Fluorescite

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Fluorescein sodium 25%{relative}

Հասանելի է:

Alcon Laboratories Australia Pty Ltd (NZ)

INN (Միջազգային անվանումը):

Fluorescein sodium 25% w/w

Դոզան:

25 %

Դեղագործական ձեւ:

Solution for injection

Կազմը:

Active: Fluorescein sodium 25%{relative} Excipient: Hydrochloric acid as 1N solution, to pH 9.0-9.8 Sodium hydroxide as 1N solution, to pH 9.0-9.8 Water for injection

Միավորները փաթեթում:

Ampoule, glass, 12 x 2mL ampoules, 12 dose units

Դաս:

Prescription

Ռեկվիզորի տեսակը:

Prescription

Պատրաստված է:

Eastman Chemical Company

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Ampoule, glass, 12 x 2mL ampoules - 12 dose units - 48 months from date of manufacture stored at or below 30°C

Հաստատման ամսաթիվը:

1990-08-24

Տեղեկատվական թերթիկ

Internal document code
1
Fluo080920cNZ
FLUORESCITE
TM 10%
_FLUORESCEIN SODIUM _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE YOU ARE GIVEN
FLUORESCITE
TM 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
www.medsafe.govt.nz.
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 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”
•
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

Ապրանքի հատկությունները

Internal document code
1
Fluo26May22iNZ
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
FLUORESCITE
TM
(fluorescein) Injection 10%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluorescite
TM
injection
10%
contains
100
mg/mL
fluorescein
(equivalent
to
113.2
mg/mL
fluorescein sodium).
3.
PHARMACEUTICAL FORM
Solution, sterile pyrogen-free injection.
Unpreserved with a pH of 8.0 to 9.8.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Indicated in diagnostic fluorescein angiography or angioscopy of the
fundus and of the iris
vasculature.
4.2.
DOSE 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
immediately before any Fluorescite
TM
injection 10% is administered. When assured that extravasation has not
occurred, the room light
may
be
switched
off
and
the
Fluorescite
TM
injection
10%
administration
completed.
Lumi