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XEOMIN 200 UNITS POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A

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Package leaflet:
Information for the user

50 units powder for solution for injection
100 units powder for solution for injection
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.

120

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 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.
Talk to your doctor or pharmacist before XEOMIN is used:


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



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



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

measured
in mm

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


difficulty in breathing, swallowing or speaking



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

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

3. How to use XEOMIN
XEOMIN may only be administered by doctors with appropriate
specialist knowledge of treatment with Botulinum neurotoxin
type A.
The optimum dose, frequency 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.



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



different treatment intervals

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.



injections into another muscle

Eyelid spasm (blepharospasm)



marginally varying effectiveness of the active substance of
XEOMIN



non-response/therapy failure during the course of treatment

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. 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. Treatment intervals will be determined by your doctor
based on your actual need.

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

What is in this leaflet:
1.

130

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.
Increased muscle tension/uncontrollable muscle stiffness
in shoulders, arms or hands (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
shoulder, 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.
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.
The effect of XEOMIN may be reduced by certain medicines for
malaria and rheumatism (known as aminoquinolines).
Pregnancy, breast-feeding and fertility
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.



if you have or have had swallowing difficulties

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 suffer or have suffered from seizures

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 are due to have surgery

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

Normally, no additional benefit is conferred by treating more frequently than every three months.
Twisted neck (spasmodic torticollis)
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. 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.
Treatment intervals will be determined by your doctor based on
your actual need.
Increased muscle tension/uncontrollable muscle stiffness
in shoulders, arms or hands (spasticity of the upper limb)
The recommended dose is up to 500 units per treatment session and no more than 250 units should be administered to the
shoulder muscles. 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,
however, it may last significantly longer or shorter. The period
between each treatment session should be at least 12 weeks.
Treatment intervals will be determined by your doctor based on
your actual need.
Method of administration
Dissolved XEOMIN is intended for injections into the muscle (intramuscular use; see information for healthcare professionals at
the end of this leaflet).
If you are given more XEOMIN than you require
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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, nausea, tinnitus
(ringing in the ears) or a low blood pressure.
Side effects such as excessive muscle weakness or swallowing
difficulties may be 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 and/or 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

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known to cause similar reactions. An allergic reaction can cause
any of the following symptoms:
• difficulty with breathing, swallowing or speaking due to the
swelling of the face, lips, mouth or throat


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.

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measured
in mm

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 50, 100 or 200 units Clostridium Botulinum neurotoxin type A (150 kD), free from complexing
proteins.


The other ingredients are: human albumin, sucrose.

Eyelid spasm (blepharospasm)

What XEOMIN looks like and contents of the pack

The following side effects have been observed with XEOMIN:

XEOMIN is presented as a powder for solution for injection. The
powder is white.

Very common (may affect more than 1 in 10 people):
Drooping eyelid (ptosis), dry eyes

Dissolving the powder produces a clear, colourless solution.

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)

XEOMIN 50 units powder for solution for injection: Pack sizes of
1, 2, 3 or 6 vials

Uncommon (may affect up to 1 in 100 people):
Rash

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

Twisted neck (spasmodic torticollis)

Not all pack sizes may be marketed.

The following side effects have been observed with XEOMIN:

Marketing Authorisation Holder
Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100
60318 Frankfurt/Main
Germany
P.O. Box 11 13 53
60048 Frankfurt/Main
Germany

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 spasms, 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.
Increased muscle tension/uncontrollable muscle stiffness
in shoulders, arms or hands (spasticity of the upper limb)
The following side effects have been observed with XEOMIN:
Common (may affect up to 1 in 10 people):
Dry mouth
Uncommon (may affect up to 1 in 100 people):
Headache, reduced sense of touch (hypoaesthesia), muscular
weakness, pain in extremity, weakness (asthenia), musculoskeletal pain (myalgia), swallowing difficulties (dysphagia), nausea
Not known (cannot be estimated from the available data):
Injection site pain
Some of these side effects may be disease related.
Post-marketing experience
There have been reports of flu-like symptoms and hypersensitivity reactions, such as swelling swelling of the soft tissue (oedema, also distant from the injection site), 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 (UK) or via
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel:
+353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie,
e-mail: medsafety@hpra.ie (IE).. By reporting side effects, you
can help provide more information on the safety of this medicine.
5. How to store XEOMIN

XEOMIN 100 units powder for solution for injection: Pack sizes
of 1, 2, 3, 4 or 6 vials

Manufacturer
Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstraße 100
60318 Frankfurt/Main
P.O. Box 11 13 53
60048 Frankfurt/Main
Germany
Telephone: +49-69/1503-1
Fax: +49-69/1503-200
This medicinal product is authorised in the Member States
of the EEA under the following names:
XEOMIN: Austria, Bulgaria, Cyprus, Croatia, Czech Republic, Denmark, Estonia, Germany, Greece, Finland,
France, Hungary, Iceland, Ireland, Italy, Latvia,
Liechtenstein, Lithuania, Luxembourg, Malta, The
Netherlands, Norway, Poland, Portugal, Romania,
Slovak Republic, Slovenia, Spain, Sweden, United
Kingdom
XEOMEEN: Belgium
This leaflet was last revised in 12/2017.
The following information is intended for healthcare professionals only:

ent 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:
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

20 units

0.25 ml

0.5 ml

1 ml

10 units

0.5 ml

1 ml

2 ml

8 units

0.625 ml

1.25 ml

2.5 ml

5 units

1 ml

2 ml

4 ml

4 units

1.25 ml

2.5 ml

5 ml

2 ml

4 ml

Not applicable

2.5 ml

5 ml

Not applicable

2.5 units
2 units
1.25 units

4 ml

Not applicable

Vial with
200 units

Not applicable

Instructions for disposal
Any solution for injection that has been stored for more than
24 hours as well as any unused solution for injection should be
discarded.
Procedure to follow for a safe disposal of vials, syringes and
materials used
Any unused vials or remaining 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).
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.
Recommendations should any incident occur during the handling of Botulinum toxin type A
• 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, proceed as mentioned above by carefully collecting the pieces of broken glass and wiping up the
product, avoiding any cuts to the skin.

Instructions for reconstitution of the solution for injection:

• If the product comes into contact with skin, rinse the affected area abundantly with water.

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

• If product gets into the eyes, rinse thoroughly with plenty of
water or with an ophthalmic eyewash solution.

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

• If product comes into contact with a wound, cut or broken
skin, rinse thoroughly with plenty of water and take the appropriate medical steps according to the dose injected.

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 sodium chloride solution (see dilution
table) 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 reconstitution
should remain in the vial and the required amount of solution
should be drawn up with a new sterile syringe suitable for injection.

These instructions for use, handling and disposal should be
strictly followed.

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.
Do not throw away any medicines via wastewater.
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 differ-

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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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