DBL™ Carboplatin Injection

New Zealand - English - Medsafe (Medicines Safety Authority)

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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: Water for injection
Units in package:
Vial, 50 mg/5 mL, 5 mL
Prescription type:
Manufactured by:
Johnson Matthey Pharmaceutical Materials
Therapeutic indications:
· advanced stage ovarian cancer of epithelial origin.
Product summary:
Package - Contents - Shelf Life: Vial, 50 mg/5 mL - 5 mL - 18 months from date of manufacture stored at or below 25°C protect from light 24 hours opened stored at or below 25°C protect from light - Vial, 150 mg/15 mL - 15 mL - 18 months from date of manufacture stored at or below 25°C protect from light 24 hours opened stored at or below 25°C protect from light - Vial, 450 mg/45 mL - 45 mL - 18 months from date of manufacture stored at or below 25°C protect from light 24 hours opened stored at or below 25°C protect from light
Authorization number:
Authorization date:

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Carboplatin Injection



DBL Carboplatin Injection (all presentations) is a sterile solution of carboplatin in Water for

Injections BP. The vials contain 5, 15, 45 or of 10 mg/mL carboplatin. The solution does not

contain any preservatives.

For the full list of excipients, see section 6.1.



DBL Carboplatin Injection is a solution for injection.

It is clear, colourless or slightly yellow solution free from particulates and is presented in vials.

The pH of the injection ranges between 4.0 to 7.0.



4.1 Therapeutic indications

Carboplatin is indicated in the treatment of:

advanced stage ovarian cancer of epithelial origin

small cell lung carcinoma

carcinoma of the head and neck

carcinoma of the testis

paediatric cerebral tumours

soft tissue sarcoma


4.2 Dose and method of administration


Contains no antimicrobial agent. Product is for single use in one patient only. Discard

any residue.

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Adults: The recommended dose of carboplatin in previously untreated adults with normal renal

function is 400 mg/m

given as a single intravenous infusion over 15 to 60 minutes. Therapy

should not be repeated until four weeks after the previous carboplatin course.

It is recommended that according to clinical circumstances the initial dosage may require

reduction by 20 to 25% in patients with risk factors such as increasing age, previous

myelosuppressive therapy and poor performance status.

Dosage modification may be required when carboplatin is used in combination with other

myelosuppressive drugs or radiation therapy, to minimise additive myelosuppressive effects.

Determination of haematologic nadir by weekly blood counts during initial courses is

recommended for future dosage adjustment and scheduling of carboplatin.

Impaired Renal Function: In patients with initial impaired renal function reduction of dosage

of carboplatin may be required. Haematologicial nadirs and renal function should be monitored

in these circumstances.

A suggested dosage schedule in patients with impaired renal function based on creatinine

clearance is as follows:

Creatinine Clearance

Dose of Carboplatin

>40 mL/min.

400 mg/m

20-39 mL/min.

250 mg/m

0-19 mL/min.

150 mg/m

Children: Sufficient usage of carboplatin in paediatrics has not occurred to allow specific

dosage recommendations to be made. Physicians are advised to refer to recently published

literature for information on the current dosing regimens for particular tumours.

Method of Administration

For instructions on dilution of the medicine before administration, see section 6.6.

4.3 Contraindications

Carboplatin is contraindicated in patients with the following conditions:

Severe myelosuppression

Pre-existing severe renal impairment; dose adjustment may allow use in the presence

of mild renal impairment (see section 4.2)









Severe bleeding

Pregnancy or lactation.

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4.4 Special warnings and precautions for use

Carboplatin should only be administered to patients under the supervision of a qualified

physician who is experienced in the use of chemotherapeutic agents. Diagnostic and treatment

facilities should be readily available for appropriate management of therapy and possible


Bone Marrow Function

Carboplatin should be administered with caution to patients with significant bleeding or with

bone marrow depression.

Peripheral blood counts and renal function should be monitored closely. Blood counts should

be performed prior to commencement of carboplatin therapy and weekly thereafter. Aside

from monitoring toxicity, this practice will help determine the nadir and recovery of the

haematological parameters and assist in the subsequent dose adjustments. Lowest levels in

white cells and platelets are generally seen between days 14 and 28, and days 14 and 21

respectively after initial therapy. A greater reduction in platelets is seen in patients who

previously received extensive myelosuppressive chemotheraphy than non-treated patients.

White blood cells counts less than 2x10

cells/L (2,000 cells/mm

) or platelets less than 50x10

cells/L (50,000 cells/mm

) should cause consideration of postponement of carboplatin therapy

until bone marrow recovery is evident, which is usually 5 to 6 weeks. Transfusions may be


The occurrence, severity and protraction of toxicity are likely to be greater in patients who have

received extensive prior treatment for their disease, have poor performance status and who are

more advance in age. Dosage reduction may be necessary is cases of severe toxicity.

Carboplatin courses should not, in general, be repeated more frequently than every four weeks

in order to ensure that the nadir in blood counts has occurred and that there has been recovery

to a satisfactory level.

Hypersensitivity Reactions

Hypersensitivity and anaphylactic reactions to carboplatin have been reported. These allergic

reactions have been similar in nature and severity to those reported with other platinum

containing compounds. Symptoms include rash, urticaria, erythema, pruritus, bronchospasm

and hypotension. 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.

Use in renal impairment

Renal function should be assessed prior to and during therapy. Myelosuppression as a result

of carboplatin treatment is closely related to the renal clearance of the drug. Therefore in

patients who have abnormal renal function or who are receiving concomitant therapy with

nephrotoxic drugs, myelosuppression, especially thrombocytopenia, may be more severe and


Renal toxicity is not usually dose-limiting. Pre-treatment and post-treatment hydration is not

necessary. However, about 25% of patients show decreases in creatinine clearance and, less

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frequently, rises in serum creatinine and blood urea nitrogen may be seen. Impairment of renal

function is more likely to be seen in patients who have previously experience nephrotoxicity

as a result of cisplatin therapy. Concomitant administration of other nephrotoxic drugs (e.g.,

aminoglycoside antibiotics) may increase the risk of nephrotoxicity (see section 4.5)

Central Nervous System (CNS)/Hearing Functions

Neurotoxicity, such as paraesthesias and decreased deep tendon reflexes, and ototoxicity are

more likely to be seen in patients who have received cisplatin previously. Routine neurologic

examination is advisable during carboplatin therapy, particularly in patients previously treated

with cisplatin and in patients over 65 years of age. Ototoxicity is cumulative. The frequency

and severity of hearing disorders increases with high dose regimens and repeated doses, or

prior treatment with cisplatin (as cisplatin is also toxic). Assessment of hearing should be

performed on a regular basis. The risk of 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.

Blood and Lymphatic System Disorders

Haemolytic anemia 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 hemolytic

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.

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Gastrointestional Effects

Gastrointestinal, 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 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


Immunosuppresant Effects/Increased Susceptibility to Infections

Administration of live or live attenuated vaccines in patients immunocompromised by

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


Carboplatin should be administered with caution to patients with herpes zoster, existing or

recent chicken pox, or recent exposure to chicken pox, due to the risk of severe generalised

disease. It should also be administered with caution to patients with other infections.

The myelosuppressive effects of carboplatin may adversely affect dental procedures, resulting

in an increased incidence of microbial infection, delayed healing and gingival bleeding. Where

possible, dental work should be completed prior to initiation of carboplatin therapy, or deferred

until blood counts have returned to normal. Patients should be instructed on proper oral

hygiene during treatment, including caution in the use of toothbrushes, dental floss and



Aluminium-containing equipment should not be used (see section 4.5).

Use in elderly patients

Carboplatin-induced peripheral neuropathy appears to be more common in those over 65 years

of age than in younger patients. Elderly patients may have decreased renal and haematopoietic

function, and may be more susceptible to other effects of the drug (see section 4.8).

Paediatric population

Safety and efficacy in children have not been established.

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4.5 Interaction with other medicines and other forms of interaction

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 drug (see section


Concurrent therapy with nephrotoxic drugs may increase or exacerbate toxicity due to

carboplatin-induced changes in renal clearance. Patients receiving aminoglycoside antibiotics

or other nephrotoxic drugs should not be treated with carboplatin.

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

ototoxicity, and the drugs should be used concurrently with caution.

Combination therapy with other myelosuppressive drugs may require modification of the dose

or timing of carboplatin therapy to minimize additive myelosuppressive effects. Dosage

reduction is recommended if carboplatin is administered concurrently with radiation therapy.

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

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.

In patients who have previously received cisplatin, neurotoxicity such as paraesthesias,

decreased deep tendon reflexes, and ototoxicity are more likely to be seen. The frequency and

severity of hearing disorder increases with prior treatment with cisplatin (as cisplatin is also

ototoxic). Paraesthesias present prior to treatment, especially if caused by cisplatin, may persist

or worsen during carboplatin therapy.

In patients receiving carboplatin concomitantly with paclitaxel, myalgias and arthralgias

commonly occur. Fatigue has also been reported in patients receiving this combination.

Pain, most likely related to tumour size, and asthenia occur frequently in patients receiving

carboplatin in conjunction with cyclophosphamide. Visual disturbances have been reported in

patients receiving usual dosages of carboplatin in conjunction with cyclophosphamide.

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


Both men and women receiving carboplatin should be informed of the potential risk of adverse

effects on reproduction. Women of childbearing potential should be advised to avoid becoming

pregnant by using effective contraception during treatment and up to 6 months after therapy.

For women who are pregnant or become pregnant during therapy, genetic counseling should

be provided.

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Carboplatin is genotoxic. Men being treated with carboplatin are advised not to father a child

during and up to three months after treatment and to seek advice on conservation of sperm prior

to treatment because of the possibility of irreversible infertility due to therapy with carboplatin.

Male and female fertility may be impacted by treatment with carboplatin. Most forms of

chemotherapy have been associated with reduction of oogenesis and spermatogenesis and

patients receiving carboplatin should be warned of this potential. Although not reported with

carboplatin, this has been reported with other platinum agents. Recovery of fertility after

exposure can occur but is not guaranteed. Both men and women should seek advice for fertility

preservation before treatment with carboplatin.

Pregnancy – Category D

This category specifies drugs which have caused or may be expected to cause an increased

incidence of human foetal malformations or irreversible damage. These drugs may also have








mutagenic. Use in pregnancy is not recommended. Women of child bearing potential should










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


It is not known whether carboplatin is excreted in breast milk. To avoid possible harmful

effects in the infant, breast-feeding is not advised during carboplatin 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

Myelosuppression is the dose-limiting toxicity of carboplatin. It is generally reversible and is

not cumulative when carboplatin is used as single agent and at the recommended frequencies

of administration.

Adverse effects which have been observed in studies to date can be grouped under the

following organ systems:-

Blood and lymphatic system disorders:

Leucopenia (55%), thrombocytopenia (32%),

anaemia (59%). Myelosuppression is dose-related, and appears to be most common and more

severe in patients who have received prior antineoplastic therapy (especially cisplatin), those

who have received or who are currently receiving other myelosuppressive drugs or radiation

therapy, and those with renal impairment. Transfusional support has been required in about

one-fifth of patients.

Haemolytic anemia (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.

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Haemolytic uremic syndrome (HUS) has been reported.

Gastrointestinal disorders:

Nausea and vomiting (53%), nausea only (25%), diarrhoea (6%),









administration of carboplatin and disappear within 24 hours, but may persist for up to 3 days

in some patients. Vomiting may be delayed for 24 hours or longer after treatment in some

patients. Nausea and vomiting are readily controlled (or may be prevented) with antiemetic

medication. Gastrointestinal pain, mucositis and stomatitis have also been reported.

Renal and urinary disorders:

Decrease in creatinine clearance (25%); increases in uric acid

(25%), blood urea nitrogen (16%) and serum creatinine (7%). Acute renal failure has been

reported rarely. Mild and transient elevations of serum creatinine and of blood urea nitrogen








creatinine clearance) becomes more prominent at relatively high dosages or in patients

previously treated with Cisplatin.


Decreases in serum magnesium (37%), potassium (16%) and, rarely, calcium

(5%). Carboplatin may also cause decreases in serum sodium levels. These changes have not

been severe enough to cause clinical symptoms.

Nervous system disorders

: Peripheral neuropathy (6%) which was mild and dysgeusia

(<1%). 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. Central neurotoxicity has also been reported, although this

may be related to concomitant antiemetic therapy. Fatigue has been reported in patients

receiving carboplatin concomitantly with paclitaxel. Dysgeusia has been reported in patients

taking carboplatin.

Ear and labyrinth disorders:

Subclinical decrease in hearing acuity as determined by

audiogram, in the high frequency (4,000 – 8,000Hz) range (15%); clinical ototoxicity, usually

manifested as tinnitus (1%). Pre-existing hearing impairment may persist or worsen with

carboplatin therapy. In patients who developed hearing loss as a result of cisplatin therapy, the

impairment may persist or worsen.

Hepatobiliary disorders:

Increases in liver enzymes have been transient in the majority of

cases. Alkaline phosphatase (ALP) (30%), aspartate aminotransferase (AST) (15%),

bilirubin (4%). 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:

In less than 2% of patients reactions similar to those seen after

cisplatin have been observed. Erythematous rash, fever, perioral tingling, urticaria, pruritus,

bronchospasm, hypotension, hypoxia and pyrexia have been observed. Anaphylaxis and

anaphylactoid reactions have also occurred, while exfoliative dermatitis has been reported

rarely. In a few cases, no cross-reactivity was present. The frequency of allergic reactions is

higher in patients who receive carboplatin in conjunction with other antineoplastic agents.

Hypersensitivity reactions may occur within a few minutes after IV administration of


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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 carboplatin.

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.

Cardiac Disorders:

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

infarction, cardiac arrest, angina, myocardial ischaemia), Kounis syndrome (vasospastic

allergic angina).

Vascular Disorders:

Cerebrovascular events.

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:

Myalgia/arthralgia. This can

commonly occur in patients receiving carboplatin together with paclitaxel (see section 4.5).

Metabolism and Nutrition Disorders:

electrolyte abnormalities (hypokalaemia,

hypocalcaemia, hyponatraemia and/or hypomagnesaemia).


alopecia (2%), flu-like syndrome (1%), reaction at injection site (<1%). Taste

abnormalities, and adverse respiratory and genitourinary effects have also been reported. Pain,

most likely related to tumour size, and asthenia occur frequently in patients receiving

carboplatin in conjunction with cyclophosphamide.

Reporting of Suspected Adverse Reactions

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















4.9 Overdose

No overdosage occurred during clinical trials. Should it occur, the patient may need to be

sustained through complications relating to myelosuppression, renal impairment and hepatic

impairment. From reports in which doses up to 1600 mg/m

were used, patients were said to

feel extremely unwell and developed diarrhoea and alopecia.

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

POISON (0800 764766).

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5.1 Pharmacodynamic properties

Mechanism of action

Carboplatin, an analogue of cisplatin, is an antineoplastic agent which interferes with DNA

intrastrand and interstrand crosslinks in cells exposed to the drug. DNA reactivity has been

correlated with cytotoxicity.

5.2 Pharmacokinetic properties


After a one-hour infusion of the drug (dose range 20 to 520 mg/m

) plasma levels of total

platinum and ultrafilterable (free) platinum decay biphasically following first order kinetics.

For ultrafilterable platinum reported values for the initial phases of the half life (t

alpha ½

) are

about 90 minutes and in the later phase the half life (t

beta ½

) 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. Carboplatin is a stable molecule. All free platinum is in the

form of carboplatin in the first 4 hours.


65% of the carboplatin dose is eliminated in the urine within 24 hours of administration with

32% of the dose being excreted as unchanged drug. Most of the drug is excreted in the first

6 hours.

Initially protein binding is low. During the first 4 hours after administration 0-29% of

carboplatin is protein bound. By 24 hours 85-89% is protein bound. Excretion of carboplatin

is by glomerular filtration. Patients with poor renal function have a higher Area Under Curve

for total platinum and a reduction in dosage is recommended.

5.3 Preclinical safety data


Carboplatin has been shown to be mutagenic in mammalian cells. Patients should be advised

of its mutagenic potential and should use effective contraception for an adequate duration of

time after ceasing therapy.


No data available.

Reproductive and developmental toxicity

No data available.

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6.1 List of excipients


Water for injections

6.2 Incompatibilities

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

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

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

Parenteral drugs should be inspected visually for particulate matter and discolouration, prior

administration, whenever solution and container permit. If particulate matter observed, shake

and re-inspect. Vials with visible particulate matter should not be used.

6.3 Shelf life

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

6.4 Special precautions for storage

DBL Carboplatin Injection (glass vials) should be stored at or below 25

C. Do not freeze.

Protect from light.

Carboplatin has been found to be stable for 24 hours when mixed within 5% glucose in water.

These products contain no antimicrobial agent. However in order to reduce microbiological

contamination hazard, infusion should be commenced as soon as practicable after preparation.

Infusion should be completed with in 24 hours of preparation and any residue discarded.

6.5 Nature and contents of container



50 mg/5mL

1 x 5 mL glass vial

150 mg/15mL

1 x 20 mL glass vial

450 mg/45mL

1 x 50 mL glass vial

6.6 Special precautions for disposal and other handling

Preparation of Carboplatin Solution

Equipment containing aluminium components should be avoided (See section 4.4). DBL

Carboplatin Injection is a ready to use solution containing 10 mg/mL carboplatin is Water for

Injections B.P.

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The injections may be further diluted in 5% Glucose Intravenous Infusion B.P. To reduce

microbiological hazard, use as soon as practicable after preparation. If storage is necessary,

hold at 2-8

C for not more than 24 hours.

Handling Guidelines

Carboplatin should be prepared for administration only by professionals who have been

trained in the safe use of the preparation.

Operations such as transfer to syringes should be carried out only in the designated area.

The personnel carrying out these procedures should be adequately protected with

clothing, gloves and eye shield.

Pregnant personnel are advised not to handle chemotherapeutic agents.


In the event of contact with the skin or eyes, the affected area should be washed with

copious amounts of water or normal saline. A bland cream may be used to treat transient

stinging of the skin. Medical advice should be sought if the eyes are affected.

In the event of spillage, operators should put on gloves and mop up the spilled material

with a sponge kept in the area for that purpose. Rinse the area twice with water. Put all

solutions and sponges into a plastic bag and then seal it. The bag should be prominently

labelled with the words “Cytotoxic Waste” or similar.


Syringes, containers, absorbent materials, solution and any other material which has come into

contact with carboplatin should be placed in a thick plastic bag or other impervious container

and incinerated at 1000

C or more.



Prescription Medicine



Pfizer New Zealand Limited

P O Box 3998

Auckland, New Zealand

Toll Free Number: 0800 736 363



21 July 1989

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21 January 2020

™ = Trademark


Section changed

Summary of new information


Minor editorial changes.

Addition of information concerning reversible posterior leukoencephalopathy

syndrome (RPLS).

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