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ZOMACTON 4MG INJECTION
Active substance(s): SOMATROPIN
Each Zomacton 4mg Injection carton contains a powder and solvent for solution for injection. The sterile freeze-dried powder
contains the active ingredient Somatropin (Human Growth
Hormone). The powder also contains the inactive ingredient
mannitol. It is supplied in clear glass vials.
The solvent is supplied in an ampoule and is used to dissolve the
active ingredient before it is used. The solvent contains sodium
chloride and benzyl alcohol (preservative), in water for injection.
MA holder: Ferring Pharmaceuticals Ltd., Drayton Hall,
Church Road, West Drayton UB7 7PS UK.
Wasserburger Arzneimittelwerk GmbH Herdestrasse 2 and
Tergernau 18, 83512 Wasserburg, Germany and assembled by
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
The active ingredient, Somatropin, is the same as naturally
occurring growth hormone, but is synthetically produced. This
means there is no risk of developing Creutzfeldt-Jakob disease
which can be caused by growth hormone extracted from infected
Zomacton 4mg Injection is used for the long-term treatment of:
Short stature when present as a feature of Turner’s syndrome
BEFORE STARTING TREATMENT WITH
The parent/s or carer of the child must read the following questions
and decide whether any of them apply to the child. If the answer
to any of the questions is YES and the doctor does not know about
it, tell the doctor BEFORE starting treatment with the medicine.
Is the child less than 3 years old?
Have you been told or do you think that the growth of the
Does the child have an active tumour (cancer). Tumours must
be inactive and you must have finished your anti-tumour
treatment before you can start your treatment with Zomacton
Does the child have diabetes mellitus (sugar diabetes), or is
there a family history of diabetes mellitus?
Is the child taking medication for any other hormone
Only a doctor can prescribe this medicine. It should
never be given to anyone except the person it has been
prescribed for. It may harm them even if they have the
Is the child taking any other medicines that the doctor does
not know about including over the counter medicines?
Is the child allergic to any of the ingredients listed?
In case of pregnancy or breast feeding, the doctor must also be told.
The solution contains benzyl alcohol 9 mg/ml.
Due to the presence of benzyl alcohol as excipient, ZOMACTON
may cause toxic reactions and allergic reactions in infants and
children up to 3 years old and must not be given to premature
babies or neonates.
PRECAUTIONS AND WARNINGS
If you develop any of the following while you are on treatment with
Zomacton 4mg Injection, contact the doctor or nearest hospital
casualty department at once:
a limp, or hip or knee pain;
repeated or prolonged headache;
problems with vision;
Please read this information carefully before starting
nausea and/or vomiting.
treatment with the medicine.
Some children with growth hormone deficiency have developed
leukaemia (increased number of white blood cells), whether or not
they have received treatment with growth hormone. However there
you have any questions or there is anything you are unsure is no evidence that leukaemia incidence is increased in growth
hormone recipients without predisposing factors. No cause and
about, ask your doctor or pharmacist.
effect relationship with growth hormone treatment has been proven.
Pancreatitis shouls be considered in somatropin-treated children who
develop abdominal pain.
period. Make sure the preparation is allowed to warm up to room
The powder should only be mixed with the solvent supplied with temperature before use. If the solution remains cloudy, discard
it. Use 1.3 ml of the solvent to form a solution of 3.3 mg/ml (for the vial and its contents. Do NOT use Zomacton 4mg Injection
if it is past the expiry date shown on the box, vial and ampoule.
use with the ZomaJet 2 Vision, conventional syringe or
If you are unsure about the storage, ask your pharmacist. It is
needle device Ferring Pen). Alternatively, use 3.2 ml of the
best to return all old and unused medication to your pharmacist
solvent to form a solution of 1.3 mg/ml (for use only with a
for safe disposal.
conventional syringe). Your doctor will have told you which
concentration to use. Using the syringe provided, the liquid
PLEASE DO NOT THROW THIS LEAFLET AWAY UNTIL THE
should be injected into the vial containing the powder. To
MEDICINE IS FINISHED AS IT MAY BE NEEDED AGAIN.
prevent foaming of the solution, inject the solvent against the
wall of the vial. The vial must then be swirled gently until the
INSTRUCTIONS FOR RECONSTITUTION
powder has completely dissolved and a clear,
1a. Fit the needle onto the graduated
colourless solution is produced. Avoid shaking or vigorous mixa
ing. If the solution is cloudy or contains particles, the vial and its
b. Remove the plastic top on the
contents should be discarded. In case of cloudiness after refrig- b
eration, the product should be allowed to warm up to room temperature. If cloudiness persists, discard the vial and its contents.
The clear, colourless solution should then be administered as
2. Snap o the top of the liquid
you have been shown at the clinic, using the syringe, ZomaJet
ampoule. Remove the plastic
2 Vision or Ferring Pen provided for this purpose.
HOW TO MAKE UP THE MEDICINE
USING YOUR MEDICINE
The doctor will calculate the precise dose of drug you require,
according to your weight. The maximum recommended dosage
is 0.27 mg per kg bodyweight, per week.
This weekly amount may be divided into seven doses with one
dose each day. The dose is administered subcutaneously with a
syringe, with the needle-free ZomaJet 2 Vision or with the
needle device Ferring Pen. Your doctor will have given you
dosage instructions and told you which method of
administration to use.
In the event of a missed dose, do not worry. Carry on as usual
and administer the next dose at your usual time.
An overdose may cause hypoglycaemia (low blood sugar), followed by hyperglycaemia (high blood sugar). In the event of an
overdose, contact the doctor or nearest hospital casualty department at once. The e ects of repeated overdosing are unknown.
If you miss a dose for any reason, you may experience hypoglycaemia (low blood sugar level). Although the long-term e ectiveness of the treatment will not be a ected, you should consult
your doctor if this happens.
Disturbances in blood sugar, including diabetes mellitus have
been observed. Very rare cases of leukaemia have been reported,
but it appears to be no more common than in children not treated
with growth hormone.
The subcutaneous administration of growth hormone may lead
to an increase or decrease of fat at the site of administration. It
is therefore recommended to frequently change the site of
administration. On rare occasions, patients develop pain and an
itchy rash at the site of administration.
If you experience any incidence of blistering, bruising or abscess
(redness, swelling, pain, heat, boil formation) following the use
of the ZomaJet 2 Vision, please inform your doctor.
Transient headache has been reported during growth hormone
replacement therapy. Rarely, a slight transient oedema (swelling
may occur during treatment with
due to the build up of
In some cases, especially during the rst few weeks of therapy,
repeated or prolonged headache, nausea and/or vomiting and
visual problems may occur.
If these or any other undesirable e ects are experienced, please
inform your doctor.
STORING YOUR MEDICINE
Zomacton 4mg Injection should be stored upright in the refrigerator (2-8°C) and protected from light, both before and after
making up the solution. Once the powder has been mixed with
the solvent, the resulting solution must be used within 14 days.
You should discard any solution left in the vial at the end of this
cover on the needle. Make sure
that the plunger is completely
pushed in before introducing the
needle into the ampoule.
Slowly draw up the required volume in the syringe. Your doctor
will have told you to use either
1.3 ml or 3.2 ml:
• 1.3 ml for a concentration of
3.3 mg/ml (administered using a
syringe, ZomaJet 2 Vision or
• 3.2 ml for a concentration of
1.3 mg/ml (administered using a
3. To prevent foaming of the solution, inject the liquid against the
side of the vial.
4. The vial must then be swirled
gently until the powder has dissolved completely and a clear,
colourless solution is produced.
Avoid shaking or vigorous mixing. If the solution is cloudy or
contains particles, the vial and its
contents should be discarded. In
case of cloudiness after refrigeration, the product should be
allowed to warm up to room temperature (25°C). If cloudiness still
persists, discard the vial and its
The clear, colourless solution
should then be administered
subcutaneously as you have been
shown at the clinic using the
syringe, ZomaJet 2 Vision
or Ferring Pen.
Pharmaceutical companies are not allowed to discuss
prescription medicines with patients.
Zomacton® 4mg Injection: PL 03194/0052
Isotonic Saline Solution 0.9% containing Benzyl Alcohol 0.9%:
was last revised in June 2013.
Zomacton and ZomaJet are Registered Trademarks.