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BOCOUTURE 4 UNITS/0.1ML POWDER FOR SOLUTION FOR INJECTION

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Package leaflet:
Information for the user

4 units/0.1 ml powder for solution for 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)



if you have or have had swallowing difficulties



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



if you are due to have surgery

Repeated injections with BOCOUTURE

Botulinum toxin 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 repeated injections with BOCOUTURE, the effect
may increase or decrease. Possible reasons for this are:
your doctor may follow a different procedure when preparing the solution for injection



injections into another muscle

If you are given more BOCOUTURE than you require



non-response/treatment failure in the course of the treatment

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.

• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.

If you develop swallowing, speech or breathing difficulties,
please seek immediate medical care or ask your relatives to
do so (see section 4).

• 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.

Special Populations
There is limited information on the treatment of patients over
65 years of age. Therefore, BOCOUTURE should not be used
in patients over the age of 65 years.
Children and adolescents

2. What you need to know before you use BOCOUTURE
3. How to use BOCOUTURE

As there is no information regarding the use in children and
adolescents, BOCOUTURE should not be given to patients
under the age of 18 years.
Other medicines and BOCOUTURE

4. Possible side effects

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

5. How to store BOCOUTURE

The effect of BOCOUTURE may be increased by:

6. Contents of the pack and other information



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
BOCOUTURE.

1. What BOCOUTURE is and what it is used for
BOCOUTURE is a medicine that relaxes the muscles.
It works by blocking the nerve impulses in all injected muscles. This prevents muscles from contracting leading to temporary and reversible relaxation.
BOCOUTURE is used for temporary improvement of vertical
frown lines between the eyebrows and of lateral periorbital
lines seen at maximum smile in adults under 65 years of age
when the severity of these lines has an important psychological impact for the patient.
2. What you need to know before you use BOCOUTURE
Do not use BOCOUTURE


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.
Talk to your doctor before BOCOUTURE 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

For the treatment of lateral periorbital lines seen at maximum smile (crow’s feet lines) your doctor will inject a standard dose of 24 units (12 units per eye). The recommended
volume of 0.1 ml with 4 units will be applied bilaterally in 3
injection sites and will result in a total injection volume of 0.3
ml per eye.



Your doctor will clarify the reasons for this and discuss them
with you.

1. What BOCOUTURE is and what it is used for

Lateral Periorbital Lines seen at maximum smile (Crow’s
feet lines)

A reduction in lateral periorbital lines seen at maximum smile
mostly occurs within 6 days with the maximum effect observed on day 14. The effect lasts for up to 3 months after the
injection.

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

What is in this leaflet:

A reduction in the vertical lines between the eyebrows generally occurs within 2 to 3 days with the maximum effect
observed on day 30. The effect lasts for up to 4 months after
the injection.

In these cases, BOCOUTURE must be used carefully.
The effect of BOCOUTURE 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.
BOCOUTURE 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. BOCOUTURE is not recommended if you are breast-feeding.
Driving and using machines
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.

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.
An allergic reaction may occur with BOCOUTURE. 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. These effects cannot be ruled out completely when
using BOCOUTURE.
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.
Side effects may be related to the medicine, injection technique or both. At the injection sites, the action of Botulinum
toxin causes localised muscle weakness. Drooping eyelids
can be caused by the injection technique and the effect of
the medicine. Usually, side effects occur in the first week after the injection and are temporary in nature.
The following reactions may occur around the injection site:


Pain



Inflammation



Pins and needles

BOCOUTURE may only be administered by doctors with appropriate specialist knowledge of treatment with Botulinum
neurotoxin.



Decreased skin sensation



Tenderness

Dissolved BOCOUTURE is intended for injections into the
muscle (intramuscular use; see information for healthcare
professionals at the end of this leaflet).



Itching



Swelling (general)



Swelling of the soft tissue (oedema)



Skin redness (erythema)

Vertical Lines between the Eyebrows (Glabellar Frown
Lines)



Localised infection



Haematoma

When treating your vertical lines between the eyebrows (glabellar frown lines) the usual total dose is 20 units. Your doctor will inject the recommended volume of 0.1 ml (4 units)
BOCOUTURE into each of the 5 injection sites. The total
dose may be increased by the physician to up to 30 units if
required by the individual needs of the patient, with at least
‘3-months’ interval between treatments.



Bleeding



Bruising

3. How to use BOCOUTURE

The interval between two treatments should not be less than
3 months.

Patients with a fear of injections may experience temporary
generalised reactions, e.g.


Fainting

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Circulatory problems



Nausea



Noises in the ears

Other possible side effects
Vertical Lines between the Eyebrows (Glabellar Frown
Lines)
The following side effects have been observed when using
BOCOUTURE:

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 BOCOUTURE 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.
6. Contents of the pack and other information

Common (may affect up to 1 in 10 people):


Headache

What BOCOUTURE contains



Muscle activity disorders (raised eyebrows)



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


Nasopharyngitis



Bronchitis



Influenza like illness



Localised muscle weakness in the face (drooping eyebrow, brow ptosis)



Drooping eyelids (eyelid ptosis)



Accumulation of fluid in the eyelids (eyelid oedema)



Blurred vision



Muscle twitching (muscle spasm)



Feeling of heaviness at the upper part of the face



Feeling of tightness at the injection site



Tiredness



Pain or bruising at the injection site



Itching



Skin nodule



Depression



Insomnia

Lateral Periorbital Lines seen at maximum smile (Crow’s
feet lines)
The following side effects have been observed when using
BOCOUTURE:
Common (may affect up to 1 in 10 people):



The active substance is: Botulinum toxin type A (150 kD),
free from complexing proteins.
One vial contains 50 units Botulinum toxin type A (150 kD),
free from complexing proteins.
0.1 ml solution contains 4 units of Botulinum toxin type A
(150 kD), free from complexing proteins when reconstituted in 1.25 ml.
The other ingredients are: human albumin, sucrose.

What BOCOUTURE looks like and contents of the pack

Pack sizes of 1, 2, 3 or 6 vials.
Marketing Authorisation Holder

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

Dry eye

Instructions for reconstitution of the solution for injection:



Bruising at the injection site

50 units of BOCOUTURE are reconstituted prior to use in
1.25 ml unpreserved sodium chloride 9 mg/ml (0.9 %) solution for injection. This corresponds to a concentration of
40 units/ml. Reconstitution and dilution should be performed
in accordance with good clinical practice guidelines, particularly with respect to asepsis.

Excessive muscle weakness



Swallowing difficulties



Swallowing difficulties causing inhalation of foreign bodies resulting in lung inflammation and, in some cases,
death

Such side effects are caused by the relaxation of muscles far
from the injection site.
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
national reporting system listed in Appendix V. By reporting
side effects, you can help provide more information on the
safety of this medicine.

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


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.



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



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



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.

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

This leaflet was last revised in .





Any unused vials, residual reconstituted solution in the vial
and/or syringes should be autoclaved. Alternatively, the remaining BOCOUTURE 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).

Not all pack sizes may be marketed.

The following information is intended for healthcare
professionals only:

The following very rare side effects have been observed during Botulinum toxin treatment of conditions other than vertical lines between the eyebrows or lateral periorbital lines
seen at maximum smile (see section 2):

Procedure to follow for a safe disposal of vials, syringes and
materials used

Dissolving the powder produces a clear, colourless, particlefree solution.

Eyelid swelling

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.

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

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



Post-marketing experience

Instructions for disposal

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

5. How to store BOCOUTURE
Keep this medicine out of the 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

Reconstituted BOCOUTURE is a clear, colourless solution
free of particulate matter.
BOCOUTURE must not be used if the reconstituted solution
(prepared as above) has a cloudy appearance or contains
floccular or particulate matter.

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Expand Transcript

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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