SODIOFOLIN 50 MG/ML SOLUTION FOR INJECTION OR INFUSION
Active substance: DISODIUM FOLINATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER Sodiofolin 50 mg/ml, solution for injection or infusion Folinic acid (as disodium folinate) Read all of this leaflet carefully before you start using this medicine. - Keep this leaflet. You may need to read it again. - you have any further questions, ask your doctor or If pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - any of the side effects gets serious, or if you notice If any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Sodiofolin 50 mg/ml is and what it is used for 2. Before you use Sodiofolin 50 mg/ml 3. How to use Sodiofolin 50 mg/ml 4. Possible side effects 5. How to store Sodiofolin 50 mg/ml 6. Further information
WHAT SODIOFOLIN 50 MG/ML IS AND WHAT IT 1. IS USED FOR - Folinic acid, a compound derived from the vitamin B12 group, is an antidote to the anticancer medicine methotrexate (rescue therapy). - Folinic acid increases the action of the anticancer medicine fluorouracil; the two substances are used together for treatment of cancer. Sodiofolin 50 mg/ml has been prescribed by your doctor: - either for the prevention of possible side-effects resulting from methotrexate therapy - or for treatment of cancer in combination therapy with fluorouracil 2. BEFORE YOU USE SODIOFOLIN 50 MG/ML Do not use Sodiofolin 50 mg/ml - you are allergic (hypersensitive) to disodium if folinate or any of the other ingredients of Sodiofolin 50 mg/ml (see point 6 of this leaflet). - in combination with fluorouracil if you: - are pregnant or breast feeding, - ave severe diarrhoea (watery stools or bowel h movements), - ave symptoms of gastrointestinal toxicity such as h diarrhoea, feeling or being sick or mouth ulcers. Your doctor will monitor these symptoms until they resolve. - you have certain blood disorders (pernicious anaemia if or other anaemias due to shortage of vitamin B12).
Your doctor will check these before your treatment. Take special care when taking Sodiofolin 50 mg/ml - you are of older age or debilitated, as elderly or if debilitated patients may be at increased risk of severe toxicity. - you are suffering from convulsion (epilepsy), if as you are at increased risk of seizures. This will require regular monitoring of your blood in order to check the level of anti-epileptic medication. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. - Sodiofolin 50 mg/ml is used for the treatment of cancer in combination with fluorouracil. You must be aware that this combination of medicines might cause side-effects (see point 4 of this leaflet). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. - The effectiveness of some medicines (phenytoin, primidone and phenobarbital) used to treat convulsion (epilepsy) may be reduced which may lead to increased risk of seizures. Pregnancy and breast-feeding Ask your doctor for advice before taking any medicine. You should not take Sodiofolin 50 mg/ml in combination with fluorouracil if you are pregnant, planning to become pregnant or while you are breast-feeding. Driving and using machines Your ability to drive or operate machinery is not affected
by Sodiofolin 50 mg/ml. But you should consider your general condition before driving or operating machinery. 3. HOW TO USE SODIOFOLIN 50 MG/ML Sodiofolin 50 mg/ml will be given to you - by an injection into your vein (intravenous injection) or - by a drip given into a vein (intravenous infusion). The dose given depends on your size. It varies with your surface area. Technically, this is measured in square metres (m2), but actually is worked out from your height and weight. Preventing possible side-effects during a therapy with methotrexate (rescue treatment) Your doctor uses Sodiofolin 50 mg/ml as a preventive treatment, which follows the administration of methotrexate. Sodiofolin 50 mg/ml is given intravenously (into your vein). The used amount depends on the measured methotrexate blood levels. The infusion thearapie using Sodiofolin 50 mg/ml starts not later than 18 to 30 hours after the start of methotrexate infusion. The infusion therapy using Sodiofolin 50 mg/ml ends 72 hours after the start of methotrexate infusion at the earliest. Treatment of carcinoma using Sodiofolin 50 mg/ml in combination with fluorouracil All dosage schedules have been determined by clinical studies carried out in large numbers of patients. Your doctor can choose from weekly, monthly or other regimens. All schedules use a combination of the two
substances disodium folinate (Sodiofolin 50 mg/ml) and fluorouracil. The following schedules have been used in adults and elderly in the treatment of advanced carcinoma of the colon and rectum and are given as examples. There are no data on the use of these combinations in children. Your doctor will explain to you how this works and how often you will receive your mediciation: 1. Weekly schedule of fluorouracil and Sodiofolin 50 mg/ml. This involves either: - 2 hour intravenous infusion (drip) of Sodiofolin A 50 mg/ml, followed by a single intravenous injection of fluorouracil (Moderately high dose fluorouracil treatment). or - 1 - 2 hour intravenous infusion of Sodiofolin a 50 mg/ml, followed by a 24 hour infusion of fluorouracil (High dose fluorouracil treatment) given weekly in cycles of six weeks according to your response. The six week cycle may be repeated after an interval of 2 weeks, if necessary, and the number of cycles will depend on the response of the tumor. 2. Monthly schedule of fluorouracil and Sodiofolin 50 mg/ml. This involves single intravenous injections of Sodiofolin 50 mg/ml, followed by a single intravenous injection of fluorouracil, given once a day together for 5 successive days (= 1 cycle). The cycle is repeated after 4 weeks, and then according to the response of the tumour. This schedule may be followed at a higher dosage (Moderately high dose Sodiofolin 50mg/ml) or alternatively, at a lower dosage (Low dose Sodiofolin 50 mg/ml).
If you receive more Sodiofolin 50 mg/ml than you should It is very unlikely that you will receive more Sodiofolin 50mg/ml than you should. You will be monitored by a doctor or a nurse during the treatment with this medicine to ensure safe and proper administration of the solution. 4. POSSIBLE SIDE EFFECTS Like all medicines, Sodiofolin 50 mg/ml can cause side effects, although not everybody gets them. The following side effects have been observed when Sodiofolin 50 mg/ml was administered: - Isolated cases of allergic reactions such as sensitisation (state of being sensitive) and urticaria (hives), including mild or severe allergic reactions (e.g. swelling of lips or tongue or face, difficulty breathing, chest pain, collapse). If you experience any of these allergic reactions please consult your doctor or hospital immediately. - Gastrointestinal (digestive) disorders after high doses - Occasionally fever Sodiofolin 50mg/ml can enhance the action and the side-effects of the anticancer medicine fluorouracil. The most frequently reported side-effects of this combination therapy are: - life-threatening diarrhoea (watery stools or bowel movements) has been observed in patients receiving the weekly moderately high-dose fluorouracil regimen. - dehydration - stomatitis (oral ulceration)
- leucopenia (decrease in the number of white blood cells) If you experience stomatitis (mild to moderate oral ulceration) or diarrhoea (watery stools or bowel movements) two times per day, be sure to consult your doctor immediately. Less commonly: - infections - thrombocytopenia (decrease in the number of blood platelets) - nausea (sickness) with or without vomiting - constipation - feeling of discomfort - alopecia (loss of hair) - dermatitis (inflammation of the skin) - anorexia (lack of appetite) If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE SODIOFOLIN 50 MG/ML Keep out of the reach and sight of children. Do not use Sodiofolin 50 mg/ml after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Store in a refrigerator (2 C - 8 C).
Keep the vial in the outer carton in order to protect from light. 6. FURTHER INFORMATION What Sodiofolin 50 mg/ml contains - The active substance is Folinic acid (as disodium folinate. - he other ingredients are sodium hydroxide, T hydrochloric acid and water for injection. What Sodiofolin 50 mg/ml looks like and contents of the pack One 2 ml / 4ml / 6 ml / 7 ml / 8 ml / 10 ml / 18 ml vial contains 109.3 mg / 218.6 mg / 327.9 mg / 382.55 mg / 437.2 mg / 546.5 mg / 983.7 mg disodium folinate equivalent to 100 mg / 200 mg / 300 mg / 350 mg / 400 mg / 500 mg / 900 mg folinic acid. Sodiofolin 50 mg/ml is supplied in sealed glass vials in packs of 1 or 5. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing authorisation holder: medac Gesellschaft fr klinische Spezialprparate mbH Fehlandtstr. 3 20354 Hamburg, Germany Manufacturer: medac Gesellschaft fr klinische Spezialprparate mbH Theaterstr. 6 22880 Wedel, Germany This leaflet was last approved in 06/2008.
85500-VPGB CA
WHAT SODIOFOLIN 50 MG/ML IS AND WHAT IT 1. IS USED FOR - Folinic acid, a compound derived from the vitamin B12 group, is an antidote to the anticancer medicine methotrexate (rescue therapy). - Folinic acid increases the action of the anticancer medicine fluorouracil; the two substances are used together for treatment of cancer. Sodiofolin 50 mg/ml has been prescribed by your doctor: - either for the prevention of possible side-effects resulting from methotrexate therapy - or for treatment of cancer in combination therapy with fluorouracil 2. BEFORE YOU USE SODIOFOLIN 50 MG/ML Do not use Sodiofolin 50 mg/ml - you are allergic (hypersensitive) to disodium if folinate or any of the other ingredients of Sodiofolin 50 mg/ml (see point 6 of this leaflet). - in combination with fluorouracil if you: - are pregnant or breast feeding, - ave severe diarrhoea (watery stools or bowel h movements), - ave symptoms of gastrointestinal toxicity such as h diarrhoea, feeling or being sick or mouth ulcers. Your doctor will monitor these symptoms until they resolve. - you have certain blood disorders (pernicious anaemia if or other anaemias due to shortage of vitamin B12).
Your doctor will check these before your treatment. Take special care when taking Sodiofolin 50 mg/ml - you are of older age or debilitated, as elderly or if debilitated patients may be at increased risk of severe toxicity. - you are suffering from convulsion (epilepsy), if as you are at increased risk of seizures. This will require regular monitoring of your blood in order to check the level of anti-epileptic medication. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. - Sodiofolin 50 mg/ml is used for the treatment of cancer in combination with fluorouracil. You must be aware that this combination of medicines might cause side-effects (see point 4 of this leaflet). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. - The effectiveness of some medicines (phenytoin, primidone and phenobarbital) used to treat convulsion (epilepsy) may be reduced which may lead to increased risk of seizures. Pregnancy and breast-feeding Ask your doctor for advice before taking any medicine. You should not take Sodiofolin 50 mg/ml in combination with fluorouracil if you are pregnant, planning to become pregnant or while you are breast-feeding. Driving and using machines Your ability to drive or operate machinery is not affected
by Sodiofolin 50 mg/ml. But you should consider your general condition before driving or operating machinery. 3. HOW TO USE SODIOFOLIN 50 MG/ML Sodiofolin 50 mg/ml will be given to you - by an injection into your vein (intravenous injection) or - by a drip given into a vein (intravenous infusion). The dose given depends on your size. It varies with your surface area. Technically, this is measured in square metres (m2), but actually is worked out from your height and weight. Preventing possible side-effects during a therapy with methotrexate (rescue treatment) Your doctor uses Sodiofolin 50 mg/ml as a preventive treatment, which follows the administration of methotrexate. Sodiofolin 50 mg/ml is given intravenously (into your vein). The used amount depends on the measured methotrexate blood levels. The infusion thearapie using Sodiofolin 50 mg/ml starts not later than 18 to 30 hours after the start of methotrexate infusion. The infusion therapy using Sodiofolin 50 mg/ml ends 72 hours after the start of methotrexate infusion at the earliest. Treatment of carcinoma using Sodiofolin 50 mg/ml in combination with fluorouracil All dosage schedules have been determined by clinical studies carried out in large numbers of patients. Your doctor can choose from weekly, monthly or other regimens. All schedules use a combination of the two
substances disodium folinate (Sodiofolin 50 mg/ml) and fluorouracil. The following schedules have been used in adults and elderly in the treatment of advanced carcinoma of the colon and rectum and are given as examples. There are no data on the use of these combinations in children. Your doctor will explain to you how this works and how often you will receive your mediciation: 1. Weekly schedule of fluorouracil and Sodiofolin 50 mg/ml. This involves either: - 2 hour intravenous infusion (drip) of Sodiofolin A 50 mg/ml, followed by a single intravenous injection of fluorouracil (Moderately high dose fluorouracil treatment). or - 1 - 2 hour intravenous infusion of Sodiofolin a 50 mg/ml, followed by a 24 hour infusion of fluorouracil (High dose fluorouracil treatment) given weekly in cycles of six weeks according to your response. The six week cycle may be repeated after an interval of 2 weeks, if necessary, and the number of cycles will depend on the response of the tumor. 2. Monthly schedule of fluorouracil and Sodiofolin 50 mg/ml. This involves single intravenous injections of Sodiofolin 50 mg/ml, followed by a single intravenous injection of fluorouracil, given once a day together for 5 successive days (= 1 cycle). The cycle is repeated after 4 weeks, and then according to the response of the tumour. This schedule may be followed at a higher dosage (Moderately high dose Sodiofolin 50mg/ml) or alternatively, at a lower dosage (Low dose Sodiofolin 50 mg/ml).
If you receive more Sodiofolin 50 mg/ml than you should It is very unlikely that you will receive more Sodiofolin 50mg/ml than you should. You will be monitored by a doctor or a nurse during the treatment with this medicine to ensure safe and proper administration of the solution. 4. POSSIBLE SIDE EFFECTS Like all medicines, Sodiofolin 50 mg/ml can cause side effects, although not everybody gets them. The following side effects have been observed when Sodiofolin 50 mg/ml was administered: - Isolated cases of allergic reactions such as sensitisation (state of being sensitive) and urticaria (hives), including mild or severe allergic reactions (e.g. swelling of lips or tongue or face, difficulty breathing, chest pain, collapse). If you experience any of these allergic reactions please consult your doctor or hospital immediately. - Gastrointestinal (digestive) disorders after high doses - Occasionally fever Sodiofolin 50mg/ml can enhance the action and the side-effects of the anticancer medicine fluorouracil. The most frequently reported side-effects of this combination therapy are: - life-threatening diarrhoea (watery stools or bowel movements) has been observed in patients receiving the weekly moderately high-dose fluorouracil regimen. - dehydration - stomatitis (oral ulceration)
- leucopenia (decrease in the number of white blood cells) If you experience stomatitis (mild to moderate oral ulceration) or diarrhoea (watery stools or bowel movements) two times per day, be sure to consult your doctor immediately. Less commonly: - infections - thrombocytopenia (decrease in the number of blood platelets) - nausea (sickness) with or without vomiting - constipation - feeling of discomfort - alopecia (loss of hair) - dermatitis (inflammation of the skin) - anorexia (lack of appetite) If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE SODIOFOLIN 50 MG/ML Keep out of the reach and sight of children. Do not use Sodiofolin 50 mg/ml after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Store in a refrigerator (2 C - 8 C).
Keep the vial in the outer carton in order to protect from light. 6. FURTHER INFORMATION What Sodiofolin 50 mg/ml contains - The active substance is Folinic acid (as disodium folinate. - he other ingredients are sodium hydroxide, T hydrochloric acid and water for injection. What Sodiofolin 50 mg/ml looks like and contents of the pack One 2 ml / 4ml / 6 ml / 7 ml / 8 ml / 10 ml / 18 ml vial contains 109.3 mg / 218.6 mg / 327.9 mg / 382.55 mg / 437.2 mg / 546.5 mg / 983.7 mg disodium folinate equivalent to 100 mg / 200 mg / 300 mg / 350 mg / 400 mg / 500 mg / 900 mg folinic acid. Sodiofolin 50 mg/ml is supplied in sealed glass vials in packs of 1 or 5. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing authorisation holder: medac Gesellschaft fr klinische Spezialprparate mbH Fehlandtstr. 3 20354 Hamburg, Germany Manufacturer: medac Gesellschaft fr klinische Spezialprparate mbH Theaterstr. 6 22880 Wedel, Germany This leaflet was last approved in 06/2008.
85500-VPGB CA
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
