natgillin/translations-raw huggingface dataset:
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
V ženskej a podskupine pacientov čiernej pleti, ktoré z celkovej populácie zúčastňujúcej sa štúdie predstavovali 32 % a 26 %, renálny benefit nebol zrejmý, hoci sa pri hodnotení intervalov spoľahlivosti nedal úplne vylúčiť.
AngiotensinII is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
Ifirmasta patrí do skupiny liekov známych ako antagonisty receptorov angiotenzínu-II. Angiotenzín-II je látka produkovaná v organizme, ktorá sa viaže na receptory v krvných cievach a tým spôsobuje ich zúženie.
What Ifirmasta looks like and contents of the pack Ifirmasta 150 mg film-coated tablets are: white, oval film-coated tablets.
Ako vyzerá Ifirmasta a obsah balenia Ifirmasta 150 mg filmom obalené tablety sú: biele, oválne filmom obalené tablety.
Blood and lymphatic system disorders: Not known:
Poruchy krvi a lymfatického sytému:
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
5,5 mEq/l) vyskytla u 46,3% pacientov v skupine na irbesartane a 26,3
Reduction of blood pressure with 0.5 mg/kg (low), 1.5 mg/kg (medium) and 4.5 mg/kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
cieľovými titrovanými dávkami irbesartanu sa pozorovalo u 318 hypertenzívnych alebo rizikových (diabetických, rodinná anamnéza hypertenzie) detí a mladistvých vo veku 6 až 16 rokov počas trojtýždňového obdobia.
A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing.
Po opakovanom dávkovaní raz denne sa pozoruje limitovaná plazmatická akumulácia irbesartanu (<20
fatigue Uncommon: chest pain
únava Menej časté: bolesť na hrudníku
In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function, - if you are going to have an operation (surgery) or be given anaesthetics,
V tomto prípade vám má lekár pravidelne kontrolovať krvné testy, najmä hladinu draslíka v krvi v prípade zhoršenej funkcie obličiek.
Ifirmasta 300 mg film-coated tablets Each film-coated tablet contains 16 mg castor oil.
Každá filmom obalená tableta obsahuje 16 mg ricínového oleja.
Vascular disorders: Common:
Poruchy ciev: Časté:
Pharmacotherapeutic group: angiotensin II antagonist, plain, ATC code: C09CA04.
ATC kód: C09CA04.
Following oral or intravenous administration of
Po perorálnom alebo intravenóznom podaní irbesartanu značenom
KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05
Bucharest Tel: + 402 (0)1 310 66 05
Ifirmasta 150 mg film-coated tablets Each film-coated tablet contains 8 mg castor oil.
Každá filmom obalená tableta obsahuje 8 mg ricínového oleja.
Ifirmasta belongs to a group of medicines known as angiotensin-II receptor antagonists.
Farmakoterapeutická skupina: antagonisty Angiotenzínu-II, samotné.
Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
% diabetických hypertenzných pacientov s chronickou renálnou insuficienciou a zjavnou proteinúriou a ktoré prevyšovali placebo.
No dose adjustment is necessary in patients with mild to moderate hepatic impairment.
U pacientov s miernou až stredne ťažkou poruchou funkcie pečene nie je potrebné upravovať dávku.
While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Vo všetkých liečebných skupinách boli dosiahnuté podobné hodnoty krvného tlaku, v skupine liečenej irbesartanom s dávkou 300 mg dosiahlo sledovaný ukazovateľ klinickej proteinúrie menej jedincov (5,2
- Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
U pacientov s vysokým krvným tlakom a diabetom 2. typu predstavuje dávka 300 mg (štyri tablety denne) raz denne uprednostňovanú udržiavaciu dávku pri liečbe pridruženého ochorenia obličiek.
- Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
U pacientov s vysokým krvným tlakom a diabetom 2. typu predstavuje dávka 300 mg (dve tablety denne) raz denne uprednostňovanú udržiavaciu dávku pri liečbe pridruženého ochorenia obličiek.
Hepatobiliary disorders: Uncommon: jaundice Not known:
Poruchy pečene a žlčových ciest: Menej časté: žltačka Neznáme:
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
% pacientov v skupine na irbesartane v dávke 300 mg a u 22 % pacientov v skupine na placebe.
- Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
U pacientov s vysokým krvným tlakom a diabetom 2. typu predstavuje dávka 300 mg raz denne uprednostňovanú udržiavaciu dávku pri liečbe pridruženého ochorenia obličiek.
90 tablets: EU/1/08/480/024
90 tabliet: EU/1/08/480/020
14 tablets: EU/1/08/480/013 28 tablets: EU/1/08/480/014 30 tablets: EU/1/08/480/023 56 tablets: EU/1/08/480/015 56 x 1 tablets: EU/1/08/480/016 84 tablets: EU/1/08/480/017 90 tablets: EU/1/08/480/024 98 tablets: EU/1/08/480/018
EU/1/08/480/016 84 tabliet: EU/1/08/480/017 90 tabliet: EU/1/08/480/024 98 tabliet: EU/1/08/480/018
14 tablets: EU/1/08/480/007 28 tablets: EU/1/08/480/008 30 tablets: EU/1/08/480/021 56 tablets: EU/1/08/480/009 56 x 1 tablets: EU/1/08/480/010 84 tablets: EU/1/08/480/011 90 tablets: EU/1/08/480/022 98 tablets: EU/1/08/480/012
EU/1/08/480/010 84 tabliet: EU/1/08/480/011 90 tabliet: EU/1/08/480/022 98 tabliet: EU/1/08/480/012
14 tablets: EU/1/08/480/001 28 tablets: EU/1/08/480/002 30 tablets: EU/1/08/480/019 56 tablets: EU/1/08/480/003 56 x 1 tablets: EU/1/08/480/004 84 tablets: EU/1/08/480/005 90 tablets: EU/1/08/480/020 98 tablets: EU/1/08/480/006
84 tabliet: EU/1/08/480/005 90 tabliet: EU/1/08/480/020 98 tabliet: EU/1/08/480/006
E. J. Busuttil Ltd. Tel: + 356 21 445 885
Τel: + 356 21 445 885
Ifirmasta 150 mg film-coated tablets Each film-coated tablet contains 150 mg irbesartan (as hydrochloride).
Každá filmom obalená tableta obsahuje 150 mg irbesartanu vo forme hydrochloridu.
Marketing Authorisation Holder and Manufacturer KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Držiteľ rozhodnutia o registrácii a výrobca: KRKA, d.d.,
Blister (PVC/PE/PVDC/Alu): 56 x 1 film-coated tablets in perforated unit dose blisters in box.
56 x 1 filmom obalená tableta v perforovaných jednodávkových blistroch v škatuľke.
Tecnimede España Ind.
Tecnimede España Ind. Fca.,
Eg Labo Laboratoires Eurogenerics
Francúzsko Eg Labo Laboratoires Eurogenerics
Member State in EEA
Členský štát v EHP
Jadran-Galenski Laboratorij D.D.
Chorvátsko Jadran-Galenski Laboratorij D.D.
Teva Santé
Francúzsko Teva Santé
Deutsche Bundeswehr Kommando Sanitätsdienst der Bundeswehr
Sanitätsdienst der Bundeswehr
Laboratoires Gerda
Francúzsko Laboratoires Gerda
Hospira France
Francúzsko Hospira France
Arrow Generiques
Francúzsko Arrow Generiques
INN/Active substance + Strength
INN/liečivo + sila
Ciclum Farma Unipessoal Lda.
Portugalsko Ciclum Farma Unipessoal Lda.
Gold Farma
Portugalsko Gold Farma
Pliva Hrvatska D.O.O.
Chorvátsko Pliva Hrvatska D.O.O.
Tecnimede - Sociedade TécnicoMedicinal, Sa
Portugalsko Tecnimede - Sociedade Técnico-Medicinal, Sa
Gp - Genéricos Portugueses, Lda.
Portugalsko Gp - Genéricos Portugueses, Lda.
Luxembourg Sanofi Belgium
Luxembursko Sanofi Belgium
Pentafarma - Sociedade Tecnico-Medicinal S.A.
Portugalsko Pentafarma - Sociedade Tecnico-Medicinal S.A.
Pharmakern PortugalProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
Portugalsko Pharmakern PortugalProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
Zwitter Pharmaceuticals επε Letrina
Pharmaceuticals επε Letrina
Istituto Luso Farmaco D'italia S.P.A.
Luso Farmaco D'italia S.P.A.
Luxembourg Bayer Sa Nv
Luxembursko Bayer Sa Nv
Teva Uk Limited
Uk Limited
Baldacci - Portugal, S.A.
Portugalsko Baldacci - Portugal, S.A.
Cipla (Eu) Limited
Cipla (Eu)
Czech Republic Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F.
Portugalsko Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F.
436.37mg Tablet
436,37 mg tableta
Belupo D.D.
Chorvátsko Belupo D.D.
Luxembourg Eurogenerics N.V./S.A.
Luxembursko Eurogenerics N.V./S.A.
Laboratoires Alter
Francúzsko Laboratoires Alter
Angelini Farmacêutica, Lda
Portugalsko Angelini Farmacêutica, Lda
Krka-Farma D.O.O.
Chorvátsko Krka-Farma D.O.O.
B. Braun Medical, Lda.
Portugalsko B. Braun Medical, Lda.
Laboratórios Basi - Indústria Farmacêutica, S.A.
Portugalsko Laboratórios Basi - Indústria Farmacêutica, S.A.
Laboratorios Berenguer Infale, S.L.
Španielsko Laboratorios Berenguer Infale, S.L.
Krka Farmacêutica, Unipessoal Lda.
Portugalsko Krka Farmacêutica, Unipessoal Lda.
Alpha-Medical D.O.O.
Chorvátsko Alpha-Medical D.O.O.
Luxembourg Sandoz N.V.
Luxembursko Sandoz N.V.
Tetrafarma- Produtos Farmacêuticos, Lda.
Portugalsko Tetrafarma- Produtos Farmacêuticos, Lda.
Laboratórios AzevedosIndústria Farmacêutica, S.A.
Portugalsko Laboratórios AzevedosIndústria Farmacêutica, S.A.
Cipla (Uk) Limited
Cipla (Uk)
Sopharma Ad ципрофлоксацин софарма
Ad ципрофлоксацин софарма
Luxembourg Apotex Europe B.V.
Luxembursko Apotex Europe B.V.
Iip - Institut Für Industrielle Pharmazie Forschungs- Und Entwicklungsgesellschaft Mbh
Pharmazie Forschungs- Und Entwicklungsgesellschaft Mbh
Aurovitas Unipessoal, Lda.
Portugalsko Aurovitas Unipessoal, Lda.
Hospira Portugal Lda
Portugalsko Hospira Portugal Lda
Sapiens Pharmaceuticals Ltd Levoxacin
Pharmaceuticals Ltd Levoxacin
Tedec-Meiji Farma, S.A.
Španielsko Tedec-Meiji Farma, S.A.
Moxifloxacin Heumann Moxifloxacin Hydrochloride Ph. Eur.
Moxifloxacin Heumann moxifloxacíniumchlorid Ph. Eur.
Bluepharma Indústria Farmacêutica S.A.
Portugalsko Bluepharma Indústria Farmacêutica S.A.
Jaba Recordati, S.A.
Portugalsko Jaba Recordati, S.A.
Sanofi - Produtos Farmaceuticos Lda
Portugalsko Sanofi - Produtos Farmaceuticos
Ksk-Pharma Ag
Ksk-Pharma
Ciprofloxacin Dr. Reddy's Laboratories (Uk) Ltd
Ciprofloxacin Dr. Reddy's Laboratories (Uk)
Belgium B.Braun Melsungen Ag
Francúzsko B.Braun Melsungen Ag
Bialfar - Produtos Farmacêuticos, S.A.
Portugalsko Bialfar - Produtos Farmacêuticos, S.A.
Ranbaxy (Uk) Limited
Ranbaxy (Uk)
Fresenius Kabi D.O.O.
Chorvátsko Fresenius Kabi D.O.O.
Tolife - Produtos Farmacêuticos, S.A.
Portugalsko Tolife - Produtos Farmacêuticos, S.A.
Sandoz D.O.O.
Chorvátsko Sandoz D.O.O.
Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Zaklady Farmaceutyczne "polpharma"
Maco Pharma
Francúzsko Maco Pharma
Czech Republic Generics [uk] Limited
Veľká Británia Generics [uk]
Annex IB List of nationally authorised medicinal products recommended for variation
Príloha IB Zoznam vnútroštátne povolených liekov, v prípade ktorých sa odporúča zmena rozhodnutia o registrácii
Hameln Pharma Plus Gmbh Levofloxacin Hameln Levofloxacin Hemihydrate 256.5mg/50 Ml
Hameln Pharma Plus Gmbh Levofloxacin Hameln levofloxacín, hemihydrát; 256,5 mg/50 ml
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева Levofloxacin 5mg/Ml
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева levofloxacín, 5 mg/ml
Flumequine 0.4g Tablet
Apurone flumechín; 0,4 g tableta tableta
Alkaloid D.O.O.
Chorvátsko Alkaloid D.O.O.
Sapiens Pharmaceuticals Ltd Ciproflox
Pharmaceuticals Ltd Ciproflox
Almus, Lda
Portugalsko Almus, Lda
Belgium Hospira Benelux Bvba
Hospira Benelux
Laboratorios Tecnobío, S.A.
Španielsko Laboratorios Tecnobío, S.A.
Luxembourg Mylan Bvba/Sprl
Luxembursko Mylan Bvba/Sprl
Fresenius Kabi Pharma Portugal Lda.
Kabi Pharma Portugal Lda.
Farmaco Biochimico Toscano
Farmaco Biochimico
Levofloxacino Apotex Ag
Levofloxacino Apotex
Annex IA List of nationally authorised medicinal products recommended for suspension
Príloha IA Zoznam vnútroštátne povolených liekov, v prípade ktorých sa odporúča pozastavenie rozhodnutia o registrácii
Pierre Fabre Medicament
Francúzsko Pierre Fabre
Czech Republic Mylan S.A.S
Francúzsko Mylan S.A.S
Evolupharm
Francúzsko Evolupharm
Ciprofloxacin Wockhardt Uk
Ciprofloxacin Wockhardt
Nobel Pharma Co., Ltd.
Nobel Pharma Co.,
Pipemidic Acid Trihydrate 471.22mg Capsule
Pipemid kyselina pipemidová, trihydrát; 471,22 mg kapsula kapsula
Pharmas D.O.O.
Chorvátsko Pharmas D.O.O.
Pipemidic Acid Trihydrate 235.63mg Capsule
Urotractin kyselina pipemidová, trihydrát; 235,63 mg kapsula tvrdá kapsula
Fresenius Kabi France S.A.S.
Kabi France S.A.S.
Levofloxacino Efg Teva Levofloxacin Hemihydrate 500mg Tablet
Levofloxacino Efg Teva levofloxacín, hemihydrát; 500 mg tableta
Verisfield (Uk) Ltd
Verisfield (Uk)
Ofloxacine Macopharma Ofloxacin 5mg/Ml
Ofloxacine Macopharma ofloxacín, 5 mg/ml
Amneal Pharma Europe Limited Ciprofloxacin Amneal Pharma Europe
Limited Ciprofloxacin Amneal Pharma Europe
Panpharma
Pharma
Labesfal Laboratorios Almiro, S.A.
Portugalsko Labesfal Laboratorios Almiro, S.A.
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева Levofloxacin Hemihydrate 512.46mg Tablet
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева levofloxacín, hemihydrát; 512,46 mg tableta
Claris Lifesciences (Uk) Limited Ciprofloxacin Claris Lifesciences (Uk)
Limited Ciprofloxacin Claris Lifesciences (Uk)
Levofloxacin Macleods Pharma Uk
Levofloxacin Macleods Pharma
Pefloxacin Mesilate Dihydrate 515.3mg/5 Ml
Abaktal pefloxacíniummesilát, dihydrát; 515,3 mg/5 ml
Belgium Mylan Bvba/Sprl
Francúzsko Mylan Bvba/Sprl
Generics Pharma Hellas Ltd Ciprofloxacin Generics Ciprofloxacin 2mg/Ml
Generics Pharma Hellas Ltd Ciprofloxacin Generics ciprofloxacín, 2 mg/ml
Prulifloxacin 600mg
Chinoplus prulifloxacín, 600 mg
Ciprofloxacin Uro Al
Ciprofloxacin Uro
Centrofarma Lda
Portugalsko Centrofarma
Pipemidic Acid Trihydrate 471.25mg Capsule
Urotractin kyselina pipemidová, trihydrát; 471,25 mg kapsula tvrdá kapsula
Dr. Reddy's Laboratories (Uk) Ltd.
Veľká Británia Dr. Reddy's Laboratories (Uk)
Netherlands Double-E Pharma Ltd
Chorvátsko Double-E Pharma Ltd
Denk Pharma Gmbh & Co. Kg Levofloxacin Denk Pharma Gmbh & Co. Kg
Kg Levofloxacin Denk Pharma Gmbh
Ofloxacin 2mg/Ml
ofloxacín, 2 mg/ml
Enoxacin Sesquihydrate 217mg Tablet
Enoxor enoxacín, seskvihydrát; 217 mg tableta
Levofloxacin Infomed Fluids
Levofloxacin Infomed
Ofloxacine Macopharma Ofloxacin 200mg/40 Ml
Ofloxacine Macopharma ofloxacín, 200 mg/40 ml
Sanofi-Aventis France
Francúzsko Sanofi-Aventis
Fresenius Kabi Bulgaria Eood левофлоксацин каби Levofloxacin 5mg/Ml
Kabi Bulgaria Eood левофлоксацин каби levofloxacín, 5 mg/ml
Moxifloxacin Hydrochloride 454,27mg Tablet
Pharm moxifloxacíniumchlorid; 454,27 mg tableta
Nalidixic Acid Remedica Nalidixic Acid 500mg Tablet
Remedica kyselina nalidixová, 500 mg tableta tableta
Ofloxacine 400 Pch Ofloxacin 400mg Tablet
Ofloxacine 400 Pch ofloxacín, 400 mg tableta
Ciprofloksacin Infomed Fluids
Ciprofloksacin Infomed
Ratiopharm Oy
Ratiopharm
Ciprofloxacin Infomed Fluids
Ciprofloxacin Infomed
Ciprovian®, 400mg/200ml
400 mg/200 ml
Levofloxacin Ipca Laboratories Uk
Levofloxacin Ipca Laboratories
Ciprofloxacin Hydrochloride Monohydrate 443mg/200 Ml
Ciprofloksacin Lek ciprofloxacíniumchlorid, monohydrát; 443 mg/200 ml
Cinoxacin 500mg Capsule
Urocinox cinoxacín, 500 mg kapsula tvrdá kapsula
Tablet
Medicament
Belgium Biocodex Benelux Nv/Sa
Francúzsko Biocodex Benelux
Aurobindo Pharma (Malta) Limited ципрофлоксацин уробиндо
Limited ципрофлоксацин уробиндо
Belgium Pharmathen S.A.
Veľká Británia Pharmathen S.A.
Laboratórios Atral, S.A.
Portugalsko Laboratórios Atral, S.A.
Ofloxacine Arrow
Lévofloxacine Arrow
Uab Sanofi-Aventis Lietuva
Uab Sanofi-Aventis
Docpharm Arzneimittelvertrieb GmbH & Co.
Docpharm Arzneimittelvertrieb GmbH
Norfloxacin 1 A Pharma Norfloxacin 400mg Tablet
Norfloxacin 1 A Pharma norfloxacín, 400 mg tableta filmom obalená tableta
Netherlands Hikma Farmacêutica (Portugal), S.A.
Portugalsko Hikma Farmacêutica (Portugal), S.A.
Pefloxacin Mesilate 558.5mg Tablet
Labocton pefloxacíniummesilát; 558,5 mg tableta
Levofloxacin Teva Uk Levofloxacin 5mg/Ml
Levofloxacin Teva Uk levofloxacín, 5 mg/ml
Laboratórios Delta, S.A.
Portugalsko Laboratórios Delta, S.A.
Moxifloxacin 1a Pharma Moxifloxacin 400mg Tablet
Moxifloxacin 1a Pharma moxifloxacín, 400 mg tableta filmom obalená tableta
Levofloxacin 250mg/50 Ml
levofloxacín, 250 mg/50 ml
Ciprofloxacin Nivoflox Ciprofloxacin Hydrochloride Monohydrate 582mg Capsule
Ciprofloxacin Nivoflox ciprofloxacíniumchlorid, monohydrát; 582 mg kapsula kapsula
Enoxacin 200mg Tablet
Enoxor enoxacín, 200 mg tableta
Synoptis Pharma Sp Z O O Levofloxacin Genoptim Levofloxacin 250mg Tablet
Synoptis Pharma Sp Z O O Levofloxacin Genoptim levofloxacín, 250 mg tableta filmom obalená tableta
Levofloxacin Hemihydrate 512.5mg/100 Ml
Leflokin levofloxacín, hemihydrát; 512,5 mg/100 ml
Levofloxacina Ciclum Levofloxacin Hemihydrate 513mg Tablet
Levofloxacina Ciclum levofloxacín, hemihydrát; 513 mg tableta
Pefloxacin Laropharm Pefloxacin 400mg Tablet
Pefloxacin Laropharm pefloxacín, 400 mg tableta filmom obalená tableta
Biocodex Benelux Nv/Sa
Biocodex Benelux
Ofloxacine Evolugen Ofloxacin 200mg Tablet
Ofloxacine Evolugen ofloxacín, 200 mg tableta
Fresenius Kabi Austria Gmbh Moxifloxacin Kabi
Fresenius Kabi Nederland B.V. Moxifloxacine Fresenius
Acido Pipemidico Eg Pipemidic Acid 400mg Capsule Capsule, Hard
Acido Pipemidico Eg kyselina pipemidová, 400 mg kapsula tvrdá kapsula
Synoptis Pharma Sp Z O O Levofloxacin Genoptim Levofloxacin 500mg Tablet
Synoptis Pharma Sp Z O O Levofloxacin Genoptim levofloxacín, 500 mg tableta filmom obalená tableta
Pefloxacin Mesilate 80mg/Ml
Peflacine pefloxacíniummesilát, 80 mg/ml
Ciprofloxacina Normon Ciprofloxacin 254.4mg/100 Ml
Ciprofloxacina Normon ciprofloxacín; 254,4 mg/100 ml
Pefloxacin 400mg/5 Ml
Abaktal pefloxacín, 400 mg/5 ml
Moxifloxacina Double-E Pharma
Moxifloxacina Double-E
Pefloxacin Mesilate Dihydrate 558.56mg Tablet
Abaktal pefloxacíniummesilát, dihydrát; 558,56 mg tableta
Moxifloxacin Eberth Moxifloxacin 1.6mg/Ml
Moxifloxacin Eberth moxifloxacín; 1,6 mg/ml
Levofloxacin Hemihydrate 256.2mg/50 Ml
Leflokin levofloxacín, hemihydrát; 256,2 mg/50 ml
Ciprofloxacina Normon Ciprofloxacin 508.8mg/200 Ml
Ciprofloxacina Normon ciprofloxacín; 508,8 mg/200 ml
Levofloxacin Dr. Eberth Levofloxacin 250mg/50 Ml
Levofloxacin Dr. Eberth levofloxacín, 250 mg/50 ml
Ciprofloxacin Hydrochloride 669.4mg Tablet, Ciprofloxacin Hydrated 506mg Tablet
Od ciprofloxacíniumchlorid; 669,4 mg tableta/ciprofloxacín, hydratovaný; 506 mg tableta tableta s riadeným uvoľňovaním
Moksifloksacin Pharmas Moxifloxacin 400mg/250 Ml
Moksifloksacin Pharmas moxifloxacín, 400 mg/250 ml
Ciprofloxacină Arena Ciprofloxacin Hydrochloride 116.4mg Tablet
Ciprofloxacină Arena ciprofloxacíniumchlorid; 116,4 mg tableta
Moksifloksacin Alvogen Moxifloxacin 1.6mg/Ml
Moksifloksacin Alvogen moxifloxacín; 1,6 mg/ml
Ofloxacină Laropharm Ofloxacin 200mg Tablet
Ofloxacină Laropharm ofloxacín, 200 mg tableta
Sanofi-Aventis Aebe
Sanofi-Aventis
Netherlands Krka, D.D., Novo Mesto
Francúzsko Krka, D.D., Novo Mesto
B. List of nationally authorised medicinal products recommended for variation Member
Zoznam vnútroštátne povolených liekov, v prípade ktorých sa odporúča zmena rozhodnutia o registrácii Členský štát v EHP
Ofloxacin 1 A Pharma Ofloxacin 100mg Tablet
Ofloxacin 1 A Pharma ofloxacín, 100 mg tableta
Inresa Arzneimittel Gmbh
Arzneimittel Gmbh
Bayer Portugal Lda
Portugal Lda
Ciprofloxacina Wynn Ciprofloxacin Hydrochloride 291mg Tablet, Opadry Y-17000 White 10mg Tablet
Ciprofloxacina Wynn ciprofloxacíniumchlorid, 291 mg tableta/biela obaľovacia sústava Opadry Y1-7000, 10 mg tableta tableta
Ciprofloxacin Aurobindo Ciprofloxacin 500mg Tablet
Ciprofloxacin Aurobindo ciprofloxacín, 500 mg tableta tableta
Cuminol
Fresenius
Ciprofloxacin Villerton Ciprofloxacin 200mg/100 Ml | Ciprofloxacin 400mg/200 Ml
Ciprofloxacin Villerton ciprofloxacín, 200 mg/100 ml| ciprofloxacín 400 mg/200 ml
Hospira Uk Ltd
Veľká Británia Hospira Uk Ltd
Ciprofloxacino Aristo Ciprofloxacin 250mg
Ciprofloxacino Aristo ciprofloxacín, 250 mg
Czech Republic +pharma Arzneimittel Gmbh Levofloxacin +pharma Levofloxacin Hemihydrate 256.23mg Tablet
+pharma Arzneimittel Gmbh Levofloxacin +pharma levofloxacín, hemihydrát; 256,23 mg tableta
Teva Pharma - Produtos Farmacêuticos Lda
Portugalsko Teva Pharma - Produtos Farmacêuticos
Pefloxacin Mesilate 3.2mg/Ml
Peflacine pefloxacíniummesilát; 3,2 mg/ml
Ciprofloxacin Hydrochloride 669.4mg Tablet
Ciproxin ciprofloxacíniumchlorid, 669,4 mg tableta tableta s riadeným uvoľňovaním
Ciprofloxacin Hydrochloride Monohydrate 222mg/100 Ml
Ciprofloksacin Lek ciprofloxacíniumchlorid, monohydrát; 222 mg/100 ml
Pipemidic Acid 400mg Tablet Film-Coated Tablet
Pipram kyselina pipemidová, 400 mg tableta filmom obalená tableta perorálne použitie
Levofloxacin φαρματεν Levofloxacin Hemihydrate 5.1246mg/Ml
Levofloxacin φαρματεν levofloxacín, hemihydrát; 5,1246 mg/ml
Levofloxacin Hemihydrate 5.13mg/Ml
Kg levofloxacín, hemihydrát; 5,13 mg/ml
Ofloxacine Biogaran Ofloxacin 200mg Tablet
Ofloxacine Biogaran ofloxacín, 200 mg tableta
Moxifloxacin Hexal
Moxifloxacin HEC
Czech Republic +pharma Arzneimittel Gmbh Levofloxacin +pharma Levofloxacin Hemihydrate 512.46mg Tablet
+pharma Arzneimittel Gmbh Levofloxacin +pharma levofloxacín, hemihydrát; 512,46 mg tableta
Ofloxacino Ranbaxy Ofloxacin 200mg Tablet
Ofloxacino Ranbaxy ofloxacín, 200 mg tableta
Bayer Healthcare
Healthcare
Lomefloxacin Hydrochloride 400mg Tablet
Maxaquin lomefloxacíniumchlorid, 400 mg tableta
Moxifloxacin Orion Moxifloxacin Hydrochloride 436.37mg Tablet
Moxifloxacin Orion moxifloxacíniumchlorid, 436,37 mg tableta
Ciprofloxacino Normon Ciprofloxacin 2mg/Ml
Ciprofloxacino Normon ciprofloxacín, 2 mg/ml
Moxifloxacin Sandoz Moxifloxacin 400mg/250 Ml
Moxifloxacin Sandoz moxifloxacín, 400 mg/250 ml
Ciprofloxacina Farmoz Ciprofloxacin 200mg/100 Ml
Ciprofloxacina Farmoz ciprofloxacín 200 mg/100 ml
Moxifloxacin-Q Pharma Moxifloxacin 400mg Tablet
Moxifloxacin-Q Pharma moxifloxacín, 400 mg tableta filmom obalená tableta
Claris Lifesciences (Uk) Limited Ciprofloxacin Claris Lifesciences Uk
Limited Ciprofloxacin Claris Lifesciences
Moxifloxacin 1600µg/Ml
Moflaxa moxifloxacín, 1 600 µg/ml
Levofloxacin Hospira Uk Levofloxacin 500mg/100 Ml
Levofloxacin Hospira Uk levofloxacín, 500 mg/100 ml
Bayer Vital Gmbh
Vital Gmbh
Moxifloxacin 400mg/250 Ml
moxifloxacín; 400 mg/250 ml
Lomefloxacin Hydrochloride 441.6mg Tablet
Uniquin lomefloxacíniumchlorid; 441,6 mg tableta
Ciprofloxacina Wynn Ciprofloxacin Hydrochloride 582mg Tablet, Opadry Y-17000 White 20mg Tablet
Ciprofloxacina Wynn ciprofloxacíniumchlorid, 582 mg tableta/biela obaľovacia sústava Opadry Y1-7000, 10 mg tableta tableta
Luxembourg Teva Pharma Belgium N.V./S.A Levofloxacine Teva
Luxembursko Teva Pharma Belgium N.V./S.A
Ciprofloxacina Germed Pharma
Ciprofloxacina Germed
Ciprofloxacina Infomed Ciprofloxacin 2mg/Ml
Ciprofloxacina Infomed ciprofloxacín, 2 mg/ml
Pefloxacin Mesilate Dihydrate 558.5mg Tablet
Abaktal pefloxacíniummesilát, dihydrát; 558,5 mg tableta