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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 0.56 g powder for solution for injection with 10 U reteplase (INN)
1 vial contains 10 U* reteplase** in 0.56 g powder
Potency of reteplase is expressed in units (U) by using a reference standard which is specific for reteplase and is not comparable with units used for other thrombolytic agents.
For a full list of excipients see section 6.1.
* Potency of reteplase is expressed in units (U) by using a reference standard which is specific for reteplase and is not comparable with units used for other thrombolytic agents.
**Recombinant plasminogen activator produced in Escherichia coli by recombinant DNA technology.
4.2 Posology and method of administration
The reconstituted solution must be used immediately. Visual inspection of the solution is necessary after reconstitution. Only clear, colourless solutions should be injected. If the solution is not clear and colourless it should be discarded.
Heparin and Rapilysin are incompatible with combined in solution. Other incompatabilities may also exist. No other medication should be added to the injection solution (see below and 6.2 Incompatibilities).
Use in children
There is no experience in children
Safety and effectiveness of reteplase in children have not been established. Treatment of children is not recommended.
4.3 Contraindications
Hypersensitivity to Rapilysin is contraindicated in patients with known hypersensitivity to the active substance (reteplase), polysorbate 80 or any of the other ingredients.
4.4 Special warnings and special precautions for use
Use in children
Safety and effectiveness of reteplase in children have not been established. Treatment of children is not recommended
4.8 Undesirable effects
The most commonly reported adverse drug reaction associated with reteplase treatment is haemorrhage, predominantly at the injection site. Local reactions at injection site can also occur. As with other thrombolytic agents, recurrent ischaemia / angina, hypotension and heart failure / pulmonary oedema have been reported frequently as sequelae of myocardial infarction and / or thrombolytic administration.
6.2 Incompatibilities
Heparin and Rapilysin are incompatible when combined in solution. Other incompatibilities may also exist. No other medicines should be added to the injection solution.
6.3 Shelf life
Shelf-life as package for sale:
Rapilysin 10 U vials have a shelf life of 3 years.
When reconstituted as directed, the solution must be used immediately.
6.4 Special precautions for storage
For storage conditions of the reconstituted medicinal product, see section 6.3.
6.6 Instructions for use and handling, and disposalSpecial precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Heparin and Rapilysin are incompatible when combined in solution. Other compatibilities may also exist. No other medication should be added to the injection solution.
8. Disconnect the syringe from the reconstitution spike and attach the sterile needle provided. The dose is not ready for intravenous administration.
9. The reconstituted solution must be used immediately. Visual inspection of the solution is necessary after reconstitution. Only clear, colourless solutions should be injected. If the solution is not clear and colourless it should be discarded.
10. No other medicines should be injected through the line reserved for Rapilysin either at the same time, or prior to, or following Rapilysin injection. This applies to all products including heparin and acetylsalicylic acid, which should be administered before and following the administration of reteplase to reduce the risk of re-thrombosis.
11. In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % dextrose solution prior to and following the Rapilysin injection (see section 4.2 Posology and method of administration).
10. DATE OF REVISION OF THE TEXT
Amended to: 10 August 2006
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