FETCROJA Powder for concentrate for solution for infusion (2024)

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Περιεχόμενα

1. Name of the medicinal product

Fetcroja 1 g powder for concentrate for solution for infusion.

2. Qualitative and quantitative composition

Each vial contains cefiderocol sulfate tosylate equivalent to 1 g of cefiderocol. Excipient with known effect: Each vial contains 7.64 mmol of sodium (approximately 176 mg). For the full list of ...

3. Pharmaceutical form

Powder for concentrate for solution for infusion (powder for concentrate). White to off-white powder.

4.1. Therapeutic indications

Fetcroja is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4 and 5.1). Consideration should be given to official ...

4.2. Posology and method of administration

It is recommended that Fetcroja should be used to treat patients that have limited treatment options only after consultation with a physician with appropriate experience in the management of infectious ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to any cephalosporin antibacterial medicinal product. Severe hypersensitivity (e.g. anaphylactic ...

4.4. Special warnings and precautions for use

Hypersensitivity reactions Hypersensitivity has been reported with cefiderocol (see sections 4.3 and 4.8). Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam ...

4.5. Interaction with other medicinal products and other forms of interaction

Based on in vitro studies and two phase 1 clinical studies no significant drug-drug interactions are anticipated between cefiderocol and substrates, inhibitors or inducers of cytochrome P450 enzymes ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of cefiderocol sodium in pregnant women. Animal studies do not indicate direct or indirect harmful effects ...

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

Summary of the safety profile The most common adverse reactions were diarrhoea (8.2%), vomiting (3.6%), nausea (3.3%) and cough (2%). Tabulated list of adverse reactions The following adverse reactions ...

4.9. Overdose

There is no information on clinical signs and symptoms associated with an overdose of cefiderocol. In the event of overdose, patients should be monitored and treatment discontinuation and general supportive ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use ATC code: J01DI04 Mechanism of action Cefiderocol is a siderophore cephalosporin. In addition to passive diffusion through outer ...

5.2. Pharmacokinetic properties

After multiple dose administration of cefiderocol, there is no accumulation of cefiderocol administered every 8 hours in healthy adult subjects with normal renal function. Distribution The binding of cefiderocol ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, or genotoxicity. Carcinogenicity studies with cefiderocol have not been conducted. Cefiderocol ...

6.1. List of excipients

Sucrose Sodium chloride Sodium hydroxide (pH adjustment)

6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. If treatment with a combination of another medicinal product and Fetcroja is unavoidable, administration ...

6.3. Shelf life

Powder: 3 years. Stability of reconstituted solution in the vial: Chemical and physical in-use stability after reconstitution has been demonstrated for 1 hour at 25°C. From a microbiological ...

6.4. Special precautions for storage

Store in a refrigerator (2°C-8°C) Store in the original carton in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

6.5. Nature and contents of container

14 mL vial (Type I clear glass vial), chlorobutyl elastomeric stopper, and aluminum seal with a plastic flip-off cap. The vials are packed in a cardboard carton. Pack size of 10 vials.

6.6. Special precautions for disposal and other handling

Each vial is for single use only. The powder should be reconstituted with 10 mL of either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% dextrose injection taken from the 100 mL bags that ...

7. Marketing authorization holder

Shionogi B.V., Herengracht 464, 1017CA Amsterdam, Netherlands

8. Marketing authorization number(s)

EU/1/20/1434/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 23 april 2020

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