Oxaliplatin 5mg/Ml Powder For Solution For Infusion
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Name of Product: Oxaliplatin SUN 5 mg/ml concentrate for solution for infusion |
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EUUK- Untited Kingdom |
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SPIL - Halol | ||
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044BP1587A |
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248 x 375 mm |
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41 x 16 mm |
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Super Fine 40 GSM Tissue Paper ITC |
100 % - BLACK |
Artwork Prepared by : Sun Pharmaceutical Industries Limited Packaging Development Department [PDD] SPIL - Vadodara | |||
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Folding 375--3--46.88 mm 248--3 zigzag--41.33 mm | |||||
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Prepared by Sign Date |
Checked by Sign Date |
Approved by Sign Date |
Approved by RA Sign Date | ||
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FONTS SPECIFICATION | |
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Patient info. Leaflet |
Swiss 721 CN BT - 10 pt |
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Title and Tiltle Heading |
Swiss 721 CN BT - 13 pt and 11 pt |
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Body Text |
Swiss 721 CN BT - 8 pt |
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044BP 1 587A
Package leaflet: Information for the user
Oxaliplatin 5 mg/ml, powder for solution for infusion
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.
- This medicine has been prescribed for you. 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 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
Oxaliplatin 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 anticancer agents, 5-fluorouracil and folinic acid.
2. What you need to know before you use Oxaliplatin
You should not be given Oxaliplatin if
- you are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6)
- you are breast-feeding
- you already have a reduced number of blood cells (white blood cells and/or platelets)
- you already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes
- you have severe kidney problems.
Even if you are male, please ensure that you read the section of this leaflet that concerns pregnancy and breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before using Oxaliplatin if
- you have ever suffered an allergic reaction to platinum-containing medicines such as carboplatin or cisplatin. Allergic reactions can occur during any oxaliplatin infusion.
- you have moderate kidney problems
- 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.
Other medicines and Oxaliplatin
Tell your doctor or pharmacist if you are using have recently used or might use any other medicines.
Pregnancy and breast feeding
It is not recommended that you become pregnant during treatment with oxaliplatin and must use an effective method of contraception. Female patients should take appropriate contraceptive measures during and after cessation of therapy continuing for 4 months.
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 may result in increased risk of dizziness, nausea and vomiting and other neurological symptoms that may affect walking and balance. If this happens to you, you should not drive or operate machinery. If you have vision problems whilst taking Oxaliplatin do not drive, operate heavy machines or engage in dangerous activities.
3. How to use Oxaliplatin
Oxaliplatin may only be given to adults.
For single use only.
Dosage
The dose of Oxaliplatin is based on your body surface area (calculated from your height and weight). The dose will also depend on results of blood tests and whether you have previously experienced side effects with Oxaliplatin. The recommended dose for adults including the elderly is 85 mg/m2 of body surface
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.
- Oxaliplatin is given by injection into a vein (an 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.
- 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 nurse or doctor immediately.
Frequency of administration
You should usually receive your infusion once every two 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 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.
If you have any further questions on the use of this medicine, ask your doctor.
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.
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 particles in your vomit
- stomatitis / mucositis (sore lips or mouth ulcers)
- unexplained respiratory symptoms such as dry cough, difficulties in breathing or crackles
- a group of symptoms of an allergic reaction 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: may affect more than 1 in 10 people
- Oxaliplatin can affect the nerves (peripheral sensory 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 experience difficulties in performing delicate tasks, such as buttoning clothes.
- Although in the majority of cases these symptoms disappear 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 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 the 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
Oxaliplatin 5 mg/ml, powder for solution for infusion
Oxaliplatin
The following information is intended for medical or healthcare professionals only:
Oxaliplatin 5 mg/ml, powder for solution for infusion
Instruction for handling and disposal
As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions.
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 suitable labelled rigid containers. See below chapter “Disposal".
If oxaliplatin powder, reconstituted solution or solution for infusion, should come into contact with skin or mucous membranes, wash immediately and thoroughly with water.
Disposal
Remnants of the medicinal product as well as 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
Special precautions for administration
DO NOT use injection equipment containing aluminium.
DO NOT administer oxaliplatin undiluted.
Only glucose 5% (50 mg/ml) solution for infusion 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.
Instruction for use with folinic acid (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 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 must not contain trometamol as an excipient and must only be diluted using isotonic glucose 5% solution, never in alkaline solutions or sodium chloride containing solutions.
Instructions for use with 5-fluorouracil
Oxaliplatin should always be administered before fluoropyrimidines - i.e. 5-fluorouracil.
After oxaliplatin administration, flush the line and then administer 5-fluorouracil.
For additional information on medicinal products combined with oxaliplatin, see the corresponding summary of product characteristics.
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.
Reconstituted solutions should be diluted immediately with 5% glucose solution.
Inspect visually prior to use. Only clear solutions without particles should be used. 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.
Dilution for intravenous infusion
Only to be used with recommended diluents.
Withdraw the required amount of reconstituted solution from the vial(s) and then dilute with 250 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/m, i.e. the concentration range over which the physico-chemical stability for oxaliplatin has been demonstrated
Folding
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248-3 zigzag~4i.33 mm Size: 375x248 mm
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Administration by intravenous infusion
Chemical and physical in-use stability has been demonstrated for 24 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.
Inspect visually prior to use. Only clear solutions without particles should be used.
This medicinal product is for single use only. Any unused solution for infusion should be discarded.
NEVER use sodium chloride solution or chloride containing solutions for either reconstitution or dilution.
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 solution for infusion with 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.
Incompatibilities
This medicinal product should not be mixed with other medicinal products except for those mentioned in the section “Reconstitution of the solution”. Oxaliplatin can be co-administered with folinic acid via a Y-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 (see below section “Reconstitution of the solution”).
Do not reconstitute or dilute for infusion with saline or other solutions containing chloride ions (including calcium, potassium or sodium chloride). Do not use injection equipment containing aluminium.
Storage conditions
Medicinal product as packaged for sale:
This medicinal product does not require any special storage conditions.
Reconstituted solution in the original vial:
From a microbiological point of view, the reconstituted solution should be diluted immediately.
- allergic reactions, skin rash including red and itchy skin, mild hair loss (alopecia)
- alteration in blood tests including those relating to abnormalities on liver function.
Common: may affect up to 1 in 10 people
- infection due to a reduction in white blood cells
- indigestion and heart burn, hiccups, flushing and 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
- high blood pressure
- depression and sleeplessness
- conjunctivitis and visual problems.
Uncommon: may affect up to 1 in 100 people
- blockage or swelling of the bowel
- nervousness.
Rare: may affect up to 1 in 1,000 people
- 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: may affect up to 1 in 10,000 people
- presence of blood or dark brown coffee-coloured particles in your vomit.
Frequency unknown (cannot be assessed):
- convulsion.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.
This medicine does not require any special storage conditions when the vial is unbroken.
6. Contents of the pack and other information
What Oxaliplatin 5 mg/ml, powder for solution for infusion contains
- The active substance is oxaliplatin.
- The other ingredient is lactose monohydrate.
One ml of the reconstituted solution contains 5 mg oxaliplatin.
50 mg vial: Each vial contains 50 mg oxaliplatin for reconstitution in 10 ml of solvent.
100 mg vial: Each vial contains 100 mg oxaliplatin for reconstitution in 20 ml of solvent.
What Oxaliplatin 5 mg/ml, powder for solution for infusion looks like and contents of the pack
Powder for solution for infusion: A white or almost white powder, which is provided in a colourless glass vial that has a rubber closure and has a metallic cap containing a plastic disk.
Pack sizes:
1 x 50 mg vial 5 x 50 mg vial 1 x 100 mg vial 5 x 100 mg vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 2132 JH Hoofddorp The Netherlands
This medicinal product is authorised in the Member states of the EEA under the following names:
Oxaliplatin SUN 5 mg/ml, Pulver zur Herstellung einer Infusionslosung Oxaliplatine SUN 5 mg/ml, poudre pour solution pour perfusion Oxaliplatino SUN 5 mg/ml, polvo para solucion para perfusion Oxaliplatine SUN 5 mg/ml, poeder voor oplossing voor infusie Oxaliplatin 5 mg/ml, powder for solution for infusion
Do not use this medicine after the expiry date which is stated on the This leaflet was last revised in 04/2014
label and carton after EXP
The expiry date refers to the last day of that month.
The reconstituted solution should immediately be diluted with 5% glucose solution to give a concentration between 0.2 mg/ml and 0.7 mg/ml. Once diluted the solution for infusion should be used immediately. Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
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Germany
France
Spain
The Netherlands United Kingdom
Infusion preparation:
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 infusion preparation should be used immediately. If not used immediately, in-use storage times and conditions prior to used are the responsibility of the used 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.
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Oxaliplatin should not come into contact with the eyes or shin. If there is any accidental spillage, tell the doctor or nurse immediately. When the infusion has finished, any remaining oxaliplatin will be disposed of carefully by the doctor or nurse.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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Folding
I 375--3--46.88 mm 3/5 mm
248-3 zigzag--4i.33 mm Size: 375x248 mm
100
95
75
25
5
0
Oxaliplatin Infusion 5mg-ml-PIL-EUUK-375x248mm-24-04-14
24 April 2014 16:47:47