Revasc 15mg/0.5ml powder and solvent for solution forinjection

The common name of the active substance in Revasc is desirudin. Desirudin is a recombinant DNA product derived from yeast cells. Desirudin belongs to a group of medicines called anticoagulants, which prevent blood clots from forming in the blood vessels.

Revasc is used to prevent blood clotting after elective hip or knee replacement surgery, as harmful blood clots can form in the blood vessels of the legs. It is often given for several days after operations because blood clots are most likely to form when you are resting in bed.

You must not be given Revasc

• if you are hypersensitive (allergic) to natural or synthetic hirudin, including desirudin or any of theother ingredients of Revasc
• if you are bleeding a lot or have any serious bleeding disorder (e.g. haemophilia)
• if you have serious kidney or liver disease
• if you have a heart infection
• if you have an uncontrolled high blood pressure
• if you are pregnant.

Take special care with Revasc

Make sure you tell your doctor if you are likely to have an increased risk of bleeding, which may be the case if you have, or have had:

• bleeding disorders or a family history of bleeding disorder
• stomach ulcers or any other bleeding disease of the gut
• history of a stroke, or bleeding within the brain or eye
• a recent operation (including dental surgery) or biopsy or pricking of a blood vessel within the lastmonth
• recently a brief shortage of blood supply to a part of the brain within the last six months
• bleeding in the gut or lung within the past three months.

Your risk of bleeding may also be increased:

• if you have recently given birth, fallen, or suffered a blow to the body or head
• if you are already taking medicines, especially blood-thinners (see below).

If any of the above apply to you, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly.

Cross-sensitivity to other hirudin products is possible. You should also inform your doctor if you have ever received Revasc, hirudin or an hirudin analogue.

Children
There is no experience with Revasc in children.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• medicines used to prevent blood-clotting (warfarin, heparin and dicoumarol)
• medicines which affect the function of platelets (particles in the blood involved in blood- clotting), e.g. acetylsalicylic acid, a substance present in many medicinal products used to relieve pain and lower fever, and other non-steroidal anti-inflammatory agents.

Pregnancy and breast-feeding

You should not be given Revasc if you are pregnant. Revasc can cause serious harm to your baby. It is therefore important to tell your doctor if you are pregnant or planning to become pregnant. If you are of a child-bearing age, a pregnancy test may be done by your doctor to make sure you are not pregnant.

It is advisable not to breast-feed during treatment.

You will be given Revasc as an injection under the skin.

Administration is by subcutaneous injection, preferably at an abdominal site. Injections should be rotated between at least four different sites. The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used. Treatment with desirudin is then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully mobile, whichever occurs first. Currently, there is no clinical experience to support the use of Revasc beyond 12 days.

Usual dosage

Always take Revasc exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dosage is 15mg injected twice a day for 9 days to a maximum of 12 days. You will be given the first injection within 5 to 15 minutes before the operation. If you need treatment for longer than 12 days, the doctor may switch you to another similar medicine.

If you have a kidney or liver disease, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly.

If you are given more than you should

Overdose with Revasc may lead to bleeding. If this occurs, Revasc will be stopped and treatment given for the bleeding.

If a dose is missed

If a dose of this medicine is missed, it should be given to you as soon as possible. If it is almost time for the next dose you will skip the missed dose and go back to the normal dosage schedule. The dose should not be doubled.

Like all medicines, Revasc can cause side effects, although not everybody gets them. Some of these side effects may be similar to the effects of surgery. The most likely side effect is bleeding.

Tell the doctor or nurse as soon as possible if any of the following side effects occur, some of which may be confused with side effects of surgery:

Commonreported side effects (likely to affect between 1 in 10 and 1 in 100 patients):Unusual tiredness or weakness (anaemia), nausea, oozing of fluid from wounds, low blood pressure, fever, inflammation of veins sometimes accompanied by a clot, lumps at injection sites, bruising, swelling of the legs caused by fluid retention, non-fatal allergic reactions.

Uncommon side effects (likely to affect between 1 in 100 and 1 in 1,000 patients): Increase in liver enzymes, dizziness, sleeplessness, confusion, feeling breathless, vomiting (with or without blood), constipation, blood in your urine, difficulty in urinating, rash, itching (urticaria), low levels of potassium in the blood, burning feeling when passing urine with also an increased frequency of urination, slow healing of wounds, nose bleeds, high blood pressure, pain (including pain in legs, stomach and/or chest).

Rareside effects (likely to affect between 1 in 1,000 and 1 in 10,000 patients):
Anti-hirudin antibodies have been detected upon re-exposure

Isolated cases of fatal bleeding have been reported.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

Keep out of the reach and sight of children.

Do not use Revasc after the expiry date which is stated on the carton and the pack.

Do not store above 25°C. Keep the vial and ampoule in the outer carton.

After reconstitution, immediate use is recommended. However, the in-use stability has been demonstrated for 24 hours between 2°C and 8°C (in a refrigerator).

Do not use Revasc if you notice that the solution for injection contains visible particles.

Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Revasc contains

The active substance is desirudin (15mg/0.5ml powder).
The other ingredients in the powder are magnesium chloride and sodium hydroxide. In the solvent the ingredients are mannitol and water.

Important information about some of the ingredients of Revasc

This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i.e. essentially ?sodium-free?.

What Revasc looks like and contents of the pack

Revasc consists of a vial containing a white powder and an ampoule containing clear, colourless solvent for solution for injection.

Pack sizes: 1 vial and 1 ampoule in one package
2 vials and 2 ampoules in one package
10 vials and 10 ampoules in one package

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is:
Canyon Pharmaceuticals Limited
20-22 Bedford Row
London WC1R 4JS
United Kingdom.

The manufacturer is:
Canyon Pharmaceuticals GmbH
Unter Gereuth 10
D-79353 Bahlingen a.K.
Germany

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