FrancophonIA/ELRC3.0 huggingface dataset:
English: Set your calorie and fat targets
Croatian: Odredite ciljni broj kalorija i količinu masti
English: - Keep this medicine out of the sight and reach of children.
Croatian: DJECE Čuvati izvan pogleda i dohvata djece.
English: - if you are pregnant or breast-feeding.
Croatian: - Ako ste trudni ili dojite.
English: - If you are pregnant or breast-feeding.
Croatian: - ako ste trudni ili dojite.
English: The tablet should be chewed.
Croatian: Tabletu treba progutati s vodom.
English: alli is used for weight loss alongside reduced calorie, lower-fat meals in overweight adults, aged 18 or over.
Croatian: alli se koristi uz nisko kaloričnu dijetu s manjim sadržajem masti za smanjenje tjelesne težine odraslih osoba, starijih od 18 godina s prekomjernom tjelesnom težinom.
English: An additional contraceptive method is recommended in case of severe diarrhoea (see section 4.4).
Croatian: U slučaju teškog proljeva preporučuje se korištenje dodatne kontracepcijske metode (vidjeti dio 4.4).
English: 2 years.
Croatian: minuta.
English: - Do not take more than 3 capsules a day.
Croatian: - Nemojte uzimati više od 3 kapsule na dan.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION alli 60 mg hard capsules orlistat
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA alli 60 mg tvrde kapsule orlistat
English: Do not take more than 3 tablets a day.
Croatian: Nemojte uzeti više od 3 tablete na dan.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product not subject to medical prescription.
Croatian: Lijek se izdaje bez recepta.
English: 59.0 kg and over
Croatian: 59,0 kg i više
English: - If you have cholestasis (condition where the flow of bile from the liver is blocked).
Croatian: Ako imate kolestazu (stanje pri kojem je blokirano otjecanje žuči iz jetre).
English: - Do not take more than 3 tablets a day.
Croatian: - Nemojte uzimati više od 3 tablete na dan.
English: Concurrent use of alli and ciclosporin is contraindicated (see section 4.3).
Croatian: Primjena alli kapsula istodobno s ciklosporinom je kontraindicirana (vidjeti dio 4.3).
English: - if you are taking a medicine for diabetes.
Croatian: - ako uzimate lijek za šećernu bolest.
English: If patients have been unable to lose weight after 12 weeks of treatment with alli, they should consult their doctor or a pharmacist.
Croatian: Ne počne li se težina smanjivati ni nakon 12 tjedana uzimanja alli tableta, treba se posavjetovati s liječnikom ili ljekarnikom.
English: 1400 calories
Croatian: 1400 kalorija
English: Do not take more than 3 capsules a day.
Croatian: Nemojte uzeti više od 3 kapsule na dan.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 60 mg orlistat.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 60 mg orlistata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each chewable tablet contains 27 mg orlistat.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta za žvakanje sadrži 27 mg orlistata.
English: • if you are pregnant or breast-feeding.
Croatian: • ako ste trudni ili dojite.
English: Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are taken at the same time (see section 4.4).
Croatian: Uzimaju li se orlistat i levotiroksin istodobno, može nastupiti hipotireoza i/ili može oslabiti kontrola hipotireoze (vidjeti dio 4.4).
English: INSTRUCTIONS ON USE Weight loss aid
Croatian: Pomoć smanjenju tjelesne težine
English: For information on how to set your calorie and fat targets, see Further helpful information in the blue pages in section 6.
Croatian: Za obavijesti kako odabrati ciljni broj kalorija i količinu masti pogledajte Ostale korisne informacije na plavim stranicama u dijelu 6. alli se može uzeti neposredno prije, za vrijeme ili do jedan sat nakon obroka.
English: 65.8 kg and over
Croatian: 65,8 kg i više
English: - Fatty or oily stools.
Croatian: - Masne ili uljaste stolice
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION alli 27 mg chewable tablets orlistat
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA alli 27 mg tablete za žvakanje orlistat
English: 4.1 Therapeutic indications alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet. 4.2 Posology and method of administration
Croatian: (indeks tjelesne mase, BMI ≥28kg/m2) i mora se primjenjivati zajedno s blago hipokaloričnom dijetom sa smanjenim unosom masti.
English: Sími: + 354 530 3700
Croatian: GlaxoSmithKline ehf. Sími: + 354 530 3700
English: 1600 calories
Croatian: 1600 kalorija
English: medicines
Croatian: FARMACEUTSKI
English: Name and address of the manufacturer(s) responsible for batch release alli 60 mg hard capsules: Famar S.A., 48 KM Athens-Lamia, 190 11 Avlona, Greece alli 27 mg chewable tablets: Famar S.A., 49 KM Athens-Lamia, 190 11 Avlona, Greece
Croatian: Famar S.A., 48 KM Athens-Lamia, 190 11 Avlona, Grčka alli 27 mg tablete za žvakanje:
English: 84.0 kg and over
Croatian: 84,0 kg i više
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako imate poteškoća s bubrezima, kažite to liječniku prije nego što počnete uzimati alli.
English: Famar S.A, 48 KM Athens-Lamia,
Croatian: Famar S.A, 49 KM Athens-Lamia, 190 11 Avlona,
English: • if you have kidney disease.
Croatian: • ako imate bolest bubrega.
English: Common side effects - Effects seen in blood tests - Learn to deal with diet-related treatment effects How to store alli
Croatian: Naučite kako se nositi s učincima lijeka povezanima s prehranom Kako čuvati alli
English: INFORMATION IN BRAILLE alli 27 mg chewable tablets
Croatian: 16. PODACI NA BRAILLEOVOM PISMU alli 27 mg tablete za žvakanje
English: Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com www.alli.sk
Croatian: Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com www.alli.sk
English: The most common side effects are caused by the way the capsules work and result from some of the fat being passed out of your body.
Croatian: Naučite kako se nositi s učincima lijeka alli povezanima s prehranom ili unosom masti Najčešće nuspojave prouzrokovane su načinom na koji kapsule djeluju i posljedica su odstranjivanja masti iz tijela.
English: The most common side effects are caused by the way the tablets work and result from some of the fat being passed out of your body.
Croatian: Naučite kako se nositi s učincima lijeka alli povezanima s prehranom ili unosom masti Najčešće nuspojave prouzročene su načinom na koji tablete djeluju i posljedica su odstranjivanja masti iz tijela.
English: NAME OF THE MEDICINAL PRODUCT alli 27 mg chewable tablets orlistat
Croatian: NAZIV LIJEKA alli 27 mg tablete za žvakanje orlistat
English: Kidney disease
Croatian: Bolesti bubrega
English: NAME OF THE MEDICINAL PRODUCT alli 27 mg chewable tablets
Croatian: NAZIV LIJEKA alli 27 mg tablete za žvakanje
English: Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are co-administered (see section 4.5).
Croatian: Pri primjeni orlistata istodobno s levotiroksinom može nastupiti hipotireoza i/ili može dovesti do smanjene kontrole hipotireoze (vidjeti dio 4.5).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON SLEEVE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJI DIO KUTIJE
English: Magyarország GlaxoSmithKline Kft. Consumer Healthcare Tel.: + 36 1 225 5800
Croatian: Consumer Healthcare Tel.: + 36 1 225 5800
English: Pregnancy and breast-feeding Driving and using machines
Croatian: Upravljanje vozilima i strojevima
English: • if you are taking a medicine for diabetes.
Croatian: • ako uzimate lijek za šećernu bolest.
English: Acarbose
Croatian: Nuspojava
English: Ireland.
Croatian: Republika Irska.
English: • do not take more than three capsules a day.
Croatian: • ne uzimajte više od tri kapsule dnevno.
English: INFORMATION IN BRAILLE alli 60 mg hard capsules
Croatian: 16. PODACI NA BRAILLEOVOM PISMU alli 60 mg tvrde kaspule
English: See leaflet for further information.
Croatian: Za više informacija pročitajte uputu o lijeku.
English: Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant clinical findings.
Croatian: 4.9 Predoziranje Ispitivane su jednokratne doze od 800 mg i višekratne doze do 400 mg orlistata triput na dan tijekom
English: - a thyroid medicine (levothyroxine) as it may be necessary to adjust your dose and take your medicines at different times of the day.
Croatian: - akarbozu (antidijabetički lijek koji se koristi za liječenje diabetes mellitusa tipa 2). alli se ne preporučuje ljudima koji uzimaju akarbozu. - lijek za štitnjaču (levotiroksin) jer će dozu možda trebati prilagoditi i možda ćete svaki lijek morati uzimati u drugo doba dana.
English: Tel: + 420 222 001 111 gsk.czmail@gsk.com www.alli.cz
Croatian: GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 gsk.czmail@gsk.com www.alli.cz
English: Τ.Θ.
Croatian: KG,
English: - Warfarin or other medicines used to thin the blood.
Croatian: - s varfarinom ili ostalim lijekovima za razrjeđivanje krvi.
English: Height
Croatian: Visina
English: Orlistat may potentially reduce the absorption of antiretroviral medicinal products for HIV and could negatively affect the efficacy of antiretroviral medicinal products for HIV (see section 4.5).
Croatian: a te može imati negativan utjecaj na djelotvornost antiretrovirusnih lijekova za liječenje HIV-a (vidjeti dio 4.5).
English: The use of orlistat may be associated with kidney stones in patients suffering from chronic kidney disease.
Croatian: U bolesnika s kroničnom bolesti bubrega, uzimanje orlistata može biti povezano s pojavom bubrežnih kamenaca.
English: GlaxoSmithKline Consumer Healthcare s.a./n.v.
Croatian: GlaxoSmithKline Consumer Healthcare S.p.A.
English: The multivitamin should contain vitamins A, D, E and K. You should take the multivitamin at bedtime, when you will not be taking alli, to help ensure that the vitamins are absorbed.
Croatian: Multivitaminski pripravak konzumirajte u vrijeme odlaska na počinak, kad nećete uzimati alli, kako biste osigurali da se vitamini apsorbiraju.
English: Iron oxide black (E172) Propylene glycol
Croatian: Tinta za označavanje šelak željezov oksid, crni (E172) propilenglikol Prsten kapsule želatina polisorbat 80
English: - if you have kidney disease.
Croatian: Ako imate bolest bubrega.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON SLEEVE,
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKI DIO KUTIJE
English: - Sudden bowel motions.
Croatian: - Iznenadne stolice
English: 1.55 m 67.25 kg 5' 0''
Croatian: 1,50 m 63 kg 1,55 m 67,25 kg 1,60 m 71,75 kg
English: MARKETING AUTHORISATION NUMBERS
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: If you miss a meal, or your meal contains no fat, do not take a capsule.
Croatian: Propustite li obrok, ili ako obrok ne sadrži masti, ne uzimajte kapsule. alli ne djeluje ako u hrani nema određene količine masti.
English: Adults 18 and over - Take one capsule, three times a day.
Croatian: Uzimanje kapsula alli - Odrasli u dobi od 18 godina i stariji - Koliko dugo trebam uzimati alli?
English: Preparing to lose weight - Choose your start date - Decide on your weight loss goal - Set your calorie and fat targets Taking alli - Adults 18 and over - How long should I take alli for?
Croatian: - Uzimanje tableta alli - Odrasli u dobi od 18 godina i stariji - Koliko dugo trebam uzimati alli?
English: - you should take a multivitamin (containing vitamins A, D, E and K) once a day, at bedtime.
Croatian: - ne uzimajte više od tri tablete dnevno. - morate uzimati multivitamine (koji sadrže vitamine A, D, E i K) jednom dnevno prije spavanja.
English: - If you miss a meal, or your meal contains no fat, do not take a capsule.
Croatian: - Propustite li obrok, ili ako obrok ne sadržava mast, ne uzimajte kapsulu. alli ne djeluje ako u hrani nema određene količine masti.
English: 1.85 m 95.75 kg 6 ' 0 ''
Croatian: 1,65 m 76,25 kg 1,70 m 81 kg 1,75 m 85,75 kg 1,80 m 90,75 kg 1,85 m 95,75 kg 1,90 m 101 kg
English: - If you get any side effects, talk to your doctor or pharmacist.
Croatian: - Ako trebate dodatne informacije ili savjet, obratite se svom liječniku ili ljekarniku.
English: 70.3 kg and over
Croatian: 70,3 kg i više
English: - You can keep your daily dose of alli in the blue carry case (shuttle) included in this pack.
Croatian: - Dnevnu dozu alli kapsula možete držati u plavom priručnom spremniku, uključenom u ovo pakiranje.
English: Capsule content
Croatian: 1 priručni spremnik
English: Hepatic and renal impairment
Croatian: Poremećaji jetre i žuči
English: GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co.
English: Oily spotting Flatus with discharge Faecal urgency Fatty oily stool Oily evacuation Flatulence
Croatian: Nadutost i vjetrovi Urgencija pražnjenja crijeva Masna, uljasta stolica
English: Decide on your weight loss goal
Croatian: Odredite cilj mršavljenja
English: If you miss a meal, or your meal contains no fat, do not take a tablet.
Croatian: Propustite li obrok, ili ako obrok ne sadrži masti, ne uzimajte tabletu. alli ne djeluje ako u hrani nema određene količine masti.
English: - If you are taking warfarin or other medicines used to thin the blood.
Croatian: - Ako uzimate varfarin ili druge lijekove za razrjeđivanje krvi.
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako trebate dodatne informacije ili savjet, obratite se svom liječniku ili ljekarniku.
English: - if you are taking warfarin or any other medicines used to thin the blood.
Croatian: - ako uzimate varfarin ili bilo koji drugi lijek za razrjeđivanje krvi.
English: - if you are taking medicines for HIV.
Croatian: • ako uzimate lijekove za liječenje HIV-a.
English: • if you are taking warfarin or any other medicines used to thin the blood.
Croatian: • ako uzimate varfarin ili bilo koji drugi lijek za razrjeđivanje krvi.
English: - If it is less than an hour since your last main meal, take the missed tablet.
Croatian: Ako propustite uzeti tabletu: - ako je od zadnjeg obroka prošlo manje od jednog sata, uzmite tabletu koju ste propustili.
English: High-density polyethylene (HDPE) bottle with childresistant closure containing 42, 60, 84, 90 or 120 hard capsules.
Croatian: 42, 60, 84, 90 ili 120 tvrdih kapsula u boci od polietilena visoke gustoće (HDPE ) sa zatvaračem sigurnim za djecu.
English: For waist circumference, the mean change was -4.5 cm for orlistat 60 mg (baseline 103.7 cm) and -3.6 cm for placebo (baseline 103.5 cm).
Croatian: Srednja promjena opsega struka iznosila je -4,5 cm za orlistat 60 mg (početna vrijednost
English: - If you miss a meal, or your meal contains no fat, do not take a tablet.
Croatian: - Propustite li obrok, ili ako obrok ne sadržava mast, ne uzimajte tabletu. alli ne djeluje ako u hrani nema određene količine masti.
English: Tel.: + 48 (0)22 576 96 00
Croatian: GlaxoSmithKline Consumer Healthcare Sp. z o.o. Tel.: + 48 (0)22 576 96 00
English: GlaxoSmithKline ehf.
Croatian: Magyarország GlaxoSmithKline Kft.
English: - if you are taking a medicine for epilepsy.
Croatian: - ako uzimate lijek za epilepsiju. - ako imate bolest bubrega.
English: Tel:+385 1 6051 999
Croatian: GlaxoSmithKline d.o.o. Tel:+385 1 6051 999
English: If you miss taking a tablet:
Croatian: Uzimanje tableta alli
English: - If you are taking a medicine for high cholesterol as it may be necessary to adjust your dose.
Croatian: Posavjetujte se s liječnikom kada uzimate alli - ako uzimate i lijek za visok krvni tlak, jer će njegovu dozu možda trebati prilagoditi, - ako uzimate i lijek za povišeni kolesterol, jer će njegovu dozu možda trebati prilagoditi. alli s hranom i pićem
English: - Do not take 2 tablets at the same time to make up for a forgotten tablet.
Croatian: Ne uzimajte alli istodobno s ovim lijekovima
English: High-density polyethylene (HDPE) bottle with child resistant closure containing 42, 60, 84, 90 or 120 tablets.
Croatian: 42, 60, 84, 90 ili 120 tableta u boci od polietilena visoke gustoće (HDPE ) sa zatvaračem sigurnim za djecu.
English: België/Belgique/Belgien GlaxoSmithKline Consumer Healthcare s.a./n.v.
Croatian: België/Belgique/Belgien GlaxoSmithKline Consumer Healthcare s.a./n.v. Tél/Tel: + 32 10858600
English: Biotransformation
Croatian: Metabolizam
English: Pooled data
Croatian: Objedinjeni podaci
English: It is therefore important that you commit to a lower-fat diet to manage these effects.
Croatian: Kako biste ublažili te učinke važno je da provodite dijetu s manjim sadržajem masti.
English: ATC vet code: QD11AH91
Croatian: ATCvet kod: QD11AH91
English: 601 Cornhusker Highway 68521 Lincoln, Nebraska UNITED STATES
Croatian: 601 Cornhusker Highway 68521 Lincoln, Nebraska
English: In such cases appropriate treatment should be administered immediately.
Croatian: U takvim slučajevima treba odmah primijeniti odgovarajuće liječenje.
English: Do not use in dogs less than 3 kg bodyweight.
Croatian: Ne smije se primjenjivati na psima s tjelesnom težinom manjom od 3 kg.
English: The product should appear clear to opalescent without any visible particle.
Croatian: Proizvod treba izgledati bistro do opalescentno, bez vidljivih čestica.
English: This is likely due to the highly targeted mechanism of action of lokivetmab in the context of a complex disease and heterogeneous pathogenesis.
Croatian: Vjerojatan uzrok toga je visoko postavljen mehanizam djelovanja lokivetmaba u kontekstu kompleksne bolesti i heterogene patogeneze.
English: Secondary packaging: cardboard box.
Croatian: Sekundarno pakovanje: kartonska kutija.
English: When administering vaccines at the same time as this veterinary medicinal product, it is advised that each injection be given at different sites.
Croatian: Kada se istodobno primjenjuju cjepiva s ovim veterinarsko-medicinskim proizvodom, savjetuje se svaku injekciju dati u različito mjesto.
English: In those cases, withdraw the appropriate content from each required vial into the same syringe.
Croatian: . U takvim slučajevima izvucite odgovarajući sadržaj iz svake potrebne bočice u istu štrcaljku.
English: Polysorbate 80
Croatian: Polisorbat 80
English: To allow for mixing of the solution, gently invert the syringe three or four times before administering.
Croatian: Da biste otopinu promiješali, pažljivo preokrenite štrcaljku tri ili četiri puta prije primjene.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara ili farmaceuta kako odlagati veterinarsko - medicinske proizvode koji vam više nisu potrebni.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25/04/2017
Croatian: Datum prvog odobrenja: 25/04/2017
English: Avoid excessive shaking.
Croatian: Izbjegavati prekomjerno potresanje.
English: In case of adverse clinical signs after an overdose the dog should be treated symptomatically.
Croatian: U slučaju štetnih kliničkih znakova nakon predoziranja, psa treba liječiti simptomatski.
English: Agents for dermatitis, excluding corticosteroids.
Croatian: Tvari protiv dermatitisa, isključujući kortikosteroide.
English: The induction of such antibodies is uncommon and may have no effect (transient anti-drug antibodies) or may result in a noticeable decrease in efficacy (persistent anti-drug antibodies) in animals that responded to treatment previously.
Croatian: Nastanak takvih protutijela nije uobičajen te možda neće imati nikakav učinak (prolazna protutijela na lijek) ili može rezultirati primjetnim smanjenjem djelotvornosti (trajna protutijela na lijek) kod životinja koje su prethodno dobro reagirale na liječenje.
English: Refer also to section 4.5 of the SPC.
Croatian: Također pogledajte odjeljak 4.5 sažetka opisa proizvoda.
English: It is not expected for this to cause any adverse effects, however, repeated self-administration may increase the risk of hypersensitivity reactions.
Croatian: Ne očekuje se da će to uzrokovati nekakve nuspojave, međutim, ponovna samoprimjena može povećati rizik od reakcija preosjetljivosti.
English: CYTOPOINT strength (mg) to be administered
Croatian: Jačina CYTOPOINTA (mg) koju treba primijeniti
English: Pharmacotherapeutic group: Other dermatological preparations.
Croatian: Farmakoterapijska grupa: ostali dermatološki pripravci.
English: In cases of atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).
Croatian: U slučajevima atopijskog dermatitisa preporučuje se istražiti i liječiti faktore koji uzrokuju komplikacije, kao što su bakterijske, gljivične ili parazitske infekcije/infestacije (npr. buhe i šugarci).
English: Histidine hydrochloride monohydrate Trehalose dihydrate Disodium edetate
Croatian: Histidin hidroklorid monohidrat Trehaloza dihidrat Dinatrijev edetat Metionin
English: These final reports should be provided by April 2018 and November 2019, for the ongoing 300 L and 2000 L stability studies, respectively.
Croatian: Završni izvještaj mora biti dostavljen do travnja 2018. godine (za ispitivanje stabilnosti koje se trenutno provodi na veličini serije: 300 L) te do studenog 2019. godine (za ispitivanje stabilnosti koje se trenutno provodi na veličini serije: 2000 L).
English: Accidental self-injection may result in an immune response to lokivetmab.
Croatian: Nehotično samoinjiciranje može rezultirati imunološkim odgovorom na lokivetmab.
English: The blocking of IL-31 by lokivetmab prevents IL-31 from binding to its co-receptor and thereby inhibits IL-31 mediated cell signalling, providing relief from Atopic Dermatitis-related pruritus and anti-inflammatory activity.
Croatian: Blokiranjem IL-31, lokivetmab sprječava IL-31 u vezanju na njegov koreceptor i time inhibira staničnu signalizaciju posredovanu s IL-31, ublažujući pruritus povezan s atopijskim dermatitisom i djelujući protuupalno.
English: Active substance stability: The applicant should complete the ongoing lokivetmab stability evaluation up to 36 months at the different batch sizes.
Croatian: Stabilnost djelatne tvari: Podnositelj zahtjeva je dužan provesti procjenu stabilnosti tvari lokivetmab, od 36 mjeseci, za različite veličine serija.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse reactions other than those mentioned in section 4.6 were observed in laboratory overdose studies.
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno U laboratorijskim ispitivanjima predoziranja, nisu zabilježene nuspojave izuzev onih navedenih u odjeljku 4.6.
English: Treatment should be administered as needed.
Croatian: Liječi se prema potrebi.
English: Administer the entire contents (1 ml) of the vial.
Croatian: Primijenite cijeli sadržaj (1 ml) bočice.
English: Neurological signs (seizure, convulsion or ataxia) have been rarely observed in spontaneous reports following use of the veterinary medicinal product.
Croatian: Neurološki znakovi (napadaji, konvulzije ili ataksija) rijetko su opaženi u spontanim prijavama nakon primjene veterinarsko-medicinskog proizvoda.
English: If the animal does not show a better response after a second dose, the veterinary surgeon should consider alternative treatments.
Croatian: Ukoliko životinja ne pokaže bolji odgovor nakon druge doze, veterinar bi trebao uzeti u obzir druge načine liječenja.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation; therefore its use is not recommended during pregnancy, lactation or in breeding animals.
Croatian: Neškodljivost ovog veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije; stoga se njegova upotreba ne preporučuje tijekom graviditeta, laktacije ili na rasplodnim životinjama.