FrancophonIA/ELRC3.0 huggingface dataset:
English: No information is available from dialysed patients, therefore pioglitazone should not be used in such patients.
Croatian: Nema dostupnih informacija o bolesnicima na dijalizi pa se pioglitazon ne smije primjenjivati u tih bolesnika.
English: Your blood sugar will be checked, and your dose of Glidipion may need to be changed.
Croatian: Provjerit će Vam šećer u krvi i nakon toga možda promijeniti dozu lijeka Glidipion.
English: Do not use Glidipion after the expiry date which is stated on the carton and the blister pack after the word “EXP”.
Croatian: Glidipion se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „Rok valjanosti“.
English: Glidipion tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Croatian: Glidipion tablete sadrže laktozu hidrat te se stoga ne smiju primjenjivati u bolesnika s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcijom glukoze-galaktoze.
English: In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those ≥65 years compared to 4.0% in patients less than 65
Croatian: U bolesnika na inzulinu bez pioglitazona, incidencija srčanog zatajenja bila je 8,2% kod osoba u dobi ≥65 godina, u odnosu na 4,0% u bolesnika mlađih od 65 godina.
English: A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Croatian: Kliničko ispitivanje pioglitazona u usporedbi s monoterapijom gliklazidom bilo je produljeno na dvije godine kako bi se procijenilo vrijeme do prestanka odgovora na terapiju (definirano kao nastanak HbA1c ≥8,0% nakon prvih šest mjeseci terapije).
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Glidipion 45 mg tablete pioglitazon Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: If you stop taking Glidipion
Croatian: Ako prestanete uzimati Glidipion
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.
Croatian: Aluminij/aluminij blisteri, pakiranja od 14, 28, 30, 50, 56, 84, 90, 98 i 100 tableta.
English: Uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness - increased appetite
Croatian: manje često (mogu se javiti u do 1 na 100 ljudi) - šećer u mokraći, proteini u mokraći - povišenje enzima - osjećaj vrtnje (vrtoglavica) - znojenje - umor - pojačan apetit
English: - if you have heart failure or have had heart failure in the past.
Croatian: (pogledajte dio 6 za popis pomoćnih tvari). - ako imate zatajenje srca ili ste prije imali zatajenje srca.
English: - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
Croatian: - u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) u kojih se kontrola ne postiže dijetom i tjelovježbom i u kojih metformin nije prikladan zbog kontraindikacija ili nepodnošenja.
English: - hypersensitivity to the active substance or to any of the excipients - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria.
Croatian: - preosjetljivošću na djelatnu tvar ili neku od pomoćnih tvari - zatajenjem srca ili anamnezom zatajenja srca (NYHA stadiji I do IV) - oštećenjem funkcije jetre - dijabetičkom ketoacidozom - postojećim ili preboljenim karcinomom mokraćnog mjehura - neispitanom makroskopskom hematurijom.
English: Bladder cancer has been experienced uncommonly (up to 1 in 100 people) in patients taking pioglitazone.
Croatian: Karcinom mokraćnog mjehura manje je često (u do 1 na 100 ljudi) nastao u bolesnika koji uzimaju pioglitazon.
English: The usual starting dose is one tablet of 15 mg or 30 mg of pioglitazone to be taken once daily.
Croatian: Uobičajena početna doza je jedna tableta od 15ili-ili od 30 mg pioglitazona jedanput na dan.
English: Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency.
Croatian: Nuspojave koje su bile zabilježene češće (>0,5%) nego uz placebo ili kao izolirani slučaj u bolesnika koji su primali pioglitazon u dvostruko slijepim ispitivanjima navedene su niže prema MedDRA pojmovima, klasifikaciji organskih sustava i apsolutnoj učestalosti.
English: - The other ingredients are lactose monohydrate, hydroxypropylcellulose, carmellose calcium and magnesium stearate.
Croatian: - Pomoćne tvari su laktoza hidrat, hidroksipropilceluloza, karmelozakalcij i magnezijev stearat.
English: What you need to know before you take Glidipion Do not take Glidipion
Croatian: Što morate znati prije nego počnete uzimati Glidipion
English: The other side effects that have been experienced by some patients taking pioglitazone:
Croatian: Ostale nuspojave koje su osjetili neki bolesnici koji uzimaju pioglitazon su:
English: If you forget to take Glidipion
Croatian: Ako ste zaboravili uzeti Glidipion
English: • The risk of bladder cancer and relevant risk minimisation advice.
Croatian: • Rizik od karcinoma mokraćnog mjehura i odgovarajuće savjete o smanjivanju značajnih rizika.
English: Glidipion contains lactose monohydrate
Croatian: Glidipion sadrži laktozu hidrat
English: Common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence (wind)
Croatian: često (mogu se javiti u do 1 na 10 ljudi) - glavobolja - omaglica - bol u zglobovima - impotencija - križobolja - nedostatak zraka - malo sniženje broja crvenih krvnih stanica - nadutost (vjetrovi)
English: Localised swelling (oedema) has also been experienced very commonly in patients taking pioglitazone in combination with insulin.
Croatian: Lokalizirano oteknuće (edemi) također su vrlo često nastajali u bolesnika koji su uzimali pioglitazon u kombinaciji s inzulinom.
English: Contains lactose monohydrate.
Croatian: Sadrži laktozu hidrat.
English: In comparator groups, addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
Croatian: U skupinama koje su primale usporedni lijek, dodavanje sulfonilureje metforminu rezultiralo je prosječnim povećanjem tjelesne težine za 1,3 kg, a dodavanje metformina sulfonilureji smanjenjem tjelesne težine za 1,0 kg.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Croatian: U nekih bolesnika koji su dugo imali šećernu bolest tipa 2 i srčanu bolest ili su preboljeli moždani udar a liječili su se pioglitazonom i inzulinom, došlo je do zatajenja srca.
English: If you experience this symptom for the first time, talk to your doctor as soon as possible.
Croatian: Ako prvi put osjetite ovaj simptom, čim prije razgovarajte s Vašim liječnikom.
English: The tablets are supplied in aluminium blister packs of 14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.
Croatian: Tablete se isporučuju u aluminijskim blister pakiranjima s 14, 28, 30, 50, 56, 84, 90, 98 i 100 tableta.
English: In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
Croatian: U PROactive ispitivanju kardiovaskularnih ishoda, 5238 bolesnika sa šećernom bolešću tipa 2 i postojećom teškom makrovaskularnom bolešću bilo je randomizacijom raspodijeljeno u skupinu koja je primala pioglitazon i onu koja je primala placebo uz postojeću antidijabetičku i kardiovaskularnu terapiju u trajanju do 3,5 godine.
English: In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Croatian: U kliničkim ispitivanjima pioglitazona, incidencija povišenja ALT-a za više od tri puta iznad gornje granice normale bila je jednaka onoj uz placebo, ali manja od one opažene u skupinama koje su kao usporedni lijek primale metformin ili sulfonilureju.
English: not known not known not known not known not known
Croatian: Preosjetljivost i alergijske reakcije nepoznato nepoznato nepoznato nepoznato nepoznato
English: EU/1/12/756/003 EU/1/12/756/004 EU/1/12/756/005 EU/1/12/756/006 EU/1/12/756/007 EU/1/12/756/008 EU/1/12/756/009 EU/1/12/756/010 EU/1/12/756/011 EU/1/12/756/012 EU/1/12/756/013 EU/1/12/756/014 EU/1/12/756/015 EU/1/12/756/016 EU/1/12/756/017 EU/1/12/756/018 EU/1/12/756/019 EU/1/12/756/020 EU/1/12/756/021 EU/1/12/756/022 EU/1/12/756/023 EU/1/12/756/024 EU/1/12/756/025 EU/1/12/756/026 EU/1/12/756/027
Croatian: EU/1/12/756/001 EU/1/12/756/002 EU/1/12/756/003 EU/1/12/756/004 EU/1/12/756/005 EU/1/12/756/006 EU/1/12/756/007 EU/1/12/756/008 EU/1/12/756/009 EU/1/12/756/010 EU/1/12/756/011 EU/1/12/756/012 EU/1/12/756/013 EU/1/12/756/014 EU/1/12/756/015 EU/1/12/756/016 EU/1/12/756/017 EU/1/12/756/018 EU/1/12/756/019 EU/1/12/756/020 EU/1/12/756/021 EU/1/12/756/022 EU/1/12/756/023 EU/1/12/756/024 EU/1/12/756/025 EU/1/12/756/026 EU/1/12/756/027
English: How to take Glidipion
Croatian: Kako uzimati Glidipion
English: Your doctor will ask you to have blood tests periodically during treatment with Glidipion.
Croatian: Liječnik će tražiti da za vrijeme liječenja lijekom Glidipion povremeno napravite krvne pretrage da bi se provjerilo radi li Vaša jetra normalno.
English: You can usually continue to take other medicines whilst you are being treated with Glidipion.
Croatian: Za vrijeme liječenja lijekom Glidipion obično možete nastaviti uzimati druge lijekove.
English: Each tablet contains 113.31 mg of lactose monohydrate (see section 4.4).
Croatian: Pomoćne tvari s poznatim učinkom: Jedna tableta sadrži 113,31 mg laktoza hidrata (vidjeti dio 4.4).
English: Carmellose calcium Hydroxypropylcellulose Lactose monohydrate Magnesium stearate
Croatian: 6.1 Popis pomoćnih tvari karmelozakalcij hidroksipropilceluloza laktoza hidrat magnezijev stearat
English: 4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Croatian: Provedena je analiza objedinjenih podataka o prijelomima kostiju kao nuspojavama u randomiziranim, usporednim lijekom kontroliranim, dvostruko slijepim kliničkim ispitivanjima u više od 8100 bolesnika u skupinama liječenima pioglitazonom i 7400 bolesnika u skupinama liječenima usporednim lijekom u trajanju do 3,5 godine.
English: Actavis Export Int. Ltd., Malta.
Croatian: Ltd., Malta.
English: Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 15 mg, 30 mg ili 45 mg pioglitazona (u obliku pioglitazonklorida).
English: Glidipion 15 mg, 30 mg and 45 mg tablets Glidipion 15 mg tablets
Croatian: Glidipion 15 mg, 30 mg i 45 mg tablete Glidipion 15 mg tablete
English: How to store Glidipion
Croatian: Kako čuvati Glidipion
English: Each tablet contains 37.77 mg of lactose monohydrate (see section 4.4).
Croatian: Pomoćne tvari s poznatim učinkom: Jedna tableta sadrži 37,77 mg laktoza hidrata (vidjeti dio 4.4).
English: as triple oral therapy in combination with - metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Croatian: - metforminom i sulfonilurejom, u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) s nedostatnom kontrolom glikemije usprkos dvojnoj peroralnoj terapiji.
English: Each tablet contains 75.54 mg of lactose monohydrate (see section 4.4).
Croatian: Pomoćne tvari s poznatim učinkom: Jedna tableta sadrži 75,54 mg laktoza hidrata (vidjeti dio 4.4).
English: The packs with 14, 28, 56, 84 and 98 tablets contain blisters with abbreviations for days of the week printed on the blister (Mon., Tue., Wed., Thu., Fri., Sat., Sun.).
Croatian: Pakiranja s 14, 28, 56, 84 i 98 tableta sadrže blistere s tiskanim kraticama naziva dana u tjednu (Pon, Uto, Sri, Čet, Pet, Sub, Ned).
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).
Croatian: Zabilježeno je da istodobna primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) povećava, a s rifampicinom (induktor citokroma P450 2C8) snižava koncentracije pioglitazona u plazmi (vidjeti dio 4.5).
English: You may take your tablets with or without food.
Croatian: Glidipion s hranom i pićem Tablete možete uzimati s hranom ili bez nje.
English: The risk of fractures should be considered in the long term care of patients treated with pioglitazone (see section 4.8).
Croatian: Rizik od prijeloma treba uzeti u obzir kod dugotrajnog liječenja bolesnika pioglitazonom (vidjeti dio
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Croatian: Zabilježeno je da istodobna primjena pioglitazona s rifampicinom (induktor citokroma P450 2C8) rezultira smanjenjem AUC-a pioglitazona za 54%.
English: Allergic reactions have been reported (frequency not known) in patients taking Glidipion.
Croatian: Kod bolesnika koji su uzimali Glidipion prijavljene su alergijske reakcije (nepoznate učestalosti).
English: Glidipion 15 mg tablets Glidipion 30 mg tablets Glidipion 45 mg tablets
Croatian: Glidipion 15 mg tablete Glidipion 30 mg tablete Glidipion 45 mg tablete
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Glidipion.
Croatian: Kad uzimate Glidipion, možete ponovno imati ovulaciju pa mogućnost trudnoće može biti povećana.
English: This medicine does not require any special storage precautions.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Lijek ne zahtjeva posebne uvjete čuvanja.
English: IJsland / Islande / Island
Croatian: Actavis Group PTC ehf. IJsland / Islande / Island
English: Blurred vision due to swelling (or fluid) at the back of the eye (frequency not known) has also been reported in patients taking pioglitazone.
Croatian: U bolesnika koji uzimaju pioglitazon zabilježen je i zamagljen vid zbog oticanja (ili tekućine) stražnje strane oka (nepoznata učestalost).
English: Tel: +4021 230 65 24
Croatian: Teva Pharmaceuticals S.R.L Tel: +4021 230 65 24
English: common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon
Croatian: Pretrage povećana tjelesna težina često često često često često povišena kreatin fosfokinaza u krvi često povišena laktična dehidrogenaza manje često povišena alanin aminotransferaza nepoznato nepoznato nepoznato nepoznato nepoznato
English: - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
Croatian: - metforminom, u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) s nedostatnom kontrolom glikemije usprkos monoterapiji metforminom u najvećoj podnošljivoj dozi. - sulfonilurejom, samo u odraslih bolesnika s nepodnošenjem metformina ili u kojih je metformin kontraindiciran, s nedostatnom kontrolom glikemije usprkos monoterapiji sulfonilurejom u najvećoj podnošljivoj dozi.
English: Glidipion 30 mg tablets
Croatian: Glidipion 30 mg tablete
English: EU/1/12/756/001 [14 tablets] EU/1/12/756/002 [28 tablets] EU/1/12/756/003 [30 tablets] EU/1/12/756/004 [50 tablets] EU/1/12/756/005 [56 tablets] EU/1/12/756/006 [84 tablets] EU/1/12/756/007 [90 tablets] EU/1/12/756/008 [98 tablets] EU/1/12/756/009 [100 tablets]
Croatian: EU/1/12/756/001 [14 tableta] EU/1/12/756/002 [28 tableta] EU/1/12/756/003 [30 tableta] EU/1/12/756/004 [50 tableta] EU/1/12/756/005 [56 tableta] EU/1/12/756/006 [84 tablete] EU/1/12/756/007 [90 tableta] EU/1/12/756/008 [98 tableta] EU/1/12/756/009 [100 tableta]
English: EU/1/12/756/019 [14 tablets] EU/1/12/756/020 [28 tablets] EU/1/12/756/021 [30 tablets] EU/1/12/756/022 [50 tablets] EU/1/12/756/023 [56 tablets] EU/1/12/756/024 [84 tablets] EU/1/12/756/025 [90 tablets] EU/1/12/756/026 [98 tablets] EU/1/12/756/027 [100 tablets]
Croatian: EU/1/12/756/019 [14 tableta] EU/1/12/756/020 [28 tableta] EU/1/12/756/021 [30 tableta] EU/1/12/756/022 [50 tableta] EU/1/12/756/023 [56 tableta] EU/1/12/756/024 [84 tablete] EU/1/12/756/025 [90 tableta] EU/1/12/756/026 [98 tableta] EU/1/12/756/027 [100 tableta]
English: Glidipion 45 mg tablets
Croatian: Glidipion 45 mg tablete
English: EU/1/12/756/010 [14 tablets] EU/1/12/756/011 [28 tablets] EU/1/12/756/012 [30 tablets] EU/1/12/756/013 [50 tablets] EU/1/12/756/014 [56 tablets] EU/1/12/756/015 [84 tablets] EU/1/12/756/016 [90 tablets] EU/1/12/756/017 [98 tablets] EU/1/12/756/018 [100 tablets]
Croatian: EU/1/12/756/010 [14 tableta] EU/1/12/756/011 [28 tableta] EU/1/12/756/012 [30 tableta] EU/1/12/756/013 [50 tableta] EU/1/12/756/014 [56 tableta] EU/1/12/756/015 [84 tablete] EU/1/12/756/016 [90 tableta] EU/1/12/756/017 [98 tableta] EU/1/12/756/018 [100 tableta]
English: The tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with ‘TZ15' on one side.
Croatian: Tablete su bijele, okrugle, ravne s ukošenim rubom, promjera 5,5 mm s utisnutom oznakom ‘TZ15' na jednoj strani.
English: Glidipion 15 mg tablets
Croatian: Glidipion 15 mg tablete
English: Glidipion 15 mg tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with ‘TZ15' on one side.
Croatian: Glidipion 15 mg tablete su bijele, okrugle, ravne s ukošenim rubom, promjera 5,5 mm s utisnutom oznakom ‘TZ15' na jednoj strani.
English: Glidipion 30 mg tablets pioglitazone
Croatian: Glidipion 30 mg tablete pioglitazon
English: Glidipion 45 mg tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with ‘TZ45' on one side.
Croatian: Glidipion 45 mg tablete su bijele, okrugle, ravne s ukošenim rubom, promjera 8 mm s utisnutom oznakom ‘TZ45' na jednoj strani.
English: Glidipion 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with ‘TZ30' on one side.
Croatian: Glidipion 30 mg tablete su bijele, okrugle, ravne s ukošenim rubom, promjera 7 mm s utisnutom oznakom ‘TZ30' na jednoj strani.
English: Uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Croatian: često (mogu se javiti u do 1 na 10 ljudi) - infekcija dišnih puteva - poremećen vid - povećanje tjelesne težine - utrnulost manje često (mogu se javiti u do 1 na100 ljudi) - upala sinusa (sinusitis) - poteškoće sa spavanjem (nesanica)
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Croatian: Nositelj odobrenja za stavljanje lijeka u promet
English: Glidipion 45 mg tablets pioglitazone
Croatian: Glidipion 45 mg tablete pioglitazon
English: Glidipion 15 mg tablets pioglitazone
Croatian: Glidipion 15 mg tablete pioglitazon
English: Sími: +354 550 3300
Croatian: Actavis Group PTC ehf. Sími: +354 550 3300
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U
English: In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Croatian: HDL-kolesterola u usporedbi s placebom, uz mala ali ne i klinički značajna povišenja razine LDLkolesterola.
English: Each tablet contains 30 mg pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 30 mg pioglitazona (u obliku hidroklorida).
English: Each tablet contains 45 mg pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 45 mg pioglitazona (u obliku hidroklorida).
English: Distribution
Croatian: PROMET
English: MANUFACTURER'S BATCH NUMBER
Croatian: IME NOSITELJA
English: Актавис ЕАД Teл.
Croatian: Actavis Export Int.
English: Fri.
Croatian: Nuspojava
English: Symptomatic treatment may be required.
Croatian: Može biti potrebno simptomatsko liječenje.
English: This summary was last updated in October 2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u listopadu 2015.
English: The relative reduction in mastitis incidence was 26%.
Croatian: Relativno smanjenje pojave mastitisa iznosilo je 26 %.
English: The intervals between the two injections should not be less than 3 days or more than 17 days.
Croatian: Intervali između dviju injekcija ne smiju biti kraći od tri dana ili duži od 17 dana.
English: The full EPAR for Imrestor can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Imrestor nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: A second injection is given within 24 hours after calving.
Croatian: Druga injekcija daje se u roku od 24 sata nakon teljenja.
English: In a field trial involving 2465 cows the incidence of clinical mastitis during days 3 to 30 of milk production was 9.1% (113/1235) in the Imrestor-treated group compared with 12.4% (152/1230) in the group given a dummy injection.
Croatian: U terenskom ispitivanju, koje je obuhvatilo 2465 krava, pojava kliničkog mastitisa u razdoblju od 3. do 30. dana proizvodnje mlijeka iznosila je 9,1 % (113/1235) u skupini liječenoj Imrestorom u usporedbi s 12,4 % (152/1230) u skupini kojoj je dana lažna injekcija.
English: People who are hypersensitive (allergic) to pegbovigrastim should avoid contact with Imrestor.
Croatian: Osobe koje su preosjetljive (alergične) na pegbovigrastim trebaju izbjegavati kontakt s Imrestorom.
English: These clinical signs typically appear between 30 minutes and 2 hours after the first dose and resolve within 2 hours.
Croatian: Ovi klinički znakovi uglavnom se pojavljuju u razdoblju između 30 minuta i dva sata nakon prve doze te nestaju unutar dva sata.
English: Why is Imrestor approved?
Croatian: Zašto je Imrestor odobren?
English: What is Imrestor and what is it used for?
Croatian: Što je Imrestor i za što se koristi?
English: Pegbovigrastim is a modified form of a natural protein, bovine granulocyte colony stimulating factor (bG-CSF), that stimulates the production and activity of a type of white blood cells called neutrophils.
Croatian: Pegbovigrastim je modificirani oblik prirodnog proteina, faktor stimulacije kolonije goveđega granulocita (bG-CSF) koji stimulira proizvodnju i aktivnost vrste bijelih krvnih stanica koje se nazivaju neutrofilima.
English: There may also be other effects including nausea (feeling sick), and rashes or other hypersensitivity reactions (e.g. breathing difficulties and low blood pressure).
Croatian: Također se mogu javiti i druge nuspojave poput mučnine (osjećaja slabosti) i osipa ili drugih reakcija preosjetljivosti (npr. poteškoće s disanjem i nizak krvni tlak).
English: It is not intended to provide practical advice on how to use Imrestor.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju VMP-a Imrestor.