AETHOXYSKLEROL 2% lauromacrogol 400 40mg/2mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lauromacrogol 400, Quantity: 40 mg

Available from:

Accelagen Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: ethanol; dibasic sodium phosphate dihydrate; monobasic potassium phosphate; water for injections

Administration route:

Intravenous

Units in package:

5 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: The solutions are indicated for the treatment of varicose veins (up to 6mm diameter) of the lower limbs by compression sclerotherapy.

Product summary:

Visual Identification: Clear, colourless to weakly yellowish-greenish solution; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2001-07-27

Patient Information leaflet

Aethoxysklerol
®
1
AETHOXYSKLEROL®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY I AM GIVEN AETHOXYSKLEROL?
Aethoxysklerol contains the active ingredient lauromacrogol 400.
Aethoxysklerol is used to treat varicose veins.
For more information, see Section 1. Why I am given Aethoxysklerol? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN AETHOXYSKLEROL?
Do not use if you have ever had an allergic reaction to Aethoxysklerol
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Aethoxysklerol? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Aethoxysklerol may interfere with some medicines and affect how they
work.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS AETHOXYSKLEROL GIVEN?
•
Your doctor injects Aethoxysklerol into the varicose vein and selects
the appropriate dose.
•
After injection, a firm compression bandage or elastic stocking will
be applied.
More information can be found in Section 4. How is Aethoxysklerol
given? in the full CMI.
5.
AFTER AETHOXYSKLEROL INJECTION
THINGS YOU
SHOULD DO
•
Keep a record of your injections.
•
Keep follow-up appointments with your doctor or clinic.
THINGS TO BE
CAREFUL OF
•
Make sure you tell your doctor if you think you may be having an
allergic reaction to Aethoxysklerol.
•
Make sure the bandage does not slip down.
LOOKING AFTER
YOUR MEDICINE
•
Keep it in the original pack, at room temperature (below 30°C), and
do not expose to excessive heat.
Keep it where young children cannot reach it.
For more information, see Section 5. After Aethoxysklerol injection in
the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
All medicines can have

Summary of Product characteristics

Aethoxysklerol Injection Product Information
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION - AETHOXYSKLEROL
®
(LAUROMACROGOL 400)
1. NAME OF THE MEDICINE
Lauromacrogol 400.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Aethoxysklerol is a sterile solution of lauromacrogol 400 available in
four strengths 0.5%,
1%, 2%, 3% buffered to pH 6.5 – 8.0.
Aethoxysklerol 0.5% contains 10 mg lauromacrogol 400 in 2 mL ampoule.
Aethoxysklerol 1% contains 20 mg lauromacrogol 400 in 2 mL ampoule.
Aethoxysklerol 2% contains 40 mg lauromacrogol 400 in 2 mL ampoule.
Aethoxysklerol 3% contains 60 mg lauromacrogol 400 in 2 mL ampoule.
Not all presentations are distributed in Australia.
List of excipients with known effect: ethanol.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to very faintly greenish yellow solution.
4. CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
The solutions are indicated for the treatment of varicose veins (up to
6 mm diameter) of
the lower limbs by compression sclerotherapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage and selection of the Aethoxysklerol concentration depends on
the size of the
varices to be sclerosed. Sclerotherapy is followed by compression
bandaging of the limb.
Extensive varicosis should always be treated in several sessions. When
first treating a
patient prone to hypersensitivity reactions, no more than one
injection should be given.
Depending on the outcome and size of the area to be sclerosed, several
injections may be
given at subsequent treatment sessions, provided that the maximum
dosage 2 mg/kg
body weight per day is not exceeded.
METHOD OF ADMINISTRATION
•
Aethoxysklerol is to be injected into the lumen of the affected vein.
•
Aethoxysklerol is for single use in one patient only. Any unused
product should be
disposed of appropriately.
•
Only inject into a leg placed horizontally or elevated 30-45° above
the horizontal.
The most appropriate syringe and needle size for each vein size sh