FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/001 - 1 vial
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/748/001 - 1 bočica
English: Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Croatian: Tablični popis nuspojava za docetaksel 75 mg/m2 u kombinaciji s cisplatinom i 5-fluorouracilom za terapiju karcinoma glave i vrata
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Croatian: Proljev stupnja 4 Prva epizoda: smanjiti doze docetaksela i 5-FU za 20 % Druga epizoda: prekinuti liječenje
English: Citric acid (pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari polisorbat 80 etanol bezvodni citratna kiselina (prilagodba pH)
English: Infusion site reaction
Croatian: Opći poremećaji i reakcije na mjestu primjene reakcija na mjestu primjene infuzije
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/003 - 1 vial
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/748/003 - 1 bočica
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Croatian: Poremećaji probavnog sustava mučnina (G 3/4: 2,4%); stomatitis/faringitis (G3/4:
English: Dry skin ; Desquamation
Croatian: Poremećaji kože i potkožnog tkiva suhoća kože; deskvamacija
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Croatian: Tablični popis nuspojava za docetaksel 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
English: Gastrointestinal haemorrhage (G3/4:
Croatian: Srčani poremećaji ishemija miokarda (G3/4:
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Croatian: Tablični popis nuspojava kod karcinoma dojke za docetaksel 100 mg/m² u monoterapiji
English: Vomiting (G3/4: 5%); Constipation
Croatian: trombocitopenija (G3/4: 0,6%); febrilna neutropenija
English: Diarrhoea (G3/4: 6.2%);
Croatian: Infekcije i infestacije infekcija (G3/4: 6,3%);
English: Nausea (G3/4: 5%); Stomatitis (G3/4: 7.8%);
Croatian: Poremećaji probavnog sustava mučnina (G3/4: 3,3%); stomatitis (G3/4: 1,7%); povraćanje (G3/4: 0,8%);
English: Nail disorders (severe: Skin reaction (no severe)
Croatian: Poremećaji kože i potkožnog tkiva alopecija; poremećaji noktiju (ne teški)
English: Immune system disorders Metabolism and nutrition disorders Nervous system disorders
Croatian: Poremećaji metabolizma i prehrane anoreksija
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² in combination with cisplatin
Croatian: Tablični popis nuspojava kod karcinoma nemalih stanica pluća za docetaksel 75 mg/m² u kombinaciji s cisplatinom MedDRA klasifikacija organskih sustava
English: Hearing impaired (G3/4: 1.2%)
Croatian: bol izazvana karcinomom (G3/4: 1,2%)
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m² as a 1 hour intravenous infusion every 3 weeks).
Croatian: Za liječenje docetakselom u monoterapiji (100 mg/m2 u obliku jednosatne intravenske infuzije svaka 3 tjedna) bilo je randomizirano 256
English: Arrhythmia (G3/4:
Croatian: Krvožilni poremećaji hipotenzija (G3/4:
English: Peripheral motor neuropathy (G3/4: 2.5%)
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija periferna motorna neuropatija (G3/4: 2,5%)
English: Nail disorders (severe: 0.7%); Skin reaction (G3/4:< 0.2%)
Croatian: Poremećaji kože i potkožnog tkiva kožna reakcija (G3/4: 0,8%)
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin
Croatian: Tablični popis nuspojava kod karcinoma dojke za docetaksel 75 mg/m² u kombinaciji s doksorubicinom MedDRA klasifikacija organskih sustava
English: Peripheral motor neuropathy (G3/4: 0.4%)
Croatian: Poremećaji živčanog sustava neuropatija (G3/4: 0,6%)
English: Weight increased (G3/4: Weight decreased (G3/4:
Croatian: Pretrage porast tjelesne težine (G3/4: 0%); gubitak tjelesne težine (G3/4: 0,2%)
English: The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Croatian: Ishodi djelotvornosti za skupinu docetaksela u odnosu na kontrolnu skupini prikazani su u sljedećoj tablici:
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy
Croatian: Pri primjeni docetaksela u kombinaciji s drugim citostaticima i/ili radioterapijom, zabilježeni su slučajevi akutne mijeloične leukemije i mijelodisplastičnog sindroma.
English: Number
Croatian: Ishod
English: Patients with severe liver impairment (see sections 4.2 and 4.4).
Croatian: Docetaksel se ne smije primjenjivati u bolesnika s teškim oštećenjima jetre, jer o tome ne postoje dostupni podaci (vidjeti dio 4.2. i 4.4).
English: Musculoskeletal, connective tissue bone disorders
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva mialgija
English: p = Hazard ratio*
Croatian: Podskupina bolesnika p= Omjer hazarda
English: Arrhythmia (G3/4: 0.2%)
Croatian: Srčani poremećaji aritmija (G3/4: 0,2%);
English: Venous disorder (G3/4: 0.6%)
Croatian: Poremećaji imunološkog sustava preosjetljivost (G3/4: 0,6%)
English: Hypotension
Croatian: Toksičnost
English: Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Croatian: ili 4 treba smanjiti dozu na 60 mg/m
English: Patient subset
Croatian: Podskupina bolesnika Broj bolesnika u
English: Vomiting (G3/4: 0.6%)
Croatian: bol izazvana karcinomom (G3/4: 0,6%)
English: Packaging Content Package size
Croatian: Pakovanje Sadržaj Veličina pakovan ja
English: Via Virgilio Maroso, 50, 00142 Rome, Italy
Croatian: Via Virgilio Maroso, 50, 00142 Rim, Italija
English: Arnulfstrasse 29, München, 80636,Germany
Croatian: KGaA Arnulfstrasse 29, München, 80636, Njemačka
English: Budějovická 778/3, Michle 140 00 Prague 4, Czech Republic
Croatian: Budějovická 778/3, Michle 140 00 Prague 4, Češka Republika
English: Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Spain
Croatian: Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Španjolska
English: Bristol-Myers Squibb GesmbH Rivergate / Gate 1 / 5.OG, Handelskai 92, 1200 Vienna, Austria
Croatian: Bristol-Myers Squibb GesmbH Rivergate / Gate 1 / 5.OG, Handelskai 92, 1200 Beč, Austrija
English: Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands
Croatian: Orteliuslaan 1000, 3528 BD Utrecht, Nizozemska
English: Orteliuslaan 1000, Utrecht, 3528 BD, The Netherlands
Croatian: Orteliuslaan 1000, Utrecht, 3528 BD, Nizozemska
English: Budějovická 778/3, Michle, 140 00 Prague, Czech Republic
Croatian: Budějovická 778/3, Michle, 140 00 Prag, Češka Republika
English: Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals, Swords, County Dublin, Ireland
Croatian: Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals, Swords, County Dublin, Irska meke kapsule
English: s.r.o.
Croatian: Prilog I.
English: Chaussée De La Hulpe, 185, 1170 Bruxelles, Belgium
Croatian: Bristol-Myers Squibb Belgium S.A. Chaussée De La Hulpe, 185, 1170 Bruxelles, Belgija
English: Bristol-Myers Squibb GmbH & Co. KGaA
Croatian: Bristol-Myers Squibb GmbH & Co.
English: Bristol-Myers Squibb spol.
Croatian: Bristol-Myers Squibb spol. s.r.o.
English: 300 MBq/ml Solution for injection
Croatian: 300 MBq/ml Otopina za injekciju U venu
English: See ‘Do not take
Croatian: Pogledajte 'Ne uzimajte
English: Children and adolescents
Croatian: Djeca ili adolescenti
English: The following additional risks are considered relevant for long-term use
Croatian: Sljedeći dodatni rizici smatraju se relevantnim pri dugotrajnoj primjeni:
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve dodatne informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet:
English: If you take more SOMAC Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Croatian: Ako uzmete više lijeka SOMAC Control nego što ste trebali Obavijestite liječnika ili ljekarnika ako ste uzeli više od preporučene doze.
English: What SOMAC Control is and what it is used for
Croatian: Što je SOMAC Control i za što se koristi
English: SOMAC Control may stop certain other medicines from working properly.
Croatian: SOMAC Control može zaustaviti djelovanje nekih drugih lijekova.
English: SOMAC Control has no or negligible influence on the ability to drive and use machines.
Croatian: SOMAC Control ne utječe ili neznatno utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
English: To avoid this interference, SOMAC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Croatian: Kako bi se izbjegla ova interferencija, liječenje lijekom SOMAC Control potrebno je prekinuti najmanje 5 dana prije mjerenja razine CgA (vidjeti dio 5.1.).
English: SOMAC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Croatian: SOMAC Control se ne preporučuje za primjenu u djece i adolescenata u dobi ispod 18 godina jer nema dovoljno podataka o sigurnosti i djelotvornosti.
English: SOMAC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
Croatian: SOMAC Control 20 mg želučanootporne tablete se ne smiju žvakati ni lomiti, već ih se mora progutati cijele s tekućinom prije obroka.
English: If you take SOMAC Control for longer periods, this may cause additional risks, such as:
Croatian: Uzimanje lijeka Somac Control tijekom duljih razdoblja može izazvati dodatne rizike, kao što su:
English: SOMAC Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Croatian: SOMAC Control je dostupan u Al/Al blisterima sa ili bez kartonskog pojačanja.
English: You must not use SOMAC Control if you are taking HIV protease inhibitors.
Croatian: Ne smijete koristiti SOMAC Control ako uzimate inhibitore HIV proteaze.
English: What SOMAC Control is and what it is used for What you need to know before you take SOMAC Control How to take SOMAC Control Possible side effects
Croatian: Što je SOMAC Control i za što se koristi Što morate znati prije nego počnete uzimati SOMAC Control Kako uzimati SOMAC Control Moguće nuspojave
English: Stop taking SOMAC Control when you are completely symptom-free.
Croatian: Prestanite uzimati SOMAC Control kada nastupi potpuno povlačenje simptoma.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/
English: - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your SOMAC Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Croatian: - metotreksat (koristi se za liječenje reumatoidnog artritisa, psorijaze ili raka) - ako uzimate metotreksat liječnik će možda preporučiti da privremeno prekinete uzimati SOMAC Control jer pantoprazol može povisiti razine metotreksata u krvi.
English: - if you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with SOMAC Control.
Croatian: - ako dobijete osip na koži, posebice na područjima izloženima suncu obavijestite svojeg liječnika što je prije moguće, jer ćete možda morati prekinuti liječenje lijekom SOMAC Control.
English: See ‘Other medicines and SOMAC Control'.
Croatian: Pogledajte 'Ostali lijekovi i SOMAC Control'.
English: What SOMAC Control contains - The active substance is pantoprazole.
Croatian: Što SOMAC Control sadrži - Djelatna tvar je pantoprazol.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Recite svom liječniku ili ljekarniku ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: SOMAC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.
Croatian: SOMAC Control ne smiju koristiti djeca i mladi u dobi do 18 godina jer ne postoje podaci o sigurnosti primjene u ovoj mlađoj dobnoj skupini.
English: Disorientation (and all aggravations)
Croatian: dezorijentira nost (i pogoršanje istog)
English: SOMAC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Croatian: SOMAC Control sadrži djelatnu tvar pantoprazol, koja blokira „pumpu“ koja proizvodi želučanu kiselinu.
English: What you need to know before you take SOMAC Control
Croatian: Što morate znati prije nego počnete uzimati SOMAC Control
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping SOMAC Control.
Croatian: Ako nastupe lezije, posebice na suncem izloženim područjima kože, te ako su popraćene artralgijom, bolesnik treba odmah potražiti medicinsku pomoć, a zdravstveni radnik treba razmotriti prekid liječenja lijekom SOMAC Control.
English: Do not take SOMAC Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6) - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Croatian: Nemojte uzimati SOMAC Control: - ako ste alergični na pantoprazol ili bilo koji sastojak ovog lijeka (navedeno u dijelu 6) - ako uzimate inhibitore HIV proteaze kao što su atazanavir i nelfinavir (za liječenje infekcije
English: SOMAC Control should not be used during breast-feeding.
Croatian: Somac Control ne smije se koristiti tijekom dojenja.
English: Other medicines and SOMAC Control
Croatian: Drugi lijekovi i SOMAC Control
English: Do not take SOMAC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Croatian: Ne uzimajte SOMAC Control s drugim lijekovima koji ograničavaju količinu proizvodnje želučane kiseline, kao što su drugi inhibitor protonske pumpe (omeprazol, lanzoprazol ili rabeprazol) ili H2 antagonist (npr. ranitidin, famotidin).
English: If you forget to take SOMAC Control
Croatian: Ako ste zaboravili uzeti SOMAC Control
English: This leaflet was last revised in {mm/yyyy}
Croatian: Ova uputa je zadnji puta revidirana u MM/GGGG
English: However, you may take SOMAC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Croatian: Ako je potrebno, SOMAC Control možete uzimati s antacidima (npr. megaldrat, alginatna kiselina, natrijev bikarbonat, aluminijev hidroksid, magnezijev karbonat ili kombinacije navedenih).
English: SOMAC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Croatian: SOMAC Control može smanjiti apsorpciju djelatnih tvari čija bioraspoloživost ovisi o pH želuca (npr. ketokonazol).
English: What SOMAC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Croatian: Kako SOMAC Control izgleda i sadržaj pakiranja Želučanootporne tablete su žute, ovalne, bikonveksne, filmom obložene tablete sa smeđom oznakom "P20" na jednoj strani.
English: Liver enzymes increased (transaminases , γ-GT)
Croatian: Poremećaji jetre i žuči povišenje jetrenih enzima (transaminaze, γ-GT)
English: Talk to your doctor before taking SOMAC Control - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test. - if you have ever had a skin reaction after treatment with a medicine similar to SOMAC Control that reduces stomach acid.
Croatian: - ako ste stariji od 55 godina i svakodnevno uzimate lijekove za probavne smetnje koji se izdaju bez recepta - ako ste stariji od 55 godina i imate bilo kakve nove ili nedavno promijenjene simptome refluksa - ako ste imali čir na želucu ili operaciju želuca - ako imate probleme s jetrom ili žuticu (žutilo kože ili očiju) - ako redovno posjećujete liječnika zbog neke ozbiljne bolesti ili stanja - ako ste naručeni na endoskopiju ili C-urea izdisajni test - ako ste ikad imali kožnu reakciju nakon terapije s lijekom sličnim lijeku SOMAC Control koji smanjuje želučanu kiselinu.
English: You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with SOMAC Control, but this medicine is not meant to bring immediate relief.
Croatian: Možete osjetiti olakšanje od simptoma refluksa kiseline ili žgaravice nakon samo jednog dana liječenja s SOMAC Control, ali ovaj lijek nije namijenjen trenutnom olakšanju simptoma.
English: Adverse reactions with pantoprazole in clinical trials and post-marketing experience
Croatian: Nuspojave pantoprazola u kliničkim ispitivanjima i iskustvu nakon stavljanja u promet Učestalost Organski sustav
English: How to take SOMAC Control
Croatian: Kako uzimati SOMAC Control
English: - You should not take SOMAC Control tablets for more than 4 weeks without consulting a doctor.
Croatian: - Ne smijete uzimati SOMAC Control tablete dulje od 4 tjedna bez savjetovanja s liječnikom.
English: Do not take SOMAC Control tablets for more than 4 weeks without consulting your doctor.
Croatian: Nemojte uzimati SOMAC Control tablete dulje od 4 tjedna bez savjetovanja s liječnikom.
English: - warfarin and phenprocoumon (used to thin blood and prevent clots).
Croatian: SOMAC Control'. - ketokonazol (koristi se za gljivične infekcije) - varfarin i fenprokumon (koristi se za razrjeđivanje krvi i sprječavanje ugrušaka).
English: - Uncommon side effects (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test; fracture in the hip, wrist or spine.
Croatian: - Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): Glavobolja; omaglica; proljev; mučnina, povraćanje; nadutost i vjetrovi; zatvor; suha usta; bol i nelagoda u trbuhu; kožni osip ili koprivnjača; svrbež; osjećaj slabosti; iscrpljenost ili opće loše osjećanje; poremećaji sna; povišenje jetrenih enzima u krvnim pretragama; prijelom kuka, zapešća ili kralježnice.
English: How to store SOMAC Control
Croatian: Kako čuvati SOMAC Control
English: SOMAC Control 20 mg gastro-resistant tablets Pantoprazole
Croatian: SOMAC Control 20 mg želučanootporne tablete pantoprazol
English: SOMAC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Croatian: SOMAC Control je indiciran za kratkotrajno liječenje simptoma refluksa (npr. žgaravica, regurgitacija kiseline) u odraslih.
English: Hepatocellular injury; Jaundice; Hepatocellular failure
Croatian: povišenje bilirubina oštećenje jetre; žutica; hepatocelularno zatajenje
English: SOMAC Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Croatian: SOMAC Control se koristi za kratkotrajno liječenje simptoma refluksa (npr. žgaravica, vraćanje kiseline iz želuca u usta) u odraslih.
English: Stevens-Johnson syndrome; Lyell syndrome;
Croatian: StevensJohnsonov sindrom; Lyellov sindrom; erythema multiforme; fotoosjetljivost; subakutni kožni lupus eritematodes (pogledajte dio
English: SOMAC Control 20 mg gastro-resistant tablets
Croatian: SOMAC Control 20 mg želučanootporne tablete
English: - if you are due to have a specific blood test (Chromogranin A) - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Croatian: - ako morate napraviti određenu krvnu pretragu (kromogranin A). - ako istodobno s pantoprazolom uzimate inhibitore HIV proteaze kao što su atazanavir i nelfinavir
English: Agranulocytosis Thrombocytopenia; Leukopenia,
Croatian: Poremećaji krvi i limfnog sustava agranulocito za trombocitope nija; leukopenija, pancitopenija
English: anaphylactic reactions and anaphylactic shock)
Croatian: Poremećaji imunološkog sustava preosjetljivos t (uključujući anafilaktičke reakcije i anafilaktički šok)
English: Hyperlipidaemias and lipid increases (triglycerides, cholesterol);
Croatian: Poremećaji metabolizma i prehrane hiperlipidemi je i povišenja lipida (triglicerida, kolesterola); promjene u tjelesnoj težini hiponatrijemija; hipomagnezijemi ja; hipokalcijemija
English: Takeda Italia S.p.A. Tel: +3906502601
Croatian: Tel: +3906502601
English: Magyarország Takeda Pharma Kft. Tel: +361 2707030
Croatian: Takeda Pharma AS Tel: +372 617 7669
English: Takeda Pharma sp. z o.o.
Croatian: Magyarország Takeda Pharma Kft.
English: Tel.: + 48 22 608 13 00
Croatian: Takeda Pharma sp. z o.o. Tel.: + 48 22 608 13 00
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivno g sustava i dojki ginekomastij
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nacionalna nadležna tijela države(a) članice(a) ili referentne(ih) države(a) članice(a), ako je primjenjivo, treba(ju) osigurati da nositelj(i) odobrenja ispuni(e) sljedeće uvjete:
English: Date of first authorisation: 13/12/2016
Croatian: Datum prvog odobrenja: 13/12/2016
English: The product should not enter watercourses as this may be dangerous for fish and other aquatic organisms.
Croatian: Proizvod ne bi smio ući u vodene tokove jer to može biti opasno za ribe i druge vodene organizme.
English: ATCvet code: QP51AX08.
Croatian: ATCvet kod: QP51AX08.
English: Once broached, use by …
Croatian: Jednom odčepljeno upotrijebiti do…
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Pitajte svog veterinara kako odlagati lijekove koji vam više nisu potrebni.
English: 3) If the metering pump is used for the first time (or hasn't been used for a few days), carefully pump till a drop of solution is formed on top of the nozzle.
Croatian: 3) Ako se mjerna pumpica upotrebljava prvi put (ili nije bila u upotrebi nekoliko dana), pažljivo pumpajte sve dok se na vrhu mlaznice ne pojavi kap otopine.
English: Repetitive contact with the product may lead to skin allergies.
Croatian: Učestali kontakt s proizvodom može dovesti do alergije kože.
English: Keep the bottle in the outer carton in order to protect from light.
Croatian: Držite bocu u vanjskom kartonu radi zaštite od svjetla.
English: If eye irritation persists, seek medical advice.
Croatian: Ako nadražaj očiju ne prestane, potražite savjet liječnika.
English: Highest values have been found in the liver and the kidney.
Croatian: Najviše vrijednosti pronađene su u jetri i bubrezima.
English: The active substance in HALAGON is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u HALAGON dozvoljena je tvar kako je navedeno u tablici 1 Dodatka Uredbi Komisije (EU) br. 37/2010: