Bocouture 50unit powder for solution for injection vials

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Botulinum toxin type A

Tersedia dari:

Merz Pharma UK Ltd

Kode ATC:

M03AX01

INN (Nama Internasional):

Botulinum toxin type A

Dosis:

50unit

Bentuk farmasi:

Powder for solution for injection

Rute administrasi :

Intramuscular

Kelas:

No Controlled Drug Status

Jenis Resep:

Caution - AMP level prescribing advised

Ringkasan produk:

BNF: 04090300; GTIN: 04046222182502

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOCOUTURE 50 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.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

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 relaxes the muscles.
It works by blocking the nerve impulses in all injected muscles. This
prevents muscles from contracting
leading to temporary and reversible relaxation.
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

Karakteristik produk

OBJECT 1
BOCOUTURE 50 UNITS POWDER FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 05-Feb-2018 | Merz Pharma
UK Ltd
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
inje