PHEBRA CALCIUM GLUCONATE 953mg/10mL Injection vial

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

calcium gluconate monohydrate, Quantity: 95.3 mg/mL

Tersedia dari:

Phebra Pty Ltd

Bentuk farmasi:

Injection, solution

Komposisi:

Excipient Ingredients: calcium saccharate; water for injections

Rute administrasi :

Intravenous

Unit dalam paket:

10 mL x 10

Jenis Resep:

Not scheduled. Not considered by committee

Indikasi Terapi:

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.

Ringkasan produk:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

1991-10-14

Selebaran informasi

Calcium Gluconate Injection
Page 1 of 3
_Version 05 _
CALCIUM GLUCONATE
INJECTION
CONTAINS 95 MG/ML CALCIUM GLUCONATE MONOHYDRATE AND 3.0 MG/ML CALCIUM
SACCHARATE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Calcium Gluconate
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 Gluconate
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
GLUCONATE INJECTION IS
USED FOR
Calcium gluconate is a calcium salt
used to treat or prevent a lack of
calcium in the body. Other reasons for
treatment with Calcium Gluconate
Injection are:
•
high potassium levels in the blood
•
an overdose of magnesium sulfate
i.e. Epsom salts
•
sudden severe stomach pain
•
during heart resuscitation to
strengthen the heart muscle.
This medicine works by increasing the
level of calcium in the blood or by
binding to excess potassium or
magnesium in the blood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
BEFORE YOU ARE GIVEN
CALCIUM GLUCONATE
INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN CALCIUM
GLUCONATE INJECTION IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing calcium
gluconate
•
any of the ingredients listed at the
end of this leaflet.
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
GLUCONATE INJECTION IF THE CALCIUM
LEVELS IN YOUR BLOOD OR URINE ARE
ABOVE NORMAL LEVELS.
Some conditions
that may cause high levels of calcium
are:

Karakteristik produk

PRODUCT INFORMATION
Australian Product Information- Calcium Gluconate Injection
Version 11
Page 1 of 10
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_.
Calcium Gluconate Injection is a solution containing 95.3 mg/mL
calcium gluconate and 3.0 mg/mL calcium
saccharate in water for injections BP. The calcium saccharate is a BP
approved stabiliser for the supersaturated
solution.
Each mL of the injection contains:
•
8.9 milligrams of calcium ions
•
equivalent to 0.22 millimoles of calcium ions
•
equivalent to 0.44 mEq of calcium ions.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Calcium Gluconate Injection is a viscous, supersaturated, colourless
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.
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 PRECIPITATE IS
PRESENT_.
Calcium gluconate is usually administered intravenously as a 10%
solution by slow in