XEOMIN 50 units powder for solution for injection

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

CLOSTRIDIUM BOTULINUM, TOXIN TYPE, A

Inapatikana kutoka:

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

ATC kanuni:

M03AX01

INN (Jina la Kimataifa):

CLOSTRIDIUM BOTULINUM TOXIN TYPE A 50 U

Dawa fomu:

POWDER FOR SOLUTION FOR INJECTION

Tungo:

CLOSTRIDIUM BOTULINUM TOXIN TYPE A 50 U

Dawa ya aina:

POM

Eneo la matibabu:

MUSCLE RELAXANTS

Idhini hali ya:

Authorised

Idhini ya tarehe:

2013-12-16

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
XEOMIN 50 UNITS POWDER FOR SOLUTION FOR INJECTION
XEOMIN 100 UNITS POWDER FOR SOLUTION FOR INJECTION
XEOMIN 200 UNITS POWDER FOR SOLUTION FOR INJECTION
Clostridium Botulinum neurotoxin type A (150 kD), free from complexing
proteins
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE 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 XEOMIN is and what it is used for
2.
What you need to know before XEOMIN is used
3.
How to use XEOMIN
4.
Possible side effects
5.
How to store XEOMIN
6.
Contents of the pack and other information
1.
WHAT XEOMIN IS AND WHAT IT IS USED FOR
XEOMIN is a medicine that contains the active substance Botulinum
Neurotoxin Type A which
relaxes the injected muscles or decreases the salivary flow at the
respective administration site.
XEOMIN is used for the treatment of the following conditions in adults
•
eyelid spasm (blepharospasm) and spasms affecting one side of the face
(hemifacial spasm)
•
twisted neck (spasmodic torticollis)
•
increased muscle tension/uncontrollable muscle stiffness in shoulders,
arms and/or hands
(spasticity of the upper limb)
•
chronic drooling (sialorrhea) due to neurological disorders.
XEOMIN is used in children and adolescents aged 2 to 17 years and
weighing ≥ 12 kg for the treatment
of
•
chronic drooling (sialorrhea) due to neurological / neurodevelopmental
disorders.
2.
WHAT YOU NEED TO KNOW BEFORE XEOMIN IS USED
DO NOT USE XEOMIN
•
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 hav

Tabia za bidhaa

Page 1 of 22
1.
NAME OF THE MEDICINAL PRODUCT
XEOMIN 50 units powder for solution for injection
XEOMIN 100 units powder for solution for injection
XEOMIN 200 units powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_XEOMIN 50 units powder for solution for injection _
One vial contains 50 units of Clostridium Botulinum neurotoxin type A
(150 kD), free from
complexing proteins*.
_XEOMIN 100 units powder for solution for injection _
One vial contains 100 units of Clostridium Botulinum neurotoxin type A
(150 kD), free from
complexing proteins*.
_XEOMIN 200 units powder for solution for injection _
One vial contains 200 units of Clostridium Botulinum neurotoxin type A
(150 kD), free from
complexing proteins*.
_* _
_Botulinum neurotoxin 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
White powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
XEOMIN is indicated for the symptomatic treatment in adults of
•
blepharospasm and hemifacial spasm,
•
cervical dystonia of a predominantly rotational form (spasmodic
torticollis),
•
spasticity of the upper limb,
•
chronic sialorrhea due to neurological disorders.
XEOMIN is indicated for the symptomatic treatment in children and
adolescents aged 2 to 17 years and
weighing ≥ 12 kg of
•
chronic sialorrhea due to neurological / neurodevelopmental disorders.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DUE TO UNIT DIFFERENCES IN THE POTENCY ASSAY, UNIT DOSES FOR XEOMIN
ARE NOT INTERCHANGEABLE
WITH THOSE FOR OTHER PREPARATIONS OF BOTULINUM TOXIN TYPE A.
For detailed information regarding clinical studies with XEOMIN in
comparison to conventional
Botulinum toxin type A complex (900 kD), see section 5.1.
Page 2 of 22
XEOMIN may only be administered by physicians with suitable
qualifications and the requisite
experience in the application of Botulinum toxin type A.
The optimum dose, frequency and number of injection sit