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OXALIPLATIN MEDAC 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): OXALIPLATIN

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Oxaliplatin 5 mg/ml · 70480-VBGB-EXT · AA · 05.14 · Pharma-Code: -Format: 680 x 148 mm · HKS 44 · Corrective action: KV01_jem_25.04.14 / KV02_jem_28.04.14 / KV03_osc_20.05.14

Package leaflet: Information for the user

Oxaliplatin 5 mg/ml
concentrate for solution for infusion

Oxaliplatin is an antineoplastic or anticancer medicine and
contains platinum.
2. What you need to know before you use
Oxaliplatin

oxaliplatin
Read all of this leaflet carefully before you start
using 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
or pharmacist.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Oxaliplatin is and what it is used for
2. What you need to know before you use
Oxaliplatin
3. How to use Oxaliplatin
4. Possible side effects
5. How to store Oxaliplatin
6. Contents of the pack and other information

1. What Oxaliplatin is and what it is used for

Do not use Oxaliplatin
• if you are allergic to oxaliplatin 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 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 precautions
Talk to your doctor or pharmacist before using
Oxaliplatin.
Take special care with Oxaliplatin
• if you have moderate or mild kidney problems.
• if you have ever suffered an allergic reaction to
platinum-containing medicines (e.g. carboplatin or
cisplatin). Allergic reactions can occur during any
oxaliplatin infusion.
• if you have any liver problems.
• if you are pregnant or planning a pregnancy.
It is very important that you discuss this with your
doctor before you receive any treatment.

Other medicines and Oxaliplatin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
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.
It is not recommended that you become pregnant during
treatment with oxaliplatin and you must use an effective
method of contraception. Female patients should take
appropriate contraceptive measures during and after
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 on treatment with
Oxaliplatin.
Driving and using machines
Treatment with Oxaliplatin involves 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 this medicine,
do not drive, operate machinery or engage in potentially
dangerous activities.

The active ingredient of Oxaliplatin is oxaliplatin.
Oxaliplatin is used to treat cancer of the large bowel
(treatment of stage III colon cancer after complete
resection of primary tumour, metastatic cancer of colon
and rectum). Oxaliplatin is used in combination with other
anticancer medicines called 5-fluorouracil and folinic acid.

Oxaliplatin can cause infertility, which may be irreversible.
Male patients are therefore advised not to father children
during and up to 6 months after the treatment and to seek
advice on conservation of sperm prior to treatment. Male
patients should take appropriate contraceptive measures
during and after therapy continuing for 6 months.

3. How to use Oxaliplatin
Oxaliplatin may only be administered to adults.
For single use only.

Dose
The dose depends on the body surface area (calculated
in m²), which is determined from your height and weight.
In addition the dose depends on the results of blood tests
and whether you have previously experienced side effects
with oxaliplatin.
The usual dose for adults, including elderly patients,
is 85 mg/m² body area.
Route of administration
Oxaliplatin will be prescribed to you by a doctor with
experience in the treatment of cancer.
You will be treated by a healthcare professional, who will
have made up the required dose of Oxaliplatin.
Oxaliplatin is given by slow injection into a vein
(intravenous infusion) over a 2 to 6 hour period.
Oxaliplatin will be given to you at the same time
as folinic acid and before the infusion of 5-fluorouracil.
You should usually receive your infusion once every
2 weeks.
Duration of use
The duration of therapy will be decided by your doctor.
Your treatment will last a maximum of 6 months when
used after complete removal of your tumour.
If you use more Oxaliplatin than you should
As this medicine is administered by a healthcare
professional, it is highly unlikely that you have received too
much or too little. However, do inform your doctor if you
have any concerns.
In case of overdose, you may experience increased side
effects. Your doctor will give you appropriate treatment for
these side effects.
If you have any further questions on the use of this
medicine, ask you doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Please inform your doctor immediately if you notice
any of the following side effects:
• Abnormal occurrence of bruises, bleeding,
or signs of infection such as a sore throat or
a high body temperature.
• Persistent or severe diarrhoea or vomiting.
• Presence of blood or dark brown coffee-coloured
particles in your vomit.
• Sore lips or mouth ulcers (stomatitis/mucositis).
• Unexplained respiratory symptoms such as dry cough,
difficulty in breathing or crackles.
• Swelling of the hands, feet, ankles, face, lips, mouth
or the pharynx (which may give rise to difficulties in
swallowing or breathing) – symptoms of angiooedema.
• 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).
Very common side effects
(may affect more than 1 in 10 people)
• 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
symptoms are often provoked by exposure to cold,
for example by opening the refrigerator or holding a
cold drink. You may also experience difficulties with
the performance of fine motor movements such as
buttoning up clothing. Even though in the majority of
cases these symptoms disappear completely, there is
a possibility that they will persist 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 may sometimes cause an unpleasant
sensation in the throat, which is especially noticeable on
swallowing and which gives an impression of shortness
of breath. If this occurs, it usually does so during or
within a few hours after the end of the infusion, and
is triggered by exposure to cold. This unpleasant
phenomenon does not last long and regresses without
needing any treatment. Your doctor will decide on any
adjustment of treatment.
• Signs of infection, such as sore throat and high body
temperature.
• 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.
• An increased risk of bleeding and occurrence of
extravasation (leaking of fluid into the surrounding tissue).
• Skin pallor, weakness, and breathlessness.
• Allergic reactions – red itching rash, swelling of
the hands, feet, ankles, face, lips, mouth, and the
throat (which can lead to difficulties in breathing and
swallowing), which may produce a sensation of incipient
loss of consciousness.
• Complete or partial loss of appetite.
• High levels of blood glucose (blood sugar), which can
cause a strong thirst, a dry mouth, or an increased
frequency of passing urine.
• Irregular heartbeat (caused by a low level of potassium
in blood).
• Tiredness, disorientation, muscle twitching, cramp
attacks, and profound coma (caused by a low level
of sodium in blood).



















Disturbances of the sense of taste.
Headaches.
Nosebleeds.
Shortness of breath.
Cough.
Nausea and vomiting – to avoid these effects you will
usually be given medication by your doctor before, and
if necessary, also after the treatment.
Diarrhoea. Contact you doctor without delay if the
diarrhoea or vomiting is persistent or severe.
Swelling of the nerves to your muscles, neck stiffness,
abnormal tongue sensation possibly altering speech,
stomatitis/mucositis (sore lips or mouth ulcers).
Abdominal pains, constipation.
Skin disorders.
Loss of hair.
Backache.
Tiredness, loss of strength, sensation of weakness,
pains in the whole body.
Pain or skin reddening both around and directly
at the injection site during the infusion.
Fever, rigors (tremors).
Alteration in blood tests including those relating
to abnormalities in liver function.
Weight gain.

Common side effects (may affect up to 1 in 10 people)
• Infection due to a reduction in white blood cells.
• Inflammation of nasal mucous membranes.
• Respiratory tract infection.
• Loss of fluid with tissue dehydration.
• Pronounced excitability and irritability.
• Dizziness.
• Swelling of muscle-supplying nerves.
• Stiff neck, light intolerance, aversion to dazzling light,
headaches.
• Conjunctivitis, visual disturbances.
• Abnormal bleeding, blood in urine or stool.

• Blood clot formation, usually in a leg,
with painful swelling and reddening.
• Blood clot in the lung, causing chest pains
and breathlessness.
• Attacks of skin reddening.
• Pains in the chest, hiccups.
• Digestive disturbances, heartburn.
• Peeling skin, rash, increased sweating
and nail disorders.
• Pains in the joints and bones.
• Pains when passing urine or a change
in urination frequency.
• Blood tests showing a change in kidney function.
• Loss of weight.
• Depression.
• Sleep disturbances.
Uncommon side effects (may affect up to 1 in 100 people)
• Hearing disturbances.
• Intestinal obstruction, intestinal swelling.
• Anxiety or nervousness.
• Higher acidity of the blood.
Rare side effects (may affect up to 1 in 1,000 people)
• Indistinct speech.
• Deafness.
• Scarring and thickening in the lungs with difficulties in
breathing, sometimes fatal (interstitial lung disease).
• Inflammations causing abdominal pains and diarrhoea.
• Reversible short-term loss of vision.
Very rare side effects (may affect up to 1 in
10,000 people)
• Liver disorders, for which your doctor will be
watching out.
• Changes in kidney function.
• Presence of blood or dark brown coffee-coloured
particles in your vomit.

Oxaliplatin 5 mg/ml · 70480-VBGB-EXT · AA · 05.14 · Pharma-Code: -Format: 680 x 148 mm · HKS 44 · Corrective action: KV01_jem_25.04.14 / KV02_jem_28.04.14 / KV03_osc_20.05.14

Not known (frequency cannot be estimated from the
available data)
• Convulsion.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information
on the safety of this medicine.

5. How to store Oxaliplatin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the label and the carton after EXP.
The expiry date refers to the last day of that month.
Prior to mixing keep this medicine in the outer carton
in order to protect from light. Do not freeze.
Oxaliplatin should not come into contact with the eyes or
skin. If there is any accidental spillage, tell the doctor or
medicinal health care professional immediately.
This medicine is for single use only. When the infusion
has finished, Oxaliplatin will be disposed carefully by the
doctor or health care professional.
After dilution in 5 % glucose solution, chemical and
physical in-use stability has been demonstrated for
48 hours at +2 °C to +8 °C and for 6 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.
6. Contents of the pack and other information

Manufacturer:
AqVida GmbH
Kaiser-Wilhelm-Str. 89
20355 Hamburg
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:

What Oxaliplatin contains
The active substance is oxaliplatin. 1 ml of the concentrate
for solution for infusion contains 5 mg oxaliplatin.
Each vial of 10 ml of concentrate contains
50 mg oxaliplatin.
Each vial of 20 ml of concentrate contains
100 mg oxaliplatin.
Each vial of 40 ml of concentrate contains
200 mg oxaliplatin.

Czech Republic, Portugal, Slovakia:
Oxaliplatina medac
Denmark, Finland, Sweden, United Kingdom:
Oxaliplatin medac
Germany: medoxa
France: OXALIPLATINE MEDAC
Poland: Oksaliplatyna medac
This leaflet was last revised in 05/2014.

The other ingredient is water for injections.
What Oxaliplatin looks like and contents of the pack
Oxaliplatin is a clear, colourless concentrate for solution
for infusion.

The following information is intended for healthcare
professionals only:

Pack sizes
Packs with 1 vial containing 10 ml, 20 ml or
40 ml of concentrate.

Handling instructions for safe use
Like other potentially toxic substances, oxaliplatin
solutions must be prepared and handled with due care.

Marketing authorisation holder and manufacturer:

The handling of this cytotoxic agent by medical health
care professionals requires all safety measures ensuring
protection of the user and his/her environment.

Marketing authorisation holder:
medac Gesellschaft für Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

Injection solutions of cytotoxic medicinal products must be
prepared by specially trained personnel familiar with the
medicinal product used, under conditions guaranteeing

protection of the environment, and especially protection of
the personnel involved in accordance with the hospital’s
standard procedures. This requires the provision of
a working area designated for this purpose, in which
smoking, eating, and drinking are prohibited.
The personnel must be provided with suitable working
equipment, and in particular with long-sleeve laboratory
coats, protective masks, head coverings, protective
goggles, sterile disposable gloves, protective workplace
coverings, containers, and collection bags for waste.
Excrement and vomit must be handled with care.
Pregnant women must be warned against handling
cytotoxic substances and must avoid them.
Any broken containers must be handled with the same
care and treated as contaminated waste. Contaminated
waste should be placed in solid suitably labeled containers
for disposal by incineration. See below chapter “Waste
disposal”.
If oxaliplatin concentrate for solution for infusion should
come into contact with skin, wash immediately and
thoroughly with water.
If oxaliplatin concentrate for solution for infusion should
come into contact with mucous membranes, wash
immediately and thoroughly with water.
Preparation for the intravenous administration
Special precautions for use
• The product MUST NOT be used with aluminumcontaining injection equipment.
• The product MUST NOT be administered undiluted.
Only glucose 5 % (50 mg/ml) infusion solution is to be
used as a diluent.
• The product MUST NOT be diluted with sodium chloride
or chloride-containing solutions.

• The product MUST NOT be mixed with any other
medicinal products in the same infusion bag or
administered simultaneously in the same infusion line.
• The product MUST NOT be mixed with alkaline
medicinal agents or solutions, in particular
5-fluorouracil, folinic acid preparations containing
trometamol as an excipient and trometamol salts of
other active ingredients. Alkaline medicinal agents or
solutions will adversely affect the stability of oxaliplatin.
Instructions for use with folinic acid (e.g. with calcium
folinate or disodium folinate)
250 to 500 ml of 5 % (50 mg/ml) glucose infusion solution
containing 85 mg/m² oxaliplatin is infused simultaneously
by the i.v. route with the folinic acid infusion solution
(folinic acid in 5 % glucose) using a Y-line placed
immediately before the site of infusion, over a period of
2 to 6 hours.
The two medicines must not be mixed in the same infusion
bag. The folinic acid must not contain trometamol as a
constituent, and only isotonic 5 % glucose solution may
be used for its dilution. Never use any alkaline or sodium
chloride solution, or any other solution containing chloride
for dilution.
Instructions for use with 5-fluorouracil
Oxaliplatin should always be administered before
fluoropyrimidines, i.e. 5-fluorouracil.

Reconstituted solutions showing signs of precipitation
must not be used, and should be destroyed with due
observation of legal regulations for disposal of hazardous
waste (see below).
Use only the recommended solvents (see below).
Only clear solutions without particles should be used.
Preparation of the infusion solution
Withdraw the required amount of concentrate from
the vial(s) and then dilute with 250 ml to 500 ml of a
glucose 5 % (50 mg/ml) solution to give an oxaliplatin
concentration between 0.2 mg/ml and 0.7 mg/ml.
Over this concentration range the physicochemical
stability of oxaliplatin has been demonstrated.

Never use sodium chloride or chloride containing solutions
for dilution.
The compatibility of oxaliplatin solution for infusion
has been tested with representative, PVC-based,
administration sets.
Infusion of the solution
The administration of oxaliplatin does not require
prehydration.
Oxaliplatin diluted in 250 to 500 ml of a glucose 5 %
(50 mg/ml) 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.

Administer by intravenous infusion.
After dilution in glucose 5 % (50 mg/ml) solution, chemical
and physical in-use stability has been demonstrated for
48 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.

After the administration of Oxaliplatin the access must
be rinsed through before the administration of
5-fluorouracil.

Inspect visually prior to use. Only clear solutions without
particles should be used.

For further information on medicinal products given in
combination with oxaliplatin, see the corresponding
Summary of Product Characteristics.

The medicinal product is for single use only. Any unused
infusion solution should be discarded (see chapter “Waste
disposal” below).

Waste disposal
Remnants of this medicinal product and all material used
for dilution and administration must be destroyed in
accordance with the hospital’s standard procedures for
cytotoxic substances and local requirements for disposal
of hazardous waste.

70480-VBGB-EXT
AA

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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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