AETHOXYSKLEROL Solution for injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Aethoxysklerol 2.5 mg/ml solution for injection. Aethoxysklerol 5 mg/ml solution for injection. Aethoxysklerol 10 mg/ml solution for injection. Aethoxysklerol 20 mg/ml solution for injection. Aethoxysklerol ...
2. Qualitative and quantitative composition
The active substance in Aethoxysklerol is lauromacrogol 400 also known as polidocanol. Each <b>ml</b> solution for injection contains: Each <b>2ml ampoule</b> of solution contains: Aethoxysklerol ...
3. Pharmaceutical form
Solution for injection. Clear, colourless to very faintly greenish yellow sterile solution. pH 7.0–8.0 Osmolality 920–975 mOsmol/kg
4.1. Therapeutic indications
Aethoxysklerol is indicated for sclerotherapy of varicose veins of the lower extremities.
4.2. Posology and method of administration
Different concentrations of Aethoxysklerol are required, depending on the type and size of the varicose veins to be treated. If several concentrations are stated for a certain type of vein (see table below), ...
4.3. Contraindications
Known hypersensitivity to lauromacrogol 400 or any of the excipients listed in section 6.1 Uncontrolled systemic diseases (such as diabetes melitus, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, ...
4.4. Special warnings and precautions for use
Aethoxysklerol should only be administered by healthcare professionals experienced in sclerotherapy and the required preparation techniques. <u>Sclerotherapy of varicose veins should be used with caution ...
4.5. Interaction with other medicinal products and other forms of interaction
Lauromacrogol 400 is a local anaesthetic. When combined with other anaesthetics, there is a risk of an additive effect of these anaesthetics on the cardiovascular system.
4.6. Fertility, pregnancy and lactation
Pregnancy Safety for use in pregnancy has not been established. Studies in animals showed reproductive toxicity, but no teratogenic potential (see section 5.3). Treatment should be postponed until after ...
4.7. Effects on ability to drive and use machines
No negative effects on the ability to drive and use machines are known for Aethoxysklerol.
4.8. Undesirable effects
The most commonly reported side effects are temporary in most cases and include short-term injection site pain, injection site intravaricose blood clots and temporary skin discolouration after treatment. ...
4.9. Overdose
Local overdose (caused by the injected volume or concentration being too high) may cause local necrosis, especially after extravenous injection. For management of local toxicity after improper administration ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> sclerosing agents for local injection <b>ATC code:</b> C05BB02 Lauromacrogol 400 (also known as polidocanol) is the active ingredient of Aethoxysklerol, has world-wide ...
5.2. Pharmacokinetic properties
Six healthy subjects received an injection of 37 mg <sup>14</sup>C-lauromacrogol 400 as a strongly diluted solution into the great saphenous vein. The concentration-time course of lauromacrogol 400 in ...
5.3. Preclinical safety data
In animal experiments, Aethoxysklerol has a relatively low acute toxicity. Safety pharmacology studies showed negative chronotropic, inotropic and dromotropic effects, with a blood pressure drop. Additional ...
6.1. List of excipients
Ethanol 96% Potassium dihydrogen phosphate Disodium phosphate dihydrate Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
3 years. The ampoule is intended for single use. After first opening, the medicinal product should be used immediately. Any residual amount must be discarded.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
<b>2ml ampoule (Type I glass):</b> Ampoule identification<br />Stripe colours & format Aethoxysklerol 2.5 mg/ml Two red Aethoxysklerol 5 mg/ml Two white and one red Aethoxysklerol 10 mg/ml One ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal. Preparation of the Microfoam Preparation of the microfoam using the Tessari and Dual Syringe System (DSS) techniques, respectively, is described below. Other suitable ...
7. Marketing authorization holder
Ferndale Pharmaceuticals Ltd, Unit 740, Thorp Arch Estate, Wetherby, West Yorkshire, LS23 7FX
8. Marketing authorization number(s)
Aethoxysklerol 2.5 mg/ml 5 mg/ml 10 mg/ml 20 mg/ml 30 mg/ml Authorisation number PL20685/0042 PL20685/0039 PL20685/0040 PL20685/0043 PL20685/0041
9. Date of first authorization / renewal of the authorization
24/12/2018
10. Date of revision of the text
24/12/2018
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