WATER FOR INJECTIONS water for injections 10 mL ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

water for injections, Quantity: 10 mL

Available from:

Interpharma Pty Ltd

INN (International Name):

water for injections

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients:

Administration route:

Intravenous, Intramuscular, Subcutaneous

Units in package:

50 ampoules

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Water for Injections is used for the reconstitution and preparation of aqueous injections.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-07-16

Patient Information leaflet

WFI_CMI_V3.0
Page 1 of 1
WATER FOR INJECTIONS BP
Water for Injections 5mL, 10mL and 20mL ampoules
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet contains some
common questions about Water
for Injections.
It does not contain all the
available information. It does
not take the place of talking to
your doctor, nurse or
pharmacist.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT WATER FOR INJECTIONS
IS USED FOR
Water for Injections is sterile
water used to dilute or dissolve
drugs.
Carefully follow all directions
given to you by your doctor.
They may differ from the
information contained
in this leaflet.
BEFORE YOU ARE GIVEN
WATER FOR INJECTION
_WHEN YOU MUST NOT USE IT _
Water for Injections will only
be used if the package is
undamaged, the use-by
(expiry) date marked on the
pack has not been passed and
the solution is clear, colourless
and free of particles.
It must not be injected unless it
has been used to dissolve or
dilute necessary drugs to be
administered by your doctor or
nurse.
_TAKING OTHER MEDICINES _
TELL YOUR DOCTOR IF YOU ARE
TAKING ANY OTHER MEDICINES,
INCLUDING ANY THAT YOU BUY
WITHOUT A PRESCRIPTION FROM
YOUR PHARMACY, SUPERMARKET
OR HEALTH FOOD SHOP.
Your doctor, nurse or
pharmacist can tell you what to
do if you are taking any of
these medicines.
IF YOU HAVE NOT TOLD YOUR
DOCTOR ABOUT ANY OF THESE
THINGS, TELL THEM BEFORE YOU
ARE GIVEN ANY INJECTION.
HOW WATER FOR INJECTION IS
GIVEN
Water for Injections will be
used to dissolve or dilute other
drugs, which may then be
given by injection. Injections
are usually given in your upper
arm muscle (intramuscularly),
under the skin
(subcutaneously) or directly
into a vein (intravenously)
by a doctor or trained nurse.
STORAGE
Your doctor or pharmacist will
store Water for Injections
under the recommended
conditions.
It should be kept in a cool dry
place where the temperature
stays below 25 degrees C.
DISPOSAL
Your doctor nurse or
pharmacist will safel

Summary of Product characteristics

_Version 2.0 _
PRODUCT INFORMATION
WATER FOR INJECTIONS BP
I)
NAME OF THE MEDICINE
Water for Injections
O
H H
CAS Number: 7732-18-5
II)
DESCRIPTION
The chemical name for water is hydrogen oxide.
Molecular Formula: H
2
O
Molecular Weight: 18.02
Water for Injections is a sterile, non-isotonic, clear, colourless
solution in a ready-to-
use, single dose presentation. It does not contain preservatives.
III)
INDICATIONS
Water
for
Injections
is
used
for
the
reconstitution
and
preparation
of
aqueous
injections.
IV)
PRECAUTIONS
Before dissolving or diluting any substance or preparation, ensure
that Water for
Injections
is
the
recommended
solvent
or
diluent
by
consulting
the
Product
Information for the substance, drug or preparation. Prior to using
Water for Injections
to dissolve or dilute any substances or preparations, check the
compatibility of all
additives and drugs.
Ensure that the solution prepared with Water for Injections is
isotonic with blood
before intravenous administration.
USE IN PREGNANCY: Category A.
_ _
_Australian Pregnancy Categorisation: _
_Version 2.0 _
_ _
_ _
_Drugs which have been taken by a large number of pregnant women and
women of _
_childbearing age without any proven increase in the frequency of
malformations or _
_other direct or indirect harmful effects on the foetus having been
observed. _
Water for Injections has been administered to a large number of
pregnant women and
women
of
childbearing
age
without
any
proven
increase
in
the
frequency
of
malformations or other direct or indirect harmful effects on the
foetus having been
observed. Check the Product Information document of the drug to be
dissolved or
diluted to ensure that it is safe to use during pregnancy.
USE IN LACTATION: Water for Injections can be administered to women
who are breast-
feeding.
Check the Product Information document of the drug to be dissolved or
diluted to
ensure that it is safe to use during lactation.
V)
ADVERSE EFFECTS
No adverse reactions are known to be associated with Water for
Injections. There
should be