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BOCOUTURE 50 UNITS POWDER FOR SOLUTION FOR INJECTION

Active substance(s): BOTULINUM TOXIN TYPE A (150KD) FREE FROM COMPLEXING PROTEINS

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Package leaflet:
Information for the user

50 units powder for solution for injection

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.

• 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

A reduction in the vertical lines between the eyebrows seen
at maximum frown 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.

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

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

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

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.



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

• 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:

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

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

• 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 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 BOCOUTURE is and what it is used for

injections into another muscle

• non-response/treatment failure in the course of the treatment
Your doctor will clarify the reasons for this and discuss them
with you.
If you develop swallowing, speech or breathing difficulties,
please seek immediate medical care or ask your relatives to
do so (see section 4).
Elderly

3. How to use BOCOUTURE

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.

4. Possible side effects

Children and adolescents

5. How to store 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.

2. What you need to know before BOCOUTURE is used

6. Contents of the pack and other information
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 upper
facial lines in adults under 65 years of age when the severity
of these lines has an important psychological impact for the
patient:
• moderate to severe vertical lines between the eyebrows
seen at maximum frown and/or
• moderate to severe lateral periorbital lines seen at
maximum smile and/or
• moderate to severe horizontal forehead lines seen at
maximum contraction
2. What you need to know before BOCOUTURE is used
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

MN xxxxx MC xxxx, GB

to 30 units if required by the individual needs of the patient,
with at least ‘3 months’ interval between treatments.

Other medicines and BOCOUTURE
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
The effect of BOCOUTURE 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
BOCOUTURE.
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.
3. How to use BOCOUTURE
BOCOUTURE may only be administered by healthcare professionals with appropriate specialist knowledge of treatment with Botulinum neurotoxin.
Vertical Lines between the Eyebrows seen at maximum
frown (Glabellar Frown Lines)
When treating your vertical lines between the eyebrows seen
at maximum frown (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

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.
Horizontal Forehead Lines seen at maximum contraction
When treating horizontal forehead lines seen at maximum
contraction your doctor will use a dose within a range of 10
to 20 units according to the individual needs of the patient.
The recommended injection volume of totally 0.25 ml (10
units) or 0.5 ml (20 units) will be injected into the five horizontally aligned injection sites (0.05 ml = 2 U, 0.075 ml = 3 U, or
0.1 ml = 4 U, per injection point respectively).
A reduction in the horizontal forehead lines seen at maximum
contraction usually occurs within 7 days with the maximum
effect observed on day 30. The effect lasts up to 4 months
after the injection.
Method of administration
Dissolved BOCOUTURE is intended for injections into the
muscle (intramuscular use; see information for healthcare
professionals at the end of this leaflet).
The interval between two treatments should not be less than
3 months.
If you are given more BOCOUTURE 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.
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:



Feeling of heaviness

• Pain



Nausea

• Inflammation

Post-marketing experience

Instructions for reconstitution of the solution for injection:



Pins and needles



Decreased skin sensation

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.

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.

• Tenderness
• Itching


Swelling (general)



Swelling of the soft tissue (oedema)



Skin redness (erythema)



Localised infection

• Haematoma
• Bleeding
• Bruising
Patients with a fear of injections may experience temporary
generalised reactions, e.g.
• Fainting


Circulatory problems

• Nausea


Noises in the ears

The following very rare side effects have been observed during Botulinum toxin treatment of conditions other than upper facial lines (see section 2):


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
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.

The following information is intended for healthcare
professionals only:

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.

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

5. How to store BOCOUTURE
Keep this medicine out of the sight and reach of children.

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

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.

• Headache

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.

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)

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 BOCOUTURE if the solution has
a cloudy appearance or contains visible particles.

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.
Instructions for disposal



Drooping eyelids (eyelid ptosis)



Accumulation of fluid in the eyelids (eyelid oedema)



Blurred vision

For instructions on disposal, please see information for
healthcare professionals at the end of this leaflet.



Muscle twitching (muscle spasm)

Do not throw away any medicines via wastewater.



Feeling of heaviness at the upper part of the face

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



Feeling of tightness at the injection site

6. Contents of the pack and other information

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).

• Tiredness


Pain or bruising at the injection site

• Itching


Skin nodule

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

What BOCOUTURE contains
• 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.
1 ml solution contains 40 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

The following side effects have been observed when using
BOCOUTURE:

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

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

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



Eyelid swelling



Dry eye



Bruising at the injection site

Upper Facial Lines

Pack sizes of 1, 2, 3 or 6 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder

Very common (may affect more than 1 in 10 people):

Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100
60318 Frankfurt/Main
Germany



Manufacturer

The following side effects have been observed when using
BOCOUTURE to treat upper facial lines:
Headache

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


Numbness



Bruising at the injection site



Pain at the injection site



Drooping eyelids (eyelid ptosis)



Dry eye

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



Facial asymmetry

This leaflet was last revised in 03/2016.

MN xxxxx MC xxxx, GB

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

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.

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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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