Skip to Content

OXALIPLATIN 5MG/ML POWDER FOR SOLUTION FOR INFUSION

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxaliplatin 5mg/ml powder for solution for infusion
Oxaliplatin
If you have any further questions on the use of this medicine, ask
Read all of this leaflet carefully before you start using this
your doctor, nurse or pharmacist.
medicine, because it contains important information for you.
• Keep this leaflet. You may need to read it again
4. Possible side effects
• If you have any further questions, ask your doctor or your
pharmacist
Like all medicines, this medicine can cause side effects, although
• If you get any side effects, talk to your doctor or pharmacist.
not everybody gets them.
This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Oxaliplatin 5mg/ml is and what it is used for
What you need to know before you use Oxaliplatin 5mg/ml
How to use Oxaliplatin 5mg/ml
Possible side effects
How to store Oxaliplatin 5mg/ml
Contents of the pack and other information

1. What Oxaliplatin 5mg/ml is and what it is used for
The active ingredient of Oxaliplatin 5mg/mlis oxaliplatin.
Oxaliplatin 5mg/ml is used to treat cancer of the large bowel
(treatment of stage III coloncancer after complete resection of
primary tumour, metastatic cancer of colonand rectum). Oxaliplatin
is used in combination with other anticancer medicines called 5
fluorouracil (5-FU) and leucovorin (folinic acid).
Oxaliplatin 5mg/ml is an antineoplastic or anticancer drug and
contains platinum.
2. What you need to know before you use Oxaliplatin 5mg/ml
Do not use Oxaliplatin 5mg/ml
• if you are allergic to oaxaliplatin or any of the other ingredients of
this medicine (listed in section 6).
• if you are breast-feeding.
• if you already have a reduced number of red or white 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 severe kidney problems.
Warnings and precaution
Talk to your doctor or pharmacist before using Oxaliplatin 5mg/ml:
• If you have ever suffered an allergic reaction to platinumcontaining medicines such as carboplatin, cisplatin. Allergic
reactions can occur during any oxaliplatin infusion.
• If you have moderate kidney problems.
• If you have any liver problems.
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. Male patients should take
appropriate contraceptive measures during and after cessation of
therapy continuing for 6 months.
Consult your doctor if one of the above warnings applies to you or
has done in the past.
Other medicines and Oxaliplatin 5mg/ml
Please tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
It is not recommended that you become pregnant during treatment
with oxaliplatin and an effective method of contraception must
be used. Female patients should take appropriate contraceptive
measures during and after cessation of therapy continuing for 4
months.
If you are pregnant or planning a pregnancy it is very important
that you discuss this with your doctor before you receive any
treatment.
If you get pregnant during your treatment, you must immediately
inform your doctor.
You must not breast-feed while you are treated with oxaliplatin.
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Driving and using machines
Oxaliplatin treatment may result in an increased risk of dizziness,
nausea and vomiting, and other neurological symptoms that affect
walking and balance. If this happens you should not drive or operate
machinery.
If you have vision problems while taking Oxaliplatin 5mg/ml, do not
drive, operate heavy machines, or engage in dangerous activities.
3. How to use Oxaliplatin 5mg/ml
Oxaliplatin 5mg/ml is intended for adults only.
For single use only.
Dosage
The dose of oxaliplatin is based on your body surface area. This is
calculated from your height and weight.
The usual dose for adults including the elderly is 85 mg/m2 of body
surface area. The dose you receive will also depend on results
of blood tests and whether you have previously experienced side
effects with oxaliplatin.
Method and route of administration
• Oxaliplatin will be prescribed for you by a specialist in cancer
treatment
• You will be treated by a healthcare professional, who will have
made up the required dose of oxaliplatin.
Frequency of administration
You should usually receive your infusion once every 2 weeks.
Duration of treatment
The duration of the treatment will be determined by your doctor.
Your treatment will last a maximum of 6 months when used after
complete resection of your tumour.
If you use more Oxaliplatin 5mg/ml than you should
As this medicine is administered by a healthcare professional it is
highly unlikely that you will be given too much or too little.
In case of overdose, you may experience increased side effects.
Your doctor may give you appropriate treatment for these side
effects.

Side effects may be
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data
If you experience any side effect it is important that you inform your
doctor before your next treatment.
You will find described below the side effects that you could
experience.
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
• Presence of blood or dark brown coffee-coloured granules in your
vomit
• Stomatitis/mucositis (sore lips or mouth ulcers)
• Unexplained respiratory symptoms such as dry cough, difficulties
inbreathing or crackles,
• A group of symptoms such as headache, altered
mental functioning, seizures and abnormal vision from
blurriness to vision loss (symptoms of reversible posterior
leukoencephalopathy syndrome, a rare neurological disorder).
Other known side effects of oxaliplatin are:
Very common (affects more than 1 user in 10)
• Oxaliplatin can affect the nerves (peripheral neuropathy). You
may feel a tingling and/or numbness in the fingers, toes, around
the mouth or in the throat, which may sometimes occur in
association with cramps.
These effects are 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 themselves
completely there is a possibility of persistent symptoms of
peripheral sensory neuropathy after the end of the treatment.
• 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.
• Oxaliplatin may cause diarrhoea, mild nausea (feeling sick) and
vomiting (being sick); however medication to prevent the sickness
is usually given to you by your doctor before treatment and may
be continued after treatment.
• Oxaliplatin causes temporary reduction in the number of blood
cells.
The reduction of red cells may cause anaemia (a reduction of
red cells),abnormal bleeding or bruising (due to a reduction in
platelets).
The reduction in white blood cells may make you prone to
infections.
Your doctor will take blood to check that you have sufficient blood
cells before you start treatment and before each subsequent
course.
• Sensation of discomfort close to or at the injection site during the
infusion
• Fever, rigors (tremors), mild or severe tiredness, body pain
• Weight changes, loss or lack of appetite, taste disorders,
constipation
• Headache, back pain
• Swelling of the nerves to your muscles, neck stiffness, abnormal
tongue sensation possibly altering speech, stomatitis/mucositis
(sore lips or mouth ulcers)
• Stomach pain
• Abnormal bleeding including nose bleeds
• Coughing, difficulty in breathing
• Allergic reactions, skin rash which may be red and itchy, mild hair
loss (alopecia)
• Alteration in blood tests including those relating to abnormalities
in liver function.
Common (affects 1 to 10 users in 100)
• Infection due to a reduction in white blood cells
• Indigestion and heart burn, hiccups, flushing, dizziness
• Increased sweating and nail disorders, flaking skin
• Chest pain
• Lung disorders and runny nose
• Joint pain and bone pain
• Pain on passing urine and changes in kidney function, changes
of frequency of urination, dehydration
• Blood in the urine/stools, swelling of the veins, clots in the lung
• Depression and insomnia
• Conjunctivitis and visual problems.
Uncommon (affects 1 to 10 users in 1000)
• Blockage or swelling of the bowel
• Nervousness.
Rare (affects 1 to 10 users in 10 000)
• Loss of hearing
• Scarring and thickening in the lungs with difficulties in breathing,
sometimes fatal (interstitial lung disease)
• Reversible short-term loss of vision.
Very rare (affects less than 1 person in 10 000)
• Presence of blood or dark brown coffee-coloured granules in your
vomit.
Frequency unknown (cannot be assessed)
• Convulsion.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

5. How to store Oxaliplatin 5mg/ml
Keep this medicine out of the sight and reach of children.
Expiry date:
Do not use this medicine after the expiry date, which is stated on the
carton and vial after EXP (abbreviation used for expiry date). The
expiry date refers to the last day of that month.
Storing your medicine
Unopened vial : This medicinal product does not require any special
storage conditions.

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 % 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 %
solution, never in alkaline solutions or sodium chloride or chloride
containing solutions.

Storage conditions for the reconstituted and diluted solutions
are given in the information intended for medical and healthcare
professionals.

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).

When the infusion has finished, any unused solution will be
disposed of carefully by the doctor or nurse. Do not throw away any
medicines via wastewater. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the
environment.

For additional information on medicinal products combined with
oxaliplatin, see the corresponding manufacturer’s summary of
product characteristics.

6. Contents of the pack and other information

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.

What Oxaliplatin 5mg/ml contains
The active substance is oxaliplatin. One ml of the reconstituted
concentrate solution contains 5mg oxaliplatin.
50mg vial: Each vial contains 50mg oxaliplatin for reconstitution in
10ml of solvent.
The other ingredient is lactose monohydrate.

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.

What Oxaliplatin 5mg/ml looks like and contents of the pack
Oxaliplatin 5mg/ml is a white or almost white powder, which is
provided in a glass vial with bromobutyl rubber closures and
aluminium-plastic combination cap. The vials are supplied in
cartons of one vial.
Pack size: 1 x 50mg vial
Oxaliplatin 5mg/ml has to be diluted before it can be injected into
a vein. This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about anything,
ask your doctor or pharmacist.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cadiasun Pharma GmbHLendersweg 27, 47877 Willich,
Germany
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
This medicinal product is authorised in the Member States of
the EEA under the following names:
The Netherlands: OxaliplatinCadiasun 5mg/ml poeder voor
oplossing voor infusie
Spain:
Oxaliplatino Cadiasun 5mg/ml polvo para solución
para perfusion EFG
United Kingdom: Oxaliplatin 5mg/ml powder for solution for infusion
This leaflet was last approved in: 08/2012

Only to be used with recommended diluents.
Reconstituted solutions should be diluted with 5% glucose solution.
Reconstituted solution is a clear, colorless to light straw-colored
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 1.0 mg/ml.
Administer by intravenous infusion.
After dilution in glucose 5% (50 mg/ml) solution, chemical and
physical in-use stability has been demonstrated for 24 hours at 2°C
to 8°C.
From a microbiological point of view, the solution for infusion 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 the solution 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 solution or chloride containing
solutions for either reconstitution or dilution.

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 preparation 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.
Excreta 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 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 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 others
active substances. Alkaline medicinal products or solutions will
adversely affect the stability of oxaliplatin.

The compatibility of Oxaliplatin solution for infusion has been tested
with representative, PVC-based, administrative sets.
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 standard procedures applicable to cytotoxic
agents in accordance with local requirements related to the disposal
of hazardous waste.

Expand Transcript

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.

Hide