PERFAN Concentrate for solution for injection or infusion (2011)
Βιβλιογραφική αναφορά
Συγγραφείς
Carinopharm GmbH
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Περιεχόμενα
1. Name of the medicinal product
Perfan 5mg/ml Concentrate for Solution for Injection or Infusion.
2. Qualitative and quantitative composition
Each ml of the concentrate contains 5 mg enoximone. Each 20ml ampoule contains 100 mg enoximone. When diluted as recommended, the resulting diluted solution contains 2.5 mg of enoximone per ml. Also includes: ...
3. Pharmaceutical form
Concentrate for solution for injection or infusion. Clear, yellow solution.
4.1. Therapeutic indications
Perfan 5mg/ml concentrate for solution for injection or infusion indicated for the treatment of congestive cardiac failure.
4.2. Posology and method of administration
Perfan 5mg/ml concentrate for solution for injection or infusion must be diluted 1:1 with either 0.9% sodium chloride injection or water for injection before administration. <u>Loading Dose:</u> 0.5mg/kg ...
4.3. Contraindications
Perfan 5mg/ml concentrate for solution for injection for infusion is contra-indicated in patients with a known hypersensivitity to enoximone or any of the components of the medicinal product.
4.4. Special warnings and precautions for use
Enoximone therapy has been associated with reductions in platelet counts to below 100x 10<sup>6</sup>/L. Platelet count should be monitored. Enoximone should be used with caution in patients with congestive ...
4.5. Interaction with other medicinal products and other forms of interaction
No clinical manifestation of sun toward drug interaction were observed in patients receiving Perfan 5mg/ml concentrate for solution for injection or infusion most of whom concomitantly recieved one or ...
4.6. Pregnancy and lactation
There are no adequate and well-controlled studies in pregnant women. Perfan 5 mg/ml concentrate for solution for injection or infusion should be used during pregnancy only if the potential benefit justifies ...
4.7. Effects on ability to drive and use machines
Not applicable as the product is used on hospitalised patients.
4.8. Undesirable effects
Side effects include ectopic beats, ventricular tachyarrhythmias, supraventricular and other arrythmias, hypotension, headache, insomnia, nausea and/or vomiting or diarrhoea. Chills, oliguria, urinary ...
4.9. Overdose
Intravenous administration of Perfan 5 mg/ml concentrate for solution for injection or infusion has been shown to produce reductions in blood pressure with occasional instances of hypotensive symptoms. ...
5.1. Pharmacodynamic properties
Enoximone, an imidazolone, has both positive inotropic and vasolidator properties, inhibiting cardiac phosphodiesterase III with an increase in cAMP.
5.2. Pharmacokinetic properties
Enoximone half-life ranged from 3 to 8 hours for enoximone and 6-11 hours for the sulphoxide. 0.45% of the intact drug was recovered from the urine and 74% of the metabolite, which is pharmacologically ...
5.3. Preclinical safety data
Not applicable.
6.1. List of excipients
Ethanol, anhydrous Sodium hydroxide Propylene glycol Water for injections
6.2. Incompatibilities
Perfan 5mg/ml concentrate for solution for infusion may only be diluted with sodium chloride solution or water for injections (see section 6.6). Other drugs or fluids must not be mixed in the same container ...
6.3. Shelf life
Unopened: 3 years. Use immediately once diluted.
6.4. Special precautions for storage
Do not store above 30ºC. In-use: see section 6.3 and section 6.6.
6.5. Nature and contents of container
Glass ampoules (TypeI Ph.Eur.) of 20ml in cartons containing 10 ampoules.
6.6. Special precautions for disposal and other handling
Prior to administration, Perfan 5mg/ml concentrate for solution for injection or infusion must be diluted 1:1 with isotonic sodium chloride solution or water for injections. Dilution should take place ...
7. Marketing authorization holder
Carinopharm GmbH, Bahnhofstraße 18, 31008 Elze, Germany
8. Marketing authorization number(s)
PA1682/1/1
9. Date of first authorization / renewal of the authorization
Date of first authorization: 10 October 1988 Date of last renewal: 10 October 2008
10. Date of revision of the text
January 2011
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