Letybo 50 units powder for solution for injection

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Saadav alates:

CROMA-PHARMA GmbH Industriezeile 6 2100 Leobendorf , Austria

ATC kood:

M03AX01

INN (Rahvusvaheline Nimetus):

BOTULINUM TOXIN TYPE A 50 U

Ravimvorm:

POWDER FOR SOLUTION FOR INJECTION

Koostis:

BOTULINUM TOXIN TYPE A 50 U

Retsepti tüüp:

POM

Terapeutiline ala:

MUSCLE RELAXANTS

Toote kokkuvõte:

Licence number in the source country: NOT APPLICAPABLE

Volitamisolek:

Authorised

Loa andmise kuupäev:

2022-10-07

Infovoldik

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
LETYBO 50 UNITS POWDER FOR SOLUTION FOR INJECTION
botulinum toxin type A
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 or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Letybo is and what it is used for
2.
What you need to know before you use Letybo
3.
How to use Letybo
4.
Possible side effects
5.
How to store Letybo
6.
Contents of the pack and other information
1.
WHAT LETYBO IS AND WHAT IT IS USED FOR
Letybo contains the active substance botulinum toxin type A. It works
by blocking nerve impulses to
the muscles in which it has been injected. It prevents muscles from
contracting, leading to a temporary
paralysis.
Letybo is used in adults less than 75 years of age to temporarily
improve moderate to severe
VERTICAL
LINES BETWEEN THE EYEBROWS,
when their presence has a significant psychological impact on them.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LETYBO
DO NOT USE LETYBO:
•
if you are allergic to botulinum toxin type A or any of the other
ingredients of this medicine
(listed in section 6)
•
if you have muscle activity disorders, such as myasthenia gravis,
Lambert-Eaton syndrome,
amyotrophic lateral sclerosis
•
if you have acute infection or inflammation at the proposed injection
sites
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Letybo if you have:
•
any disorder affecting muscles and/or their direct nervous system
control
•
difficulties swallowing or breathing, or have had these in the past
•
a bleeding disorder
If you have a history of these problems, Letybo is not recommended for
you.
2
Needle-related pain and/or fear of injections can lead to feeling
faint due to a sudden drop in blood
pressure.
S

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Letybo 50 units powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 50 units botulinum toxin type A produced by
_Clostridium botulinum_
.
After reconstitution each 0.1 mL of the solution contains 4 units.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Letybo is indicated for the temporary improvement in the appearance of
moderate to severe vertical
lines between the eyebrows in adults <75 years old seen at maximum
frown (glabellar lines), when the
severity of the facial lines has an important psychological impact.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Letybo should only be administered by physicians with appropriate
qualifications and expertise in this
treatment and use of the required equipment.
Posology
The recommended dose is a total of 20 units divided into five
injections of 4 units (0.1 mL) each:
2 injections in each
_corrugator supercilii_
muscle and 1 injection in the
_procerus_
muscle.
Botulinum toxin units are not interchangeable from one product to
another.
Doses recommended are different from other botulinum toxin
preparations.
Treatment interval should not be more frequent than every three
months.
In the absence of any undesirable effects secondary to the previous
treatment session, initiation of a
further treatment session with at least a three-month interval between
the treatment sessions is
possible.
In case of treatment failure one month after a previous treatment
session, i.e. in the absence of
significant improvement from baseline, the following approaches may be
considered:
•
Analysis of the causes of failure, e.g. incorrect muscles injected,
injection technique, formation
of toxin neutralising antibodies, insufficient dose.
•
Re-evaluation of the relevance of treatment with botulinum toxin type
A.
_ _
The efficacy and safety of repeat injections of L