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OXALIPLATIN HOSPIRA 5 MG/ML POWDER FOR SOLUTION FOR INFUSION

Active substance(s): OXALIPLATIN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Oxaliplatin Hospira 5 mg/ml
powder for solution for infusion
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Oxaliplatin Hospira is and what it is used for
2. Before you use Oxaliplatin Hospira
3. How to use Oxaliplatin Hospira
4. Possible side effects
5. How to store Oxaliplatin Hospira
6. Further information

1. WHAT OXALIPLATIN Hospira IS AND WHAT IT IS USED FOR
Oxaliplatin is an anti-cancer drug and is used to treat metastatic (advanced)
cancer of the colon (large bowel) or rectum (back passage), or as additional
treatment following surgery to remove a tumour (growth) in the colon.
It is used in combination with another anti-cancer medicine called
5-fluorouracil (5-FU) and folinic acid (FA).

2. BEFORE YOU USE OXALIPLATIN Hospira
Do not use Oxaliplatin Hospira:
• if you are hypersensitive (allergic) to oxaliplatin or any of the other
ingredients of Oxaliplatin Hospira, lactose monohydrate,
• if you are breast-feeding,
• if you already have a reduced number of blood cells,
• if you already have tingling and numbness in the fingers and/or toes, and
have difficulty performing delicate tasks, such as buttoning clothes,
• if you have a severe kidney problem.
Take special care with Oxaliplatin Hospira:
• if you have mild or moderate kidney problems,
• if you have ever suffered an allergic reaction to other platinum-containing
medicines such as carboplatin or cisplatin.

Taking other medicines
Please tell your doctor if you are taking or have recently taken, any other
medicines, including medicines obtained without a prescription.

Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
You must not become pregnant during treatment with oxaliplatin and must
use an effective method of contraception. If pregnancy occurs during your
treatment, you must immediately inform your doctor. You should take
appropriate contraceptive measures during and after cessation of therapy
during 4 months for women and 6 months for men.
Oxaliplatin may have an anti-fertility effect, which could be irreversible.
Male patients are therefore advised not to father a child during and up to
6 months after treatment and to seek advice on conservation of sperm prior
to treatment.

Breast-feeding
Do not use Oxaliplatin Hospira whilst breast-feeding.

Driving and using machines
Since oxaliplatin treatment may result in an increase risk of dizziness,
nausea and vomiting, and other neurological symptoms that affect gait and
balance, it may lead to a minor or moderate influence on your ability to drive
and use machines. This medicine may cause temporary loss of vision. You
should not drive or operate machinery if you suffer from this side effect.

3. HOW OXALIPLATIN Hospira IS USED
For adults only.
Oxaliplatin Hospira will be prescribed by a specialist in cancer treatment.
The dose depends on your body surface area (calculated by m2) and your
state of health. It also depends on other medicines that are used in your
cancer treatment. The duration of your treatment will be determined by your
doctor.
Oxaliplatin Hospira is given by injection into a vein (an intravenous infusion)
over a 2-6 hour period.
The usual dose for adults, including the elderly, is 85 mg/m2 of body surface
area once every 2 weeks, before the infusion of the other anti-cancer
medicines.
The dose you receive and duration of administration will depend on results
of blood tests and whether you have previously experienced side effects
with oxaliplatin. Your next dose may need to be postponed dependant on
your blood cell levels or the severity of any mouth soreness. Your doctor will
test your nervous system prior to each administration and at certain times
afterwards.

If you are given more Oxaliplatin Hospira than you should:
As this medicine is given in a hospital, it is unlikely that you will be given too
little or too much, however tell your doctor if you have any concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, oxaliplatin can cause side effects, although not
everybody gets them. If you experience any side effect it is important that
you inform your doctor before your next treatment.

Tell your doctor immediately if you notice any of the following:

• Abnormal bruising, bleeding or signs of infection such as a sore throat
and high temperature
• Persistent or severe diarrhoea or vomiting
• Stomatitis/mucositis (sore lips or mouth ulcers)
• Unexplained respiratory symptoms such as a non-productive cough,
difficulty in breathing or crackles
• Symptoms of angioedema - swelling of the hands, feet, ankles, face, lips,
mouth or throat (which may cause difficulty in swallowing or breathing)
• A group of symptoms such as seizures, headache, high blood pressure,
confusion and loss of vision. These symptoms could be caused by
reversible posterior leukoencephalopathy syndrome (a rare disorder of
the nervous system).

The most common side effects (in more than 10% of patients) are:

• A disorder of the nerves which can cause weakness, tingling or
numbness in the fingers, toes, around the mouth or in the throat that may
sometimes occur in association with cramps. This is often triggered by
exposure to cold e.g. opening a refrigerator or holding a cold drink. You
may also have difficulty in performing delicate tasks, such as buttoning
clothes. Although in the majority of cases these symptoms resolve
completely there is a possibility of persistent symptoms after the end of
the treatment

The following information is intended for medical or healthcare professionals
only:

INSTRUCTIONS FOR USE, HANDLING
AND DISPOSAL
As with other potentially toxic compounds, caution should be exercised when
handling and preparing oxaliplatin solutions.

Instructions for Handling
The handling of this cytotoxic agent by healthcare personnel requires every
precaution to guarantee the protection of the handler and his surroundings.
The preparations of injectable solutions of cytotoxic agents must be carried
out by trained specialist personnel with knowledge of the medicines
used, in conditions that guarantee the integrity of the medicinal product,
the protection of the environment and in particular the protection of the
personnel handling the medicines, in accordance with the hospital policy.
It requires a preparation area reserved for this purpose. It is forbidden to
smoke, eat or drink in this area.
Personnel must be provided with appropriate handling materials, notably
long sleeved gowns, protection masks, caps, protective goggles, sterile
single-use gloves, protective covers for the work area, containers and
collection bags for waste.
Faeces and vomit must be handled with care.
Pregnant women must be warned to avoid handling cytotoxic agents.
Any broken container must be treated with the same precautions and
considered as contaminated waste. Contaminated waste should be
incinerated in suitably labelled rigid containers. See below chapter
“Disposal”.
If oxaliplatin powder, reconstituted solution or solution for infusion, should
come into contact with skin, wash immediately and thoroughly with water.
If oxaliplatin powder, reconstituted solution or solution for infusion, should
come into contact with mucous membranes, wash immediately and
thoroughly with water.

Special precautions for administration

• DO NOT use injection equipment containing aluminium
• DO NOT administer undiluted
• Only glucose 5% (50 mg/ml) infusion solution is to be used as a diluent. DO
NOT reconstitute or dilute for infusion with saline sodium chloride or chloride
containing solutions
• DO NOT mix with any other medicinal products in the same infusion bag or
administer simultaneously by the same infusion line
• DO NOT mix with alkaline medicinal products or solutions, in particular
5 fluorouracil, folinic acid preparations containing trometamol as an excipient
and trometamol salts of other active substances. Alkaline medicinal products
or solutions will adversely affect the stability of oxaliplatin
Instruction for use with folinic acid (FA) (as calcium folinate or disodium
folinate)
Oxaliplatin 85 mg/m² intravenous infusion in 250 to 500 ml of glucose 5%
(50 mg/ml) solution is given at the same time as folinic acid (FA) intravenous
infusion in glucose 5% (50 mg/ml) solution, over 2 to 6 hours, using a Y-line
placed immediately before the site of infusion. These two medicinal products
should not be combined in the same infusion bag. Folinic acid (FA) must not
contain trometamol as an excipient and must only be diluted using isotonic
glucose 5% (50 mg/ml) solution, never in alkaline solutions or sodium chloride
or chloride containing solutions.
Q71949
4XXXXX

Component Specification

Requester

Item number:

Q71949

Request number:

AS1024

Country:

United Kingdom

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q61511 / 484069

Inventory code(s):
M5350AGB1 (05350A-GB)
M5352AGB1 (05352A-GB)
OI template:
Amalia version:
Mulgrave version:

88S119
4
4

Dimensions:
Container(s):
Supplier:
Stock:

118 x 570 mm (20 panels)
vial
Howden Printing
View Hi-Corona 47 GSM/
Teropaque 50 gsm
28.5 x 118 mm
Yes
No

Folded dimensions:
Printed both sides:
Perforated:

Pharma code:
Decimal (Binary)
Pharma code length: ## mm
Mulgrave 4 series no.: XX

Colours
Black:

Signed:
Date:
Version 1
Technician:
Date:

DB
15/Jul/11

Version 2
Technician:
Date:

JH
18/Jul/11

Version 3
Technician:
Date:

JH
27/Jul/11

Version 4
Technician:
Date:

JL
17/Jan/12

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
Date:

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dd/mmm/yy

Version 7
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• Some people have experienced a tingling shock-like sensation passing
down the arms or trunk when the neck is flexed
• Oxaliplatin can sometimes cause an unpleasant sensation in the throat,
in particular when swallowing, and give the sensation of shortness of
breath. This sensation, if it happens, usually occurs during or within
hours of the infusion and may be triggered by exposure to the cold.
Although unpleasant, it will not last long and goes away without the need
for any treatment. Your doctor may decide to alter your treatment as a
result
• Signs of infection such as a sore throat and high temperature
• Reduction in the number of white blood cells, which make infections
more likely
• Reduction in blood platelets, which increases risk of bleeding or bruising
• Reduction in red blood cells, which can make the skin pale and cause
weakness or breathlessness. Your doctor will take blood to check that
you have sufficient blood cells before you start treatment and before
each subsequent course
• Allergic reactions - skin rash including red itchy skin, swelling of the
hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty
in swallowing or breathing) and you may feel you are going to faint
• Loss or lack of appetite
• Too high levels of glucose (sugar) in your blood which may cause a great
thirst, dry mouth or a need to urinate more often
• Low blood levels of potassium which can cause abnormal heart rhythm
• High blood levels of sodium which can cause tiredness, weakness,
irritability, fits or coma
• Taste disorder
• Headache
• Nosebleeds
• Shortness of breath
• Coughing
• Nausea (feeling sick), vomiting (being sick) - medication to prevent
sickness is usually given to you by your doctor before treatment and may
be continued after treatment
• Diarrhoea, if you suffer from persistent or severe diarrhoea or vomiting
contact your doctor immediately for advice
• Sore mouth or lips, mouth ulcers
• Stomach pain, constipation
• Skin disorder
• Hair loss
• Back pain
• Tiredness, loss of strength/weakness, body pain
• Pain or redness close to or at the injection site during the infusion
• Fever
• Blood tests which show changes in the way the liver is working
• Weight increase

Common side effects (in 1 to 10% of patients) are:























Runny nose
Chest infection
Dehydration
Excessive excitability or irritability
Dizziness
Swelling of the nerves to your muscles
Neck stiffness, intolerance/dislike of bright light and headache
Conjunctivitis, visual problems
Abnormal bleeding, blood in the urine and stools
Blood clot, usually in a leg, which causes pain swelling or redness
Blood clot in the lungs which causes chest pain and breathlessness
Flushing
High blood pressure
Chest pain, hiccups
Indigestion and heartburn
Flaking skin, skin rash, increased sweating and nail disorder
Joint pain and bone pain
Pain on passing urine or a change in frequency when passing urine
Blood tests which show changes in the way the kidney is working
Loss of weight
Depression
Difficulty sleeping

Uncommon side effects (in 0.1% to 1% of patients) are:





Hearing problems
Blockage or swelling of the bowel
Feeling anxious or nervous
Blood tests which show an increase in acidity

Rare side effects (in 0.01% to 0.1% of patients) are:

• Slurred speech
• Deafness
• Unexplained respiratory symptoms, difficulties in breathing, scarring of
the lungs which causes shortness of breath. This can sometimes be fatal
• Inflammation which causes abdominal pain or diarrhoea
• Reversible and temporary vision loss
• Severe abdominal pain, feeling sick or being sick (pancreatitis)

Very rare effects (less than 1 in 10,000 patients) are:
• Liver disease that your doctor will monitor you for
• Changes in kidney function

Frequency unknown
• Convulsion

If any of the side effects get serious or, if you notice any side effects not
mentioned in this leaflet, please inform your doctor.

5. HOW TO STORE OXALIPLATIN Hospira
Keep out of the reach and sight of children. No special precautions for
storage for the unopened vial. Do not use after the expiry date, the last day
of the month, which is stated on the carton and label.
The reconstituted solution should be diluted immediately in glucose 5%
(50 mg/ml) solution to give a concentration between not less than 0.2 mg/ml
and 0.7 mg/ml. Once diluted the infusion preparation should be used
immediately. Chemical and physical in-use stability has been demonstrated
for 48 hours at 2°C to 8°C. If not used immediately, in-use storage times
and conditions are the responsibility of the user and would not normally
be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in
controlled and validated aseptic conditions.

6. FURTHER INFORMATION
What Oxaliplatin Hospira contains

• The active substance is oxaliplatin
• The other ingredient is lactose monohydrate
Oxaliplatin Hospira is in the form of a powder for solution for infusion. The
medicine comes in glass containers called vials containing 50 mg or 100 mg
of oxaliplatin. One ml of reconstituted solution contains oxaliplatin 5 mg. The
vials are wrapped in a protective plastic to reduce the risk of spillage if the
vials break - these are referred to as ONCO-TAIN®. The vials are available
in single packs.
A solution is made by mixing the powder with water for injections or 5%
glucose. This solution is then diluted further in 5% glucose and can be given
as an infusion via a drip.
The Marketing Authorisation Holder and company responsible for batch
release in the EU is Hospira UK Limited, Warwickshire, CV31 3RW, UK.
This package leaflet has been approved in

Instruction for use with 5 fluorouracil (5 FU)
Oxaliplatin should always be administered before fluoropyrimidines – i.e.
5 fluorouracil (5 FU).
After oxaliplatin administration, flush the line and then administer 5 fluorouracil
(5 FU).
For additional information on medicinal products combined with oxaliplatin, see
the corresponding manufacturer’s summary of product characteristics.
• USE ONLY the recommended solvents (see below).
• Any reconstituted solution that shows evidence of precipitation should not
be used and should be destroyed with due regard to legal requirements for
disposal of hazardous waste (see below).

Reconstitution of the solution

• Water for Injections or 5% glucose solution should be used to reconstitute the
solution.
• For a vial of 50 mg: add 10 ml of solvent to obtain a concentration of 5 mg
oxaliplatin/ml.
• For a vial of 100 mg: add 20 ml of solvent to obtain a concentration of 5 mg
oxaliplatin/ml.
From a microbiological and chemical point of view, the reconstituted solution
should be diluted immediately with 5% glucose solution.
Inspect visually prior to use. Only clear solutions without particles should be
used.
The medicinal product is for single use only. Any unused infusion solution
should be discarded.

Dilution for intravenous infusion

Withdraw the required amount of reconstituted solution from the vial(s)
and then dilute with 250 ml to 500 ml of a 5% glucose solution to give an
oxaliplatin concentration between not less than 0.2 mg/ml and 0.7 mg/ml. The
concentration range over which the physico-chemical stability of oxaliplatin has
been demonstrated is 0.2 mg/ml to 1.3 mg/ml.
Administer by IV infusion.
Chemical and physical in-use stability has been demonstrated for 48 hours at
2°C to 8°C.
From a microbiological point of view, this 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.
Inspect visually prior to use. Only clear solutions without particles should be
used.
The medicinal product is for single use only. Any unused infusion solution
should be discarded.
NEVER use sodium chloride or chloride containing solutions for either
reconstitution or dilution.

Infusion

The administration of oxaliplatin does not require prehydration.
Oxaliplatin diluted in 250 to 500 ml of a 5% glucose solution to give a
concentration not less than 0.2 mg/ml must be infused either by peripheral
vein or central venous line over 2 to 6 hours. When oxaliplatin is administered
with 5-fluorouracil, the oxaliplatin infusion must precede the administration of
5-fluorouracil.

Disposal

Remnants of the medicinal product as well as all materials that have been used
for reconstitution, for dilution and administration must be destroyed according to
hospital standard procedures applicable to cytotoxic agents in accordance with
local requirements related to the disposal of hazardous waste.
Q71949
4XXXXX

Component Specification

Requester

Item number:

Q71949

Request number:

AS1024

Country:

United Kingdom

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q61511 / 484069

Inventory code(s):
M5350AGB1 (05350A-GB)
M5352AGB1 (05352A-GB)
OI template:
Amalia version:
Mulgrave version:

88S119
4
4

Dimensions:
Container(s):
Supplier:
Stock:

118 x 570 mm (20 panels)
vial
Howden Printing
View Hi-Corona 47 GSM/
Teropaque 50 gsm
28.5 x 118 mm
Yes
No

Folded dimensions:
Printed both sides:
Perforated:

Pharma code:
Decimal (Binary)
Pharma code length: ## mm
Mulgrave 4 series no.: XX

Colours
Black:

Signed:
Date:
Version 1
Technician:
Date:

DB
15/Jul/11

Version 2
Technician:
Date:

JH
18/Jul/11

Version 3
Technician:
Date:

JH
27/Jul/11

Version 4
Technician:
Date:

JL
17/Jan/12

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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