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Active ingredient:
Carboplatin 10 mg/mL;  ;  
Available from:
Pfizer New Zealand Limited
INN (International Name):
Carboplatin 10 mg/mL
10 mg/mL
Pharmaceutical form:
Solution for injection
Active: Carboplatin 10 mg/mL     Excipient: Nitrogen Water for injection
Units in package:
Vial, plastic, 1 x 5 mL, 5 mL
Prescription type:
Manufactured by:
Johnson Matthey Pharmaceutical Materials
Product summary:
Package - Contents - Shelf Life: Vial, plastic, 1 x 5 mL - 5 mL - 24 months from date of manufacture stored at or below 25°C - Vial, plastic, 1 x 15 mL - 15 mL - 24 months from date of manufacture stored at or below 25°C - Vial, plastic, 1 x 45 mL - 45 mL - 24 months from date of manufacture stored at or below 25°C
Authorization number:
Authorization date:


Page 1

Carboplatin Injection


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Carboplatin Injection.

It does not contain all the available

information. It does not take the place

of talking to your doctor or pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of

you using Carboplatin Injection against

the benefits it is expected to have for


If you have any concerns about using

this medicine, ask your doctor or


Keep this leaflet.

You may need to read it again.

What Carboplatin

Injection is used for

Carboplatin belongs to a group of

anticancer medicines known as

platinum complexes. Carboplatin

works by preventing the growth of

cancer cells and eventually destroying

them. It is used for cancer of the ovary.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it for

another reason.

This medicine is available only with a

doctor’s prescription.

Before you are given

Carboplatin Injection

When you must not be given


Do not use Carboplatin Injection if:

you have an allergy to carboplatin,

cisplatin or other medicines

containing platinum

you have kidney disease or poor

kidney function

you have a low blood count

Do not use this medicine if you are

pregnant or planning to become


It may affect your developing baby if

you take it during pregnancy.

Do not breast feed if you are using

this medicine.

If you are not sure you should be

given Carboplatin, talk to your


Before you are given it

Tell your doctor if you have allergies

to any other medicines, foods,

preservatives or dyes.

Tell your doctor if you are pregnant

or plan to become pregnant.

Tell your doctor if you are breast-

feeding or plan to breast-feed.

Tell your doctor if you have or have

had any of the following medical


any sort of infection e.g. sinusitis,

tooth abscess, etc

abnormal or heavy bleeding

bleeding gums

unusual tiredness

poor kidney function

problems with hearing.

Tell your doctor if you are going to

be vaccinated (have an injection to

prevent a certain disease).

If you have not told your doctor

about any of the above, tell him/her

before you are given Carboplatin.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a prescription

from your pharmacy, supermarket

or health food shop.

Some medicines and Carboplatin may

interfere with each other. These


other anticancer drugs

drugs that affect the kidneys such

as some antibiotics

some vaccinations (injections to

prevent you getting a certain


You may need different amounts of

your medicines or you may need to

take different medicines. Your doctor

will advise you.

How Carboplatin is


Carboplatin is given by slow injection

into a vein. It must only be given by a

doctor or a nurse.

Your doctor will decide what dose,

how often and how long you will

receive it.

This depends on your condition and

other factors, such as your weight, age,

blood tests, how well your kidneys are

working and whether or not other

medicines are being given at the same



Page 2

If you are given too much


Overdose is unlikely as treatment is

given in hospital under the supervision

of a doctor.

However, if you are given too much

Carboplatin, you may experience some

of the effects listed under “Side Effects”


Ask your doctor if you have any


Your doctor has information on how to

recognise and treat an overdose.

While you are being

treated with


Things you must do

Keep all of your doctor’s

appointments so that your progress

can be checked.

You will also have blood tests to check

for side effects.

Tell any other doctors, dentists and

pharmacists who treat you that you

are using this medicine.

If you become pregnant while using

this medicine, tell your doctor


Side effects

Tell your doctor, nurse or

pharmacist as soon as possible if you

do not feel well while you are using

Carboplatin Injection.

Like other medicines, Carboplatin can

cause some side effects. If they occur,

most are likely to be minor or

temporary. However, some may be

serious and need medical attention.

Tell your doctor immediately if you

notice any of the following:

fever and chills, sore throat, sweats

or feel generally unwell

wheezing or shortness of breath

during administration

pain and redness at site of injection

bleeding, unusual bruising,

bleeding gums, blood in the urine

or stools, or pinpoint red spots

rash, fever or itching

hearing loss or ringing in the ears


tingling or a loss of sensation in the

fingers or toes

blurred vision

mouth ulcers

nausea, vomiting

hair loss, especially of the scalp

diarrhoea, constipation

a feeling of tiredness

joint pain, muscle pain

chest pain, stroke

decrease in urine

These may be serious side effects.

You may need urgent medical

attention. Serious side effects are rare.

Other side effects not listed above may

also occur in some patients.

Tell your doctor if you notice any

other effects.

Some side effects may only be seen by

your doctor.

Product description

What it looks like

Carboplatin Injection is a clear,

colourless solution in a plastic vial.

It comes in three sizes: 50 mg of

carboplatin in 5 mL, 150 mg in 15 mL

and 450 mg in 45 mL.


Carboplatin Injection contains

carboplatin as the active ingredient.

It also contains Water for Injections. It

does not contain a preservative.


Carboplatin is supplied in Australia by:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Toll Free Number: 1800-675 229

It is supplied in New Zealand by:

Pfizer New Zealand Ltd

PO Box 3998


Toll Free Number: 0800-736 363

Australian Registration Numbers

50 mg /5 mL

AUST R 42853

150 mg /15 mL

AUST R 49348

450 mg /45 mL

AUST R 49349

Date of preparation

This leaflet was prepared in December


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Carboplatin Injection, 50 mg/5 mL, 150 mg/15 mL and 450 mg/45 mL.



Carboplatin is a sterile, hypotonic, preservative-free solution of carboplatin 10 mg/mL in Water

for Injections.

For the full list of excipients, see section 6.1.



Solution for injection.



4.1 Therapeutic indications

For the treatment of advanced ovarian carcinoma of epithelial origin.

4.2 Dose and method of administration


The recommended dosage for previously untreated adults (normal renal function) is 400mg/m²

as a single intravenous infusion over 15-60 minutes.

Therapy should not be repeated again until four weeks have elapsed.

In patients with risk factors such as previous myelosuppressive therapy or in the aged, the initial

dosage may need to be reduced to 20-25%.

Determination of the haematological nadir by weekly blood counts is recommended for

adjusting future doses and scheduling of carboplatin.

Dose Adjustments

Patients with Impaired Renal Function

As carboplatin is excreted by the kidney and is nephrotoxic the optimum dosage should be

determined by frequent monitoring of the haematological nadir and renal function.

The suggested dosage schedule for patients with impaired renal function based on creatinine

clearance is:

Creatinine Clearance

Carboplatin Dose

> 40 mL/min

400 mg/m²

20-39 mL/min

250 mg/m²

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0-19 mL/min

150 mg/m²

Paediatric population

Insufficient information is available to make specific recommendations.

Combination Therapy

Carboplatin may be used in combination with other anti-neoplastic agents and hence the dosage

will vary according to the protocol used.

The optimal use of carboplatin in combination with other myelosuppressive drugs will require

dosage adjustments and frequent haematological monitoring.

Method of Administration

Aluminium reacts with carboplatin causing precipitate formation and loss of potency, therefore

aluminium-containing equipment should not be used for preparation or administration of


Prior to administration, carboplatin solutions should be inspected visually for particulate

matter. Dilutions may be made in Glucose 5% Intravenous Infusion to concentrations as low

as 0.1 mg/mL. The product and admixture contain no antimicrobial agent. In order to reduce

microbiological hazards it is recommended that further dilution should be effected immediately

prior to use and infusion commenced as soon as practicable after preparation of the admixture.

Infusion should be completed within 24 hours of preparation and any residue discarded (see

Section 6.6).

4.3 Contraindications

Treatment with carboplatin is contraindicated in the following conditions:








platinum-containing compounds (e.g. cisplatin)

in the presence of severe renal impairment

in the presence of severe bone marrow depression

in the presence of substantial bleeding

in pregnancy and lactation.

4.4 Special warnings and precautions for use

Carboplatin should be administered only by a qualified physician experienced in the use of

chemotherapeutic agents. Close monitoring for toxicity is mandatory, particularly in the case

of administration of high drug dosages.

Carboplatin is a highly toxic drug with a narrow therapeutic index and a therapeutic effect is

unlikely to occur without some evidence of toxicity.

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Bone Marrow Function

Bone marrow suppression (leucopenia, neutropenia and thrombocytopenia) is dose-dependent

and is the dose-limiting toxicity of carboplatin. Peripheral blood cell counts should be

performed at frequent intervals (before start of therapy and weekly thereafter) in patients

receiving carboplatin. Although at the recommended drug doses the haematologic toxicity of








thrombocytopenia) may occur in patients with renal impairment and in patients who are

concurrently receiving (or have received) other myelosuppressive drugs or radiation therapy.

Dose adjustment criteria for patients who experience myelosuppression following a dose of

carboplatin are provided under Dosage and Administration. As an alternative to dosage

reduction, administration of the full therapeutic dose of the drug may be delayed until recovery

of neutrophil and platelet counts (values ≥ 2000/mm3 and 100,000/mm3 respectively).

Treatment of severe haematologic toxicity may consist of supportive care, anti-infective agents

for complicating infections, transfusions of blood products, autologous bone marrow rescue,

peripheral stem cell transplantation and haematopoietic agents (colony-stimulating factors).

Blood and Lymphatic System Disorders

Haemolytic anaemia with the presence of serologic drug-induced antibodies has been reported

in patients treated with carboplatin. This event can be fatal.

Haemolytic-uremic syndrome (HUS) is a potentially life-threatening side effect. Carboplatin

should be discontinued at the first sign of any evidence of microangiopathic haemolytic

anaemia, such as rapidly falling haemoglobin with concomitant thrombocytopenia, elevation

of serum bilirubin, serum creatinine, blood urea nitrogen, or lactate dehydrogenase (LDH).

Renal failure may not be reversible with discontinuation of therapy and dialysis may be


Secondary Leukaemia

Acute promyelocytic leukaemia (APL) and myelodysplastic syndrome (MDS)/acute myeloid












antineoplastic treatments.

Hepatobiliary Disease

Cases of hepatic veno-occlusive disease (sinusoidal obstructive syndrome) have been reported.

Some of them were fatal.

Renal Function

Carboplatin is excreted primarily in the urine and renal function must be monitored in patients

receiving the medicine. Creatinine clearance appears to be the most sensitive measure of

kidney function in patients receiving carboplatin. Dose adjustment criteria for patients with

impaired renal function are provided under Dosage and Administration. Unlike cisplatin, pre-

and post-treatment hydration is not necessary with carboplatin as the drug has a relatively low

nephrotoxic potential, however, previous therapy with cisplatin or concomitant administration

of other nephrotoxic drugs


aminoglycoside antibiotics) may

increase the

risk of

nephrotoxicity (see Section 4.5).

Central Nervous System (CNS)/Hearing Functions

Routine neurologic examination is advisable during carboplatin therapy, particularly in patients

previously treated with cisplatin and in patients over 65 years of age. Carboplatin may produce

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cumulative ototoxicity. Audiograms should be performed prior to initiating therapy and during

treatment or when auditory symptoms occur. Clinically important deterioration of auditory








ototoxicity may be increased by concomitant administration of other ototoxic drugs (e.g.,

aminoglycosides) (see section 4.5).

Delayed onset hearing loss has been reported in paediatric patients. Long-term audiometric

follow-up in this population is recommended.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)










chemotherapy. RPLS is a rare, reversible after treatment discontinuation, rapidly evolving









blindness, and other visual and neurological disturbances. Diagnosis of RPLS is based upon

confirmation by brain imaging, preferably MRI.

Gastrointestinal Effects

Carboplatin can induce emesis. The incidence and severity of emesis may be reduced by

pre-treatment with antiemetics or by carboplatin administration as a continuous IV infusion

over 24 hours, or as IV administration of divided doses over 5 consecutive days rather than as

a single infusion. Selective inhibitors of type 3 (5-HT3), serotonergic receptors (e.g.,

ondansetron) or substituted benzamides (e.g., metoclopramide) may be particularly effective

antiemetics, and combination therapy may be considered for patients experiencing severe or

refractory emetogenic effects.

Tumour Lysis Syndrome (TLS)

Patients at high risk of TLS such as patients with high proliferative rate, high tumor burden and

high sensitivity to cytotoxic agents should be monitored closely and appropriate precaution


Hypersensitivity Reactions

As in the case of other platinum complexed compounds, allergic reactions to carboplatin have

been reported. Patients should be monitored for possible anaphylactoid reactions and

appropriate equipment and medication should be readily available to treat such reactions (e.g.,

antihistamines, corticosteroids, epinephrine, oxygen) whenever carboplatin is administered.

Immunosuppressant Effects/Increased Susceptibility to Infections







chemotherapeutic agents including carboplatin, may result in serious or fatal infections.

Vaccination with a live vaccine should be avoided in patients receiving carboplatin. Killed or

inactivated vaccines may be administered; however, the response to such vaccines may be


4.5 Interaction with other medicines and other forms of interaction

Carboplatin is mostly used in combination with antineoplastic drugs having similar cytotoxic

effects. In these circumstances additive toxicity is likely to occur. Concomitant use of

carboplatin and other myelosuppressive agents or radiation therapy

may potentiate the

hematologic toxicity.

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An increased incidence of emesis has been reported when carboplatin and other emetogenic

drugs are given concurrently or carboplatin is administered to patients who previously received

emetogenic therapy.

Concomitant administration of carboplatin and aminoglycosides results in an increased risk of

nephrotoxicity and/or ototoxicity and the drugs should be used concurrently with caution. The

use of other nephrotoxic drugs results in a potentiation of renal effects by carboplatin.

Carboplatin interacts with aluminium to form a black precipitate of platinum and loss of

potency. Aluminium-containing IV sets, needles, catheters and syringes should not be used for


A decrease in phenytoin serum levels has been observed with concurrent administration of

carboplatin and phenytoin/fosphenytoin. This may lead to exacerbation of seizures.

4.6 Fertility, pregnancy and lactation


Women of childbearing potential should be advised to avoid becoming pregnant while

receiving carboplatin and to use effective contraception during treatment with carboplatin and

for at least six months after the last dose. Men with female partners of childbearing potential

should be advised to use effective contraception during treatment with carboplatin and for at

least three months after the last dose.

Male and female fertility may be impacted by treatment with carboplatin. Both men and

women should seek advice for fertility preservation before treatment with carboplatin.

Pregnancy - Category D

Carboplatin has been shown to be embryo-toxic and mutagenic, and its use in pregnant women

is not recommended. Women of child-bearing potential should use adequate contraception and

carboplatin should only be used in women of child-bearing potential if the expected benefits

outweigh the risks of such therapy. If the patient becomes pregnant whilst receiving the drug

she should be advised of the potential hazard to the foetus.


It is not clearly established whether carboplatin or its platinum-containing metabolites are

distributed into human milk. However, because of the potential for serious adverse reactions in

infants should the drug pass into the milk, nursing should be discontinued during therapy.

4.7 Effects on ability to drive and use machinery

The effect of carboplatin on the ability to drive or use machinery has not been systematically


4.8 Undesirable effects

Many side effects of carboplatin therapy are unavoidable due to the pharmacological actions

of the drug. However, the adverse effects are generally reversible if detected early.

Adverse reactions as reported for the various organ systems are as follows:

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Neoplasms benign, malignant and unspecified

There have been rare reports of acute myelogenous leukemias and myelodysplastic syndromes

arising in patients who have been treated with carboplatin, mostly when given in combination

with other potentially leukemogenic agents.

Blood and lymphatic system disorders

The major and dose-limiting toxicity of carboplatin is bone marrow suppression, which is

manifested by thrombocytopenia, leucopenia, neutropenia and/or anaemia. Myelosuppression

is dose-related. Platelet and leucocyte/granulocyte nadirs usually occur two to three weeks

from drug administration. Recovery is generally adequate to allow the administration of the










(haemoglobin less than 11 g/dL), which may be symptomatic, occurs in a substantial proportion

of patients. This effect may be cumulative and transfusions may be needed particularly in

patients receiving prolonged therapy (e.g., more than 6 cycles).

Haemolytic anaemia (sometimes fatal) has also been reported.

Clinical sequelae of bone marrow/haematologic toxicity such as fever, infections, sepsis/septic

shock and haemorrhage may be expected.

Haemolytic uremic syndrome (HUS) has been reported.

Metabolism and nutrition disorders








Gastrointestinal disorders

Nausea and/or vomiting, which generally are mild to moderate in severity, may occur within

6-12 hrs after carboplatin administration and may persist up to 24 hours or longer. Other GI

effects such as mucositis, stomatitis, diarrhoea, constipation and abdominal pain have also been


Nervous system disorders

Peripheral neuropathies may occur, mainly in the form of paraesthesias and decreased deep

tendon reflexes. The effect, more common in patients over 65 years of age, appears to be

cumulative, occurring mainly in patients receiving prolonged therapy and/or in those who have

received prior cisplatin therapy. CNS effects may also occur. In some cases the neurotoxicity

seen with carboplatin may be the result of a combination with some delayed effect of prior

cisplatin therapy. Dysgeusia has been reported in patients taking carboplatin.

Ear and labyrinth disorders

Tinnitus and hearing loss has been reported in patients receiving carboplatin.

Eye disorders

Visual abnormalities, such as transient sight loss (which can be complete for light and colours)

or other disturbances may occur in patients treated with carboplatin. Improvement and/or total

recovery of vision usually occurs within weeks after the drug is discontinued. Cortical

blindness has been reported in patients with impaired renal function receiving high-dose


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Cardiac disorders

Cardiac failure; ischaemic coronary artery disorders (e.g., myocardial infarction, cardiac arrest,

angina, myocardial ischaemia), Kounis syndrome.

Vascular disorders

Cerebrovascular events.

Renal and urinary disorders

Acute renal failure has been reported rarely. Mild and transient elevations of serum creatinine








nephrotoxicity (e.g., impaired creatinine clearance) becomes more prominent at relatively high

dosages or in patients previously treated with cisplatin.

Hepatobiliary disorders









aminotransferase or bilirubin concentrations may occur. Substantial abnormalities in liver

function test have been reported in patients treated with carboplatin at high doses and

autologous bone marrow transplantation.

Immune system disorders

Allergic reactions to carboplatin have been reported. These include anaphylaxis/anaphylactoid

reactions, hypotension, bronchospasm, and pyrexia. Hypersensitivity reactions may occur

within a few minutes after IV administration of carboplatin.

Skin and subcutaneous tissue disorders

Exfoliative dermatitis may rarely occur. Erythematous rash, pruritus, urticaria, and alopecia

have also been reported in association with carboplatin.

Musculoskeletal and connective tissue disorders


General disorders and administration site conditions

Asthenia, flu-like symptoms, reactions at injection site.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are

asked to report any suspected adverse reactions

4.9 Overdose

There are no known antidotes for carboplatin overdosage; thus every possible measure should

be taken to avoid an overdose including full awareness of the potential danger of an overdose,

careful calculation of the dose to be administered and availability of adequate diagnostic and

treatment facilities. Acute overdosage with carboplatin may result in an enhancement of its

expected toxic effects (e.g., severe myelosuppression, intractable nausea and vomiting, severe

neurosensorial toxicities, liver failure, kidney failure, etc). Death may follow. Haemodialysis

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is only effective, even then partially, up to 3 hours after administration because of the rapid

and extensive binding of platinum to plasma proteins. Signs and symptoms of overdosage

should be managed with supportive measures.

For advice on the management of overdose please contact the National Poisons Centre on 0800

POISON (0800 764766).



5.1 Pharmacodynamic properties


Carboplatin is an antineoplastic agent. It is an analogue of cisplatin, but it seems to be less

toxic. Like cisplatin, it appears to form intra- and inter-strand crosslinks in cells which modifies

DNA structure and inhibits DNA synthesis. It does not appear to be phase-specific in the cell


5.2 Pharmacokinetic properties


Protein binding is less than with cisplatin, initially protein binding is low with up to 29% of

carboplatin bound during the first 4 hours. However, platinum from carboplatin is irreversibly

bound to plasma proteins (by 24 hours 85-89% is bound) and is slowly eliminated with a

minimum half-life of 5 days.

Elimination and Excretion

After intravenous infusion of single doses over one hour, plasma concentrations of total

platinum and free platinum decline biphasically following first order kinetics. For free

platinum, reported values for the initial phase of the half-life (t

alpha 1/2

) are about 90 minutes and

in the later phase the half-life (t

beta 1/2

) is about 6 hours. Total platinum elimination has a similar

initial half-life, while in the later phase the half-life of total platinum may be greater than 24

hours. All free platinum is in the form of carboplatin in the first four hours.

The kidney is the major route of excretion. Most excretion occurs within the first 6 hours after

administration with 50% to 70% excreted within 24 hours. 32% of the dose is excreted as

unchanged medicine. A reduction in dosage is recommended for patients with poor renal


5.3 Preclinical safety data

Carcinogenicity and Mutagenicity

Secondary malignancies are potential delayed effects of many antineoplastic agents although

it is not clear whether the effect is related to their mutagenic or immunosuppressive action.

The effect of dose and duration of therapy is also unknown although risk seems to increase

with long-term use. Although information is limited, available data seems to indicate that the

carcinogenic risk is greatest with the alkylating agents.


in vitro

in vivo

studies have shown carboplatin to be mutagenic.

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6.1 List of excipients

Water for injection


6.2 Incompatibilities

Carboplatin may interact with aluminium to form a black precipitate. Needles, syringes,

catheters or IV administration sets that contain aluminium parts which may come in contact

with carboplatin should not be used for preparation or administration of the medicine.

6.3 Shelf life

24 months from date of manufacture stored at or below 25°C.

6.4 Special precautions for storage

Store at or below 25ºC. Protect from light.

6.5 Nature and contents of container

Carboplatin injection is available as follows:



50 mg/5 mL

1 × 5 mL plastic vial

150 mg/15 mL

1 × 15 mL plastic vial

450 mg/45 mL

1 × 45 mL plastic vial

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

The usual precautions for handling and preparing cytotoxic drugs should be observed when

administering carboplatin:

Personnel should be trained in good technique for handling. Pregnant staff should be excluded

from working with carboplatin.

Preparation should be performed in a designated area ideally in a vertical laminar flow hood,

with the work surface covered with disposable plastic-backed absorbent paper.

Care should be taken to prevent inhaling particles and exposing the skin to carboplatin.

Adequate protective clothing should be worn, such as PVC gloves, safety glasses, disposable

gowns and masks.

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It is recommended that lock fittings are used in the assembly of syringes and giving sets to

avoid leakage.

In the event of contact with the eyes, wash with water or saline. If the skin comes into contact

with the drug wash thoroughly with water and in both cases seek medical advice. Seek

immediate medical attention if the drug is ingested or inhaled.

All used material, needles, syringes, vials and other items which have come into contact with

cytotoxic drugs should be incinerated. Excreta should be similarly treated. Contaminated

surfaces should be washed with copious amounts of water.

Use immediately upon opening. Discard any unused portion.



Prescription Medicine.



Pfizer New Zealand Limited

P O Box 3998

Auckland, New Zealand

Toll Free number: 0800 736 363



01 October 1992


21 January 2020

Summary table of changes

Section changed

Summary of new information


Minor editorial changes.

Addition of information concerning reversible posterior leukoencephalopathy

syndrome (RPLS).

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