OXALIPLATIN

Main information

  • Trade name:
  • OXALIPLATIN ACCORD oxaliplatin 100 mg/20 mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OXALIPLATIN ACCORD oxaliplatin 100 mg/20 mL concentrated injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209720
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209720

OXALIPLATIN ACCORD oxaliplatin 100 mg/20 mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

9/10/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. OXALIPLATIN ACCORD oxaliplatin 100 mg/20 mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

10/02/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: Adjuvant treatment of stage III (Duke's C) colon cancer after complete

resection of the primary tumour; Treatment of advanced colorectal cancer.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. OXALIPLATIN ACCORD oxaliplatin 100 mg/20 mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

A clear, colourless solution in a clear glass vial. When examined under

suitable conditions of visibility it should be practically free from visible

particles.

Active Ingredients

Oxaliplatin

100 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 10:12:05 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

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OXALIPLATIN ACCORD

Oxaliplatin Concentrated Injection 50 mg/10 mL and 100 mg/20 mL

Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before

you are given this medicine.

This leaflet answers some common

questions about Oxaliplatin Accord.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have benefits and risks.

Your doctor has weighed the risks of

using this medicine against the benefits

they expect it will have for you.

If you have any concerns about

taking this medicine, ask your doctor

or pharmacist.

Keep this leaflet with this medicine.

You may need to read it again.

What Oxaliplatin Accord

is used for

Oxaliplatin Accord is used to treat

cancer of the large intestine and rectum

(colorectal cancer). Oxaliplatin Accord

is used in combination with other anti-

cancer drugs; fluorouracil (FU), and

folinic acid. The active ingredient in

Oxaliplatin Accord is called oxaliplatin.

Cancer cells are normal cells which

have changed so that they grow in an

uncontrolled way. Oxaliplatin works by

interfering with cancer cell growth.

Because of the similarities between

cancer cells and normal cells, anti-

cancer drugs often have unwanted

effects on the body.

Your doctors have decided to treat you

with Oxaliplatin Accord because they

believe that the benefit of Oxaliplatin

Accord treatment will be greater than

the unwanted effects.

Many of the side effects from anti-

cancer drugs are predictable and can be

prevented or lessened. Your doctor and

other staff will take all of the

precautions needed to reduce the

unwanted effects of treatment.

This medicine is only available with a

doctor's prescription.

Before you are given

Oxaliplatin Accord

When you must not be

given it

You should not be given Oxaliplatin

Accord

if you are allergic to the active

ingredient oxaliplatin.

If you have had an allergic reaction to

oxaliplatin before, you should not

receive it again.

You must not be given Oxaliplatin

Accord

if you are pregnant or

breastfeeding.

Oxaliplatin may cause birth defects if

you are being treated with it at the time

of conception or it is given to women

who are already pregnant. Adequate

contraception is required during

treatment with oxaliplatin. You should

discuss this with your doctor. Nursing

mothers are advised not to breastfeed

while receiving oxaliplatin, as the effect

of breast milk from such patients is

unknown.

You must not be given it if you have

severe kidney disease.

What you should tell

your Doctor

You must tell your doctor if:

You have had a reaction to any other

platinum compound,

You have severe kidney disease,

You have nerve damage

(neuropathy),

You have any other medical

condition that he or she is not aware

You are taking any other medicines,

including medicines that you have

bought without a prescription from a

pharmacy, supermarket or health

food shop.

Your doctor or pharmacist can tell you

what to do if you are taking any of these

medicines.

How Oxaliplatin Accord

is given

Oxaliplatin Accord will be given to you

as an infusion into one of your veins

(this is called an intravenous infusion).

The infusion will be given over 2 - 6

hours.

The dose of Oxaliplatin Accord is

calculated according to your body

surface area, which is calculated from

your weight and height. The usual dose

is 85 mg/m² every two weeks. Your

doctor may change the dose in some

circumstances.

Each course of treatment is called a

cycle; your doctor will tell you how

many cycles you will receive.

Oxaliplatin Accord will be used with

fluorouracil (FU) and folinic acid.

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Oxaliplatin Accord

is not

recommended in children.

While you are using

Oxaliplatin Accord

Things you must do:

Avoid cold foods and drinks and cover

skin prior to exposure to cold during or

within 48 hours following being given

oxaliplatin, since neurological effects

may be brought on or worsened by

exposure to cold.

Contact your doctor immediately if you

develop fever, particularly in

association with persistent diarrhoea or

evidence of infection since this may

indicate low blood count.

Contact your doctor if persistent

vomiting, diarrhoea, signs of

dehydration, cough or breathing

difficulties or signs of allergic reaction

occur.

Visual disturbance is a rare side effect

of Oxaliplatin Accord. Contact your

doctor if this happens to you, and do not

drive or use machinery until your vision

is clear.

Side Effects

Tell your doctor or nurse as soon as

possible if you do not feel well while

Oxaliplatin Accord is being given to

you.

You should also tell your doctor if

you do not feel well between courses

of Oxaliplatin Accord.

All medicines can have side effects. It is

important to understand the side effects

that Oxaliplatin Accord

may cause,

even though you may not experience

them. As well as the predictable side

effects of Oxaliplatin Accord, there are

other effects that occur much more

rarely.

If you have any side effects or notice

anything unusual it is important to

inform your doctor before your next

treatment.

Your doctor will decide whether such

effects are because of your treatment,

and what action needs to be taken.

This section explains the side effects of

Oxaliplatin Accord, and some of the

checks made before each treatment to

prevent excessive side effects.

Physical Condition

. Before each

treatment with Oxaliplatin Accord

you will be examined for any

condition that may be affected by

chemotherapy (for example,

infection, or loss of feeling). This

will include those conditions

caused by previous treatment, those

caused by your disease, and those

caused by other things.

Loss of feeling.

Oxaliplatin Accord

can affect nerves in the hands and

feet. This is common soon after

treatment and can appear as

tingling or numbness in the fingers

or toes, and may be made worse by

cold temperatures or by contact

with cold water or other cold

objects. These symptoms often go

away between treatments, but may

last longer and get worse with

repeated treatment. In some

patients the limbs may become

weak or painful. However, in most

patients these symptoms improve

after treatment is stopped.

Tell your doctor if any of these things

happen. Your doctor will examine you

before treatment to see if you are

affected.

Nausea and Vomiting.

Severe

nausea and vomiting is uncommon

with Oxaliplatin Accord. Mild

nausea and vomiting is more

common. Medication to prevent the

sickness caused by Oxaliplatin

Accord

will be given before

treatment, and may sometimes be

continued after treatment.

Diarrhoea.

Severe diarrhoea may

occur during treatment with Oxaliplatin

Accord.

If you suffer from persistent or severe

diarrhoea or vomiting, contact your

doctor urgently for treatment advice.

Low Blood Counts.

Oxaliplatin

Accord can affect the body's ability

to make blood cells. There are three

types of blood cells checked before

each treatment; platelets, which

help control bleeding; white blood

cells, which help fight infection;

and red blood cells which move

oxygen around the body. If your

blood count is too low, your

treatment may be postponed, or the

dose reduced.

Tell your doctor if you notice any

bruising or abnormal bleeding, or

have an infection. These may be signs

of a low blood count.

Difficulty swallowing.

Some

patients may experience a sudden,

temporary feeling of difficulty with

swallowing or breathing. This

sensation, if it occurs, usually

happens during the infusion or

within hours after the infusion. It

may be triggered by swallowing a

cold drink. Although unpleasant,

this feeling does not last long, and

goes away by itself.

Tell your doctor if this happens to

you.

Other known side effects of Oxaliplatin

Accord

are:

mucositis (sore lips or mouth

ulcers)

abdominal pain

constipation

anorexia

changes to liver function

mild hair loss (alopecia)

fever

inflammation around the injection

site

tiredness

skin rash

allergic reactions

conjunctivitis

altered taste

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abnormal tongue sensation

nose bleeds

feeling of chest pressure

voice disturbance (rare)

loss of hearing (rare)

lung disorders (rare)

visual disturbance (rare)

Other side effects not listed above

may also occur in some patients. Tell

your doctor if you notice anything

else that is making you feel unwell.

If you receive too much

(Overdose)

Your doctor will decide what dose of

Oxaliplatin Accord you need, and this

will be given under close supervision,

usually in a hospital setting. The risk of

an overdosage in these circumstances is

low. In the event of an overdose

occurring, your doctor will decide on

the treatment necessary.

Storage

Store below 25°C. Protect from light.

Do not freeze.

Shelf life after dilution

After dilution in 5% glucose, chemical

and physical in-use stability has been

demonstrated for up to 48 hours at 2°C

to 8°C and for 24 hours at 25°C.

From a microbiological point of view,

the infusion preparation should be used

immediately. If not used immediately,

in-use storage times and conditions

prior to use are the responsibility of the

user and would normally not be longer

than 24 hours at 2°C to 8°C unless

dilution has taken place in controlled

and validated aseptic conditions.

Special precautions for

administration

DO NOT use injection equipment

containing aluminium.

DO NOT administer undiluted.

DO NOT mix or administer with

sodium chloride injection or any

other solution containing chlorides

DO NOT mix with any other

medication or administer

simultaneously by the same infusion

line (in particular fluorouracil and

folinic acid). A Y-tube may be used

(see Infusion)

USE ONLY the recommended

diluents (see below).

Any diluted solution that shows

evidence of precipitation should not

be used and should be destroyed.

Preparation of Infusion Solution

Dilution before Infusion

Oxaliplatin injection MUST be further

diluted in an infusion solution of 250-

500 mL of 5% glucose injection. From a

microbiological and chemical point of

view, this infusion preparation should

be used immediately. Inspect visually

prior to use. Only clear solutions

without particles should be used. The

product is for single use in one patient

only. Discard any residue. NEVER use

sodium chloride solution for dilution.

Infusion

The administration of oxaliplatin does

not require prehydration. Oxaliplatin

diluted in 250 to 500 mL of a glucose

5% injection must be infused either by

central venous line or peripheral vein

over 2 to 6 hours. When oxaliplatin is

administered with fluorouracil, the

oxaliplatin infusion should precede that

of fluorouracil.

Oxaliplatin can be co-administered with

folinic acid infusion using a Y-tube

placed immediately before the site of

injection. The drugs should not be

combined in the same infusion bag.

Folinic acid must be diluted using

isotonic infusion solutions such as 5%

glucose solution but NOT sodium

chloride solutions or alkaline solutions.

Flush the line after oxaliplatin

administration.

While oxaliplatin has minimal to no

vesicant potential, extravasation may

result in local pain and inflammation

which may be severe and lead to

complications especially when

oxaliplatin is infused through a

peripheral vein. In case of oxaliplatin

extravasation, the infusion must be

stopped immediately and the usual local

symptomatic treatment initiated.

Disposal

All materials that have been used for

dilution and administration must be

destroyed according to local statutory

requirements

Do not use it after the expiry date

(EXP) printed on the vial.

This is not all the information that is

available on Oxaliplatin Accord. If you

have any more questions or are not sure

about anything ask to your doctor or

pharmacist.

Product Description

What it looks like

Oxaliplatin Accord

comes as a

concentrated solution in a glass vial.

Pack size: 1 vial.

Ingredients

Each Oxaliplatin Accord

vial contains

the active ingredient, oxaliplatin 50 mg

or 100 mg.

Beside the active ingredient Oxaliplatin

Accord

concentrated injection contains

lactose monohydrate and water for

injections.

Name and Address of the

Sponsor

Accord Healthcare Pty Ltd

Lvl 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

Australian Registration Numbers

50 mg/10 mL: AUST R 209719

100 mg/20 mL: AUST R 209720

Date of preparation

This leaflet was prepared on 10

February 2017.