Revasc

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

desirudin

Available from:

Canyon Pharmaceuticals Ltd.

ATC code:

B01AE01

INN (International Name):

desirudin

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Venous Thrombosis

Therapeutic indications:

Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement surgery.

Product summary:

Revision: 12

Authorization status:

Withdrawn

Authorization date:

1997-07-09

Patient Information leaflet

21
B. PACKAGE LEAFLET
Medicinal product no longer authorised
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
REVASC 15MG/0.5ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Desirudin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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.
IN THIS LEAFLET
:
1.
What Revasc is and what it is used for
2.
Before you use Revasc
3.
How to use Revasc
4.
Possible side effects
5.
How to store Revasc
6.
Further information
1.
WHAT REVASC IS AND WHAT IT IS USED FOR
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.
2.
BEFORE YOU USE REVASC
YOU MUST NOT BE GIVEN REVASC
- 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.
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
-

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Revasc 15mg/0.5ml powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each vial contains 15 mg desirudin.
After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml
Desirudin consists in a single chain polypeptide of 65 amino acid
residues and 3 disulphide bridges.
* produced by recombinant DNA technology in yeast cells.
** corresponding to approximately 270,000 antithrombin units (ATU) or
18,000 ATU per mg of
desirudin with reference to the WHO Second International Standard for
alpha-thrombin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White powder and clear, colourless solvent for solution for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of deep venous thrombosis in patients undergoing elective
hip or knee replacement
surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Revasc should be initiated under the guidance of a
physician with experience in
coagulation disorders. Instructions for the preparation of Revasc are
provided in section 6.6.
Adult and elderly patients
The recommended dose is 15 mg twice daily. 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 days up to a maximum
of 12 days or until the patient
is fully ambulant, whichever occurs first. Currently, there is no
clinical experience to support the use
of desirudin beyond 12 days.
Administration is by subcutaneous injection, preferably at an
abdominal site. Injections should be
rotated between at least four different sites.
Children
There is no experience in children.
Patients with renal impairment
Desirudin is contraindicated in patients with severe renal impairment
(creatinine clearance of less
than 30ml/min corresponding to a serum creatinine > 2.5mg/dl o