Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for intravenous infusion 1000 mL Freeflex bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Buy It Now

Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

potassium chloride, Quantity: 0.3 g/L; magnesium chloride hexahydrate, Quantity: 0.3 g/L; sodium chloride, Quantity: 6.02 g/L; sodium acetate trihydrate, Quantity: 4.63 g/L

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

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

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

1000mL x 10 bags

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Ionolyte is indicated for:,- mild metabolic acidosis,- as a source of water and electrolytes

Product summary:

Visual Identification: Ionolyte solution for infusion is a clear and colourless solution.; Container Type: Bag; Container Material: Plastic; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-05-09

Patient Information leaflet

CMI for Ionolyte
Mar 2016
Filename: IonCMI210316-clean
Page 1 of 3
Change: Address Change + AAN
IONOLYTE
®
SODIUM
CHLORIDE,
SODIUM
ACETATE
TRIHYDRATE,
POTASSIUM
CHLORIDE
AND
MAGNESIUM
CHLORIDE HEXAHYDRATE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ionolyte. It does
not
contain
all
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 risk of you using this product
against the benefits they expect it
will have for you.
PLEASE READ THIS LEAFLET CAREFULLY.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST. KEEP THIS
LEAFLET. YOU MAY NEED TO READ IT
AGAIN.
WHAT IS IONOLYTE USED
FOR
Ionolyte is a sterile infusion solution
used
as
a
source
of
water
and
electrolytes (salts). It is also used
when there is an acid imbalance in
the body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED
FOR YOU.
Ionolyte is not addictive.
BEFORE
YOU
ARE
GIVEN
IONOLYTE
_ _
_WHEN _
_YOU _
_MUST _
_NOT _
_BE _
_GIVEN _
_IONOLYTE _
You
must
NOT
be
given
this
product if:

You have too much fluid in your
body and you have been told
that you have a condition known
as hyperhydration

You
have
been
told
that
you
have pulmonary edema where
too much fluid is in your lungs

You
have
been
told
that
you
have a congestive heart failure
(a condition in which your heart
cannot pump enough blood to
other organs of your body)

You
have
severely
impaired
kidney function

You have decreased acidity of
the blood caused by a metabolic
disorder

You have high potassium levels
in your blood

You are allergic (hypersensitive)
to any of the active and inactive
ingredients of this product
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN THIS MEDICINE,
TALK TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN IONOLYTE _
Your
doctor
may
need
to
take
special precautions and will decide
whether you can receive Ionolyte if:

You s

Read the complete document

Summary of Product characteristics

Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION IONOLYTE (SODIUM
CHLORIDE, SODIUM ACETATE TRIHYDRATE, POTASSIUM
CHLORIDE AND MAGNESIUM CHLORIDE HEXAHYDRATE)
1. NAME OF MEDICINE
Sodium
chloride,
sodium
acetate
trihydrate,
potassium
chloride
and
magnesium
chloride hexahydrate.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ionolyte solution for infusion is a clear and colourless solution.
1000 mL of Ionolyte solution for infusion contains:
Sodium chloride
6.02 g
Sodium acetate trihydrate
4.63 g
Potassium chloride
0.30 g
Magnesium chloride hexahydrate
0.30 g
Electrolytes per 1000 mL:
Sodium (Na
+
)
137 mmol
Potassium (K
+
)
4 mmol
Magnesium (Mg
2+
)
1.5 mmol
Chloride (Cl
-
)
110 mmol
Acetate (CH
3
COO
-
)
34 mmol
List of excipients:
Sodium hydroxide
pH adjustment
Hydrochloric acid
pH adjustment
Water for Injections
q.s. to 1000 mL
Osmolality:
approx. 265 mOsm/kg water
Titratable acidity:
< 2.5 mmol NaOH/L
pH:
6.9 to 7.9
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Solution for infusion.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ionolyte is indicated for:
-
mild metabolic acidosis
-
as a source of water and electrolytes
4.2 DOSE AND METHOD OF ADMINISTRATION
As directed by the physician. Dosage and rate of administration is
dependent on age,
weight
and
clinical
condition
of
the
patient
as
well
as
laboratory
determinations
(including acid-base balance) and the concomitant therapy.
Page 2 of 10
Product is for single use in one patient only. Discard any residue.
Contains no
antimicrobial preservatives. To be used immediately after the bag is
opened.
Parenteral medicine products should be inspected visually for
particulate matter and
discolouration prior to the administration whenever solution and
container permit.
All injections in FREE_flex_
®
bags are intended for intravenous administration using
sterile equipment.
SPECIAL HANDLING INSTRUCTIONS
BEFORE ADMINISTERING THE PRODUCT IN PLASTIC BAGS TO PATIENT, REVIEW
THESE DIRECTIONS:
FREE_FLEX_
® IV SOLUTION CONTAINER
(1)

Read the complete document