Consumer medicine information

Fasturtec

Rasburicase

BRAND INFORMATION

Brand name

Fasturtec

Active ingredient

Rasburicase

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Fasturtec.

SUMMARY CMI

Fasturtec®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Fasturtec?

Fasturtec contains the active ingredient rasburicase. Fasturtec is used to prevent and treat high blood levels of uric acid that may arise from chemotherapy for cancers of the blood such as leukaemia or lymphoma.

For more information, see Section 1. Why am I using Fasturtec? in the full CMI.

2. What should I know before I use Fasturtec?

Do not use if you have ever had an allergic reaction to Fasturtec or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Fasturtec? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Fasturtec and affect how it works.

For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Fasturtec?

  • The dose of Fasturtec is calculated according to your body weight. The usual dose is 0.2 mg for each kilogram you weigh.
  • Fasturtec is given to you as an infusion into one of your veins (this is called an intravenous infusion).

More instructions can be found in Section 4. How do I use Fasturtec? in the full CMI.

5. What should I know while using Fasturtec?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Fasturtec.
Things you should not do
  • Give Fasturtec to anyone else, even if they have the same condition as you.
  • Use Fasturtec to treat any other complaints unless your doctor tells you to.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Fasturtec affects you.
Drinking alcohol
  • Tell your doctor that you drink alcohol.
Looking after your medicine
  • Fasturtec will normally be stored in the pharmacy or on the ward. The injection is kept refrigerated (2°C to 8°C). Do not freeze it.

For more information, see Section 5. What should I know while using Fasturtec? in the full CMI.

6. Are there any side effects?

Common side effects: Fever, nausea, vomiting, diarrhoea, headache, skin rash and hives. These side effects can also occur as a result of the chemotherapy medicine you may be receiving.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Fasturtec®

Active ingredient: rasburicase

Consumer Medicine Information (CMI)

This leaflet provides important information about using Fasturtec. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Fasturtec.

Where to find information in this leaflet:

1. Why am I using Fasturtec?
2. What should I know before I use Fasturtec?
3. What if I am taking other medicines?
4. How do I use Fasturtec?
5. What should I know while using Fasturtec?
6. Are there any side effects?
7. Product details

1. Why am I using Fasturtec?

Fasturtec contains the active ingredient rasburicase.
Fasturtec is a recombinant form of the urate-oxidase enzyme, which converts uric acid into a substance called allantoin that is easier for your kidneys to remove from the body.

Fasturtec is used to prevent and treat high blood levels of uric acid that may arise from chemotherapy for cancers of the blood such as leukaemia or lymphoma.

2. What should I know before I use Fasturtec?

Warnings

Do not use Fasturtec if you:

  • are allergic to rasburicase, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • have G6PD (glucose-6-phosphate dehydrogenase) deficiency
  • have any condition that causes haemolytic anaemia

Check with your doctor if you:

  • have a previous history of allergy, asthma, or allergic reactions
  • take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. Fasturtec is not recommended for use during pregnancy unless your doctor has discussed the risks and benefits with you.

Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known whether Fasturtec passes into breast milk.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Fasturtec and affect how it works.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Fasturtec.

4. How do I use Fasturtec?

How much to take / use

  • The dose of Fasturtec is calculated according to your body weight. The usual dose is 0.2 mg for each kilogram you weigh. Your doctor may change the dose in some circumstances.

When to take / use Fasturtec

  • Fasturtec is normally given once a day, and may be given for a number of days.

How is Fasturtec given

  • Fasturtec is given to you as an infusion into one of your veins (this is called an intravenous infusion).
  • The infusion will be given over a 30 minute time span.
  • Fasturtec must only be given under supervision of a trained doctor.

If you are given too much Fasturtec (overdose)

Your doctor will decide what dose of Fasturtec you need, and this will be given under close supervision. The risk of an overdose in these circumstances is low. In the event of an overdose, your doctor will decide on the necessary treatment.

Your doctor or pharmacist has information on how to recognise symptoms of an overdose. Ask your doctor or pharmacist if you have any concerns.

5. What should I know while using Fasturtec?

Things you should do

Tell any other healthcare professionals treating you that you are currently using Fasturtec.

Things you should not do

  • Give Fasturtec to anyone else, even if they have the same condition as you.
  • Use Fasturtec to treat any other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Fasturtec affects you.

Fasturtec's effect on your ability to drive or operate machinery has not been studied.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol consumption while being treated with Fasturtec has not been studied.

Looking after your medicine

  • Fasturtec will normally be stored in the pharmacy or on the ward. The injection is kept refrigerated (2°C to 8°C). Do not freeze it.

Follow the instructions in the carton on how to take care of your medicine properly.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do

These side effects can also occur as a result of the chemotherapy medicine you may be receiving.

  • Fever
  • Nausea
  • Vomiting
  • Diarrhoea
  • Headache
  • Skin rash
  • Hives
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • Seizures
  • Hot flushes
  • Tightness in the chest
  • Difficulty in breathing
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems or in New Zealand at pophealth.my.site.com/carmreportnz/s/. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What Fasturtec contains

Active ingredient
(main ingredient)		Rasburicase 1.5 mg
Other ingredients
(inactive ingredients)		Alanine
Mannitol
Dibasic sodium phosphate dihydrate
Monobasic disodium phosphate
Dibasic sodium phosphate dodecahydrate
Poloxamer
Water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What Fasturtec looks like

Fasturtec comes as a clear glass vial containing a white powder, along with an ampoule containing liquid to dissolve the powder. AUST R 80836

Who distributes Fasturtec

Distributed in Australia by:

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

Distributed in New Zealand by:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
Email: [email protected]

This leaflet was prepared in July 2024.

Published by MIMS September 2024

BRAND INFORMATION

Brand name

Fasturtec

Active ingredient

Rasburicase

Schedule

S4

 

1 Name of Medicine

Rasburicase.

2 Qualitative and Quantitative Composition

Each vial contains 1.5 mg rasburicase.
1 mg of rasburicase corresponds to 18.2 EAU. One enzyme activity unit (EAU) corresponds to the enzyme activity that converts 1 micromol of uric acid into allantoin per minute under the operating conditions described: +30°C ± 1°C TEA pH 8.9 buffer.
Rasburicase is a recombinant urate-oxidase enzyme produced by a genetically modified Saccharomyces cerevisiae strain. Rasburicase is a tetrameric protein with identical sub units of a molecular mass of about 34 kDa.
For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.
Crimped, colourless glass vial containing white to off-white pellet.

4 Clinical Particulars

4.1 Therapeutic Indications

Rasburicase is indicated for the treatment and prophylaxis of acute hyperuricaemia, in patients with haematological malignancy at risk of a rapid tumour lysis.

4.2 Dose and Method of Administration

Rasburicase is to be used immediately prior to and during the initiation of chemotherapy only, as at present, there is insufficient data to recommend multiple treatment courses.
In patients who are not hyperuricemic at baseline, chemotherapy regimens should be started within 24 hours of first administration of rasburicase. In patients who are hyperuricemic at baseline, chemotherapy regimens should be started within 48 hours of first administration of rasburicase.

Children and adults.

The recommended dose for rasburicase is 0.20 mg/kg/day. Rasburicase is administered as a once daily 30 minute intravenous infusion in 50 mL of a 0.9% sodium chloride solution. The duration of treatment with rasburicase may vary between 5 and 7 days. No dose adjustment is necessary for special populations (renally or hepatically impaired patients). Administration of rasburicase does not require any change in the timing or schedule of initiation of cytoreductive chemotherapy.

Administration.

Do not use an in-line filter. Rasburicase solution should be infused through a different line than that used for infusion of chemotherapeutic agents to prevent any possible drug incompatibility. If use of a separate line is not possible, the line should be flushed out with saline solution between chemotherapeutic agents infusion and rasburicase. Rasburicase should be administered under the supervision of a trained physician. It contains no antimicrobial agent. Rasburicase is for single use in one patient only. Discard any residue.

Uric acid analysis.

If it is necessary to monitor a patient's uric acid level, a strict sample handling procedure must be followed to minimise ex vivo degradation of the analyte. Blood must be collected into prechilled tubes containing heparin anticoagulant. Samples must be immersed in an ice/water bath. Plasma samples should immediately be prepared by centrifugation in a precooled centrifuge (4°C). Finally, plasma must be maintained in an ice/water bath and analysed for uric acid within 4 hours.

Preparation.

Rasburicase must be reconstituted with the solvent supplied and further diluted only in 0.9% sodium chloride injection. Do not use any glucose intravenous infusion for dilution due to potential incompatibility. This product should not be mixed with other drugs for its infusion.

Reconstitution of the solution.

Under controlled and validated aseptic conditions, add 1 mL of solvent to each vial containing 1.5 mg of rasburicase and mix by swirling very gently. Do not shake. Inspect visually prior to use. Only clear solutions without particles should be used. The solvent contains no preservative, therefore the solution should be reconstituted immediately prior to further dilution, and in no case be stored for longer than 24 hours at 2-8°C.

Dilution before infusion.

The required quantity of solution (according to the patient's bodyweight) is to be further diluted with 0.9% sodium chloride injection to make up a total volume of 50 mL. As the reconstituted solution contains no preservative the diluted solution should be infused immediately, and in no case be stored for longer than 24 hours at 2-8°C.

Infusion.

The final solution should be infused over 30 minutes. Rasburicase solution should be infused through a different line from that used for infusion of chemotherapeutic agents, to prevent any possible drug incompatibility. If use of a separate line is not possible, the line should be flushed out with saline solution between chemotherapeutic agents infusions and rasburicase.

4.3 Contraindications

Hypersensitivity to rasburicase, other uricases or any of the excipients.
G-6-PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia. (Hydrogen peroxide is a byproduct of the conversion of uric acid to allantoin. In order to prevent possible haemolytic anaemia induced by hydrogen peroxide, rasburicase is contraindicated in patients with these disorders).

4.4 Special Warnings and Precautions for Use

Administration of rasburicase reduces the uric acid level to below normal levels and by this mechanism reduces the chance of development of renal failure due to precipitation of uric acid crystals in renal tubules as a consequence of hyperuricaemia. Tumour lysis can also result in hyperphosphataemia, hyperkalaemia and hypocalcaemia. Rasburicase is not directly effective in the treatment of these abnormalities. Therefore, patients must be monitored closely.

Hypersensitivity.

Rasburicase, like other proteins, has the potential to induce allergic responses in humans, including anaphylaxis and/or anaphylactic shock with potential fatal outcome. Clinical experience with rasburicase demonstrates that patients should be closely monitored for the onset of allergic type undesirable effects, especially skin allergic reactions, bronchospasm or severe hypersensitivity reactions including anaphylaxis (see Section 4.8 Adverse Effects (Undesirable Effects)). In case of severe allergic reaction, treatment should be immediately and permanently discontinued and appropriate therapy initiated.
Caution should be used in patients with a history of atopic allergies.
At the present, there is insufficient data available on patients being retreated to recommend multiple treatment courses. Antirasburicase antibodies have been detected in treated patients and healthy volunteers administered rasburicase. In healthy volunteers, 53% subjects receiving rasburicase had antirasburicase antibodies one month post-last dose. Most of the positive subjects were no longer positive at 1 year.
Methaemoglobinaemia has been reported in patients receiving rasburicase. It is not known whether patients with deficiency of methaemoglobin reductase or of other enzymes with antioxidant activity are at increased risk of methaemoglobinaemia. Rasburicase should be immediately and permanently discontinued in patients having developed methaemoglobinaemia, and appropriate measures initiated.
Haemolysis has been reported in patients receiving rasburicase. In such cases, treatment should be immediately and permanently discontinued and appropriate measures initiated.
Rasburicase has not been investigated in patients with hyperuricaemia in the context of myeloproliferative disorders.
There is no data available to recommend the sequential use of rasburicase and allopurinol.

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

In vivo drug-drug interaction studies have not been conducted. In rats and baboons, rasburicase did not appear to induce or inhibit hepatic cytochrome P450 isoforms. In vitro, rasburicase did not metabolise 6-mercaptopurine monohydrate, cytarabine or methotrexate.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No adverse effects on fertility were observed in male and female rats at intravenous doses up to 10 mg/kg/day at which systemic exposure (plasma AUC) was about 12 times greater than that in humans at the maximum recommended dose. The interpretation of the preclinical studies is hampered due to the presence of endogenous urate oxidase in standard animal models.
(Category B2)
No clinical data on exposed pregnancies are available. Rasburicase has been shown to be teratogenic in rabbits given doses of 10, 50 and 100 times the human dose and in rats given doses 250 times the human dose. Animal studies with respect to effects on parturition and postnatal development have not been performed. The potential risk for humans is unknown. Rasburicase should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
 It is unknown whether rasburicase is excreted in human milk, therefore it should not be used in breastfeeding women.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Because rasburicase is concomitantly administered as supportive care to cytoreductive chemotherapy of advanced malignancies, a significant burden of adverse events is expected from the underlying disease state and its treatment.
Undesirable effects possibly attributable to rasburicase reported in clinical trials involving 347 subjects are shown in Table 1.
The most significant drug related adverse events were allergic reactions, mainly rashes (1.4%) and urticaria. Cases of rhinitis, hypotension, bronchospasm (< 1%) and severe hypersensitivity reactions including anaphylaxis (< 1%) have also been attributed to rasburicase.
Because the enzymatic conversion of uric acid to allantoin by rasburicase produces hydrogen peroxide, haemolytic anaemia and methaemoglobinaemia have been observed in certain at risk populations such as those with G-6-PD deficiency. In trials, 0.9% subjects developed haemolytic anaemia, one of these subjects was documented to have G-6-PD deficiency.

Postmarketing data.

Adverse reactions reported during the postmarketing period are detailed below. These reactions are classified within body system categories using the following definitions:
Very common: ≥ 1/10 (≥ 10%), common: ≥ 1/100 and < 1/10 (≥ 1% and < 10%), uncommon: ≥ 1/1000 and < 1/100 (≥ 0.1% and < 1.0%), rare: ≥ 1/10,000 and < 1/1000 (≥ 0.01% and < 0.1%), very rare: < 1/10,000 (< 0.01%), not known: frequency cannot be estimated from available data.

Nervous system disorders.

Uncommon: convulsion. Frequency not known: muscle contractions involuntary.

Blood and lymphatic system disorders.

Uncommon: haemolysis which could be related to G-6-PD deficiency, methemoglobinemia.

Immune system disorders.

Common: allergic reactions. These mainly include rash and urticaria.
Cases of rhinitis, bronchospasm, hypotension, anaphylaxis and/or anaphylactic shock with potential fatal outcome have been reported.

Reporting suspected adverse effects.

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.

4.9 Overdose

Signs and symptoms.

In view of the mechanism of action of rasburicase, an overdose will lead to low or undetectable plasma uric acid concentrations and increased production of hydrogen peroxide.

Management.

Thus patients suspected of receiving an overdose should be monitored for haemolysis, and general supportive measures should be initiated as no specific antidote for rasburicase has been identified.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03AF07.

Mechanism of action.

In humans, uric acid is the final step in the catabolic pathway of purines. The acute increase in plasma levels of uric acid subsequent to the lysis of large numbers of malignant cells and during cytoreductive chemotherapy may lead to degradation of renal function and renal failure which results from the precipitation of crystals of uric acid in renal tubules. Rasburicase is a potent uricolytic agent that catalyses enzymatic oxidation of uric acid into allantoin, a water soluble product, more easily excreted by the kidney in the urine. The enzymatic oxidation of uric acid leads to stoichiometric formation of hydrogen peroxide. The increase of hydrogen peroxide over ambient levels can be eliminated by endogenous antioxidants and the only increased risk for haemolysis is in G-6-PD deficient and inherited anaemia patients.
In healthy volunteers, a marked dose related decrease in plasma uric acid levels was observed across the dose range 0.05 mg/kg to 0.20 mg/kg of rasburicase. This dose related decrease in plasma uric acid levels was seen within four hours post-first dose and remained for up to 24 hours post-last dose of rasburicase.

Clinical trials.

ACT2511 (n = 107) and ACT2694 (n = 131) were phase II, open label, multicentre studies of rasburicase used as uricolytic therapy for the prophylaxis and treatment of hyperuricaemia in patients with leukemia or lymphoma. Patients in ACT2511 received 0.15 mg/kg, while those in ACT2694 received either 0.15 mg/kg (n = 12) or 0.20 mg/kg (n = 119). Primary endpoint was plasma uric acid concentrations over time. Overall, plasma uric acid fell rapidly after the first dose, and remained several-fold below the mean baseline value during rasburicase treatment. The mean percentage reduction (± SD) in uric acid four hours after the first dose was 88% ± 12% in ACT2511 and 84.9% ± 12.6% in ACT2694. (See Table 2.)
EFC2975 was a randomised, multicentre open label phase III study, comparing rasburicase (n = 27) 0.20 mg/kg versus allopurinol (n = 25) for the treatment and prophylaxis of hyperuricaemic patients with leukemia and lymphoma. At 4 hours after the first dose, there was a significant difference (p < 0.0001) in the mean percent reduction from baseline plasma uric acid concentration in the rasburicase group (86.0 ± 7.0%) compared to that for the allopurinol group (12.1 ± 13.3%). Time to first confirmation of normal levels of uric acid in hyperuricaemic patients is four hours for rasburicase and 24 hours for allopurinol. Rasburicase induced excretion of the serum phosphate load prevented further deterioration of renal function from calcium/phosphorus precipitation. (See Table 3.)

5.2 Pharmacokinetic Properties

After infusion of rasburicase at a dose of 0.20 mg/kg/day, steady state is achieved at day 2-3. No unexpected accumulation of rasburicase was observed. In patients the volume of distribution ranged from 110-127 mL/kg, which is comparable to the physiological vascular volume. Clearance of rasburicase was ca. 3.5 mL/h/kg and the elimination half-life ca. 19 hours. The patients included in the pharmacokinetic studies were mainly children and adolescents. Based upon these limited data, it seems that clearance is increased (ca. 35%) in children and adolescents compared to adults, resulting in a lower systemic exposure.
Rasburicase is a protein, and therefore: 1) not expected to bind to proteins; 2) expected that metabolic degradation will follow the pathways of other proteins, i.e. peptide hydrolysis, 3) unlikely to be candidate for drug-drug interactions.
Renal elimination of rasburicase is considered to be a minor pathway for rasburicase clearance. As metabolism is expected to occur by peptide hydrolysis, impaired liver function is not expected to affect the pharmacokinetics.

5.3 Preclinical Safety Data

Genotoxicity.

Assays for gene mutations (histidine reversion in S. typhimurium and mouse lymphoma gene mutation assay), chromosomal damage (cytogenetics in human peripheral blood lymphocytes in vitro and micronucleus test in rats in vivo) and DNA damage (in vitro rat hepatocyte assay) did not provide any evidence of a genotoxic potential.

Carcinogenicity.

Long-term animal studies on carcinogenicity are not available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The excipients contained in the Fasturtec 1.5 mg vials are: alanine, mannitol, dibasic sodium phosphate dihydrate, monobasic sodium phosphate, dibasic sodium phosphate dodecahydrate. The solvent contains poloxamer and water for injections.

6.2 Incompatibilities

Rasburicase solution should be infused through a different line from that used for infusion of chemotherapeutic agents, to prevent any possible drug incompatibility. If use of a separate line is not possible, the line should be flushed out with saline solution between chemotherapeutic agents infusions and rasburicase.
Do not use any glucose intravenous infusion for dilution due to potential incompatibility. This product should not be mixed with other drugs for its infusion.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. (Refrigerate. Do not freeze).

Reconstituted solution.

The solvent contains no preservative, therefore the solution should be reconstituted immediately prior to further dilution, and in no case be stored for longer than 24 hours at 2-8°C.

Diluted solution.

As the reconstituted solution contains no preservative the diluted solution should be infused immediately, and in no case be stored for longer than 24 hours at 2-8°C.

6.5 Nature and Contents of Container

Fasturtec is a sterile powder supplied in a stoppered clear glass vial, accompanied by a solvent in a clear glass ampoule.
Package size: 3 vials of rasburicase and 3 ampoules of solvent per box.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

No data available.

CAS number.

134774-45-1.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes