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MYCAMINE Powder for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Mycamine 50 mg powder for solution for infusion. Mycamine 100 mg powder for solution for infusion.

Qualitative and quantitative composition

Mycamine 50 mg: Each vial contains 50 mg micafungin (as sodium). After reconstitution each ml contains 10 mg micafungin (as sodium). Mycamine 100 mg: Each vial contains 100 mg micafungin (as sodium). ...

Pharmaceutical form

Powder for solution for infusion. White compact powder.

Therapeutic indications

Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly: Treatment of invasive candidiasis. Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate. ...

Posology and method of administration

Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections. Posology Specimens for fungal culture and other relevant laboratory studies (including histopathology) ...

Contraindications

Hypersensitivity to the active substance, to other echinocandins or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Hepatic effects The development of foci of altered hepatocytes (FAH) and hepatocellular tumours after a treatment period of 3 months or longer were observed in rats. The assumed threshold for tumour development ...

Interaction with other medicinal products and other forms of interaction

Micafungin has a low potential for interactions with medicines metabolised via CYP3A mediated pathways. Drug interaction studies in healthy human subjects were conducted to evaluate the potential for interaction ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of micafungin in pregnant women. In animal studies micafungin crossed the placental barrier and reproductive toxicity was seen (see section 5.3). The potential ...

Effects on ability to drive and use machines

Micafungin has no or negligible influence on the ability to drive or use machines. However, patients should be informed that dizziness has been reported during treatment with micafungin (see section 4.8). ...

Undesirable effects

Summary of the safety profile Based on clinical trial experience, overall 32.2% of the patients experienced adverse drug reactions. The most frequently reported adverse reactions were nausea (2.8%), blood ...

Overdose

Repeated daily doses up to 8 mg/kg (maximum total dose 896 mg) in adult patients have been administered in clinical trials with no reported dose-limiting toxicity. In one spontaneous case, it was reported ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antimycotics for systemic use, other antimycotics for systemic use ATC code: J02AX05 Mode of action Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an ...

Pharmacokinetic properties

Absorption Pharmacokinetics are linear over the daily dose range of 12.5 mg to 200 mg and 3 mg/kg to 8 mg/kg. There is no evidence of systemic accumulation with repeated administration and steady-state ...

Preclinical safety data

The development of foci of altered hepatocytes (FAH) and hepatocellular tumours in rats was dependent on both dose and duration of micafungin treatment. FAH recorded after treatment for 13 weeks or longer ...

List of excipients

Lactose monohydrate Citric acid anhydrous (to adjust the pH) Sodium hydroxide (to adjust the pH)

Incompatibilities

This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned in section 6.6.

Shelf life

Unopened vial: 3 years. Reconstituted concentrate in vial Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C when reconstituted with sodium chloride 9 mg/ml (0.9%) ...

Special precautions for storage

Unopened vials: This medicinal product does not require any special storage conditions. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Nature and contents of container

10 ml Type I glass vial with an isobutylene-isoprene (PTFE-laminated) rubber stopper and a flip-off cap. The vial is wrapped with an UV-protective film. Pack size: packs of 1 vial.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements. Mycamine must not be mixed or co-infused with other medicinal products except those mentioned below. Using ...

Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands

Marketing authorization number(s)

EU/1/08/448/001 EU/1/08/448/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 25 April 2008 Date of latest renewal: 19 February 2018

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