Revasc
desirudin
PACKAGE LEAFLET: INFORMATION FOR THE USER
Desirudin
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, nurse or your pharmacist.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
What Revasc is and what it is used for
Before you use Revasc
How to use Revasc
Possible side effects
How to store Revasc
Further information
Medicinal product no longer authorised
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.
if you are hypersensitive (allergic) to natural or synthetic hirudin, including desirudin or any of the other 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.
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 last month
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.
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)
Medicinal product no longer authorised
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.
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.
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.
Overdose with Revasc may lead to bleeding. If this occurs, Revasc will be stopped and treatment given for the bleeding.
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:
Medicinal product no longer authorised
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.
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).
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.
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.
This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i.e. essentially ‘sodium- free’.
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
Medicinal product no longer authorised
Not all pack sizes may be marketed.
The marketing authorisation holder is: Canyon Pharmaceuticals Limited
7th Floor
52-54 Gracechurch Street London EC3V 0EH United Kingdom
The manufacturer is:
Canyon Pharmaceuticals GmbH Unter Gereuth 10
D-79353 Bahlingen a.K. Germany