natgillin/translations-raw huggingface dataset:
- cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indometacin, ketoprofen for pain or inflammation - furosemide for heart disease - cimetidine for reducing gastric acid - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - cholestyramine for high cholesterol or relief from itching in liver disease - activated charcoal to reduce absorption of medicines or other substances
- peroralna kontracepcijska sredstva (ki vsebujejo etinilestradiol in levonorgestrel), - cefaklor, benzilpenicilin (penicilin G), ciprofloksacin za zdravljenje okužb, - indometacin, ketoprofen za bolečine ali vnetja, - furosemid za srčno bolezen, - cimetidin za zmanjšanje izločanja želodčne kisline, - zidovudin za okužbo z virusom HIV, - rosuvastatin, simvastatin, atorvastatin, pravastatin za hiperholesterolemijo (visok holesterol), - sulfasalazin za kronično vnetno črevesno bolezen in revmatoidni artritis, - holestiramin za povišan holesterol ali lajšanje srbenja pri bolezni jeter, - aktivno oglje za zmanjšanje absorpcije zdravil ali drugih snovi.
What you need to know before you take AUBAGIO Do not take AUBAGIO:
Kaj morate vedeti, preden boste vzeli zdravilo AUBAGIO
How to store AUBAGIO 6.
Shranjevanje zdravila AUBAGIO 6.
Do not stop taking AUBAGIO or change your dose without talking to your doctor first.
Če ste prenehali jemati zdravilo AUBAGIO Ne prekinite zdravljenja z zdravilom AUBAGIO brez posvetovanja s svojim zdravnikom.
Polyamide/aluminium/poly(vinyl chloride) -aluminium perforated unit-dose blister packs in cartons containing 10x1 film-coated tablets.
Enoodmerni perforirani pretisni omoti poliamid/aluminij/polivinilklorid v škatlah po 10 x 1 filmsko obloženih tablet.
• Complete blood cell count including differential white blood cell and platelet count.
• celotno krvno sliko z diferencialno sliko levkocitov in številom trombocitov.
If this is not well tolerated, cholestyramine 4 g three times a day for 11 days can be used.
Če bolnik tega odmerka ne prenaša dobro, se lahko uporabi odmerek holestiramina 4 g trikrat na dan, 11 dni.
- if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6), - if you have severe liver problems, - if you are pregnant, think you may be pregnant, or are breast-feeding, - if you suffer from a serious problem which affects your immune system e.g. acquired immunodeficiency syndrome (AIDS), - if you have a serious problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, - if you are suffering from a serious infection, - if you have severe kidney problems which require dialysis, - if you have very low levels of proteins in your blood (hypoproteinaemia), If you are not sure, talk to your doctor or pharmacist before taking this medicine.
(AIDS), - če imate resne težave s kostnim mozgom ali če imate v krvi nizko število rdečih ali belih krvničk ali znižano število krvnih ploščic, - če imate resno okužbo, - če imate hude težave z ledvicami, ki zahtevajo dializo, - če imate zelo znižane ravni beljakovin v krvi (hipoproteinemija), Če ste negotovi, se pred začetkom jemanja tega zdravila posvetujte s svojim zdravnikom ali farmacevtom.
- 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).
- Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, natrijev karboksimetilškrob (vrsta A), hidroksipropilceluloza, magnezijev stearat, hipromeloza, titanov dioksid
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%).
Podskupina bolnikov je imela sekundarno progresivno (0,8 %) ali progresivno recidivno multiplo sklerozo (1,7 %).
In placebo-controlled studies, peripheral neuropathy, including both polyneuropathy and mononeuropathy (e.g., carpal tunnel syndrome), was reported more frequently in patients taking teriflunomide than in patients taking placebo.
V s placebom kontroliranih študijah so pri bolnikih, ki so prejemali teriflunomid, pogosteje kot pri bolnikih, ki so prejemali placebo, poročali o periferni nevropatiji, vključno s polinevropatijo in mononevropatijo (npr. sindromom karpalnega kanala).
Metabolism and nutrition disorders
Presnovne in prehranske motnje dislipidemija
Teriflunomide is contraindicated in pregnancy (see section 4.3).
Teriflunomid je kontraindiciran med nosečnostjo (glejte poglavje 4.3).
The majority of patients had relapsing-remitting multiple sclerosis (91.5%), but a subgroup of patients had secondary progressive (4.7%) or progressive relapsing multiple sclerosis (3.9%).
Podskupina bolnikov je imela sekundarno progresivno (4,7 %) ali progresivno recidivno multiplo sklerozo (3,9 %).
The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy.
Bolnico je treba poučiti, da v primeru zakasnitve pri pojavu menstruacije ali drugega razloga, ob katerem posumi na nosečnost, nemudoma obvesti zdravnika zaradi preiskave za nosečnost.
Teriflunomide is contraindicated in patients with severe hepatic impairment (see section 4.3).
Teriflunomid je kontraindiciran pri bolnikih s hudo okvarjenim delovanjem jeter (glejte poglavje 4.3).
Check with your doctor if you are not sure.
To bo preveril vaš zdravnik.
• Educational card for patients
• Opozorilno kartico za bolnika.
A consistent treatment effect on relapses and time to 3-month sustained disability progression in a subgroup of patients in TEMSO (n 127) with high disease activity was observed.
V študiji TEMSO so pri podskupini bolnikov (n  127) z zelo aktivno boleznijo ugotovili, da zdravljenje vpliva na recidive (zagone) in čas do 3-mesečnega ohranjenega napredovanja nezmožnosti.
How to take AUBAGIO
Kako jemati zdravilo AUBAGIO
• Affects liver function
• vpliva na delovanje jeter,
A mean decrease less than 15% from baseline affecting white blood cell count has been observed (see section 4.8).
Opazili so povprečno zmanjšanje števila levkocitov < 15 % od izhodiščne vrednosti (glejte poglavje 4.8).
The median EDSS score at baseline was 2.50; 298 patients (25.5%) had an EDSS score › 3.5 at baseline.
Mediana vrednost EDSS v izhodišču je bila 2,50; 298 bolnikov (25,5 %) je v izhodišču imelo vrednost EDSS > 3,5.Povprečno trajanje bolezni, od pojava prvih simptomov, je bilo 8,0 let.
Anemia, decreased platelet counts and effects on the immune system, including leukopenia, lymphopenia and secondary infections, were related to the effects on the bone marrow and/or lymphoid organs.
limfopenijo in sekundarnimi okužbami, so bili povezani z učinki na kostni mozeg in/ali limfne organe.
Effect of teriflunomide on oral contraceptives: 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of teriflunomide.
Po ponavljajočih se odmerkih teriflunomida so ugotovili povečanje povprečnih vrednosti Cmax (1,58-krat) in AUC0-24 (1,54-krat) za etinilestradiol in Cmax (1,33-krat) in AUC0-24 (1,41-krat) za levonorgestrel.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijsk a pljučna bolezen
There were no external malformations in the offspring of male rats administered teriflunomide prior to mating with untreated female rats.
Če so teriflunomid dali podganam moškega spola pred parjenjem z nezdravljenimi podganami ženskega spola, moški potomci niso imeli zunanjih malformacij.
AUBAGIO 14 mg film-coated tablets teriflunomide
AUBAGIO 14 mg filmsko obložene tablete teriflunomid
Severe skin reactions Cases of severe skin reactions have been reported with teriflunomide post-marketing (see section 4.4).
V obdobju po prihodu zdravila na trg so pri uporabi teriflunomida poročali o hudih kožnih reakcijah (glejte poglavje 4.4).
Effect of teriflunomide on CYP2C8 substrate: repaglinide There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of CYP2C8 in vivo.
Po ponavljajočih se odmerkih teriflunomida so ugotovili povečanje povprečnih vrednosti Cmax (1,7-krat) in AUC (2,4-krat) repaglinida, kar nakazuje, da je teriflunomid zaviralec CYP2C8 in vivo.
Influenza, Upper respiratory tract infection, Urinary tract infection, Bronchitis, Sinusitis, Pharyngitis, Cystitis, Gastroenteritis viral,
Infekcijske in parazitske bolezni gripa, okužba zgornjih dihal, okužba sečil, bronhitis, sinusitis, faringitis, cistitis, virusni gastroenteritis oralni herpes, zobna okužba, laringitis, tinea pedis hude okužbe, vključno s sepsoa
Mild allergic reactions
Bolezni imunskega sistema blage alergijske reakcije
ALT >3 ULN and TBILI >2 ULN
ALT > 3 ULN in TBILI > 2 ULN 5/994 (0,5%)
Use in males
Uporaba pri moških
What AUBAGIO is and what it is used for What AUBAGIO is
Kaj je zdravilo AUBAGIO in za kaj ga uporabljamo
Pollakiuria
ZLOŽENKA
Elevations of liver enzymes have been observed in patients receiving teriflunomide (see section 4.8).
Pri bolnikih, ki so prejemali teriflunomid , so ugotovili zvišanje ravni jetrnih encimov (glejte poglavje 4.8.).
Other side effects can occur with the following frequencies: Very common (may affect more than 1 in 10 people) Headache
Pogosti (pojavijo se lahko pri do 1 od 10 uporabnikov)
- 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
pekoč občutek, mravljinčenje ali bolečine v dlaneh in prstih (sindrom karpalnega kanala), - občutek razbijanja srca, - povišan krvni tlak, - bruhanje, zobobol, bolečina v zgornjem delu trebuha, - izpuščaj, akne, - bolečine v kitah, sklepih, kosteh, mišicah (mišično-skeletna bolečina), - pogostejše uriniranje kot običajno, - močnejše menstrualne krvavitve, - bolečine, - pomanjkanje energije ali občutek šibkosti (astenija), - izguba telesne mase.
- you are switching to or from AUBAGIO.
- če začenjate ali končujete jemanje zdravila AUBAGIO.
• Do this until the levels of AUBAGIO in your blood are low enough - your doctor will check this.
• Kontracepcijo lahko prekinete šele, ko so ravni zdravila AUBAGIO v vaši krvi dovolj nizke.
For rosuvastatin, a dose reduction by 50% is recommended for coadministration with teriflunomide.
Pri sočasnem jemanju teriflunomida in rosuvastatina je priporočljivo zmanjšanje odmerka rosuvastatina za 50 %.
Effect of teriflunomide on organic anion transporter 3 (OAT3) substrates There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of OAT3 in vivo.
Po ponavljajočih se odmerkih teriflunomida so ugotovili povečanje povprečnih vrednosti Cmax (1,43-krat) in AUC (1,54-krat) cefaklora, kar nakazuje, da je teriflunomid zaviralec OAT3 in vivo.
cysts and polyps) There does not appear to be an increased risk of malignancy with teriflunomide in the clinical trial experience.
Na osnovi izkušenj v kliničnih preskušanjih ne izgleda, da teriflunomid poveča tveganja za maligne bolezni.
A total of 618 patients were randomised to receive 7 mg (n=205) or 14 mg (n=216) of teriflunomide or placebo (n=197).
Skupaj so randomizirali 618 bolnikov in sicer 205 na prejemanje 7 mg teriflunomida, 216 na prejemanje 14 mg teriflunomida in 197 na prejemanje placeba.
- severe skin reactions which might include symptoms of skin rash, blistering, or ulcers in your mouth - severe infections or sepsis (a potentially life-threatening type of infection) which might include symptoms of high fever, shaking, chills, reduced urine flow, or confusion - serious liver disease which might include symptoms of yellowing of your skin or the whites of your eyes, darker urine than normal, unexplained nausea and vomiting, or abdominal pain - inflammation of the lungs which might include symptoms of shortness of breath or persistent cough - inflammation of the pancreas which might include symptoms of severe pain in the upper abdominal area that may also be felt in your back, nausea, or vomiting
temnejši urin kot je normalno, nepojasnjeno slabost v želodcu in bruhanje ali bolečine v trebuhu, - vnetje pljuč, ki lahko vključuje simptome, kot so kratka sapa ali trdovraten kašelj, - vnetje trebušne slinavke, ki lahko vključuje simptome, kot so hude bolečine v zgornjem predelu trebuha, ki se lahko širijo v hrbet, slabost v želodcu ali bruhanje.
What AUBAGIO is used for
Za kaj zdravilo AUBAGIO uporabljamo
Hazard ratio (CI95%)
Klinični izidi letna stopnja recidivov razlika tveganja (95-odstotni IZ)
Teriflunomide 14 mg
teriflunomid 14 mg placebo teriflunomid 14 mg placebo
AUBAGIO helps to protect against attacks on the central nervous system by the immune system by limiting the increase of some white blood cells (lymphocytes).
Z omejevanjem povečevanja nekaterih belih krvnih celic (limfocitov) zdravilo AUBAGIO pomaga ščititi pred napadi imunskega sistema na centralni živčni sistem.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports (PSURs)
• Redno posodobljena poročila o varnosti zdravila (PSUR)
• Blood pressure
• krvni tlak,
Common (may affect up to 1 in 10 people) - Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, gastroenteritis viral, oral herpes, tooth infection, laryngitis, fungal infection of the foot - Laboratory values: a decrease in the number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase) have been observed.
- gripa, okužba zgornjih dihal, okužba sečil, bronhitis, sinusitis, boleče žrelo in nelagoden občutek pri požiranju, cistitis, virusni gastroenteritis, herpes v ustih, zobna okužba, laringitis, glivična okužba stopala, - laboratorijske vrednosti: zmanjšanje števila rdečih krvničk (anemija), opazili so spremembe preiskav za jetra in bele krvničke (glej poglavje 2), kot tudi zvišanje encima v mišicah (kreatin fosfokinaza), - blage alergijske reakcije, - občutek tesnobe, - mravljinčenje, šibkost, otrplost, mravljinčenje ali bolečine v ledvenem predelu ali nogi (išias); otrplost,
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET
PODATKI NA VMESNI OVOJNINI
Therefore, the plausibility of observed decreased ionised calcium levels needs to be questioned in patients under treatment with leflunomide or teriflunomide.
Zato se je treba pri bolnikih, ki prejemajo leflunomid ali teriflunomid, v primeru izmerjene znižane koncentracije ioniziranega kalcija vprašati o verodostojnosti dobljenega izvida.
sanofi-aventis groupe
Imetnik dovoljenja za promet z zdravilom: sanofi-aventis groupe
Interstitial lung disease (ILD) has been reported with teriflunomide in the postmarketing setting.
V obdobju po začetku trženja teriflunomida so poročali o intersticijski pljučni bolezni (ILD-interstitial lung disease).
Therefore, when warfarin is co-administered with teriflunomide, close INR follow-up and monitoring is recommended.
Zato je priporočljivo natančno spremljanje vrednosti INR, če se sočasno uporabljata varfarin in teriflunomid.
No dosage adjustment is necessary for patients with mild, moderate or severe renal impairment not undergoing dialysis.
Pri bolnikih z blago, zmerno ali hudo okvarjenim delovanjem ledvic, ki se ne zdravijo z dializo, prilagoditev odmerka ni potrebna.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT-DOSE BLISTER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Therefore no dose adjustment is anticipated in mild, moderate and severe renal-impaired patients.
Zato pri bolnikih z blago, zmerno ali hudo okvarjenim delovanjem ledvic prilagoditve odmerka ni pričakovati.
Therefore no dose adjustment is anticipated in mild and moderate hepatic-impaired patients.
Zato pri bolnikih z blago ali zmerno okvarjenim delovanjem jeter prilagoditve odmerka ni pričakovati.
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.
Do teh učinkov je večinoma prišlo v prvih 6 mesecih zdravljenja, pri 121 od 139 bolnikov (87,1 %), zdravljenih s teriflunomidom 14 mg, pa je prišlo do resolucije.
Switching to or from AUBAGIO
Prehod na zdravilo AUBAGIO ali prehod z zdravila AUBAGIO na drugo zdravilo
AUBAGIO 14 mg film-coated tablets
IME ZDRAVILA AUBAGIO 14 mg filmsko obložene tablete
There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of teriflunomide.
Po ponavljajočih se odmerkih teriflunomida so ugotovili povečanje povprečnih vrednosti Cmax (2,65-krat) in AUC (2,51-krat) rosuvastatina.
Hypersensitivity reactions (immediate or delayed) including anaphylaxis and angioedema
Bolezni živčevja parestezija, išias, sindrom karpalnega kanala hiperestezij a, nevralgija, periferna nevropatija preobčutlji vostne reakcije (takojšnje ali z zakasnitvij o), vključno z anafilaksijo in angioedem om
Hazard ratio (CI95%) 3-month Sustained Disability Progression week
(95-odstotni IZ) 3-mesečno ohranjeno napredovanje nezmožnosti v 108. tednu razmerje ogroženosti (95-odstotni IZ)
As AUBAGIO decreases the number of white cells in the blood this may affect your ability to fight the infection.
Ker zdravilo AUBAGIO zmanjšuje število belih krvničk v krvi,
How to store AUBAGIO
Shranjevanje zdravila AUBAGIO
Do not take AUBAGIO if you are, or think you may be pregnant.
Če ste noseči ali menite, da bi lahko bili noseči, ne jemljite zdravila AUBAGIO.
Teriflunomide is contraindicated during breast-feeding (see section 4.3).
Jemanje teriflunomida med dojenjem je kontraindicirano (glejte poglavje 4.3).
Interstitial lung disease
Psihiatrične motnje tesnoba
No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
Pri bolnikih z blago ali zmerno okvarjenim delovanjem jeter prilagoditev odmerka ni potrebna.
Route/method of administration
Postopek in pot uporabe zdravila
Hazard ratio (CI95%) 6-month Sustained Disability Progression week
6-mesečno ohranjeno napredovanje nezmožnosti v 108. tednu razmerje ogroženosti (95-odstotni IZ)
Musculoskeletal pain,
Žilne bolezni glavobol hipertenzijab
Mild thrombocytopen ia (platelets <100G/l)
Bolezni krvi in limfatičnega sistema nevtropenijab, anemija blaga trombocito penija (trombociti <100 g/l)
Menorrhagia
Sre
Tell your doctor immediately, if you notice any of the following serious side effects: - allergic reactions which might include symptoms of rash, hives, swelling of lips, tongue or face or sudden difficulty breathing.
Če opazite katerega od naslednjih resnih neželenih učinkov, se nemudoma posvetujte s svojim zdravnikom: - alergijske reakcije, ki lahko vključujejo simptome, kot so izpuščaj, koprivnica, oteklost ustnic, jezika ali obraza ali nenadno težko dihanje, - hude kožne reakcije, ki lahko vključujejo simptome, kot so izpuščaj na koži, nastajanje mehurjev ali razjede v ustih, - hude okužbe ali sepsa (vrsta okužbe, ki je lahko smrtno nevarna), ki lahko vključujejo simptome, kot so visoka telesna temperatura, tresenje, mrzlica, zmanjšan tok urina ali zmedenost, - resna bolezen jeter, ki lahko vključuje simptome, kot so porumenelost kože ali očesnih beločnic,
Oral herpes, Tooth infection, Laryngitis, Tinea pedis
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišičnoskeletne bolečine, mialgija, artralgija
Fri
Redki
Not known e increaseb
Sanofi AB
FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
FR - Francija EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila in imetnikov dovoljenja za promet z zdravilom v državah članicah
CZ - Czech Republic
CZ - Češka Republika
PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
PL - Poljska Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
2114 Aglantzia
2114 Aglantzia Lefkosia
FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
FR - Francija CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
BG - Bulgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
BG - Bolgarija Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
HU - Hungary sanofi-aventis zrt.
HUMadžarska sanofi-aventis zrt.
SI - Slovenia CSC Pharma d.o.o.
SI - Slovenija CSC Pharma d.o.o.
RO - Romania S.C. MAGISTRA C&C S.R.L.
RO - Romunija S.C. MAGISTRA C&C S.R.L.
SK - Slovakia Zentiva k.s., Evropská 846/176a, 160 00, Praha
SK - Slovaška Zentiva k.s., Evropská 846/176a, 160 00, Praha
BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
BG - Bolgarija Sopharma AD 16 Iliensko shosse str. 1220 Sofia
BG - Bulgaria Inbiotech Ltd 5A Triaditza str.
BG - Bolgarija Inbiotech Ltd 5A Triaditza str.
BG - Bulgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
BG - Bolgarija CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
50 MG/5ML Oral suspension Oral use
50 MG/5ML Oral suspension Peroralna uporaba
BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
BG - Bolgarija Actavis EAD 29 Atanas Dukov str. Sofia 1407
FR - France THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
FR - Francija THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
RO - Romania S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
RO - Romunija S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
N. Psychiko 15451
N. Psychiko 15451 Greece
RO - Romania LABORATORI GUIDOTTI SpA Via Livornese, 897
RO - Romunija LABORATORI GUIDOTTI SpA Via Livornese, 897
AT - Austria CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
AT - Avstrija CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
AT - Austria CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
AT - Avstrija CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
RO - Romania CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
RO - Romunija CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
CY - Cyprus CODAL SYNTO LTD 33 Thekla Lysioti str.
CODAL SYNTO LTD 33 Thekla Lysioti str.
RO - Romania Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
RO - Romunija Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
CY - Cyprus CHR. K. UNIMED LTD 21 Davlou
CHR. K. UNIMED LTD 21 Davlou
RO - Romania Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
RO - Romunija Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
RO - Romania S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
RO - Romunija S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti