natgillin/translations-raw huggingface dataset:
- Feeling your heartbeat - Increase in blood pressure - Being sick (vomiting), toothache, upper abdominal pain - Rash, acne - Pain of the tendons, joints, bones, muscle pain (musculoskeletal pain), - Needing to urinate more often than usual - Heavy periods - Pain - Lack of energy or feeling weak (asthenia) - Weight loss
(ischias); pocit znecitlivenia, pálenia, brnenia alebo bolesti v rukách a prstoch (syndróm karpálneho tunela) - pocit búšenia srdca - zvýšenie krvného tlaku - príznaky nevoľnosti (vracanie), bolesť zubov, bolesť v hornej časti brucha - vyrážka, akné - bolesť šliach, kĺbov, kostí, svalov (muskuloskeletálna bolesť) - nutkanie na močenie častejšie ako zvyčajne - silná menštruácia - bolesť - nedostatok energie alebo pocit slabosti (asténia) - úbytok hmotnosti
- Mild allergic reactions - Feeling anxious - Pins and needles, feeling weak, numb, tingling or pain in the lower back or leg (sciatica); feeling numb, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
- mierne alergické reakcie - pocit úzkosti - mravčenie, pocit slabosti, znecitlivenia, brnenia alebo bolesti v dolnej časti chrbta alebo v nohách
In the placebo-controlled studies, mean decreases in serum uric acid at a range of 20 to 30% were observed in patients treated with teriflunomide compared to placebo.
V placebom kontrolovaných štúdiách sa u pacientov liečených teriflunomidom pozoroval v porovnaní s placebom priemerný pokles hladiny kyseliny močovej v sére v rozmedzí 20 až 30 %. Priemerný pokles hladiny fosforu v sére bol v skupine liečenej teriflunomidom v porovnaní s placebom približne 10 %. Tieto účinky sa považujú za dôsledok zvýšenia renálnej tubulárnej exkrécie a nemali by byť spojené so zmenami glomerulárnych funkcií.
AUBAGIO 14 mg tablets teriflunomide
NÁZOV LIEKU AUBAGIO 14 mg tablety teriflunomid
Severe skin reactions Cases of severe skin reactions have been reported with teriflunomide post-marketing (see section 4.4).
Po uvedení na trh boli v súvislosti s teriflunomidom hlásené prípady závažných kožných reakcií (pozri časť
The majority of patients had relapsing-remitting multiple sclerosis (97.5%), but a subgroup of patients had secondary progressive (0.8%) or progressive relapsing multiple sclerosis (1.7%).
%), ale podskupina pacientov mala sekundárne progresívnu (0,8
Hazard ratio (CI95%) 3-month Sustained Disability Progression week
Progresia 3-mesačnej trvalej invalidity týždeň 108 Pomer rizika (95 % CI)
Tell your your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ak teraz užívate alebo ste v poslednom čase užívali, či práve budete užívať ďalšie lieky, povedzte to svojmu lekárovi alebo lekárnikovi.
Risk difference (CI95%) Relapse-free week 108
Bez relapsu týždeň 108 Pomer rizika (95 % CI)
In placebo-controlled studies the following was established: - systolic blood pressure was >140 mm Hg in 19.9% of patients receiving 14 mg/day teriflunomide as compared to 15.5% receiving placebo; - systolic blood pressure was >160 mm Hg in 3.8% of patients receiving 14 mg/day teriflunomide as compared to 2.0% receiving placebo; - diastolic blood pressure was >90 mm Hg in 21.4% of patients receiving 14 mg/day teriflunomide as compared to 13.6% receiving placebo.
% pacientov liečených dávkou 14 mg teriflunomidu denne v porovnaní s 15,5 % pacientov užívajúcich placebo; - systolický krvný tlak bol >160 mm Hg u 3,8
Most cases were described as diffuse or generalised over the scalp (no complete hair loss reported) and occurred most often during the first 6 months and with resolution in 121 of 139 (87.1%) patients treated with teriflunomide 14 mg. Discontinuation because of alopecia was 1.3% in the teriflunomide 14 mg teriflunomide group, versus 0.1% in the placebo group.
Väčšina prípadov bola opísaná ako difúzna alebo generalizovaná alopécia na temene hlavy (nebola hlásená úplná strata vlasov) a najčastejšie sa vyskytla počas prvých 6 mesiacov a u 121 zo 139 (87,1
Teriflunomide is contraindicated during breast-feeding (see section 4.3).
Teriflunomid je kontraindikovaný počas dojčenia (pozri časť 4.3).
In placebo-controlled studies, frequencies for asthenia were 2.0%, 1.6% and 2.2% in the placebo, teriflunomide 7 mg and teriflunomide 14 mg group, respectively.
%, 1,6 % v skupine s teriflunomidom 7 mg a 2,2
Clastogenicity observed in vitro was considered to be an indirect effect related to nucleotide pool imbalance resulting from the pharmacology of DHO-DH inhibition.
Klastogenita pozorovaná in vitro sa považovala za nepriamy účinok súvisiaci s nerovnováhou zásoby nukleotidov vznikajúcej v dôsledku farmakológie inhibície DHO-DH. Menej významný metabolit TFMA (4-trifluórometylanilín) mal mutagénne a klastogénne účinky in vitro, ale nie in vivo.
Sanofi Oy Puh/Tel: +358 (0) 201 200 300
T/A SANOFI Tel: +353 (0) 1 403 56 00
Respiratory, thoracic and mediastinal disorders
Poruchy dýchacej sústavy, hrudníka a mediastína intersticiáln e ochorenie pľúc
How to take AUBAGIO
Čo je AUBAGIO
Hyperaesthesia, Neuralgia, Peripheral neuropathy
Poruchy nervového systému bolesť hlavy parestézia, ischias, syndróm karpálneho tunela hyperestézia, neuralgia, periférna neuropatia
Severe skin reactionsa, Psoriasis (including pustular)b
Poruchy kože a podkožného tkaniva alopécia vyrážka, akné ochorenia nechtov závažné kožné reakciea, psoriáza (vrátane pustulárnej psoriázy)b
The number of patients with permanent treatment discontinuation in the subcutaneous interferon beta-1a group was 30 out of 104 (28 .8%), the reasons being adverse events (21.2%), lack of efficacy (1.9%), other reason (4.8%) and poor compliance to protocol (1%).
V skupine liečenej subkutánnym interferónom beta-1a bola liečba trvalo ukončená u 30 zo 104 pacientov (28,8
Package leaflet: Information for the patient AUBAGIO 14 mg film-coated tablets teriflunomide
Písomná informácia pre používateľa AUBAGIO 14 mg filmom obalené tablety teriflunomid
Skin and subcutaneous tissue disorders
Poruchy obličiek a močových ciest polakizúria
Hazard ratio (CI95%) 6-month Sustained Disability Progression week
Progresia 6-mesačnej trvalej invalidity týždeň 108
The effect on red blood cell (RBC) (<2%) and platelet counts (<10%) was less pronounced.
Účinok na červené krvinky (RBC, red blood cell)
The elimination of teriflunomide from the circulation can be accelerated by administration of cholestyramine or activated charcoal, presumably by interrupting the reabsorption processes at the intestinal level.
Elimináciu teriflunomidu z obehu možno urýchliť podaním cholestyramínu alebo aktívneho uhlia.
Hypersensitivity reactions (immediate or delayed) including anaphylaxis and angioedema
Poruchy imunitného systému mierne alergické reakcie reakcie z precitlive nosti (okamžité alebo oneskorené
No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
U pacientov s miernou alebo stredne závažnou poruchou funkcie pečene nie je potrebná úprava dávkovania.
There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of teriflunomide.
Po opakovaných dávkach teriflunomidu došlo k nárastu priemerných hodnôt rosuvastatínu Cmax (2,65násobne) a AUC (2,51-násobne).
Change relative to placebo (CI95%) Number of unique active lesions /scan Change relative to placebo (CI95%)  p<0.0001  p<0.001  p<0.01  p<0.05 compared to placebo (1) BOD: burden of disease: total lesion volume (T2 and T1 hypointense) in ml
Zmena BOD týždeň 108 Zmena oproti placebu Priemerný počet Gd zvýraznených lézií v týždni 108 Zmena oproti placebu (95 % CI)
Repeated doses of teriflunomide decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that teriflunomide may be a weak inducer of CYP1A2 in vivo.
% a AUC o 55 %, čo naznačuje, že teriflunomid môže byť slabým induktorom cytochrómu CYP1A2 in vivo.
No dosage adjustment is necessary for patients with mild, moderate or severe renal impairment not undergoing dialysis.
U pacientov s miernou, stredne závažnou alebo závažnou poruchou funkcie obličiek, ktorí nepodstupujú dialýzu, nie je potrebná úprava dávkovania.
AUBAGIO 14 mg film-coated tablets
NÁZOV LIEKU AUBAGIO 14 mg filmom obalené tablety
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET
BYŤ UVEDENÉ NA STREDNOM OBALE PÚZDRO
Tell your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, as you need to ensure that most of this medicine has left your body before trying to become pregnant.
Pokiaľ plánujete po ukončení liečby AUBAGIOM otehotnieť, informujte o tom svojho lekára.
- The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (Type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigo carmine aluminum lake (E132).
- Ďalšie zložky sú monohydrát laktózy, kukuričný škrob, mikrokryštalická celulóza, sodná soľ karboxymetylškrobu
Pollakiuria
Dávkovanie
Mild thrombocytopen ia (platelets <100G/l)
Poruchy krvi a lymfatického systému neutropéniab, anémia mierna trombocytopén ia (krvné doštičky <100g/l)
Gadolinium-enhancing lesions at baseline: no data.
Údaje o gadolíniom zvýraznených léziách nie sú k dispozícii.
Musculoskeletal pain,
Poruchy ciev hypertenziab
Therefore no dose adjustment is anticipated in mild and moderate hepatic-impaired patients.
Preto sa u pacientov s miernou alebo stredne závažnou poruchou funkcie pečene nepredpokladá potreba úpravy dávkovania.
The number of patients with permanent treatment discontinuation in the teriflunomide 14 mg group was 22 out of 111 (19.8%), the reasons being adverse events (10.8%), lack of efficacy (3.6%), other reason (4.5%) and lost to follow-up (0.9%).
V skupine liečenej teriflunomidom v dávke 14 mg bola liečba trvalo ukončená u 22 pacientov zo 111 (19,8
Therefore no dose adjustment is anticipated in mild, moderate and severe renal-impaired patients.
Preto sa u pacientov s miernou, stredne závažnou alebo závažnou poruchou funkcie obličiek nepredpokladá potreba úpravy dávkovania.
Gammaglutamyltransfer ase (GGT) increaseb, Aspartate aminotransferas
Poruchy pečene a žlčových ciest zvýšená alanínamin otransferáz a (ALT)b zvýšená gammaglutamyltransfer áza (GGT)b, zvýšená aspartátaminotra akútna hepatitída
Musculoskeletal and connective tissue disorders
Poruchy kostrovej a svalovej sústavy a spojivového tkaniva muskuloskeletál na bolesť, myalgia, artralgia
UAB „SANOFI-AVENTIS LIETUVA“ Tel: +370 5 2755224
Tel: +370 5 2755224
Over 21 days, 60.1% of the administered dose is excreted via feces (37.5%) and urine (22.6%).
% podanej dávky, a to stolicou (37,5
Vomiting, Toothache
Vistor hf.
Contents of the pack and other information What AUBAGIO contains
Ako uchovávať AUBAGIO 6. Obsah balenia a ďalšie informácie
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Zoznam názvov, farmaceutických foriem, množstvá účinných látok v liekoch, spôsob podávania a držitelia rozhodnutia o registrácii v členských štátoch
Rua João deDeus,19 Venda Nova
Rua João deDeus,19 Venda
EL - Greece PHARMACEUTICAL INDUSTRY PROEL EPAM.
EL - Grécko PHARMACEUTICAL INDUSTRY PROEL EPAM.
0065 Fiano Romano (Roma) Italy
0065 Fiano Romano (Roma)
HU - Hungary sanofi-aventis zrt.
HU - Maďarsko sanofi-aventis zrt.
20092 Cinisello Balsamo (Milano) Italy
20092 Cinisello Balsamo (Milano)
Estrada Marco do Grilo - Zemouto 2830-000 Coina
Marco do Grilo - Zemouto 2830-000 Coina
Zona Industrial da AbrunheiraEdifício 1 - 2º I - Sintra Business Park 2710-089 Sintra
Zona Industrial da AbrunheiraEdifício 1 - 2º I - Sintra Business Park 2710-089
20060 Bussero (MI) Italy
20060 Bussero (MI)
BG - Bulgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
BG - Bulharsko Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
BG - Bulharsko Sopharma AD 16 Iliensko shosse str. 1220 Sofia
Damastown - Dublin Ireland
Damastown - Dublin
Garden-Bloco 9, Lj 910 2765-187 Estoril
Garden-Bloco 9, Lj 910 2765-187
Germed Pharma Spa Via Cesare Cantù, 11
Pharma Spa Via Cesare Cantù, 11
Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal
Edifício D. Amélia, Piso 1, Ala B 2770-229
EL - Greece DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
EL - Grécko DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Nice Premier - Arenas 455, promenade des Anglais 06299 NICE
VECCHI & C. PIAM s.a.p.a.
& C. PIAM s.a.p.a.
RO - Romania S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
92517 BOULOGNE BILLANCOURT Cedex France
92517 BOULOGNE BILLANCOURT
Magis Farmaceutici Spa Via Cacciamali, 34-36-38/B 25125 Brescia Italy
IT - Taliansko Magis Farmaceutici Spa Via Cacciamali, 34-36-38/B 25125 Brescia
EL - Greece ANTOR EPE P. Mavromihali 1
EL - Grécko ANTOR EPE P. Mavromihali 1
Francia Farmac.Ind.Far.Bio.Srl Via dei Pestagalli, 7
IT - Taliansko Francia Farmac.Ind.Far.Bio.Srl Via dei Pestagalli, 7
EL - Greece B.I.
EL - Grécko B.I.
Benedetti & Co spa Via Bolognese,
& Co spa Via Bolognese,
EL - Greece KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
EL - Grécko KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671
So.Se.Pharm Srl Via dei Castelli Romani, 22 00040 Pomezia (Roma) Italy
IT - Taliansko So.Se.Pharm Srl Via dei Castelli Romani, 22 00040 Pomezia (Roma)
New Research Srl Via della Tenuta di Torrenova, 142 00133 Roma
Tenuta di Torrenova, 142 00133 Roma
Via Domenico Scarlatti, 31 20124 Milano Italy
Via Domenico Scarlatti, 31 20124
10 Esqº - Torre Fernão de Magalhães 1998-025 Lisboa
Fernão de Magalhães 1998-025 Lisboa
EL - Greece ALET PHARMACEUTICALS M. Alexander 121
PHARMACEUTICALS M. Alexander 121
Almus Srl Via Cesarea, 11/10 16121 Genova Italy
Srl Via Cesarea, 11/10 16121
SIAR Pharma Srl Via Verdi, 33
Pharma Srl Via Verdi, 33
AT - Austria CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
Pharmaceuticals Handels GmbH Gewerbestraße 18-20
EL - Greece COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
Agias Varvaras 53-55 Dafni, Athens 17235
Levofarma Srl Via Conforti, 42
Srl Via Conforti, 42
Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqº 1499-016 Algés
Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqº1499-016
Aurobindo Pharma Italia Srl Vicolo San Giovanni sul Muro, 9 20121 Milano
Pharma Italia Srl Vicolo San Giovanni sul Muro, 9 20121
EL - Greece S.J.A.
EL - Grécko S.J.A.
Industriestrasse, 25 D-83607 HolzkirchenGermany
D-83607 HolzkirchenGermany
BG - Bulgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
BG - Bulgaria Zentiva k.s.
BG - Bulharsko Zentiva k.s.
Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal
Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal
Farmac.Caber Spa Viale Città D'Europa, 681 00144 Roma Italy
IT - Taliansko Farmac.Caber Spa Viale Città D'Europa, 681 00144
NIMESULIDE / BIOMEDICA CHEMICA
NIMESULIDE / BIOMEDICA
50 MG/5ML Oral suspension Oral use
50 MG/5ML Perorálna suspenzia
Rua Engenheiro Ferreira Dias, 728, 3º Piso Sul 4149-014 Porto Portugal
Dias, 728, 3º Piso Sul 4149-014
SI-1000 Ljubljana
SI-1000
Kato Patissia 10445
Patissia 10445
HU - Hungary PannonPharma Kft. Pannonpharma út 1.
HU - Maďarsko PannonPharma Kft.
AULIN, granule pentru suspensie orală, 100 mg/plic mg/sachet
AULIN, granule pentru suspensie orală, 100 mg/plic mg/vrecko
RO - Romania S.C. MAGISTRA C&C S.R.L.
MAGISTRA C&C S.R.L.
Edifício Monsanto 2790-012 Portela de Carnaxide Portugal
Edifício Monsanto 2790-012
Laboratori Alter Srl Via Egadi, 7
Srl Via Egadi, 7
N. Psychiko 15451
Psychiko 15451
NIMESIL, granule pentru suspensie orală, 100 mg mg/sachet
NIMESIL, granule pentru suspensie orală, 100 mg mg/vrecko
Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora PORTUGAL
Rua João de Deus, 19 2700-487
200 MG/SUPP Suppository
200 MG/SUPP Čapík
Arrowblue Produtos Farmacêuticos S.A. Av. D. João II,
Arrowblue Produtos Farmacêuticos S.A.
RO - Romania LABORATORI GUIDOTTI SpA Via Livornese, 897
IT - Taliansko Lab.Guidotti Spa Via Livornese, 897
Dr Reddy's Srl Via Fernanda Wittengs, 3 20123 Milano Italy
Srl Via Fernanda Wittengs, 3 20123 Milano
SK - Slovakia Zentiva k.s., Evropská 846/176a, 160 00, Praha
Evropská 846/176a, 160 00, Praha
Rua João Chagas, 53 - 3º 1499-040 Cruz QuebradaDafundo
Rua João Chagas, 53 - 3º 1499-040
EL - Greece MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003
EL - Greece FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
Dervenakion 38 & Sahini Gerakas 15344
BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
BG - Bulharsko Actavis EAD 29 Atanas Dukov str.
EL - Greece BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
EL - Grécko BOEHRINGER INGELHEIM HELLAS S.A.
S.A. Rua João Chagas, 53 - 3º 1495-764 Cruz Quebrada Portugal
Rua João Chagas, 53 - 3º 1495-764
20144 Milano Italy
20126 Milano
12, rue Danjou
"Le Quintet" - Bâtiment A 12, rue Danjou
Mylan Spa Via Vittor Pisani, 20 20124 Milano Italy
IT - Taliansko Mylan Spa Via Vittor Pisani, 20 20124
PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
PL - Poľsko Pabianickie Zakłady Farmaceutyczne Polfa S.A.
Viale Papiniano, 22/B 20100 Milano Italy
IT - Taliansko MDM Spa Viale Papiniano, 22/B 20100 Milano
Aesculapius Farmaceutici Srl Via Cozzaglio, 24
Srl Via Cozzaglio, 24
EL - Greece ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
EL - Grécko ANTONIOS POLYCHRONIS OF MARINOU
RO - Romania S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
B-dul Theodor Pallady nr. 44B sector 3, Bucuresti Romania
BG - Bulgaria Laboratori Guidotti S.p.A.
BG - Bulharsko Laboratori Guidotti S.p.A.
EL - Greece RAFARM AEBE Korintou 12
EL - Grécko RAFARM AEBE
FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
EG LABO - Laboratoires EuroGenerics
Limassol, CY-3505
P.O. Box 51409 Limassol, CY-3505 Cyprus
SK - Slovakia Laboratori Guidotti S.p.A.
SK - Slovensko Laboratori Guidotti S.p.A.
Selvi Laboratorio Bioterapico Spa Via Procoio, 28
Spa Via Procoio, 28
Actavis Group PTC EHF Reykjavikurvegi 76-78 Hafnarf Joerdur Iceland
EHF Reykjavikurvegi 76-78
RO - Romania Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
LV - Latvia
LT - Litva
Sandoz Spa Largo U. Boccioni, 1 21040 Origgio (VA) Italy
IT - Taliansko Sandoz Spa Largo U. Boccioni, 1
EL - Greece BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
EL - Grécko BIOSPRAY ABEE 18TH Km Marathonos
Sarda Pharmaceutica Srl Via Castiglione, 92/B 09100 Cagliari Italy
IT - Taliansko Sarda Pharmaceutica Srl Via Castiglione, 92/B
EL - Greece BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
EPE 30 Km Athens-Lavrion
EL - Greece LEOVAN, M. LEWN & SIA EE Argonafton 22
EL - Grécko LEOVAN, M. LEWN
AT - Austria CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
Straße 395 b A-1190 Wien
Union Health Srl Via Roccamandolfi, 1 00156 Roma Italy
IT - Taliansko Union Health Srl Via Roccamandolfi, 1
SI - Slovenia CSC Pharma d.o.o.
SI - Slovinsko CSC
Largo Boccioni 1 21040 Origgio Varese Italy
Origgio Varese Italy
Sofar Spa Via Isonzo, 8 20100 Milano Italy
IT - Taliansko Sofar Spa Via Isonzo, 8
LT - Lithuania Zentiva k.s.
LV - Lotyšsko Zentiva k.s.
EL - Greece REMEK PHARMACEUTICALS ABEE Pentelis 34
EL - Grécko REMEK PHARMACEUTICALS ABEE
A-2102 Bisamberg
Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg
Ranbaxy Italia Spa Piazza Filippo Meda, 3 20121 Milano Italy
IT - Taliansko Ranbaxy Italia Spa Piazza Filippo Meda, 3
FARMA A.E. Aristotelous 73
Aristotelous 73
LT - Lithuania Medochemie Ltd. P.O.
LV - Lotyšsko Medochemie Ltd.
RO - Romania S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
Ştirbei Vodă nr. 53-55 sector 1, Bucureşti Romania
I.B.N.
IT - Taliansko I.B.N.
EL - Greece VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
& Korinthou 12 Neo Psychiko 15451
EL - Greece PHARMACYPRIA HELLAS A.E. Paster 6
EL - Grécko PHARMACYPRIA HELLAS A.E.
Helsinn Birex Pharmac.Ltd Mulhuddart, 15
IT - Taliansko Helsinn Birex Pharmac.Ltd Mulhuddart, 15
Ranbaxy Portugal - Comércio e Desenvol.
Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.
EL - Greece LAVIPHARM HELLAS A.E. Agias Marinas
EL - Grécko LAVIPHARM HELLAS A.E.
EL - Greece PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
EL - Grécko PHARMATHEN INTERNATIONAL S.A.
MG/SACHET
MG/VRECKO
PL - Poland Medicom International s.r.o.
Medicom International s.r.o.
Farmac.Damor Spa Via Emilio Scaglione, 27 80145 Napoli Italy
IT - Taliansko Farmac.Damor Spa Via Emilio Scaglione, 27
Angenerico Spa Via Nocera Umbra, 75 00181 Roma Italy
IT - Taliansko Angenerico Spa Via Nocera Umbra, 75
560 10 San Piero a Grado Pisa Italy
560 10 San Piero a Grado
EL - Greece MED-ONE S.A., HELLAS Parnithos Avenue 211
HELLAS Parnithos Avenue 211
Ratiopharm GmbH Graf-Arcostrasse, 2 ULM D-89070
IT - Taliansko Ratiopharm GmbH Graf-Arcostrasse, 2
Pensa Pharma Spa Via Rosellini Ippolito, 12 20124 Milano Italy
Pharma Spa Via Rosellini Ippolito, 12
EL - Greece HELP ABEE Valaoritou 10
EL - Grécko HELP ABEE
Teva Italia Srl Via Messina, 38 20154 Milano Italy
IT - Taliansko Teva Italia Srl Via Messina, 38
RO - Romania Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
Str. Nicolae Caramfil nr. 71-73, et.
Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 - Abrunheira
Rua da Tapada Grande, 2 - Abrunheira
Savio Srl Via E. Bazzano, 14 16019 Ronco Scrivia (GE) Italy
16019 Ronco Scrivia (GE)
EL - Greece NORMA HELLAS A.E. Menandrou 54
EL - Grécko NORMA HELLAS A.E.
Eg S.p.A.
S.C.
Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98
Basi - Indústria Farmacêutica, S.A.
SK - Slovakia Medicom International s.r.o.
SK - Slovensko Medicom
NIMESULIDE Benedetti & Co
NIMESULIDE Benedetti
EL - Greece FARMILIA E.E.
EL - Grécko FARMILIA
Ecobi Farmaceutici sas Via E. Bazzano, 26 16019 Ronco Scrivia (GE) Italy
Farmaceutici sas Via E. Bazzano, 26
Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira
Farmoz - Sociedade Técnico Medicinal, S.A.
Ilfov,
Ilfov, Romania
Dorom Srl Via Messina, 38 20154 Milano Italy
IT - Taliansko Dorom Srl Via Messina, 38
EL - Greece MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
EL - Grécko MEDARTE PHARMACEUTICLS ABEE
Piam Farmaceutici Spa Via Padre G. Semeria, 5 16131 Genova Italy
IT - Taliansko Piam Farmaceutici Spa Via Padre G. Semeria, 5
56010 Pisa-La Vettola
56010 Pisa-La Vettola Italy
EL - Greece VOCATE PHARMAKEFTIKI A.E. Gounari 150
EL - Grécko VOCATE PHARMAKEFTIKI A.E.
Pisa-La Vettola
Hafnarf Joerdur
EL - Greece INTERMED ABEE Kalyftaki 27
EL - Grécko INTERMED
6308 Larnaca
09100 Cagliari
FR - France HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
PHARMACEUTICALS Ltd Damastown Mulhuddart
Granules for oral solution in sachet
Granulát na perorálny roztok vo vrecku
Agips Farmaceutici Srl Via Amendola, 4 16035 Rapallo (GE) Italy
IT - Taliansko Agips Farmaceutici Srl Via Amendola, 4
EL - Greece BIOMEDICA-CHEMICA A.E. G. Lyra 25
EL - Grécko BIOMEDICA-CHEMICA
LT - Lithuania Laboratori Guidotti S.p.A.
LV - Lotyšsko Laboratori Guidotti S.p.A.
HU - Hungary Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
HU - Maďarsko Eurodrug Lab.
EL - Greece EVAGGELOS KALOFOLIAS & SIA O.E.
EL - Grécko EVAGGELOS KALOFOLIAS
Granules for oral solution
Granulát na perorálnu suspenziu
CY - Cyprus CODAL SYNTO LTD 33 Thekla Lysioti str.
CY - Cyprus CODAL SYNTO
Hexal AG
Rapallo (GE)
Crinos spa Via Pavia, 6 20136 Milano Italy
IT - Taliansko Crinos spa Via Pavia, 6
EL - Greece ARMEDICA A.E. Agias Markellis 17
EL - Grécko MEDICHROM A.E.
The warnings are appropriate.
Tieto upozornenia sú náležité.
The active substance is well known and is included in veterinary medicinal products currently authorised in the EU.
Táto účinná látka je dobre známa a nachádza sa vo veterinárnych liekoch, ktoré sú v súčasnosti schválené v EÚ.