Consumer medicine information

ProHance

Gadoteridol

BRAND INFORMATION

Brand name

ProHance

Active ingredient

Gadoteridol

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using ProHance.

WHAT IS IN THIS LEAFLET?

This leaflet answers some common questions about ProHance®.

It does not contain all the available information.

It does not take the place of talking with your radiologist, your doctor or your pharmacist.

All products of this type have risks and benefits. Your radiologist and your doctor have weighed the risk of you being given ProHance® against the benefits they expect it will have for you.

If you have any concerns about being given this preparation, ask your radiologist, doctor or pharmacist.

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

WHAT ProHance® IS USED FOR AND HOW IT WORKS

Prohance® is a substance known as a paramagnetic contrast medium. It is used in magnetic resonance imaging (MRI) to enhance or improve the scans or images (pictures) of certain parts of the body (in particular, the brain, spine and surrounding tissue), obtained by MRI alone. ProHance® can also be used for whole body MRI, including the head, neck, liver, breast, musculoskeletal system (all of the muscles, bones, joints and related structures that are involved in the movement of the parts and organs of the body) and diseases of the soft tissues.

ProHance® is given by injection into a vein. ProHance® is not recommended for use in children under the age of 2 years as there is not enough experience with the use of ProHance® in this group.

MRI is a medical technology which uses magnetic fields and radio waves to produce images of parts of the body, which a doctor can then use to make a diagnosis. MRI examinations are carried out by specialist doctors called radiologists, using sophisticated medical equipment. MRI does not use X-rays and therefore the minor risks associated with X-rays are avoided.

BEFORE YOU HAVE AN INJECTION OF ProHance®

You must NOT have an injection of ProHance®:

If you are allergic to the active ingredient of ProHance®, gadoteridol, or the other ingredients in ProHance® injection, or to similar active ingredients of other paramagnetic contrast media, e.g. gadopentetic acid and gadodiamide (brand name: Omniscan®).

Children under 6 months of age must not be given ProHance®.

Which precautions or warnings should be observed?

ProHance works because it contains a metal called gadolinium.

Caution must be taken if you have severe kidney disease. There have been reported cases of nephrogenic systemic fibrosis (NSF) (a disease that causes thickening and hardening of the skin and may involve other organs) after the injection of some gadolinium-containing contrast agents in patients with severe kidney disease.

Studies have shown that small amounts of gadolinium can remain in the body, including the brain. No side effects have been seen due to gadolinium remaining in the brain. In order to minimize this potential risk the lowest effective dose will be given to you and a benefit risk assessment will be performed by your physician before giving you a repeated dose.

Use in pregnancy

It is not known if ProHance® harms the developing baby. Hence, it should only be used in pregnancy if the benefit to the mother outweighs the risk to the developing baby. Therefore, do not have an injection of ProHance® unless you have discussed the risks and benefits involved with your radiologist and doctor and decided to do so.

Use in breastfeeding

It is not known if ProHance® passes into human milk. Because many substances do pass into human milk, discuss with your radiologist if it is necessary to temporarily discontinue breastfeeding.

THEREFORE, BEFORE HAVING AN INJECTION OF ProHance®, TELL YOUR RADIOLOGIST IF:

  1. you are allergic to:
  • the active ingredient of ProHance®, gadoteridol, or the other ingredients in ProHance® injection, or to similar active ingredients of other paramagnetic resonance contrast media, e.g. gadopentetic acid and gadodiamide (Omniscan®)
  • any other medicines or any foods, dyes or preservatives,
  1. you suffer from any other medical conditions including kidney disease,
  2. your child (who is undergoing an MRI examination) is under 2 years of age,
  3. you are pregnant,
  4. you are breastfeeding,
  5. you have kidney disease,
  6. you are diabetic and suffer from kidney disease,
  7. you carry a pacemaker,
  8. you have been implanted any metallic objects, such as replacement joints, aneurism clips, plates, screws,
  9. if you have had a diagnostic examination (X-ray or MRI) with the injection of a contrast medium within the last 24 hours.

Taking other medicines

No interactions between ProHance® and other medicines are known.

HOW ProHance® IS USED

ProHance® is injected into a vein in the course of the MRI procedure. The dose depends on your bodyweight and will be decided by the radiologist. It is likely to be between 0.2 to 0.6mL per kg of body weight for adults and to be 0.2mL per kg of body weight for children aged 2 years and older. The radiologist will take special care when injecting elderly patients with ProHance®.

Following the injection of ProHance®, the radiologist will inject 5mL of normal saline to flush the ProHance® through.

The MRI procedure is usually completed within an hour of the ProHance® injection.

What if you receive too much (an overdose)?

No cases of overdose have occurred as yet. In the unlikely event that you should receive an overdose, your radiologist will know how to treat you.

DURING THE MRI EXAMINATION

Follow the radiologist’s instructions during the MRI examination.

AFTER THE INJECTION OF ProHance®:

While ProHance® will not affect your ability to drive or operate machinery, you may wish to have a family member or friend drive you home after the MRI examination.

SIDE EFFECTS

The most common side effects of ProHance® are an unusual taste in the mouth (possibly a metallic taste) and nausea. These side effects occur in about 1.4% of patients.

Rarely (in less than 1% of patients), it may cause swelling of the face, stiff neck, pain, pain at the spot where the injection was given, a reaction at the spot where the injection was given, pain in the chest, headache, fever, itching, watery eyes, stomach cramps, tingling sensation in the throat, closure of the vocal chords, flushed feeling, fainting, allergic reaction, low blood pressure, fast heart beat, changes in the rhythm of the heart, swollen and/or itching tongue, sore gums, dry mouth, loose bowels, vomiting, frequency and urgency to pass the urines, kidney insufficiency in patients with diabetes and kidney disease, anxiety, dizziness, tingling sensations, mental decline, loss of co-ordination in the arm, staring, fits, breathlessness/shortness of breath, runny nose, cough, rash, itchy rash, hives, reddening and inflammation of the skin, tingling sensation in the extremities, fingers and toes, ringing in the ears, temporary non-harmful changes in the amount of iron in the blood.

Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them.

There have been some cases of life-threatening allergic reaction with similar products and therefore the possibility of allergic reaction occurring with ProHance® cannot be ruled out. Your radiologist has appropriate medicines and equipment on hand to treat you, in the unlikely event that you should experience an allergic reaction to ProHance®.

TELL THE RADIOLOGIST IMMEDIATELY IF YOU ARE NOT FEELING WELL AFTER RECEIVING AN INJECTION OF ProHance®, DURING THE MRI EXAMINATION AND AFTERWARDS.

PRODUCT DESCRIPTION

What it looks like

ProHance® is a sterile solution (clear, colourless to slightly yellow in colour). It is available in the following strengths and sizes of vials and syringes:

Vials: 10mL, 15mL and 20mL; cartons of 10.

Syringes: 10mL and 15mL; cartons of 1 and 5.

Ingredients

ProHance® contains gadoteridol (the active ingredient) in a strength of 279.3mg per mL. It also contains the following inactive ingredients: calteridol calcium, trometamol, hydrochloric acid, sodium hydroxide and water for injections.

STORAGE

ProHance® should be stored below 25°C and protected from light and secondary X-rays. Do not freeze.

FURTHER INFORMATION

ProHance® is registered in Australia with the registration numbers:

Vials

AUST R 263733 ProHance® gadoteridol 2.793g/10mL

AUST R 72671 ProHance® gadoteridol 4.1895g/15mL

AUST R 72672 ProHance® gadoteridol 5.586g/20mL

Syringes

AUST R 72674 ProHance® gadoteridol 2.793g/10mL

AUST R 72675 ProHance® gadoteridol 4.1895g/15mL

SPONSOR

Bracco Pty Ltd
14 Allambie Avenue, East Lindfield, NSW 2070
[email protected]

DISTRIBUTOR

Regional Health Care Products
Mediconsumables Pty Ltd
(ACN 001 394 323)
3-11 Primrose Avenue
Rosebery NSW 2018

This Consumer Medicine Information was compiled July 2018

Published by MIMS October 2018

BRAND INFORMATION

Brand name

ProHance

Active ingredient

Gadoteridol

Schedule

Unscheduled

 

Notes

Distributed by Regional Health Care Products Mediconsumables Pty Ltd

1 Name of Medicine

Gadoteridol.

2 Qualitative and Quantitative Composition

ProHance (gadoteridol) is a nonionic paramagnetic contrast medium for magnetic resonance imaging (MRI). Chemically, gadoteridol is [10-(2-hydroxypropyl-O)-1,4,7,10-tetraazacyclododecane- 1,4,7- triyltriacetato O1, O4, O7, N1, N4, N7, N10 (3-)]gadolinium (III). Gadoteridol is freely soluble in water and methanol, soluble in isopropanol, sparingly soluble in dimethylformamide, slightly soluble in acetonitrile and methylene chloride and very slightly soluble in ethyl acetate, acetone, toluene and hexane.
ProHance contains gadoteridol 279.3 mg per mL (0.5 M).
ProHance has a pH of 6.5 to 8. Pertinent physicochemical data follow:

Parameter.

Osmolality (mOsmol/kg water) at 37°C: 630; viscosity (cP) at 20°C: 2.0; viscosity (cP) at 37°C: 1.3; specific gravity at 25°C: 1.140; density (g/mL) at 25°C: 1.137; octanol:H2O coefficient: -3.68 ± 0.02.
ProHance has an osmolality 2.2 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sterile clear colourless to slightly yellow solution for intravenous injection.

4 Clinical Particulars

4.1 Therapeutic Indications

ProHance is indicated for use in adults and children from 2 years of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood brain barrier or abnormal vascularity. ProHance can also be used for whole body MRI.

4.2 Dose and Method of Administration

ProHance is administered by intravenous injection. ProHance vials and syringes contain no antimicrobial agent and are for single use only. They are to be used once only and any residue discarded.
Extreme caution during injection of any contrast media is necessary to avoid extravasation.

Adults.

The recommended dose range of ProHance for imaging most brain and spine pathologies is 0.1 mmol/kg (0.2 mL/kg).
However, doses of 0.3 mmol/kg (0.6 mL/kg) have been shown to be useful in patients suspected of having cerebral metastases or other poorly enhancing lesions. The lowest effective dose should be used.
When triple dosage is used for poorly enhancing lesions, 20 minute delayed scans might increase lesion conspicuity.
The recommended dose for whole body MRI is 0.1 mmol/kg (0.2 mL/kg).

Children (2 years and above).

The recommended dose for brain imaging and spine pathologies is 0.1 mmol/kg (0.2 mL/kg).
The safety and efficacy of doses higher than 0.1 mmol/kg and sequential or repeat procedures have not been established.

Elderly.

Caution should be exercised in elderly patients.
To ensure complete injection of the contrast medium, the injection should be followed by a 5 mL normal saline flush.
The imaging procedure should be completed within one hour after injecting ProHance.
ProHance should not be mixed with any other drug.

Repeat procedures.

Sequential use during the same diagnostic session has been studied in adult central nervous system use only. If the physician determines repeat dosing is required, repeated doses within the same diagnostic session should be administered about 30 minutes apart, and the time interval between repeated enhanced magnetic resonance sessions should be of at least six hours, to allow for normal clearance of contrast medium from the body.

4.3 Contraindications

A history of previous hypersensitivity to ProHance, its constituents or other gadolinium based contrast media. ProHance is contraindicated in children under 6 months of age.

4.4 Special Warnings and Precautions for Use

Gadoteridol must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions (e.g. coma, encephalopathy, seizures), have been reported with intrathecal use. Gadoteridol should be strictly administered via intravenous injection.

Warning: Nephrogenic systemic fibrosis.

Gadolinium-based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF) in patients with:
acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m2); or
acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

Nephrogenic systemic fibrosis (NSF).

Gadolinium based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs.
Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with noncontrast enhanced MRI or other modalities.
The GBCA associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2) as well as patients with acute kidney injury of any severity due to the hepatorenal syndrome or in the perioperative liver transplantation period. As there is a possibility that NSF may occur with ProHance it should only be used in these patients after careful consideration. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug induced kidney toxicity.
Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (e.g. age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.
Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended ProHance dose and allow a sufficient period of time for elimination of the drug prior to readministration. For patients receiving haemodialysis, physicians may consider the prompt initiation of haemodialysis following the administration of a GBCA in order to enhance the contrast agent's elimination. The usefulness of haemodialysis in the prevention of NSF is unknown.

Accumulation of gadolinium in the brain.

The current evidence suggests that gadolinium accumulates in the brain after multiple administrations of GBCAs. Increased signal intensity on non-contrast T1 weighted images of the brain has been observed after multiple administrations of GBCAs in patients with normal renal function. Gadolinium has been detected in brain tissue after multiple exposures to GBCAs, particularly in the dentate nucleus and globus pallidus. The evidence suggests that gadolinium accumulation is higher after repeat administration of linear than after repeat administration of macrocyclic agents.
The clinical significance of gadolinium accumulation in the brain is presently unknown. In order to minimize potential risks associated with gadolinium accumulation in the brain, it is recommended to use the lowest effective dose and perform a careful benefit risk assessment before administering repeated doses.

Central nervous system disorders.

Like with other gadolinium chelate containing contrast media, special precaution including close monitoring and availability of equipment and drugs necessary to counter any convulsions is necessary in patients with a low threshold for seizures.

Hypersensitivity reactions.

As with other gadolinium chelates, there were reports of anaphylactic/ anaphylactoid or allergic reactions. These reactions manifested in varying degree of severity up to anaphylactic shock, leading to rare cases of fatal outcome, and involved one or more body systems, mostly respiratory, cardiovascular and/or mucocutaneous systems (see Section 4.8 Adverse Effects (Undesirable Effects)).
Appropriate drugs and instruments for emergency measures must therefore be available. The accepted safety considerations and procedures that are required for magnetic resonance imaging are applicable when ProHance is used for contrast enhancement, in particular, the exclusion of ferromagnetic objects, for example cardiac pacemakers or aneurism clips. MR procedures should only be performed (both with or without contrast) in a patient with an implanted metallic object that has been previously tested and demonstrated to be safe in MR imaging.

Renal impairment.

Use in renally impaired patients.

Since gadoteridol is cleared from the body by glomerular filtration, caution should be exercised in patients with impaired renal function. A suitable interval of time greater than 24 hours (preferably 48 hours), should elapse between two separate examinations with ProHance (gadoteridol) or between evaluations with iodine contrast media and ProHance. ProHance injection has been shown to be dialyzable in in vitro experiments.
Rare cases of renal tubular necrosis leading to acute renal failure have been reported in patients with pre-existing severe renal dysfunction due to diabetic nephropathy.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

Due to limited safety data in clinical trials ProHance should be limited to use in children over the age of 2 years.

Effects on laboratory tests.

No clinically significant changes or trends in laboratory tests were seen in clinical trials with gadoteridol.
Transitory changes in serum iron (within normal range in the majority of cases) have been observed in some cases after administration of ProHance. These changes were shown not to be clinically significant.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are no known drug interactions with gadoteridol. ProHance should not be mixed with any other drug.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

ProHance did not affect fertility in rats at exposures (AUC) 9.1 and 2.7 times the human exposure at 0.1 and 0.3 mmol/kg, respectively.
(Category B3)
ProHance was not embryotoxic or teratogenic in rabbits at 6 mmol/kg (6 and 18 times the human high and low dose, respectively, based on body surface area) and in rats at 10 mmol/kg (4.5 and 15 times the human exposure based on AUC).
In a peri/post natal study in rats administered gadoteridol from gestation day 17 to the end of the lactation period, increased deaths of offspring occurred in the first 4 days post partum at 0.67 and 2.3 times the human exposure at the high and low dose, respectively. There are no adequate and well controlled studies in pregnant women. ProHance should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteridol.
 Gadoteridol was excreted in rat milk. In a peri/post natal study in rats administered gadoteridol from gestation day 17 to the end of the lactation period, increased deaths of offspring occurred in the first 4 days post partum at 0.67 and 2.3 times the human exposure at the high and low dose respectively. The no-effect dose for rat pup survival corresponds to 0.17 and 0.57 times the human exposure, respectively.
It is not known whether ProHance is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when the drug is administered to a nursing mother and consideration should be given to temporarily discontinuing nursing until at least 24 hours after the administration of ProHance.

4.7 Effects on Ability to Drive and Use Machines

There are no known effects of ProHance on the ability to drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials.

Intracranial/ spinal indications.

See Tables 1 and 2.

Whole of body indication.

See Table 3.

Paediatric indication.

See Table 4.

Postmarketing data.

Spontaneously reported serious adverse reactions (SAR) divided by symptoms and body system.

Adverse reactions have been reported rarely (less than 0.1% patients) since marketing of the compound.
Reported adverse reactions in MedDRA terminology (MedDRA 5.0) included (see Table 5):

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

There have been no cases of overdose reported to date, consequently, neither signs nor symptoms of overdosage have been identified. In the event of overdosage occurring, the patient should be observed and treated symptomatically.
ProHance can be removed by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Gadoteridol is a nonionic paramagnetic contrast medium for magnetic resonance imaging. When placed in a magnetic field, gadoteridol decreases T1 relaxation times in targeted areas. At recommended doses, the effect is observed with greatest sensitivity in the T1 weighted sequences.
Current evidence suggests that gadolinium accumulates in the brain after repeated administrations of Gadolinium-based contrast agents (GBCAs) although the exact mechanism of gadolinium passage into the brain has not been established.

Clinical trials.

CNS.

Clinical trials involved 428 evaluable patients with suspected intracranial or spinal pathology. The efficacy evaluation assessed incidence and degree of enhancement as well as diagnostic information gained from postdose versus predose images of ProHance. Additional information on both brain and spinal tumours was gained for the majority of patients in the studies.
Contrast enhancement was noted in all studies for at least 70% of patients with brain pathology and for at least 57% of patients with spinal pathology. Additional diagnostic information on both brain and spinal tumours was gained for the majority of patients in all studies.

High dose CNS.

An open label multicentre study in the USA that involved 49 evaluable patients indicated that for brain metastases, a dose of 0.1 mmol/kg followed by an additional 0.2 mmol/kg could increase diagnostic sensitivity. This was further investigated in the USA looking at a higher dose of ProHance (0.1 mmol/kg) followed 7 days later by repeat MRI with an additional 0.3 mmol/kg in 107 patients.
For intracranial and spinal lesions, comparative studies of 0.1 mmol/kg Magnevist, followed 1-7 days later by repeat MRI using 0.3 mmol/kg ProHance, were conducted on 176 patients. An increase in diagnostic information was seen in more than half the cases. The main diagnostic gain was in the number of lesions visualised.

Whole body.

A total of 1,021 evaluable patients were included in seven studies. These studies were performed in specific body areas to demonstrate the safe and effective use of ProHance in MRI of the whole body. The areas of the body investigation were intracranial head and neck, breast, liver, musculoskeletal system and soft tissue trunk and limbs. The most important additional information was improved visualisation, definition of lesion borders, disease classification and lesion detection.

Paediatric.

A study was conducted in the USA to determine the efficacy of ProHance in children from 6 months to 20 years suspected of having neurological pathology (31 patients < 5 years, 23 patients 5 to < 10 years, 47 patients 10 to < 18 years, two patients 18 to 20 years). Three blinded readers independently evaluated 76 intracranial cases; all images were felt to be of diagnostic quality. The postcontrast images provided additional diagnostic information compared to the precontrast images and this was statistically significant for one of the three blinded readers (P < 0.001). Additional diagnostic information was provided postcontrast in 95%, 30% and 67% of cases by three different blinded readers. The information provided by postcontrast images most frequently was improved visualisation, definition of lesion borders and lesion detection.
The three blinded readers independently evaluated 16 spinal cases. The postcontrast images provided additional diagnostic information compared to the precontrast images and this was statistically significant for one reader (P < 0.001). Additional diagnostic information was provided postcontrast in 100%, 33% and 40% of cases by three readers. The information provided by postcontrast images most frequently was improved visualisation, lesion detection, disease classification and definition of lesion borders.

5.2 Pharmacokinetic Properties

The pharmacokinetics of intravenously administered gadoteridol in normal subjects conforms to a two compartment open model with mean distribution and elimination half-lives (reported as mean ± SD) of about 0.20 ± 0.04 hours and 1.57 ± 0.08 hours, respectively. Gadoteridol is exclusively eliminated in the urine with 94.4 ± 4.8% (mean ± SD) of the dose excreted within 24 hours post injection. There is no detectable biotransformation or decomposition of gadoteridol.
The renal and plasma clearance rates (1.41 ± 0.33 mL/min/kg and 1.50 ± 0.35 mL/min/kg, respectively) of gadoteridol are essentially identical, indicating no alteration in kinetics on passage through the kidneys and that the drug is essentially cleared through the kidneys. The volume of distribution (204 ± 58 mL/kg) is equal to that of extracellular water, and clearance is similar to that of substances which are subject to glomerular filtration.

5.3 Preclinical Safety Data

Genotoxicity.

ProHance did not induce gene mutation in Salmonella typhimurium, E. coli or mouse lymphoma cells, or chromosomal aberrations in CHO cells in vitro or in bone marrow cells in mice in vivo.

Carcinogenicity.

There were no carcinogenicity studies for gadoteridol.

6 Pharmaceutical Particulars

6.1 List of Excipients

Calteridol calcium, trometamol, hydrochloric acid, sodium hydroxide and water for injections.
ProHance contains no antimicrobial preservative.

6.2 Incompatibilities

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

6.3 Shelf Life

36 months.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light and secondary X-rays. Do not freeze.
Should freezing occur in the vial, bring the solution to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, ProHance will return to a clear, colourless to slightly yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. Should solids persist, discard the vial.
If solid particles remain, the vials should be discarded.

6.5 Nature and Contents of Container

Glass vials.

15 mL and 20 mL; cartons of 10 vials.

Glass syringes.

10 mL and 15 mL; cartons of 1 and 5 syringes.

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.


CAS number.

120066-54-8.

7 Medicine Schedule (Poisons Standard)

Not scheduled. Not considered by committee.

Summary Table of Changes