FrancophonIA/ELRC3.0 huggingface dataset:
English: and spirochaetes such as Brachyspira hyodysenteriae and Brachyspira pilosicoli and Lawsonia intracellularis.
Croatian: Valnemulin pokazuje snažnu aktivnost protiv Mycoplasma spp. i spiroheta poput Brachyspira hyodysenteriae i Brachyspira pilosicoli i Lawsonia intracellularis.
English: Valnemulin binds to the ribosome and inhibits bacterial protein synthesis.
Croatian: Valnemulin se veže na ribosom i inhibira sintezu bakterijskih proteina.
English: Valnemulin1 Valnemulin Porcine, rabbit
Croatian: Valnemulin Valnemulin Svinja,
English: PHARMACEUTICAL FORM Premix for medicated feeding stuff
Croatian: Farmaceutski oblik Premiks za izradu ljekovite hrane.
English: Pigs and rabbits should not receive products containing monensin, salinomycin or narasin, during or at least 5 days before or after treatment with valnemulin.
Croatian: Svinje i kunići ne trebaju primati monenzin, salinomicin ili narazin tijekom najmanje pet dana prije ili nakon liječenja valnemulinom.
English: Adverse reactions have occurred following the use of Econor.
Croatian: Nakon primjene Econora pojavile su se nuspojave.
English: Treatment and prevention of swine enzootic pneumonia
Croatian: Liječenje i prevencija enzootske pneumonije svinja
English: Manufacturer's batch number Batch {number}
Croatian: 22. Broj proizvodne serije <Lot> {broj}
English: - 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: - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: - 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: - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve)
English: The treatment of swine dysentery.
Croatian: Liječenje dizenterije svinja.
English: Treatment of swine dysentery
Croatian: Liječenje dizenterije svinja
English: Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg feed may result in transient reduction in food consumption associated with unpalatability during the first few days of feeding in pigs.
Croatian: Valnemulin je dobro prihvaćen u hrani za životinje, ali primjena u hrani za životinje u koncentracijama iznad 200 mg valnemulina/kg hrane može rezultirati u prolaznom smanjenju konzumacije hrane koje je povezano s neugodnim okusom tijekom prvih nekoliko dana hranjenja u svinja.
English: Treatment of swine enzootic pneumonia.
Croatian: Liječenje enzootske pneumonije svinja.
English: It is important to institute medication as early as possible in an outbreak of porcine proliferative enteropathy.
Croatian: Važno je organizirati liječenje bolesti čim prije u samom začetku proliferativne enteropatije svinja.
English: No radio-labelled metabolism studies were conducted in rabbits.
Croatian: Na kunićima nisu provedena ispitivanja metabolizma primjenom izotopa.
English: Special warning(s)
Croatian: 12. POSEBNO(A) UPOZORENJE(A)
English: This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
Croatian: Ta je doza djelotvorna u liječenju kliničke bolesti, ali više doze ili dulje trajanje liječenja mogu biti potrebni za potpunu eliminaciju infekcije.
English: Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg feed may result in transient reduction in food consumption associated with unpalatability during the first few days of feeding.
Croatian: Valnemulin je dobro prihvaćen u hrani za životinje, ali primjena u hrani za životinje u koncentracijama iznad 200 mg valnemulina/kg hrane može rezultirati u prolaznom smanjenju konzumacije hrane koje je povezano s neugodnim okusom tijekom prvih nekoliko dana hranjenja.
English: The required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature (e.g. wheat middlings) in the proportion: 1 part Econor 10% premix to 10 parts feed ingredient.
Croatian: Potrebna količina proizvoda temeljito se miješa sa sastojkom hrane slične fizičke prirode (primjerice s finim česticama pšeničnih mekinja) u omjeru: 1 dio Econor 10 % premiksa na 10 dijelova sastojka hrane.
English: Do not administer the veterinary medicinal product to pigs or rabbits receiving ionophores.
Croatian: Ne primjenjivati veterinarsko-medicinski proizvod na svinjama ili kunićima koje primaju ionofore.
English: Treatment and prevention of swine enzootic pneumonia.
Croatian: Liječenje i prevencija enzootske pneumonije svinja.
English: STATEMENT OF ACTIVE SUBSTANCES Valnemulin 500 mg/g (equivalent to 532.5 mg/g valnemulin hydrochloride)
Croatian: 500 mg/g (odgovara 532,5 mg/g valnemulinklorida)
English: 10-12 mg/kg bodyweight/day
Croatian: 10 - 12 mg/kg tjelesne mase/dan
English: Econor 10% premix for medicated feed for pigs and rabbits is available in 1 kg and 25 kg bags.
Croatian: Econor 10 % premiks za izradu ljekovite hrane za svinje i kuniće dostupan je u vrećama od 1 kg i 25
English: As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the potential build-up of resistance.
Croatian: Pored veterinarsko-medicinskih proizvoda treba uvesti mjere dobre higijenske prakse kako bi se smanjio rizik od infekcije i uvela kontrola mogućeg nastanka rezistencije.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/98/010/021 (1 kg)
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/98/010/021 (1 kg)
English: Their occurrence appears to be mainly associated with breed mixes that include Danish and/or Swedish Landrace.
Croatian: Njihovo se pojavljivanje čini uglavnom povezano s križanim pasminama koje uključuju danski i/ili švedski landras.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 50% premix for medicated feed for pigs Econor 10% premix for medicated feed for pigs and rabbits
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Econor 50 % premiks za izradu ljekovite hrane za svinje Econor 10 % premiks za izradu ljekovite hrane za svinje i kuniće
English: 532.5 mg/g equivalent to valnemulin
Croatian: 532,5 mg/g odgovara valnemulinu
English: MARKETING AUTHORISATION NUMBER(S) EU/2/98/010/025
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/98/010/025
English: Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.
Croatian: Trebalo bi razmotriti, stavljanje ljekovitih premiksa u gotovu hranu za životinje, u službenim vodičima.
English: SPECIAL STORAGE PRECAUTIONS
Croatian: 13. Posebne mjere čuvanja
English: In-feed use.
Croatian: Primjena u hrani za životinje.
English: STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES Valnemulin 100 mg/g (equivalent to 106.5 mg/g valnemulin hydrochloride)
Croatian: Valnemulin 100 mg/g (odgovara 106,5 mg/g valnemulinklorida)
English: 3-4 mg/kg bodyweight/day
Croatian: 3 - 4 mg/kg tjelesne mase/dan
English: It is important to institute treatment as early as possible in an outbreak of swine dysentery.
Croatian: Važno je organizirati liječenje bolesti čim prije u samom začetku dizenterije svinja.
English: Dosage guidance table
Croatian: Tablica s dnevnim vodičem doza
English: Name and address of the manufacturers responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog(ih) za puštanje serije u promet
English: Application in feed
Croatian: Primjena u hrani za životinje
English: Econor 50% 400 mg/kg feed Econor 10% 2 g/kg feed
Croatian: Econor 50 % 400 mg/kg hrane Econor 10 % 2 g/kg hrane
English: Equivalent to valnemulin base
Croatian: SASTAV DJELATNIH TVARI Valnemulin
English: Do not administer the product to pigs or rabbits receiving ionophores.
Croatian: Ne primjenjivati proizvod na svinjama ili kunićima koje primaju ionofore.
English: Incorporation of 200 mg active substance per kg feed with:
Croatian: Miješanje 200 mg djelatne tvari po kg hrane s:
English: Do not administer the product to pigs receiving ionophores.
Croatian: Ne primjenjivati proizvod na svinjama koje primaju ionofore.
English: STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES Valnemulin hydrochloride
Croatian: SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Valnemulinklorid
English: Treatment of clinical signs porcine proliferative enteropathy (ileitis)
Croatian: Liječenje kliničkih znakova proliferativne enteropatije svinja (ileitisa)
English: Special warnings for use in pigs:
Croatian: Posebna mjere opreza prilikom primjene na svinjama:
English: Brachyspira pilosicoli
Croatian: Epizootska enteropatija kunića
English: PACKAGE LEAFLET: Econor 50% premix for medicated feed for pigs
Croatian: UPUTA O VMP: Econor 50 % premiks za izradu ljekovite hrane za svinje
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 10% oral powder for pigs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Econor 10 % peroralni prašak za svinje
English: PACKAGE LEAFLET: Econor 10% oral powder for pigs
Croatian: UPUTA O VMP: Econor 10 % peroralni prašak za svinje
English: Econor 50% 150 mg/kg feed Econor 10% 750 mg/kg feed
Croatian: Econor 50 % 150 mg/kg hrane Econor 10 % 750 mg/kg hrane
English: Incorporation of 75 mg active substance per kg feed with:
Croatian: Miješanje 75 mg djelatne tvari po kg hrane s:
English: Finisher
Croatian: kunić
English: Laboratory studies in rats and mice have not produced any evidence of teratogenic effect, however, the safety of the veterinary medicinal product in pregnant and lactating sows has not been established.
Croatian: Dok u laboratorijskim ispitivanjima na štakorima i miševima nisu otkriveni dokazi teratogenih učinaka, neškodljivost tijekom graviditeta i laktacije u svinja nije utvrđena.
English: In-feed use for rabbits:
Croatian: Primjena u hrani za kuniće:
English: METHOD AND ROUTE(S) OF ADMINISTRATION In-feed use.
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: Silica Colloidal anhydrous Isopropyl myristate Lactose.
Croatian: Silicijev dioksid, koloidni, bezvodni Izopropil miristat Laktoza
English: Econor 50% 50 mg/kg feed Econor 10% 250 mg/kg feed
Croatian: Econor 50 % 50 mg/kg hrane Econor 10 % 250 mg/kg hrane
English: Econor 10% 750 mg/kg feed
Croatian: Econor 10 % 750 mg/kg hrane
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 50% premix for medicated feed for pigs Valnemulin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Econor 50 % premiks za izradu ljekovite hrane za svinje Valnemulin
English: Econor 50% mg Econor 50% premix/kg feed = Dosage required (mg/kg) x 2 x bodyweight (kg)/Daily feed intake (kg).
Croatian: Econor 50 % mg Econor 50 % premiks/kg hrane = potrebna doza (mg/kg) x 2 x tjelesna masa (kg)/dnevnog unosa hrane (kg).
English: The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
Croatian: Liječenje kliničkih znakova proliferativne enteropatije svinja (ileitisa).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 10% oral powder for pigs Valnemulin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Econor 10 % peroralni prašak za svinje Valnemulin
English: Adverse reactions following the use of Econor are mainly associated with breeds and cross- breeds of Danish and/or Swedish Landrace.
Croatian: Nuspojave nakon primjene Econora uglavnom su povezane s pasminama i mješancima danskog i/ili švedskog landrasa.
English: To achieve good mixture and homogeneity of incorporation, the use of a pre-mixture is recommended.
Croatian: Da biste postigli dobru smjesu i homogenost miješanja djelatne tvari preporučena je upotreba predsmjese.
English: WITHDRAWAL PERIOD(S) Meat and offal: 1 day.
Croatian: KARENCIJA(E) Meso i jestive iznutrice: 1 dan.
English: Econor 10% mg Econor 10% premix/kg feed = Dosage required (mg/kg) x 10 x bodyweight (kg)/Daily feed intake (kg).
Croatian: Econor 10 % mg Econor 10 % premiks/kg hrane = potrebna doza (mg/kg) x 10 x tjelesna masa (kg)/dnevnog unosa hrane (kg).
English: Marketing authorisation number(s) EU/2/98/010/017 (1 kg) EU/2/98/010/018 (25 kg)
Croatian: 21. Broj(evi) odobrenja za stavljanje u promet EU/2/98/010/017 (1 kg)
English: Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
English: Incorporation of 35 mg active substance per kg feed with:
Croatian: Miješanje 35 mg djelatne tvari po kg hrane s:
English: 1.0-1.5 mg/kg bodyweight/day minimum of 7 days and up to 4 weeks
Croatian: 1,0 - 1,5 mg/kg tjelesne mase/dan
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Econor 50% premix contains valnemulin in the form of valnemulin hydrochloride.
Croatian: Econor 50 % premiks sadrži valnemulin u obliku valnemulinklorida.
English: Econor 10% 350 mg/kg feed
Croatian: Econor 10 % 350 mg/kg hrane
English: Econor 50% 400 mg/kg feed
Croatian: Econor 50 % 400 mg/kg hrane
English: Econor 10% 250 mg/kg feed
Croatian: Econor 10 % 250 mg/kg hrane
English: Swine dysentery 3-4 mg/kg bodyweight/day
Croatian: Ciljna doza 3 mg/kg tjelesne mase/dan
English: Mycoplasma hyopneumoniae
Croatian: Hipromeloza
English: Mixing instructions: mg Econor 50% premix/kg feed = Dosage required (mg/kg) x 2 x bodyweight (kg)/Daily feed intake (kg)
Croatian: Upute o miješanju: mg Econor 50 % premiks/kg hrane = potrebna doza (mg/kg) x 2 x tjelesna masa (kg)/dnevnog unosa hrane (kg)
English: Valnemulin hydrochloride
Croatian: Djelatna tvar valnemulinklorid
English: Incorporation of 25 mg active substance per kg feed with:
Croatian: Miješanje 25 mg djelatne tvari po kg hrane s:
English: Shelf life when incorporated into common rabbit feed and protected from light and moisture: 4 weeks.
Croatian: Rok valjanosti poslije stavljanja u standardnu hranu za kuniće i zaštićeno od svjetlosti i vlage: 4 tjedna.
English: Econor 50% 150 mg/kg feed
Croatian: Econor 50 % 150 mg/kg hrane
English: Econor 50% 50 mg/ kg feed
Croatian: Econor 50 % 50 mg/kg hrane
English: Shelf life when incorporated into pelleted pig feed and protected from light and moisture: 3 weeks.
Croatian: Rok valjanosti poslije stavljanja u peletiranu hranu za svinje i zaštićeno od svjetlosti i vlage: 3 tjedna.
English: Daily dose calculation: Amount Econor (mg) required = Dose required (mg/kg) x pig bodyweight (kg) x 10 / daily feed intake (in kg).
Croatian: Potrebna količina Econor (mg) = potrebna doza (mg/kg) x tjelesna masa svinje (kg) x 10/dnevni unos hrane (kg).
English: Amount Econor 10% oral powder (mg) required = Dose required (mg/kg) x pig bodyweight (kg) x 10 / daily feed intake (kg).
Croatian: Potrebna količina Econor 10 % peroralnog praška (mg) = potrebna doza (mg/kg) x tjelesna masa svinje (kg) x 10/dnevni unos hrane (kg).
English: Silica, colloidal anhydrous Isopropyl myristate Lactose
Croatian: Silicijev dioksid, koloidni, bezvodni Izopropilni miristat Laktoza
English: To achieve good mixture and homogeneity of incorporation, the use of a pre-mixture is required.
Croatian: Da biste postigli dobru smjesu i homogenost miješanja djelatne tvari potrebna je primjena predsmjese.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 50% premix for medicated feed for pigs Valnemulin hydrochloride
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Econor 50 % premiks za izradu ljekovite hrane za svinje Valnemulinklorid
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 10% oral powder for pigs Valnemulin hydrochloride
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Econor 10 % peroralni prašak za svinje Valnemulinklorid
English: Grower
Croatian: NUSPOJAVE
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE ALUMINIUM-LINED PLASTIC BAGS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU
English: Shelf life when incorporated into meal pig feed and protected from light and moisture: 3 months.
Croatian: Rok valjanosti poslije stavljanja u hranu za svinje i zaštićeno od svjetlosti i vlage: 3 mjeseca.
English: Sow
Croatian: kg.
English: The required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature (e.g. wheat middlings) and for rabbits in rabbit standard feed (e.g. mash, pellets) in the proportion: 1 part Econor 10% premix to 10 parts feed ingredient.
Croatian: Potrebna količina proizvoda temeljito se miješa sa sastojkom hrane slične fizičke prirode (primjerice s finim česticama pšeničnih mekinja) te za kuniće u standardnoj hrani za kuniće
English: 106.5 mg/g equivalent to valnemulin 100 mg/g.
Croatian: 106,5 mg/g odgovara valnemulinu
English: mg Econor 10% premix/kg feed = Dosage required (mg/kg) x 10 x bodyweight (kg)/Daily feed intake (kg)
Croatian: Upute o miješanju: mg Econor 10 % premiks/kg hrane = potrebna doza (mg/kg) x 10 x tjelesna masa (kg)/dnevnog unosa hrane (kg)
English: Other provisions
Croatian: Ostali sastojci:
English: This dose level is effective under normal situation in the treatment of clinical signs of disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
Croatian: Ta je doza djelotvorna u liječenju kliničke bolesti, ali više doze ili dulje trajanje liječenja mogu biti
English: Pigs
Croatian: Krmača
English: and Escherichia coli.
Croatian: salinomicin ili narazin.
English: Two hours after withdrawal of product given in feed twice daily for 4 weeks at a dose of 15 mg/kg bodyweight/day, liver concentration was 1.58 µg/g and lung concentration 0.23 µg/g whereas concentrations in plasma were below the limit of detection.
Croatian: Dva sata nakon povlačenja premiksa koji se primjenjuje u hrani za životinje dva puta dnevno tijekom četiri tjedna pri dozi od 15 mg/kg tjelesne mase/dan,
English: Pharmacologically active substance
Croatian: Farmakološk i djelatna tvar
English: * colony forming units
Croatian: * jedinice koje stvaraju kolonije
English: 1.3∙108 to 9.0∙108 CFU*/dose.
Croatian: -1 Živa nepatogena Escherichia coli O8:K87: 1.3∙108 do 9.0∙108 CFU*/dozi.
English: Vial (glass) 50 doses 4 vials Zero days
Croatian: 50 doza 4 bočice Nula dana
English: Can't be sold separately.
Croatian: Ne može se prodavati zasebno.
English: Date of latest renewal: 28 April 2017.
Croatian: Datum posljednje obnove odobrenja: 28. travanj 2017.
English: The response rate in these patients was about 52 %.
Croatian: Stopa odgovora u ovih bolesnika bila je približno 52%.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.1 međutim, nije moguće dati preporuku o doziranju.
English: The occurrence of osteonecrosis is multifactorial and is associated with various risk factors.
Croatian: Pojavljivanje osteonekroze je multifaktorijalno i povezano je s različitim faktorima rizika.
English: Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Croatian: Mnogi od tih bolesnika također su primali kemoterapiju i kortikosteroide i imali su znakove lokalne infekcije uključujući osteomijelitis.
English: Anxiety, sleep disturbance Confusion
Croatian: anksioznost, poremećaj spavanja konfuzija
English: If any of these apply to you, tell your doctor straight away.
Croatian: Ako se nešto od navedenog odnosi na Vas, odmah obavijestite liječnika.
English: - A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Croatian: - Poremećaj rada bubrega koji se zove Fanconijev sindrom (obično ga utvrđuje Vaš liječnik pomoću određenih testova urina).
English: - Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Croatian: - teška alergijska reakcija: nedostatak zraka, oteklina koja uglavnom zahvaća lice i grlo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 August 2012.
Croatian: Datum prvog odobrenja: 3. kolovoza 2012.
English: In some instances the hypocalcaemia may be life-threatening.
Croatian: U nekim situacijama hipokalcemija može biti životno opasna.
English: In some instances, the hypocalcaemia may be life-threatening (see section 4.8).
Croatian: U nekim situacijama hipokalcemija može biti životno opasna (vidjeti dio 4.8).
English: • Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Croatian: • jakost bisfosfonata (veći rizik za vrlo jake spojeve), put primjene (veći rizik pri parenteralnoj primjeni) i kumulativna doza bisfosfonata.
English: The contributive role of zoledronic acid therapy in these cases could not be excluded.
Croatian: Doprinos terapije zoledronatnom kiselinom u ovim slučajevima se ne može isključiti.
English: - Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Croatian: Obratite se liječniku ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
English: The time to onset for occurrence of osteonecrosis also has similar pattern when compared to osteonecrosis of the jaw/external auditory canal.
Croatian: Vrijeme do pojave osteonekroze također ima sličan obrazac kad se uspoređuje s osteonekrozom čeljusti/vanjskog slušnog kanala.
English: • The total time between dilution, storage in the refrigerator and end of administration must not exceed 96 hours.
Croatian: • Ukupno vrijeme od razrjeđenja i čuvanja u hladnjaku do završetka primjene ne smije biti dulje od 96 sati.
English: If a lower dose of Zoledronic acid medac is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Croatian: Ako je potrebna niža doza Zoledronatne kiseline medac, prvo izvucite odgovarajući volumen kako je navedeno niže, i potom ga dodatno razrijedite sa 100 ml otopine za infuziju.
English: - Painful redness and/or swelling of the eye.
Croatian: - bolno crvenilo i/ili oticanje oka.
English: Your doctor, pharmacist or nurse knows how to store Zoledronic acid medac properly (see section 6).
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra znaju kako ispravno čuvati Zoledronatnu kiselinu medac (vidjeti dio 6).
English: Unopened bottle: 3 years.
Croatian: 6.3 Rok valjanosti Neotvorena boca: 3 godine.
English: Zoledronic acid medac is not recommended for use in adolescents and children below the age of 18 years.
Croatian: Ne preporučuje se primjena Zoledronatne kiseline medac u adolescenata i djece mlađe od 18 godina.
English: • Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Croatian: • istodobnu terapiju: kemoterapiju, inhibitore angiogeneze (vidjeti dio 4.5), radioterapiju glave i vrata, kortikosteroide.
English: Therefore, the product information should be updated to reflect in sections 4.4 and 4.8 of the SmPC a warning on osteonecrosis of other anatomical sites and add this adverse reaction with a frequency very rare.
Croatian: Zbog toga je potrebno ažurirati informacije o lijeku da SmPC u dijelovima 4.4 i 4.8 sadrži upozorenje o osteonekrozi na drugim anatomskim mjestima te da se doda ova nuspojavu s učestalošću vrlo rijetko.
English: - to reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
Croatian: - smanjenje količine kalcija u krvi u odraslih bolesnika kad je količina kalcija prevelika zbog prisutnosti tumora.