FrancophonIA/ELRC3.0 huggingface dataset:
English: Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Croatian: Olanzapin može antagonistički djelovati na učinke izravnih i neizravnih agonista dopamina.
English: Nervous system disorders
Croatian: Opća aktivnost središnjeg živčanog sustava
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); problems with speech; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness;urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Croatian: Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba) uključuju preosjetljivost (npr. oticanje u ustima i grlu, svrbež; osip); šećernu bolest ili pogoršanje šećerne bolesti, ponekad povezano s ketoacidozom (ketonima u krvi i mokraći) ili komom; napadaje, obično povezane s napadajima u povijesti bolesti (epilepsija); mišićnu ukočenost ili grč (uključujući pokrete očiju); poteškoće s govorom; usporen rad srca; osjetljivost na sunčevu svjetlost; krvarenje iz nosa; nadimanje trbuha; gubitak pamćenja ili zaboravljivost; nemogućnost zadržavanja mokraće (inkontinencija); nemogućnost mokrenja; ispadanje kose; izostanak ili smanjenje mjesečnice i promjene na grudima u muškaraca i žena, kao što je poremećaj stvaranja majčinog mlijeka ili abnormalan rast.
English: If this happens after you have been given OLANZAPINE CIPLA tell your doctor.
Croatian: Vam se ovo pojavi nakon uzimanja lijeka OLANZAPINE CIPLA, obratite se svom liječniku.
English: In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen.
Croatian: U mladunčadi štakora kojima je davan olanzapin primijećeni su zastoj u fetalnom razvoju i
English: Glucosuria
Croatian: BLISTERA
English: Olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
Croatian: Početna doza olanzapina bila je 2,5 mg/dan te je potom titrirana do najviše 15 mg/dan na temelju
English: If you forget to take OLANZAPINE CIPLA Take your tablets as soon as you remember.
Croatian: Uzmite tablete čim se sjetite.
English: Photosensitivity reaction Alopecia
Croatian: Poremećaji kože i potkožnog tkiva reakcija fotoosjetljivosti alopecija
English: Olanzapine Cipla 2.5 mg, 5 mg, 7.5 mg and 15 mg coated tablets are available in 28 and 56 blister packs.
Croatian: Olanzapin Cipla 2,5 mg , 5 mg , 7,5 mg i 15 mg obložene tablete su dostupne u 28 i 56 blister omot . Olanzapin Cipla 10 mg obložene tablete su dostupne u 7 , 28 i 56 žulj paketima
English: Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor;; unusual movements(dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males..
Croatian: Česte nuspojave (mogu se pojaviti u do 1 na 10 osoba) uključuju promjene razina nekih krvnih stanica, cirkulirajućih masti u krvi te, u ranim fazama liječenja, privremena povećanja razine jetrenih enzima; povišene razine šećera u krvi i mokraći; povećanje razine mokraćne kiseline i kreatin fosfokinaze u krvi; pojačan apetit; omaglicu; nemir; nevoljno drhtanje; neuobičajene pokrete (diskinezije); zatvor; suha usta; osip; slabost; pojačan umor; zadržavanje vode u tijelu koje dovodi do oticanja ruku, zglobova ili stopala; vrućicu; bol u zglobovima te seksualne poremećaje kao što su smanjeni libido u muškaraca i žena ili erektilna disfunkcija u muškaraca.
English: In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/hr, respectively).
Croatian: U ispitanika pušača s blago poremećenom funkcijom jetre prosječno poluvrijeme eliminacije bilo je produljeno (39,3 sata), a klirens (18,0 l/h) smanjen kao i u zdravih ispitanika nepušača (48,8 sati
English: The most frequently (seen in ≥ 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Croatian: Najčešće prijavljene nuspojave (uočene u ≥ 1% bolesnika) povezane s primjenom olanzapina u kliničkim ispitivanjima bile su somnolencija, povećanje tjelesne težine, eozinofilija, povišene vrijednosti prolaktina, kolesterola, glukoze i triglicerida (vidjeti dio 4.4), glikozurija, povećan apetit, omaglica, akatizija, parkinsonizam parkinsonizam, leukopenija, neutropenija (vidjeti dio 4.4), diskinezija, ortostatska hipotenzija, antikolinergički učinci, prolazni asimptomatski porasti vrijednosti jetrenih aminotransferaza (vidjeti dio 4.4), osip, astenija, umor, pireksija, artralgija, povišena razina alkalne fosfataze, visoka razina gama glutamiltransferaze, visoka razina mokraćne kiseline, visoka
English: CARTON OF COATED TABLETS IN BLISTERS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA S OBLOŽENIM TABLETAMA U BLISTERIMA
English: In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
Croatian: U 18-mjesečnom ispitivanju istodobne terapije u bolesnika s maničnim ili miješanim epizodama, koji su stabilizirani olanzapinom i stabilizatorom raspoloženja (litij ili valproat), dugotrajna istodobna terapija olanzapinom s litijem ili valproatom nije bila statistički značajno superiorna u odnosu na litij ili valproat primijenjen u monoterapiji za odgađanje relapsa bipolarnog poremećaja definiranog prema
English: 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Croatian: 7 Akutni simptomi kao što su znojenje, nesanica, tremor, anksioznost, mučnina i povraćanje prijavljeni
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking OLANZAPINE CIPLA.
Croatian: • U bolesnika koji uzimaju lijek OLANZAPINE CIPLA uočena je visoka razina šećera i masnoća u krvi (trigliceridi i kolesterol).
English: As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Croatian: S obzirom da olanzapin in vitro pokazuje antagonizam s dopaminom, on može imati antagonističke učinke na izravne i
English: Coated tablet Blue, elliptical, convex, coated tablets with ‘NEO' debossed on one side and plain on the other side.
Croatian: Plavi, eliptična, konveksna, obložene tablete s "NEO" debossed na jednoj strani i ravni na drugoj
English: 4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
Croatian: 3 Uočeno za početne normalne razine natašte (< 5,17 mmol/l) koje su porasle na visoke razine (≥ 6,2 mmol/l).
English: Musculoskeletal and connective tissue disorders Arthralgia9
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva rabdomioliza11
English: Hypersensitivity11
Croatian: preosjetljivost11
English: Opadry II White containing: Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
Croatian: : Opadry bijeli sadrži hipromeloze ( E464 ) , titan dioksid ( E171 ) , laktoza monohidrat , polietilen glikol 3000 i glicerola triacetatna - 15 mg tablete
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet Obložene tablete:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove
English: Children and adolescents OLANZAPINE CIPLA is not for patients who are under 18 years.
Croatian: OLANZAPINE CIPLA nije za primjenu u bolesnika mlađih od 18 godina.
English: Medicinal product subject to medical prescription.
Croatian: Vidjeti Uputu o lijeku za dodatne informacije.
English: After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
Croatian: Prosječno poluvrijeme eliminacije olanzapina u zdravih ispitanika nakon peroralne primjene varira
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava preosjetljivost11
English: Olanzapine Cipla 7.5 mg coated tablets
Croatian: NAZIV GOTOVOG LIJEKA OLANZAPINE CIPLA 7,5 mg obložene tablete
English: The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
Croatian: Pokazalo se da istodobna primjena aktivnog ugljena smanjuje oralnu bioraspoloživost
English: Olanzapine Cipla 7.5 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 7.5' debossed on one side and ‘NEO' on the other.
Croatian: Olanzapin Cipla 7,5 mg obložene tablete su bijele , okrugle, bikonveksne , obložene tablete s ' OLZ 7.5 ' debossed s jedne strane i " NEO " s druge strane.
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking OLANZAPINE CIPLA and regularly during treatment.
Croatian: Prije početka uzimanja lijeka OLANZAPINE CIPLA te redovito tijekom liječenja, liječnik bi Vam trebao obaviti krvne pretrage kako bi provjerio razinu šećera i
English: COLD-FORMED ALUMINIUM BLISTER STRIPS
Croatian: TABLETE: OZNAČAVANJE NA FOLIJI BLISTERA
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U
English: Seizures
Croatian: Predoziranje
English: Tablet coat
Croatian: OLANZAPINE CIPLA tablete morate
English: Each coated tablet contains 7.5 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna obložena tableta sadrži 7,5 mg olanzapina.
English: What Olanzapine Cipla contains
Croatian: Što OLANZAPINE CIPLA sadrži
English: OLANZAPINE CIPLA coated tablets are for oral use.
Croatian: OLANZAPINE CIPLA obložene tablete uzimaju se kroz usta.
English: In most of these cases, a history of seizures or risk factors for seizures were reported.
Croatian: U većini ovih slučajeva prijavljeni su napadaji u anamnezi ili
English: 3 years 6.4 Special precautions for storage
Croatian: 6.3 Rok valjanosti
English: Olanzapine Cipla 10 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 10' debossed on one side and ‘NEO' on the other.
Croatian: Olanzapin Cipla 10 mg obložene tablete su bijele , okrugle, bikonveksne , obložene tablete s ' OLZ 10 ' debossed s jedne strane i " NEO " s druge strane.
English: Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
Croatian: Često su uočeni upala pluća, povišena tjelesna temperatura, letargija, eritem, vizualne
English: Only take other medicines while you are on OLANZAPINE CIPLA if your doctor tells you that you can. You might feel drowsy if OLANZAPINE CIPLA is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Croatian: Ako uzimate lijek OLANZAPINE CIPLA u kombinaciji s antidepresivima, lijekovima za tjeskobu ili lijekovima koji Vam pomažu zaspati (trankvilizeri), možete se osjećati omamljeno.
English: EU/1/07/426/007 - Olanzapine Cipla - 10 mg - coated tablets - 7 tablets per box EU/1/07/426/008 - Olanzapine Cipla - 10 mg - coated tablets - 28 tablets per box EU/1/07/426/009 - Olanzapine Cipla - 10 mg - coated tablets - 56 tablets per box
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/426/007 - Olanzapin Cipla - 10 mg - obložene tablete - 7 tableta po kutiji EU/1/07/426/008 - Olanzapin Cipla - 10 mg - obložene tablete - 28 tableta po kutiji EU/1/07/426/009 - Olanzapin Cipla - 10 mg - obložene tablete - 56 tableta po kutiji
English: Olanzapine Cipla 10 mg coated tablets
Croatian: NAZIV GOTOVOG LIJEKA OLANZAPINE CIPLA 10 mg obložene tablete
English: - Tablet coat: - 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets: Opadry white containing hypromellose (E464), titanium dioxide (E171), lactose monohydrate, polyethylene glycol 3000 and glycerol triacetate - 15 mg tablets: Opadry Blue containing hypromellose (E464), titanium dioxide (E171), polyethylene glycol 6000, indigo carmine aluminium lake (E132), brilliant blue FCF aluminium lake (E133) and iron oxide black (E172)
Croatian: : Opadry Blue sadrže hipromeloze ( E464 ) , titan dioksid ( E171 ) , polietilen glikol 6000 , indigo karmina aluminija jezero ( E132 ) , briljantne plavo FCF aluminija jezero ( E133 ) i
English: Neutropenia10
Croatian: pankreatitis11
English: Olanzapine Cipla 5 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 5' debossed on one side and ‘NEO' on the other.
Croatian: Olanzapin Cipla 5 mg obložene tablete su bijele , okrugle, bikonveksne , obložene tablete s ' OLZ 5 ' debossed s jedne strane i " NEO " s druge strane.
English: Abdominal distension9 Pancreatitis11
Croatian: konstipaciju i suha usta distenzija abdomena9
English: Each coated tablet contains 2.5 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna obložena tableta sadrži 2,5 mg olanzapina.
English: Each coated tablet contains 10 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna obložena tableta sadrži 10 mg olanzapina.
English: Coated tablet White, round, biconvex, coated tablets with ‘2.5' debossing on one side and ‘OLZ' on the other.
Croatian: Bijela, okrugli, bikonveksne, obložene tablete s 2,5 debossing na jednu stranu i 'OLZ' na druge.
English: Cytochromes P450
Croatian: Polietilen glikol 3000
English: Coated tablet White, round, biconvex, coated tablets with ‘OLZ 7.5' debossing on one side and ‘NEO' on the other.
Croatian: Bijela, okrugli, bikonveksne, obložene tablete s 'OLZ 7.5' debossing na jednoj strani i 'NEO' na druge.
English: Olanzapine Cipla 2.5 mg coated tablets
Croatian: NAZIV GOTOVOG LIJEKA OLANZAPINE CIPLA 2,5 mg obložene tablete
English: Olanzapine Cipla 15 mg coated tablets
Croatian: NAZIV GOTOVOG LIJEKA OLANZAPINE CIPLA 15 mg obložene tablete
English: Coated tablet White, round, biconvex, coated tablets with ‘OLZ 10' debossing on one side and ‘NEO' on the other.
Croatian: Bijela, okrugli, bikonveksne, obložene tablete s 'OLZ 10' debossing na jednu stranu i 'NEO' na druge.
English: Olanzapine Cipla 5 mg coated tablets
Croatian: NAZIV GOTOVOG LIJEKA OLANZAPINE CIPLA 5 mg obložene tablete
English: Each coated tablet contains 5 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna obložena tableta sadrži 5 mg olanzapina.
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high
Croatian: 4 Uočeno za početne normalne razine natašte (< 5,56 mmol/l) koje su porasle na visoke razine
English: Coated tablet White, round, biconvex, coated tablets with ‘OLZ 5' debossing on one side and ‘NEO' on the other.
Croatian: Bijela, okrugli, bikonveksne, obložene tablete s 'OLZ 5' debossing na jednoj strani i 'NEO' na druge.
English: Each coated tablet contains 15 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna obložena tableta sadrži 15 mg olanzapina.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: OD LIJEKA, KADA JE POTREBNO
English: The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena olanzapina s antiparkinsonicima u bolesnika s Parkinsonovom
English: Excipient with known effect: Each coated tablet contains 161.3 mg lactose monohydrate For the full list of excipients, see section 6.1.
Croatian: Jedna obložena tableta sadrži 161.3 mg laktoze hidrata.
English: Excipient with known effect: Each coated tablet contains 322.6 mg lactose monohydrate For the full list of excipients, see section 6.1.
Croatian: Jedna obložena tableta sadrži 322.6 mg laktoze hidrata.
English: EU/1/07/426/010 - Olanzapine Cipla - 15 mg - coated tablets - 28 tablets per box EU/1/07/426/011 - Olanzapine Cipla - 15 mg - coated tablets - 56 tablets per box
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/426/010 - Olanzapin Cipla - 15 mg - obložene tablete - 28 tableta po kutiji EU/1/07/426/011 - Olanzapin Cipla - 15 mg - obložene tablete - 56 tableta po kutiji
English: EU/1/07/426/003 - Olanzapine Cipla - 5 mg - coated tablets - 28 tablets per box EU/1/07/426/004 - Olanzapine Cipla - 5 mg - coated tablets - 56 tablets per box
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/426/003 - Olanzapin Cipla - 5 mg - obložene tablete - 28 tableta po kutiji EU/1/07/426/004 - Olanzapin Cipla - 5 mg - obložene tablete - 56 tableta po kutiji
English: 5.2 Pharmacokinetic properties
Croatian: Pharmadox Zdravstvo ograničenom
English: EU/1/07/426/005 - Olanzapine Cipla - 7.5 mg - coated tablets - 28 tablets per box EU/1/07/426/006 - Olanzapine Cipla - 7.5 mg - coated tablets - 56 tablets per box
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/426/005 - Olanzapin Cipla - 7,5 mg - obložene tablete - 28 tableta po kutiji EU/1/07/426/006 - Olanzapin Cipla - 7,5 mg - obložene tablete - 56 tableta po kutiji
English: EU/1/07/426/001 - Olanzapine Cipla - 2.5 mg - coated tablets - 28 tablets per box EU/1/07/426/002 - Olanzapine Cipla - 2.5 mg - coated tablets - 56 tablets per box
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/426/001 - Olanzapin Cipla - 2,5 mg - obložene tablete - 28 tableta po kutiji EU/1/07/426/002 - Olanzapin Cipla - 2,5 mg - obložene tablete - 56 tableta po kutiji
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: POSEBNE MJERE ČUVANJA Čuvati u originalnom pakiranju.
English: There is a risk of feeling drowsy when you are given OLANZAPINE CIPLA.
Croatian: Kad uzimate lijek OLANZAPINE CIPLA postoji rizik da se osjećate omamljeno.
English: Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Croatian: antikolinergički učinci uključujući konstipaciju i suhoću usta distenzija abdomena9
English: Olanzapine Cipla 15 mg coated tablets olanzapine
Croatian: Olanzapin Cipla 15 mg obložene tablete su plave , eliptična
English: Elevated glucose levels4
Croatian: Polietilen glikol 3000 glicerol triacetatna
English: Common
Croatian: Ako
English: Packaging Content Package size
Croatian: Put primjene Ambalaža Sadržaj Veličina pakiranja
English: The tablet can be divided into equal halves.
Croatian: Tableta se može podijeliti u jednake polovice.
English: A clinical response is normally seen within 3-4 days.
Croatian: Klinički odgovor obično se vidi za 3-4 dana.
English: The active substance in Metacam is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u Metacamu je dozvoljena tvar kako je navedeno u tablici 1. Priloga Uredbi Komisije (EU) br. 37/2010:
English: EXP {month/year} 3 ml:
Croatian: EXP {mjesec/godina} 3 ml:
English: Can Parellada Industrial 08228 Terrassa, Barcelona SPAIN
Croatian: Can Parellada Industrial 08228 Terrassa, Barcelona ŠPANJOLSKA
English: 7 tablets 84 tablets 252 tablets
Croatian: 7 tableta 84 tablete 252 tablete
English: 21 % of the recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in the faeces (49 % as unchanged meloxicam, 30 % as metabolites).
Croatian: Od izlučene doze 21% eliminira se u mokraću (2% kao nepromijenjen meloksikam, 19% kao metaboliti), a 79% izmetom (49% kao nepromijenjen meloksikam, 30% kao metaboliti).
English: 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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1. Priloga Uredbi Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tim veterinarsko-medicinskim proizvodima.
English: When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98 %.
Croatian: Kada se proizvod primjenjuje u skladu s preporučenim režimom doziranja, oralna bioraspoloživost iznosi približno 98%.
English: Wash the small container with water and dry prior to the next use.
Croatian: Isperite mali spremnik vodom i osušite prije sljedeće primjene.
English: In this case do not use oral follow up treatment.
Croatian: U tom slučaju nemojte za nastavak liječenja primijeniti oralnu terapiju.
English: Metacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.
Croatian: Metacam tablete za žvakanje mogu se davati s hranom ili bez nje, aromatizirane su i većina pasa ih uzima dragovoljno.
English: The major metabolites found in all species were the 5-hydroxy- and 5-carboxymetabolites and the oxalyl-metabolite.
Croatian: Osnovni metaboliti nađeni u svih vrsta bili su 5-hidroksi- i 5-karboksi-metaboliti te oksalil-metabolit.
English: Instructions for opening the child-resistant blisters:
Croatian: Upute za otvaranje blistera zaštićenih od djece:
English: Carton box of blister
Croatian: Kutija blistera
English: One tablet contains:
Croatian: Jedna tableta sadrži:
English: This product for dogs should not be used in cats due to the different dosing devices.
Croatian: Ovaj proizvod za pse ne smije se koristiti za mačke zbog različitih naprava za doziranje.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE MEDICINSKOG PROIZVODA
English: In case additional pain relief is required, multimodal pain therapy should be considered.
Croatian: U slučaju da je potrebno dodatno ublažavanje bolova, treba razmotriti mogućnost multimodalne terapije bola.
English: Guinea pigs: No data available.
Croatian: Zamorčad: Podaci nisu dostupni.
English: For dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.
Croatian: Za pse težine manje od 4 kg, preporučuje se primjena Metacam oralne suspenzije za pse.