FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of the combination of desloratadine and pseudoephedrine sulphate in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni kombinacije desloratadina i pseudoefedrinsulfata u trudnica ograničeni (manje od 300 trudnoća).
English: • Patients with a history of myocardial infarction, diabetes mellitus, bladder neck obstruction, or positive anamnesis of bronchospasm
Croatian: • u bolesnika koji u anamnezi imaju infarkt miokarda, diabetes mellitus, opstrukciju vrata mokraćnog mjehura ili bronhospazam
English: • dry eye
Croatian: • suhe oči
English: The mean time to maximum plasma concentrations (Tmax) for desloratadine occurred at approximately 4-5 hours post dose and mean peak plasma concentrations (Cmax) and area under the concentration-time curve (AUC) of approximately 1.09 ng/ml and 31.6 ng•hr/ml, respectively, were observed.
Croatian: Prosječno vrijeme do postizanja maksimalne koncentracije u plazmi (tmax) za desloratadin iznosi približno 4-5 sati nakon primjene doze, a opažene su srednje vrijednosti vršnih koncentracija u plazmi (Cmax) od približno 1,09 ng/ml te područje pod krivuljom koncentracija-vrijeme (AUC) od oko 31,6 ng•h/ml.
English: This is especially important if you are taking: - digitalis, a medicine used to treat certain heart disorders - medicines for blood pressure (e.g. α-methyldopa, mecamylamine, reserpine, veratrum alkaloids and guanethidine) - decongestants by oral or nasal route (such as phenylpropanolamine, phenylephrine, ephedrine,
Croatian: Ovo je posebno važno ako uzimate: - digitalis, lijek za liječenje nekih srčanih poremećaja - lijekove za krvni tlak (npr. α-metildopu, mekamilamin, rezerpin, alkaloide čemerike i gvanetidin) - dekongestive koji se uzimaju kroz usta ili nos (kao što su fenilpropanolamin, fenilefrin, efedrin,
English: This medicine is for oral use.
Croatian: Ovaj lijek je za primjenu kroz usta.
English: In addition, if you experience or are diagnosed with any of the following conditions you should talk to your doctor, pharmacist or nurse as they may advise you to stop taking Aerinaze: - high blood pressure - a fast or pounding heart beat - abnormal heart rhythm - feeling sick and headache or increase headache while using Aerinaze.
Croatian: Osim toga, morate reći svom liječniku, ljekarniku ili medicinskoj sestri ako imate ili Vam je dijagnosticirano neko od sljedećih stanja jer će Vam možda savjetovati da prestanete uzimati Aerinaze: - visok krvni tlak - brzo kucanje ili lupanje srca - nepravilan srčani ritam - mučninu i glavobolju ili pojačanje glavobolje dok uzimate lijek Aerinaze - ako imate napadaje u osobnoj ili obiteljskoj povijesti bolesti - teške kožne reakcije, uključujući znakove i simptome kao što su crvenilo kože, mnogo prištića,
English: This is due to the alpha-mimetic activity of pseudoephedrine sulphate in combination with other vasoconstrictors such as bromocripitine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine or any other decongestant medicinal product used as a nasal decongestant, either by oral route or by nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline…).
Croatian: To je zbog alfa-mimetičkih učinaka pseudoefedrinsulfata u kombinaciji s drugim vazokonstriktorima, poput bromokripitina, pergolida, lizurida, kabergolina, ergotamina, dihidroergotamina ili nekog drugog dekongestiva koji se koristi kao nazalni dekongestiv, bilo peroralnim ili nazalnim putem (fenilpropanolamin, fenilefrin, efedrin, oksimetazolin, nafazolin…).
English: Aerinaze should not be used during breast-feeding.
Croatian: Lijek Aerinaze se ne bi trebao primjenjivati tijekom dojenja.
English: Blue, immediate-release layer maize starch microcrystalline cellulose edetate disodium citric acid stearic acid colorant (Indigo carmine E132 Aluminium lake).
Croatian: Plavi sloj s trenutnim oslobađanjem kukuruzni škrob celuloza, mikrokristalična dinatrijev edetat citratna kiselina stearatna kiselina bojilo (indigo carmine aluminium lake (E132)).
English: oxymetazoline, naphazoline) - diet pills (appetite suppressants) - amphetamines - medicines for migraines e.g. ergot alkaloids (such as, dihydroergotamine, ergotamine, or methylergometrine) - medicines for Parkinson's disease or for infertility e.g. bromocriptine, cabergoline, lisuride and pergolide - antacids for indigestion or stomach problems - a medicine for diarrhoea called kaolin.
Croatian: oksimetazolin, nafazolin) - tablete za mršavljenje (koje smanjuju tek) - amfetamine - lijekove za liječenje migrene, npr. ergot-alkaloide (kao što su dihidroergotamin, ergotamin ili metilergometrin) - lijekove za liječenje Parkinsonove bolesti ili neplodnosti, npr. bromokriptin, kabergolin, lizurid i pergolid - antacide za liječenje loše probave ili želučanih problema - lijek za liječenje proljeva koji se zove kaolin - tricikličke antidepresive (npr. nortriptilin), antihistaminike (npr. cetirizin, feksofenadin).
English: The active substance is excreted in breast milk of breast-feeding women.
Croatian: Djelatna tvar se izlučuje u majčino mlijeko dojilja.
English: • stomach flu
Croatian: • želučana gripa
English: Therefore absorption of pseudoephedrine sulphate was not affected by the Aerinaze formulation.
Croatian: To znači da formulacija lijeka Aerinaze nije utjecala na apsorpciju pseudoefedrinsulfata.
English: Aerinaze 2.5 mg/120 mg modified-release tablets
Croatian: Aerinaze 2,5 mg/120 mg tablete s prilagođenim oslobađanjem
English: Aerinaze 2.5 mg/120 mg modified-release tablets desloratadine/pseudoephedrine sulphate
Croatian: Aerinaze 2,5 mg/120 mg tablete s prilagođenim oslobađanjem desloratadin/pseudoefedrinsulfat
English: Desloratadine and pseudoephedrine sulphate are both excreted in human milk.
Croatian: Desloratadin i pseudoefedrinsulfat se izlučuju u majčino mlijeko.
English: • runny nose
Croatian: • upala nosa
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva manje često pruritus
English: Insomnia, somnolence, sleep disorder, nervousness
Croatian: Psihijatrijski poremećaji često manje često nesanica, somnolencija, poremećaj spavanja, nervoza agitiranost, anksioznost, razdražljivost
English: CNS stimulation is particularly likely in children, as are atropine-like symptoms (dry mouth, fixed and dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms).
Croatian: Stimulacija SŽS-a kao i simptomi nalik onima kod trovanja atropinom (suha usta, fiksirane i proširene zjenice, crvenilo praćeno osjećajem užarenosti, hipertermija i gastrointestinalni simptomi) naročito su mogući u djece.
English: - Desloratadine and Pseudoephedrine sulphate:
Croatian: • Desloratadin i pseudoefedrinsulfat
English: Cases of severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.
Croatian: Za lijekove koji sadrže pseudoefedrin prijavljeni su slučajevi teških kožnih reakcija poput akutne generalizirane egzantematozne pustuloze (AGEP).
English: No clinically relevant interactions or changes in desloratadine plasma concentrations were observed in clinical trials with desloratadine in which erythromycin or ketoconazole were co-administered.
Croatian: U kliničkim ispitivanjima desloratadina u kojima se istodobno primjenjivao eritromicin ili ketokonazol nisu opažene klinički značajne interakcije niti promjene koncentracija desloratadina u plazmi.
English: • changes in frequency of urination
Croatian: • promjene učestalosti mokrenja
English: • inflammation of the nose
Croatian: • nadraženost nosa
English: Palpitation, supraventricular extrasystoles
Croatian: Srčani poremećaji često manje često tahikardija palpitacije, supraventrikularne ekstrasistole
English: OUTER CARTON OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS
Croatian: KUTIJA SA 2, 4, 7, 10, 14, 20 TABLETA S PRILAGOĐENIM
English: Use with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and obstruction of the vesical cervix.
Croatian: Primjenjivati uz oprez u bolesnika sa stenozirajućim peptičkim vrijedom, opstrukcijom pilorusa i duodenuma te opstrukcijom vrata mokraćnog mjehura.
English: For pseudoephedrine sulphate, the mean Tmax occurred at 6-7 hours post dose and mean peak plasma concentrations (Cmax and AUC) of approximately 263 ng/ml and 4,588 ng•hr/ml, respectively, were observed.
Croatian: Za pseudoefedrinsulfat je srednja vrijednost tmax iznosila 6-7 sati nakon primjene doze, a opažene su srednje vrijednosti vršnih koncentracija u plazmi (Cmax i AUC) od približno 263 ng/ml odnosno 4588 ng•h/ml.
English: Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
Croatian: Simpatomimetički amini mogu izazvati stimulaciju središnjeg živčanog sustava uz konvulzije ili kardiovaskularni kolaps praćen hipotenzijom.
English: How to store Aerinaze
Croatian: Kako čuvati Aerinaze
English: - if you have intestinal ulcers leading to the narrowing of the stomach, small intestine or esophagus (stenosing peptic ulcer) - if you have intestinal blockage (pyloral or duodenal blockage) - if you have bladder neck blockage (vesical cervix blockage) - if you have a history of difficulty breathing due to tightening of the lung muscles
Croatian: (stenozirajući peptički vrijed) - ako imate blokadu crijeva (blokadu pilorusa ili dvanaesnika) - ako imate blokadu vrata mokraćnog mjehura (blokadu u vratnom dijelu mjehura) - ako ste u prošlosti imali poteškoće s disanjem zbog stezanja mišića u plućima (bronhospazam) - ako imate problema s jetrom, bubrezima ili mokraćnim mjehurom.
English: Perioperative acute hypertension can occur if volatile halogenated anaesthetics are used during treatment with indirect sympathomimetic agents.
Croatian: Ako se tijekom liječenja neizravnim simpatomimeticima primjenjuju halogenirani hlapivi anestetici, može doći do perioperativne akutne hipertenzije.
English: For pseudoephedrine sulphate, mean steady state peak plasma concentrations (Cmax and AUC (0-12 h)) of 459 ng/ml and 4,658 ng•hr/ml were observed.
Croatian: Za pseudoefedrinsulfat su opažene srednje vrijednosti koncentracija u plazmi u stanju dinamičke ravnoteže (Cmax i AUC (0-12 h)) od približno 459 ng/ml odnosno 4658 ng•h/ml.
English: Abnormal behaviour, aggression
Croatian: Psihijatrijski poremećaji vrlo rijetko nepoznato halucinacije abnormalno ponašanje, agresija
English: Rhinitis, sinusitis, epistaxis, nasal discomfort, rhinorrhea, dry throat, hyposmia
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja često manje često faringitis rinitis, sinusitis, epistaksa, nelagoda u nosu, rinoreja, suho grlo, hiposmija
English: For desloratadine, mean steady state peak plasma concentrations (Cmax and AUC (0-12 h)) of approximately 1.7 ng/ml and 16 ng•hr/ml were observed, respectively.
Croatian: Za desloratadin su opažene srednje vrijednosti koncentracija u plazmi u stanju dinamičke ravnoteže (Cmax i AUC (0-12 h)) od približno 1,7 ng/ml i 16 ng•h/ml.
English: - Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate.
Croatian: - Jedna tableta sadrži 2,5 mg desloratadina i 120 mg pseudoefedrinsulfata.
English: • abnormal stool
Croatian: • neuobičajena stolica
English: Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products.
Croatian: Uz lijekove koji sadrže pseudoefedrin mogu nastati teške kožne reakcije poput akutne generalizirane egzantematozne pustuloze (AGEP).
English: - if you have medical of familial history of seizures - severe skin reactions, including signs and symptoms such as reddening of the skin, many small pimples, with or without fever
Croatian: Za lijekove koji sadrže pseudoefedrin prijavljeni su slučajevi teških kožnih reakcija, uključujući znakove i simptome poput vrućice, crvenila kože i mnogo prištića.
English: • irritability
Croatian: • razdražljivost
English: Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate.
Croatian: Jedna tableta sadrži 2,5 mg desloratadina i 120 mg pseudoefedrinsulfata.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava vrlo rijetko konvulzije
English: Depression may follow rapid withdrawal.
Croatian: Nakon nagle obustave lijeka može nastupiti depresija.
English: Pruritus
Croatian: Nuspojave
English: - Desloratadine
Croatian: • Desloratadin
English: Hypersensitivity (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Croatian: Poremećaji imunološkog sustava vrlo rijetko reakcije preosjetljivosti (poput anafilaksije, angioedema, dispneje, pruritusa, osipa i urtikarije)
English: Dyspepsia, nausea, abdominal pain, gastroenteritis, abnormal faeces
Croatian: Poremećaji probavnog sustava često manje često konstipacija dispepsija, mučnina, bol u abdomenu, gastroenteritis, neuobičajena stolica
English: • inflammation of the sinus
Croatian: • upala sinusa
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane nepoznato povećan apetit
English: Magyarország MSD Pharma Hungary Kft. Tel.: +36 1 888-5300 hungary_msd@merck.com
Croatian: Tel.: +36 1 888-5300 hungary_msd@merck.com
English: Hepatic enzymes increased
Croatian: Pretrage manje često povišene razine jetrenih enzima
English: • cabergoline
Croatian: • kabergolinom
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva vrlo rijetko mialgija
English: Pseudoephedrine sulphate provides a nasal decongestant effect after oral administration due to its vasoconstrictive action.
Croatian: Budući da djeluje vazokonstriktivno, pseudoefedrinsulfat nakon peroralne primjene ima dekongestivan učinak na nosnu sluznicu.
English: The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
Croatian: U ispitivanjima provedenima s desloratadinom i loratadinom pokazano je da lijek nema kancerogeni potencijal.
English: • liver inflammation
Croatian: • upala jetre
English: Gastric lavage with physiologic saline solution may be performed, particularly in children.
Croatian: U djece se može provesti ispiranje želuca fiziološkom otopinom, a u odraslih vodom iz slavine.
English: Pseudoephedrine sulphate carries the risk of abuse.
Croatian: Postoji rizik od zlouporabe pseudoefedrinsulfata.
English: Decreased milk production in nursing mothers has been reported with pseudoephedrine sulphate.
Croatian: Pri primjeni pseudoefedrinsulfata prijavljeno je smanjeno stvaranje mlijeka u dojilja.
English: If you stop taking Aerinaze If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: UAB Merck Sharp & Dohme Tel. + 370 5 278 02 47 msd_lietuva@merck.com
Croatian: + 370 5 278 02 47 msd_lietuva@merck.com
English: • diarrhoea
Croatian: • dekongestive
English: Headache, fatigue, dry mouth
Croatian: Poremećaji oka manje često zamagljen vid, suhe oči
English: • stomach ache
Croatian: • suha usta
English: Decreased milk production in nursing mothers has been reported with pseudoephedrine sulphate, a component of Aerinaze.
Croatian: Kod primjene pseudoefedrinsulfata, jedne sastavnice lijeka Aerinaze, u dojilja je prijavljeno smanjeno stvaranje mlijeka.
English: • tiredness
Croatian: • valunzi
English: Dizziness, psychomotor hyperactivity
Croatian: Poremećaji živčanog sustava često manje često omaglica, psihomotorička hiperaktivnost hiperkinezija, stanje smetenosti
English: --1 Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/turkey/Turkey/1/2005 (H5N1) - like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
Croatian: --1 Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)* soja: A/turkey/Turkey/1/2005 (H5N1) - sličan soj (NIBRG-23) (klada 2.2.1) 7,5 mikrograma** po dozi od 0,5 ml * umnožen u oplođenim kokošjim jajima iz jata zdravih kokoši ** izraženo u mikrogramima hemaglutinina.
English: 9.75 milligrams polysorbate 80 1.175 milligrams sorbitan trioleate 1.175 milligrams
Croatian: 9,75 miligrama polisorbat 80 1,175 miligrama sorbitan trioleat 1,175 miligrama
English: Adjuvant MF59C.1 containing: squalene
Croatian: Adjuvans MF59C.1 koji sadrži: skvalen
English: 10 pre-filled syringes
Croatian: 10 štrcaljki s uloškom
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nacionalna nadležna tijela države članice (država članica) ili referentne države članice (referentnih država članica), ako je primjenjivo, trebaju osigurati da nositelj(i) odobrenja ispune sljedeće uvjete:
English: The MAHs shall identify a specific patient population for which the benefits of the product outweigh the risk.
Croatian: Nositelji odobrenja trebaju utvrditi specifičnu populaciju bolesnika za koju koristi ovog lijeka nadmašuju rizike.
English: Conditions for lifting the suspension of the marketing authorisation
Croatian: Uvjeti za ukidanje suspenzije odobrenja za stavljanje lijeka u promet
English: Annex IV Conditions for lifting the suspension of the marketing authorisation
Croatian: Dodatak IV Uvjeti za ukidanje suspenzije odobrenja za stavljanje lijeka u promet
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina lijeka, puteva primjene, nositelja odobrenja u državama članicama
English: 52 Boulevard du Parc 92521 NEUILLY SUR SEINE cedex
Croatian: 52 Boulevard du Parc 92521 NEUILLY SUR SEINE cedex France
English: Roche Latvija SIA 8b G.Astras Street, Riga, LV1082,
Croatian: Roche Latvija SIA 8b G.Astras Street, Riga, LV1082, Latvia
English: 79639 Grenzach-Wyhlen Germany
Croatian: 1 79639 GrenzachWyhlen
English: Rocephin zur Infusion 2 g 2 g
Croatian: Rocephin zur Infusion 2 g
English: Roche (Hungary) Ltd. Edison utca 1
Croatian: Roche (Hungary) Ltd.
English: Roche (Hellas) SA 4, Alamanas & Delfon Str., Maroussi 15125, Attiki
Croatian: Roche (Hellas) SA 4, Alamanas & Delfon Str.,
English: Roche România SRL Piaţa Presei Libere, Nr. 3-5, Clădirea City Gate-Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti, România
Croatian: Rumunjska Roche România SRL Piaţa Presei Libere, Nr. 3-5,
English: Rocephalin cum lidocain 1 g
Croatian: Rocephalin cum lidocain
English: Roche Nederland B.V. Beneluxlaan 2a, 3446 GR Woerden Netherlands
Croatian: 3446 GR Woerden Netherlands
English: Roche Farmacêutica Química, Lda., Estrada Nacional 249-1, 2720-413 Amadora, Portugal
Croatian: 2720-413 Amadora, Portugal
English: 1 g
Croatian: Dodatak I
English: Powder for solution for injection/infusion
Croatian: Prašak za otopinu za injekciju/ infuziju
English: Powder for solution for injection or infusion
Croatian: Prašak za otopinu za injekciju ili infuziju
English: Intravenous use or subcutaneous use
Croatian: U venu ili potkožno
English: Rocephin 500 mg
Croatian: Rocephin 0,5 i.v. 500 mg
English: Powder and solvent for solution for IM injection Intramuscular use
Croatian: Prašak i otapalo za otopinu za i.m. injekciju
English: Intramuscular use or subcutaneous use
Croatian: U mišić ili potkožno
English: Powder and solvent for solution for IV injection Intravenous use
Croatian: Prašak i otapalo za otopinu za i.v. injekciju
English: MA (EU) Number (Invented) name
Croatian: (Novoizumljeno) ime
English: ATCvet code: QI09AB02.
Croatian: ATCvet kod: QI09AB02.
English: No information is available.
Croatian: Nema dostupnih informacija.
English: la Selva, 135
Croatian: Avda. la Selva, 135
English: Shake well before use.
Croatian: Dobro protresti prije uporabe.
English: - Temperature rise of maximum 1.1 °C was observed.
Croatian: - Uočena je povišena tjelesna temperatura za najviše 1,1°C.
English: Date of first authorisation: 17/08/2017
Croatian: Datum prvog odobrenja: 17/08/2017
English: Temperatures returned to normal within 24 hrs.
Croatian: Temperature su se vratile na normalnu unutar 24 sata.
English: Each dose of 1 ml contains:
Croatian: Jedna doza od 1 ml sadrži:
English: - Mild depression during the day of vaccination.
Croatian: - Blaga depresija na dan cijepljenja.
English: Administer a single intramuscular injection of 1 ml in the neck muscles.
Croatian: Primijenite jednu intramuskularnu injekciju od 1 ml u područje vratnih mišića.
English: Store and transport refrigerated (2 ºC - 8 ºC).
Croatian: Čuvati i prevoziti na hladnom (2 °C - 8 °C).
English: Shelf life of the veterinary medicinal product as packaged for sale: 36 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 36 mjeseci.
English: Duration of immunity: 112 days after vaccination.
Croatian: Trajanje imunosti: 112 dana nakon cijepljenja.
English: EXP {month/year} Once broached use within 10 hours.
Croatian: Jednom načeto upotrijebiti unutar 10 sati.
English: If you notice any effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
English: The excipients (including adjuvants) 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 (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe 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: EU/2/17/214/001 (10 doses (10 ml)) EU/2/17/214/002 (50 doses (50 ml)) EU/2/17/214/003 (100 doses (100 ml)) EU/2/17/214/004 (250 doses (250 ml)) EU/2/17/214/005 (10 x 10 doses (10 ml))
Croatian: EU/2/17/214/001 (10 doza (10 ml)) EU/2/17/214/002 (50 doza (50 ml)) EU/2/17/214/003 (100 doza (100 ml)) EU/2/17/214/004 (250 doza (250 ml)) EU/2/17/214/005 (10 x 10 doza (10 ml))
English: Allow the vaccine to reach room temperature (15-25 ºC) before administration.
Croatian: Prije primjene pričekajte da cjepivo dostigne sobnu temperaturu (15-25 ˚C).
English: Do not use in cases of hypersensitivity to the active substance, to the adjuvants or to any of the excipients.
Croatian: Ne primjenjivati u slučaju preosjetljivosti na djelatne tvari, na adjuvanse ili na bilo koju od pomoćnih tvari.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara kako odlagati veterinarsko-medicinske proizvode koji vam više nisu potrebni.
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia).
Croatian: Farmakoterapijska grupa: imunološki proizvodi za svinje, inaktivirana bakterijska cjepiva (uključujući mikoplazmu, toksoid i klamidiju).
English: Major incompatibilities: Do not mix with any other veterinary medicinal product.
Croatian: Inkompatibilnosti: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.