XEOMIN 50 units powder for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clostridium botulinum neuro-toxin type a (150 kd), free from complexing proteins

Available from:

Merz Pharmaceuticals GmbH

ATC code:

M03AX; M03AX01

INN (International Name):

Clostridium botulinum neuro-toxin type a (150 kd), free from complexing proteins

Dosage:

50

Pharmaceutical form:

Powder for solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other muscle relaxants, peripherally acting agents; botulinum toxin

Authorization status:

Marketed

Authorization date:

2014-01-31

Patient Information leaflet

•
marginally varying effectiveness of the active substance of XEOMIN
•
non-response/therapy failure during the course of treatment
_EYELID SPASM (BLEPHAROSPASM)AND SPASMS AFFECTING ONE SIDE OF THE FACE
_
_(HEMIFACIAL SPASM)_
Talk to your doctor before XEOMIN is used, if you:
•
have had an eye surgery. Your doctor will then take additional
precautions.
•
are at risk of developing a disease called narrow angle glaucoma. This
disease
can cause the inner eye pressure to rise and may lead to a damaging of
your
optic nerve. Your doctor will know if you are at risk.
During treatment, small punctuated bleedings may occur in the soft
tissues of the
eyelid. Your doctor can limit these by immediately applying gentle
pressure at the
injection site.
After you receive a XEOMIN injection into your eye muscle your
blinking rate may
be reduced. This can lead to a prolonged exposure of the transparent
front part
of the eye (cornea). This exposure may lead to a damaging of the
surface and an
inflammation (corneal ulceration).
_TWISTED NECK (SPASMODIC TORTICOLLIS)_
After the injection you may develop mild to severe swallowing
difficulties. This may
lead to problems with breathing and you may have a higher risk of
inhaling foreign
substances or fluids. Foreign substances in your lungs may lead to an
inflammation
or infection (pneumonia). Your doctor will give you special medical
treatment if
needed (e.g. in the form of artificial nutrition).
Swallowing difficulties can last for up to two to three weeks after
injection, for one
patient a duration of up to five months is known.
If you have been inactive for a long period of time, any activity
should be started
gradually after the XEOMIN injection.
_INCREASED MUSCLE TENSION/UNCONTROLLABLE MUSCLE STIFFNESS_
XEOMIN can be used to treat increased muscle tension/uncontrollable
muscle
stiffness in parts of your upper limb, e.g. your arm or hand. XEOMIN
is effective in
combination with the usual standard treatment methods. XEOMIN should
be used
together with these other methods.
It is

Summary of Product characteristics

Health Products Regulatory Authority
11 April 2022
CRN00CW6X
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
XEOMIN 50 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*.
_* 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.
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 sites should be
determined by the physician individually for each
patient. A titration of the dose should be performed.
_The recommended single doses of XEOMIN should not be exceeded._
Posology
_Blepharospasm and hemifacial spasm_
Health Products Regulatory Authority
11 April 2022
CRN00CW6X
Page 2 of 18
The initial recommended dose is 1.25 to 2.5 units per inject