Consumer medicine information

Cerezyme

Imiglucerase

BRAND INFORMATION

Brand name

Cerezyme

Active ingredient

Imiglucerase

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cerezyme.

What is in this leaflet

This leaflet answers some common questions about Cerezyme.

It does not contain all the available information.

It does not take the place of talking to your treating physician or a trained health care professional.

All medicines have risks and benefits. Your treating physician has weighed the risks of you or your child having Cerezyme against the benefits they expect it will have.

If you have any concerns about this medicine, ask your treating physician or nurse.

Keep this leaflet. You may need to read it again.

What Cerezyme is used for

Cerezyme is used as enzyme replacement therapy to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, who show signs of the disease such as: anaemia (low number of red blood cells), low numbers of platelets (a type of blood cell) which can lead to a tendency to bleed, spleen or liver enlargement or bone disease. Gaucher disease is a disease in which the enzyme β-glucocerebrosidase in the body does not work properly.

How it works

Patients with Gaucher disease do not produce enough of their own active enzyme, β -glucocerebrosidase. The reduced β -glucocerebrosidase activity in patients results in the accumulation of a fatty substance in the body called glucocerebroside. Cerezyme is an enzyme replacement therapy that is intended to restore a level of enzyme activity enough to remove the built up glucocerebroside and to prevent further build up.

Before you are given Cerezyme

When you or your child must not be given it

Do not use Cerezyme if you or your child have a known, severe, life-threatening allergic reaction to:

  • Cerezyme
  • any of the ingredients listed at the end of this leaflet

Symptoms of an allergic reaction may include:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • skin rash, itching or hives

If you are not sure whether you or your child should have Cerezyme, talk to your treating physician or nurse.

Before you or your child are given it

Tell your treating physician if you or your child have received Cerezyme or another drug and experienced any of the following:

  • life-threatening allergic reaction
  • difficulty breathing

Tell your treating physician if you or your child have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes.

Tell your treating physician if you or your child have previously had surgery to remove the spleen.

Tell your treating physician if you are pregnant or intend to become pregnant. There is no information available regarding the use of Cerezyme in pregnant women. Your treating physician will discuss the possible risks and benefits of having Cerezyme during pregnancy.

Tell your treating physician if you are breast-feeding or plan to breast feed. It is not known whether Cerezyme passes into breast milk. Your treating physician will discuss the possible risks and benefits of having Cerezyme during breast-feeding.

Taking other medicines

Tell your treating physician or nurse if you or your child are taking any other medicines, or health supplements, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Cerezyme may interfere with each other. No studies have been carried out on drug interactions.

How Cerezyme is given

Cerezyme is given through a drip into a vein (intravenously) by a trained Healthcare professional in a hospital, or in a clinic. The infusion can last 1or 2 hours.

It is supplied as a powder which will be mixed with sterile water before it is given.

Your treating physician will decide on the dose and frequency of infusion that is most suitable.

If you are given too much (overdose)

There have been no reported overdoses of Cerezyme.

Your treating physician is trained to work out the correct dose and to contact the Australian Poisons Information Centre (telephone 13 11 26), or the New Zealand National Poisons Centre (telephone 0800 POISON or 0800 764 766) in case of an overdose.

Things you or your child must do

Keep appointments with your treating physician or clinic.

It is important to have the infusion with Cerezyme at the appropriate times to make sure the medicine has the best chance of providing effective treatment for the condition.

After having Cerezyme

Have any tests when your treating physician says to. Your treating physician may wish to test your or your child's body's response to Cerezyme to make sure that it is working.

Things to be careful of

Be careful driving or operating machinery until you know how Cerezyme affects you. Cerezyme is unlikely to have any effect on your ability to drive a car or operate machinery. Make sure that you know how you react to Cerezyme before you drive a car or operate machinery or do anything else that may be dangerous if you are dizzy, light-headed, tired or drowsy.

Side effects

Tell your treating physician or nurse as soon as possible if you or your child do not feel well after having Cerezyme.

Cerezyme may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You or your child may need urgent medical treatment if you notice some side effects.

Ask your treating physician or nurse to answer any questions you may have.

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

  • nausea
  • vomiting

These are mild to moderate side effects of Cerezyme.

Tell your treating physician or nurse immediately if you notice any of the following:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • local reaction around the injection site such as redness, itchiness, tenderness, pain or discomfort, warmth, burning or stinging, swelling or the formation of hard lumps or scars
  • flushing or redness of the skin
  • headaches
  • stomach ache or cramp
  • diarrhoea
  • rash or hives
  • tiredness
  • dizziness

These may be serious side effects of Cerezyme, which may require urgent medical attention.

Tell your treating physician if you notice anything else that is making you or your child feel unwell.

Other side effects not listed above may occur.

Storing Cerezyme

Cerezyme will usually be stored in the hospital or clinic pharmacy refrigeration at 2°C - 8°C.

Reconstituted and diluted Cerezyme should be protected from light.

Product Description

What it looks like

Cerezyme is a white to off-white powder before it is prepared for infusion and a clear, colourless solution after it has been prepared for infusion.

Ingredients

Active ingredient:

imiglucerase

Other ingredients:

sodium citrate dihydrate, mannitol, citric acid monohydrate and polysorbate 80.

Supplied by

In Australia this product is registered by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Toll Free Number: 1800 818 806
Email: [email protected]

AUST R 74277

In New Zealand this product is registered by:

sanofi-aventis new zealand limited
Level 8
56 Cawley Street, Ellerslie,
Auckland
NEW ZEALAND
Phone: (09) 580 1810
Email: [email protected]

CEREZYME® is a registered trademark of Genzyme Corporation, USA.

Most recent amendment : October 2019

czm-ccdsv4-cmiv4-22oct19

Published by MIMS December 2019

BRAND INFORMATION

Brand name

Cerezyme

Active ingredient

Imiglucerase

Schedule

S4

 

1 Name of Medicine

Imiglucerase-rch.

6.7 Physicochemical Properties

Cerezyme contains a nominal value of 400 units* of imiglucerase.
*An Enzyme Unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β-D-glucopyranoside (pnp-Glc) per minute at 37°C.

CAS number.

154248-97-2.

2 Qualitative and Quantitative Composition

Each vial contains 400 units* of imiglucerase**.
*An Enzyme Unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β-D-glucopyranoside (pNP-Glc) per minute at 37°C.
**Imiglucerase is a recombinant, macrophage-targeted, variant of human β-glucocerebrosidase, purified from Chinese Hamster Ovary cells. It catalyses the hydrolysis of the glycolipid, glucocerebroside, to glucose and ceramide following the normal degradation pathway for membrane lipids.

Excipients.

For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cerezyme is provided as a white to off-white sterile lyophilised powder in a clear glass vial and contains a nominal value of 400 units* of imiglucerase.
After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per mL (400 U/10 mL).
The reconstituted solution must be diluted further in sodium chloride.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC code: A16AB02.

Mechanism of action.

Imiglucerase is a recombinant, macrophage targeted, variant of human β-glucocerebrosidase, purified from Chinese hamster ovary cells. It catalyses the hydrolysis of the glycolipid, glucocerebroside, to glucose and ceramide following the normal degradation pathway for membrane lipids.
Glucocerebroside is primarily derived from haematopoietic cell turnover. Gaucher disease is characterised by a functional deficiency in β-glucocerebrosidase enzymatic activity and the resultant accumulation of lipid glucocerebroside in tissue macrophages, which become engorged and are termed Gaucher cells.
Gaucher cells are typically found in liver, spleen and bone marrow and occasionally, as well, in lung, kidney and intestine. Secondary haematological sequelae include severe anaemia and thrombocytopenia in addition to the characteristic progressive hepatosplenomegaly. The skeletal complications are a common, and frequently the most debilitating and disabling, feature of Gaucher disease. Possible skeletal complications are osteonecrosis, osteopenia with secondary pathological fractures, remodelling failure, osteosclerosis and bone crises.
Imiglucerase replaces the deficient enzyme activity, hydrolysing glucosylceramide, thus correcting initial pathophysiology and preventing secondary pathology. Cerezyme reduces spleen and liver size, improves or normalises thrombocytopenia and anaemia, improves or normalises bone mineral density and bone marrow burden, and reduces or eliminates bone pain and bone crises. Cerezyme decreases chitotriosidase, a biomarker for glucosylceramide accumulation in macrophages and response to treatment.
The rate and extent of response to Cerezyme treatment is dose-dependent. Generally, improvements in organ systems with a faster turnover rate, such as the haematological, can be noted far more rapidly than in those with a slower turnover, such as the bone.

Clinical trials.

After the completion of the pivotal clinical trial, at 6 months, patients continued to be followed for an extended study period of 26 to 29 months. In addition, a separate dosing schedule comparison study was conducted.
Tables 2 and 3 describe the design features and results of these studies.
In an International Collaborative Gaucher Group (ICGG) Gaucher Registry analysis of a large cohort of patients (n = 528) with Gaucher disease type 1, a time- and dose-dependent effect for Cerezyme was observed for haematological and visceral parameters (platelet count, haemoglobin concentration, spleen and liver volume) within the dose range of 15, 30 and 60 U/kg body weight once every 2 weeks. Patients treated with 60 U/kg body weight every 2 weeks showed a faster improvement and a greater maximum treatment effect as compared to patients receiving the lower doses. (Grabowski et al, 2009).
Similarly, in an ICGG Gaucher Registry analysis of bone mineral density using dual-energy X-ray absorptiometry (DXA) in 342 patients, after 8 years of treatment normal bone mineral density was achieved with a Cerezyme dose of 60 U/kg body weight once every 2 weeks, but not with lower doses of 15 and 30 U/kg body weight once every 2 weeks (Wenstrup et al, 2007).
Evaluation of treatment efficacy data captured from the International Collaborative Gaucher Group Registry (ICGG/Gaucher Registry), published literature, and from a Japanese post-marketing study show evidence of improvement in non-neurological manifestations (anemia, thrombocytopenia, bone disease, hepatomegaly, and splenomegaly) for type 3 patients, similar to that observed in type 1 patients.

5.2 Pharmacokinetic Properties

During 1 hour intravenous infusions of 4 doses (7.5, 15, 30 and 60 U/kg) of Cerezyme, steady-state enzymatic activity was achieved within 30 minutes. Following infusion, plasma enzymatic activity declined rapidly with a half-life ranging from 3.6 to 10.4 minutes. Plasma clearance ranged from 9.8 to 20.3 mL/min/kg (mean ± SD 14.5 ± 4.0 mL/min/kg). The volume of distribution corrected for weight ranged from 0.09 to 0.15 L/kg (mean ± SD 0.12 ± 0.02 L/kg). These variables do not appear to be influenced by dose or duration of infusion, however, only 1 or 2 patients were studied at each dose level and infusion rate.

5.3 Preclinical Safety Data

Genotoxicity.

No evidence of mutagenic activity was seen in a bacterial gene mutation (AMES) test, however, assays for chromosomal aberrations have not been carried out.

Carcinogenicity.

Studies have not been conducted to assess the potential effects of Cerezyme on carcinogenesis.

4 Clinical Particulars

4.1 Therapeutic Indications

Cerezyme (imiglucerase) is indicated for long-term enzyme replacement therapy for patients with a confirmed diagnosis of non-neuronopathic (type 1) or chronic neuronopathic (type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease.
The non-neurological manifestations of Gaucher disease include one or more of the following conditions: a) anaemia; b) thrombocytopenia; c) bone disease; d) hepatomegaly or splenomegaly.

4.3 Contraindications

There are no known contraindications to the use of Cerezyme. Treatment with Cerezyme should be carefully re-evaluated if there is significant clinical evidence of hypersensitivity to the product.

4.4 Special Warnings and Precautions for Use

Therapy with Cerezyme should be directed by physicians knowledgeable in the management of patients with Gaucher disease.

Immunogenicity.

Hypersensitivity reactions to Cerezyme may occur. Treatment should be carefully evaluated if there is significant clinical evidence of hypersensitivity to the product (see Section 4.3 Contraindications).
Current data suggest that, during the first year of therapy, IgG antibodies to Cerezyme are formed in approximately 15% of the treated patients. It appears that patients who will develop IgG antibody are most likely to do so within 6 months of treatment and will rarely develop antibodies to Cerezyme after 12 months of therapy. It is suggested that patients be monitored periodically for IgG antibody formation to imiglucerase during the first year of treatment.
Patients with antibodies to Cerezyme have a higher risk of hypersensitivity reaction (see Section 4.8 Adverse Effects (Undesirable Effects)). If a patient experiences a reaction suggestive of hypersensitivity, subsequent testing for imiglucerase antibodies is advised. Anaphylactoid reactions have been reported in less than 1% of the patient population. Further treatment with imiglucerase should be conducted with caution. Most patients have successfully continued therapy after a reduction in the rate of infusion and pretreatment with antihistamines and/or corticosteroids.
Patients who have developed antibodies or symptoms of hypersensitivity to Ceredase (alglucerase) should be treated with caution when administering Cerezyme.

Pulmonary hypertension.

In less than 1% of the patient population, pulmonary hypertension has also been observed during treatment with Cerezyme. Pulmonary hypertension is a known complication of Gaucher disease and has been observed both in patients receiving and not receiving Cerezyme. No causal relationship with Cerezyme has been established. Patients with respiratory symptoms should be evaluated for the presence of pulmonary hypertension.
Patients who have undergone a splenectomy have an increased risk of pulmonary hypertension. Cerezyme therapy reduces the requirement for splenectomy in most cases and early treatment with Cerezyme has been associated with a reduced risk of pulmonary hypertension. Routine evaluation to detect the presence of pulmonary hypertension after diagnosis of Gaucher disease and over time is recommended. Patients diagnosed with pulmonary hypertension, in particular, should receive adequate doses of Cerezyme to ensure control of underlying Gaucher disease as well as be evaluated for the need of additional pulmonary hypertension specific treatments.

Neurologic symptoms.

There is insufficient evidence that the use of imiglucerase improves neurologic symptoms in patients with type 2 or type 3 Gaucher disease.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Interactions between Cerezyme and other medicinal products have not been studied. Other forms of interactions such as with food are unlikely.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies have not been conducted to assess the potential effects of Cerezyme on impairment of fertility in animals or humans.
(Category B2)
(Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.)
Animal reproduction studies have not been conducted with Cerezyme.
It is not known whether Cerezyme can cause foetal harm when administered to a pregnant woman, or can affect reproductive capacity. Cerezyme should be given to a pregnant woman only if clearly needed and after a careful risk/ benefit analysis has been conducted for both the mother and foetus.
Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium. This includes an increased risk of skeletal manifestations, exacerbation of cytopenia, haemorrhage and an increased need for transfusion. Both pregnancy and lactation are known to stress maternal calcium homeostasis and to accelerate bone turnover. This may contribute to skeletal disease burden in Gaucher disease.
Animal studies are insufficient with respect to assessing the effects of Cerezyme on human pregnancy, embryonal/ foetal development, parturition and postnatal development. It is not known whether Cerezyme passes via the placenta to the developing foetus. No clinical trial data on exposed pregnancies are available for Cerezyme. From extensive postmarketing experience, however, safety information on the use of Cerezyme in over 150 pregnancies is available. These data suggest that Cerezyme may be used to better control progression of underlying Gaucher disease in pregnancy.
Among over 150 Cerezyme exposed pregnancies, the nature and prevalence of major congenital malformation and foetal death were not different from the occurrences expected in the general population. The available postmarketing data show that Cerezyme treatment in pregnant patients has, in the majority of cases, led to uncomplicated pregnancies and birth of healthy infants.
In pregnant Gaucher patients and those intending to become pregnant, a risk/ benefit treatment assessment is required for each pregnancy. Treatment naïve women should be advised to consider commencing therapy prior to conception in order to attain optimal health. In women receiving Cerezyme treatment, continuation throughout pregnancy should be considered. Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualisation of dose according to the patient's needs and therapeutic response.
Caution should be exercised when prescribing to pregnant women.
It is not known whether Cerezyme is excreted in human milk. However, the enzyme is likely to be digested in the child's gastrointestinal tract. Caution should therefore be exercised when Cerezyme is administered to a nursing woman. There are no animal studies on the effects of imiglucerase on lactation or the potential for excretion of imiglucerase in milk.

4.8 Adverse Effects (Undesirable Effects)

Experience in patients treated with Cerezyme has revealed that approximately 13.8% of patients experienced adverse events which were judged to be related to Cerezyme administration and which occurred with an increase in frequency. Some of the adverse events were related to the route of administration. These include discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. Each of these events were found to occur in < 1% of the total patient population.
Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of patients. Onset of such symptoms has occurred during or shortly after infusions; these symptoms include pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnoea, coughing, cyanosis and hypotension (see Section 4.4 Special Warnings and Precautions for Use). Anaphylactoid reactions have also been reported (see Section 4.4 Special Warnings and Precautions for Use). Each of these events were found to occur in < 1.5% of the total patient population. Pretreatment with antihistamines and/or corticosteroids and reduced rate of infusion has allowed continued use of Cerezyme in most patients.
Additional adverse reactions that have been reported in approximately 6.2% of patients treated with Cerezyme include nausea, abdominal pain, vomiting, diarrhoea, rash, fatigue, headache, fever, dizziness, chills, backache and tachycardia. Each of these events were found to occur in < 1.5% of the total patient population.
In addition to the adverse reactions that have been observed in patients treated with Cerezyme, transient peripheral oedema has been reported for this therapeutic class of drug.
A completed post-marketing clinical study conducted in Japan (protocol 8-98) investigated the use of Cerezyme in patients with neuronopathic Gaucher disease. During this study, one type 3 Gaucher patient experienced an adverse event of nail disorder which was considered potentially related to Cerezyme therapy. No additional adverse events were reported that were related to Cerezyme.

Reporting suspected adverse events.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

4.2 Dose and Method of Administration

After reconstitution with water for injection and dilution with 0.9% sodium chloride intravenous solution the preparation is administered by intravenous infusion over 1 to 2 hours.
Dosage should be individualised for each patient. Initial dosages range from 2.5 U/kg of bodyweight 3 times a week to 60 U/kg once every 2 weeks. 60 U/kg every 2 weeks is the dosage for which most data are available. Disease severity may dictate that treatment be initiated at a relatively high dose or relatively frequent administration. Dosage adjustments should be made on an individual basis, and may increase or decrease, based on achievement of therapeutic goals as assessed by routine comprehensive evaluations of the patient's clinical manifestations.
Initial doses of 60 U/kg of body weight once every 2 weeks have shown improvement in haematological and visceral parameters within 6 months of therapy, and continued use has either stopped progression of or improved bone disease. Administration of doses as low as 15 U/kg of body weight once every 2 weeks has been shown to improve haematological parameters and organomegaly, but not bone parameters.

Method of administration.

Preparation and administration instructions: use aseptic techniques.
The lyophilised powder has to be reconstituted with water for injection, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion. It is recommended that the diluted solution be filtered through an in-line low protein-binding 0.2 micrometre filter during administration.
1. Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.
Occasionally, small dosage adjustments may be made to avoid discarding partially used vials. Dosages may be rounded to the nearest full vial as long as the monthly administered dosage remains substantially unaltered.
2. Reconstitute each vial with water for injection. The final concentrations and administration volumes are provided in Table 1.
Avoid forceful impact of water for injection on the powder and, by mixing gently, avoid foaming of the solution. The pH of the reconstituted solution is approximately 6.1.
3. Before further dilution, visually inspect the reconstituted solution in each vial for foreign particles and discolouration. Do not use vials exhibiting foreign particles or discolouration. Do not use Cerezyme after the expiration date on the vial.
Cerezyme contains no preservatives or antimicrobial agent. Use once and discard any residue. Any unused reconstituted solution must be discarded appropriately.
4. The reconstituted solution contains 40 units imiglucerase per mL. The reconstituted volume allows accurate withdrawal of a nominal volume of 10.0 mL for the 400 unit vial.
5. Withdraw the reconstituted solution from each of the reconstituted vials and dilute with 0.9% sodium chloride intravenous solution to a total volume of 100 to 200 mL. Mix the infusion solution gently. Being a protein solution, slight flocculation (described as thin translucent fibres) occurs occasionally after dilution. The diluted solution may be filtered through an in-line low protein binding 0.2 micrometre filter during administration.
It is recommended that the diluted solution be administered within 3 hours. The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored for up to 24 hours between 2°C and 8°C, protected from light, but microbial safety will depend on the reconstitution and dilution having been performed aseptically.

4.7 Effects on Ability to Drive and Use Machines

Cerezyme is presumed to be safe and unlikely to produce an effect on ability to drive or use machines.

4.9 Overdose

Experience with doses up to 240 U/kg every two weeks have been reported. At that dose there have been no reports of obvious toxicity.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764766 (New Zealand).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Mannitol, sodium citrate dihydrate, citric acid monohydrate, polysorbate 80.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

Unopened vial.

3 years.

Diluted solution.

If necessary, the product diluted in 0.9% Sodium Chloride intravenous solution can be stored for up to 24 hours between 2°C - 8°C, protected from light, but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Cerezyme, after reconstitution, has been shown to be stable for up to 12 hours when stored at room temperature (25°C) and at 2°C - 8°C. Cerezyme, when diluted, has been shown to be stable for up to 24 hours when stored at 2°C - 8°C. After reconstitution, promptly dilute vials and do not store for subsequent use.

6.4 Special Precautions for Storage

The lyophilised product is stored between 2°C - 8°C.
For storage condition after dilution of Cerezyme, see Section 6.3 Shelf Life.

6.5 Nature and Contents of Container

Cerezyme is supplied in clear glass 20 mL vials. The closure consists of a siliconised butyl rubber stopper with a tamper-proof flip-top cap.
Each vial is for single use only. To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.3 mL.
Pack size: 400 unit vial.

6.6 Special Precautions for Disposal

In Australia and New Zealand, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes