Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
calcium folinate hydrate, Quantity: 18.6 mg (Equivalent: calcium folinate hydrate, Qty 15 mg; Equivalent: folinic acid, Qty 15 mg)
Pfizer Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate
Oral
10
(S2) Pharmacy Medicine
Leucovorin Calcium 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.,Leucovorin Calcium has also shown good results in reducing the toxicity and circumventing the effect of folic acid antagonists, if therapeutically desired.
Visual Identification: Light yellow, round, flat, scored, uncoated tablet, engraved with CF.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-10-08
DBL™ Leucovorin Calcium 1 DBL™ LEUCOVORIN CALCIUM CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING DBL LEUCOVORIN CALCIUM? DBL Leucovirin Calcium Tablet contains the active ingredient calcium folinate hydrate and DBL Leucovorin Calcium Injection contains the active ingredient calcium folinate. It is a type of Vitamin B used to treat some types of anaemia when they occur during pregnancy and infancy or caused by liver disease, inadequate food intake or poor food absorption. It may also be used to treat the toxic effects of some medicines. For more information, see Section 1. Why am I using DBL Leucovorin Calcium? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DBL LEUCOVORIN CALCIUM? Do not use if you have ever had an allergic reaction to calcium folinate or any of the ingredients listed at the end of the CMI or if you have a type of anaemia caused by too little vitamin B12. Talk to your doctor if you have any other medical conditions, have problems with your kidneys or have diarrhoea; if you take any other medicines or are pregnant or plan to become pregnant or are breastfeeding. Discuss the need for any restrictions with food and drink with your doctor. For more information, see Section 2. What should I know before I use DBL Leucovorin Calcium? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DBL Leucovorin Calcium and affect how it works. It is especially important to tell your doctor if you are taking medicine to treat epilepsy. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE DBL LEUCOVORIN CALCIUM? Your doctor will decide what dose and how long you will receive DBL Leucovorin Calcium. This depends on the condition you are being treated for. More instructions can be found in Section 4. How do I use DBL Leucovorin Calcium? in the full CMI. 5. WHAT SHOULD I K Կարդացեք ամբողջական փաստաթուղթը
Version: pfpleutb10422 Supersedes: hhpleuvi10120 & pfpleutb11219 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION – DBL TM LEUCOVORIN CALCIUM (CALCIUM FOLINATE HYDRATE) TABLETS AND (CALCIUM FOLINATE) INJECTION 1. NAME OF THE MEDICINE Folinic acid (as calcium folinate hydrate) - tablets. Folinic acid (as calcium folinate) - injections. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TABLETS Each DBL Leucovorin Calcium Tablet contains 15 mg folinic acid (as calcium folinate hydrate). SOLUTION FOR INJECTIONS Each 2 mL DBL Leucovorin Calcium Injection 15 mg/2 mL contains 15 mg folinic acid (as calcium folinate). Each 5 mL DBL Leucovorin Calcium Injection 50 mg/5 mL contains 50 mg folinic acid (as calcium folinate). Each 30 mL DBL Leucovorin Calcium Injection 300 mg/30 mL contains 300 mg folinic acid (as calcium folinate). EXCIPIENTS WITH KNOWN EFFECTS TABLETS Contains sugars as lactose. Each DBL Leucovorin Calcium Tablet contains 141.4 mg of lactose monohydrate. SOLUTION FOR INJECTION DBL Leucovorin Calcium Injection 15 mg/2 mL contains 8.1 mg/mL of sodium chloride. DBL Leucovorin Calcium Injection 50 mg/5 mL and 300 mg/30 mL contains 8.5 mg/mL of sodium chloride. For the full list of excipients, see Section 6.1 List of excipients. Version: pfpleutb10422 Supersedes: hhpleuvi10120 & pfpleutb11219 Page 2 of 14 3. PHARMACEUTICAL FORM TABLETS DBL Leucovorin Calcium Tablets are light yellow, round, flat, scored, uncoated tablets, engraved with CF. SOLUTION FOR INJECTION DBL Leucovorin Calcium Injection is a clear straw-to pale yellow coloured sterile, isotonic solution free from visible particular matter. The solution does not contain a bactericide. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Folinic acid 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. Folinic acid has also shown g Կարդացեք ամբողջական փաստաթուղթը