Oxaliplatin 5 Mg/Ml Concentrate For Solution For Infusion
VH/bOOA XXXXXXXXX
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Oxaliplatin 5 mg/ml
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The following information is intended for 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 nursing and medical 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 section“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 drugs in the same infusion bag or administer simultaneously by the same infusion line.
DO NOT mix with alkaline drugs 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 (as calcium folinate or disodium folinate)
Oxaliplatin 85 mg/m2 intravenous infusion in 250 to 500 ml of 5% glucose solution is given at the same time as folinic acid intravenous infusion in 5% glucose solution, over 2 to 6 hours, using a Y-line placed immediately before the site of infusion. These two drugs 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 or chloride containing solutions.
Instruction for use with 5-lluorouracil 15-FU)
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 drugs 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
• 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: may affect up to 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: may affect up to 1 in 100 people
• Blockage or swelling of the bowel,
• Feeling anxious or nervous
• Hearing problems
• Blood tests which show an increase in the body’s acidity
• Temporary loss of vision.
Rare: may affect up to 1 in 1,000 people
• Loss of hearing,
• Deafness
• Slurred speech
• 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
• Scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease),
• Reversible short-term loss of vision.
• Deafness
• Reversible short-term loss of vision,
• Scarring of the lungs which may cause shortness of breath and/oBowel inflammation which causes abdominal pain and/or diarrhoea which may be bloody,
• 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).
Very rare: may affect up to 1 in 10,000 people
• Liver disease
• Kidney inflammation and kidney failure
Unknown: frequency cannot be estimated from the available data
• Allergic vasculitis (inflammation of blood vessels)
• Auto-immune reaction leading to reduction of all blood cell lines (autoimmune pancytopenia).
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.
Do not use this medicine after the expiry date which is stated on the label and carton after Exp. The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light. Do not freeze. Store below 25°C.
Do not use Oxaliplatin if you notice that the solution is not clear and free of particles.
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
6. Contents of the pack and other information What Oxaliplatin contains:
- The active substance is Oxaliplatin. 1 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 succinic acid, sodium hydroxide and water for injections
What Oxaliplatin looks like and contents of the pack
This medicinal product is a concentrate for solution for infusion. It is a clear, colourless concentrate for solution for infusion free from visible particles.
Each vial contains 50 mg, 100 mg or 200 mg oxaliplatin. The concentrate is supplied in 10 ml, 20 ml and 40 ml concentrate in a Type I clear glass vial with chlorobutyl elastomer stopper and aluminium flip-off overseal. Each vial may be shrink wrapped and may/ may not be packed in a plastic container.
The vials are supplied in cartons of one vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court
Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Austria |
Oxaliplatin Kabi 5 mg/ml Konzentrat zur Herstellung einer Infusionslosung |
|
Belgium |
Oxaliplatin Fresenius 5mg/ml Concentraat voor oplossing voor intraveneuze infusie |
|
Bulgaria |
Oxaliplatin Kabi 5 mg/ml KompmpaT 3a HHd>y3HOHeH pa3TBop |
|
Estonia |
Oxaliplatin Kabi 5 mg/ml |
|
Latvia |
Oxaliplatin Kabi 5 mg/ml koncentrats infuziju skiduma pagatavosanai |
|
Lithuania |
Oxaliplatin Kabi 5 mg/ml koncentratas infuziniam tirpalui |
|
Luxembourg |
Oxaliplatin Kabi 5 mg/ml Konzentrat zur Herstellung einer Infusionslosung |
|
Romania |
Oxaliplatin Kabi 5mg/ml concentrat pentru solutie perfuzabila |
|
Slovenia |
Oksaliplatin Kabi 5 mg/ml koncentrat za raztopino za infundiranje |
|
Sweden |
Oxaliplatin Fresenius Kabi 5 mg/ml, koncentrat till infusionsvatska, losning |
|
United kingdom |
Oxaliplatin 5 mg/ml concentrate for solution for infusion |
This leaflet was last revised in May 2016
The following information is intended for 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 nursing and medical 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 section“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 drugs in the same infusion bag or administer simultaneously by the same infusion line.
DO NOT mix with alkaline drugs 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 (as calcium folinate or disodium folinate)
Oxaliplatin 85 mg/m2 intravenous infusion in 250 to 500 ml of 5% glucose solution is given at the same time as folinic acid intravenous infusion in 5% glucose solution, over 2 to 6 hours, using a Y-line placed immediately before the site of infusion. These two drugs 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 or chloride containing solutions.
Instruction for me with 5-fluorouracil (5-FU)
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 drugs 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
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• 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: may affect up to 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
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• Reduction in the number of a special form of white blood cells accompanied by fever and/or generalized infection
• Throat or chest tightness
Uncommon: may affect up to 1 in 100 people
• Blockage or swelling of the bowel,
• Feeling anxious or nervous
• Hearing problems
• Blood tests which show an increase in the body’s acidity
• Temporary loss of vision.
Rare: may affect up to 1 in 1,000 people
• Loss of hearing,
• Deafness
• Slurred speech
• 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
• Scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease),
• Reversible short-term loss of vision.
• Deafness
• Reversible short-term loss of vision,
• Scarring of the lungs which may cause shortness of breath and/oBowel inflammation which causes abdominal pain and/or diarrhoea which may be bloody,
• 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).
Very rare: may affect up to 1 in 10,000 people
• Liver disease
• Kidney inflammation and kidney failure
Unknown: frequency cannot be estimated from the available data
• Allergic vasculitis (inflammation of blood vessels)
• Auto-immune reaction leading to reduction of all blood cell lines (autoimmune pancytopenia).
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.
Do not use this medicine after the expiry date which is stated on the label and carton after Exp. The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light. Do not freeze. Store below 25°C.
Do not use Oxaliplatin if you notice that the solution is not clear and free of particles.
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
6. Contents of the pack and other information What Oxaliplatin contains:
- The active substance is Oxaliplatin. 1 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 succinic acid, sodium hydroxide and water for injections
What Oxaliplatin looks like and contents of the pack
This medicinal product is a concentrate for solution for infusion. It is a clear, colourless concentrate for solution for infusion free from visible particles.
Each vial contains 50 mg, 100 mg or 200 mg oxaliplatin. The concentrate is supplied in 10 ml, 20 ml and 40 ml concentrate in a Type I clear glass vial with chlorobutyl elastomer stopper and aluminium flip-off overseal. Each vial may be shrink wrapped and may/ may not be packed in a plastic container.
The vials are supplied in cartons of one vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court
Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Austria |
Oxaliplatin Kabi 5 mg/ml Konzentrat zur Herstellung einer Infusionslosung |
|
Belgium |
Oxaliplatin Fresenius 5mg/ml Concentraat voor oplossing voor intraveneuze infusie |
|
Bulgaria |
Oxaliplatin Kabi 5 mg/ml KOH^mpaT 3a nH+v3noHeH pa3TBop |
|
Estonia |
Oxaliplatin Kabi 5 mg/ml |
|
Latvia |
Oxaliplatin Kabi 5 mg/ml koncentrats infuziju skiduma pagatavosanai |
|
Lithuania |
Oxaliplatin Kabi 5 mg/ml koncentratas infuziniam tirpalui |
|
Luxembourg |
Oxaliplatin Kabi 5 mg/ml Konzentrat zur Herstellung einer Infusionslosung |
|
Romania |
Oxaliplatin Kabi 5mg/ml concentrat pentru solutie perfuzabila |
|
Slovenia |
Oksaliplatin Kabi 5 mg/ml koncentrat za raztopino za infundiranie |
|
Sweden |
Oxaliplatin Fresenius Kabi 5 mg/ml, koncentrat till infusionsvatska, losning |
|
United kingdom |
Oxaliplatin 5 mg/ml concentrate for solution for infusion |
This leaflet was last revised in May 2016
[ Vinod Pal ] D:\FK-DATA\Europe\Oxaliplatm\RTU\IRL+UK\PL 187270012\GBR+IRL\Bordon\2016 APR\Oxaliplatin RTU Pack Insert-GBR+IRE-Bordon-PL 187270012.indd
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Times New Roman 9.5 pt Ver.: 03
Last modified: 10 May 2016 12:15 PM
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Reason for the Artwork* : Revision of Text/Size |
Dimension : 280 x 455 mm | ||||||
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Artwork No. : XXXXXXXXXX |
Supersedes No. : XXXXXXXXXX | ||||||
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Form No.: SOP/PDD/003-03 Rev. 05 CONFIDENTIAL * Attached separate sheet if required