BAXTER CARDIOPLEGIA SOLUTION A, 1000mL solution bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium chloride, Quantity: 6.43 g/L; potassium chloride, Quantity: 1.19 g/L; magnesium chloride hexahydrate, Quantity: 3.25 g/L; calcium chloride dihydrate, Quantity: 0.176 g/L

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

calcium chloride dihydrate,magnesium chloride hexahydrate,potassium chloride,Sodium chloride

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: water for injections; hydrochloric acid

Administration route:

Intracardial

Units in package:

1000mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

OTHER CONDITIONS: The pH of the Solution must be adjusted to 7.4 to 7. 8 with 10mL of Sodium Bicarbonate 8.4% w/v Injection BP (not supplied) BEFORE USE. INDICATIONS: Following pH adjustment with 10mL of Sodium Bicarbonate 8.4% w/v Injection BP, Cardioplegia "A" Solution is used in combination with ischaemia and hypothermia to induce cardiac arrest during open heart surgery and to preserve the myocardium during asystole.

Product summary:

Visual Identification: Clear, colourless solution.; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1996-07-10

Patient Information leaflet

CARDIOPLEGIA “A” SOLUTION FOR CARDIAC PERFUSION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
PAGE
What Cardioplegia “A” Solution is used for?
1
Before Cardioplegia “A” Solution is used on you
1
Using Cardioplegia “A” Solution
1
_When is Cardioplegia “A” Solution used? _
_ _
1
_Amount of Cardioplegia “A” Solution used _
_ _
1
_Inadequate Dosage _
_ _
1
_Overdosage _
_ _
1
Side Effects
2
What Cardioplegia “A” Solution looks like
2
Ingredients
2
Manufacturer
2
This leaflet does not contain all of the available information about
Cardioplegia “A” Solution. It does
not take the place of talking to your Doctor.
WHAT CARDIOPLEGIA “A” SOLUTION IS USED FOR
Cardioplegia “A” Solution is used in Open-Heart Surgery to stop
the heart and to protect the heart
muscle during your operation.
BEFORE CARDIOPLEGIA “A” SOLUTION IS USED ON YOU
1. Ask your Doctor about the risks and benefits of using Cardioplegia
“A” Solution while you are
pregnant.
2. Inform your Doctor if you are breast feeding.
It is not recommended to use Cardioplegia “A” Solution if you are
breast feeding. Your baby can
absorb Cardioplegia “A” Solution from breast milk if you are
breastfeeding.
USING CARDIOPLEGIA “A” SOLUTION
_When is Cardioplegia “A” Solution used? _
_ _
Cardioplegia “A” Solution is used, by your surgeon, during
Open-Heart surgery by pouring the
solution through your heart.
_Amount of Cardioplegia “A” Solution used: _
_ _
The volume of Cardioplegia “A” Solution used is dependent on your
weight, height and body surface
area. It is also dependent on the duration of the surgery and type of
Open-Heart surgery.
Cardioplegia “A” Solution may be re-introduced every 20-30 minutes
or sooner depending on the
temperature of your body (which must be between 15-20 degrees Celsius)
and whether your heart
starts to beat again during surgery.
_Inadequate Dosage: _
_ _
Inadequate dosage of Cardioplegia “A” Solution may result in
uneven cooling of your heart and may
not sto

Summary of Product characteristics

BAXTER CARDIOPLEGIA SOLUTION A
Version 1.1
1 of 7
AUSTRALIAN PRODUCT INFORMATION –
BAXTER CARDIOPLEGIA SOLUTION A
(SODIUM CHLORIDE, POTASSIUM CHLORIDE,
CALCIUM CHLORIDE DIHYDRATE,
MAGNESIUM CHLORIDE HEXAHYDRATE)
1
NAME OF THE MEDICINE
Sodium chloride, potassium chloride, calcium chloride dihydrate and
magnesium chloride
hexahydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baxter Cardioplegia Solution A is a sterile, non-pyrogenic solution in
a VIAFLEX bag. It is
used to induce cardiac stasis and to protect the myocardium during
open-heart surgery.
Baxter Cardioplegia Solution A is an isotonic crystalloid solution
based on extracellular fluid
ionic concentrations. Approximate osmolality is 275 mOsm/kg and
approximate pH is 3.7.
Each 1000 mL contains:
ACTIVE INGREDIENT
QUANTITY
Sodium chloride
6.43 g
Potassium chloride
1.19 g
Magnesium chloride hexahydrate
3.25 g
Calcium chloride dihydrate
176 mg
The mixture contains the following ions in 1000 mL:
Sodium
110 mmol
Chloride
160 mmol
Potassium
16 mmol
Magnesium
16 mmol
Calcium
1.2 mmol
For the full list of excipients, see section 6.1 List of Excipients.
BAXTER CARDIOPLEGIA SOLUTION A REQUIRES THE ASEPTIC ADDITION OF 10 ML OF SODIUM BICARBONATE
8.4% W/V INJECTION PRIOR TO USE TO ADJUST THE PH TO 7.4 - 7.8.
FOLLOWING PH ADJUSTMENT THE TOTAL
SODIUM IONIC CONCENTRATION IS 120 MMOL/L.
3
PHARMACEUTICAL FORM
Sterile aqueous solution (for cardiac perfusion).
BAXTER CARDIOPLEGIA SOLUTION A
Version 1.1
2 of 7
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Following pH adjustment with 10 mL of Sodium Bicarbonate 8.4% w/v
Injection, Baxter
Cardioplegia Solution A is used in combination with ischaemia and
hypothermia to induce
cardiac arrest during open heart surgery and to preserve the
myocardium during asystole.
4.2
DOSE AND METHOD OF ADMINISTRATION
It is important that an appropriate dose of Baxter Cardioplegia
Solution A is used to ensure that
all areas of the myocardium are cooled evenly, especially those areas
distal to arterial
obstruction in patients with coronary