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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

DIFLICIR Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

DIFICLIR 200 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 200 mg of fidaxomicin. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Capsule shaped tablets of 14 mm, white to off-white in colour, debossed with FDX on one side and 200 on the other side.

Therapeutic indications

DIFICLIR film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body ...

Posology and method of administration

Posology Adults The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days. DIFICLIR 40 mg/ml granules for oral suspension may be used in adult patients with ...

Contraindications

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

Special warnings and precautions for use

Hypersensitivity reactions Hypersensitivity reactions including severe angioedema have been reported (see section 4.8). If a severe allergic reaction occurs during treatment with fidaxomicin, the medicinal ...

Interaction with other medicinal products and other forms of interaction

Effect of P-gp inhibitors on fidaxomicin Fidaxomicin is a substrate of P-gp. Co-administration of single doses of the P-gp inhibitor cyclosporine A and fidaxomicin in healthy volunteers, resulted in a ...

Fertility, pregnancy and lactation

Pregnancy There are no data available from the use of fidaxomicin in pregnant women. Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary ...

Effects on ability to drive and use machines

DIFICLIR has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most common adverse reactions are vomiting (1.2%), nausea (2.7%) and constipation (1.2%). Tabulated list of adverse reactions Table 1 displays adverse reactions associated ...

Overdose

No adverse reactions for acute overdose have been reported during clinical studies or from post-marketing data. However, the potential for adverse reactions cannot be ruled out and general supportive measures ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, antibiotics ATC code: A07AA12 Mechanism of action Fidaxomicin is an antibiotic belonging to the macrocyclic ...

Pharmacokinetic properties

Absorption The bioavailability in humans is unknown. In healthy adults, C<sub>max</sub> is approximately 9.88 ng/ml and AUC<sub>0-t</sub> is 69.5 ng•hr/ml following administration of 200 mg fidaxomicin, ...

Preclinical safety data

Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, and reproductive toxicity. Reproductive and fertility parameters ...

List of excipients

Core tablets: Microcrystalline cellulose Pregelatinised starch (maize) Hydroxypropyl cellulose Butylated hydroxytoluene Sodium starch glycolate Magnesium stearate Coating: Polyvinyl alcohol Titanium dioxide ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

100 1 film-coated tablet in alu/alu perforated unit dose blisters. 20 1 film-coated tablet in alu/alu perforated unit dose blisters. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

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

Marketing authorization number(s)

EU/1/11/733/003-004

Date of first authorization / renewal of the authorization

Date of first authorisation: 5 December 2011 Date of latest renewal: 22 August 2016

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