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  • Aethoxysklerol 3.0%

    Aethoxysklerol is a sterile solution that is injected into varicose veins to cause closure of the af ...click for more

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Aethoxysklerol 3.0%


Aethoxysklerol (polidocanol, laureth-9) is a TGA approved prescription medicine used in sclerotherapy procedures to treat varicose veins.


How it works
Upon injection, Aethoxysklerol works by causing the lining of the blood vessel to break up and also stops the flow of blood through that vein. The affected area is then squeezed by application of a compression bandage which helps to complete closure of the varicose vein.


Additional information can be found on these medical information sites:


 
 

For further information about Aethoxysklerol, please contact Getz Healthcare at: customersupport.au@getzhealthcare.com


Patient Information


Aethoxysklerol®

Generic name Laureth-9


Consumer Medicine Information


All medicines have risks and benefits. Your doctor has weighed the risks of you having Aethoxysklerol against the benefits they expect it will have for you.


If you have any concerns about this medicine, ask your doctor, nurse or pharmacist. Keep this leaflet, you may need to read it again.


What Aethoxysklerol is used for


Aethoxysklerol is a sterile solution that is injected into varicose veins to cause closure of the affected vein and shrink the vessel(s).


How it works
Upon injection, Aethoxysklerol works by causing the lining of the blood vessel to break up and also stops the flow of blood through that vein. The affected area is then squeezed by application of a compression bandage which helps to complete closure of the varicose vein.


Before you are given Aethoxysklerol


When you must not be given it


Do not have Aethoxysklerol injected if you have an allergy to:

  • Laureth-9 or any of the ingredients listed at the end of this leaflet

Symptoms of an allergic reaction may include:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • skin rash, itching or hives

Do not have Aethoxysklerol injected if you have any of the following medical conditions:

  • you are confined to bed or have difficulty in walking
  • you have severe arterial disease
  • blockage of blood vessels by blood clots or at least three of the following: you take oral contraceptive pills or hormone replacement medication, you are overweight, smoke or remain immobile for long periods
  • swelling and redness along a vein which is extremely tender when touched
  • acute infection of the skin (hot, tender and red skin, sometimes with fever and chills)
  • any allergic disease
  • acute infections
  • uncontrolled systemic disease such as diabetes, overactive thyroid gland with increased sweating, tremors and rapid heart rate, tuberculosis, asthma, tumors, severe venous abnormalities, blood poisoning (symptoms may include high fever, chills, head - ache, confusion, rapid breathing), a disease of the blood with a reduced number of red or white blood cells or platelets (symptoms may include tiredness, headaches, dizziness, being short of breath when exercising and looking pale; frequent infections such as fever, severe chills, sore throat or mouth ulcers; bleeding or bruising more easily than normal, nosebleeds), any lung or skin disease

If you are not sure whether you should have injections of Aethoxysklerol, talk to your doctor.


Before you are give it:
Tell your doctor if have, or have had, any medical conditions, especially the following:

  • a blood clotting disorder
  • arterial disease with severe pain on walking (only if treatment of spider veins is intended)
  • numbness or weakness of the arms and legs
  • excessive accumulation of fluid in the leg
  • blood vessels affected by diabetes
  • recent feverish temperature
  • you are over 75 years old and in poor health

Tell your doctor if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes

Tell your doctor if you are pregnant or intend to become pregnant. Aethoxysklerol is not recommended for use during pregnancy. If there is a need to consider injections during your pregnancy, your doctor will discuss the benefits and risks with you.


Tell your doctor if you are breast-feeding. It is not known whether Aethoxysklerol passes into breast milk. If there is a need to consider injections whilst you are breast feeding, your doctor will discuss the benefits and risks with you.


Tell your doctor if you have suffered from alcoholism. Aethoxysklerol contains ethanol.


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.

Some medicines and Aethoxysklerol may interfere with each other. These include:

  • anesthetics (medicines causing loss of feeling, especially pain)

These medicines may be affected by Aethoxysklerol or may affect how well it works. (You may need different amounts of these medicines, or you may need to take different medicines) Your doctor or pharmacist will advise you and decide whether or not to give the medicine.


How and when Aethoxysklerol is given


Aethoxysklerol is given by injection into the varicose vein. It should always be injected by a doctor who has been trained in the proper techniques for injecting varicose veins. The actual dose andion of the Aethoxysklerol concentration to be used will depend on the size of the varicose vein to be treated. Before injection, the leg must be lifted to a horizontal position or preferably lifted 30-45° above the horizontal.


Once the injection site has been covered, a firm compression bandage or elastic stocking will be applied. Immediately after fitting of the bandage, you will be asked to walk for 30 minutes in the surgery. The bandage or stocking should be worn for several days or weeks, depending on the size of the varicose veins treated. For very small vessels a period of 2-7 days is usually sufficient.


For larger varicose veins, longer compression-treatment with bandages is recommended. The bandage may need to be worn for 4-6 weeks.


Several repeat treatments at intervals of 1-2 weeks may be necessary, depending on the severity and extent of the varicose veins.


The success of treatment depends heavily on the thorough and careful follow-up compression treatment. Please follow the advice of your doctor.


How much is given
Your doctor will decide on the dose depending on the size and type of vein to be treated.


If you given too much
It is unlikely that you will be given too much medicine. Extensive varicose veins will always be treated in several sessions. If there is any likelihood of a hypersensitivity (allergic-type) reaction, only one injection will be given. Depending on the outcome and size of the area to be treated, several injections may be given at subsequent treatment sessions.



After Aethoxysklerol injection


Things you must do:


Keep a record of your injections


Keep follow-up appointments with your doctor or clinic. It is important to have your follow-up injections of Aethoxysklerol at the appropriate times to help make sure the treatment is successful.


Things to be careful of
Make sure that the bandage does not slip down, if you suspect that the compression bandage is not doing its job see your doctor.


Side effects


Tell your doctor as soon as possible if you do not feel well after having an injection of Aethoxysklerol.
Aethoxysklerol may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.


Tell your doctor if you notice any of the following and they worry you:

  • pinkish, itchy swellings on the skin, also called hives or nettle rash
  • asthma
  • headache or migraine
  • tingling or numbness o the hands or feet
  • feeling of confusion or dizziness
  • visual disturbances
  • fast or irregular heart beats, also called palpitations
  • development of new tiny blood vessels
  • swelling and redness along a vein which is extremely tender when touched
  • fainting
  • narrowing or blockage of blood vessels
  • difficulty in breathing or sensation of pressure in the chest
  • coughing
  • taste disturbance or loss of taste
  • nausea
  • darker areas of shin or bruising
  • skin rash, hives, redness of the skin or any other skin reaction
  • excessive growth of normal hair at the injection site
  • pain in the limb
  • pain or blood clot formation at the injection site
  • local tissue death
  • appearance of lumps or swelling at the injection site
  • fever, sensation of heat
  • unusual weakness or generally felling unwell
  • change of blood pressure
  • nerve injury

Some of the side effects listed above are more common but most of them are rare or very rare. They are usually mild and short-lived.


Tell your doctor immediately if you notice any of the following:

  • sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, difficulty in swallowing, shortness of breath, wheezing or trouble breathing
  • stroke
  • loss of consciousness
  • heart attack
  • blood clot, usually in a leg, which causes pain, swelling or redness
  • blockage of lung artery which causes chest pain and breathlessness
  • collapse due to very low blood pressure

These may be serious side effects.Tell your doctor immediately or go to Accident and Emergency at your nearest hospital. You may need urgent medical attention. Most of the serious side effects are very rare.


Other side effects not listed above may occur in some patients. Tell you doctor if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.


Storing Aethoxysklerol


Aethoxysklerol is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store Aethoxysklerol:

  • Keep it where children cannot reach it
  • Keep Aethoxysklerol in the original pack until it is time for it to be given
  • Keep it at room temperature (below 25° C), do not expose to excessive heat

Product description


What it looks like
A clear, colourless to faintly yellowish-green solution, free of particles


Other ingredients: ethanol, sodium phosphate, potassium phosphate, water


Aethoxysklerol does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.


Distributor in Australia

Manufacturer

Getz Healthcare Pty Ltd.
5 Orion Road
Lane Cove, NSW, 2066
Sydney, Australia
Phone: 1300 886 385
http://estore-au.getzhealthcare.com

Chemische Fabrik
Kreussler & Co. GmbH
Rheingaustrasse 87-93
65203 Wiesbaden


PRODUCT INFORMATION


AETHOXYSKLEROL® (LAURETH-9)


NAME OF THE MEDICINE


Laureth-9 (polidocanol): Chemical name: Polyethylene glycol monododecyl ether (WHO).

Molecular formula: C12 H25 (OCH2 CH2 )n OH where the mean of n is approximately 9.


CAS 9002-92-0          Mean MW ≅ 600


Laureth-9 is a mixture of monolauryl ethers of macrogols containing an average of 9 oxyethylene groups in the polyoxyethylene chain, it contains a lipophilic and a hydrophilic part. This molecular structure leads to the characteristic physio-chemical property of the sub- stance, the surface activity.


DESCRIPTION


Aethoxysklerol is a sterile solution of laureth-9 available in four strengths 0.5%, 1%, 2%, 3% buffered to pH 6.5 - 8.0. Excipients in Aethoxysklerol are ethanol, sodium phosphate-dibasic dihydrate, potassium phosphate monobasic and water for injections.


PHARMACOLOGY

The action of laureth-9 in this technique is considered to be that of irritation to the intima of the vein wall (disruption of the vascular endothelium causing a thrombus formation that occludes the blood vessel reducing it to a fibrotic cord). Subsequent application of a compression bandage or stocking to the leg compresses the vein walls so that the vein is permanently occluded by the development of fibrosis in the wall of the compressed vein. Toxicological effects of laureth-9 occurred at relatively low dose levels in experimental animals, with rabbits being the most sensitive species examined. Dose related decreases in cardiac contractility, heart rate, blood pressure, and PQ interval were observed in rats treated with laureth-9 at ≥ 0.25 mg/kg IV. However, in the animal studies, the drug was administered intrave-nously without compression of the vein, as is the case for the clinical use of laureth-9. Other effects, such as emesis, hypersalivation and spasm were also observed in animals, and tended to occur during and soon after laureth-9 administration.


CLINICAL TRIALS

The pivotal trial in the USA consisted of two substudies in 324 patients comparing Aethoxysklerol and sodium tetradecyl sulfate (STS) in the treatment of varicose veins of the lower extremities. The primary efficacy variable for both studies was Disappearance of Varicosities which was determined by a panel of three vascular surgeons who were blinded to the treatment conditions and rated on a scale of 1 to 5. The secondary efficacy variables were Overall Clinical Improvement (deter mined by the same panel) on an eleven point scale and Patient Satisfaction determined by patients on a four point scale. No difference was detected with regard to primary endpoint, disappearance score, for any of the three vein size strata in either sub study.


Table 1: Disappearance scores (Ohio Sub study)

Vein Size

STS

Aethoxysklerol

LSM Diff*

P-value

≤1mm

4.30 (n=21)

3.96 (n=25)

+0.34

0.104

≥1-3mm

4.00 (n=23)

4.28 (n=23)

-0.28

0.191

≥3-6mm

4.27 (n=25)

4.51 (n=25)

-0.25

0.219

* difference of least-squares means (- score flavors Aethoxysklerol over STS) from ANOVA model


Table 2: Disppearance scors (MICA Sub study)

Vein Size

STS

Aethoxysklerol

LSM Diff*

P-value

≤1mm

4.20 (n=32)

4.51 (n=26)

-0.31

0.055

≥1-3mm

4.29 (n=28)

4.31 (n=27)

-0.04

0.832

≥3-6mm

4.48 (n=27)

4.56 (n=27)

-0.09

0.581

* difference of least-squares means (- score flavors Aethoxysklerol over STS) from ANOVA model


Overall clinical improvement was greater in Aethoxysklerol treated patients than in STS patients with the between treatment difference being statistically significant in the MICA sub study (p=0.020) and not statistically significant in the Ohio sub study (p=0.051). There were no statistically significant differences in either sub study in patient satisfaction score after controlling for vein size.


INDICATIONS

The solutions are indicated for the treatment of varicose veins (up to6 mm diameter) of the lower limbs by compression sclerotherapy.


CONTRAINDICATIONS

Sclerotherapy of varices of the lower limbs is contraindicated in:

  • know allergy to laureth-9 or any of the excipients
  • bed-ridden patients, and patients unable to walk
  • arterial disease such as severe artherosclerotic peripheral vascular disease
  • patients with thromboembolic disorders and patients with high risk of thrombosis (those with multiple risk factors such as taking oral contraceptive tablets, hormone replacement therapy, adiposis, smoking, longer periods of immobilisation)
  • Other contraindications include acute superficial thrombophlebitis; significant valvular or deep vein incompetence; huge superficial veins with wide open communications to deeper veins; acute cellulitis; phlebitis migrans; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumours unless the tumour has been removed; uncontrolled systemic disease such as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases

Depending on severity, sclerotherapy may be contraindicated in:

  • known hypercoagulability
  • spider veins: arterial occlusive disease (Fontaine stage II)
  • leg oedema (if it cannot be influenced by compression)
  • symptoms of diabetic micro-angiopathy
  • neuropathy
  • inflammatory skin reactions in the injection area
  • acute severe cardiac diseases (endocarditis, myocarditis). Note that heart failure, if stabilised by previous treatment, is not a contraindication to sclerotherapy. The same applies to arterial hypertension if it has been adequately managed by previous treatment
  • febrile states
  • advanced age with impaired mobility or very poor general condition

PRECAUTIONS

Effects on Fertility No effect on fertility was observed when male and female rats were treated intermittently with laureth-9 at IV doses up to 10 mg/kg (once a week exposure in rats was about 80% of the maximum human dose in terms of surface area) prior to mating. Aethoxysklerol should only be administered by physicians experienced in injection sclerotherapy. Thorough assessment for valvular competence and deep vein patency should be undertaken prior to injection. Careful needle placement and slow injection technique of the minimum effective dose are essential. Aethoxysklerol must never be injected intra-arterially because this can cause severe necrosis that may necessitate amputation. A vascular surgeon must be called in immediately if any such incidents occur.

In order to avoid undue adverse reactions when performing sclerotherapy in the ankle area, only a small quantity of a low concentration of Aethoxysklerol should be used. The risk of inadvertent intra-arterial injection in the foot and ankle region should also be taken into consideration. Laureth-9 (polidocanol) is a local anaesthetic. When combined with other anaesthetics, there may be a risk of intensifying desired or undesired effects of anaesthetics on the cardiovascular system (e.g. proarrhythmic effect). All Aethoxysklerol preparations contain 5% (v/v) ethanol (to be considered in cases of patients with former alcoholism).


Anaphylaxis

Although the incidence of anaphylactic reactions is very rare when Aethoxysklerol is injected into veins, the physician carrying out the procedure should be equipped for anaphylactic emergencies should they occur. The injection should be stopped immediately and standard emergency procedure should be followed including the administration of oxygen, adrenaline and intravenous steroids. Airway management including intubation should not be delayed if upper airway obstruction is progressive.


Allergy

Prior to treatment, a history of allergy should be taken for all patients, in particular allergic reactions to previous administration of Aethoxysklerol.


Effects on Fertility

No effect on fertility was observed when male and female rats were treated intermittently with laureth-9 at IV doses up to 10 mg/kg (once a week exposure in rats was about 80% of the maximum human dose in terms of surface area) prior to mating.


Use in Pregnancy (Category B3)

Studies in rats have shown that laureth-9 and/or its metabo lites cross the placenta and distribute to the foetus. Administration of laureth-9 by IV injection at doses ≥ 2.5 mg/kg to pregnant rabbits once daily from gestation day 6 to 14-18 was associated with increased resorptions, foetal malforma tions (mainly of the limbs and head) and foetal death. The no-effect dose for embryofoetal toxicity and malformations was 1.25 mg/kg IV (about 20% of the maximum proposed human dose of 2 mg/kg IV, based on body surface area). No evidence for a teratogenic effect of laureth-9 was noted in rats at doses up to 4mg/kg/day IV treated daily from gestation days 7-17 (about 80% of the maximum human dose based on body surface area). However, this dose of laureth-9 caused an increase in the number of runts in rats. Treatment of rats with laureth-9 at IV doses ≥ 2.5 mg/kg (about 20% of the maximum dose based on body surface area) from late gestation and during the lactation period was associated with an increased number of stillbirths and abortions. A no-effect dose for these effects was not established. There are no adequate and well-controlled studies in pregnant women. Therefore, laureth-9 should not be used in pregnant women.


Use in Lactation

It is not known whether laureth-9 is excreted into human milk. Because many drugs are excreted in human milk, caution should be exercised when Aethoxysklerol is administered to a nursing woman. Laureth-9 and/or its metabolites were found in the milk of lactating rats for at least 48hr after a single IV dose of [ 14 C]-laureth-9. Administration of laureth-9 at IV doses up to 10 mg/kg (about 80% of the maximum human dose based on body surface area) to lactating rats had no effect on offspring development.


Paediatric Use

There are no data and therefore Aethoxysklerol is not recommended for use in children.


Genotoxicity

In short-term studies investigating the genotoxic potential of laureth-9, no evidence of mutagenicity was noted; however, a concentration-dependent increase in the incidence of chromosomal abnormalities (polyploid cells) was observed in cultured Chinese hamster fibroblasts, suggesting a possible genotoxic effect of the drug.

Carcinogenicity

The carcinogenic potential of laureth-9 has not been adequately assessed in long-term animal studies.


INTERACTIONS WITH OTHER MEDICINES

There are no data on drug interactions with laureth-9.


ADVERSE EFFECTS

Pivotal Clinical Trial Aethoxysklerol and sodium tetradecyl sulfate injection caused reactions that were expected based upon the known pharmacological properties of the drugs and/or the mode of application of the drug (needle injection). Immediate local reactions (pain on injection, inflammation, swelling and local allergic reactions) and delayed local reactions (hyperpigmentation, vein thrombosis, ecchymosis and neovascularisation) were all related to the injected agent and to the known effects on vascular endo thelium. In both groups the most common repeated adverse events were hyperpigmentation, vein thrombosis, ecchymosis and pain on injection. All adverse events (independent of the number of treatments per patient)


OHIO sub study

MICA sub study

STS

Aethoxysklerol

STS

Aethoxysklerol

N

75

75

91

81

Any

89%

88%

100%

98%

Hyper pigmentation

72%

65%

64%

53%

Skin necrosis

4.0%

2.7%

5.5%

0.0%

Rash

-

-

8.8%

11%

Vein thrombosis*

59%

61%

46%

42%

Neovascularisation

5.3%

9.3%

11%

7.2%

Ecchymosis

63%

49%

70%

58%

Pain

31%

45%

41%

43%

Local allergy

4.0%

6.7%

36%

23%

Inflammation

4.0%

0.0%

59%

41%

Swelling

-

-

40%

19%

Oedema

-

-

2.2%

0.0%

Taste disturbance

0.0%

2.7%

1.1%

0.0%

Visual field defect

-

-

1.1%

0.0%

Paraesthesia

0.0%

1.3%

2.2%

3.6%

Dizziness

-

-

2.2%

0.0%

* It should be noted that while vein thrombosis is reported as an adverse event, it is often part of the pharmacological mechanism of action of laureth-9 and is expected with sclerotherapy.


Post Marketing

Spontaneous reporting world-wide of adverse reactions associated with the use of Aethoxysklerol. The following adverse reactions have been observed with the frequencies seen below:
Very common ( ≥ 1/10); common ( ≥ 1/100 - < 1/10); uncommon ( ≥ 1/1,000 - < 1/100); rare ( ≥ 1/10,000 - < 1/1,000); very rare (< 1/10,000 or not known).


Immune system disorders

Very rare: anaphylactic shock, angioedema, urticaria generalised, asthma

Nervous system disorders

Very rare: cerebrovascular accident, headache, migraine, paraesthesia (local), loss of consciousness, confusional state, dizziness

Eye disorders

Very rare: visual disturbance

Cardiac disorders

Very rare: cardiac arrest, palpitations

Vascular disorders

Common: neovascularisation, haematoma

Uncommon: thrombophlebitis superficial, phlebitis

Rare: deep vein thrombosis (unknown aetiology, possibly due to the underlying disease)

Very rare: pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis

Respiratory, thoracic and mediastinal disorders

Very rare: dyspnoea, chest discomfort, cough

Gastrointestinal disorders

Very rare: dysgeusia, nausea

Skin and subcutaneous tissue disorders

Common: skin hyperpigmentation, ecchymosis

Uncommon: dermatitis allergic, urticaria contact, skin reaction, erythema

Very rare: hypertrichosis (in the area of sclerotherapy)

Musculoskeletal, connective tissue and bone disorders

Rare: pain in extremity

General disorders and administration site conditions

Common: injection site pain (short-term), injection site thrombosis (local intravaricose blood clots)

Uncommon: necrosis, induration, swelling

Very rare: pyrexia, hot flush, asthenia, malaise

Investigations

Very rare: blood pressure abnormal

Injury, poisoning and procedural complications

Uncommon: nerve injury


DOSAGE AND ADMINISTRATION

Dosage andion 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 patient use only.
  • Only inject into a leg placed horizontally or elevated 30-45º above the horizontal.

The most appropriate syringe and needle size for each vein size should be used. After puncture of the vein, the injection should usually take place with the patient in a horizontal position. Intravenous placement of the needle should be assured. Especially for smaller veins, directing the needle tangentially will assist in the intravenous positioning. The injection of Aethoxysklerol should be done slowly, avoiding administration into the surrounding tissue.

Sclerotherapy of reticular varices, spider veins, central veins of spider veins, small varices

One or two repeat treatments may be necessary, depending on the extent of the varices and on the treatment success.

Sclerotherapy of medium-sized varices

Several repeat treatments at intervals of 1-2 weeks may be necessary, depending on the severity and extent of the varices and on the success of the previous treatments.


Subsequent Care

The success of compression sclerotherapy depends on the thorough and careful follow-up compression treatment

Once the injection sites have been covered, a firm compression bandage or elastic stocking should be applied. The patient should walk, preferably under observation, for at least 30 minutes.
Sclerotherapy of reticular varices, spider veins, central veins of spider veins, small varices
The bandage should usually be worn for 2-3 days after sclerotherapy of spider veins, otherwise for 3-7 days.
Sclerotherapy of medium-sized varices
The bandage should usually be worn for 4-6 weeks.


Dosage

A guide to the most appropriate dose of Aethoxysklerol is given in the following table.

Indication

Volume / Injection

Concentration

Spider veins

0.1 - 0.2 mL

0.5%

Central veins of spider veins

0.1 - 0.2 mL

1%

Reticular/small varices

0.1 - 0.3 mL

1%

Medium size varices

0.5 - 1 mL

2 - 3%

OVERDOSAGE

Overdose (caused by injection of an excessive amount of Aethoxysklerol for the vein size being injected) may result in local necrosis, especially if extravasation occurred. No serious sequelae were observed in patients who received Aethoxysklerol doses in excess of the recommended maximum dose of 2 mg/kg body weight per day. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).


PRESENTATION AND STORAGE CONDITIONS

Aethoxysklerol 0.5% contains 10 mg laureth-9 in 2 mL ampoule.

Pack of 5 ampoules

Aethoxysklerol 1% contains 20 mg laureth-9 in 2 mL ampoule.

Pack of 5 ampoules

Aethoxysklerol 2% contains 40 mg laureth-9 in 2 mL ampoule.

Pack of 5 ampoules

Aethoxysklerol 3% contains 60 mg laureth-9 in 2 mL ampoule.

Pack of 5 ampoules


The solutions should be stored below 25ºC and used before the expiry date on the container.


NAME AND ADDRESS OF THE SPONSOR

Getz Healthcare Pty Ltd.
5 Orion Road
Lane Cove, NSW, 2066
Sydney, Australia


POISON SCHEDULE OF THE MEDICINE

Schedule 4


DATE OF FIRST INCLUSION IN THE ARTG

05/07/2001


DATE OF MOST RECENT AMENDMENT

30/01/2012


Aethoxysklerol is a registered trademark of Kreussler & Co. GmbH, Germany




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