BOCOUTURE 100 units powder for solution for injection

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

BOTULINUM TOXIN, TYPE A

Tilgængelig fra:

Merz Pharmaceuticals GmbH Eckenheimer Landstrasse 100, D-60318 Frankfurt am Main, Germany

ATC-kode:

M03AX01

INN (International Name):

BOTULINUM TOXIN TYPE A 100 U

Lægemiddelform:

POWDER FOR SOLUTION FOR INJECTION

Sammensætning:

BOTULINUM TOXIN TYPE A 100 U

Recept type:

POM

Terapeutisk område:

MUSCLE RELAXANTS

Autorisation status:

Authorised

Autorisation dato:

2019-01-09

Indlægsseddel

Page 1 of 9
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOCOUTURE 50 UNITS POWDER FOR SOLUTION FOR INJECTION
BOCOUTURE 100 UNITS POWDER FOR SOLUTION FOR INJECTION
Botulinum toxin type A (150 kD), free from complexing proteins
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 BOCOUTURE is and what it is used for
2.
What you need to know before BOCOUTURE is used
3.
How to use BOCOUTURE
4.
Possible side effects
5.
How to store BOCOUTURE
6.
Contents of the pack and other information
1.
WHAT BOCOUTURE IS AND WHAT IT IS USED FOR
BOCOUTURE is a medicine that contains the active substance Botulinum
toxin type A which
relaxes the injected muscles.
BOCOUTURE is used for temporary improvement of upper facial lines in
adults under 65 years of
age when the severity of these lines has an important psychological
impact for the patient:
•
moderate to severe vertical lines between the eyebrows seen at maximum
frown and/or
•
moderate to severe lateral periorbital lines seen at maximum smile
and/or
•
moderate to severe horizontal forehead lines seen at maximum
contraction
2.
WHAT YOU NEED TO KNOW BEFORE BOCOUTURE IS USED
DO NOT USE BOCOUTURE
•
if you are allergic to Botulinum neurotoxin type A or any of the other
ingredients of this
medicine (listed in section 6)
•
if you suffer from a generalised disorder of muscle activity (e.g.
myasthenia gravis, Lambert-
Eaton syndrome)
•
if you have an infection or inflammation at the proposed injection
site.
WARNINGS AND PRECAUTIONS
Side effects may occur from misplaced injections of Botulinum
neurotoxin type A temporarily
paralysing nearby muscle groups. There have been very ra

Produktets egenskaber

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BOCOUTURE 50 units powder for solution for injection
BOCOUTURE 100 units powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_BOCOUTURE 50 units _
One vial contains 50 units of Botulinum toxin type A (150 kD), free
from complexing proteins*.
_BOCOUTURE 100 units _
One vial contains 100 units of Botulinum toxin type A (150 kD), free
from complexing proteins*.
_* _
_Botulinumtoxin type A, purified from cultures of Clostridium
Botulinum (Hall strain)_
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection (powder for injection)
White powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BOCOUTURE is indicated for the temporary improvement in the appearance
of upper facial lines
in adults below 65 years when the severity of these lines has an
important psychological impact for
the patient:
•
moderate to severe vertical lines between the eyebrows seen at maximum
frown (glabellar
frown lines) and/or
•
moderate to severe lateral periorbital lines seen at maximum smile
(crow’s feet lines) and/or
•
moderate to severe horizontal forehead lines seen at maximum
contraction
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DUE TO UNIT DIFFERENCES IN THE POTENCY ASSAY, UNIT DOSES FOR BOCOUTURE
ARE NOT
INTERCHANGEABLE WITH THOSE FOR OTHER PREPARATIONS OF BOTULINUM TOXIN
TYPE A.
For detailed information regarding clinical studies with BOCOUTURE in
comparison to
conventional Botulinum toxin type A complex (900 kD), see section 5.1.
GENERAL
BOCOUTURE may only be administered by physicians with suitable
qualifications and the
requisite experience in the application of Botulinum toxin type A.
POSOLOGY
_VERTICAL LINES BETWEEN THE EYEBROWS SEEN AT MAXIMUM FROWN (GLABELLAR
FROWN LINES) _
After reconstitution of BOCOUTURE a dose of 4 units is injected into
each of the 5 injection sites:
two injections in each corrugator muscle and one injection in the
procerus muscle, which
c