FrancophonIA/ELRC3.0 huggingface dataset:
English: Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 USA
Croatian: Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 SAD
English: In some limited cases with newborn calves, positive ear notches for BVDV vaccine strain were reported by molecular diagnostic tests.
Croatian: U malom broju slučajeva u tek oteljene teladi pozitivne oznake na ušima za cjepni soj BVDV zabilježene su u molekularnim dijagnostičkim ispitivanjima.
English: Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim s otapalom priloženim za primjenu s veterinarsko-medicinskim proizvodom.
English: After reconstitution, administer one dose (2 ml) of the vaccine by intramuscular (IM) injection.
Croatian: Poslije rekonstitucije primijenite jednu dozu (2 ml) cjepiva intramuskularnom (i.m.) injekcijom.
English: The vaccine is designed to stimulate the development of an active immune response against BVDV-1 and BVDV-2 in cattle.
Croatian: Namjena je cjepiva potaknuti razvoj aktivnog imunosnog odgovora protiv virusa BVDV-1 i BVDV-2 u goveda.
English: Shelf life after reconstitution according to directions:
Croatian: Rok valjanosti nakon rekonstitucije u skladu s uputama:
English: The field studies to investigate the efficacy of the vaccine were done in herds where persistently infected animals had been removed.
Croatian: Terenska ispitivanja za dokazivanje učinkovitosti cjepiva provedena su na stadima iz kojih su uklonjene trajno zaražene životinje.
English: CONTRAINDICATION
Croatian: KONTRAINDIKACIJA
English: Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Croatian: Ne primjenjivati u slučajevima preosjetljivosti na djelatnu tvar ili na bilo koju od pomoćnih tvari.
English: For active immunisation of cattle from 3 months of age to reduce hyperthermia and to minimise the reduction of leukocyte count caused by bovine viral diarrhoea virus (BVDV-1 and BVDV-2), and to reduce virus shedding and viraemia caused by BVDV-2.
Croatian: Za aktivnu imunizaciju goveda u dobi od 3 mjeseca nadalje kako bi se smanjila hipertermija i umanjila redukcija broja leukocita uzrokovana virusom virusnog proljeva goveda (BVDV-1 i BVDV-2) i smanjilo izlučivanje virusa te viremija uzrokovana virusom BVDV-2.
English: Each dose (2 ml) contains: Lyophilisate:
Croatian: Svaka doza (2 ml) sadrži: Liofilizat:
English: It is recommended to vaccinate before pregnancy to ensure protection against persistent infection of the foetus.
Croatian: Preporučuje se provesti cijepljenje prije graviditeta kako bi se osigurala zaštita od trajne infekcije ploda.
English: Reconstitute the lyophilisate by adding the full content of the solvent at room temperature.
Croatian: Rekonstituirajte liofilizat dodavanjem cijele količine otapala na sobnoj temperaturi.
English: It is recommended to vaccinate cattle at least 3 weeks before insemination/mating to provide foetal protection from the first day of conception.
Croatian: Preporučuje se cijepiti goveda barem 3 tjedna prije inseminacije/parenja kako bi se osigurala zaštita fetusa od prvog dana začeća.
English: For active immunisation of cattle against BVDV-1 and BVDV-2, to prevent the birth of persistently infected calves caused by transplacental infection.
Croatian: Za aktivnu imunizaciju goveda protiv BVDV-1 i BVDV-2 kako bi se spriječilo teljenje trajno zaražene teladi uzrokovano transplacentarnom infekcijom.
English: EXP {month/year} Once reconstituted use within: 8 hours.
Croatian: EXP {mjesec/godina} Nakon rekonstitucije upotrijebiti unutar: 8 sati.
English: 3 weeks after immunisation.
Croatian: Početak imunosti: 3 tjedna nakon imunizacije.
English: 5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml)
Croatian: 5 doza (10 ml) 10 doza (20 ml) 25 doza (50 ml)
English: EXP {month/year} Once reconstituted use within 8 hours.
Croatian: EXP {mjesec/godina} Nakon rekonstitucije upotrijebiti unutar 8 sati.
English: Keep the bottle in the outer carton.
Croatian: Držati bočicu u vanjskom kartonu.
English: The cornerstone of bovine viral diarrhoea (BVD)-eradication is identification and culling of persistently infected animals.
Croatian: Kod eradikacije virusa virusnog proljeva goveda (BVD) najvažnije je identificirati i smanjiti populaciju trajno zaraženih životinja.
English: This may result in transplacental transmission on the vaccine virus, but no adverse effects on foetus or pregnancy was observed in studies.
Croatian: To može uzrokovati transplacentarnu transmisiju cjepnog virusa, ali u ispitivanjima nisu uočene nuspojave na plod ili na graviditet.
English: Longlasting viremia has been observed after vaccination, in particular in pregnant seronegative heifers (10 days in a study).
Croatian: Dugotrajna viremija uočena je nakon cijepljenja, posebice kod steonih seronegativnih junica (10 dana u ispitivanju).
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: Sukladno članku 71. Direktive 2001/82/EZ i Europskog parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz,
English: Solvent: Clear, colourless solution.
Croatian: Otapalo: bistra, bezbojna otopina.
English: Mild swellings or nodules up to 3 cm diameter were observed at the injection site and disappeared within 4 days post vaccination (clinical studies).
Croatian: Blaga oticanja ili čvorići promjera do 3 cm uočeni su na mjestu primjene injekcije, a nestali su unutar 4 dana nakon cijepljenja (klinička ispitivanja).
English: Shelf life after reconstitution: 8 hours.
Croatian: Rok valjanosti nakon rekonstitucije: 8 sati.
English: Bovine viral diarrhoea virus type 1: 104.0-106.0 TCID50, Bovine viral diarrhoea virus type 2: 104.0-106.0 TCID50.
Croatian: virus virusnog proljeva goveda tip 1: 104,0-106,0 TCID50, virus virusnog proljeva goveda tip 2: 104,0-106,0 TCID50.
English: While persistent infection of the foetus caused by the vaccine was not observed, transmission of vaccine virus to the foetus may occur..
Croatian: Iako perzistentna infekcija ploda uzrokovana cjepivom nije uočena, prijenos cjepnog virusa na fetus je moguć.
English: Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections
Croatian: Otapalo: natrijev klorid kalijev klorid kalijev dihidrogenfosfat dinatrijev hidrogenfosfat voda za injekcije
English: High density polyethylene (HDPE) bottles sof solvent, closed with a siliconised chlorobutyl rubber stopper with lacquered aluminium seal.
Croatian: Bočice od polietilena visoke gustoće (HDPE), zatvorene silikoniziranim čepom od klorobutilne gume i lakiranim aluminjskim nepropusnim zatvaračem.
English: Modified live BVDV*-1, non-cytopathic parent strain KE-9: 104.0-106.0 TCID50**, Modified live BVDV*-2, non-cytopathic parent strain NY-93: 104.0-106.0 TCID50**.
Croatian: Modificirani živi BVDV*-1, necitopatogeni roditeljski soj KE-9: 104,0-106,0 TCID50**, Modificirani živi BVDV*-2, necitopatogeni roditeljski soj NY-3: 104,0-106,0 TCID50**.
English: EU/2/14/176/013 50 doses EU/2/14/176/014 4 x 50 doses EU/2/14/176/015 6 x 50 doses EU/2/14/176/016 10 x 50 doses
Croatian: EU/2/14/176/013 50 doza EU/2/14/176/014 4 x 50 doza EU/2/14/176/015 6 x 50 doza EU/2/14/176/016 10 x 50 doza
English: Each dose (2 ml) contains: BVDV-1: 104.0-106.0 TCID50, BVDV-2: 104.0-106.0 TCID50.
Croatian: Svaka doza (2 ml) sadrži: BVDV-1: 104,0-106,0 TCID50, BVDV-2: 104.0-106,0 TCID50.
English: 5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml) 50 doses (100 ml) 4 x 5 doses (10 ml) 4 x 10 doses (20 ml) 4 x 25 doses (50 ml) 4 x 50 doses (100 ml) 6 x 5 doses (10 ml) 6 x 10 doses (20 ml) 6 x 25 doses (50 ml) 6 x 50 doses (100 ml) 10 x 5 doses (10 ml) 10 x 10 doses (20 ml) 10 x 25 doses (50 ml) 10 x 50 doses (100 ml)
Croatian: 5 doza (10 ml) 10 doza (20 ml) 25 doza (50 ml) 50 doza (100 ml) 4 x 5 doza (10 ml) 4 x 10 doza (20 ml) 4 x 25 doza (50 ml) 4 x 50 doza (100 ml) 6 x 5 doza (10 ml) 6 x 10 doza (20 ml) 6 x 25 doza (50 ml) 6 x 50 doza (100 ml) 10 x 5 doza (10 ml) 10 x 10 doza (20 ml) 10 x 25 doza (50 ml) 10 x 50 doza (100 ml)
English: Potassium hydroxide L-Glutamine acid Potassium dihydrogen phosphate Dipotassium phosphate Sodium chloride Water for injections
Croatian: Liofilizat: saharoza želatina kalijev hidroksid L-glutaminska kiselina kalijev dihidrogenfosfat dikalijev fosfat natrijev klorid voda za injekcije
English: The vaccine strains are able to infect sheep and swine when administered intranasally, but no adverse reactions or spreading to in-contact animals has been demonstrated.
Croatian: Cjepni sojevi mogu zaraziti ovcu i svinju kada se primjenjuju intranazalno, ali nisu dokazane nuspojave ili širenje virusa na životinje u kontaktu sa zaraženom životinjom.
English: Furthermore, an increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section 4.6).
Croatian: Nadalje, porast rektalno mjerene tjelesne temperature često se javlja unutar 4 sata nakon primjene i spontano nestaje unutar 24 sata (vidi odjeljak 4.6).
English: PACKAGE SIZE
Croatian: VELIČINE PAKOVANJA
English: Type I amber glass vials closed with siliconised bromobutyl rubber stopper with lacquered aluminium seal.
Croatian: Bočice od stakla tipa I, boje jantara, zatvorene čepom od silikonizirane bromobutilne gume i lakiranim aluminijskim nepropusnim zatvaračem.
English: An increase in body temperature within the physiological range is common within 4 hours of vaccination and spontaneously resolves within 24 hours (clinical studies).
Croatian: Porast tjelesne temperature unutar fiziološkog raspona često se javlja unutar 4 sata od cijepljenja i spontano nestaje u roku od 24 sata (klinička ispitivanja).
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: posjedovanje, prodaju, opskrbu i/ili primjenu imunoloških veterinarsko-medicinskih proizvoda na cijelom ili na dijelu svog teritorija ako je utvrđeno da: a) će primjena proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu ili iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.
English: EU/2/14/176/005 10 doses and 20 ml EU/2/14/176/006 10 doses and 20 ml (4 x) EU/2/14/176/007 10 doses and 20 ml (6 x) EU/2/14/176/008 10 doses and 20 ml (10 x) EU/2/14/176/009 25 doses and 50 ml EU/2/14/176/010 25 doses and 50 ml (4 x) EU/2/14/176/011 25 doses and 50 ml (6 x) EU/2/14/176/012 25 doses and 50 ml (10 x) EU/2/14/176/013 50 doses and 100 ml EU/2/14/176/014 50 doses and 100 ml (4 x) EU/2/14/176/015 50 doses and 100 ml (6 x) EU/2/14/176/016 50 doses and 100 ml (10 x)
Croatian: EU/2/14/176/005 10 doza i 20 ml EU/2/14/176/006 10 doza i 20 ml (4 x) EU/2/14/176/007 10 doza i 20 ml (6 x) EU/2/14/176/008 10 doza i 20 ml (10 x) EU/2/14/176/009 25 doza i 50 ml EU/2/14/176/010 25 doza i 50 ml (4 x) EU/2/14/176/011 25 doza i 50 ml (6 x) EU/2/14/176/012 25 doza i 50 ml (10 x) EU/2/14/176/013 50 doza i 100 ml EU/2/14/176/014 50 doza i 100 ml (4 x) EU/2/14/176/015 50 doza i 100 ml (6 x) EU/2/14/176/016 50 doza i 100 ml (10 x)
English: EU/2/14/176/001 5 doses and 10 ml EU/2/14/176/002 5 doses and 10 ml (4 x) EU/2/14/176/003 5 doses and 10 ml (6 x) EU/2/14/176/004 5 doses and 10 ml (10 x)
Croatian: EU/2/14/176/001 5 doza i 10 ml EU/2/14/176/002 5 doza i 10 ml (4 x) EU/2/14/176/003 5 doza i 10 ml (6 x) EU/2/14/176/004 5 doza i 10 ml (10 x)
English: Furthermore, a increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section “Adverse reactions”).
Croatian: Nadalje, porast rektalno mjerene tjelesne temperature često se javljao unutar 4 sata nakon primjene i spontano nestaje unutar 24 sata (vidjeti odjeljak “Nuspojave”).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box: 5 doses, 10 doses, 25 doses, 50 doses lyophilisate and 10 ml, 20 ml, 50 ml, 100 ml solvent
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija: 5 doza, 10 doza, 25 doza, 50 doza liofilizata i otapalo od 10 ml, 20 ml, 50 ml i 100 ml
English: Keep the lyophilisate and the solvent vials in the outer carton.
Croatian: Držati bočice liofilizata i otapala u vanjskom kartonu.
English: Sucrose
Croatian: Otapalo:
English: Bovela lyophilisate for suspension for injection for cattle
Croatian: Bovela liofilizat za suspenziju za injekciju za goveda
English: Mild swellings or nodules up to 3 cm diameter were observed at the injection site after administration of a 10-fold overdose and disappeared within 4 days post vaccination.
Croatian: Nakon primjene 10 puta veće doze opažena su blaga oticanja ili čvorići promjera do 3 cm na mjestu primjene injekcije, a nestali su unutar 4 dana poslije cijepljenja.
English: Intramuscular use.
Croatian: U mišić.
English: PACKAGE LEAFLET: Bovela lyophilisate and solvent for suspension for injection for cattle
Croatian: UPUTA O VMP: Bovela liofilizat i otapalo za suspenziju za injekciju za goveda
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Lyophilisate vials: 50 doses
Croatian: Bočice s liofilizatom: 50 doza
English: Pharmacotherapeutic group: immunologicals for bovidae, live viral vaccines.
Croatian: Farmakoterapijska grupa: imunološki proizvodi za goveda, živa virusna cjepiva ATCvet kod: QI02AD02
English: Keep the vials in the outer carton.
Croatian: Držati bočice u vanjskom kartonu.
English: Bovela lyophilisate and solvent for suspension for injection for cattle.
Croatian: Bovela liofilizat i otapalo za suspenziju za injekciju za goveda
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vials: 5 doses, 10 doses and 25 doses
Croatian: Bočice s liofilizatom: 5 doza, 10 doza i 25 doza
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE PROMET
English: Gelatine
Croatian: OBLIK
English: 1 lyophilisate vial of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 1 solvent bottle of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
Croatian: 1 bočica liofilizata od 10 ml (5 doza), 20 ml (10 doza), 50 ml (25 doza) ili 100 ml (50 doza) i 1 bočica otapala od 10 ml, 20 ml, 50 ml ili 100 ml pakirane u jednoj kartonskoj kutiji.
English: 6 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 6 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
Croatian: 6 bočica liofilizata od 10 ml (5 doza), 20 ml (10 doza), 50 ml (25 doza) ili 100 ml (50 doza) i 6 bočica otapala od 10 ml, 20 ml, 50 ml ili 100 ml pakiranih u jednoj kartonskoj kutiji.
English: 4 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 4 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
Croatian: 4 bočice liofilizata od 10 ml (5 doza), 20 ml (10 doza), 50 ml (25 doza) ili 100 ml (50 doza) i 4 bočice otapala od 10 ml, 20 ml, 50 ml ili 100 ml pakirane u jednoj kartonskoj kutiji.
English: 10 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 10 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
Croatian: 10 bočica liofilizata od 10 ml (5 doza), 20 ml (10 doza), 50 ml (25 doza) ili 100 ml (50 doza) i 10 bočica otapala od 10 ml, 20 ml, 50 ml ili 100 ml pakiranih u jednoj kartonskoj kutiji.
English: MA (EU) number (Invented) name
Croatian: (Novoizumljeno) ime
English: • dementia (loss of intellectual function).
Croatian: • demencije (gubitka intelektualne funkcije).
English: The medicine is used to help in the diagnosis of the following conditions in adults (aged 18 years or over):
Croatian: Lijek se primjenjuje kao pomoć u dijagnosticiranju sljedećih stanja u odraslih osoba (u dobi od 18 godina i starijih):
English: What is Striascan and what is it used for?
Croatian: Što je Striascan i za što se koristi?
English: Further information on Striascan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/striascan.
Croatian: Više informacija o lijeku Striascan dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/striascan.
English: Striascan is a diagnostic medicine.
Croatian: Striascan je dijagnostički lijek.
English: If this happens, the amount of Striascan attaching to these nerve cells is greatly reduced, which can be seen on the scan.
Croatian: Ako do toga dođe, količina lijeka Striascan koja se veže za te živčane stanice uvelike se smanjuje, što se može vidjeti na skenu.
English: A scan is taken 3 to 6 hours after the injection.
Croatian: Tri do šest sati nakon davanja injekcije snima se sken.
English: Resuscitation equipment should be available before Striascan is given, in case the patient has an allergic reaction.
Croatian: Oprema za oživljavanje treba biti dostupna prije davanja lijeka Striascan u slučaju da bolesnik doživi alergijsku reakciju.
English: • movement disorders such as those in Parkinson's disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles.
Croatian: • poremećaja kretanja poput onih u Parkinsonovoj bolesti i drugih srodnih bolesti, pri čemu gubitak živčanih stanica uzrokuje tremor (drhtanje), poremećaj hodanja (poteškoća s načinom hodanja bolesnika) i ukočenost mišića.
English: Between 1 to 4 hours before receiving Striascan, patients must also take another medicine, such as iodine tablets, to prevent the radioactive iodine in Striascan from getting into the thyroid gland.
Croatian: Između jednog do četiri sata prije primanja lijeka Striascan bolesnici moraju uzeti još jedan lijek, kao što su tablete koje sadrže jod, kako bi se spriječilo da radioaktivni jod iz lijeka Striascan dospije u štitnjaču.
English: Because tremor can also occur in ‘essential tremor' (tremor whose cause is unknown), Striascan can help distinguish between essential tremor and diseases related to Parkinson's disease;
Croatian: Budući da se tremor može javiti i kod „esencijalnog tremora” (tremor čiji je uzrok nepoznat), Striascan može pridonijeti razlikovanju između esencijalnog tremora i bolesti srodnih Parkinsonovoj bolesti;
English: What measures are being taken to ensure the safe and effective use of Striascan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Striascan?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Striascan has been shown to be comparable to DaTSCAN.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da je lijek Striascan usporediv s lijekom DaTSCAN.
English: Side effects reported with Striascan are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Striascan pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Striascan is given by slow injection lasting at least 15 to 20 seconds into an arm vein.
Croatian: Striascan se daje sporom injekcijom u venu na ruci u trajanju od najmanje 15 do 20 sekundi.
English: Striascan can only be obtained with a prescription and should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia.
Croatian: Striascan se izdaje samo na recept i treba ga primjenjivati samo u bolesnika koje je uputio liječnik s iskustvom u upravljanju poremećajima kretanja ili demencijom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Striascan have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Striascan nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Because Striascan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Striascan generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: An overview of Striascan and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Striascan i zašto je odobren u EU-u
English: Striascan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called DaTSCAN.
Croatian: To znači da Striascan sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom DaTSCAN.
English: Striascan is used to help distinguish between a type of dementia known as ‘dementia with Lewy bodies' and Alzheimer's disease.
Croatian: Striascan se primjenjuje radi boljeg razlikovanja između vrste demencije zvane „demencija Lewyjevih tjelešaca” i Alzheimerove bolesti.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, DaTSCAN, and do not need to be repeated for Striascan.
Croatian: Ispitivanja koristi i rizika od djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom DaTSCAN i stoga ih nije potrebno ponavljati za Striascan.
English: What are the benefits and risks of Striascan?
Croatian: Koje su koristi i rizici od lijeka Striascan?
English: There was no need for ‘bioequivalence' studies to investigate whether Striascan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Croatian: Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se lijek Striascan slično referentnom lijeku da bi postigao istu razinu djelatne tvari u krvi.
English: Other information about Striascan
Croatian: Ostale informacije o lijeku Striascan
English: It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.
Croatian: Koristi se za detekciju gubitka živčanih stanica u području mozga koje se naziva striatum, posebno stanica koje otpuštaju kemijski glasnik dopamin.
English: Ioflupane attaches specifically to structures on nerve cell endings that are responsible for the transport of dopamine.
Croatian: Ioflupan se posebno veže na strukture na završetcima živčanih stanica koje su odgovorne za prijenos dopamina.
English: This is because Striascan is given by injection into a vein, so the active substance is delivered straight into the bloodstream.
Croatian: To je zbog toga što se lijek Striascan daje injekcijom u venu te tako djelatna tvar dospijeva izravno u krvotok.
English: For more information about using Striascan, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Striascan pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.