somatropin (rbe), recombinant human growth hormone
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions that you may have about ZOMACTON.
It does not contain all the available information. It does not take the place of talking with your doctor, nurse or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using ZOMACTON against the expected benefits it will have for you.
If you have any concerns about this medicine, ask your doctor, nurse or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What ZOMACTON is used for
ZOMACTON is a growth hormone. The active ingredient is somatropin.
ZOMACTON is used for the long-term treatment of children who have growth failure due to a low secretion of natural human growth hormone. ZOMACTON acts the same way as growth hormone naturally produced by the body increasing the height and size of body organs. The product as supplied is intended for your child's use only. It should not be used in adults.
However, your doctor may prescribe ZOMACTON for another purpose. Ask your doctor if you have any questions about why ZOMACTON has been prescribed.
Before you use ZOMACTON
ZOMACTON should only be used under the supervision of a doctor experienced in the treatment of growth hormone deficiency.
When you must not use ZOMACTON (discuss with your doctor)
Your doctor will not prescribe ZOMACTON if your child:
has closed epiphyses (this means that your bones have finished growing)
has an active tumour or evidence of cancer growth
is currently being treated for cancer
has a serious injury or illness, or surgical procedure, requiring intensive care.
Do not use ZOMACTON if:
the expiry date (EXP) printed on the packaging has passed
the packaging is torn or shows signs of tampering.
Do not give this medicine to anyone other than the person for whom it has been prescribed.
Before you start to use ZOMACTON
Before you start to use ZOMACTON you should tell your doctor if your child has or has ever had:
an allergic reaction to foods, dyes, preservatives or any other medicines
an allergic reaction to benzyl alcohol or meta-cresol, which are preservatives in the ZOMACTON mixing solutions.
How to use ZOMACTON
ZOMACTON is injected under the skin (sub-cutaneous) by use of a needle or the ZOMAJET needle-free administration device, which is supplied separately. It is important to use a different site every day to prevent wasting of skin fat at the injection site.
Your doctor, nurse or pharmacist will tell you how many milligrams (mg) of ZOMACTON you must use each day.
It is very important that you use your ZOMACTON exactly as you have been instructed.
Use your ZOMACTON in the evening if possible. Normally, growth hormone is made by the body at night. Giving the injection at night helps to copy this process.
Allow the product to warm to room temperature before injecting and check for cloudiness. If cloudy do not use.
Tell your doctor, nurse or pharmacist if you forget to use your ZOMACTON. Do not use a double dose to make up for the dose you missed.
Do not stop using your ZOMACTON without your doctor's permission. Missing injections can reduce effectiveness and you risk being taken off growth hormone altogether.
The growth hormone is supplied in a powder form that must be prepared for injection by mixing it with a diluent (a liquid in which it can be mixed for injection) before use. If you are using ZOMACTON 4 mg, you will need 1.3 mL of the diluent to reconstitute the powder for injection. For ZOMACTON 10 mg, use the entire contents of the pre-filled solvent syringe to reconstitute the powder for injection.
Once you have reconstituted the growth hormone with the diluent, it is ready for injection. Each reconstituted vial contains a preservative and enough medication for several doses.
You will be taught to mix and inject your ZOMACTON using needles or the ZOMAJET needle-free administration device. It is a good idea to refer to the instruction sheet you receive each time you mix and inject.
The ZOMAJET 2 Vision model is for use with ZOMACTON 4 mg and the ZOMAJET Vision X is for use with ZOMACTON 10 mg. Each device is supplied with 3 heads in different sizes that are labelled A, B and C. Detailed instructions for choosing the correct head, self-injecting and evaluating your injection technique come with the ZOMAJET needle free device. If you experience problems using the ZOMAJET device, contact your nurse or physician.
While you are using ZOMACTON
Tell your doctor, nurse or pharmacist if you have any concerns while using ZOMACTON.
Things you must do
Speak to your doctor or pharmacist before use if you have concerns about how the product looks e.g. if it looks different from normal.
After mixing, check to make sure that the powder is completely dissolved and the solution is clear. You can assist the powder to dissolve by using a slow swirling motion. However, do not shake as this may deactivate the growth hormone.
Things you must not do
ZOMACTON should be used strictly according to the instructions you have been given. Do not change the dose unless your doctor has told you to.
You must not miss injections regularly.
Do not heat or freeze your mixed or unmixed ZOMACTON.
Do not give your ZOMACTON to anyone else.
Things to be careful of
The instructions for mixing the ZOMACTON powder must be followed exactly otherwise problems such as the following may occur:
loss of ZOMACTON activity
broken or jammed administration device.
If any of these problems occur contact the person who trained you on how to mix your ZOMACTON.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription. In particular, tell your doctor if you are taking:
any medicine for the treatment of diabetes
thyroxine (thyroid hormone) for the treatment of thyroid deficiency
corticosteroids such as cortisol or dexamethasone e.g. for the treatment of severe asthma, some skin conditions or rheumatoid arthritis
epilepsy medicines, e.g. carbamazepine, ethosuximide or tiagabine
cyclosporine e.g. for the treatment of severe skin disease (psoriasis), rheumatoid arthritis or after transplant surgery.
ZOMACTON, like all medicines, may cause unwanted side effects in some people.
The most commonly reported side-effects are:
pain at the injection site
injection site bruising or bleeding
low blood sugar.
Tell your doctor immediately if you notice any of the following:
wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy rash (hives) or fainting. These could be a symptom of an allergic reaction
hip pain or limp. If your child develops hip pain or limp contact your doctor.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known. It is important that you tell your doctor about anything unusual, even if it is not mentioned on the list.
Do not be alarmed by this list of possible side effects. Your child may not experience any of them.
Store your ZOMACTON (mixed or unmixed) in the refrigerator at 2-8°C. It must not be frozen or heated above 25°C. Protect from light.
After making up, the ZOMACTON 4 mg solution is stable for 14 days in the refrigerator and the ZOMACTON 10 mg solution is stable for 28 days if the refrigerator. Discard any remaining solution after this time.
Take ZOMACTON out of the refrigerator approximately 1/2 hour before your injection. This will bring it to room temperature (about 25°C). It is more comfortable to inject at this temperature.
Contact your doctor, nurse or pharmacist if you have any questions about storing ZOMACTON.
What ZOMACTON looks like
The ZOMACTON 4 mg pack contains two components:
a) a vial containing a white powder (which contains growth hormone)
b) a vial containing a solution (diluent) for reconstitution of the white powder.
The ZOMACTON 10 mg pack contains three components:
a) a vial containing a white powder (which contains growth hormone)
b) a pre-filled syringe containing a solution (diluent) for reconstitution of the white powder
c) an adapter for connecting the pre-filled syringe to the vial before reconstitution.
ZOMACTON 4 mg contains the active ingredient somatropin. It also contains mannitol. The diluent contains sodium chloride, benzyl alcohol and water.
ZOMACTON 10 mg contains the active ingredient somatropin. It also contains mannitol. The diluent contains meta-cresol and water.
ZOMACTON can be identified by the Australian Register Number:
ZOMACTON 4 mg AUST R 79590
ZOMACTON 10 mg AUST R 156226
ZOMACTON is supplied by:
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1,
20 Bridge Street,
Pymble NSW 2073
This leaflet was prepared in August 2010.