WATER FOR INJECTIONS BP, water for injections, 10 mL, solution for injection, ampoule

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

现在购买

资料单张 资料单张 (PIL)
24-08-2020
产品特点 产品特点 (SPC)
24-08-2020
公众评估报告 公众评估报告 (PAR)
28-11-2017

有效成分:

water for injections, Quantity: 10 mL

可用日期:

Fresenius Kabi Australia Pty Ltd

INN(国际名称):

water for injections

药物剂型:

Injection, solution

组成:

Excipient Ingredients:

给药途径:

Intramuscular, Intravenous, Subcutaneous

每包单位数:

Carton of 50's, Carton of 20's

处方类型:

Not scheduled. Not considered by committee

疗效迹象:

Water for Injections BP is used to dissolve or dilute substances or preparations for parenteral administration. ,Water for Injections BP may also be used as an irrigating solution for small wounds or during minor surgical procedures.

產品總結:

Visual Identification: Clear, colourless, particle-free; Container Type: Ampoule; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

授权状态:

Licence status A

授权日期:

2013-04-30

资料单张

                                CMI for WFI Ampoules
Mar 2016
Filename:WFIampCMI300316_clean
Page 1
Change: Address change
WATER FOR INJECTIONS BP
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
THIS
LEAFLET
ANSWERS
SOME
COMMON QUESTIONS
ABOUT WATER
FOR
INJECTIONS
BP.
IT
DOES
NOT
CONTAIN
ALL
THE
AVAILABLE
INFORMATION THAT IS KNOWN ABOUT
WATER FOR INJECTIONS BP. 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 PHARMACIST.
KEEP THIS LEAFLET. You may need to
read it again.
WHAT
WATER
FOR
INJECTIONS
BP
IS
USED
FOR
Water
for
Injections
BP
is
sterile
water
used
to
dilute
or
dissolve
drugs.
Water for Injections BP can also be
used for washing small wounds and
during minor surgical procedures.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the information
contained in this leaflet.
BEFORE YOU ARE GIVEN
WATER FOR INJECTIONS BP
_WHEN YOU MUST NOT USE IT _
_ _
WATER FOR INJECTIONS BP WILL ONLY
BE USED IF IT IS CLEAR, COLOURLESS
AND FREE OF PARTICLES, THE PACKAGE
IS
UNDAMAGED
AND
THE
USE
BY
(EXPIRY) DATE MARKED ON THE PACK
HAS NOT BEEN PASSED. 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 OR PHARMACIST 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
INJECTIONS BP IS GIVEN
Water for Injections BP will be used
to
dissolve
or
dilute
other
drugs
which may then be injected by your
nurse or doctor.
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.
Water for Inject
                                
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产品特点

                                AUSTRALIAN PRODUCT INFORMATION-
WATER FOR INJECTION BP (WATER FOR INJECTION
)
Australian PI – December 2018
Page 1 of 6
1 NAME OF MEDICINE
Water for Injections
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Water for Injections BP injection solution contains 100% v/v water for
injections.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Solution for injection
Water for Injections is a clear, colourless, particle-free, odourless
and tasteless liquid. It is sterile, with
a pH of 5.0-7.0 and contains no anti-microbial agents.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Water for Injections is used to dissolve or dilute substances or
preparations for parenteral
administration.
Water for Injections may also be used as an irrigating solution for
small wounds or during minor
surgical procedures.
4.2
Dose and method of administration
For dissolving or diluting agents for parenteral administration
The dosage for Water for Injections is that required to dissolve or
dilute other agents. Aseptic technique
must be used when preparing solutions for parenteral administration.
Check the Product Information
of
any
substance, preparation
or
drug before use
to ensure appropriate
solubility, dilution
or
compatibility with other additives.
Solutions prepared with Water for Injections may be administered
intravenously, intramuscularly or
subcutaneously using strict aseptic technique. Care should be
exercised that all solutions prepared with
Water for Injections are isotonic before use (See 4.4 Special warnings
and Precautions for use). Water
for Injections is for use for a single patient on a single occasion.
Any residue should be discarded.
AUSTRALIAN PRODUCT INFORMATION-
WATER FOR INJECTION BP (WATER FOR INJECTION
)
Australian PI – December 2018
Page 2 of 6
Usually solutions are prepared immediately before use. The Product
Information of substances or drugs
to be dissolved or diluted must be consulted to ascertain the maximum
time between aseptic
preparation and use of the solution.
F
                                
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