Skip to Content

BOCOUTURE 100 UNITS POWDER FOR SOLUTION FOR INJECTION

Active substance(s): BOTULINUM TYPE A TOXIN - HAEMAGGLUTININ COMPLEX

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet:
Information for the user

• 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 mu­
scle 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

100 units powder for solution for injection

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

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


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


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.
• 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.

if you have or have had swallowing difficulties

if you are due to have surgery

Repeated injections with BOCOUTURE
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

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, ple­
ase seek immediate medical care or ask your relatives to do so
(see section 4).

What is in this leaflet:

Elderly

1.

What BOCOUTURE is and what it is used for

2.

What you need to know before BOCOUTURE is used

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.

3.

How to use BOCOUTURE

Children and adolescents

4.

Possible side effects

5.

How to store BOCOUTURE

6.

Contents of the pack and other information

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

1. What BOCOUTURE is and what it is used for

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

BOCOUTURE is a medicine that relaxes the muscles.

The effect of BOCOUTURE may be increased by:

It works by blocking the nerve impulses in all injected muscles.
This prevents muscles from contracting leading to temporary
and reversible relaxation.

• medicines used to treat certain infectious diseases (specti­
nomycin or aminoglycoside antibiotics [e.g. neomycin, ka­
namycin, tobramycin])

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:

• 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.

• 
moderate to severe vertical lines between the eyebrows
seen at maximum frown and/or

In these cases, BOCOUTURE must be used carefully.

• moderate to severe lateral periorbital lines seen at maximum smile and/or

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

• moderate to severe horizontal forehead lines seen at maximum contraction

Pregnancy, breast-feeding and fertility

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 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.

• if you suffer from a generalised disorder of muscle activity
(e.g. myasthenia gravis, Lambert-Eaton syndrome)

Driving and using machines

• if you have an infection or inflammation at the proposed injection site.

You should not drive or engage in other potentially hazardous
activities if drooping eyelids, weakness (asthenia), muscle wea­
kness, dizziness or vision disorders occur.

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

If in doubt, ask your doctor for advice.
3. How to use BOCOUTURE
BOCOUTURE may only be administered by doctors 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 to
30 units if required by the individual needs of the patient, with at
least ‘3-months’ interval between treatments.

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.
Lateral Periorbital Lines seen at maximum smile (Crow’s
feet lines)
For the treatment of lateral periorbital lines seen at maximum smile (crow’s feet lines) your doctor will inject a stan­
dard dose of 24 units (12 units per eye). The recommen­
ded 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.
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 mu­
scle (intramuscular use; see information for healthcare professi­
onals 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, alt­
hough 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 medici­
ne. 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

Post-marketing experience



Decreased skin sensation



Tenderness



Itching

There have been reports of flu-like symptoms and hypersensi­
tivity reactions, such as swelling, swelling of the soft tissue (oe­
dema), redness, itching, rash (local and generalised) and breathlessness.



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 ge­
neralised 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.

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

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


Headache

Unopened vial: Do not store above 25 °C.



Muscle activity disorders (raised eyebrows)

Reconstituted solution: Chemical and physical in-use stability
has been demonstrated for 24 hours at 2 °C to 8 °C.



Nasopharyngitis



Bronchitis



Influenza like illness

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

100 units of BOCOUTURE are reconstituted prior to use in 2.5 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.
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 so­
lution is drawn up into a syringe. After vertical insertion of
the needle through the rubber stopper, the solvent is injec­
ted gently into the vial in order to avoid foam formation. A
20-27 G short bevel needle is recommended for reconstituti­
on. 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.

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.

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

The following information is intended for healthcare professionals only:
Instructions for reconstitution of the solution for injection:

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.

Reconstituted BOCOUTURE is a clear, colourless solution free
of particulate matter.



Drooping eyelids (eyelid ptosis)

Your doctor should not use BOCOUTURE if the solution has a
cloudy appearance or contains visible particles.



Accumulation of fluid in the eyelids (eyelid oedema)

Do not throw away any medicines via wastewater.



Blurred vision



Muscle twitching (muscle spasm)

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



Feeling of heaviness at the upper part of the face



Feeling of tightness at the injection site



Tiredness

What BOCOUTURE contains

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



Pain or bruising at the injection site



Itching



Skin nodule



Depression

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).



Insomnia

• The active substance is: Botulinum toxin type A
(150 kD), free from complexing proteins.
One vial contains 100 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 2.5 ml.

6. Contents of the pack and other information

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

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



What BOCOUTURE looks like and contents of the pack

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.

The following side effects have been observed when using
BOCOUTURE:

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

Recommendations should any incident occur during the hand­
ling of Botulinum toxin

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

• Any spills of the product must be wiped up: either using
absorbent material impregnated with any of the above so­
lutions in case of the powder, or with dry, absorbent ma­
terial in case of reconstituted product. The contaminated
surfaces should be cleaned using absorbent material impregnated with any of the above solutions, then dried.

The other ingredients are: human albumin, sucrose.



Eyelid swelling

Dissolving the powder produces a clear, colourless, particle-free so­
lution.



Dry eye

Pack sizes of 1, 2, 3 or 6 vials.



Bruising at the injection site

Not all pack sizes may be marketed.

Upper Facial Lines

Marketing Authorisation Holder

The following side effects have been observed when using
BOCOUTURE to treat upper facial lines:
Very common (may affect more than 1 in 10 people):

Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100
60318 Frankfurt/Main
Germany



Manufacturer

Headache

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

Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstraße 100
60318 Frankfurt/Main



Numbness



Bruising at the injection site



Pain at the injection site

P.O. Box 11 13 53
60048 Frankfurt/Main



Drooping eyelids (eyelid ptosis)

Germany



Dry eye



Facial asymmetry

Telephone: +49-69/15 03-1
Fax: +49-69/15 03-200



Feeling of heaviness

This leaflet was last revised in 08/2016.



Nausea

MN xxxxx MC xxxx, GB

• If a vial is broken, proceed as mentioned above by carefully
collecting the pieces of broken glass and wiping up the pro­
duct, avoiding any cuts to the skin.
• If the product comes into contact with skin, rinse the affec­
ted 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.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide