposuction, difficulty swallowing, enlargement
of the thyroid g

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Belkyra 10 mg/ml solution for injection
2.
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 4.23 mg sodium.
For the full list of excipients, see section 6.1.
3.
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 with that of biological tissues and fluids at an osmolality
of 300 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
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 patient
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The total volume injected and the number of treatment sessions should
be tailored to the individual
patient’s submental fat distribution and treatment goals.
Inject 0.2 ml (2 mg) per injection site, 1 cm apart. The maximum dose
of 10 ml (100 mg equivalent to
50 injections) should not be exceeded in one treatment session.
Up to a maximum of 6 treatment sessions can be performed. Most
patients experience improvement in
2 to 4 treatment sessions.
The time interval between treatment sessions should be at least 4
weeks.
To improve patient comfort during injection, oral analgesics or
NSAIDs, topical and/or injectable
local anaesthesia (eg, lidocaine) and/or cooling using ice gel packs
may be applied to the area of
injection at the discretion of the healthcare professional.
Special populations
_Renal impairment _
_ _
No dose adjustment is considered necessary (see section 5.2).
_Hepatic impairment _
_ _
No dose adjustment is considered necessary (see section 5.2).
_Elderly (aged 65 years and above) _
_ _
No dose adjustment is c