Consumer medicine information

Zomacton 10 mg Powder for Injection

Somatropin (rbe)

BRAND INFORMATION

Brand name

Zomacton 10 mg Powder for Injection

Active ingredient

Somatropin (rbe)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Zomacton 10 mg Powder for Injection.

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 your child using ZOMACTON against the expected benefits it will have for your child.

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.

Ask your doctor if you have any questions about why this medicine has been prescribed.

Your doctor may have prescribed ZOMACTON for another purpose.

This medicine is only available with a doctor's prescription.

This medicine is not expected to affect the ability to drive a car or operate machinery or your child's ability to ride a bike or climb trees.

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 an allergy to any of the ingredients listed at the end of this leaflet
  • 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
  • has severe kidney disease and requires kidney transplantation.

This medicine is not to be used in females of childbearing potential.

The effects of the medicine during pregnancy and in females of childbearing potential have not been investigated.

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 your child starts to use ZOMACTON you should tell your doctor if your child has or has ever had:

  • previous cancerous growth
  • inflammation of the pancreas (severe upper stomach pain, often with nausea and vomiting)
  • diabetes mellitus (sugar diabetes)
  • glucose intolerance
  • thyroid disease
  • active cancer including brain cancer
  • high blood pressure in the head
  • a limp, or hip or knee pain (caused by slipped capital femoral epiphysis, SCFE)
  • Prader-Willi syndrome - a genetic condition characterised by learning difficulties, growth abnormalities, and obsessive eating
  • Leukaemia (increased number of white blood cells)
  • Scoliosis, a condition characterised by curvature of the spine
  • an allergic reaction to foods, dyes, preservatives or any other medicines
  • an allergic reaction to any of the ingredients listed at the end of this leaflet.

Tell your doctor if your child is breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before your child starts using ZOMACTON.

Using ZOMACTON

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 your child must use each day.

It is very important that your child uses ZOMACTON exactly as instructed.

ZOMACTON should be used 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 your child forgets to use ZOMACTON. Do not use a double dose to make up for the dose that has been missed.

Do not stop using ZOMACTON without your doctor's permission. Missing injections can reduce effectiveness and you risk being taken off growth hormone altogether.

Preparation

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. 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 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 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, selfinjecting 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 your child is 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.

Side Effects

ZOMACTON, like all medicines, may cause unwanted side effects in some people.

Do not be alarmed by the following list of side effects. Your child may not experience any of them.

Ask your doctor or pharmacist to answer any questions that you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • pain at the injection site
  • injection site bruising or bleedingan underactive thyroid gland, causing a decrease in metabolism (e.g. tiredness, lethargy, muscle weakness, cramps, feeling the cold, a low heart rate, dry and flaky skin, hair loss, a deep and husky voice, weight gain)
  • build-up of fluid in the body and/ or swelling of hands ankles or feet
  • unusual weakness
  • joint pain
  • aching muscles, muscle tenderness or weakness, not caused by exercise
  • headache
  • unusual muscle stiffness causing poor control of movement.

The above list includes the more common side effects of your medicine (affecting between 1 in 10 and 1 in 100 patients).

Tell your doctor as soon as possible if you notice any of the following:

  • tiredness, headaches, being short of breath when exercising, dizziness and looking pale
  • fast heart beat
  • dizziness
  • swelling under the eyes
  • unusual changes in vision or double vision
  • vomiting
  • abdominal pain
  • excessive gas in the stomach or bowel
  • nausea
  • general weakness
  • bleeding, shrinkage or wastage at the injection site or elsewhere
  • low blood sugar
  • high phosphate levels in the blood
  • bone pain
  • numbness, tingling, or burning sensations in the thumb and fingers
  • stiffness in the extremities
  • a new abnormal growth in any part of the body
  • sleepiness
  • rapid, uncontrollable movements of the eyes
  • loss of control of the bladder
  • blood in urine
  • passing more urine than normal
  • mood swings
  • genital discharge
  • excessive hairiness.

The above list includes serious side effects which may require medical attention. Serious side effects are usually rare or very rare (affecting less than 1 in 1,000 patients).

If you notice any of the following, tell your doctor immediately or go to the Accident and Emergency at your nearest hospital:

  • 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
  • high blood pressure
  • diarrhea
  • kidney problems
  • diabetes mellitus type II (sugar diabetes)
  • numbness or weakness of the arms and legs
  • tingling or numbness
  • high blood pressure in the brain
  • inability/trouble sleeping
  • leukaemia
  • swollen breast tissue/breast enlargement in males.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. Very serious side effects are usually rare or very rare (affecting between 1 in 1,000 and 1 in 10,000 patients).

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

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.

Storage

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 10 mg solution is stable for 28 days if in 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.

Product Description

What ZOMACTON looks like

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 prefilled syringe to the vial before reconstitution.

Ingredients

ZOMACTON 10 mg contains the active ingredient somatropin. It also contains mannitol. The diluent contains metacresol and water.

Sponsor

ZOMACTON is supplied by:

Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1,
20 Bridge Street,
Pymble NSW 2073, Australia.

AUST R 156226 - ZOMACTON somatropin 10 mg multidose powder for injection vial with diluent syringe

This leaflet was prepared in February 2017. #21143-v6A

ZOMACTON is a registered trademark of Ferring B.V.

® = Registered Trademark

BRAND INFORMATION

Brand name

Zomacton 10 mg Powder for Injection

Active ingredient

Somatropin (rbe)

Schedule

S4

 

Name of the medicine

Somatropin (rbe).

Excipients.

10 mg vial.

Powder: mannitol 10 mg, dibasic sodium phosphate dodecahydrate 3.57 mg, dibasic sodium phosphate dihydrate 0.79 mg. Diluent: metacresol 3.3 mg and water for injections to 1 mL.

Description

Zomacton contains somatropin which is a protein having the structure (191 amino acid residues) of the major component of growth hormone produced by the human pituitary gland. It is produced in E. coli, by a method based on recombinant DNA technology.
Zomacton is a sterile white lyophilised powder intended for injection after reconstitution. It is supplied with preserved diluent. The multidose vials are intended to be used for a single patient only. The composition of each strength of Zomacton and accompanying diluent is specified below:
Zomacton 10 mg. Powder: somatropin 10 mg, mannitol 10 mg, dibasic sodium phosphate dodecahydrate 3.57 mg, dibasic sodium phosphate dihydrate 0.79 mg. Diluent: metacresol 3.3 mg and water for injections to 1 mL.

Pharmacology

Pharmacotherapeutic group: Somatropin and somatropin agonists. ATC code: H01 AC 01.

Pharmacodynamics.

Pharmacodynamic properties of Zomacton are identical to human growth hormone. Human growth hormone stimulates linear growth and increased IGF-1 (Insulin-like growth factor/somatomedin-C) concentrations in children with growth hormone deficiency. The measurable increase in linear growth results from the effect of Zomacton on the epiphyseal growth plates of long bone. Zomacton is intended to supply the lack of naturally secreted hormone. Somatropin increases skeletal and cell growth in patients with growth hormone deficiency. It increases protein and carbohydrate metabolism.

Clinical Trials

A clinical study in 162 children showed an increase during 24 weeks to 24 months of treatment from an annualised growth velocity of 32 to 91 mm at six months, 83 mm at 12 months and 75 mm at 24 months. 70 children were studied for 24 months and there are no data for final height. The dose administered was usually 0.1 mg/kg thrice weekly.
Pharmacokinetics following intravenous administration of Zomacton 0.1 mg/kg showed the elimination half-life was about 25 minutes and the mean plasma clearance was 133 mL/minute in healthy male volunteers. In the same volunteers, after a subcutaneous injection of Zomacton 0.1 mg/kg to the forearm, the mean peak serum concentration was 80 ± 50 nanogram/mL which occurred approximately seven hours postinjection and the apparent elimination half-life was approximately 2.7 hours. Compared to intravenous administration, the extent of systemic availability from subcutaneous administration was approximately 70%.
Both strengths of Zomacton when administered by conventional subcutaneous injection and by the Zomajet needle free device were compared in bioequivalence studies conducted in adults. Local tolerability of Zomacton administered via the Zomajet device was evaluated in an open safety study in children aged 3 to 17 years. Efficacy studies in the paediatric population comparing Zomacton administration via the Zomajet device and conventional needle injections have not been evaluated.

Indications

Long-term treatment of children who have growth failure due to inadequate secretion of growth hormone.

Contraindications

Zomacton should not be used in subjects with closed epiphyses.
Zomacton should not be used if there is evidence of an active tumour. Intracranial tumours should be inactive and anti-tumour therapy completed before initiating use of Growth Hormone therapy (see Precautions). Treatment should be discontinued if there is evidence of tumour growth.
Zomacton should not be used in adults. No studies have been carried out to support its use in adults.
Multi-dose Zomacton vials, reconstituted with bacteriostatic saline, should not be used in patients with hypersensitivity to the active substance or to any of the excipients.
Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure, or similar condition should not be treated with Zomacton (see Precautions).
In children with chronic renal disease, treatment with Zomacton should be discontinued at renal transplantation (see Precautions).

Precautions

The maximum recommended daily dose should not be exceeded (see Dosage and Administration).
Local reaction at injection site should be avoided by changing the injection site to avoid the risk of lipoatrophy.
In patients with previous malignant diseases special attention should be given to signs and symptoms of relapse.
Although rare, pancreatitis should be considered in somatropin-treated patients, especially children who develop abdominal pain.

Insulin sensitivity.

Because of the diabetogenic effect of somatropin, Zomacton should be used with caution in patients with diabetes mellitus. Regular blood glucose testing and close supervision is imperative in such cases. Because somatropin may reduce insulin sensitivity, patients should be monitored for evidence of glucose intolerance. For patients with diabetes mellitus, the insulin dose may require adjustment after somatropin containing product therapy is initiated. Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy. Zomacton should also be used with caution in patients with a family history predisposing for the disease.

Thyroid function.

Patients should be euthyroid before Zomacton treatment is initiated. Periodic monitoring of thyroid function is recommended to detect hypothyroidism emerging during treatment. Growth hormone increases the extrathyroidal conversion of T4 to T3 and may, as such, unmask incipient hypothyroidism. Monitoring of thyroid function should therefore be conducted in all patients. In patients with hypopituitarism, standard replacement therapy must be closely monitored when somatropin therapy is administered.

Intracranial lesions or other active neoplasms.

Patients with growth hormone deficiency secondary to intracranial lesions should be closely observed to detect progression or recurrence of the underlying disease. In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm. Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.
Discontinue Zomacton therapy if progression or recurrence of the lesion occurs (see Contraindications).

Intracranial hypertension.

Rare cases of benign intra-cranial hypertension have been reported. In the event of severe or recurring headache, visual problems, and nausea/vomiting, a fundoscopy for papilloedema is recommended. If papilloedema is confirmed, diagnosis of benign intra-cranial hypertension should be considered and if appropriate growth hormone treatment should be discontinued (see Adverse Effects).
At present, there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension. If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.

Slipped capital femoral epiphysis.

Slipped epiphyses are more likely to occur in children receiving growth hormone, and any child with a limp should be evaluated as this may indicate a slipped epiphysis.

Prader-Willi syndrome.

While Zomacton is not indicated for the treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome, it should be noted that there have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea or unidentified respiratory infection.

Leukaemia.

Leukaemia has been reported in a small number of growth hormone deficient patients treated with somatropin as well as in untreated patients (see Adverse Effects). However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.

Antibodies.

As with all somatropin containing products, a small percentage of patients may develop antibodies to somatropin (see Adverse Effects). Testing for antibodies to somatropin should be carried out in any patient who fails to respond to therapy.

Precautions regarding preservatives.

Myositis is a very rare adverse event that may be related to the preservative metacresol in the diluent for Zomacton 10 mg. In the case of myalgia or disproportionate pain at the injection site, myositis should be considered and, if confirmed, a Zomacton presentation without metacresol should be used.

Scoliosis.

Scoliosis may progress in any child during rapid growth. Signs of scoliosis should be monitored during somatropin treatment.

Effects on fertility.

Studies in animals have not been conducted to assess the effect of Zomacton on fertility.

Use in pregnancy.

(Category B2)
For Zomacton, no clinical data on exposed pregnancies are available. There is no data from the use of Zomacton during pregnancy in animals. Therefore, Zomacton is not recommended during pregnancy and in women of childbearing potential not using contraception.

Use in lactation.

There have been no studies conducted with Zomacton in lactating women. It is not known whether this drug is excreted in human milk however, absorption of intact protein from the gastrointestinal tract of the infant is unlikely. Because many drugs are excreted in human milk, caution should be exercised when Zomacton is administered to lactating women.

Genotoxicity.

Somatropin showed no evidence of mutagenic activity in bacterial or mammalian cells and showed no activity in an assay for DNA damage in rodent hepatic cells.

Carcinogenicity.

Associations between elevated serum IGF-1 concentrations and risks of certain cancers have been reported in epidemiological studies. Causality has not been demonstrated. The clinical significance of these associations, especially for subjects treated with somatropin who do not have growth hormone deficiency and who are treated for prolonged periods, is not known.

Effect on ability to drive and use machines.

Zomacton has no or negligible influence on the ability to drive and use machines.

Interactions

Concomitant treatment with glucocorticoids inhibits the growth promoting effects of somatropin containing products. Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth hormone.
High doses of androgens, oestrogens, or anabolic steroids can accelerate bone maturation and may, therefore, diminish gain in final height.
Because somatropin can induce a state of insulin resistance, insulin dose may have to be adjusted in diabetic patients receiving concomitant Zomacton.
Data from an interaction study performed on growth hormone deficient adults suggests that somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes. The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be especially increased resulting in lower plasma levels of these compounds. The clinical significance of this is unknown.

Adverse Effects

In clinical trials (n = 164) the following side effects were noted: headaches (14%), injection site pain (8%), injection site haematoma (4%), oedema (2%), hypothyroidism (6%). The incidence of side effects is similar to that seen in other growth hormone clinical studies.
The subcutaneous administration of growth hormone may lead to loss or increase of adipose tissue at the injection site. On rare occasions patients have developed pain and an itchy rash at the site of injection.
Antibodies anti-somatropin: the protein somatropin may give rise to the formation of antibodies (see Precautions). Depending on the concerned product, these antibodies have been identified in a definite percentage of the treated population. Their binding capacity and their titres are generally low with no clinical consequence. However, testing for antibodies to somatropin should be performed in case of absence of response to somatropin therapy.
Symptoms of fluid retention can be experienced, especially in the early phase of Zomacton therapy.
Leukaemia: cases of leukaemia (very rare) have been reported in children with a growth hormone deficiency, some of them being treated with somatropin and included in the post-marketing experience. However, there is no evidence of an increased risk of leukaemia without predisposition factors (see Precautions).
Slipped capital femoral epiphysis and Legg-Calve-Perthes disease have been reported in children treated with growth hormone. Slipped capital femoral epiphysis occurs more frequently in case of endocrine disorders and Legg-Calve-Perthes is more frequent in case of short stature (see Precautions). But, it is unknown if these 2 pathologies are more frequent or not while treated with somatropin. A discomfort, a pain in the hip and/or the knee must evocate their diagnosis.
Other adverse drug reactions may be considered as class effect, as the hyperglycaemia due to the decrease in insulin-sensitivity, the decrease in free thyroxin level and the possible development of a benign intra-cranial hypertension. See Table 1.

Post-marketing experience.

Pancreatitis has been reported post-marketing during growth hormone therapy (frequency unknown) (see Precautions).

Dosage and Administration

Zomacton should be used only under the supervision of a qualified physician experienced in the management of patients with growth hormone deficiency. The solution for injection should be administered subcutaneously. The injection site should be varied to prevent lipoatrophy.
Zomacton dosage must be individualised for each patient.
The duration of treatment will depend on maximum achievable therapeutic benefit.
A dosage schedule of up to 0.1 mg/kg body weight administered three times weekly by subcutaneous injection is recommended.
As an alternative, a dose of 0.17 - 0.23 mg/kg body weight (approximately 4.9 mg/m2 - 6.9 mg/m2 body surface area) per week divided into 6 - 7 s.c. injections is recommended (corresponding to a daily injection of 0.02 - 0.03 mg/kg bodyweight or 0.07 - 1.0 mg/m2 body surface area). The total weekly dose of 0.27 mg/kg or 8 mg/m2 should not be exceeded (corresponding to daily injections of up to about 0.04 mg/kg).
Somatropin therapy should be continued in children and adolescents until their epiphysis are closed.
Patients with childhood onset Growth Hormone Deficiency should be re-evaluated for growth hormone secretory capacity after growth completion.
After the dose has been determined, each vial is to be reconstituted only with the diluent supplied. To achieve a concentration of 10 mg/mL use entire contents of pre-filled diluent syringe. This is the only concentration to be used with the Zomajet Vision X device (see below).
To prepare the Zomacton, inject the diluent into the vial of Zomacton aiming the stream of liquid against the vial wall. Then swirl the product vial with a gentle rotary motion until the contents are completely dissolved. Do not shake.
After reconstitution, vial contents should be clear, without particulate matter. Occasionally, after refrigeration, some cloudiness may occur. This is not unusual for proteins like Zomacton. Allow the product to warm to room temperature. If the cloudiness persists or particulate matter is noted, the contents must not be used.
Zomacton may be administered using sterile disposable syringes and needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy. Before and after injections, the septum of the vial should be wiped with alcohol to prevent contamination of the contents after repeated needle insertions.

Use with Zomajet device.

Zomacton may also be administered by using the Zomajet needle free device. The Zomajet Vision X is for use with Zomacton 10 mg. Detailed instructions for use of the Zomajet are supplied with each device.
The Zomajet device is a needle free injection device designed to deliver growth hormone subcutaneously. There are three different sized heads, designated A, B and C which can be used with the device. Head A is appropriate for most patients; however, heads B or C may be required for a minority of patients to allow adequate administration of the somatropin.
The selection of the appropriate head is made when patients commence treatment. Patients are trained on the use of the device and to evaluate their injections in order to choose the optimal head. All patients initially begin using head A (smallest diameter). The injection is either complete (‘dry’) or incomplete (‘wet’) when used in accordance with the instructions. If the head is suitable, the injection will be ‘dry’. If the injection is ‘wet’, they try head B and subsequently, if required, head C. Patients who still have problems with ‘wet’ injections using the largest head (head C) are not good candidates for this type of administration. Once the optimal head is chosen, the patient continues with this head for all their injections, replacing the head after every 7 injections. This process ensures reproducible injections that do not impact on the systemic exposure of the growth hormone.
Detailed information on how to choose the optimal head is provided in the instructions for use supplied with the device. Once the optimal head is chosen and the correct administration technique is followed, the patient is confident that a complete (‘dry’) injection has resulted. The clinical data demonstrates bioequivalence of Zomacton administered via Zomajet (when used correctly and a ‘dry’ injection is achieved) and Zomacton administered via a conventional needle.

Overdosage

The recommended dose of Zomacton should not be exceeded.
Single overdosage may lead to low blood glucose levels initially, followed by compensatory hyperglycaemia.
The effects of long-term, repeated use of Zomacton in doses exceeding those recommended, are unknown. However, it is possible that such use might produce signs and symptoms consistent with the known effects of excess human growth hormone (e.g. acromegaly).

Presentation

Zomacton 10 mg powder for injection vial with diluent prefilled syringe and adaptor (1 mL); 1s.
After reconstitution with the volume of diluent specified below, each mL of Zomacton will contain the quantity of excipients specified in Table 2.

Storage

Zomacton, before and after reconstitution, must be stored at 2 - 8ºC. Do not freeze. The reconstituted vials should be used within 28 days (10 mg). Store the vials in an upright position.

Poison Schedule

S4.