BOCOUTURE 50 units powder for solution for injection

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS

から入手可能:

Merz Pharmaceuticals GmbH

ATCコード:

M03AX01

INN（国際名）:

CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS

投薬量:

50 unit(s)

医薬品形態:

Powder for solution for injection

治療領域:

botulinum toxin

認証ステータス:

Marketed

承認日:

2021-02-12

情報リーフレット

50 UNITS POWDER FOR SOLUTION FOR INJECTION
100 UNITS POWDER FOR SOLUTION FOR INJECTION
Botulinum toxin type A (150 kD),
free from complexing proteins
MN 66220, MC 1027, IE
PACKAGE LEAFLET:
INFORMATION FOR THE USER
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 rare reports of side
effects t

製品の特徴

Health Products Regulatory Authority
19 July 2021
CRN00C97V
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BOCOUTURE 50 units powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 50 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
corresponds to a standard dose of 20 units. The dose may
be increased by the physician to up to 30 units if required by the
individual needs of th