FLUORESCITE fluorescein 10% 500mg/5mL (as sodium) injection vial

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

fluorescein sodium, Quantity: 113.2 mg/mL (Equivalent: fluorescein, Qty 100 mg/mL)

থেকে পাওয়া:

Alcon Laboratories Australia Pty Ltd

INN (International Name):

Fluorescein sodium

ফার্মাসিউটিকাল ফর্ম:

Injection, solution

রচনা:

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

প্রশাসন রুট:

Intravenous

প্যাকেজ ইউনিট:

12 x 5mL

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

INDICATIONS AS AT 01 JAN 1991 : Indicated in diagnostic fluorescein angiography or angioscopy of the fundus and of the iris vasculature.

পণ্য সারাংশ:

Visual Identification: Red-orange solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2006-04-12

তথ্য লিফলেট

FLUORESCITE™ 10%
1
FLUORESCITE™ 10%
_fluorescein sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU ARE GIVEN FLUORESCITE INJECTION.
This leaflet answers some common
questions about Fluorescite Injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET FROM
TGA eBusiness Services
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Fluorescite
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT FLUORESCITE IS
USED FOR
Fluorescite Injection contains
fluorescein sodium which possesses
the property of "fluorescence".
Fluorescite Injection is a "diagnostic
agent".
Fluorescite allows your doctor to see
the blood moving through the small
blood vessels at the back of your
eye(s). It assists your doctor in
determining if areas of your eye(s)
are damaged or unhealthy.
_USE IN CHILDREN _
The safety and effectiveness of
Fluorescite Injection has not been
established.
BEFORE FLUORESCITE IS
USED
_WHEN IT MUST NOT BE USED _
FLUORESCITE INJECTION SHOULD NOT BE
USED IF YOU HAVE AN ALLERGY TO:
•
fluorescein sodium
•
any of the ingredients listed at the
end of this leaflet under "Product
Description"
•
any other similar medicines.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts

পণ্য বৈশিষ্ট্য

AUSTRALIAN PRODUCT INFORMATION
FLUORESCITE
TM
(FLUORESCEIN) INJECTION
1
NAME OF THE MEDICINE
Fluorescein
TM
.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUORESCITE
TM
injection 10% is a sterile solution. It contains 100 mg/mL fluorescein
(equivalent to 113.2 mg/mL fluorescein sodium).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FLUORESCITE
TM
injection 10% is supplied as a sterile, unpreserved, pyrogen free,
buffered
unit dose aqueous solution for use as a diagnostic aid that has pH of
8.0-9.8 and an osmolality
of 572-858 mOsm/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Indicated in diagnostic fluorescein angiography or angioscopy of the
fundus and of the iris
vasculature.
4.2
DOSAGE
AND
METHOD
OF
ADMINISTRATION
The usual adult dose is the contents of one FLUORESCITE
TM
injection 10% vial (5 mL of 10%
solution) via intravenous administration.
For children, the dose is calculated on the basis of 8 mg/kg of body
weight.
Parenteral drug products should be inspected visually for particulate
matter and discolouration
prior to administration. Do not mix or dilute with other solutions or
drugs. Flush intravenous
cannulae before and after drugs are injected to avoid physical
incompatibility reactions.
Product is for single use in one patient only. Discard any residue.
Contains no antimicrobial
agent.
Inject the contents of the vial rapidly into the antecubital vein
_after taking precautions to _
_avoid extravasation_
. A syringe filled with FLUORESCITE
TM
injection 10% is attached to
transparent tubing and a 23 gauge butterfly needle for injection.
Insert the needle and draw
the patient's blood to the hub of the syringe so that a
_small_
air bubble separates the patient's
blood in the tubing from the FLUORESCITE
TM
injection 10%. With the room lights on,
slowly inject the blood back into the vein while watching the skin
over the needle tip. If the
needle has extravasated, the patient's blood will be seen to bulge the
skin and the injection
should be stopped immed