BAXTER POTASSIUM CHLORIDE 40 mmol and 0.9% SODIUM CHLORIDE 1000 mL intravenous infusion bag

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

potassium chloride, Quantity: 2.98 g/L; sodium chloride, Quantity: 9 g/L

Inapatikana kutoka:

Baxter Healthcare Pty Ltd

INN (Jina la Kimataifa):

potassium chloride,sodium chloride

Dawa fomu:

Injection, intravenous infusion

Tungo:

Excipient Ingredients: water for injections; hydrochloric acid

Njia ya uendeshaji:

Intravenous

Vitengo katika mfuko:

1000 mL bag

Dawa ya aina:

Not scheduled. Not considered by committee

Matibabu dalili:

The Baxter Potassium Chloride and Sodium Chloride Intravenous Infusion is indicated as a source of water and to restore electrolyte balance as required by the patient's clinical condition, such as hypokalaemia.

Bidhaa muhtasari:

Visual Identification: Clear colourless solution; Container Type: Bag; Container Material: PVC; Container Life Time: 12 Months; Container Temperature: Store below 30 degrees Celsius

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2015-09-30

Tabia za bidhaa

BAXTER POTASSIUM CHLORIDE & SODIUM CHLORIDE Intravenous Infusion
10 mmol/100 mL, 20 mmol/1000 mL, 30 mmol/1000 mL and 40 mmol/1000 mL
Version 1.2
1 of 14
AUSTRALIAN PRODUCT INFORMATION –
BAXTER POTASSIUM CHLORIDE AND SODIUM
CHLORIDE 10 MMOL/100 ML, 20 MMOL/1000 ML,
30 MMOL/1000 ML AND 40 MMOL/1000 ML (POTASSIUM
CHLORIDE, SODIUM CHLORIDE) INTRAVENOUS
INFUSION
1
NAME OF THE MEDICINE
Potassium chloride and sodium chloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baxter Potassium Chloride and Sodium Chloride Intravenous (IV)
Infusion is a sterile, non-
pyrogenic solution. The amounts of potassium chloride and sodium
chloride dissolved in Water
for Injections are shown in Table 1 below. Hydrochloric acid may be
added for pH adjustment.
They do not contain an antimicrobial agent or added buffer, and have a
pH of 4.0 - 7.0. The
products are isotonic solutions except for Potassium chloride 30 mmol
and 0.9% Sodium
chloride and Potassium chloride 40 mmol and 0.9% Sodium chloride,
these are hypertonic
solutions.
TABLE 1: BAXTER POTASSIUM CHLORIDE AND SODIUM CHLORIDE IV INFUSION
PREPARATIONS
CODE NO*
NAME OF THE ACTIVE COMPONENTS &
CONCENTRATIONS % (MMOL/CONTAINER)
OSMOLARITY
Α
(MOSMOL/L)
ARTG
PACK SIZE
(ML)
AHB6008
Potassium Chloride 0.75% (10) &
Sodium Chloride 0.29% (5)
300 (300)
159379
100 x 48
AHB1764
Potassium Chloride 0.15% (20) &
Sodium Chloride 0.9% (154)
348 (348)
19466
1000 x 12
AHB1274
Potassium Chloride 0.224% (30) &
Sodium Chloride 0.9% (154)
368 (368)
19470
1000 x 12
AHB6034
Potassium Chloride 0.298% (40) &
Sodium Chloride 0.9% (154)
388 (388)
225806
1000 x 1
α
Osmolarity
is a calculated figure; in dilute condition, osmolarity is
approximately the same as osmolality. The
figures in the brackets are osmolality (mOsmol/kg).
*
_Not all codes are marketed_
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Clear colourless solution for Intravenous Infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The Baxter Potassium Chloride and Sodium Chloride IV Infusion