PLASMA-LYTE 148 (approx. pH 7.4) 500mL injection bag AHB2543

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium gluconate, Quantity: 5.02 g/L; sodium acetate, Quantity: 3.68 g/L; sodium chloride, Quantity: 5.26 g/L; magnesium chloride hexahydrate, Quantity: 300 mg/L; potassium chloride, Quantity: 370 mg/L

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

magnesium chloride hexahydrate,potassium chloride,sodium acetate,sodium chloride,Sodium gluconate

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium hydroxide; water for injections

Administration route:

Intravenous

Units in package:

500mL x 1, 500mL x 1 (E)

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

PLASMA-LYTE 148 (approx. pH 7.4) IV Infusion is indicated as a source of water and electrolytes or as an alkalinising agent.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Bag; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-12-11

Patient Information leaflet

_________________________________________________________________________
_______
Baxter, Plasma-Lyte 148 (approx. pH 7.4) CMI, December 2014 Page 1 of
3
PLASMA-LYTE 148 (APPROX. PH 7.4) IV INFUSION
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Plasma-Lyte 148 (approx.
pH 7.4) Infusion. It does not
contain all of the available
information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
using this medicine against
the benefit they expect it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it
again.
WHAT PLASMA-LYTE 148
(APPROX. PH 7.4) INFUSION IS
USED FOR
Plasma-Lyte 148 (approx.
pH 7.4) Infusion is a clear
sterile solution used as a
source of water and
electrolytes (salts).
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 START
PLASMA-LYTE 148 (APPROX.
PH 7.4) INFUSION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
PLASMA-LYTE 148 (APPROX.
PH 7.4) INFUSION MUST NOT
BE GIVEN TO YOU IF:
-
you have an allergy to any
ingredients contained in
this product (listed at the
end of this leaflet).
Some of the symptoms of
an allergic reaction may
include: rash, itching or
hives on the skin; swelling
of the face, lips, tongue or
other parts of the body;
shortness of breath,
wheezing or trouble
breathing.
-
the expiry date printed on
the bag container has
passed; the bag container
is damaged in any way; or
the solution is not clear.
YOU MUST TELL YOUR DOCTOR
IF YOU HAVE ANY OF THE
FOLLOWING MEDICAL
CONDITIONS:

metabolic acidosis, or
metabolic/respiratory
alkalosis (abnormal blood
pH)

heart, kidney and/or liver
disorders

conditions that may cause
retention of fluid or sodium
in the body and oedema
(build up of fluid under the
skin, particularly around
the ankl

Summary of Product characteristics

PLASMA-LYTE 148 (APPROX PH 7.4) INTRAVENOUS INFUSION
Version 1.1
1 of 12
AUSTRALIAN PRODUCT INFORMATION –
PLASMA-LYTE 148 (APPROX PH 7.4) (SODIUM CHLORIDE,
SODIUM GLUCONATE, SODIUM ACETATE TRIHYDRATE,
POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE
HEXAHYDRATE)
INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Sodium
chloride,
sodium
gluconate,
sodium
acetate
trihydrate,
potassium
chloride
and
magnesium chloride hexahydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plasma-Lyte 148 (approx pH 7.4) Intravenous (IV) Infusion is a
sterile, clear, nonpyrogenic
isotonic solution in a single dose container for intravenous
administration. It contains no
antimicrobial agents. The approximate osmolality is 271 mOsm/kg. An
injection with an
osmolality
within
the
range
of
250
to
350
mOsm/kg
is
considered
to
be
isotonic.
Administration of substantially hypertonic solutions may cause vein
damage.
Each 1000 mL of Plasma-Lyte 148 (approx pH 7.4) IV Infusion contains:
ACTIVE INGREDIENT
Sodium chloride
5.26 g
Sodium gluconate
5.02 g
Sodium acetate trihydrate
3.68 g
Potassium chloride
370 mg
Magnesium chloride hexahydrate
300 mg
EXCIPIENT
Sodium hydroxide
pH adjustment
Water for Injections
q.s. to 1000 mL
SOLUTION PROPERTIES
pH range
6.5-8.0
Approximate Osmolality
271 mOsm/kg
Approximate kilojoules
66 kJ
Plasma-Lyte 148 (approx pH 7.4) IV Infusion when administered
intravenously is a source of
water, electrolytes, and calories.
Each 1000 mL of Plasma-Lyte 148 (approx pH 7.4) IV Infusion has ionic
concentration of:
•
Sodium
140 mmol
•
Potassium
5 mmol
•
Magnesium
1.5 mmol
•
Chloride
98 mmol
•
Acetate
27 mmol
•
Gluconate
23 mmol
PLASMA-LYTE 148 (APPROX PH 7.4) INTRAVENOUS INFUSION
Version 1.1
2 of 12
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for intravenous infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plasma-Lyte 148 (approx pH 7.4) IV Infusion is indicated as a source
of water and electrolytes
or as an alkalinising agent.
4.2
DOSE AND METHOD OF ADMINISTRATION