PATENT BLUE V 50mg/2mL injection ampoule

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

patent blue V, Quantity: 25 mg/mL

Saadav alates:

Guerbet Australia Pty Ltd

INN (Rahvusvaheline Nimetus):

Patent blue V

Ravimvorm:

Injection, solution

Koostis:

Excipient Ingredients: water for injections; sodium chloride; dibasic sodium phosphate dodecahydrate

Manustamisviis:

Subcutaneous

Ühikuid pakis:

5 X 2mL

Retsepti tüüp:

Not scheduled. Not considered by committee

Näidustused:

Colours the lymph vessels so that they can then be injected with an X-ray contrast medium

Toote kokkuvõte:

Visual Identification: Deep, blue solution; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

1991-10-21

Infovoldik

PATENT BLUE V - Consumer Medicine Information
Page 1 of 2
PATENT BLUE V SOLUTION FOR INJECTION
_CONSUMER MEDICINE INFORMATION (CMI) _
_ _
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET
CAREFULLY BEFORE YOU ARE GIVEN
AN INJECTION OF PATENT BLUE
V.
It tells you some of the more
important points you need to
know about this product.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
WHAT IS IN THE
INJECTION
Patent Blue V is a sterile dye
solution for injection. It belongs
to the group of
triphenylmethane dyes used to
reveal vessels in order to
improve the visualisation of
certain vessels of your body.
WHAT PATENT BLUE V
IS USED FOR
PATENT BLUE V is used by
your doctor to prepare a
radiological examination or as a
direct aid to diagnosis of some
diseases.
BEFORE RECEIVING IT
_ _
_WHEN YOU MUST NOT BE GIVEN _
_IT _
BEFORE YOU RECEIVE AN
INJECTION OF PATENT BLUE V,
YOU MUST TELL YOUR DOCTOR IF:
•
you are allergic
(hypersensitive) to the active
substance ‘patent blue’, to
another triphenylmethane
dye or any of the other
ingredients of Patent Blue V
listed at the end of this
leaflet
•
you are pregnant.
_BEFORE YOU ARE GIVEN IT _
TELL YOUR DOCTOR IF YOU ARE
ALLERGIC TO ANY OTHER
MEDICINES OR ANY FOODS, DYES
OR PRESERVATIVES.
TELL YOUR DOCTOR OR
PHARMACIST IF YOU ARE TAKING
OR HAVE RECENTLY TAKEN ANY
OTHER MEDICINES, INCLUDING
MEDICINES OBTAINED WITHOUT A
PRESCRIPTION. IN PARTICULAR,
PLEASE INFORM YOUR DOCTOR IF
YOU ARE TAKING MEDICINES FOR
TREATING A HEART CONDITION OR
HIGH BLOOD PRESSURE.
TELL YOUR DOCTOR IF YOU ARE
PREGNANT OR YOU MAY BE
PREGNANT.
You must never be given
Patent Blue V if you are
pregnant.
TELL YOUR DOCTOR IF YOU ARE
BREASTFEEDING OR PLANNING TO
BREASTFEED.
_TAKING OTHER MEDICINES _
TELL
YOUR
DOCTOR
IF
YOU
ARE
TAKING ANY OTHER MEDICINES,
INCLUDING
ANY
THAT
YOU
GET
WITHOUT A PRESCRIPTION FROM A
PHARMACY,
SUPERMARKET
OR
HEALTH FOOD SHOP.
Some medicines may interfere
with PATENT BLUE V. These
include medicines used to treat
high blood pressure, such as
beta-blo

Toote omadused

1(6)
AUSTRALIAN PRODUCT INFORMATION
PATENT BLUE V SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Patent Blue V
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Patent Blue V injection solution contains 25 mg/mL (2.5% w/v) of
Patent Blue V (sodium salt) as
the active ingredient.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Patent Blue V injection solution is a deep blue sterile, isotonic
solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Colours the lymph vessels so that they can then be injected with an
X-ray contrast medium.
4.2
D
OSE AND METHOD OF ADMINISTRATION
For subcutaneous use only.
2 mL of Patent Blue V injection solution is diluted with an equal
volume of sterile normal saline
(an alternative method advocates dilution with 1% lignocaine
hydrochloride solution) and 0.5
mL of diluted dye is injected into the subcutaneous tissue of each
interdigital web space.
When the lower extremities are being examined, 1 mL is also injected
below the tip of each
malleolus. The lymphatics should then be visible through the skin and
it is important that there
should be no accidental spillage of the dye.
Patent Blue V may be used for children at the surgeon's discretion.
After the administration of Patent Blue V, the patient must be
monitored for at least 30 minutes.
Note. After injection of the dye a bluish coloration of the skin
occurs, which normally disappears
within 24 to 48 hours. More persistent coloration which should not be
confused with cyanosis,
may occasionally be seen in cases of lymphatic stasis or circulatory
disorder, this persistence may
be avoided by using the minimum quantity of dye. An area of blue
coloration can persist around
the injection site for 8 to 10 days.
2(6)
4.3
C
ONTRAINDICATIONS
•
Hypersensitivity to Patent Blue V, triphenylmethane dyes or any of the
excipients listed in
section 6.1.
•
Pregnancy.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
There is a risk of allergic reactions regardless of the administration
r