FLOXAPEN Powder for solution for injection / infusion (2021)

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Περιεχόμενα

1. Name of the medicinal product

Floxapen 250mg Powder for solution for Injection or Infusion.

2. Qualitative and quantitative composition

Each vial contains 250 mg flucloxacillin (as flucloxacillin sodium). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Powder for solution for injection or infusion. A fine white homogeneous sterile powder for solution for injection, infusion or nebuliser solution.

4.1. Therapeutic indications

Floxapen is indicated for the treatment of infections due to β-lactamase-producing staphylococci and other sensitive Gram-positive organisms such as streptococci (see section 5.1 for details on sensitive ...

4.2. Posology and method of administration

Posology The dosage depends on age, weight and renal function of the patient, as well as the severity and nature of the infection. For instructions on the preparation of solution see section 6.6. For incompatibilities ...

4.3. Contraindications

Flucloxacillin should not be given to patients with a history of hypersensitivity to beta‑lactam antibiotics (e.g. penicillins, cephalosporins) or excipients. Flucloxacillin is contraindicated in patients ...

4.4. Special warnings and precautions for use

Before initiating therapy with flucloxacillin, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactams. Cross-sensitivity between penicillins and cephalosporins is ...

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

Probenecid decreases the tubular secretion of flucloxacillin. Concurrent administration of probenecid delays the renal excretion of flucloxacillin. Bacteriostatic drugs (chloramphenicol, erthromycins, ...

4.6. Pregnancy and lactation

Pregnancy Animal studies with flucloxacillin have shown no teratogenic effects. Limited information is available on the use of flucloxacillin in human pregnancy. Flucloxacillin should only be used in pregnancy ...

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

The following convention has been utilised for the classification of undesirable effects: Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000). ...

4.9. Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically. Flucloxacillin is not removed from the circulation by haemodialysis.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Beta-lactamase resistant penicillins ATC code: J01CF05 Flucloxacillin is a semisynthetic penicillin (beta-lactam antibiotic; isoxazolylpenicillin) with a narrow ...

5.2. Pharmacokinetic properties

Absorption The peak serum levels of flucloxacillin reached after 1h are as follows: After 500mg by the i.m. route: approximately 16.5 mg/l. Distribution Protein binding: the serum protein binding rate ...

5.3. Preclinical safety data

Not relevant.

6.1. List of excipients

None.

6.2. Incompatibilities

Floxapen should not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions. If Floxapen is prescribed concurrently with an aminoglycoside, ...

6.3. Shelf life

As packaged for sale: 3 years. From a microbiological point of view, the product should be administered within 30 minutes of preparation. However chemical and physical in-use stability of aqueous ...

6.4. Special precautions for storage

Unopened product: Do not store above 25°C. Aqueous solutions of Floxapen may be stored for 24 hours at 2-8°C if prepared under the appropriate aseptic conditions (refer to section 6.3).

6.5. Nature and contents of container

Clear type III glass vials with butyl rubber plug, aluminium seal and green flip off cap. Boxes of 10.

6.6. Special precautions for disposal and other handling

Floxapen may be added to most intravenous fluids (e.g. Water for Injections, sodium chloride 0.9%, glucose 5%, sodium chloride 0.18% with glucose 4%). Intramuscular: Add 1.5 ml Water for Injections ...

7. Marketing authorization holder

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjördur, Iceland

8. Marketing authorization number(s)

PA1380/011/003

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 18 January 1979 Date of last renewal: 18 January 2009

10. Date of revision of the text

March 2021

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