Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) 
6.2 incompatibilities:
Leucovorin 50mg should not be mixed with other medicinal products, unless compatibility has satisfactory been shown.

Incompatibilities were reported between injectable forms of calcium folinate and injectable forms of droperidol, fluorouracil, foscarnet and methotrexate,

Droperidol
1. Droperidol 1.25mg/0.5ml and calcium folinate 5mg/0.5ml, immediate deposit with direct mixing in syringe for 5 minutes at 250C, followed by 8 minutes of centrifuging.
2. Droperidol 2.5mg/0.5ml with calcium folinate 10mg/0.5ml, immediate deposit if the products are injected sequentially in a Y-form site without flushing the Y-branch between injections.

Fluorouracil
Calcium folinate may not be mixed in the same infusion with 5-fluorouracil because a deposit can occur.
Fluorouracil 50mg/ml and calcium folinate 20mg/ml, with or without dextrose 5% in water, appear incompatible with mixing with different quantities and stored at 40C, 230C or 320C in containers in polyvinyl chloride.
Leucovorin Lyophilized Powder for Solution for Injection,   25. 3. 2015, RH Foscarnet
Foscarnet 24mg/ml and calcium folinate 20mg/ml: formation of a yellow cloudy solution has been reported.

6.3 Shelf life after the first opening of the bottle (vial)
Only for single administration. Any unused portion of the reconstituted solution must be discarded immediately after the first use.

The reconstituted product with water for injections is physical-chemically stable for 24 hours at 15-250C.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Shelf life after dilution according to directions
After dilution according to the directions with the recommended infusion fluids, 0.9% NaCl solution or 5% Glucose solution, the physical-chemical in use stability of the diluted solution has been shown for 72 hours at 15-250C.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Normally the term in the last case is no longer than 24 hours at 2-80C, unless dilution took place under controlled and validated aseptical conditions.

6.4 Special precautions for storage

Store below 25°C. Protect from light (Keep in original container). Do not refrigerate.
6.5 Nature and contents of container

Clear glass injection bottles (vials) provided with bromobutyl rubber stopper, with an aluminium seal provided with a polypropylene disc.

Leucovorin powder for solution for injection contains calcium folinate equivalent to 50 mg of folinic acid.

Leucovorin powder for solution for injection is packed in a vials of 13.5 ml in packs of 1 or 50 vials.

Not all mentioned package sizes are marketed.
6.6 instructions for use and handling
Leucovorin 50mg should be dissolved by adding 12 to 50 ml of sterile water for injections to a concentration of 10mg folinic acid per ml. Further dilution with 0.9% NaCl solution to a concentration of 0.5mg of folinic acid per ml is possible.


Leucovorin Lyophilized Powder for Solution for Injection,   25. 3. 2015, RH 

7. DRUG REGISTRATION No.:
032 59 22206 05