Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Calcium-D-saccharate tetrahydrate
Water for injections


6.2   Incompatibilities
Calcium salts can form complexes with many drugs and this may result in a precipitate.
Calcium salts are incompatible with oxidising agents, citrates, soluble carbonates, bicarbonates, oxalates, phosphates, tartrates and sulphates.
Physical incompatibility has also been reported with amphotericin, cephalothin sodium, ceftriaxone (see section 4.4), cephazolin sodium, cephamandole nafate, novobiocin sodium, dobutamine hydrochloride, prochlorperazine and tetracyclines.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 or unless compatibility has been satisfactorily demonstrated.


6.3   Shelf life
Unopened
The expiry date of the product is indicated on the packaging materials.
After dilution
When diluted to 10mg/ml, according to directions, with the recommended infusion fluids (i.e. sodium chloride 9mg/ml (0.9%) solution for injection or 50mg/ml (5%) glucose solution for injection) physical in-use stability has been demonstrated for 48 hours at room temperature.
From a microbiological point of view, the diluted 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 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.


6.4   Special precautions for storage
Do not store above 25°C.
6.5    Nature and contents of container
10ml LDPE ampoules packed in cardboard box.
Pack size: 20 ampoules.
Not all pack sizes may be marketed.

6.6    Special precautions for disposal
Disposal
No special requirements for disposal.
Handling
The product is intended for single use only. Discard any unused solution.
The medicinal product should be visually inspected for particulate matter, discoloration and the integrity of the container prior to use.
The solution should only be used if it is clear, colourless to light brownish, practically free from visible particles and the container is undamaged.
Dilution
For intravenous infusion, Calcium Gluconate 10 % Injection B.P. may be diluted 1:10 to a concentration of 10mg/ml with the following two infusion fluids: sodium chloride 9mg/ml (0.9%) solution for injection or 50mg/ml (5%) glucose solution for injection. When diluted with these recommended infusion fluids, the resulting solutions are intended for immediate single use. Dilution should be performed under controlled and validated aseptic conditions. After mixing, the container should be gently agitated to ensure homogeneity.