Package leaflet: Information for the patient. Leucovorine Sandoz 10 mg/ml, oplossing voor injectie folinic acid

Transcription

1 Package leaflet: Information for the patient Leucovorine Sandoz 10 mg/ml, oplossing voor injectie folinic acid 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, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What [nationally completed name] is and what it is used for 2. What you need to know before you are given [nationally completed name] 3. How you are given [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. What [Nationally completed name] is and what it is used for [Nationally completed name] is a solution containing the active ingredient folinic acid in form of calcium folinate, which is one of a group of medicines called detoxifying agents. [Nationally completed name] is used to reduce the side effects of certain anticancer drugs or if too much has been given in adults and children. [Nationally completed name] works by acting against drugs that work against folic acid such as methotrexate. This is called "Calcium Folinate Rescue". [Nationally completed name] may also be used in combination with 5-fluorouracil (another anticancer drug). Calcium Folinate Injection is also used to reduce the side effects of other medicines (a group of medicines called folic acid antagonists). Examples of folic acid antagonists are: trimetrexate (an antibiotic and anti-cancer medicine) trimethoprim (an antibiotic) pyrimethamine (a medicine often used to treat malaria) It may also be used to treat an overdose of these medicines. 2. What you need to know before you are given [Nationally completed name] You should not be given [Nationally completed name] if you: - are allergic to calcium folinate or any of the other ingredients of this medicine (listed in section 6) - have a decrease in the amount of red blood cells (anaemia)

2 You should not be given [nationally completed name] together with certain anticancer drugs if you are pregnant or breastfeeding (your doctor will know which these are). [Nationally completed name] should only be given by intramuscular or intravenous injection and must not be administered directly in your spine or brain (intrathecally). Warnings and precautions Talk to your doctor before you are given [nationally completed name] if you have - epilepsy - a kidney disorder Tell your doctor if you develop any of the following conditions during treatment: - diarrhoea - inflammation of the mouth Other medicines and [Nationally completed name] Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. For example - treatments for epilepsy - 5-fluorouracil (an anticancer drug) - co-trimoxazole (an antibiotic) - pyrimethamine (a treatment for malaria) Pregnancy, breast-feeding and fertility You should not be given [nationally completed name] together with 5-fluorouracil while pregnant or breast-feeding as it might harm the baby. You will only be given [nationally completed name] together with methotrexate when pregnant or breast-feeding if your doctor thinks it is necessary. Driving and using machines There is no evidence that [nationally completed name] affects driving or using machines. [Nationally completed name] contains sodium. Doses below 7ml (70mg): This medicinal product contains less than 1mmol sodium (23mg), i.e. essentially sodium-free. This medicinal product contains 3.3 mg (0.14mmol) sodium per ml. To be taken into consideration by patients on a controlled sodium diet. 3. How you are given [Nationally completed name] [Nationally completed name] will only be given by a doctor or nurse under the supervision of a doctor who has experience in the use of chemotherapy. [Nationally completed name] may be given by injection or infusion into a vein, or as an injection into a muscle.

3 The dose depends on your body surface area, the type of anticancer treatment used, and any other treatment you may be receiving. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, [nationally completed name] can cause side effects, although not everybody gets them. Tell your doctor immediately if you have a severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint. This is a serious side effect. Contact a doctor immediately. This side effect is very rare (may affect up to 1 in 10,000 people). Other side effects: The following additional side effects have been reported: Uncommon (may affect up to 1 in 100 people) fever Rare (may affect up to 1 in 1,000 people) difficulty sleeping (insomnia) agitation depression problems with the digestive system an increase in convulsions (fits) in patients with epilepsy If you receive [nationally completed name] in combination with an anticancer medicine containing fluoropyrimidines, it is more likely that you experience the following side effects of this other medicine: Very common: may affect more than 1 in 10 people nausea vomiting severe diarrhoea drying out which may be due to diarrhea inflammation of the lining of the intestine and mouth (life-threatening conditions have occurred) reduction in the number of blood cells (including life-threatening conditions) Common redness and swelling of the palms of the hands or the soles of the feet which may cause the skin to peel (hand-foot syndrome)

4 Not known: frequency cannot be estimated from the available data elevated ammonia level in the blood Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. You can also report side effects directly via [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store [Nationally completed name] 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. Store in a refrigerator (2 C - 8 C). Information about storage and the time to use [nationally completed name], after it has been diluted for infusion, are described in the information for healthcare professionals, at the end of this leaflet. Do not use this medicine if you notice cloudy appearance or particles in the solution. 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 [nationally completed name] contains The active substance is folonic acid. One ml of solution for injection/infusion contains 10 mg of folinic acid as calcium folinate hydrate. The other ingredients are sodium chloride, water for injections, sodium hydroxide, dilute hydrochloric acid. What [nationally completed name] looks like and contents of the pack [Nationally completed name] is a clear, yellowish solution. Amber glass vials packed in a carton. Vials are closed with a rubber stopper with an aluminium cap. Available pack sizes 1, 5, 10 vial with 3 ml 1, 5, 10 vial with 5 ml 1 vial with 10 ml 1 vial with 20 ml 1 vial with 35 ml 1 vial with 50 ml 1 vial with 100 ml

5 Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Houder van de vergunning voor het in de handel berengen Sandoz B.V. Veluwezoom AH Almere Nederland Fabrikant EBEWE Pharma Ges.m.b.H. Nfg.KG Mondseestraße 11 A-4866 Unterach am Attersee Oostenrijk Leucovorine Sandoz 10 mg/ml, oplossing voor injectie is in het register ingeschreven onder: RVG This medicinal product is authorised in the Member States of the EEA under the following names: Nederland: Leucovorine Sandoz 10 mg/ml, oplossing voor injectie Oostenrijk: Calciumfolinat Sandoz 10mg/ml Injektions-/Infusionslösung Bulgarije: Калциев фолинат Сандоз 10 mg/ml инжекционен/инфузионен разтвор Tsjechië: Calcium Folinate Sandoz 10 mg/ml, injekční roztok Duitsland: Calciumfolinat HEXAL 10 mg/ml Denemarken: Calciumfolinate Sandoz Finland: Calciumfolinate Sandoz Frankrijk: FOLINATE DE CALCIUM EBEWE 10 mg/ml, solution injectable/pour perfusion Kroatië: Kalcijev folinat Sandoz 10 mg/ ml otopina za injekciju/ infuziju Hongarije: Calcium folinate Sandoz 10 mg/ml oldatos injekció vagy infúzió Litouwen: Calcium folinate Sandoz 10mg/ml injekcinis ar infuzinis tirpalas Polen: Calcium folinate Sandoz Zweden: Calciumfolinate Sandoz Slovenië: Kalcijev folinat Sandoz 10 mg/ml raztopina za injiciranje/infundiranje Slowakije: Calcium folinate Sandoz 10 mg/ml Verenigd Calcium Folinate 10 mg/ml Solution for Injection or Infusion Koninkrijk: Deze bijsluiter is voor het laatst goedgekeurd in februari 2017 The following information is intended for healthcare professionals only: Instructions for use/handling For intravenous infusion, [nationally completed name] may be diluted with 0.9 % sodium chloride solution or 5 % glucose solution before use (see storage and shelf-life).

6 Prior to administration, [nationally completed name] should be inspected visually. The solution for injection or infusion should be a clear yellowish solution. If cloudy in appearance or particles are observed, the solution should be discarded. Incompatibilities Incompatibilities have been reported between injectable forms of calcium folinate and injectable forms of droperidol, fluorouracil, foscarnet and methotrexate. Droperidol 1. Droperidol 1.25 mg/0.5 ml with calcium folinate 5 mg/0.5 ml; immediate precipitation was observed after direct admixture in a syringe for 5 minutes at 25 C followed by 8 minutes of centrifugation. 2. Droperidol 2.5 mg/0.5 ml with calcium folinate 10 mg/0.5 ml; immediate precipitation was observed when the drugs were injected sequentially into a Y-connector without flushing the Y- side arm between injections. Fluorouracil Generally, calcium folinate must not be mixed in the same infusion as fluorouracil because a precipitate may form. Fluorouracil 50 mg/ml with calcium folinate 20 mg/ml, with or without dextrose 5% in water, has been shown to be incompatible when mixed in different amounts and stored at 4 C, 23 C, or 32 C in polyvinyl chloride containers. However, a 1:1 mixed solution of calcium folinate solution (10 mg/ml) and fluorouracil solution (50 mg/ml) has been shown to be compatible and stable over a period of 48 hours stored at maximum 32 C protected from light. Foscarnet The formation of a cloudy yellow solution has been reported when foscarnet 24 mg/ml is mixed with calcium folinate 20 mg/ml. Method of administration Calcium folinate should only be given by intramuscular or intravenous injection and must not be administered intrathecally. Death has been reported when folinic acid has been administered intrathecally, following intrathecal overdose of methotrexate. In the case of intravenous administration, no more than 160 mg of calcium folinate should be injected per minute due to the calcium content of the solution. Storage Store in a refrigerator (2 C - 8 C). Shelf-life Unopened 2 years After dilution for infusion

7 Chemical and physical in-use stability has been demonstrated for 28 days at 2 C to 8 C after dilution with sodium chloride 0.9 % to concentrations of 0.2 mg/ml and 4.0 mg/ml. Chemical and physical in-use stability has been demonstrated for 4 days at 2 C to 8 C after dilution with glucose 5 % to a concentration of 0.2 mg/ml and for 28 days at 2 C to 8 C after dilution to a concentration of 4.0 mg/ml. From a microbiological point of view, the product 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 to 8 C, unless dilution has taken place in controlled and validated aseptic conditions.