CALCIUM GLUCONATE - FRESENIUS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CALCIUM GLUCONATE

Available from:

MEDIC TRIM HEALTHCARE LTD

ATC code:

A12AA03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

CALCIUM GLUCONATE 902.5 MG / 10 ML

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

FRESENIUS KABI MANUFACTURING SA (PTY) LTD, SOUTH AFRICA

Therapeutic group:

CALCIUM GLUCONATE

Therapeutic area:

CALCIUM GLUCONATE

Therapeutic indications:

All conditions where injectable calcium supplement is indicated.

Authorization date:

2012-08-31

Summary of Product characteristics

ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
ךיראתב
:
_08/2012_
Physician's Package Insert
CALCIUM GLUCONATE-FRESENIUS INJECTION
For administration
I.V or I.M
COMPOSITION
Each 10 ml ampoule contains 902.5 mg Calcium gluconate.
Stabilized with 47.5 mg Calcium saccharate.
PHARMACOLOGICAL ACTION
Calcium is essential to body metabolism and must be supplemented when
deficient owing to disease states or other conditions.
INDICATIONS
All conditions where injectable calcium supplement is indicated.
Calcium gluconate is the preferred form for injection.
CONTRA-INDICATIONS
Calcium salts are contra-indicated in patients with ventricular
fibrillation,
hypercalcaemia, or hypercalciuria (hypertiroidism, vitamin D
overdosage,
decalcifying tumours such as plasmacytoma and skeletal metastases),
nephrocalcinosis, sarcoidosis, milk- alkali syndrome,
hyper-coagulability of
blood.
Intravenous
administration
of
calcium
is
contraindicated
when
serum calcium levels are above normal.
Should not be given concurrently with digitalis therapy.
Contra-
Indicated
in
severe
renal
disease;
calcium
loss
due
to
immobilization, osteoporosis.
PRECAUSIONS:
Supersaturated solutions are prone to precipitation. If precipitation
is evident
in syringes, do not use syringe. Precipitation if present in vials and
ampoules may be dissolved by heating to 80ºC in a dry heat oven for a
minimum of one hour. Shake vigorously. Allow to cool to room
temperature
before dispensing. The solution should not be used if precipitate
remains in
vials and ampoules after following the above procedure. To avoid
undesirable reactions that may follow rapid intravenous administration
of
calcium gluconate, the drug should be given slowly, e.g. approximately
1.5
ml over a period of 1 minute. When injected intravenously, calcium
gluconate should be injected through a small needle into a large vein
in
order to avoid too rapid increase in serum calcium and extravasation
of
calcium solution into the surrounding tissue with re