Xeomin 50unit powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Botulinum toxin type A

Available from:

Merz Pharma UK Ltd

ATC code:

M03AX01

INN (International Name):

Botulinum toxin type A

Dosage:

50unit

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intraglandular; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04090300; GTIN: 04046222170073

Patient Information leaflet

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 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 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 relaxes the muscles.
XEOMIN is used for the treatment of the following conditions in
adults:

eyelid spasm (blepharospasm)

twisted neck (spasmodic torticollis)

increased muscle tension/uncontrollable muscle stiffness in shoulders,
arms or hands (spasticity of
the upper limb)
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 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 that may be related to
the spread of toxin distant from the injection site to produce
symptoms consistent to Botulinum toxin
type A effects (e.g. excessive muscle weakness, swallowing
difficultie

Summary of Product characteristics

OBJECT 1
XEOMIN 200 UNITS POWDER FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 02-Nov-2017 | Merz Pharma
UK Ltd
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
One vial contains 50 units of Clostridium Botulinum neurotoxin type A
(150 kD), free from complexing
proteins*.
One vial contains 100 units of Clostridium Botulinum neurotoxin type A
(150 kD), free from complexing
proteins*.
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 of blepharospasm,
cervical dystonia of a
predominantly rotational form (spasmodic torticollis) and spasticity
of the upper limb in adults.
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.
General
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 in the
treated muscle should be determined by
the physician individually for each patient. A titration of the dose
should be performed.
Posology
_Blepharospasm_
The initial recommended dose is 1.25 to 2.5 units per injection site.
The initial dose should not exceed 25
units per eye. Total dosing should not exceed 100 units e