natgillin/translations-raw huggingface dataset:
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. 
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.
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 
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
SOMAC Control should not be used during breast-feeding. 
Somac Control ne smije se koristiti tijekom dojenja.
Other medicines and SOMAC Control 
Drugi lijekovi i SOMAC Control
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). 
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).
If you forget to take SOMAC Control 
Ako ste zaboravili uzeti SOMAC Control
This leaflet was last revised in {mm/yyyy} 
Ova uputa je zadnji puta revidirana u MM/GGGG
However, you may take SOMAC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed. 
Ako je potrebno, SOMAC Control možete uzimati s antacidima (npr. megaldrat, alginatna kiselina, natrijev bikarbonat, aluminijev hidroksid, magnezijev karbonat ili kombinacije navedenih).
SOMAC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole). 
SOMAC Control može smanjiti apsorpciju djelatnih tvari čija bioraspoloživost ovisi o pH želuca (npr. ketokonazol).
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. 
Kako SOMAC Control izgleda i sadržaj pakiranja Želučanootporne tablete su žute, ovalne, bikonveksne, filmom obložene tablete sa smeđom oznakom "P20" na jednoj strani.
Liver enzymes increased (transaminases , γ-GT) 
Poremećaji jetre i žuči povišenje jetrenih enzima (transaminaze, γ-GT)
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. 
- 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.
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. 
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.
Adverse reactions with pantoprazole in clinical trials and post-marketing experience 
Nuspojave pantoprazola u kliničkim ispitivanjima i iskustvu nakon stavljanja u promet Učestalost Organski sustav
How to take SOMAC Control 
Kako uzimati SOMAC Control
- You should not take SOMAC Control tablets for more than 4 weeks without consulting a doctor. 
- Ne smijete uzimati SOMAC Control tablete dulje od 4 tjedna bez savjetovanja s liječnikom.
Do not take SOMAC Control tablets for more than 4 weeks without consulting your doctor. 
Nemojte uzimati SOMAC Control tablete dulje od 4 tjedna bez savjetovanja s liječnikom.
- warfarin and phenprocoumon (used to thin blood and prevent clots). 
SOMAC Control'. - ketokonazol (koristi se za gljivične infekcije) - varfarin i fenprokumon (koristi se za razrjeđivanje krvi i sprječavanje ugrušaka).
- 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. 
- 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.
How to store SOMAC Control 
Kako čuvati SOMAC Control
SOMAC Control 20 mg gastro-resistant tablets Pantoprazole 
SOMAC Control 20 mg želučanootporne tablete pantoprazol
SOMAC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. 
SOMAC Control je indiciran za kratkotrajno liječenje simptoma refluksa (npr. žgaravica, regurgitacija kiseline) u odraslih.
Hepatocellular injury; Jaundice; Hepatocellular failure 
povišenje bilirubina oštećenje jetre; žutica; hepatocelularno zatajenje
SOMAC Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults. 
SOMAC Control se koristi za kratkotrajno liječenje simptoma refluksa (npr. žgaravica, vraćanje kiseline iz želuca u usta) u odraslih.
Stevens-Johnson syndrome; Lyell syndrome; 
StevensJohnsonov sindrom; Lyellov sindrom; erythema multiforme; fotoosjetljivost; subakutni kožni lupus eritematodes (pogledajte dio
SOMAC Control 20 mg gastro-resistant tablets 
SOMAC Control 20 mg želučanootporne tablete
- 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 
- ako morate napraviti određenu krvnu pretragu (kromogranin A). - ako istodobno s pantoprazolom uzimate inhibitore HIV proteaze kao što su atazanavir i nelfinavir
Agranulocytosis Thrombocytopenia; Leukopenia, 
Poremećaji krvi i limfnog sustava agranulocito za trombocitope nija; leukopenija, pancitopenija
anaphylactic reactions and anaphylactic shock) 
Poremećaji imunološkog sustava preosjetljivos t (uključujući anafilaktičke reakcije i anafilaktički šok)
Hyperlipidaemias and lipid increases (triglycerides, cholesterol); 
Poremećaji metabolizma i prehrane hiperlipidemi je i povišenja lipida (triglicerida, kolesterola); promjene u tjelesnoj težini hiponatrijemija; hipomagnezijemi ja; hipokalcijemija
Magyarország Takeda Pharma Kft. Tel: +361 2707030 
Takeda Pharma AS Tel: +372 617 7669
Takeda Pharma sp. z o.o. 
Magyarország Takeda Pharma Kft.
Tel.: + 48 22 608 13 00 
Takeda Pharma sp. z o.o. Tel.: + 48 22 608 13 00
Reproductive system and breast disorders 
Poremećaji reproduktivno g sustava i dojki ginekomastij
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): 
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:
Date of first authorisation: 13/12/2016 
Datum prvog odobrenja: 13/12/2016
The product should not enter watercourses as this may be dangerous for fish and other aquatic organisms. 
Proizvod ne bi smio ući u vodene tokove jer to može biti opasno za ribe i druge vodene organizme.
ATCvet code: QP51AX08. 
ATCvet kod: QP51AX08.
Once broached, use by … 
Jednom odčepljeno upotrijebiti do…
Ask your veterinary surgeon how to dispose of medicines no longer required. 
Pitajte svog veterinara kako odlagati lijekove koji vam više nisu potrebni.
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. 
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.
Repetitive contact with the product may lead to skin allergies. 
Učestali kontakt s proizvodom može dovesti do alergije kože.
Keep the bottle in the outer carton in order to protect from light. 
Držite bocu u vanjskom kartonu radi zaštite od svjetla.
If eye irritation persists, seek medical advice. 
Ako nadražaj očiju ne prestane, potražite savjet liječnika.
Highest values have been found in the liver and the kidney. 
Najviše vrijednosti pronađene su u jetri i bubrezima.
The active substance in HALAGON is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: 
Djelatna tvar u HALAGON dozvoljena je tvar kako je navedeno u tablici 1 Dodatka Uredbi Komisije (EU) br. 37/2010:
However, in order to make the HALAGON treatment easier, a simplified dosage scheme is proposed: 
Međutim, kako bi liječenje HALAGON-om bilo lakše, predlaže se pojednostavljena shema doziranja:
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product. 
Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1 Dodatka Uredbi Komisije (EU) br. 37/2010 navedeno da određivanje MRL-a nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju kao u ovom proizvodu.
Wear protective gloves while handling the product. 
Nosite zaštitne rukavice prilikom rukovanja proizvodom.
In case of skin and eye contact wash the exposed area thoroughly with clean water. 
U slučaju dodira s kožom i očima isperite izloženo područje temeljito čistom vodom.
1) Screw the metering pump on the bottle. 
1) Navijte mjernu pumpicu na bocu.
Not for use in animals from which milk is produced for human consumption 
Nije za primjenu u životinja koje se uzgajaju za proizvodnju mlijeka za konzumaciju
The concentrations to inhibit 50% and 90% of the parasites, in an in vitro test system, are IC50 < 0.1 μg/ml and IC90 of 4.5 
Koncentracije za inhibiciju od 50 % odnosno 90 % parazita, u sustavu testiranja in vitro, iznose IC50 <0,1 µg/ml odnosno IC90 od 4,5 µg/ml.
Unchanged halofuginone is the major component in the tissues. 
Nepromijenjeni halofuginon glavni je sastojak u tkivima.
Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists. 
Nakon što je prva telad tretirana i sva buduća novorođena telad mora biti sustavno tretirana sve dok postoji rizik od proljeva zbog postojeće infekcije s C. parvum.
Tartrazine (E102) 
Tartrazin (E102)
Halofuginone lactate is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections. 
Halofuginon laktat je sol čija su antiprotozoalna svojstva i djelotvornost protiv Cryptosporidium parvum dokazana kako u in vitro uvjetima tako i na umjetnim i prirodnim infekcijama.
In very rare cases, an increase in the level of diarrhoea has been observed in treated animals. 
U vrlo rijetkim slučajevima uočeno je povećanje proljeva kod liječenih životinja.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjski karton
The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration. 
Krajnje poluvrijeme eliminacije je 11,7 sati nakon intravenske primjene i 30,84 sati nakon jedne peroralne primjene.
Each bottle is sealed with a polypropylene cap. Each package also contains a 4 ml metering pump that consists of several components made out of high, low and linear low density polyethylene, polypropylene, stainless steel and silicone. 
Svako pakiranje sadrži i mjernu pumpicu od 4 ml koja se sastoji od nekoliko komponenti izrađenih od polietilena visoke i niske gustoće, linearnog polietilena niske gustoće, polipropilena, nehrđajućeg čelika i silikona.
For smaller or higher weights, a precise calculation should be performed (4 ml/20 kg). 
Za manju ili veću tjelesnu masu, treba izvršiti precizan izračun (4 ml/20 kg).
For oral use in calves after feeding. 
Za peroralnu uporabu u teladi nakon hranjenja.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION 
DATUM PRVOG ODOBRENJA/PRODULJENJA ODOBRENJA
Avoid skin, eye or mucosal contact with the product. 
Izbjegavajte kontakt proizvoda s kožom, očima ili sluznicom.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 
Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tog veterinarsko-medicinskog proizvoda moraju se odlagati u skladu s lokalnim zakonima.
The bioavailability of the drug in the calf following single oral administration is about 80%. 
Biodostupnost lijeka u teleta, nakon jedne peroralne primjene, je oko 80 %.
Antiparasitic agents/Agents acting against protozoa 
Antiparazitske tvari / tvari protiv protozoa
Major incompatibilities 
6.2 Glavne inkompatibilnosti
Should clinical signs of overdosing occur, the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer. 
Ako se jave klinički znakovi predoziranja liječenje se mora odmah prekinuti, a životinje treba hraniti mlijekom ili mliječnom zamjenicom bez lijekova.
To ensure a correct dosage, an appropriate doser for administration of ‘HALAGON' is included. 
Kako bi se osigurala točna doza uključen je odgovarajući dozator za primjenu „HALAGON-a”.
The plasmatic concentrations of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after single oral treatment. 
Plazmatska koncentracija halofuginona nakon ponovljenih peroralnih primjena usporediva je s farmakokinetičkim uzorkom nakon jedne peroralne terapije.
For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution. 
Za liječenje anoreksične teladi proizvod treba primijeniti s pola litre elektrolitske otopine.
5) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution. 
5) Povucite do kraja odponac mjerne pumpice kako bi se ispustila doza koja odgovara 4 ml otopine.
In new-born calves: 
U novorođene teladi:
Halofuginone (as lactate salt) 
Halofuginon (kao laktatna sol)
Cattle (newborn calves) 
Goveda (novorođena telad)
4) Restrain the calf and insert the nozzle of the metering pump into the calves mouth. 
4) Imobilizirajte tele i umetnite mlaznicu pumpe u usta teleta.
The apparent volume of distribution is 10 l/kg. 
Prividni obujam raspodjele iznosi 10 l/kg.
Administer after colostrum feeding, or after milk or milk replacer feeding only. 
Primijeniti nakon hranjenja kolostrumom, mlijekom ili mliječnim zamjenicama.
The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles). 
Djelatna tvar halofuginon je antiprotozoik iz skupine derivata kvinazolinona (dušikov poliheterociklički spoj).
0.50 mg Equivalent to 0.6086 mg of halofuginone lactate 
0,50 mg Ekvivalentno 0,6086 mg halofuginon laktata
Pharmacotherapeutic group: Other antiprotozoal agents, halofuginone. 
Farmakoterapijska skupina: drugi antiprozotoalne tvari, halofuginon.
• Prevention of diarrhoea due to diagnosed Cryptosporidium parvum infection, in farms with history of cryptosporidiosis. 
• Prevencija proljeva zbog dijagnosticirane infekcije parazitom Cryptosporidium parvum, na farmama s poviješću prethodne pojave kriptosporidioze.
08503 Gurb-Vic, Barcelona Spain 
08503 Gurb-Vic, Barcelona
Administration should start within 24 hours after the onset of diarrhoea. 
Primjena bi trebala započeti unutar 24 sata nakon pojave proljeva.
Pull twice or three times, respectively, for administration of the desired volume (8 ml for calves of 35 - 45 kg and 12 ml for calves of 45 - 60 kg, respectively). 
Povucite dva, odnosno tri puta za primjenu željene količine (8 ml za telad mase 35 - 45 kg, odnosno
• Reduction of diarrhoea due to diagnosed Cryptosporidium parvum infection. 
• Smanjenje proljeva zbog dijagnosticirane infekcije parazitom Cryptosporidium parvum.
Manufacturer responsible for batch release: Divasa-Farmavic, S.A. 
Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet: Divasa-Farmavic, S.A.
Benzoic acid (E210) 
Pomoćne tvari: Benzoična kiselina (E210)
STATEMENT OF THE MRLs 
IZVJEŠĆE O MRL-ima
0.03 mg For the full list of excipients, see section 6.1. 
Za potpuni popis pomoćnih tvari vidi dio 6.1.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch. 
U tiskanoj uputi o VMP-u moraju biti navedeni naziv i adresa proizvođača odgovornog za puštanje predmetne serije u promet.
The dosage is: 100 μg of halofuginone / kg bw / once a day for 7 consecutive days, i.e. 4 ml of HALAGON / 20 kg bw / once a day for 7 consecutive days. 
Doza je: 100 μg halofuginona / kg tjelesne mase / jednom dnevno / 7 uzastopnih dana, odnosno 4 ml HALAGON-a / 20 kg tjelesne mase / jednom dnevno / 7 uzastopnih dana.
EMDOKA bvba J. Lijsenstraat 16 B-2321 Hoogstraten Belgium 
EMDOKA bvba J. Lijsenstraat 16 B-2321 Hoogstraten Belgija
STATEMENT OF ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS 
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
It is mainly active on the free stages of the parasite (sporozoïte, merozoïte). 
Spoj ima kriptosporidiostatski učinak na Cryptosporidium parvum te je uglavnom aktivan na slobodne stadije parazita (sporozoit, merozoit).
EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium 
EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgija
Shelf-life after first opening the container: 6 months. 
Rok valjanosti nakon prvog otvaranja unutarnjeg pakiranja: 6 mjeseci.
An appropriate device for oral administration is included. 
Uključen je odgovarajući pribor za peroralnu primjenu.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Shelf-life after first opening the immediate packaging: 6 months. 
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi poslije „EXP”.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products 
6.6 Posebne mjere predostrožnosti za odlaganje neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
Clear yellow oral solution. 
Bistra žuta peroralna otopina.
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 6 months. 
Rok valjanosti veterinarsko-medicinskih proizvoda kad je zapakiran za prodaju: 3 godine.
• 45 kg < calves < 60 kg: 12 ml of HALAGON once a day during 7 consecutive days 
45 kg <telad < 60 kg: 12 ml HALAGON-a jednom dnevno, tijekom 7 uzastopnih dana.
Benzoic acid (E210) Lactic acid (E270) Tartrazine (E102) Water, Purified 
6.1 Popis pomoćnih tvari Benzoična kiselina (E210) Mliječna kiselina (E270)
Adverse reactions (frequency and seriousness) 
4.6 Nuspojave (učestalost i ozbiljnost)
Vidikovac 20, 10000 Zagreb TEL: +385 (0) 1 364 37 37 
Arnika Veterina d.o.o. Vidikovac 20, 10000 Zagreb TEL: +385 (0) 1 364 37 37
• 35 kg < calves ≤ 45 kg: 8 ml of HALAGON once a day during 7 consecutive days 
35 kg < telad ≤ 45 kg: 8 ml HALAGON-a jednom dnevno, tijekom 7 uzastopnih dana,
Cardboard box containing one bottle (high-density polyethylene) of 290 ml, 490 ml or 980 ml of the oral solution. 
Kartonska kutija sadrži jednu bocu (polietilen visoke gustoće), koja sadrži 290 ml, 490 ml ili 980 ml peroralne otopine.
2) Remove the protector cap from the nozzle. 
2) Odstranite zaštitni čep s mlaznice.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 290ml, 490 ml or 980 ml 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Boca od 290 ml, 490 ml ili 980 ml
Cardboard box with high density polyethylene bottles of 290 ml, 490 and 980 ml. 
Kartonska kutija koja sadrži jednu bocu od polietilena visoke gustoće obujma 290 ml, 490 ml ili 980 ml.
CONDITIONS OF RESTRICTIONS REGARDING SUPPLY OR USE 
UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE ILI PRIMJENE
HALAGON 0.5 mg/ml oral solution halofuginone 
HALAGON 0,5 mg/ml peroralna otopina halofuginon
HALAGON 0.5 mg/ml oral solution for calves halofuginone (as lactate salt) 
HALAGON 0,5 mg/ml peroralna otopina za telad halofuginon (kao laktatna sol)
To ensure a correct dosage, an appropriate metering pump for administration of ‘HALAGON' is included. 
Kako bi se osigurala točna doza uključena je odgovarajuća mjerna pumpica za primjenu
6) Put the protector cap back on the nozzle. 
6) Vratite zaštitni čep na mlaznicu.
Oral solution. 
Za peroralnu primjenu.
s.r.l. 
MRL-i
71 08503 Gurb-Vic, Barcelona Spain 
Sant Hipolit, Km. 71 08503 Gurb-Vic, Barcelona Španjolska
Amounts to be administered and administration route 
4.9 Količine koje se primjenjuju i način primjene
Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution. 
Osobe preosjetljive na djelatnu tvar ili bilo koju od pomoćnih tvari trebaju oprezno primjenjivati veterinarsko medicinski proizvod.
Special precautions for use 
Posebne mjere pri čuvanju
Nature and composition of immediate packaging 
6.5 Osobine i sastav unutarnjeg pakiranja
Bovine 10 μg/kg 25 μg/kg 
10 µg/kg 25 µg/kg 30 µg/kg 30 µg/kg mišići masno tkivo jetra bubrezi
HALAGON 0.5 mg/ml oral solution for calves 
HALAGON 0,5 mg / ml peroralna otopina za telad
Marketing Authorisation Holder: EMDOKA bvba John Lijsenstraat 16 
Nositelj odobrenja za stavljanje u promet: EMDOKA bvba
Target tissues 
Peroralna otopina
It is taken morning and evening. 
Uzima se ujutro i uvečer.
Further information on Stayveer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Više informacija o lijeku Stayveer dostupno je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This medicine is the same as Tracleer, which is already authorised in the EU. 
Ovaj lijek isti je kao i Tracleer, koji je već odobren u EU-u.
What measures are being taken to ensure the safe and effective use of Stayveer? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Stayveer?