CASPOFUNGIN ZENTIVA Powder for solution for infusion (2021)
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Περιεχόμενα
1. Name of the medicinal product
Caspofungin Zentiva 50 mg powder for concentrate for solution for infusion.
2. Qualitative and quantitative composition
Each 50 mg vial contains 50 mg caspofungin (as acetate). After reconstitution in 10.5 ml of water for injection, 1 ml of the concentrate contains 5.2 mg caspofungin. For the full list of excipients, see ...
3. Pharmaceutical form
Powder for concentrate for solution for infusion. White to off-white lyophilized powder.
4.1. Therapeutic indications
Treatment of invasive candidiasis in adult or paediatric patients. Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations ...
4.2. Posology and method of administration
Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections. Posology Adult patients A single 70 mg loading dose should be administered on Day-1, followed ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Anaphylaxis has been reported during administration of caspofungin. If this occurs, caspofungin should be discontinued and appropriate treatment administered. Possibly histamine-mediated adverse reactions, ...
4.5. Interaction with other medicinal products and other forms of interaction
Studies <em>in vitro</em> show that caspofungin is not an inhibitor of any enzyme in the cytochrome P450 (CYP) system. In clinical studies, caspofungin did not induce the CYP3A4 metabolism of other substances. ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited data from the use of caspofungin in pregnant women. Caspofungin should not be used during pregnancy unless clearly necessary. Animal studies have shown developmental toxicity ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Hypersensitivity reactions (anaphylaxis and possibly histamine-mediated adverse reactions) have been reported (see section 4.4). Also reported in patients with invasive aspergillosis were pulmonary oedema, ...
4.9. Overdose
Inadvertent administration of up to 400 mg of caspofungin in one day has been reported. These occurrences did not result in clinically important adverse reactions. Caspofungin is not dialysable.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antimycotics for systemic use, other antimycotics for systemic use <b>ATC code:</b> J02AX04 Mechanism of action Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) ...
5.2. Pharmacokinetic properties
Distribution Caspofungin is extensively bound to albumin. The unbound fraction of caspofungin in plasma varies from 3.5% in healthy volunteers to 7.6% in patients with invasive candidiasis. Distribution ...
5.3. Preclinical safety data
Repeated dose toxicity studies in rats and monkeys using doses up to 7-8 mg/kg given intravenously showed injection site reactions in rats and monkeys, signs of histamine release in rats, and evidence ...
6.1. List of excipients
Sucrose Mannitol Glacial acetic acid Sodium hydroxide (for pH adjustment)
6.2. Incompatibilities
Do not mix with diluents containing glucose, as caspofungin is not stable in diluents containing glucose. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...
6.3. Shelf life
2 years. Caspofungin contains no preservatives. Chemical and physical in-use stability has been demonstrated for up to 24 hours at 25°C or less and at 5 ± 3°C when reconstituted with water for injection. ...
6.4. Special precautions for storage
<u>Unopened vials:</u> store in a refrigerator (2°C-8°C). For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
6.5. Nature and contents of container
10 ml transparent Type I glass vial with grey bromobutyl rubber stopper and aluminium band with red PP flip-off cap. Supplied in packs of 1 vial.
6.6. Special precautions for disposal and other handling
Reconstitution of Caspofungin DO NOT USE ANY DILUENTS CONTAINING GLUCOSE, as caspofungin is not stable in diluents containing glucose. DO NOT MIX OR CO-INFUSE Caspofungin WITH ANY OTHER MEDICINES, as there ...
7. Marketing authorization holder
Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
8. Marketing authorization number(s)
PL 17780/0769
9. Date of first authorization / renewal of the authorization
11/01/2017 / 30/04/2021
10. Date of revision of the text
30/04/2021
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