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OXALIPLATIN HOSPIRA 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): OXALIPLATIN

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Component Specification
Item number:

Q74138

Request number:

AS2283

Country:

UK & IE

OI template:
Amalia version:
Mulgrave version:

SVI012
5
n/a

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Oxaliplatin Hospira 5 mg/ml
concentrate for solution for infusion
Oxaliplatin

380 x 240 mm
Glass Vial
SVUS
40 gsm
30 x 190 mm or 30 x 95 mm
Yes
No

Pharma code:
Pharma code length:
Supplier Code:

n/a
n/a
n/a

Colours
Black:

Requester
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: Q61840
Latest QP Release Date: 24/Sep/2015

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1. What Oxaliplatin Hospira is and what it is used for
2. What you need to know before you use Oxaliplatin Hospira
3. How to use Oxaliplatin Hospira
4. Possible side effects
5. How to store Oxaliplatin Hospira
6. Contents of the pack and other 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 other anti-cancer medicines
called 5-fluorouracil (5-FU) and folinic acid (FA).

2. What you need to know before you use Oxaliplatin
Hospira

Signed:
Date:
Version 1
Technician:
Date:

Do not use Oxaliplatin Hospira:

JL
19/Sep/12

Version 2
Technician:
Date:

DM
20/Sep/12

Version 3
Technician:
Date:

MW
21/Sep/12

Version 4
Technician:
Date:

JL
29/Oct/12

Version 5
Technician:
Date:

JL
29/Oct/12

Version 6
Technician:
Date:

KN
11/Mar/15

Version 7
Technician:
Date:

LB
19/Mar/15

Version 8
Technician:
Date:

AB
19/Mar/15

Version 9
Technician:
Date:

KN
28/May/15

Version 10
Technician:
Date:

KN
03/Jun/15

Version 11
Technician:
Date:

JW
04/Jun/15

Version 12
Technician:
Date:

XX
dd/mmm/yy

• if you are hypersensitive (allergic) to oxaliplatin or any of the
other ingredients of Oxaliplatin Hospira
• 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.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Oxaliplatin Hospira:
• if you have moderate kidney problems.
• if you have ever suffered an allergic reaction to other
platinum-containing medicines such as carboplatin or
cisplatin.

• if you have symptoms of nerve damage such as weakness,
numbness, disturbance of feeling after previous oxaliplatin
treatment. These effects are often triggered by exposure to
cold. If you notice such symptoms tell your doctor, especially
if they are troublesome and/or last longer than 7 days. Your
doctor will regularly carry out neurological examinations,
before and regularly during treatment, especially if you are
given other drugs which may cause nerve damage.
• if you have any liver problems
• if your blood cell counts are too low after previous infusions
of oxaliplatin. Your doctor will regularly take blood to check
you have sufficient blood cells.

Method and route of administration

Before and/or during treatment with oxaliplatin you may be
given special medicinal products to prevent and/or treat
vomiting.

The duration of treatment will be determined by your doctor.
Treatment for 6 months is recommended when oxaliplatin is
used after surgery to remove your cancer.

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.

If you are given more Oxaliplatin Hospira than you
should:

Children
Oxaliplatin Hospira should not be given to children.

Other medicines and Oxaliplatin Hospira
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

Pregnancy and breast-feeding
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
continuing for 4 months for women and 6 months for men.
You must not breast-feed while you are treated with oxaliplatin.

Driving and using machines
Oxaliplatin treatment may result in an increased risk of
dizziness, nausea and vomiting, and other neurological
symptoms that affect gait and balance. If this happens, you
should not drive or operate machinery.

3. How to use Oxaliplatin Hospira
For adults only.
Oxaliplatin Hospira should only be used in specialised
departments of cancer treatment and should be administered
under the supervision of an experienced specialist in cancer
treatment.

Dosage
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 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 will depend
on results of blood tests and whether you have previously
experienced side effects with oxaliplatin.

Oxaliplatin Hospira is diluted before being given by injection
into a vein (an intravenous infusion) over a 2-6 hour period.
The needle must remain in the vein while the drug is being
given. If the needle comes out or becomes loose, or the
solution is going into the tissue outside the vein (you may feel
discomfort or pain) - tell the doctor or nurse immediately.

Frequency of administration
You should usually receive your infusion once every 2 weeks.

Duration of treatment

As this medicine is administered by a healthcare professional,
it is highly unlikely that you will be given too little or too much.
In case of overdose, you may experience increased side
effects. Your doctor may give you appropriate treatment for
these side effects.
If you have any questions about your treatment, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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 dry cough,
difficulty in breathing or crackles
• Swelling of the face, lips, mouth or throat (which may cause
difficulty in swallowing or breathing), a sudden itchy rash or
a feeling that you are going to faint
• Sensation of pain or discomfort close to or at the injection
site during the infusion
• A group of symptoms such as extreme tiredness, little or
infrequent urination and abnormal bleeding or bruising
(signs of haemolytic uremic syndrome)

Very common (affects more than 1 in 10 people):
• 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
• 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.

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

SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER
HANDLING
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 concentrate or solution for infusion, should come
into contact with skin, wash immediately and thoroughly with
water.
If oxaliplatin concentrate 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% infusion solution is to be used as a diluent.
DO NOT dilute for infusion with 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% solution is given at the same time as folinic acid (FA)
intravenous infusion in glucose 5% 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
Q74138

Item number:

Q74138

infusion bag. Folinic acid (FA) must not contain trometamol as
an excipient and must only be diluted using isotonic glucose 5%
solution, never in alkaline solutions or sodium chloride or chloride
containing solutions.

Request number:

AS2283

Instruction for use with 5 fluorouracil (5 FU)

Country:

UK & IE

OI template:
Amalia version:
Mulgrave version:

SVI012
5
n/a

Component Specification

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

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).

380 x 240 mm
Glass Vial
SVUS
40 gsm
30 x 190 mm or 30 x 95 mm
Yes
No

Pharma code:
Pharma code length:
Supplier Code:

n/a
n/a
n/a

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 concentrate 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).

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.

Withdraw the required amount of concentrate from the vial(s) and
then dilute with 250 ml to 500 ml of a glucose 5% solution to give
an oxaliplatin concentration between 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.

Black:

Administer by intravenous infusion.

Requester
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: Q61840
Latest QP Release Date: 24/Sep/2015

After dilution in glucose 5% solution, chemical and physical in-use
stability has been demonstrated for 24 hours at 2°C to 8°C and for
6 hours at 25°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
dilution.

Signed:

The compatibility of Oxaliplatin solution for infusion has been
tested with representative, PVC-based, administration sets.

Date:
Version 1
Technician:
Date:

JL
19/Sep/12

Version 2
Technician:
Date:

DM
20/Sep/12

The administration of oxaliplatin does not require prehydration.

Version 3
Technician:
Date:

MW
21/Sep/12

Version 4
Technician:
Date:

JL
29/Oct/12

Version 5
Technician:
Date:

JL
29/Oct/12

Version 6
Technician:
Date:

KN
11/Mar/15

Oxaliplatin diluted in 250 to 500 ml of a glucose 5% 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.

LB
19/Mar/15

Version 8
Technician:
Date:

AB
19/Mar/15

KN
28/May/15

Version 10
Technician:
Date:

KN
03/Jun/15

JW
04/Jun/15

Version 12
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:
Version 9
Technician:
Date:
Version 11
Technician:
Date:







Concentrate for solution for infusion

Dilution for intravenous infusion

Colours



Infusion

Disposal
Remnants of the medicinal product as well as all materials that
have been used 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.























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
Low blood levels of sodium which can cause tiredness and
confusion, muscle twitching, fits or coma
Taste disorder
Headache
Nosebleeds
Shortness of breath
Coughing
Nausea, vomiting - 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 which may be accompanied by shaking (rigors)
Blood tests which show changes in the way the liver is
working.
Weight gain (when oxaliplatin is used after surgery to
remove the tumour)

Common (affects more than 1 in 100 but less than 1 in
10 people):






Runny nose
Nose and throat infection
Dehydration
Dizziness
Inflammation of the nerves accompanied by pain,
disturbances of feeling, reduced action of the nerve.
Other symptoms of nerve disorders which have been
reported include jaw or muscle spasms, twitching,
muscle contractions, coordination and balance problems,




















staggering, double or abnormal/decreased vision, drooping
of eyelids, voice problems (hoarseness or loss of voice),
speech problems, abnormal tongue sensation, facial or eye
pain.
Neck stiffness, intolerance/dislike of bright light and headache
Conjunctivitis, visual problems
Abnormal bleeding, blood in the urine, stools or vomit
Blood clot, usually in a leg, which causes pain swelling or
redness
Blood clot in the lungs which causes chest pain and
breathlessness
Flushing
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
Abnormal blood tests which show worsening in the way the
kidney is working
Weight loss (when oxaliplatin is used in the treatment of
advanced disease that has spread beyond the bowel to
other tissues)
Depression
Difficulty sleeping
Reduction in the number of a special form of white blood
cells accompanied by fever and/or generalized infection
Throat or chest tightness

Uncommon (affects more than 1 in 1,000 but less than
1 in 100 people):






Hearing problems
Blockage or swelling of the bowel
Feeling anxious or nervous
Blood tests which show an increase in the body’s acidity
Temporary loss of vision

Rare (affects more than 1 in 10,000 but less than 1 in
1,000 people):
• Slurred speech
• Deafness
• Scarring of the lungs which may cause shortness of breath
and/or cough
• Bowel inflammation which causes abdominal pain and/or
diarrhoea which may be bloody
• Inflammation of the optic nerve, visual field disturbances
• Reduction in red blood cells caused by cell destruction, and
reduction in blood platelets due to an allergic reaction
• Inflammation of the pancreas
• A group of symptoms such as headache, dizziness, fits,
high blood pressure and sight problems (signs of reversible
posterior leukoencephalopathy syndrome)

5. How to store Oxaliplatin Hospira
Store below 25°C.
Keep this medicine out of the sight and reach of children. Keep
the vial in the outer carton in order to protect from light. Do not
freeze.
Do not use this medicine after the expiry date which is stated
on the carton and label. The expiry date refers to the last day
of that month.
Once diluted the infusion preparation should be used
immediately. Chemical and physical in-use stability has been
demonstrated for 24 hours at 2°C to 8°C and 6 hours at 25°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.

6. Contents of the pack and other information
What Oxaliplatin Hospira contains
• The active substance is oxaliplatin.
One ml of concentrate for solution for infusion contains 5 mg
oxaliplatin.
10 ml of concentrate for solution for infusion contains 50 mg
of oxaliplatin.
20 ml of concentrate for solution for infusion contains
100 mg of oxaliplatin.
40 ml of concentrate for solution for infusion contains
200 mg of oxaliplatin.
• The other ingredients are tartaric acid, sodium hydroxide
and water for injections

What Oxaliplatin Hospira looks like and contents of the
pack
Oxaliplatin Hospira is in the form of a concentrate solution
for infusion (a concentrated solution which is diluted to make
a solution which can be given as a slow infusion via a drip).
Each millilitre (ml) of solution contains 5 milligrams (mg) of
oxaliplatin. It is a clear, colourless solution contained in glass
containers called vials, containing 50 mg (10 ml), 100 mg
(20 ml) and 200 mg (40 ml) of oxaliplatin. 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.
The solution is then diluted in glucose 5% solution and can be
given as an infusion via a drip.

Marketing Authorisation Holder and Manufacturer
Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ,
United Kingdom
This leaflet was last revised in 06/2015.

Very rare (affects less than 1 in 10,000 people)
• Liver disease
• Kidney inflammation and kidney failure
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any side effects not mentioned in this
leaflet.

Q74138

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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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