Phebra CALCIUM CHLORIDE DIHYDRATE 10% 1 g/10 mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcium chloride dihydrate, Quantity: 100 mg/mL

Available from:

Phebra Pty Ltd

INN (International Name):

calcium chloride dihydrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid

Administration route:

Intravenous

Units in package:

10

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Parental administration of calcium is indicated in the treatment of hypocalcaemia where 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.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2007-06-19

Patient Information leaflet

Calcium Chloride 10% Injection
Page 1 of 3
_Version 05 _
CALCIUM CHLORIDE
10% INJECTION
CONTAINS 1 G/10 ML CALCIUM CHLORIDE DIHYDRATE (10%)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Calcium Chloride
Injection. It does not contain all the
available information. It does not take
the place of talking to your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Calcium Chloride
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET
.
You may need to read it again.
WHAT CALCIUM CHLORIDE
10% INJECTION
IS USED
FOR
Calcium Chloride is a calcium salt
used primarily to treat or prevent
calcium deficiency. It is also used to
treat high levels of potassium in the
blood.
This medicine works by increasing the
level of calcium in the blood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CALCIUM
CHLORIDE INJECTION HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
BEFORE YOU ARE GIVEN
CALCIUM CHLORIDE 10%
INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN
CALCIUM
CHLORIDE INJECTION
IF YOU ARE ALLERGIC
TO CALCIUM CHLORIDE.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or
other parts of the body
•
rash, itching or hives on the skin.
YOU SHOULD NOT BE GIVEN CALCIUM
CHLORIDE INJECTION IF THE CALCIUM
LEVELS IN YOUR BLOOD OR URINE ARE
ABOVE NORMAL.
YOU SHOULD NOT BE GIVEN CALCIUM
CHLORIDE INJECTION IF YOU HAVE ANY OF
THE FOLLOWING MEDICAL CONDITIONS:
•
a dangerously fast heart beat
•
severe kidney disease or kidney
stones
•
sarcoidosis, a disease that causes
tiny lumps of cells in your body
.
CALCIUM CHLORIDE INJECTION MUST NOT
BE GIVEN TO INFANTS BY MOUTH, AS IT
MAY SEVERELY IRRITATE THEIR STOMACH.
YOU SHOULD NOT BE GIVEN CALCIUM
CHLORIDE INJECTION IF

Summary of Product characteristics

PRODUCT INFORMATION
Australian Product Information – Calcium Chloride 10% 1 g in 10 mL
Injection
Page 1 of 8
Version 11
CALCIUM CHLORIDE 10%
(CALCIUM CHLORIDE DIHYDRATE) 1G IN 10ML INJECTION
1
NAME OF THE MEDICINE
Calcium chloride dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Chloride 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
Calcium Chloride Injection is a clear, colourless sterile solution of
calcium chloride dihydrate in Water for Injections
BP with a pH of between 5 and 8.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
Calcium Chloride 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 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 to 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