Plasma-Lyte 56 in 5% glucose 1000mL injection bag AHB2574

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

potassium acetate, Quantity: 1.28 g/L; sodium chloride, Quantity: 2.34 g/L; magnesium acetate tetrahydrate, Quantity: 320 mg/L; glucose, Quantity: 50 g/L

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: water for injections; hydrochloric acid

Administration route:

Intravenous

Units in package:

1000mL x 12

Class:

Medicine Registered

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Plasma-Lyte 56 and 5% Glucose IV Infusion is indicated as a source of water, electrolytes and calories or as an alkalinising agent. PLASMA-LYTE 56 in 5% Glucose 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:

1991-09-30

Patient Information leaflet

PLASMA-LYTE 56 AND
5% GLUCOSE IV INFUSION
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Plasma-Lyte 56 and 5%
Glucose Infusion. It does not
contain all of the available
information. It does not take
the place of talking to your
doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
using this product against the
benefit they expect it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR,
NURSE OR PHARMACIST.
WHAT PLASMA-LYTE 56 AND
5% GLUCOSE INFUSION IS
USED FOR
Plasma-Lyte 56 and 5%
Glucose Infusion is a solution
used as a source of water,
electrolytes (salts) and
calories.
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 56 AND 5% GLUCOSE
INFUSION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
PLASMA-LYTE 56 AND 5%
GLUCOSE INFUSION MUST NOT
BE GIVEN TO YOU IF:
•
you have an allergy to any
ingredient listed at the end
of this leaflet;
•
you have had an allergic
reaction to corn or corn
products. Some of the
symptoms of an allergic
reaction may include skin
rash, peeling of the skin
and swelling of the face,
lips or tongue, causing
difficulty swallowing or
shortness of breath;
•
the expiry date printed on
the pack has passed.
YOU MUST TELL YOUR DOCTOR IF
YOU HAVE OR HAVE HAD ANY
OF THE FOLLOWING MEDICAL
CONDITIONS:
•
heart disease;
•
respiratory failure (lung
disease);
•
severe kidney disease;
•
high blood pressure
(hypertension);
•
build up of fluid under the
skin, particularly around
the ankles (peripheral
oedema);
•
build up of fluid in the
lungs (pulmonary
oedema);
•
high blood pressure during
pregnancy (pre-eclampsia
or eclampsia)
•
aldosteronism (a disease
that causes high levels of
hormone called
aldosterone);
•
any other condition
associated with retaining
sodium or fluid, such as
treatment with steroids;
•
d

Summary of Product characteristics

PLASMA-LYTE 56 & 5% GLUCOSE Intravenous Infusion
Version 1.1
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AUSTRALIAN PRODUCT INFORMATION –
PLASMA-LYTE 56 AND 5% GLUCOSE (SODIUM
CHLORIDE, POTASSIUM ACETATE, MAGNESIUM
ACETATE TETRAHYDRATE, GLUCOSE) INTRAVENOUS
INFUSION
1
NAME OF THE MEDICINE
Sodium chloride, potassium acetate, magnesium acetate tetrahydrate and
glucose.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plasma-Lyte 56 and 5% Glucose Intravenous (IV) Infusion is a sterile,
clear, non-pyrogenic
hypertonic solution in a single dose container for intravenous
administration. It contains no
antimicrobial agents. The approximate osmolality is 401 mOsm/kg. An
injection with an
osmolality within the range of 250 to 350 mOsm/kg is considered to be
isotonic. Plasma-Lyte
56 and 5% Glucose IV Infusion is a hypertonic solution. Administration
of substantially
hypertonic solutions may cause vein damage.
Each 1000 mL of Plasma-Lyte 56 and 5% Glucose IV Infusion contains:
ACTIVE INGREDIENT
Sodium chloride
2.34 g
Potassium acetate
1.28 g
Magnesium acetate tetrahydrate
320 mg
Glucose
50 g
EXCIPIENT
Hydrochloric acid
pH adjustment
Water for Injections
q.s. to 1000 mL
SOLUTION PROPERTIES
pH range
3.5-6.0
Approximate Osmolality
401
mOsm/kg
Approximate kilojoules
835 kJ
Each 1000 mL of Plasma-Lyte 56 and 5% Glucose IV Infusion has ionic
concentration of:
•
Sodium
40 mmol
•
Potassium
13 mmol
•
Magnesium
1.5 mmol
•
Chloride
40 mmol
•
Acetate
16 mmol
•
Glucose
278 mmol
For the full list of excipients, see Section 6.1 List of Excipients.
PLASMA-LYTE 56 & 5% GLUCOSE Intravenous Infusion
Version 1.1
2 of 13
3
PHARMACEUTICAL FORM
Solution for Intravenous Infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plasma-Lyte 56 and 5% Glucose IV Infusion is indicated as a source of
water, electrolytes and
calories or as an alkalinising agent.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
As directed by the physician. Dosage, rate and duration of
administration are to be
individualised and depend upon the indication for use, the patient’s
age, weight, clini