natgillin/translations-raw huggingface dataset:
The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo. 
Dnevni odmerki od 150 do 300 mg pri bolnikih, ki so jim krvni tlak merili v ležečem ali sedečem položaju, so 24 ur po odmerku znižali sistolični oz. diastolični krvni tlak za 8 do 13 oz. 5 do 8 mm Hg več, kot se je znižal pri bolnikih v placebo skupini.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough 
Bolezni dihal, prsnega koša in mediastinalnega prostora: Občasni: kašelj
Ifirmasta 75 mg film-coated tablets Each film-coated tablet contains 75 mg irbesartan (as hydrochloride). 
Ifirmasta 75 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 75 mg irbesartana (v obliki klorida).
Because no information is available regarding the use of Ifirmasta during breast-feeding, Ifirmasta is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant. 
Podatkov o uporabi zdravila Ifirmasta med dojenjem ni na voljo, zato uporaba zdravila Ifirmasta med dojenjem ni priporočljiva.
For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance. 
Kaže, da je hiperplazija/hipertrofija ledvičnih jukstaglomerulnih celic pri človeku, ki jemlje terapevtske odmerke, nepomembna.
A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing. 
Po ponavljajočem odmerjanju enkrat na dan so ugotovili kopičenje irbesartana v plazmi (18 %).
Ifirmasta 300 mg film-coated tablets Each film-coated tablet contains 16 mg castor oil. 
Ifirmasta 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 16 mg ricinusovega olja.
hepatitis, abnormal liver function 
Neznana: hepatitis, motnje v delovanju jeter
What Ifirmasta looks like and contents of the pack Ifirmasta 75 mg film-coated tablets are: white, oval film-coated tablets. 
Izgled zdravila Ifirmasta in vsebina pakiranja Ifirmasta 75 mg filmsko obložene tablete so bele barve, ovalne oblike.
Ifirmasta 75 mg film-coated tablets Irbesartan 
Ifirmasta 75 mg filmsko obložene tablete irbesartan
Ifirmasta 150 mg film-coated tablets Each film-coated tablet contains 8 mg castor oil. 
Ifirmasta 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 8 mg ricinusovega olja.
Ifirmasta 300 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as hydrochloride). 
Ifirmasta 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki klorida).
How to store Ifirmasta 
Shranjevanje zdravila Ifirmasta
Ifirmasta 150 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters. 
Ifirmasta 150 mg filmsko obložene tablete so na voljo v škatlah s 14, 28, 30, 56, 84, 90 in 98 filmsko obloženimi tabletami v pretisnih omotih in v škatlah s po 56 x 1 filmsko obloženimi tabletami v perforiranih blistrih.
What Ifirmasta looks like and contents of the pack Ifirmasta 300 mg film-coated tablets are: white, oval film-coated tablets. 
Izgled zdravila Ifirmasta in vsebina pakiranja Ifirmasta 300 mg filmsko obložene tablete so bele barve, ovalne oblike.
The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). 
Uporaba antagonistov angiotenzina II v prvem trimesečju ni priporočljiva (gl. poglavje 4.4).
Ifirmasta 75 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters. 
Ifirmasta 75 mg filmsko obložene tablete so na voljo v škatlah s 14, 28, 30, 56, 84, 90 in 98 filmsko obloženimi tabletami v pretisnih omotih in v škatlah s po 56 x 1 filmsko obloženimi tabletami v perforiranih blistrih.
Ifirmasta 300 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters. 
Ifirmasta 300 mg filmsko obložene tablete so na voljo v škatlah s 14, 28, 30, 56, 84, 90 in 98 filmsko obloženimi tabletami v pretisnih omotih in v škatlah s po 56 x 1 filmsko obloženimi tabletami v perforiranih blistrih.
Ifirmasta 150 mg film-coated tablets Each film-coated tablet contains 150 mg irbesartan (as hydrochloride). 
Ifirmasta 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg irbesartana (v obliki klorida).
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Film coating: 
Bolezni sečil:
What Ifirmasta looks like and contents of the pack Ifirmasta 150 mg film-coated tablets are: white, oval film-coated tablets. 
Izgled zdravila Ifirmasta in vsebina pakiranja Ifirmasta 150 mg filmsko obložene tablete so bele barve, ovalne oblike.
In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/3-6 mm Hg (systolic/diastolic). 
Pri bolnikih, pri katerih z odmerkom irbesartana, ki ga jemljejo enkrat na dan, ni dosežen nadzor krvnega tlaka, je treba uvesti še majhen odmerek hidroklorotiazida (12,5 mg), prav tako enkrat na dan.
fatigue Uncommon: chest pain 
utrujenost Občasni: bolečine v prsih
Hepatic impairment 
anafilaktični šok
Ifirmasta 300 mg film-coated tablets Irbesartan 
Ifirmasta 300 mg filmsko obložene tablete irbesartan
Rreversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. 
Sočasno jemanje litija in zaviralcev angiotenzinske konvertaze je povzročilo reverzibilno povečanje serumske koncentracije litija in toksičnost.
Skin and subcutaneous tissue disorders: Not known: 
Bolezni kože in podkožja: Neznana: levkocitoklastični vaskulitis
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system. 
Pri bolnikih z obojestransko stenozo ledvične arterije ali s stenozo arterije ene same delujoče ledvice se pri uporabi zdravil z vplivom na renin-angiotenzin-aldosteronski sistem poveča tveganje za hudo hipotenzijo in ledvično odpovedovanje.
56 tablets: EU/1/08/480/015 
56 tablet: EU/1/08/480/015
Each film-coated tablet contains 75 mg irbesartan (as hydrochloride). 
Ena filmsko obložena tableta vsebuje 75 mg irbesartana v obliki hidroklorida.
In a study, somewhat higher plasma concentrations of irbesartan were observed in female hypertensive patients. 
V raziskavi so opazili nekoliko večjo koncentracijo irbesartana pri bolnicah z visokim krvnim tlakom, razlike v razpolovnem času in kopičenju irbesartana pa ni bilo.
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. 
Pri bolnikih, ki imajo zaradi intenzivnega zdravljenja z diuretiki, omejevanja vnosa soli s hrano, driske ali bruhanja zmanjšan volumen krvi in/ali jim primanjkuje natrija, se lahko pojavi simptomatska hipotenzija, zlasti po prvem odmerku.
Ifirmasta 150 mg film-coated tablets Irbesartan 
Ifirmasta 150 mg filmsko obložene tablete irbesartan
Vascular disorders: Common: 
Žilne bolezni: Pogosti:
Each film-coated tablet contains 300 mg irbesartan (as hydrochloride). 
Ena filmsko obložena tableta vsebuje 300 mg irbesartana v obliki hidroklorida.
In patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered. 
Ledvična okvara farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali pri bolnikih na hemodializi niso bili pomembno spremenjeni.
98 tablets: EU/1/08/480/012 
98 tablet: EU/1/08/480/012
Excipient with known effect Ifirmasta 75 mg film-coated tablets Each film-coated tablet contains 4 mg castor oil. 
Ifirmasta 75 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 4 mg ricinusovega olja.
- 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. 
- Bolniki z visokim krvnim tlakom in sladkorno boleznijo tipa 2 z boleznijo ledvic Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (štiri tablete) enkrat na dan.
- 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. 
- Bolniki z visokim krvnim tlakom in sladkorno boleznijo tipa 2 z boleznijo ledvic Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (dve tableti) enkrat na dan.
28 tablets: EU/1/08/480/008 
28 tablet: EU/1/08/480/008
Each film-coated tablet contains 150 mg irbesartan (as hydrochloride). 
Ena filmsko obložena tableta vsebuje 150 mg irbesartana v obliki hidroklorida.
28 tablets: EU/1/08/480/014 
28 tablet: EU/1/08/480/014
Ear and labyrinth disorder: Not known: 
Ušesne bolezni, vključno z motnjami labirinta: Neznana: tinitus
30 tablets: EU/1/08/480/023 
30 tablet: EU/1/08/480/023
98 tablets: EU/1/08/480/018 
98 tablet: EU/1/08/480/018
90 tablets: EU/1/08/480/024 
90 tablet: EU/1/08/480/024
90 tablets: EU/1/08/480/022 
90 tablet: EU/1/08/480/022
Uncommon: diarrhoea, dyspepsia/heartburn Not known: 
Občasni: driska, dispepsija/zgaga Neznana: paragevzija
30 tablets: EU/1/08/480/021 
30 tablet: EU/1/08/480/021
- 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. 
- Bolniki z visokim krvnim tlakom in sladkorno boleznijo tipa 2 z boleznijo ledvic Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg enkrat na dan.
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 
14 tablet: EU/1/08/480/013 28 tablet: EU/1/08/480/014 30 tablet: EU/1/08/480/023 56 tablet: EU/1/08/480/015 56 x 1 tableta: EU/1/08/480/016 84 tablet: EU/1/08/480/017 90 tablet: EU/1/08/480/024 98 tablet: EU/1/08/480/018
Investigations: 
Preiskave: Zelo pogosti:
There is no clinically important effect on serum uric acid or urinary uric acid secretion. 
Na serumsko sečno kislino ali s sečem izločeno sečno kislino irbesartan nima klinično pomembnega učinka.
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 
14 tablet: EU/1/08/480/001 28 tablet: EU/1/08/480/002 30 tablet: EU/1/08/480/019 56 tablet: EU/1/08/480/003 56 x 1 tableta: EU/1/08/480/004 84 tablet: EU/1/08/480/005 90 tablet: EU/1/08/480/020 98 tablet: EU/1/08/480/006
Metabolism and nutrition disorders: Not known: 
Presnovne in prehranske motnje: Neznana: hiperkaliemija
No dose adjustment is necessary in patients with mild to moderate hepatic impairment. 
Bolnikom z ledvično okvaro odmerka ni treba prilagajati.
Hypertensive patients with type 2 diabetes and renal disease The effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. 
Analiza rezultatov raziskave, v kateri so spremljali bolnike z napredovalo ledvično boleznijo, je pokazala, da učinki irbesartana na ledvične in srčno-žilne dogodke znotraj podskupin niso enaki.
As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1). 
Tako kot zaviralci angiotenzinske konvertaze tudi irbesartan in drugi angiotenzinski antagonisti izrazito manj učinkovito znižujejo krvni tlak pri temnopoltih bolnikih.
Therefore, this combination is not recommended (see section 4.4). 
Poročila o podobnih učinkih pri irbesartanu so zelo redka, kljub temu pa takih kombinacij ne priporočamo (gl. poglavje 4.4).
Irbesartan 
Dojenje
Film-coated tablet. 
56 tablet.
Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2). 
Bolnikom, ki so dobivali majhen, srednji ali velik odmerek irbesartana, se je sistolični krvni tlak v sedečem položaju spremenil za +0,1 mm Hg, diastolični pa za -0,3 mm Hg (gl. poglavje 4.2).
- Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, and fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). 
- Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): omotica, siljenje na bruhanje, bruhanje in utrujenost.
Rebound hypertension has not been observed. 
Povratnega zvišanja krvnega tlaka po ukinitvi zdravila niso opazili.
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/1/08/480/009 56 x 1 tableta: EU/1/08/480/010 84 tablet: EU/1/08/480/011 90 tablet: EU/1/08/480/022 98 tablet: EU/1/08/480/012
Immune system disorders: Not known: 
Bolezni imunskega sistema:
Fertility 
Plodnost:
Gold Farma 
Portugalska Gold Farma
Member State in EEA 
Država članica EGP
Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda 
Portugalska Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Centrofarma Lda 
Portugalska Centrofarma Lda
Ciclum Farma Unipessoal Lda. 
Portugalska Ciclum Farma Unipessoal Lda.
Fresenius Kabi Pharma Portugal Lda. 
Portugalska Fresenius Kabi Pharma Portugal Lda.
Tecnimede - Sociedade TécnicoMedicinal, Sa 
Portugalska Tecnimede - Sociedade Técnico-Medicinal, Sa
Gp - Genéricos Portugueses, Lda. 
Portugalska Gp - Genéricos Portugueses, Lda.
Bluepharma GenéricosComércio De Medicamentos, S.A. 
Portugalska Bluepharma GenéricosComércio De Medicamentos, S.A.
Pentafarma - Sociedade Tecnico-Medicinal S.A. 
Portugalska Pentafarma - Sociedade Tecnico-Medicinal S.A.
Baldacci - Portugal, S.A. 
Portugalska Baldacci - Portugal, S.A.
Czech Republic Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. 
Portugalska Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F.
Sanofi - Produtos Farmaceuticos Lda 
Portugalska Sanofi - Produtos Farmaceuticos Lda
Netherlands Hexal Ag 
Nizozemska Hexal Ag
Netherlands Fresenius Kabi Nederland B.V. 
Nizozemska Fresenius Kabi Nederland B.V.
Netherlands Bayer Bv 
Nizozemska Bayer Bv
Angelini Farmacêutica, Lda 
Portugalska Angelini Farmacêutica, Lda
Aurobindo Pharma (Portugal), Unipessoal Lda 
Portugalska Aurobindo Pharma (Portugal), Unipessoal Lda
Bayer Portugal Lda 
Portugalska Bayer Portugal Lda
Aurovitas Unipessoal, Lda. 
Portugalska Aurovitas Unipessoal, Lda.
Laboratórios Basi - Indústria Farmacêutica, S.A. 
Portugalska Laboratórios Basi - Indústria Farmacêutica, S.A.
B. Braun Medical, Lda. 
Portugalska B. Braun Medical, Lda.
Netherlands B.Braun Melsungen Ag 
Nizozemska B.Braun Melsungen Ag
Farmoz - Sociedade Técnico Medicinal, S.A. 
Portugalska Farmoz - Sociedade Técnico Medicinal, S.A.
Bayhealth Lda. 
Portugalska Bayhealth Lda.
Krka Farmacêutica, Unipessoal Lda. 
Portugalska Krka Farmacêutica, Unipessoal Lda.
Tetrafarma- Produtos Farmacêuticos, Lda. 
Portugalska Tetrafarma- Produtos Farmacêuticos, Lda.
Netherlands Hospira Benelux Bvba 
Nizozemska Hospira Benelux Bvba
Jaba Recordati, S.A. 
Portugalska Jaba Recordati, S.A.
Laboratórios AzevedosIndústria Farmacêutica, S.A. 
Portugalska Laboratórios AzevedosIndústria Farmacêutica, S.A.
Bluepharma Indústria Farmacêutica S.A. 
Portugalska Bluepharma Indústria Farmacêutica S.A.
Hospira Portugal Lda 
Portugalska Hospira Portugal Lda
INN/Active substance + Strength 
Mednarodno nelastniško ime/učinkovina + jakost
A. List of nationally authorised medicinal products recommended for suspension Member 
A. Seznam zdravil, odobrenih po nacionalnem postopku, ki so priporočena za začasni umik Država članica EGP
Ratiopharm Lda 
Portugalska Ratiopharm Lda
Moxifloxacin Heumann Moxifloxacin Hydrochloride Ph. Eur. 
Moxifloxacin Heumann moksifloksacinijev klorid Ph. Eur.
Bialfar - Produtos Farmacêuticos, S.A. 
Portugalska Bialfar - Produtos Farmacêuticos, S.A.
Tolife - Produtos Farmacêuticos, S.A. 
Portugalska Tolife - Produtos Farmacêuticos, S.A.
Teva Pharma - Produtos Farmacêuticos Lda 
Portugalska Teva Pharma - Produtos Farmacêuticos Lda
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева Levofloxacin 5mg/Ml 
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева levofloksacin 5 mg/ml
Hameln Pharma Plus Gmbh Levofloxacin Hameln Levofloxacin Hemihydrate 256.5mg/50 Ml 
Hameln Pharma Plus Gmbh Levofloxacin Hameln levofloksacin hemihidrat 256,5 mg/50 ml
Annex I List of nationally authorised medicinal products 
Priloga I Seznam zdravil, odobrenih po nacionalnem postopku
Flumequine 0.4g Tablet 
Apurone flumekvin 0,4 g tableta tableta
Enoxacin Sesquihydrate 217mg Tablet 
Enoxor enoksacinijev seskvihidrat 217 mg tableta
B. List of nationally authorised medicinal products recommended for variation Member 
B. Seznam zdravil, odobrenih po nacionalnem postopku, ki so priporočena za spremembo dovoljenja Država članica EGP
Levofloxacino Efg Teva Levofloxacin Hemihydrate 500mg Tablet 
Levofloxacino Efg Teva levofloksacin hemihidrat 500 mg tableta
Netherlands Pharma Resources Gmbh 
Nizozemska Pharma Resources Gmbh
Fresenius Kabi Bulgaria Eood левофлоксацин каби Levofloxacin 5mg/Ml 
Fresenius Kabi Bulgaria Eood левофлоксацин каби levofloksacin 5 mg/ml
Netherlands Pharmathen S.A. 
Nizozemska Pharmathen S.A.
Netherlands Sanofi-Aventis Netherlands B.V. Pipram 
Nizozemska Sanofi-Aventis Netherlands B.V.
Mylan, Lda 
Portugalska Mylan, Lda
Pefloxacin Mesilate Dihydrate 515.3mg/5 Ml 
Abaktal pefloksacinijev mesilat dihidrat 515,3 mg/5 ml
Almus, Lda 
Portugalska Almus, Lda
Netherlands Hikma Farmacêutica (Portugal), S.A. 
Nizozemska Hikma Farmacêutica (Portugal), S.A.
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева Levofloxacin Hemihydrate 512.46mg Tablet 
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева levofloksacin hemihidrat 512,46 mg tableta
Netherlands Beximco Pharma Uk Ltd 
Nizozemska Beximco Pharma Uk Ltd
Annex IB List of nationally authorised medicinal products recommended for variation 
Priloga IB Seznam zdravil, odobrenih po nacionalnem postopku, ki so priporočena za spremembo dovoljenja
Nalidixic Acid Remedica Nalidixic Acid 500mg Tablet 
Nalidixic Acid Remedica nalidiksna kislina 500 mg tableta tableta
Labesfal Laboratorios Almiro, S.A. 
Portugalska Labesfal Laboratorios Almiro, S.A.
Ofloxacine Macopharma Ofloxacin 5mg/Ml 
Ofloxacine Macopharma ofloksacin 5 mg/ml
Pipemidic Acid Trihydrate 235.63mg Capsule 
Urotractin pipemidna kislina trihidrat 235,63 mg kapsula kapsula, trda
Netherlands Torrent Pharma Gmbh 
Nizozemska Torrent Pharma Gmbh
Netherlands Krka, D.D., Novo Mesto 
Nizozemska Krka, D.D., Novo Mesto
Generics Pharma Hellas Ltd Ciprofloxacin Generics Ciprofloxacin 2mg/Ml 
Generics Pharma Hellas Ltd Ciprofloxacin Generics ciprofloksacin 2 mg/ml
Netherlands Apotex Europe Bv 
Nizozemska Apotex Europe Bv
Netherlands Double-E Pharma Ltd 
Nizozemska Double-E Pharma Ltd
Ciprofloxacina Wynn Ciprofloxacin Hydrochloride 291mg Tablet, Opadry Y-17000 White 10mg Tablet 
Ciprofloxacina Wynn ciprofloksacinijev klorid 291 mg tableta, Opadry Y-17000 bela 10 mg tableta tableta
Ciprofloxacina Wynn Ciprofloxacin Hydrochloride 582mg Tablet, Opadry Y-17000 White 20mg Tablet 
Ciprofloxacina Wynn ciprofloksacinijev klorid 582 mg tableta, Opadry Y-17000 bela 20 mg tableta tableta
Pipemidic Acid Trihydrate 471.22mg Capsule 
Pipemid pipemidna kislina trihidrat 471,22 mg kapsula kapsula
Granules And Solvent For Oral Suspension 
ki so priporočena za začasni umik
Ciprofloxacin Villerton Ciprofloxacin 200mg/100 Ml | Ciprofloxacin 400mg/200 Ml 
Ciprofloxacin Villerton ciprofloksacin 200 mg/100 ml| ciprofloksacin 400 mg/200 ml
Ofloxacine Macopharma Ofloxacin 200mg/40 Ml 
Ofloxacine Macopharma ofloksacin 200 mg/40 ml
Prulifloxacin 600mg 
Chinoplus prulifloksacin 600 mg
Laboratórios Atral, S.A. 
Portugalska Laboratórios Atral, S.A.
Ofloxacin 2mg/Ml 
ofloksacin 2 mg/ml
Moxifloxacin 1a Pharma Moxifloxacin 400mg Tablet 
Moxifloxacin 1a Pharma moksifloksacin 400 mg tableta
Chelonia Healthcare Limited Nalidixic Acid Chelonia Healthcare 
Chelonia Healthcare Limited Nalidixic Acid Chelonia Healthcare nalidiksna kislina Bp 500 mg tableta tableta
Pipemidic Acid Trihydrate 471.25mg Capsule 
Urotractin pipemidna kislina trihidrat 471,25 mg kapsula kapsula, trda
Ciprofloxacin Hydrochloride Monohydrate 443mg/200 Ml 
Ciprofloksacin Lek ciprofloksacinijev klorid monohidrat 443 mg/200 ml
Levofloxacin Hemihydrate 256.2mg/50 Ml 
Leflokin levofloksacin hemihidrat 256,2 mg/50 ml
Ciprofloxacin Lactate 508.8mg Vial 
ciprofloksacinijev laktat 508,8 mg viala
Laboratórios Delta, S.A. 
Portugalska Laboratórios Delta, S.A.
Ciprofloxacin Lactate 254.4mg Vial 
ciprofloksacinijev laktat 254,4 mg viala
Ciprofloxacina Normon Ciprofloxacin 254.4mg/100 Ml 
Ciprofloxacina Normon ciprofloksacin 254,4 mg/100 ml
Norfloxacine Biogaran Norfloxacin 400mg Units 
Norfloxacine Biogaran norfloksacin 400 mg enote tableta
Levofloxacin Hemihydrate 512.5mg/100 Ml 
Leflokin levofloksacin hemihidrat 512,5 mg/100 ml
Levofloxacina Mylan Levofloxacin Hemihydrate 5.12mg Tablet 
Levofloxacina Mylan levofloksacin hemihidrat 5,12 mg tableta
Ciprofloxacina Normon Ciprofloxacin 508.8mg/200 Ml 
Ciprofloxacina Normon ciprofloksacin 508,8 mg/200 ml
Norfloxacin 1 A Pharma Norfloxacin 400mg Tablet 
Norfloxacin 1 A Pharma norfloksacin 400 mg tableta filmsko obložena tableta
Ciprofloxacin Hydrochloride 669.4mg Tablet, Ciprofloxacin Hydrated 506mg Tablet 
Ciproxin Xr ciprofloksacinijev klorid 669,4 mg tableta, ciprofloksacin, hidratirani 506 mg tableta tableta s prirejenim sproščanjem
Synoptis Pharma Sp Z O O Levofloxacin Genoptim Levofloxacin 500mg Tablet 
Synoptis Pharma Sp Z O O Levofloxacin Genoptim levofloksacin 500 mg tableta filmsko obložena tableta
Pefloxacin Mesilate 80mg/Ml 
Peflacine pefloksacinijev mesilat 80 mg/ml
Synoptis Pharma Sp Z O O Levofloxacin Genoptim Levofloxacin 250mg Tablet 
Synoptis Pharma Sp Z O O Levofloxacin Genoptim levofloksacin 250 mg tableta filmsko obložena tableta
Ciprofloxacin Nivoflox Ciprofloxacin Hydrochloride Monohydrate 582mg Capsule 
Ciprofloxacin Nivoflox ciprofloksacinijev klorid monohidrat 582 mg kapsula kapsula
Pefloxacin Mesilate 3.2mg/Ml 
Peflacine pefloksacinijev mesilat 3,2 mg/ml
Moxifloxacin-Q Pharma Moxifloxacin 400mg Tablet 
Moxifloxacin-Q Pharma moksifloksacin 400 mg tableta
Ciprofloxacin Hydrochloride Monohydrate 222mg/100 Ml 
Ciprofloksacin Lek ciprofloksacinijev klorid monohidrat 222 mg/100 ml