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Sclerovein®

 Sclerosant for varicose veins

  Composition

1 ml injection solution

contains

0.5%

1%

2%

3%

5%

Polidocanolum 600

5 mg

10 mg

20 mg

30 mg

50 mg

Ethanolum

50 mg

50 mg

50 mg

50 mg

50 mg

Conserv.: Chloro­

butanolumhemihydricum

5 mg

5 mg

5 mg

5 mg

5 mg

Aqua q.s. ad solutionem pro

1 ml

1 ml

1 ml

1 ml

1 ml

Properties, effects

Polidocanol has a sclerosant and at the same time a local anaesthetic effect. This permits almost painless sclerotherapy. The effect is directed mostly at the vein intima. While there is great affinity with damaged intima there is no effect on intact vascular linings, so a sclerosant effect occurs only on veins with actual varicose changes and not on veins with moderate cylindrical dilation. This sclerosant effect is due to irritation of the vein intima, which causes a local, adhesive thrombosis in the area of the damaged endothelium. The compression bandage applied after treatment presses the vein walls together and prevents re-canalisation of the organised thrombus, so that the desired conversion of the thrombus into a fibrous scar takes place.

With paravasal application of Polidocanol, the local oedema formation leads to compression of the varices and cicatricial consolidation.

With appropriate selection of concentration and dosage and with correct treatment methods and aftercare (compression treatment) Sclerovein can be easily tolerated and is a reliable and lasting sclerosant.

Pharmacokinetics

Polidocanol:

12 hours after intravenous application, about 90% of the Polidocanol administered will have been eliminated from the blood. No accumulation is to be expected even after repeated doses of Polidocanol at intervals which are normal for sclerotherapy. In a study, the following values were determined after a single intravenous dose: protein binding 64%, terminal elimination half-life 4 hours, volume of distribution 24.5 l, total clearance 11.7 l/h, renal clearance 2.43 l/h and bilary clearance 3.14 l/h.

  Ethanol:

No data are available for the level of the ethanol absorption rate.

  Distribution:

The volume of distribution of ethanol is 0.68 l/kg for a man and 0.55 l/kg for a woman, and is reached very quickly.

Ethanol enters the foetus and mother's milk.

  Metabolism:

Ethyl alcohol is oxidised by alcohol dehydrogenase in the liver to form acetaldehyde, and acetaldehyde is in turn broken down by acetaldehyde dehydrogenase to form acetic acid. This metabolic breakdown method accounts for 90-96% in man.

  Elimination:

The rate of elimination is independent of concentration and is 0.1 g/kg/h for a man and 0.085 g/kg/h for a woman (hourly breakdown c. 0.15 ‰ ). Insignificant amounts are eliminated via the lungs (2-3%) and kidneys (1-2%).

Indications/possible applications

Sclerotherapy of varices (branch varicosis; perforantes varicosis; operative main vein varicosis treatment combined with sclerotherapy), venectasias (spider veins), haemorrhoids, anal fissures and haemangiomas.

Dosage/application

  Conventional dosage

Notes on dosage

Sclerovein is for strictly intravenous injection (sclerotherapy of varices) or strictly submucous injection (sclerotherapy of haemorrhoids).

In general, a dose of 2 mg/kg body weight per day should not be exceeded.

Extensive varicosis should always be treated in several sessions.

To patients who tend to hyperactive reactions, not more than one injection should be administered during the first treatment session. Depending on the outcome of the treatment and the extent of the area to be sclerosed, several injections may be given during subsequent treatments while observing the maximum dose (2 mg/kg per day).

Sclerotherapy of varices:

The quantity of the dose and the concentration of the solution depend on the thickness of the varicose section. The smallest varices are treated with 0.5-1.0% solution, medium-sized varices with 1.0-2.0% solution and large varices with 3.0-5.0% solution. One should start with a rather weak solution and inject 0.2-0.5 ml. If the required sclerosant effect does not occur, the concentration, not the dose, is increased. In the case of very large varices up to 2 ml may be injected.

Sclerotherapy is carried out with the leg in a horizontal position or raised at 30-450 above the horizontal. The needle may be inserted with the patient standing, if the leg is subsequently raised to the horizontal position. To avoid paravenous injection with smaller varices, the air-block technique may be applied. Sclerotherapy of medium-sized and large varices should however be performed strictly intravenously and without air. The injection should not be administered too slowly, in order to prevent excessive dilution. After application of Sclerovein, the puncture site should be firmly compressed with a gauze pad and a tightly fitting, elastic compression bandage should then be applied. The bandage should be worn for c. 6-8 weeks and may only be removed with the leg raised. It is essential to replace the bandage before the patient stands up, even for a short time.

Patients should be encouraged to ambulate a lot. Bedrest is contraindicated.

The number of repeat treatments (at intervals of 1-2 weeks) depends on the extent of the varicosis.

Spider veins:

These coloured local venectasias are best sclerosed with a 0.5% Sclerovein solution. The procedure is the same as for sclerotherapy of varices. Depending on the size of the area to be sclerosed, 0.1-0.2 ml of Sclerovein 0.5% should be given intravasally per injection; for sclerotherapy of central veins 0.1-0.2 ml of Sclerovein 1% should be given. If an injection does not enter the central vein, Sclerovein 0.5% should be adminstered paravasally.

The patient should walk around for at least 30 minutes immediately after the therapy. Subsequently, firm local compression is necessary for at least 2-3 days if the therapy is to be successful.

Haemangiomas:

These are suitable for a similar procedure, though it may not be possible to sclerose the whole angioma in one session.

Haemorrhoids:

Sclerotherapy is used for internal 1st degree haemorrhoids (success rate 90%) and for 2nd degree haemorrhoids (success rate 25%). Specific preparatory measures (such as enemas) are not necessary and may in fact be problematic.

-         Blanchard's method: in the case of internal haemorrhoids Sclerovein is given as a sub mucous injection or ad to the haemorrhoidal node into the inflow areas of the haemorrhoidal bundle at 3, 7 and 11 o'clock. The injection is painless.

-         Blond's method: using a Roschke drop syringe, Sclerovein is injected in drops through the lateral proctoscope window directly into the domed haemorrhoidal node.

Dosage:

Give 0.5-1.5 ml Sclerovein 3% or 5% per node in a strictly submucous injection. An exception to this is 11 o'clock nodes in men: a maximum of 0.5 ml should be injected.

A maximum of 2 ml should be administered during the initial treatment session. In subsequent sessions (at intervals of 1-2 weeks) a maximum of 3 ml Sclerovein 3% or 2 ml Sclerovein 5% may be administered.

In the case of external haemorrhoids drops should be injected strictly subcutaneously into the pedicle. It is essential not to inject into the interior of the node, as deeper blood vessels could be sclerosed. The objective of the therapy is not to induce an intima reaction, but to produce a fibrosis which impairs the arterial supply.

Normally 4-8 sessions at monthly intervals are necessary; the intervals between injections must be of several weeks. At every session a directed history is obtained; the absence of residual infiltrates is checked by rectal palpation.

Anal fissures:

Healing of anal fissures can be achieved by sclerotherapy with Sclerovein.

Notes:

-         Sclerotherapy of varices: strictly intravenous injection, including spider veins, where possible.

-         Sclerotherapy of haemorrhoids: strictly submucous injection above the node.

-         As with all sclerosing agents, Sclerovein should never be injected intra-arterially, as this could cause severe necrosis which may necessitate amputation. If such an event should occur, a vascular surgeon should be summoned immediately (see Precautionary measures).

Restrictions on application

Contraindications:

Intra-arterial application is severely contraindicated owing to the risk of severe damage (in particular gangrene of the relevant extremity). Other contraindications include: known intolerance to sclerosing agents, history of recent thrombosis, damage to deep veins, 3rd and 4th degree arterial occlusive disease, bed-ridden patients, currently existing infections, the first trimester of pregnancy, diabetes mellitus, acute severe heart diseases, all illnesses and situations which are associated with restricted freedom of movement. Acute inflammation in the anal region is a contraindication for sclerotherapy of haemorrhoids.

Precautionary measures:

-         In addition to the information given under “Dosage/application”, the following precautionary measures should be observed: as there is a risk of shock reactions, medication to counteract these should generally be available during sclerotherapy.

-         The most frequent, serious complication is paravenous injection , followed by intra-arterial application:

-         Paravenous application can result in skin necrosis, which can result in pigment changes and loss of sensitivity. The possible involvement of an adjacent artery should be taken into account. The necrosis should be excised as soon as possible.

-         The erroneous intra-arterial injection generally causes peripheral paresis and extensive necrosis, which may in some cases even result in the loss of the extremity. Therefore the following measures should be taken after intra-arterial injection: inject 5-10 ml 1-2% Lidocaine or Mepivacaine and Heparin 500 I.U. through the same cannula. Pad the ischaemic leg well, keep it low and admit the patient to the hospital and consult a vascular surgeon.

-         In the case of nephropathies, especially glomerulonephritis and nephroses, hepatopathies, acute and chronic diseases of the cardiovascular system, febrile conditions, 2nd degree arterial occlusive disease, advanced age or generally poor health, bronchial asthma.

-         Intravasal injection in the face can cause pressure reversal in the arteries and thus cause irreversible visual disturbance (blindness).

-         When using sclerotherapy in the ankle region, only small quantities in low concentrations should be administered to prevent excessive sclerosant reactions. The risk of inadvertent intra-arterial injection in the region of the foot/ankle should also be taken into account.

Pregnancy, breast-feeding:

Pregnancy category C

No controlled studies are available for Sclerovein either for animals or for pregnant women. In these circumstances the medication should only be administered if the potential benefit outweighs the risk to the foetus. However, no sclerotherapy should be performed during the first trimester of pregnancy or after the 36th week of pregnancy.

Sclerovein should not be used for breast-feeding women.

Unwanted side-effects

Hyperpigmentation, periphlebitis and necrosis, in particular with paravasal injection. There are sometimes psychogenic reactions, collapse, breathing difficulties, a feeling of pressure, locally impaired sensitivity, in isolated cases temporary dizziness, nausea, visual disturbance and a metallic taste, rarely allergic skin reactions, extremely rarely allergic shock or asthma-like reactions. Haemorrhoids: transient pain during and after injection, especially in men in the 11 o'clock haemorrhoid region. In individual cases pain in the prostate region is possible and in rare cases it is associated with temporarily impaired erection. A small amount of bleeding can occur from the injection site and there may be small necrosis of the mucosa, which may cause some pain but heal within a few days.

Discoloration of the skin due to haemosiderin deposit after sclerotherapy at the site of the former varicose veins cannot be entirely prevented, but can be reduced by removal of the thrombus with a small stab incision. The compression bandage should be worn for 6 to 8 weeks and exposure to the sun should be avoided. It may take 1 year for the discoloration to disappear. Hypersensitivity reactions and pulmonary embolisms are rare, if indeed any causal link can be identified.

The chlorobutanol contained in the preparation can, in rare cases, cause sudden falls in blood pressure.

Interactions

As Polidocanol is also a local anaesthetic, if it is given at the same time as other anaesthetics there is a risk of intensifying their anti-arrhythmic effects. Therefore, after surgical removal of varices of main veins, sclerotherapy of varices of side branches should be carried out after an interval of 1-2 days.

Overdoses

An overdose caused by too high a dose or concentration can result in local necrosis, especially with paravenous application. In such a case, depending on the quantity and concentration of the Sclerovein injected, Procain 1% (0.5-2 ml) or physiological common salt solution (5-20 ml) should be injected at the same site, if possible in conjunction with hyaluronidase.

Miscellaneous information

Shelf-life:

The medication should only be used until the date designated by “EXP” on the packaging.

Commercial availability:

30 ml bottles of 0.5%, 1%, 2%, 3% and 5% solution.

Information prepared

December 1996

For your information:
This page has been provided for your information and to answer common questions. This web-site has been prepared to answer questions about a variety of circulatory problems, ranging from cosmetic blemishes through to more serious underlying circulatory problems.

The site is intended to be a simple guide, answering commonly asked questions. It does not replace a formal consultation with a vascular or vein specialist, who will be in a better position to answer your questions fully.

 

  Contact information
Address:43 Devonshire Street,
London W1G 7AL
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Phone    +44 (0) 7924 255336
Call Centre: 0333 900 1020
PA: Ms Vinton: +44 (0) 7956 518319
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E-Mail:
Information:      info@dr-bull.com

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APPOINTMENTS ONLINE
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Thank you for considering the Vein Clinic. If you feel that one of our treatments for spider veins or varicose veins might benefit your health or appearance, please make an appointment with us for further evaluation.

You can also take advantage of our online appointment or E-Mail Appointments online notification. Further more our call centre at 0333 900 1020 is available to you from 9:00 to 5:00 UK time

 
 
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