FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici nakon EXP.
English: Sodium benzoate
Croatian: - natrijev benzoat
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/12/2012
Croatian: Datum prvog odobrenja: 06/12/2012
English: TARGET SPECIES Cattle, pigs and horses
Croatian: CILJNE VRSTE ŽIVOTINJA Goveda, svinje i konji
English: In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Croatian: U vrlo rijetkim slučajevima mogu se javiti anafilaktoidne reakcije koje mogu biti ozbiljne (pa i smrtonosne), i treba ih liječiti simptomatski.
English: In cattle, meloxicam is also a major excretion product in milk and bile whereas urine contains only traces of the parent compound.
Croatian: Kod goveda, meloksikam se također velikim dijelom izluči u mlijeko i žuč, dok mokraća sadrži samo tragove ishodišnog spoja.
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids (oxicams).
Croatian: Farmakoterapijska skupina: protuupalni i protureumatski proizvodi, nesteroidi (oksikami).
English: Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Croatian: Ne primjenjivati kod životinja koje boluju od oštećenja funkcije jetre, srca ili bubrega i poremećaja krvarenja, ili u slučajevima u kojima postoji dokaz ulcerogenih gastrointestinalnih lezija.
English: Oral use.
Croatian: Za oralnu primjenu.
English: Approximately 98% of meloxicam is bound to plasma proteins.
Croatian: Približno 98% meloksikama vezano je za bjelančevine plazme.
English: More than 98% of meloxicam is bound to plasma proteins.
Croatian: Više od 98% meloksikama vezano je na bjelančevine plazme.
English: Elimination Meloxicam is eliminated with a terminal half-life of 7.7 hours.
Croatian: Terminalni poluživot izlučivanja meloksikama iznosi 7,7 sati.
English: 4.2 Indications for use, specifying the target species Cattle:
Croatian: 4.2 Indikacije za primjenu, navesti ciljne vrste životinja Goveda:
English: PHARMACEUTICAL FORM Oral suspension
Croatian: OBLIK Oralna suspenzija
English: Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Croatian: Ne primjenjivati kod konja koji boluju od gastrointestinalnih poremećaja kao što su nadraženost i krvarenje, oštećena funkcija jetre, srca ili bubrega i poremećaji krvarenja.
English: Ethanol (96%) 159.8 mg
Croatian: Etanol (96%)
English: For Contacera 20 mg/ml only: Eurovet Animal Health B.V. Handelsweg 25, 5531 AE Bladel, THE NETHERLANDS
Croatian: Eurovet Animal Health B.V., Handelsweg 25, 5531 AE Bladel, NIZOZEMSKA
English: The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs, although quantitatively there are differences.
Croatian: Iako kvantitativno postoje razlike, metabolizam je kvalitativno sličan kod štakora, malih pasmina svinja, ljudi, goveda i svinja.
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Croatian: Nakon jedne supkutane doze od 0,5 mg meloksikama/kg, vrijednosti Cmax od 2,1 µg/ml postignute su nakon 7,7 sati kod mladih goveda, a od 2,7 µg/ml nakon 4 sata kod krava u razdoblju laktacije.
English: In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.
Croatian: Kod konja, nakon intravenske injekcije, terminalni poluživot izlučivanja meloksikama iznosi 8,5
English: After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 µg/ml was reached after 1 hour in pigs.
Croatian: Nakon dvije intramuskularne doze od 0,4 mg meloksikama/kg, vrijednost Cmax od 1,9 µg/ml dosegnuta je kod svinja nakon 1 sata.
English: EXPIRY DATE EXP {month/year} Once broached use by…...
Croatian: ROK VALJANOSTI EXP {mjesec/godina} Jednom otvorenu, upotrijebiti do..............
English: and
Croatian: ili
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs: meat and offal: 5 days
Croatian: Goveda: meso i jestive iznutrice: 15 dana; mlijeko: 5 dana Svinje: meso i jestive iznutrice: 5 dana
English: Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.
Croatian: Oralnu suspenziju primijeniti u dozi od 0,6 mg/kg tjelesne težine, jedanput na dan do 14 dana.
English: ROUTES OF ADMINISTRATION Cattle: SC or IV.
Croatian: PUT(EVI) PRIMJENE Goveda: s.c. ili i.v.
English: MARKETING AUTHORISATION HOLDER Zoetis Belgium SA
Croatian: Nositelj odobrenja za stavljanje u promet: Zoetis Belgium SA
English: Saccharin sodium Carmellose sodium Silica, colloidal anhydrous Citric acid monohydrate Sorbitol, liquid (non-crystallising) Disodium phosphate dodecahydrate Sodium benzoate
Croatian: - karmeloza-natrij saharin natrat - dinatrijfosfat dodekahidrat - silika, bezvodni koloidalni - limunska kiselina monohidrat - aroma meda - voda za injekcije
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Croatian: Meloksikam Meloksikam Goveda, koze, svinje,
English: Uncommon adverse reactions include transient swelling at the injection site in horses, but resolves without intervention.
Croatian: Prolazno oticanje na mjestu uboda je manje učestala nuspojava kod konja, koje nestaje bez intervencije.
English: In very rare cases, adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea).
Croatian: Rijetki slučajevi nuspojava karakteristično povezanih s nesteroidnim protuupalnim lijekovima opaženi su u kliničkim ispitivanjima (lagana urtikarija, proljev).
English: Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Croatian: Meloksikam je nesteroidni protuupalni lijek (NSAID) iz skupine oksikama koji djeluje kočenjem sinteze prostaglandina, čime se postižu protuupalni, analgetički, antieksudativni i antipiretički učinci.
English: Honey flavoured, off-white to yellow viscous oral suspension.
Croatian: Prljavo bijela do žuta viskozna oralna suspenzija s okusom meda.
English: Cardboard box containing one HDPE bottle of 100 or 250 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.
Croatian: Kartonska kutija koja sadrži jednu polietilensku bočicu od 100 ml ili 250 ml s polietilenskim adapterom vrha i zatvaračem za zaštitu od djece te polipropilenska mjerna štrcaljka.
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Croatian: Meloksikam ima također svojstva protiv endotoksičnosti, jer se pokazalo da koči proizvodnju tromboksana B2 potaknutog unosom endotoksina E. coli kod teladi, kod krava u razdoblju laktacije i kod svinja.
English: Single I.V.
Croatian: Konji: i.v.
English: Meloxicam is a NSAID of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Croatian: Meloksikam je nesteroidni protuupalni lijek (NSAID) iz skupine oksikama koji djeluje kočenjem sinteze prostaglandina, čime se postižu protuupalni, antieksudativni, analgetički i antipiretički učinci.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: Sve neupotrebljene veterinarsko-medicinske proizvode ili otpadne materijale dobivene primjenom tih veterinarsko-medicinskih proizvoda treba odlagati u skladu s lokalnim propisima.
English: Pregnancy and lactation: Do not use in pregnant or lactating mares.
Croatian: Graviditet i laktacija: Ne primjenjivati kod kobila za vrijeme graviditeta ili laktacije.
English: Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.
Croatian: Izbjegavati primjenu kod teško dehidriranih, hipovolemičnih ili hipotenzivnih životinja kojima je potrebna parenteralna rehidracija, jer postoji potencijalni rizik za razvoj bubrežne toksičnosti.
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.
Croatian: Meloksikam ima također svojstva protiv endotoksičnosti, jer se pokazalo da koči proizvodnju tromboksana B2 potaknutog unosom endotoksina E. coli kod teladi i svinja.
English: To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed
Croatian: Da bi dobili odgovarajuće ublažavanje bolova tijekom operacije potrebno je primijeniti odgovarajuće analgetike
English: 6.5 Nature and composition of immediate packaging Cardboard box with 1 colourless glass vial containing 20 ml, 50 ml, 100 ml or 250 ml.
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja Kartonska kutija s 1 bezbojnom staklenom bočicom od 20 ml, 50 ml, 100 ml ili 250 ml.
English: For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, oral suspensions of meloxicam may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Croatian: Contacera 15 mg/ml oralna suspenzija može se upotrijebiti za nastavak liječenja u dozi od 0,6 mg meloksikama/kg tjelesne težine, 24 sata nakon primjene injekcije.
English: Manufacturers responsible for batch release:
Croatian: Proizvođač odgovoran za puštanje serije:
English: Single I.M.
Croatian: Svinje: i.m.
English: To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.
Croatian: Primjenjuje se ili izmiješano s hranom, ili izravno u usta u dozi od 0,6 mg/kg tjelesne težine,
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle:
Croatian: INDIKACIJA(E) Goveda:
English: To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.
Croatian: Da bi dobili odgovarajuće ublažavanje bolova tijekom operacije potrebno je primijeniti odgovarajuće analgetike.
English: For the relief of post-operative pain following dehorning in calves.
Croatian: Za ublažavanje postoperativne boli nakon postupka odrožnjavanja teladi.
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Croatian: Jedna supkutana ili intravenska injekcija u dozi od 0,5 mg meloksikama/kg tjelesne težine (tj. 2,5 ml/100 kg tjelesne težine) u kombinaciji s antibiotskom terapijom ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
English: Maximum number of piercings is 14 for the 20 ml, 50 ml and 100 ml stoppers and 20 for the 250 ml stopper.
Croatian: Najveći broj probijanja gumenog čepa je 14 puta, za 20 ml, 50 ml i 100 ml i 20 puta za 250 ml.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e) ) - česte (više od 1 ali manje od 10 tretiranih životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 tretiranih životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 tretiranih životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Shelf- life after first opening the container: 3 months.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: 3 mjeseca.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Label for 50 ml, 100 ml and 250 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Etiketa za 50 ml, 100 ml, 250 ml
English: Shelf life after first opening of the immediate packaging: 3 months.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 3 mjeseci.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Croatian: Podrobnije informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranicama Europske agencije za lijekove http://www.ema.europa.eu/.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton for 20 ml, 50 ml, 100 ml and 250 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija za 20 ml, 50 ml, 100 ml, 250 ml
English: In very rare cases, adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea).
Croatian: U kliničkim ispitivanjima opaženi su izolirani slučajevi nuspojava karakteristično povezanih s nesteroidnim protuupalnim lijekovima (lagana urtikarija, proljev).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/144/005 100 ml
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/12/144/005 100 ml
English: Muscle Liver Kidney
Croatian: Jetra Bubreg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 15 mg/ml oral suspension for horses
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Contacera 15 mg/ml oralna suspenzija za konje
English: Interactions with other medicinal products and other forms of interaction: Do not administer concurrently with glucocorticosteroids, other Non-Steroidal Anti-Inflammatory Drugs or with anticoagulant agents.
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Ne primjenjivati istodobno s glukokortikosteroidima, drugim nesteroidnim protuupalnim lijekovima ili s antikoagulacijskim sredstvima.
English: Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
Croatian: Nakon supkutane injekcije, poluživot izlučivanja meloksikama iznosi 26 sati kod mladih goveda, a
English: Horses: meat and offal: 5 days.
Croatian: Konji: meso i jestive iznutrice: 5 dana.
English: Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3ml/100 kg body weight).
Croatian: Jedna intravenska injekcija u dozi od 0,6 mg meloksikama/kg tjelesne težine (tj. 3,0 ml/100 kg tjelesne težine).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for 20 ml bottles
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: Do not administer concurrently with glucocorticoids, other Non-Steroidal Anti-Inflammatory Drugs or with anti-coagulant agents.
Croatian: Ne primjenjivati istodobno s glukokortikosteroidima, drugim nesteroidnim protuupalnim lijekovima ili s antikoagulacijskim sredstvima.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 15 mg/ml oral suspension for horses meloxicam
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Contacera 15 mg/ml oralna suspenzija za konje meloksikam
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: DODATAK II A. PROIZVOĐAČI ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: PACKAGE LEAFLET: Contacera 20 mg/ml solution for injection for cattle, pigs and horses
Croatian: UPUTA O VMP: Contacera 20 mg/ml otopina za injekcije za goveda, svinje i konje
English: SC or IV injection.
Croatian: Goveda: s.c. ili i.v. injekcija.
English: STATEMENT OF ACTIVE SUBSTANCES Meloxicam 20 mg/ml
Croatian: SASTAV DJELATNIH TVARI Meloksikam 20 mg/ml
English: Cardboard box containing one colourless glass vial of 20 ml, 50 ml, 100 ml or 250 ml.
Croatian: 15. OSTALE INFORMACIJE Kartonska kutija s 1 bezbojnom staklenom bočicom od 20 ml, 50 ml, 100 ml ili 250 ml.
English: PACKAGE LEAFLET: Contacera 15 mg/ml oral suspension for horses
Croatian: UPUTA O VMP Contacera 15 mg/ml oralna suspenzija za konje
English: Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.
Croatian: Ublažavanje upale i bolova u akutnim i kroničnim mišićno-koštanim poremećajima kod konja.
English: Meloxicam
Croatian: Mišić
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 20 mg/ml solution for injection for cattle, pigs and horses
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Contacera 20 mg/ml otopina za injekcije za goveda, svinje i konje
English: Single S.C. or I.V.
Croatian: Goveda: Jedna s.c. ili i.v. injekcija.
English: Overdose (symptoms, emergency procedures, antidotes): In the case of overdose symptomatic treatment should be initiated.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti):
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Contacera 20 mg/ml otopina za injekcije za goveda, svinje i konje meloksikam
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju da se nehotice proguta, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
English: Manufacturer responsible for batch release
Croatian: PROIZVOĐAČI ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: INDICATION(S) Read the package leaflet before use.
Croatian: Pročitati uputu o VMP prije primjene
English: In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samoinjektiranja, odmah potražiti pomoć liječnika i pokažite mu ovu uputu o
English: Horses: Do not use in pregnant or lactating mares.
Croatian: Ne primjenjivati u kobila za vrijeme graviditeta ili laktacije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton for 100 ml or 250 ml bottle
Croatian: Kartonska kutija za bočicu 100 ml ili 250 ml
English: For the relief of pain associated with equine colic.
Croatian: Za ublažavanje bolova povezanih s kolikama kod konja.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja)
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Podrobnije informacije o ovom veterinarsko - medicinskom proizvodu dostupne su na web stranicama Europske agencije za lijekove http://www.ema.europa.eu/.
English: Meat and offal: 5 days
Croatian: Konji: meso i jestive iznutrice: 5 dana
English: 5 mg. For the full list of excipients, see section 6.1.
Croatian: Pomoćne tvari navedene u dijelu 6.1 SPC ili su dozvoljene tvari za koje je u tablici 1 Dodatka
English: Meat and offal: 15 days;
Croatian: Goveda: Meso i jestive iznutrice: 15 dana; mlijeko: 5 dana.
English: You will probably need to lie down until you feel better.
Croatian: Vjerojatno ćete morati ostati ležati dok se ne budete osjećali bolje.
English: Do not stop your treatment just because you feel better.
Croatian: Nemojte prekinuti liječenje samo zato što se osjećate bolje.
English: Other symptoms may include:
Croatian: Drugi simptomi mogu uključivati:
English: Try to take ABILIFY at the same time each day.
Croatian: Pokušajte uzimati ABILIFY svaki dan u isto vrijeme.
English: It does not matter whether you take it with or without food.
Croatian: Nije važno uzimate li ga s hranom ili ne.
English: • past experience with excessive gambling
Croatian: • prethodnog iskustva pretjeranog kockanja
English: • sudden unexplained death,
Croatian: • iznenadna neobjašnjiva smrt,
English: Over 75 % of patients were less than 13 years of age.
Croatian: 75 % bolesnika bilo je mlađe od 13 godina.
English: • prolonged and/or painful erection,
Croatian: • produžena i/ili bolna erekcija,
English: ABILIFY with food, drink and alcohol
Croatian: ABILIFY s hranom, pićem i alkoholom
English: This medicine will be given to you under medical supervision; it is therefore unlikely that you will be given too much.
Croatian: Ovaj će Vam se lijek davati pod medicinskim nadzorom; stoga je mala vjerojatnost da ćete dobiti previše lijeka.
English: 3 years After first opening: 6 months.
Croatian: 3 godine Nakon prvoga otvaranja: 6 mjeseci.
English: Do not open the blister until ready to administer.
Croatian: Ne otvarajte blister dok ne budete spremni uzeti lijek.
English: Do not push the tablet through the foil because this could damage the tablet.
Croatian: Ne gurajte tabletu kroz foliju jer biste mogli oštetiti tabletu.
English: • thoughts of suicide, suicide attempt and suicide,
Croatian: • misli o samoubojstvu, pokušaj samoubojstva i samoubojstvo,
English: • fixation of the eyeballs in one position,
Croatian: • fiksacija očnih jabučica u jednom položaju,
English: If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.
Croatian: Ako ste propustili uzeti dozu, uzmite je čim se sjetite, ali nemojte uzeti dvije doze u jednom danu.
English: Via della Chimica, 9 I-36100 Vicenza(VI) Italy
Croatian: Via della Chimica, 9 I-36100 Vicenza(VI) Italija
English: It is ready to use and intended for short-term use only (see section 5.1).
Croatian: Već je pripremljena za primjenu i namijenjena samo za kratkoročnu uporabu (vidjeti dio 5.1).
English: The doctor may also want to measure your blood pressure and pulse.
Croatian: Liječnik će Vam možda željeti izmjeriti krvni tlak i puls.
English: • involuntary, irregular muscle movements, especially in the face
Croatian: • nevoljnih, nepravilnih mišićnih pokreta, osobito na licu
English: Up to three injections in 24 hours may be given.
Croatian: Smijete dobiti najviše tri injekcije u 24 sata.
English: • unusual movements (especially of the face or tongue) and reduced level of consciousness.
Croatian: • neobične kretnje (osobito lica ili jezika) i sniženu razinu svijesti.
English: Date of first authorisation: 04 June 2004 Date of latest renewal: 04 June 2009
Croatian: Datum posljednje obnove odobrenja: 04. lipnja 2009.
English: • altered or increased sexual interest,
Croatian: • promijenjen ili pojačan seksualni nagon,