BAXTER RINGERS SOLUTION injection 1000mL AHB2304

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium chloride, Quantity: 8.6 g/L; calcium chloride dihydrate, Quantity: 330 mg/L; potassium chloride, Quantity: 300 mg/L

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid

Administration route:

Intravenous

Units in package:

1000mL x 12

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

For restoring the loss of water and electrolytes as required by the clinical condition of the patient.

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

CMI
BAXTER
Page 1 of 2
RINGER’S SOLUTION INTRAVENOUS INFUSION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
RINGER’S SOLUTION IV
INFUSION. It does not
contain all of the available
information. All medicines
have risks and benefits.
Your doctor has weighed
the risks of you using
Ringer’s Solution IV
Infusion against the
benefit they expect it will
have for you.
It does not take the place of
talking to your doctor or
pharmacist.
If you have any concerns
about taking this medicine,
ask your doctor or
pharmacist.
WHAT RINGER’S
SOLUTION IV INFUSION IS
USED FOR
This medicine is used to
replace and balance body
fluid and mineral salts.
BEFORE YOU ARE GIVEN
RINGER’S SOLUTION IV
INFUSION
_THE RINGER’S SOLUTION IV _
_INFUSION SHOULD NOT BE _
_GIVEN TO YOU IF: _

you have an allergy
to any ingredient
listed at the end of
this leaflet;

you have fluid
overload or are
overhydrated;

you have swelling and
ascitic cirrhosis
(abnormal accumulation
of fluid in the abdomen
due to liver disease);

you have heart
failure;

you have serious
kidney problems
where you are
passing little or
no urine;

you have too
much potassium,
sodium, calcium
or chlorides in
your blood that is
not being
corrected with
medication;

you are taking digitalis
(a heart medication);

the expiry date printed
on the pack is overdue.
_YOU MUST TELL YOUR DOCTOR _
_IF YOU:_

have heart problem;

have kidney problems
including kidney stones
;

are taking any other
medicine including
those you can buy
without a prescription,
in particular medicines
for high blood
pressure (diuretics,
ACE inhibitors or
ARAs),
immunosuppressant
medicines (tacrolimus
or cyclosporin),
carbenoxolone,
corticosteroids or
vitamin D

are pregnant and have
‘preeclampsia’ (a
serious condition in
pregnancy that causes
high blood pressure)
HOW RINGER’S
SOLUTION IV INFUSION IS
GIVEN
_HOW MUCH IT IS GIVEN:_
Your doctor will decide how
much Ringer’s Solution IV
Infusion will be given

Summary of Product characteristics

BAXTER RINGER’S SOLUTION FOR INTRAVENOUS INFUSION
Version 1.1
1 of 11
AUSTRALIAN PRODUCT INFORMATION – BAXTER RINGER’S
SOLUTION (SODIUM CHLORIDE, POTASSIUM CHLORIDE
AND CALCIUM CHLORIDE DIHYDRATE) INJECTION FOR
INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Sodium chloride, potassium chloride and calcium chloride dihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in Baxter Ringer’s Solution for Intravenous
(IV) Infusion (Ringer’s
Solution) comprise sodium chloride (8.6 g/L), potassium chloride (0.3
g/L) and calcium
chloride dihydrate (0.33 g/L) in Water for Injections.
Baxter Ringer’s Solution is sterile and non-pyrogenic. There is no
antimicrobial agent or buffer
added. It is an isotonic intravenous solution with pH of 5.0 – 7.5
and an osmolality of
308 mOsm/kg.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Baxter Ringer’s Solution is a clear colourless solution for
Intravenous Infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baxter Ringer’s Solution is indicated for restoring the loss of
water and electrolytes as required
by the clinical condition of the patient.
4.2
DOSE AND METHOD OF ADMINISTRATION
Baxter Ringer’s Solution is for intravenous infusion as directed by
the physician. The dosage,
volume, rate and duration of administration of Baxter Ringer’s
Solution is dependent upon the
age, weight, clinical conditions of the patient and concomitant
therapy, and administration
should be determined by a physician experienced in intravenous fluid
therapy.
Fluid
balance
and
plasma
electrolyte
concentrations
(sodium,
potassium,
calcium
and
chlorides) must be monitored during administration.
Parenteral drug products should be inspected visually for particulate
matter and discolouration
prior to administration whenever solution and container permit. Do not
administer unless the
solution is clear and seal is intact. Only sterile and nonpyrogenic
equipment must be used for
intravenous administration. As with all parenter