PHEBRA CALCIUM GLUCONATE 931 mg/10 mL injection vial

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

calcium gluconate monohydrate, Quantity: 931 mg

Disponibbli minn:

Phebra Pty Ltd

Għamla farmaċewtika:

Injection, solution

Kompożizzjoni:

Excipient Ingredients: calcium saccharate; water for injections

Rotta amministrattiva:

Intravenous

Unitajiet fil-pakkett:

10 mL x 10

Tip ta 'preskrizzjoni:

Not scheduled. Not considered by committee

Indikazzjonijiet terapewtiċi:

Calcium gluconate is a calcium salt used primarily for the prevention and treatment of calcium deficiency. Parenteral administation of calcium gluconate is needed in acute hypocalcaemia and hypocalcsemic tetany. It can be given intravenously in the treatment of severe hyper-kalaemia and in overdosage of magnesium sulphate, as calcium is the antagonist of magnesium toxicity. IV injections have been used in the treatment of acute renal biliary and intestinal colic. Calcium has been used as an inotrope in cardiac resuscitation. They may also be used for the prevention of hypocalcaemia in exchange transfusions, and in long term electrolyte replacement therapy.

Sommarju tal-prodott:

Visual Identification: A clear and colourless, particle free solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2021-05-13

Fuljett ta 'informazzjoni

Calcium Gluconate Injection
V06
1
CALCIUM GLUCONATE INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CALCIUM GLUCONATE INJECTION?
Calcium Gluconate Injection contains the active ingredient calcium
gluconate monohydrate. Calcium Gluconate Injection is
used to treat or prevent a lack of calcium in the body. Other reasons
for treatment are high blood potassium levels,
magnesium sulfate overdose (i.e. Epsom salts), sudden severe stomach
pain and during heart resuscitation to strengthen the
heart muscles.
For more information, see Section 1. Why am I using Calcium Gluconate
Injection?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CALCIUM GLUCONATE INJECTION?
Do not use if you have ever had an allergic reaction to calcium
gluconate monohydrate or any of the ingredients listed at the
end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Calcium Gluconate Injection?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Calcium Gluconate Injection and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE CALCIUM GLUCONATE INJECTION?
•
Calcium Gluconate Injection must only be given by a doctor or nurse
and warmed to body temperature before use.
•
Calcium Gluconate Injection is usually given as a slow injection or
infusion into a vein.
More instructions can be found in Section 4. How do I use Calcium
Gluconate Injection?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CALCIUM GLUCONATE INJECTION?
THINGS YOU
SHOULD DO
•
If you become pregnant while being given Calcium Gluconate Injection,
tell your doctor immediately.
•
Remind any doctor, dentist, pharmacist or nurs

Karatteristiċi tal-prodott

PRODUCT INFORMATION
Australian Product Information – Calcium Gluconate Injection
Page 1 of 12
Version 1
CALCIUM GLUCONATE
(CALCIUM GLUCONATE MONOHYDRATE)
INJECTION
1
NAME OF THE MEDICINE
Calcium Gluconate monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_CALCIUM GLUCONATE IS A SUPERSATURATED SOLUTION. SUPERSATURATED
SOLUTIONS ARE PRONE TO PRECIPITATION. _
_EXAMINE THE VIAL AND DO NOT USE IF A PRECIPITATE IS PRESENT_.
The 10 mL injection is a solution containing 931 mg calcium gluconate
and 46 mg calcium saccharate in water for
injections. The calcium saccharate is a BP approved stabiliser for the
supersaturated solution.
Each 10 mL of the injection contains:
•
89 milligrams of calcium ions
•
equivalent to 2.2 millimoles of calcium ions
•
equivalent to 4.4 mEq of calcium ions.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
The injection is a clear and colourless, particle free solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Calcium gluconate is a calcium salt used primarily for the prevention
and treatment of calcium deficiency.
Parenteral administration of calcium gluconate is needed in acute
hypocalcaemia and hypocalcaemic tetany. It can
be given intravenously in the treatment of severe hyperkalaemia and in
overdosage of magnesium sulphate, as
calcium is the antagonist of magnesium toxicity. Intravenous
injections have been used in the treatment of acute
renal, biliary and intestinal colic. Calcium has been used as an
inotrope in cardiac resuscitation. They may also be
used for the prevention of hypocalcaemia in exchange transfusions, and
in long term electrolyte replacement
therapy.
PRODUCT INFORMATION
CALCIUM GLUCONATE INJECTION
Australian Product Information – Calcium Gluconate Injection
Page 2 of 12
Version 1
4.2
D
OSE AND METHOD OF ADMINISTRATION
_CALCIUM _
_GLUCONATE _
_INJECTION _
_IS _
_A _
_SUPERSATURATED _
_SOLUTION. _
_SUPERSATURATED _
_SOLUTIONS _
_ARE _
_PRONE _
_TO _
_PRECIPITATION. EXAMINE THE VIAL AND DO NOT USE IF A PRECIP