Calcium Chloride 10% (Phebra)

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Calcium chloride dihydrate 100 mg/mL; Calcium chloride dihydrate 100 mg/mL

Dostępny od:

AFT Pharmaceuticals Ltd

INN (International Nazwa):

Calcium chloride dihydrate 100 mg/mL

Dawkowanie:

1000 mg/10mL

Forma farmaceutyczna:

Solution for injection

Skład:

Active: Calcium chloride dihydrate 100 mg/mL Calcium chloride dihydrate 100 mg/mL Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Sztuk w opakowaniu:

Ampoule, glass, 10mL, 5 dose units

Klasa:

General sale

Typ recepty:

General sale

Wyprodukowano przez:

Merck KGaA

Wskazania:

Parenteral administration of calcium is indicated in the treatment of hypocalcaemia where a rapid increase in plasma calcium is required, such as in hypocalcaemic tetany and tetany due to parathyroid deficiency.

Podsumowanie produktu:

Package - Contents - Shelf Life: Ampoule, glass, 10mL - 5 dose units - 60 months from date of manufacture stored at or below 25°C - Ampoule, glass, 10mL - 50 dose units - 60 months from date of manufacture stored at or below 25°C - Vial, glass, Type I. 10mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C

Data autoryzacji:

1986-07-31

Charakterystyka produktu

NEW ZEALAND DATA SHEET
1.
CALCIUM CHLORIDE 10% (INJECTION)
Calcium chloride dihydrate 1 g in 10 mL injection solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Chloride 10% injection is available in 10 mL vials containing
1 g calcium chloride dihydrate. Each
gram of calcium chloride dihydrate represents approximately 6.8 mmol
(13.6 mEq) calcium and
13.6 mmol (13.6 mEq) chloride ions. Each mL of the 10 mL vial contains
0.68 mmol (1.36 mEq) calcium.
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Injection, solution.
Calcium Chloride 10% injection is a clear, colourless, sterile
solution of calcium chloride dihydrate in
Water for Injections BP with a pH of between 5.0 and 8.0.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Parenteral administration of calcium is indicated in the treatment of
hypocalcaemia where a rapid
increase in plasma calcium is required, such as in hypocalcaemic
tetany and tetany due to parathyroid
deficiency.
Intravenous calcium is also indicated to antagonise the cardiotoxicity
of hyperkalaemia.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Calcium Chloride 10% injection should not be administered if the
solution is cloudy or contains particles.
After use, the unused portion of each vial must be discarded. The
injection should not be given via the
subcutaneous or intramuscular route. Use in one patient on one
occasion only and discard.
Each mL of Calcium Chloride 10% injection contains approximately 0.68
mmol of calcium ions and
1.36 mmol chloride ions.
To aid in converting: 1 g elemental calcium = 25 mmol elemental
calcium = 50 mEq elemental calcium
= 3.7 g calcium chloride.
Calcium chloride must be administered slowly via a small needle into a
large vein at a rate not exceeding
0.35 – 0.7 mmol (0.7 – 1.4 mEq) per minute to avoid venous damage
and to prevent a high concentration
of calcium reaching the heart and causing syncope. The injection
should be stopped if
the patient experiences pain or redness at the injection site as this
may