[PDF] Active substance: flucloxacillin Procedure no: PSUSA

PACKAGE LEAFLET: INFORMATION FOR THE USER Flucloxacillin

Severe kidney disease: your doctor may reduce your dose, the maximum dose in adults is 1g every 8 to 12 hours Make sure you complete your prescribed course; do not stop taking

Active substance: flucloxacillin Procedure no: PSUSA

poudre pour sirop not available BE154804 TRENKER BE STAPHYCID 250 mg/5 ml, poeder voor stroop not available BE154804 TRENKER BE STAPHYCID 250 mg / 5 ml, poudre pour sirop not available 1991110826 TRENKER LU Flucloxacilline CF, poeder voor oplossing voor injectie 125 mg, 250 mg, 500 mg en 1 g not available RVG 57442 CENTRAFARM B V NL

THERAPEUTIC INDEX Flubex - Beximco Pharma

THERAPEUTIC INDEX 183 Flubex® Capsule/Syrup/DS Syrup Description Flubex is a preparation of Flucloxacillin It acts in similar way to Penicillin by inhibiting bacterial cell wall synthesis

Flucloxacillin 125mg/5ml Sugar Free Powder for Oral Solution

approved for print/date Proof Round T ecnical pproval Date sent: Date receiv ed: tem numer Originator : Origination Date : Revision Date : Revised By :

FLOXAPEN PRODUCT INFORMATION (flucloxacillin sodium

Issue 8 (Marketed) FLOXAPEN PRODUCT INFORMATION (flucloxacillin sodium/flucloxacillin magnesium) DESCRIPTION FLOXAPEN (flucloxacillin) is the sodium or magnesium salt of 3-(2'-chloro-6'-fluorophenyl)-5-methyl-4-

Phylopen - Square Pharmaceuticals

Usual children dosage: 2-10 years: half of the adult dose Under 2 years: quarter of the adult dose Dose adjustment in renal impairment : As common with other penicillins, Flucloxacillin usage in patients with renal

FLOXAM (Flucloxacilline) - Laprophan

La flucloxacilline ne devrait pas être administré conjointement avec des agents bactériostatiques En revanche, son association avec des aminoglycosides peut entraîner un effet synergique Le probénécide fait baisser la sécrétion rénale tubulaire de flucloxacilline Son administration concomitante risque d'entraîner des taux

ANTIBIOTIC DOSES - Sheffield Childrens Hospital

SC(NHS)FT Reg I D No 1246 Medical Guidelines for Paediatric Medicine

ΪϳΪΤΘΑ ήΒϤΘΒγ ΐΟέ Ϧϣ ϲϓ έΩΎλ Ϣϗέ ΔΤμϟ΍ ήϳίϮϟ έ΍ήϗ ΔϤ΋Ύϗ

Acide valproïque 57,64 mg/ml Orale (sirop) Acide valproïque 200 mg Orale Flucloxacilline 500 mg Injectable Flucloxacilline 1 g Injectable

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© European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged.

12 November 202

0

EMA/14202/2021

Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: flucloxacillin

Procedure no.:

PSUSA/00001402/202003

List of nationally authorised medicinal products

EMA/14202/2021 Page 2/26

Product Name

(in authorisation country)

MRP/DCP

Authorisation

number National Authorisation Number MAH of product in the member state

Member State where

product is authorised

Flucloxacilline Aurobindo 2 g,

poeder voor oplossing voor injectie of infusie PT/H/0670/002/DC RVG 109868 AUROBINDO PHARMA B.V. NL

Floxapen 1000 mg pó para

solução injetável ou para perfusão

PT/H/0670/001

5479969 GENERIS FARMACÊUTICA, S.A. PT

Floxapen 1000 mg pó para

solução injetável ou para perfusão

PT/H/0670/001

5479977 GENERIS FARMACÊUTICA, S.A. PT

Floxapen 2000 mg pó para

solução injetável ou para perfusão

PT/H/0670/002

5480009 GENERIS FARMACÊUTICA, S.A. PT

Floxapen 2000 mg pó para

solução injetável ou para perfusão

PT/H/0670/002

5480017 GENERIS FARMACÊUTICA, S.A. PT

Floxapen 1000 mg pó para

solução injetável ou para perfusão

PT/H/0670/0

01 5795356 GENERIS FARMACÊUTICA, S.A. PT

Floxapen 2000 mg pó para

solução injetável ou para perfusão

PT/H/0670/002

5795364 GENERIS FARMACÊUTICA, S.A. PT

Flucloxacillin 125mg/5ml Oral

Solution BP

not available PA0298/016/003 ATHLONE LABORATORIES

LIMITED

IE

List of nationally authorised medicinal products

EMA/14202/2021 Page 3/26

Flucloxacillin 125mg/5ml Oral

Solution

not available PA0298/017/003 ATHLONE LABORATORIES

LIMITED

IE

Flucloxacillin 250 mg/5ml

Granules for Oral Solution

not available PL 20416/0077 CRESCENT PHARMA LIMITED UK

Flucloxacillin 125 mg/5ml

Granules for Oral Solution

MT/H/0499/001

PL 20416/0076 CRESCENT PHARMA LIMITED UK

Flucloxacillin 125 mg/5ml

Granules for Oral Solution

MT/H/0499/001

MA1317/01201 CRESCENT PHARMA

INTERNATIONAL LIMITED

MT

Flucloxacilline Mylan 250 mg,

capsules not available RVG 10927 MYLAN B.V. NL

Flucloxacilline Mylan 500 mg,

capsules not available RVG 10928 MYLAN B.V. NL

Heracillin 500 mg filmuhúðaðar

töflur not available 843279 (IS) MEDA AB IS

Geriflox 500 mg Capsules, Hard

not available PA0577/199/001 MYLAN IRELAND LIMITED IE

Flukloxacillin Meda 1 g

filmdragerade tabletter not available 55084 MEDA AB SE

Flukloxacillin Meda 500 mg

filmdragerade tabletter not available 21624 MEDA AB SE

Flukloxacillin Meda 750 mg

filmdragerade tabletter not available 21625 MEDA AB SE

Flucloxacillin GSB 2 g Pulver

zur Herstellung einer

Injektions- /Infusionslösung

not available 136105 GSB PHARMA GMBH AT

List of nationally authorised medicinal products

EMA/14202/2021 Page 4/26

Floxapen® Vials for Injection not available PL 20075/0584 ACCORD HEALTHCARE LIMITED UK FLOXAPEN® Vials for Injection not available PL 20075/0587 ACCORD HEALTHCARE LIMITED UK FLOXAPEN® Vials for Injection not available PL 20075/0592 ACCORD HEALTHCARE LIMITED UK

Flucloxacilline CF, poeder voor

oplossing voor injectie 125 mg,

250 mg, 500 mg en 1 g

not available RVG 57442 CENTRAFARM B.V. NL

Flucloxacillin 125mg/5ml

powder for oral solution not available PL 21880/0063 MEDREICH PLC UK

Floxapen 1000 mg powder for

solution for injection or infusion

IE/H/0505/001

PA1380/011/007 ACTAVIS GROUP PTC EHF. IE

Floxapen 2000 mg powder for

solution for injection or infusion

IE/H/0505/002

PA 1380/11/8 ACTAVIS GROUP PTC EHF. IE

Floxapen 2 g Pulver zur

Herstellung einer Injektions-

bzw. Infusionslösung

IE/H/0505/002

1-31793 ACTAVIS GROUP PTC EHF. AT

Flucloxacilina Hikma 500 mg pó

para solução injetável not available 5623764 HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Flucloxacilina Hikma 500 mg pó

para solução injetável not available 5623772 HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Flucloxacilina Hikma 500 mg pó

para solução injetável not available 5623806 HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

List of nationally authorised medicinal products

EMA/14202/2021 Page 5/26

Fluclox Stragen 1g, Pulver zur

Herstellung einer Injektions-

bzw. Infusionslösung not available 6067085.00.00 STRAGEN FRANCE DE

Fluclox Stragen 2g, Pulver zur

Herstellung einer Injektions-

bzw. Infusionslösung not available 6067085.01.00 STRAGEN FRANCE DE Floxapen 500 mg Cápsulas not available 4666889 GENERIS FARMACÊUTICA, S.A. PT Floxapen 500 mg Cápsulas not available 8378703 GENERIS FARMACÊUTICA, S.A. PT

Flucloxacillin 125mg/5ml

Powder for Oral Solution Sugar

Free

UK/H/6073/001

PL 44278/0001 NOVELGENIX THERAPEUTICS

LIMITED

UK

Flucloxacillin 250mg/5ml

Powder for Oral Solution Sugar

Free

UK/H/6073/002

PL 44278/0002 NOVELGENIX THERAPEUTICS

LIMITED

UK

Flucloxacillin 250 mg/5ml

Powder for Oral Solution Sugar

Free

UK/H/6073/002

MA1136/00202 NOVELGENIX THERAPEUTICS

LIMITED

MT

Flucloxacillin 125mg/5ml

Powder for Oral Solution Sugar

Free

UK/H/6073/001

MA1136/00201 NOVELGENIX THERAPEUTICS

LIMITED

MT FLUCACID 1 g compresse not available 033623012 EURO-PHARMA S.R.L. IT

Flucloxacillin Sodium for

Injection 1 g

not available 24780/0015 VILLERTON INVEST S.A. UK

List of nationally authorised medicinal products

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