DBL™ Calcium Gluconate

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Calcium gluconate monohydrate 100 mg/mL;  

Tersedia dari:

Pfizer New Zealand Limited

INN (Nama Internasional):

Calcium gluconate monohydrate 100 mg/mL

Dosis:

1000 mg/10mL

Bentuk farmasi:

Solution for injection

Komposisi:

Active: Calcium gluconate monohydrate 100 mg/mL   Excipient: Calcium saccharate Water for injection

Unit dalam paket:

Ampoule, glass, 5x10ml, 50 mL

Kelas:

General sale

Jenis Resep:

General sale

Diproduksi oleh:

AVEBE Glucona

Indikasi Terapi:

Parenteral administration of calcium gluconate is required in acute hypocalcaemia and hypocalcaemic tetany. It may be administered intravenously as an adjunct in the treatment of severe hyperkalaemia and as an aid in the treatment of depression due to overdose of magnesium sulphate (calcium is the antagonist of magnesium toxicity). Intravenous injections of calcium have been used in the treatment of acute renal, biliary and intestinal colic. Calcium has been used as an inotrope in cardiac resuscitation. Calcium salts may also be used in the prevention of hypocalcaema in exchange transfusions and in long term electrolyte replacement therapy.

Ringkasan produk:

Package - Contents - Shelf Life: Ampoule, glass, 5x10ml - 50 mL - 36 months from date of manufacture stored at or below 30°C - Ampoule, glass, 10x10mL - 100 mL - 36 months from date of manufacture stored at or below 30°C

Tanggal Otorisasi:

1983-11-10

Karakteristik produk

Version 5.0
Page 1 of 9
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL™ Calcium Gluconate Injection BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL
™
Calcium Gluconate Injection BP contains in each 10 mL, Calcium
Gluconate BP 953
mg and Calcium Saccharate U.S.P. 30 mg. Each mL of the injection
contains 0.22 mmol
(0.45 mEq), equivalent to 8.9 mg of calcium ions.
DBL
™
Calcium Gluconate Injection BP contains aluminium which is leached
from the glass
ampoules the product is packaged in. Aluminium levels of up to 6.1 ppm
have been reported
for similar products.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL™ Calcium Gluconate Injection BP is a clear, colourless solution
.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Parenteral administration of calcium gluconate is required in acute
hypocalcaemia and
hypocalcaemic tetany.
It may be administered intravenously as an adjunct in the treatment of
severe hyperkalaemia
and as an aid in the treatment of depression due to overdosage of
magnesium sulphate
(calcium is the antagonist of magnesium toxicity).
Intravenous injections of calcium have been used in the treatment of
acute renal, biliary and
intestinal colic.
Calcium has been used as an inotrope in cardiac resuscitation.
Calcium salts may also be used for the prevention of hypocalcaemia in
exchange transfusions
and in long term electrolyte replacement therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Calcium gluconate is usually administered intravenously as a 10%
solution, by slow direct
Version 5.0
Page 2 of 9
intravenous
injection,
or
by
continuous
or
intermittent
intravenous
infusion.
Various
maximum rates of administration have been recommended for direct
intravenous injection,
including 2 mL/min, 1.5 to 3 mL/min, and 5 mL/min. By intermittent
infusion, a maximum
rate of 2 mL/min (0.9 mEq of calcium ions/min) is suggested. During
I.V. administration of
calcium, close monitoring of serum calcium levels is essential.
Calcium gluconate has also b