XEOMIN® POWDER FOR SOLUTION FOR INJECTION 50 UNITSVIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Clostridium Botulinum neurotoxin type A (150 kDa), free from complexing proteins

Available from:

MERZ ASIA PACIFIC PTE. LTD.

ATC code:

M03AX01

Dosage:

50 LD50 units

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

Clostridium Botulinum neurotoxin type A (150 kDa), free from complexing proteins 50 LD50 units

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Merz Pharma GmbH & Co. KGaA

Authorization status:

ACTIVE

Authorization date:

2014-08-12

Patient Information leaflet

1 

1. 
NAME OF THE MEDICINAL PRODUCT 

XEOMIN powder for solution for injection 50 LD
50 
units 
XEOMIN powder for solution for injection 100 LD
50 
units 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One vial contains 50 or 100 LD
50 
units* of Clostridium Botulinum neurotoxin type A (150kD), 
free from complexing proteins, human albumin, sucrose.  

*   One unit corresponds to the median lethal dose (LD
50
) when the reconstituted product is 
injected intraperitoneally into mice under defined conditions. 

3. 
PHARMACEUTICAL FORM 

Powder for solution for injection 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

XEOMIN  is indicated
for the symptomatic treatment  of  blepharospasm, cervical dystonia of a 
predominantly rotational form (spasmodic torticollis) and of post-stroke
spasticity of the upper 
limb in adults. 

XEOMIN  is indicated for the temporary improvement in the appearance of moderate to 
severe vertical lines between the eyebrows seen at frown
(glabellar frown lines) in adults 
below 65 years. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

4.2.1 METHOD OF ADMINISTRATION 

Due to unit differences in the potency  assay, unit
doses recommended for XEOMIN  are not 
interchangeable with those for other preparations of
Botulinum toxin. 

Comparative clinical study results suggest that XEOMIN and the
comparator product 
containing conventional Botulinum toxin type A complex (900 kD) are
of equal potency when 
used in a dose conversion ratio of 1:1. 

XEOMIN may only be administered by health care professionals. 

XEOMIN is reconstituted prior to use with sodium chloride
9 mg/ml (0.9%) solution for injection.  

It is good practice to perform vial reconstitution and syringe
preparation over plastic-lined paper 
towels to catch any spillage. An appropriate amoun

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
XEOMIN powder for solution for injection 50 units
XEOMIN powder for solution for injection 100 units
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 50 or 100 units of Clostridium Botulinum neurotoxin
type A (150kD), free from
complexing proteins*
* Botulinum neurotoxin type A, purified from cultures of Clostridium
Botulinum (Hall strain)
3.
PHARMACEUTICAL FORM
Powder for solution for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
XEOMIN is indicated in adults for the treatment of:

Cervical dystonia (spasmodic torticollis)

Blepharospasm

Spasticity of the upper limb
XEOMIN is indicated for the temporary improvement in the appearance of
moderate to severe

Upper facial lines
o
Glabellar frown lines
o
Lateral periorbital lines (crow’s feet lines)
o
Horizontal forehead lines
in adults below 65 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1 METHOD OF ADMINISTRATION
Due to unit differences in the potency assay, unit doses recommended
for XEOMIN are not
interchangeable with those for other preparations of Botulinum toxin.
XEOMIN may only be administered by health care professionals
with suitable qualifications and
proven experience in the application of Botulinum neurotoxin type A.
XEOMIN is reconstituted prior to use with sodium chloride 9 mg/ml
(0.9%) solution for injection.
It is good practice to perform vial reconstitution and syringe
preparation over plastic-lined paper
towels to catch any spillage. An appropriate amount of solvent is
drawn up into a syringe. A 20-27
G short bevel needle is recommended for reconstitution. After vertical
insertion of the needle
through the rubber stopper the solvent is injected gently into the
vial in order to avoid foam
formation. The vial must be discarded if the vacuum does not pull the
solvent into the vial.
Remove the syringe from the vial and mix XEOMIN with the solvent by
carefully swirling and
inverting/flipping the vial – do not shake vigorously. If needed,
the needle used for re