País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Calcium folinate pentahydrate 10.8 mg/mL (as 12.71 mg/mL of calcium folinate pentahydrate, equivalent to 10 mg/mL folinic acid)
Sandoz New Zealand Limited
Calcium folinate 10.8 mg/mL (as 12.71 mg/mL of calcium folinate pentahydrtae, equivalent to 10 mg/mL folinic acid)
50 mg/5mL
Concentrate for injection
Active: Calcium folinate pentahydrate 10.8 mg/mL (as 12.71 mg/mL of calcium folinate pentahydrate, equivalent to 10 mg/mL folinic acid) Excipient: Hydrochloric acid Nitrogen Sodium chloride Sodium hydroxide Water for injection
Prescription
Merck & Cie
As rescue therapy to reduce toxicity following high-dose methotrexate therapy. Has shown good results in the treatment of certain megaloblastic anaemias resulting from folic acid deficiency. This mainly occurs in infants, during pregnancy, in malabsorption syndromes, liver diseases, sprue and malnutrition. It is not more effective than folic acid for these conditions Overdosage of methotrexate and in impaired methotrexate elimination Reducing the toxicity and circumventing the effect of folic acid antagonists
Package - Contents - Shelf Life: Vial, glass, - 5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2016-08-04
Calcium Folinate Sandoz Calcium Folinate Sandoz _CMI_v4_Mar_2023 Page 1 of 3 CALCIUM FOLINATE SANDOZ CONSUMER MEDICINE INFORMATION LEAFLET _Calcium Folinate Sandoz _ _folinic acid (as calcium folinate) _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Calcium Folinate Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist All medicines have risks and benefits . Your doctor has weighed the risks of you taking Calcium Folinate Sandoz against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT CALCIUM FOLINATE SANDOZ IS USED FOR Calcium Folinate Sandoz contains folinic acid (as calcium folinate). It is used in two main situations: 1. When your body does not have enough folic acid. This occurs in conditions such as megaloblastic anaemia, where the level of red blood cells and iron in the blood is too low. Megaloblastic anaemia can happen during pregnancy or infancy, or due to liver disease, malnutrition, or a reduced ability to absorb folic acid from the diet. 2. As an antidote or “rescue” therapy to reduce the toxic side effects of some medications such as methotrexate. Calcium Folinate Sandoz may be used for the management of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed Calcium Folinate Sandoz. _ _ Calcium Folinate Sandoz is not addictive ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU . BEFORE YOU ARE GIVEN CALCIUM FOLINATE SANDOZ _When you must not be given _ _it _ _ _ YOU MUST NOT BE GIVEN CALCIUM FOLINATE SANDOZ IF YOU HAVE OR HAVE HAD AN ALLERGY TO CALCIUM FOLINATE SANDOZ, FOLIC ACID, OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to Calcium Folinate Sandoz may include: • shortness of b Llegiu el document complet
230320-calcium folinate sandoz-ds Page 1 of 11 NEW ZEALAND DATA SHEET CALCIUM FOLINATE SANDOZ (FOLINIC ACID) 10 MG/ML 1. PRODUCT NAME Calcium Folinate Sandoz 10 mg/mL; concentrate for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Calcium Folinate Sandoz, concentrate for injection contains 10 mg folinic acid (as calcium folinate 10.8 mg/mL). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Concentrate for injection 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS • As rescue therapy to reduce toxicity following high-dose methotrexate therapy. • Has shown good results in the treatment of certain megaloblastic anaemias resulting from folic acid deficiency. This mainly occurs in infants, during pregnancy, in malabsorption syndromes, liver diseases, sprue and malnutrition. It is not more effective than folic acid for these conditions • Overdosage of methotrexate and in impaired methotrexate elimination • Reducing the toxicity and circumventing the effect of folic acid antagonists. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSE IS EXPRESSED IN UNITS OF MG OF FOLINIC ACID. ( _as Calcium folinate potency is usually _ _expressed in terms of equivalent units of folinic acid._ ) Calcium Folinate Sandoz may be administered by the intramuscular or intravenous route. Calcium Folinate Sandoz should not be administered intrathecally. When required for intravenous infusion, folinic acid may be diluted with either glucose 5% intravenous infusion or sodium chloride 0.9% intravenous infusion to give a final concentration of 0.05 to 0.4 mg/mL. Further diluted solutions of folinic acid in glucose 5% intravenous infusion and sodium chloride 0.9% intravenous infusion are stable for 24 hours when stored between 2ºC to 8ºC. To avoid microbial contamination hazards, infusion should be commenced as soon as practicable after preparation. In the treatment of accidental overdose of folic acid antagonists e.g. methotrexate, folinic acid should be given as soon as possibl Llegiu el document complet