FrancophonIA/ELRC3.0 huggingface dataset:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:
English: Efficacy of the treatment against flea and tick infestations lasts for one month.
Croatian: Proizvod je učinkovit u liječenju invazije buha i krpelja u trajanju od jednog mjeseca nakon primjene.
English: A single treatment is effective for gastrointestinal worms.
Croatian: Jedna primjena proizvoda učinkovita je u liječenju invazije gastrointestinalnih crva.
English: Fleas and ticks need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of vector-borne diseases cannot be excluded.
Croatian: Buhe i krpelji moraju započeti hranjenje na domaćinu da budu izloženi djelovanju afoksolanera, stoga se rizik od prijenosa bolesti koje prenose vektori ne može u potpunosti isključiti.
English: Vomiting, diarrhoea, lethargy, anorexia, and pruritus were uncommonly observed.
Croatian: Povraćanje, proljev, letargija, anoreksija i pruritus nisu često zamijećeni.
English: At the discretion of the veterinarian, infested dogs should be treated with an adulticide to remove adult heartworms.
Croatian: Prema procjeni veterinara, psi koji imaju invaziju srčanog crva trebaju se liječiti adulticidom kako bi se odrasle jedinke uklonile.
English: The frequency of adverse reactions is defined using the following convention: - 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: Fleas and ticks need to start feeding on the host to become exposed to the substance afoxolaner; therefore the risk of the transmission of diseases by fleas and ticks cannot be excluded.
Croatian: Buhe i krpelji moraju započeti hranjenje na domaćinu da budu izloženi djelovanju djelatne tvari afoksolanera, stoga se rizik od prijenosa bolesti koje prenose buhe i krpelji ne može u potpunosti isključiti.
English: Each chewable tablet contains 9.375 mg afoxolaner and 1.875 mg milbemycin oxime Each chewable tablet contains 18.75 mg afoxolaner and 3.75 mg milbemycin oxime Each chewable tablet contains 37.5 mg afoxolaner and 7.5 mg milbemycin oxime Each chewable tablet contains 75 mg afoxolaner and 15 mg milbemycin oxime Each chewable tablet contains 150 mg afoxolaner and 30 mg milbemycin oxime
Croatian: Svaka žvakaća tableta sadrži 9,375 mg afoxolaner i 1,875 mg milbemycin oxime Svaka žvakaća tableta sadrži 18,75 mg afoxolaner i 3,75 mg milbemycin oxime Svaka žvakaća tableta sadrži 37,5 mg afoxolaner i 7,5 mg milbemycin oxime Svaka žvakaća tableta sadrži 75 mg afoxolaner i 15 mg milbemycin oxime Svaka žvakaća tableta sadrži 150 mg afoxolaner i 30 mg milbemycin oxime
English: When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with NEXGARD SPECTRA should start on the date when the former medication was due to have been administered.
Croatian: U slučaju da se umjesto nekog drugog proizvoda za prevenciju bolesti srčanog crva počne koristiti NEXGARD SPECTRA, prva aplikacija treba uslijediti na datum kada bi trebalo primijeniti prijašnji proizvod.
English: Prevention of thelaziosis:
Croatian: Prevencija telazioze:
English: In regions where heartworm disease is present, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA.
Croatian: U područjima gdje je bolest srčanog crva prisutna pse treba testirati na postojanje invazije srčanim crvom prije nego što se NEXGARD SPECTRA primjeni.
English: NEXGARD SPECTRA can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a monovalent flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infestations.
Croatian: NEXGARD SPECTRA može se koristiti kao dio sezonskog programa liječenja invazije buha i krpelja (umjesto liječenja proizvodom za zaštitu isključivo od buha i krpelja) u pasa koji istovremeno imaju dijagnosticiranu invaziju gastrointestinalnih nematoda.
English: Prevention of heartworm disease:
Croatian: Prevencija bolesti srčanog crva:
English: Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs for 4 weeks.
Croatian: Liječenje invazije krpelja (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) u pasa tijekom 4 tjedana.
English: NEXGARD SPECTRA can be used as part of the seasonal treatment of fleas and ticks (replacing a product authorised for the treatment of fleas/ticks only) in dogs with diagnosed concurrent gastrointestinal worm infestations.
Croatian: NEXGARD SPECTRA može se koristiti kao dio sezonskog programa liječenja invazije buha i krpelja (umjesto proizvoda za liječenje invazije isključivo buha ili krpelja) u pasa koji istovremeno imaju dijagnosticiranu invaziju gastrointestinalnih crva.
English: Dogs living in heartworm endemic areas, or those which have travelled to endemic areas, may be infested with adult heartworms.
Croatian: Psi koji žive u područjima koja su endemična za bolest srčanog crva ili oni koji su boravili u endemičnim područjima mogu imati ovog parazita.
English: Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration.
Croatian: Prevencija bolesti srčanog crva (Dirofilaria immitis larve), mjesečnom primjenom.
English: Dogs 2-3.5 kg Dogs >3.5-7.5 kg Dogs >7.5-15 kg Dogs >15-30 kg Dogs >30-60 kg
Croatian: Psi 2-3,5 kg Psi >3,5-7,5 kg Psi >7,5-15 kg Psi >15-30 kg Psi >30-60 kg
English: Ancylostoma ceylanicum is reported as being endemic only in Southeast Asia, China, India, Japan, some Pacific islands, Australia, the Arab Peninsula, South Africa and South America.
Croatian: Ancylostoma ceylanicum je prijavljena kao endemična pojava samo u jugoistočnoj Aziji, Kini, Indiji,
English: The systemic absorption of afoxolaner is high.
Croatian: Afoksolaner ima visoku sustavnu apsorpciju.
English: In heartworm endemic areas, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA.
Croatian: U endemičnim područjima za bolest srčanog crva pse treba testirati na postojanje invazije srčanim crvom prije nego što se NEXGARD SPECTRA primjeni.
English: Milbemycin oxime increases glutamate binding with consequent enhanced chloride ion flow into the cell.
Croatian: Povećava vezanje glutamata sa posljedičnim povećanim protokom iona klorida u stanicu.
English: Post-marketing safety experience
Croatian: Iskustva nakon puštanja lijeka u promet
English: Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration.
Croatian: Prevencija nastanka telazioze (odrasli oblik Thelazia callipaeda, infestacija očnim crvom), mjesečnom primjenom.
English: It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus, Ixodes hexagonus and I. scapularis, Amblyomma americanum and Haemaphysalis longicornis.
Croatian: Djeluje protiv odraslih buha te protiv nekoliko vrsta krpelja poput Rhipicephalus sanguineus, Dermacentor reticulatus i D. variabilis, Ixodes ricinus, Ixodes hexagonus i I. scapularis, Amblyomma americanum i Haemaphysalis longicornis.
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-3.5 kg) or rectangular shaped (tablets for dogs >3.5-7.5 kg, tablets for dogs >7.5-15 kg, tablets for dogs >15-30 kg and tablets for dogs >30-60 kg).
Croatian: Išarane crvenkaste do crvenkasto smeđe, kružnog (tablete za pse 2-3,5 kg) ili pravokutnog oblika (tablete za pse >3,5-7,5 kg, tablete za pse >7,5-15 kg, tablete za pse >15-30 kg i tablete za pse >30-60 kg).
English: It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, and Haemaphysalis longicornis.
Croatian: Afoksolaner djeluje protiv odraslih buha te protiv nekoliko vrsta krpelja poput Rhipicephalus sanguineus, Dermacentor reticulatus i D. variabilis, Ixodes ricinus i I. scapularis, Amblyomma americanum i Haemaphysalis longicornis.
English: Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum) with monthly administration.
Croatian: Sprečavanje angiostrongiloze (zahvaljujući smanjenju razine invazije s nezrelim odraslim oblicima (L5) i odraslim crvima Angiostrongylus vasorum) kroz mjesečnu primjenu.
English: Milbemycin oxime acts by disrupting the glutamate neuro-transmission in invertebrates.
Croatian: Milbemicin oksim djeluje na način da ometa neurotransmisiju reguliranu glutamatima kod beskralježnjaka.
English: Monthly administration of the product prevents establishment of infection with adult Thelazia callipaeda eyeworm.
Croatian: Mjesečna primjena ovog veterinarsko-medicinskog proizvoda sprečava nastanak infestacije odraslim oblikom očnog crva Thelazia callipaeda.
English: Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs.
Croatian: Liječenje invazije krpelja (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) u pasa.
English: In endemic areas, monthly administration of the product will reduce the level of infection with immature adults (L5) and adults of Angiostrongylus vasorum in the heart and lungs.
Croatian: U endemičnim područjima mjesečna primjena ovog veterinarsko medicinskog proizvoda smanjit će razinu invazije srca i pluća nezrelim odraslim oblicima (L5) i odraslim crvima Angiostrongylus vasorum.
English: After treatment of the nematode infestations, further flea and tick treatment should be continued with a monovalent product.
Croatian: Jedna primjena proizvoda učinkovita je u liječenju invazije nematoda, daljnje liječenje invazije buha i krpelja treba se odraditi proizvodom za zaštitu od buha i krpelja.
English: For each strength, the chewable tablets are available in the following pack sizes: Carton with 1 thermoformed blister containing 1, 3 or 6 chewable tablets or 15 thermoformed blisters containing 1 chewable tablet.
Croatian: Kutija s 1 termoformiranim blisterom s 1, 3 ili 6 tableta za žvakanje ili 15 termoformiranih blistera s 1 tabletom za žvakanje.
English: Milbemycin oxime is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and heartworm (Dirofilaria immitis larvae).
Croatian: Milbemicin oksim djeluje protiv nekolicine gastrointestinalnih nematoda (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), odraslih oblika i nezrelih odraslih oblika (L5) plućnog nematoda Angiostrongylus vasorum i srčanog crva (Dirofilaria immitis larve).
English: It is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and larvae of the heartworm Dirofilaria immitis.
Croatian: Djeluje protiv nekolicine gastrointestinalnih crva (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis) te protiv odraslih oblika i nezrelih odraslih oblika (L5) plućnog nematoda Angiostrongylus vasorum i larvi srčanog crva Dirofilaria immitis.
English: Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense and Ancylostoma ceylanicum) and whipworm (Trichuris vulpis).
Croatian: Liječenje invazije odraslih gastrointestinalnih nematoda sljedećih vrsta: oblići (Toxocara canis i Toxascaris leonina), kukičasti crvi (Ancylostoma caninum, Ancylostoma braziliense i Ancylostoma ceylanicum) i bičasti crv (Trichuris vulpis).
English: Manufacturer responsible for batch release: MERIAL,
Croatian: Proizvođač odgovoran za puštanje serije u promet:
English: Only negative animals should be treated.
Croatian: Samo negativnim jedinkama može se primijeniti ovaj veterinarsko-medicinski proizvod.
English: EU/2/14/177/007 - 38 mg/ 8 mg, 1 chewable tablet EU/2/14/177/008 - 38 mg/ 8 mg, 3 chewable tablets EU/2/14/177/009 - 38 mg/ 8 mg, 6 chewable tablets EU/2/14/177/018 - 38 mg/ 8 mg, 15 chewable tablets EU/2/14/177/010 - 75 mg/ 15 mg, 1 chewable tablet EU/2/14/177/011 - 75 mg/ 15 mg, 3 chewable tablets EU/2/14/177/012 - 75 mg/ 15 mg, 6 chewable tablets EU/2/14/177/019 - 75 mg/ 15 mg, 15 chewable tablets EU/2/14/177/013 -150 mg/ 30 mg, 1 chewable tablet EU/2/14/177/014 -150 mg/ 30 mg, 3 chewable tablets EU/2/14/177/015 -150 mg/ 30 mg, 6 chewable tablets EU/2/14/177/020 -150 mg/ 30 mg, 15 chewable tablets
Croatian: EU/2/14/177/001 - 9 mg/ 2 mg, 1 tableta za žvakanje EU/2/14/177/002 - 9 mg/ 2 mg, 3 tablete za žvakanje EU/2/14/177/003 - 9 mg/ 2 mg, 6 tableta za žvakanje EU/2/14/177/016 - 9 mg/ 2 mg, 15 tableta za žvakanje EU/2/14/177/004 - 19 mg/ 4 mg, 1 tableta za žvakanje EU/2/14/177/005 - 19 mg/ 4 mg, 3 tablete za žvakanje EU/2/14/177/006 - 19 mg/ 4 mg, 6 tableta za žvakanje EU/2/14/177/017 - 19 mg/ 4 mg, 15 tableta za žvakanje EU/2/14/177/007 - 38 mg/ 8 mg, 1 tableta za žvakanje EU/2/14/177/008 - 38 mg/ 8 mg, 3 tablete za žvakanje EU/2/14/177/009 - 38 mg/ 8 mg, 6 tableta za žvakanje EU/2/14/177/018 - 38 mg/ 8 mg, 15 tableta za žvakanje EU/2/14/177/010 - 75 mg/ 15 mg, 1 tableta za žvakanje EU/2/14/177/011 - 75 mg/ 15 mg, 3 tablete za žvakanje EU/2/14/177/012 - 75 mg/ 15 mg, 6 tableta za žvakanje EU/2/14/177/019 - 75 mg/ 15 mg, 15 tableta za žvakanje EU/2/14/177/013 -150 mg/ 30 mg, 1 tableta za žvakanje EU/2/14/177/014 -150 mg/ 30 mg, 3 tablete za žvakanje EU/2/14/177/015 -150 mg/ 30 mg, 6 tableta za žvakanje EU/2/14/177/020 -150 mg/ 30 mg, 15 tableta za žvakanje
English: Each chewable tablet contains the active substances:
Croatian: Svaka tableta za žvakanje sadrži djelatne tvari: NEXGARD SPECTRA
English: Ancylostoma ceylanicum is reported as being endemic only in South-East Asia, China, India, Japan, some Pacific islands, Australia, the Arab Peninsula, South Africa and South America.
Croatian: Japanu, nekim otocima u Tihom oceanu, Australiji, na Arapskom poluotoku te u Južnoj Africi i Južnoj Americi.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornog<ih> za puštanje serije u promet
English: NEXGARD SPECTRA 9 mg/ 2 mg dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg dogs >30-60 kg afoxolaner / milbemycin oxime Tablets
Croatian: NEXGARD SPECTRA 9 mg/ 2 mg psi 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg psi >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg psi >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg psi >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg psi >30-60 kg afoxolaner / milbemycin oxime Tablete
English: Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis):
Croatian: Liječenje demodikoze (uzrokovane s Demodex canis) Liječenje Sarcoptes-šuge (uzrokovane sa Sarcoptes scabiei var. canis) Prevencija bolesti srčanog crva (Dirofilaria immitis larve) kroz mjesečnu primjenu.
English: NEXGARD SPECTRA 9 mg/ 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg chewable tablets for dogs >30-60 kg afoxolaner / milbemycin oxime
Croatian: NEXGARD SPECTRA 9 mg/ 2 mg tableta za žvakanje za pse 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tableta za žvakanje za pse >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tableta za žvakanje za pse >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tableta za žvakanje za pse >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tableta za žvakanje za pse >30-60 kg afoxolaner / milbemycin oxime
English: PACKAGE LEAFLET: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg
Croatian: UPUTA O VMP: NEXGARD SPECTRA 9 mg/ 2 mg tablete za žvakanje za pse 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tablete za žvakanje za pse >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tablete za žvakanje za pse >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tablete za žvakanje za pse >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tablete za žvakanje za pse >30-60 kg
English: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg
Croatian: NEXGARD SPECTRA 9 mg/ 2 mg tablete za žvakanje za pse 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tablete za žvakanje za pse >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tablete za žvakanje za pse >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tablete za žvakanje za pse >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tablete za žvakanje za pse >30-60 kg
English: It will be given to you once every 2 weeks.
Croatian: Primit ćete je jedanput svaka 2 tjedna.
English: ATC code: A16AB07.
Croatian: ATK oznaka: A16AB07.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNA UPOZORENJE(A), AKO JE POTREBNO
English: The results are shown in Table 4.
Croatian: Rezultati su prikazani u Tablici 4.
English: The dose you receive is based on your body weight.
Croatian: Doza koju ćete primiti ovisi o Vašoj tjelesnoj težini.
English: Evaluation of motor function gave disparate results.
Croatian: Procjena motoričkih funkcija dala je različite rezultate.
English: However, motor and respiratory responses to treatment have been more variable.
Croatian: Međutim, motorički i respiratorni odgovori na liječenje bili su varijabilniji.
English: The t½ of approximately 2-3 hours was also similar in this group of patients.
Croatian: Vrijednost t½ od oko 2-3 sata također je bila slična u toj skupini bolesnika.
English: Patient data will be anonymously collected in this Registry.
Croatian: U tom će se registru podaci o bolesnicima prikupljati anonimno.
English: An infusionassociated reaction can sometimes be very severe.
Croatian: Reakcija povezana s infuzijom katkad može biti vrlo teška.
English: No interactions studies have been performed.
Croatian: Nisu provedena ispitivanja interakcija.
English: Cmax (µg/ml) AUC∞ (µg•h/ml) CL (ml/h/kg) Vss (ml/kg) Effective half-life (h)
Croatian: Cmax (µg/ml) AUC∞ (µg•h/ml) CL (ml/h/kg) Vss (ml/kg) Efektivni poluvijek (h)
English: The total time between reconstitution and completion of the infusion should not exceed 24 hours.
Croatian: Između rekonstitucije i završetka infuzije ne smije proteći više od 24 sata.
English: Wilcoxon-Mann-Whitney Test p-value
Croatian: Wilcoxon-Mann-Whitney test p-vrijednost
English: One additional patient died after study end and another one after withdrawal from the study.
Croatian: Jedan je dodatni bolesnik umro po završetku ispitivanja, a još jedan nakon povlačenja iz ispitivanja.
English: Patient response to treatment should be routinely evaluated based on a comprehensive evaluation of all clinical manifestations of the disease.
Croatian: Odgovor bolesnika na liječenje treba rutinski procjenjivati na temelju sveobuhvatne procjene svih kliničkih manifestacija bolesti.
English: Some reactions were severe (see section 4.8).
Croatian: Neke od tih reakcija bile su teške (vidjeti dio 4.8).
English: Patients improved following treatment interruption.
Croatian: Bolesnicima se stanje popravilo nakon prekida liječenja.
English: Reactions generally occurred shortly after initiation of the infusion.
Croatian: Reakcije su se obično javile ubrzo nakon početka infuzije.
English: The majority of these reactions were non-serious, mild to moderate in intensity and resolved spontaneously.
Croatian: Većina tih reakcija nije bila ozbiljna, bila je blagog do umjerenog intenziteta i spontano se povukla.
English: What Myozyme is and what it is used for
Croatian: Što je Myozyme i za što se koristi
English: Date of first authorisation: 29 March 2006 Date of latest renewal: 29 March 2011
Croatian: Datum prvog odobrenja: 29. ožujka 2006.
English: • Chest pain (not in the heart)
Croatian: • bol u prsnom košu (ne u srcu)
English: Manufacturer Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Croatian: Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
English: Two patients died and did not enter into the extension study.
Croatian: Dva su bolesnika umrla te nisu bila uključena u produžetak ispitivanja.
English: The 9 remaining patients either died (5 patients) or became invasive-ventilator dependent (4 patients).
Croatian: Preostalih 9 bolesnika je ili umrlo (5 bolesnika) ili postalo ovisno o invazivnoj mehaničkoj ventilaciji (4 bolesnika).
English: Other medicines and Myozyme
Croatian: Drugi lijekovi i Myozyme
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity.
Croatian: Neklinički podaci ne ukazuju na posebnu opasnost za ljude na temelju konvencionalnih ispitivanja farmakološke sigurnosti, toksičnosti pojedinačne ili ponovljenih doze.
English: Change from Baseline to Week 78/Last Observation*
Croatian: Promjena od početnih vrijednosti do 78. tjedna /posljednje opažanje*
English: Median Week 78/Last Observation Mean ± s.d.
Croatian: 78. tjedan/posljednje opažanje prosjek ± s.d. medijan
English: Kaplan-Meier survival rates at 12, 24 and 36 months of age were 26%, 9% and 7%, respectively.
Croatian: Stope preživljenja po Kaplan-Meieru u dobi od 12, 24 odnosno 36 mjeseci iznosile su 26%, 9% odnosno 7%.
English: • Increased or high blood pressure
Croatian: • povišen ili visok krvni tlak
English: Contents of the pack and other information What Myozyme contains
Croatian: Sadržaj pakiranja i druge informacije Što Myozyme sadrži
English: Each pack contains 1, 10 or 25 vials.
Croatian: Jedno pakiranje sadrži 1, 10 ili 25 bočica.
English: • Temporary suspension or sudden cessation of breathing
Croatian: • privremeni prekid ili nagli prestanak disanja
English: • polysorbate 80 (E433).
Croatian: • polisorbat 80 (E433).
English: *Human acid α-glucosidase is produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology.
Croatian: *Ljudska kisela α-glukozidaza proizvodi se na jajnim stanicama kineskog hrčka (CHO) tehnologijom rekombinantne DNK.
English: Use aseptic technique
Croatian: Primijenite aseptičku tehniku
English: Remove airspace within the infusion bag.
Croatian: Uklonite zrak iz infuzijske vrećice.
English: Mean ± s.d Median
Croatian: prosjek ± s.d. medijan
English: It was demonstrated that the use of a 0.2 micron in-line filter removes visible particles and does not result in an apparent loss of protein or activity.
Croatian: Pokazalo se da se uporabom ”in-line” filtra od 0,2 μm uklanjaju vidljive čestice, ali pritom ne dolazi do gubitka proteina ili aktivnosti.