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XEOMIN 200 UNITS POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A

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Job No.: me278398
Size:

300 x 390 mm

Keim GmbH

MN

00000

MC

0000

Rheinstraße 1– 5, 63225 Langen

AM

22787

MZ/AZ

0000

Standort: Otto-Hahn-Straße 41,
63456 Hanau, Tel. +49 6181-9886-10

(w x h)

Typestyle: Helvetica Neue

Xeomin 200E
GA MockUp
Großbritannien

P 295

Created at: 31.03.2016

Operator: to

1. AC:
2. AC:
3. AC:
4. AC:

5. AC:
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8. AC:

Type size: 9 pt

Stanzfarbe

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Package leaflet:
Information for the user

120

130

measured
in mm



your doctor may follow a different procedure when preparing the solution for injection



different treatment intervals



injections into another muscle



marginally varying effectiveness of the active substance of
XEOMIN

200 units powder for solution for injection



non-response/therapy failure during the course of treatment

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

If you have been inactive for a long period of time, any activity
should be started gradually after the XEOMIN injection.

Read all of this leaflet carefully before you start using
this medicine because it contains important information for you.



difficulty in breathing, swallowing or speaking

Eyelid spasm (blepharospasm)



hives, swelling including swelling of the face or throat,
wheezing, feeling faint and shortness of breath (possible
symptoms of severe allergic reactions)

Usually, the first onset of effect is observed within four days after
injection. The effect of each treatment generally lasts for about
3-4 months, however, it may last significantly longer or shorter.
The treatment can be repeated if required. The recommended
initial dose is up to 25 units per eye, and the total recommended dose in follow-up treatment sessions is up to 100 units per
session.



If you have any further questions, ask your doctor
or pharmacist.

Eyelid spasm (blepharospasm)



If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.



Talk to your doctor before XEOMIN is used, if you:



What is in this leaflet:
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

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)

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
arms or hands after a stroke (post-stroke spasticity of the
upper limb, going along with clinical pattern of flexed wrist
and clenched fist)
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 Botulinum toxin far from the injection
site (e.g. excessive muscle weakness, swallowing difficulties or
accidental swallowing of food or drink into the airways). Patients
who receive the recommended doses may experience excessive muscle weakness.
If the dose is too high or the injections too frequent, the risk of
antibody formation may increase. Antibody formation can cause
treatment with Botulinum toxin type A to fail, whatever the reason for its use.
if you suffer from any type of bleeding disorder



if you receive substances that prevent the blood from clotting (e.g. coumarin, heparin, acetylsalicylic acid, clopidogrel)



if you suffer from pronounced weakness or decreased muscle volume in the muscle where you will receive the injection

Increased muscle tension/uncontrollable muscle stiffness
in arms or hands after a stroke (post-stroke spasticity of the
upper limb)
XEOMIN can be used to treat increased muscle tension/uncontrollable muscle stiffness in parts of your upper limb, e.g. your
elbow, forearm or hand. XEOMIN is effective in combination with
the usual standard treatment methods. XEOMIN should be used
together with these other methods.
It is unlikely that this medicine will improve the range of motion of joints where the surrounding muscle has lost its ability to
stretch.

Dissolved XEOMIN is intended for injections into the muscle.
Symptoms of overdose:
Symptoms of overdose are not apparent immediately after the
injection and may include general weakness, drooping eyelid,
double vision, breathing difficulties, speech difficulties, and paralysis of the respiratory muscles or swallowing difficulties which
may result in pneumonia.
Measures in cases of overdose:
In case you feel symptoms of overdose please seek medical
emergency services immediately or ask your relatives to do so,
and have yourself admitted to hospital. Medical supervision for
up to several days and assisted ventilation may be necessary.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.

Children and adolescents
Do not give this medicine to children and adolescents between
the ages of 0-17 years because the use of XEOMIN in children
and adolescents has not yet been investigated and is therefore
not recommended.
Other medicines and XEOMIN
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
The effect of XEOMIN may be increased by:


medicines used to treat certain infectious diseases (spectinomycin or aminoglycoside antibiotics [e.g. neomycin, kanamycin, tobramycin])



other medicines that relax the muscles (e.g. muscle relaxants of the tubocurarine-type). Such medicines are used,
for example, in general anaesthesia. Before you have surgery, tell your anaesthetist if you have received XEOMIN.

In these cases, XEOMIN must be used carefully.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects such as excessive muscle weakness or swallowing
difficulties are caused by the relaxation of muscles far from the
injection site of XEOMIN. Swallowing difficulties can cause inhalation of foreign bodies resulting in lung inflammation and in
some cases, death.
An allergic reaction may occur with XEOMIN. Serious immediate
allergic reactions (anaphylaxis) or allergic reactions to the serum
in the product (serum sickness), causing for example difficulty
in breathing (dyspnoea), hives (urticaria) or swelling of the soft
tissue (oedema), have been rarely reported. Some of these reactions have been observed following the use of conventional
Botulinum toxin type A complex. They occurred when the toxin
was given alone or in combination with other products known to
cause similar reactions. An allergic reaction can cause any of the
following symptoms:

The effect of XEOMIN may be reduced by certain medicines for
malaria and rheumatism (known as aminoquinolines).



difficulty with breathing, swallowing or speaking due to the
swelling of the face, lips, mouth or throat

Pregnancy, breast-feeding and fertility



swelling of the hands, feet or ankles.

If you notice any of these side effects, please inform your
doctor immediately or ask your relatives to do so and go
to the accident and emergency department of your nearest
hospital.



if you suffer from any disease that disturbs the interaction
between nerves and skeletal muscles (peripheral neuromuscular dysfunction)

XEOMIN should not be used during pregnancy, unless your doctor decides that the necessity and potential benefit of the treatment justifies the possible risk on the foetus.



if you have or have had swallowing difficulties

XEOMIN is not recommended if you are breast-feeding.



if you have had problems with injections of Botulinum toxin
type A in the past

Driving and using machines

If you have repeated injections with XEOMIN, the effect may increase or decrease. Possible reasons for this are:

Increased muscle tension/uncontrollable muscle stiffness
in arms or hands after a stroke (post-stroke spasticity of the
upper limb)

If you are given more XEOMIN than you require

if you suffer from amyotrophic lateral sclerosis (ALS), which
can lead to generalised muscle decrease.

if you are due to have surgery

Usually, the first onset of effect is observed within seven days
after injection. The effect of each treatment generally lasts for
about 3-4 months, however, it may last significantly longer or
shorter. Treatment intervals of less than 10 weeks are not recommended. The recommended dose per single injection site
is up to 50 units, and the maximum dose for the first treatment
session is 200 units. Doses up to 300 units may be given by your
doctor in subsequent courses depending on the response.

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.



Repeated injections with XEOMIN

Twisted neck (spasmodic torticollis)

Patients reported the onset of action 4 days after treatment. An
improvement of muscle tone was perceived within 4 weeks. In
general, the treatment effect lasted 12 weeks. The recommended dose is up to 400 units per treatment session. The period
between each treatment session should be at least 12 weeks.

If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before this medicine is administered.



Normally, no additional benefit is conferred by treating more frequently than every three months.

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).

Talk to your doctor or pharmacist before XEOMIN is used:


The optimum dose and number of injection sites in the treated muscle will be chosen by your doctor individually for you. The results
of initial treatment with XEOMIN should be evaluated and may lead
to dose adjustment until the desired therapeutic effect is achieved.

Contact your doctor and seek medical attention immediately if
you experience any of the following:

Keep this leaflet. You may need to read it again.

What XEOMIN is and what it is used for

XEOMIN may only be administered by healthcare professionals
with appropriate specialist knowledge of treatment with Botulinum
neurotoxin.

If you have the impression that the effect of XEOMIN is too strong
or too weak, let your doctor know. In cases where no therapeutic
effect is apparent, alternative therapies should be taken into consideration.



1.

3. How to use XEOMIN

You should not drive or engage in other potentially hazardous
activities if drooping eyelids, weakness (asthenia), muscle weakness, dizziness or vision disorder occur.
If in doubt ask your doctor for advice.

Usually, side effects are observed within the first week after
treatment and are temporary in nature. Side effects may be related to the medicine, injection technique or both. Side effects
may be restricted to the area around the injection site (e.g. localised muscle weakness, local pain, inflammation, pins and
needles (paraesthesia), reduced sense of touch (hypoaesthesia), tenderness, swelling (general), swelling of the soft tissue
(oedema), skin redness (erythema), itching, localised infection,
haematoma, bleeding and/or bruising).
The injection of the needle may cause pain. This pain or the anxiety towards needles may lead to fainting or a low blood pressure.

MN xxxxx, GB

Approved for
printing

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Procedure No.

Identical to
approved texts

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requirements

Double
checked

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Research and Development
Regulatory Affairs

Yes

Yes

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Information Officer
Legal Department

me278398_xxxxx_Xeomin_200E_Mock Up_GA_GB.indd 1

31.03.16 11:21

Job No.: me278398
Size:

300 x 390 mm

(w x h)

Keim GmbH

MN 00000

MC

0000

Rheinstraße 1– 5, 63225 Langen

AM 22787

MZ/AZ

0000

Standort: Otto-Hahn-Straße 41,
63456 Hanau, Tel. +49 6181-9886-10

Typestyle: Helvetica Neue

Xeomin 200E
GA MockUp
Großbritannien

P 295

Created at: 31.03.2016

Operator: to

1. AC:
2. AC:
3. AC:
4. AC:

5. AC:
6. AC:
7. AC:
8. AC:

Type size: 9 pt

Stanzfarbe

Scale

0

10

20

30

40

50

60

70

80

90

100

110

Eyelid spasm (blepharospasm)
The following side effects have been observed with XEOMIN:
Very common (may affect more than 1 in 10 people):
Drooping eyelid (ptosis), dry eyes

120

measured
in mm

130

XEOMIN 200 units powder for solution for injection: Pack sizes
of 1, 2, 3, 4 or 6 vials

Instructions for disposal

Not all pack sizes may be marketed.

Any solution for injection that has been stored for more than
24 hours as well as any unused solution for injection should be
discarded.

Marketing Authorisation Holder

Common (may affect up to 1 in 10 people):
Vision blurred, visual impairment, double vision (diplopia), lacrimation increased, dry mouth, swallowing difficulties (dysphagia), headache, injection site pain, fatigue, muscular weakness,
weakness of face muscle (facial paresis), rash
Twisted neck (spasmodic torticollis)
The following side effects have been observed with XEOMIN:
Very common (may affect more than 1 in 10 people):
Swallowing difficulties (dysphagia)
Common (may affect up to 1 in 10 people):
Neck pain, muscular weakness, musculoskeletal pain (myalgia),
musculoskeletal stiffness, muscle spasm, headache, dizziness,
injection site pain, weakness (asthenia), dry mouth, nausea,
sweating increased (hyperhidrosis), upper respiratory tract infection, feeling faint (presyncope)
Uncommon (may affect up to 1 in 100 people):
Speech disorders (dysphonia), shortness of breath (dyspnoea),
rash
The treatment of twisted neck may cause swallowing difficulties
with varying degrees of severity. This may lead to breathing in
foreign materials, which may require medical intervention. Swallowing difficulties may persist for two to three weeks after injection, but has been reported in one case to last five months.
Swallowing difficulties appear to be dose-dependent.

Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100
60318 Frankfurt/Main
Germany

Procedure to follow for a safe disposal of vials, syringes and
materials used
Any unused vials, residual reconstituted solution in the vial and/
or syringes should be autoclaved. Alternatively, the remaining
XEOMIN can be inactivated by adding one of the following solutions: 70 % ethanol, 50 % isopropanol, 0.1 % SDS (anionic
detergent), diluted sodium hydroxide solution (0.1 N NaOH), or
diluted sodium hypochlorite solution (at least 0.1 % NaOCl).

Manufacturer
Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstraße 100
60318 Frankfurt/Main
P.O. Box 11 13 53
60048 Frankfurt/Main
Germany
Telephone: +49-69/15 03-1
Fax: +49-69/15 03-200

After inactivation used vials, syringes and materials should not
be emptied and must be discarded into appropriate containers
and disposed of in accordance with local requirements.

This medicinal product is authorised in the Member States
of the EEA under the following names:
XEOMIN: 
Austria, Bulgaria, Cypress, Croatia, Czech
Republic, Denmark, Estonia, Germany, Greece,
Finland, France, Hungary, Ireland, Island,
Italy, Latvia, Lichtenstein, Lithuania, Luxembourg,
Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden,
United Kingdom
XEOMEEN: Belgium
This leaflet was last revised in 04/2016.
The following information is intended for healthcare professionals only:

The following side effects have been observed with XEOMIN:

Instructions for reconstitution of the solution for injection:

Common (may affect up to 1 in 10 people):
Headache, decreased or abnormal skin sensation including partial loss of sensation or sensation of heat (dysaesthesia, hypoaesthesia), muscular weakness, feeling hot, injection site pain,
pain in extremity, swallowing difficulties (dysphagia)

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

Uncommon (may affect up to 1 in 100 people):
Weakness (asthenia), myalgia

It is good practice to reconstitute the vial contents and prepare
the syringe over plastic-lined paper towels to catch any spillage.
An appropriate amount of solvent (see dilution table) is drawn
up into a syringe. After vertical insertion of the needle through
the rubber stopper, the solvent is injected gently into the vial in
order to avoid foam formation. A 20-27 G short bevel needle is
recommended for reconstitution. 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 the vial – do not shake vigorously.
If needed, the needle used for reconstitution should remain in
the vial and the required amount of solution should be drawn up
with a new sterile syringe suitable for injection.

Post-marketing experience
There have been reports of flu-like symptoms and hypersensitivity reactions, such as swelling, swelling of the soft tissue (oedema), redness, itching, rash (local and generalised) and breathlessness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at www.mhra.gov.uk/yellowcard. By reporting
side effects, you can help provide more information on the safety of this medicine.

• Any spills of the product must be wiped up: either using
absorbent material impregnated with any of the above solutions in case of the powder, or with dry, absorbent material
in case of reconstituted product.
• The contaminated surfaces should be cleaned using absorbent material impregnated with any of the above solutions,
then dried.
• If a vial is broken, it should be proceeded as mentioned
above by carefully collecting the pieces of broken glass and
wiping up the product, avoiding any cuts to the skin.
• If the product comes into contact with skin, rinse the affected area abundantly with water.

Increased muscle tension/uncontrollable muscle stiffness
in arms or hands after a stroke (post-stroke spasticity of the
upper limb)

Some of these side effects may be disease related.

Recommendations should any incident occur during the
handling of Botulinum toxin

XEOMIN may only be applied for its intended use to treat one
patient for one session.

• If product gets into the eyes, the eyes should be rinsed thoroughly with plenty of water or with an ophthalmic eyewash
solution.
• If product comes into contact with a wound, cut or broken
skin, the area should be rinsed thoroughly with plenty of
water and the appropriate medical steps according to the
dose injected should be taken.
These instructions for use, handling and disposal should be
strictly followed.

5. How to store XEOMIN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the carton and vial label after “EXP”. The expiry date refers to
the last day of that month.
Unopened vial: Do not store above 25 °C.
Reconstituted solution: Chemical and physical in-use stability
has been demonstrated for 24 hours at 2 °C to 8 °C.
From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage times
and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2 °C to 8 °C,
unless reconstitution has taken place in controlled and validated
aseptic conditions.
Your doctor should not use XEOMIN if the solution has a cloudy
appearance or contains visible particles.
For instructions on disposal, please see information for healthcare professionals at the end of this leaflet.

Reconstituted XEOMIN is a clear, colourless solution.
XEOMIN must not be used if the reconstituted solution (prepared as above) has a cloudy appearance or contains floccular or
particulate matter.
Care should be taken to use the correct diluent volume for the
presentation chosen to prevent accidental overdose. If different
vial sizes of XEOMIN are being used as part of one injection
procedure, care should be taken to use the correct amount of
diluent when reconstituting a particular number of units per
0.1 ml. The amount of diluent varies between XEOMIN 50 units,
XEOMIN 100 units and XEOMIN 200 units. Each syringe should
be labelled accordingly.
Possible dilutions for XEOMIN 50, 100 and 200 units are indicated in the following table:

6. Contents of the pack and other information
What XEOMIN contains
• The active substance is: Clostridium Botulinum neurotoxin
type A (150 kD), free from complexing proteins.
One vial contains 200 units Clostridium Botulinum
neurotoxin type A (150 kD), free from complexing proteins.
Due to differences in the potency assay, these units
are specific to XEOMIN and are not applicable to other
Botulinum toxin preparations.


The other ingredients are: human albumin, sucrose.

What XEOMIN looks like and contents of the pack
XEOMIN is presented as a powder for solution for injection. The
powder is white.

Resulting dose in
units
per 0.1 ml

Solvent added
(sodium chloride 9 mg/ml (0.9 %) solution for injection)
Vial with 50 units

Vial with 100 units

Vial with 200 units

20 units

0.25 ml

0.5 ml

1 ml

10 units

0.5 ml

1 ml

2 ml

5 units

1 ml

2 ml

4 ml

2.5 units

2 ml

4 ml

8 ml

1.25 units

4 ml

8 ml

Not applicable

Dissolving the powder produces a clear, colourless solution.

MN xxxxx, GB

Approved for
printing

(Variation)
Procedure No.

Identical to
approved texts

Compliant
with national
requirements

Double
checked

Date, Signature

Research and Development
Regulatory Affairs

Yes

Yes

Yes

Information Officer
Legal Department

me278398_xxxxx_Xeomin_200E_Mock Up_GA_GB.indd 2

31.03.16 11:21

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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