FLUCLOXACILLIN Powder for oral solution (2022)
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Περιεχόμενα
Name of the medicinal product
Flucloxacillin 125mg/5ml Powder For Oral Solution.
Qualitative and quantitative composition
Each 5ml reconstituted solution contains Flucloxacillin Sodium equivalent to Flucloxacillin 125mg. <u>Excipient(s) with known effect:</u> Contains 5.00 mg of Sodium Benzoate and 316.120 mg of Sucrose. ...
Pharmaceutical form
Powder for oral solution. Pink free flowing powder.
Therapeutic indications
Flucloxacillin Sodium is indicated for the treatment of infections due to sensitive Gram-positive organisms, including β-lactamase-producing staphylococci and streptococci. Typical indications include: ...
Posology and method of administration
Posology The dosage depends on age, weight and renal function of the patient, as well as the severity of the infection. Adults (including the elderly) Oral: 250mg four times daily. In serious infections, ...
Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, to β-lactam antibiotics (e.g. penicillins, cephalosporins). Flucloxacillin is contra-indicated in patients with ...
Special warnings and precautions for use
The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthematous pustulosis (AGEP) (see section 4.8). In case of ...
Interaction with other medicinal products and other forms of interaction
Probenecid and sulfinpyrazone slow down the excretion of flucloxacillin by decreasing tubular secretion. Other drugs such as piperacillin, which are excreted via renal tubular secretion, may interfere ...
Pregnancy and lactation
Pregnancy Animal studies with flucloxacillin have shown no teratogenic effects. Flucloxacillin preparations have been in clinical use since 1970 and the limited number of reported cases of use in human ...
Effects on ability to drive and use machines
Flucloxacillin has no or negligible influence on the ability to drive or operate and use machines.
Undesirable effects
The following convention has been utilised for the classification of undesirable effects: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000), very ...
Overdose
With high doses (mainly parenteral) neurotoxicity may develop. Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically. Flucloxacillin is not ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-Lactamase Resistant Penicillins ATC code: J01CF05 Properties Flucloxacillin is a narrow-spectrum antibiotic of the group of isoxazolyl penicillins; it is not inactivated ...
Pharmacokinetic properties
Absorption Flucloxacillin is stable in acid media and can therefore be administered either by the oral or parenteral route. The peak serum levels of flucloxacillin reached after one hour are as follows. ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Sodium benzoate (E211) Disodium edetate Saccharin sodium Mono-Ammonium-Glycyrrhizinate Sodium citrate anhydrous (E331) Flavour pineapple Flavour menthol Erythrosine (E127) Sucrose
Incompatibilities
As for Penicillin. Incompatible with Colistin Polymixin B Sulphate. Loss of potency after mixing with Streptomycin has also been reported.
Shelf life
<u>Unopened:</u> 3 years. <u>After reconstitution or when the container is opened for the first time:</u> 7 days.
Special precautions for storage
<u>Unopened bottle:</u> Do not store above 25°C. Store in the original container. Keep the container tightly closed. <u>Reconstituted solution:</u> Store at 2-8°C.
Nature and contents of container
<u>Nature:</u> 150ml amber glass Beatson Clark container with polypropylene screw cap or 150ml high density polyethylene bottle with child resistant closure with expanded polyethylene wad: 100ml.
Special precautions for disposal and other handling
To reconstitute, add 58ml of water, replace the lid and shake the bottle well.
Marketing authorization holder
Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip, HA4 6QD, United Kingdom
Marketing authorization number(s)
PL 16363/0043
Date of first authorization / renewal of the authorization
06/11/2001
Date of revision of the text
24/03/2022
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