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CASPOFUNGIN ZENTIVA Powder for solution for infusion (2021)

Αναφορές

Βιβλιογραφική αναφορά

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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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