FrancophonIA/ELRC3.0 huggingface dataset:
English: From the data provided, it appears that within the lincomycin-spectinomycin combination only lincomycin is active against the primary causal agent of swine dysentery, the anaerobic spirochete B. hyodysenteriae, which is intrinsically resistant to spectinomycin.
Slovenian: Iz predloženih podatkov se zdi, da v kombinaciji linkomicina in spektinomicina proti primarnemu povzročitelju prašičje dizenterije, anaerobni spiroheti B. hyodysenteriae, ki je naravno odporna proti spektinomicinu, učinkuje le linkomicin.
English: On the basis of in vitro tests, some have hypothesised that a metabolite or degradation product of spectinomycin was produced in the gut and was able to reach the infection site and interfere with E. coli adherence to the respiratory mucosa.
Slovenian: Na podlagi testov in vitro je bila postavljena hipoteza, da se v črevesu tvori presnovek ali produkt razgradnje spektinomicina, ki doseže mesto okužbe in ovira priraščanje E. coli na sluznico dihal.
English: 24192 León Spain
Slovenian: León-Vilecha, 30 24192 León Spain
English: The available clinical data show that the combination, administered in the drinking water at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days (i.e. the harmonised dose for Linco-Spectin 100), is clinically effective in treating mixed infections involving B. hyodysenteriae and other enteric pathogens targeted by spectinomycin, and that in those situations it is superior to the individual substances.
Slovenian: Klinični podatki, ki so na voljo, kažejo, da je kombinacija, dana v vodo za pitje, v odmerku 3,33 mg linkomicina in 6,67 mg spektinomicina na kilogram telesne mase na dan s časom zdravljenja 7 dni (tj. v usklajenem odmerku za zdravilo Linco-Spectin 100) klinično učinkovita pri zdravljenju mešanih okužb, ki vključujejo B. hyodysenteriae in druge enterične patogene, proti katerim je usmerjen spektinomicin, ter da v teh položajih kombinacija deluje bolje od posameznih snovi.
English: 2 under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs, the CVMP recommended the indication ‘swine dysentery caused by B. hyodysenteriae' to be deleted from the http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicinal_products_cont aining_tylosin_to_be_administered_orally_via_feed_or_the_drinking_water_to_pigs/vet_referral_000098.jsp&mid=WC0b01 ac05805c5170
Slovenian: 2 v skladu s členom 35 Direktive 2001/82/ES za http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicinal_products_cont aining_tylosin_to_be_administered_orally_via_feed_or_the_drinking_water_to_pigs/vet_referral_000098.jsp&mid=WC0b01 ac05805c5170
English: Kepro B.V. Maagdenburgstraat
Slovenian: Maagdenburgstraat
English: Pigs: 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days.
Slovenian: Prašiči: 3,33 mg linkomicina in 6,67 mg spektinomicina na kg telesne mase na dan s časom zdravljenja 7 dni.
English: PYANOSID, geriamieji milteliai g/146,36 g g/146,36 g
Slovenian: PYANOSID, geriamieji milteliai g/146,36 g g/146,36 g prašiči, perutnina (brojlerji, mlade kokoši) in purani
English: Most available clinical efficacy data relate to administration of the combination as powder for use in drinking water; those from the basis for the harmonised dosing regimen of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days for Linco-Spectin 100, as approved during the Article 34 referral procedure (EMEA/V/A/088).
Slovenian: Večina razpoložljivih podatkov o klinični učinkovitosti se nanaša na uporabo kombinacije v obliki praška za dajanje v vodo za pitje; ti so osnova za usklajeni režim odmerjanja 3,33 mg linkomicina in 6,67 mg spektinomicina na kilogram telesne mase na dan s časom zdravljenja 7 dni za zdravilo Linco-Spectin 100, kot je bilo odobreno med napotitvenim postopkov v skladu s členom 34 (EMEA/V/A/088).
English: 22.2 % w/w 44.4 % w/w
Slovenian: 22.2 % w/w 44.4 % w/w prašiči, piščanci
English: LINCOTRIMEX-PREMIX Lincomycin and Spectinomycin
Slovenian: LINCOTRIMEX-PREMIX linkomicin in spektinomicin
English: • the CVMP considered that the use of premixes for medicated feeding stuff containing a combination of lincomycin and spectinomycin is supported by inadequate clinical data and the currently recommended dosing regimens entails a higher risk of selection and development of resistance due to exposition to low antimicrobial levels for prolonged periods.
Slovenian: • odbor CVMP je menil, da uporaba predmešanic za zdravilno krmno mešanico, ki vsebujejo kombinacijo linkomicina in spektinomicina, ni podprta z ustreznimi kliničnimi podatki ter da je posledica trenutno priporočenih režimov odmerjanja višje tveganje za selekcijo in razvoj odpornosti zaradi izpostavljenosti nizkim ravnem protimikrobnih učinkovin v daljših časovnih obdobjih.
English: Powder for use in drinking water or milk
Slovenian: prašek za dajanje v vodo za pitje/mleko teleta, prašički, piščanci
English: Based primarily on the latter experimental study, it is considered that the indication relating to chicken chronic respiratory disease (CRD) caused by M. gallisepticum and E. coli and associated with a low mortality rate, and the associated dosing regimen of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days, as approved during the Article 34 referral procedure (EMEA/V/A/088) for Linco-Spectin 100, are justified as the only validated indication and dosage in chickens.
Slovenian: Predvsem na podlagi slednje poskusne študije velja, da sta indikacija v zvezi s kronično respiratorno boleznijo (KRB) piščancev, ki jo povzročata M. gallisepticum in E. coli ter je povezana z nizko stopnjo umrljivosti, in s tem povezani režim odmerjanja, ki znaša 16,65 mg linkomicina in 33,35 mg spektinomicina na kilogram telesne mase (50 mg kombiniranih zdravilnih učinkovin na kilogram telesne mase) na dan s časom zdravljenja sedem dni, kot je bilo odobreno v okviru napotitvenega postopka v skladu s členom 34 (EMEA/V/A/088) za zdravilo Linco-Spectin 100, upravičena kot edina potrjena indikacija in odmerjanje pri piščancih.
English: More generally, treatment with premixes for medicated feeding stuff and oral powders to be administered with the feed to pigs containing the combination lincomycinspectinomycin as currently recommended exposes the target pathogens and other bacteria to low doses for prolonged periods, which increases risk of resistance selection.
Slovenian: V splošnem zdravljenje prašičev s predmešanicami za zdravilno krmno mešanico in peroralnimi praški za dajanje v krmo, ki vsebujejo kombinacijo linkomicina in spektinomicina, kot je trenutno priporočeno, izpostavlja ciljne patogene in druge bakterije nizkim odmerkom za daljša časovna obdobja, zaradi česar se poveča tveganje za selekcijo odpornosti.
English: Indications, dosages and residue data in chickens
Slovenian: Indikacije, odmerki in podatki o ostankih pri piščancih
English: Linco-Spectin 22 + 22 Lincomycin and Spectinomycin
Slovenian: Linco-Spectin 22 + 22 linkomicin in spektinomicin
English: • the CVMP considered that the use of powders to be administered with the feed containing a combination of lincomycin and spectinomycin is not supported by data and the currently recommended dosing regimens entails a higher risk of selection and development of resistance due to exposition to low antimicrobial levels for prolonged periods.
Slovenian: • odbor CVMP je menil, da podatki ne podpirajo uporabe praškov za dajanje v krmo, ki vsebujejo kombinacijo linkomicina in spektinomicina, ter da je posledica trenutno priporočenih režimov odmerjanja višje tveganje za selekcijo in razvoj odpornosti zaradi izpostavljenosti nizkim ravnem protimikrobnih učinkovin v daljših časovnih obdobjih.
English: Zoetis France 23-25 Avenue du Docteur
Slovenian: Zoetis France 23-25 Avenue du Docteur Lannelongue 75014 Paris France
English: The residue data presented for powders for use in drinking water do not call into question the withdrawal periods approved for each product individually at the dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw/day, for 7 days.
Slovenian: Podatki o ostankih, predstavljeni za praške za dajanje v vodo za pitje, ne postavljajo pod vprašaj karenc, odobrenih za vsako zdravilo posamezno, v odmerku 16,65 mg linkomicina in 33,35 mg spektinomicina na kilogram telesne mase na dan s časom zdravljenja sedem dni.
English: Pigs, poultry
Slovenian: prašiči, perutnina
English: Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis, it has bacteriostatic activity and is active against Mycoplasma spp.
Slovenian: Spektinomicin je aminociklitolni antibiotik in je proizvod bakterije Streptomyces spectabilis; deluje bakteriostatično ter proti nekaterim vrstam rodu Mycoplasma spp.
English: Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria and mycoplasmas.
Slovenian: Linkomicin deluje proti po gramu pozitivnim bakterijam, nekaterim anaerobnim po gramu negativnim bakterijam in mikoplazmam.
English: In chickens, powders for use in drinking water containing a combination of lincomycin and spectinomycin at a dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days is considered effective in cases of CRD caused by M. gallisepticum and E. coli, and associated with a low mortality rate.
Slovenian: Pri piščancih praški za dajanje v vodo za pitje, ki vsebujejo kombinacijo linkomicina in spektinomicina v odmerku 16,65 mg linkomicina in 33,35 mg spektinomicina na kilogram telesne mase (50 mg kombiniranih zdravilnih učinkovin na kilogram telesne mase) na dan s časom zdravljenja 7 dni, veljajo za učinkovite v primerih KRB, ki jo povzročata M. gallisepticum in E. coli ter je povezana z nizko stopnjo umrljivosti.
English: The residue data presented for powders for use in drinking water do not call into question the withdrawal periods approved for each product individually at the dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days.
Slovenian: Podatki o ostankih, predstavljeni za praške za dajanje v vodo za pitje, ne postavljajo pod vprašaj karenc, odobrenih za vsako zdravilo posamezno, v odmerku 3,33 mg linkomicina in 6,67 mg spektinomicina na kilogram telesne mase na dan s časom zdravljenja sedem dni.
English: Chickens: 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw/day, for 7 days.
Slovenian: Piščanci: 16,65 mg linkomicina in 33,35 mg spektinomicina na kg telesne mase na dan s časom zdravljenja 7 dni.
English: Concerning powders for use in drinking water containing a combination of lincomycin and spectinomycin to be administered orally to pigs at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw (10 mg combined actives/kg bw) per day for 7 days is considered effective in cases of porcine proliferative enteropathy caused by L. intracellularis, and possible associated pathogens among which is E. coli.
Slovenian: Praški za dajanje v vodo za pitje, ki vsebujejo kombinacijo linkomicina in spektinomicina ter se prašičem dajejo peroralno v odmerku 3,33 mg linkomicina in 6,67 mg spektinomicina na kg telesne mase (10 mg kombiniranih zdravilnih učinkovin na kilogram telesne mase) na dan s časom zdravljenja 7 dni, veljajo za učinkovite v primerih prašičje proliferativne enteropatije, ki jo povzročajo L. intracellularis in potencialni sorodni patogeni, med katerimi je E. coli.
English: Linco-Spectin 44 Premix Lincomycin and Spectinomycin
Slovenian: Linco-Spectin 44 Premix linkomicin in spektinomicin
English: It has little or no action against gram-negative bacteria such as Escherichia coli.
Slovenian: Na po gramu negativne bakterije, kot je Escherichia coli, deluje šibko ali ne deluje.
English: 200 Avenue de Mayenne Zone Industrielle des Touches 53000 Laval France
Slovenian: 200 Avenue de Mayenne
English: Pigs, hens pigeons, ducks, turkeys
Slovenian: prašiči, kokoši, golobi, race, purani
English: The typical dosing regimen in these studies comprises a first phase at about 150 mg combined actives/kg bw/day and a second phase at about 50 mg combined actives/kg bw/day.
Slovenian: Običajni režim odmerjanja je bil v teh študijah sestavljen iz prve faze s približno 150 mg kombiniranih zdravilnih učinkovin na kilogram telesne mase na dan in druge faze s približno 50 mg kombiniranih zdravilnih učinkovin na kilogram telesne mase na dan. Verjetno je bilo zdravilo na začetku razvito in uporabljeno na isti način kot pospeševalec rasti ter za preprečevanje umrljivosti in izgube pri rezultatih.
English: Therefore, based on the activity spectrum of the combination, on general considerations of the pathogenesis of porcine proliferative enteropathy and on the available clinical data, it is considered that the indication for the treatment and prevention of porcine proliferative enteropathy (ileitis) caused by L. intracellularis, and associated enteric pathogens (E. coli) at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days in drinking water, approved during the Article 34 referral procedure (EMEA/V/A/088) for Linco-Spectin 100, is justified.
Slovenian: Zato na podlagi spektra delovanja kombinacije, ob splošnih premislekih o patogenezi prašičje proliferativne enteropatije in glede na razpoložljive klinične podatke velja, da je indikacija za zdravljenje in preprečevanje prašičje proliferativne enteropatije (ileitisa), ki jo povzročajo L. intracellularis in sorodni enterični patogeni (E. coli), v odmerku 3,33 mg linkomicina in 6,67 mg
English: Linco-spectin 222/444,7 mg/g prášek pro podání v pitné vodě pro prasata a kura domácího
Slovenian: Linco-spectin 222/444,7 mg/g prášek pro podání v pitné vodě pro prasata a kura domácího prašiči, piščanci
English: Linco-Spectin 222 mg/g + 444,7 mg/g - Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner
Slovenian: Linco-Spectin 222 mg/g + 444,7 mg/g - Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner prašiči, piščanci
English: Linco-Spectin 100, 222/444,7 mg/g milteliai, skirti naudoti su geriamuoju vandeniu kiaulėms ir vištoms
Slovenian: Linco-Spectin 100, 222/444,7 mg/g milteliai, skirti naudoti su geriamuoju vandeniu kiaulėms ir vištoms prašiči, perutnina
English: This study showed that, overall, the lincomycin-spectinomycin combination significantly improved the tested clinical, pathological and bacteriological endpoints in an experimental model of aerosol infection, at a dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days.
Slovenian: Ta študija je dokazala, da je kombinacija linkomicina in spektinomicina v odmerku 16,65 mg linkomicina in 33,35 mg spektinomicina na kg telesne mase (50 mg kombiniranih zdravilnih učinkovin na kilogram telesne mase) na dan s časom zdravljenja sedem dni v splošnem pomembno izboljšala preskušane klinične, patološke in bakteriološke končne točke v poskusnem modelu okužbe z aerosoli.
English: Powder to be administered with the feed
Slovenian: prašek za dajanje v krmo
English: 222 mg 444,7 mg
Slovenian: 222 mg 444,7 mg prašiči, piščanci
English: Pigs, chickens
Slovenian: prašiči, piščanci
English: 222 mg 444 mg
Slovenian: 222 mg 444 mg prašiči, piščanci
English: Linco-Spectin 100, 222 + 444,7 mg/g pó para administração na água de bebida para suínos e galinhas
Slovenian: Linco-Spectin 100, 222 + 444,7 mg/g pó para administração na água de bebida para suínos e galinhas prašiči, piščanci
English: Very limited data or no data were provided to support the use of premixes for medicated feeding stuff and oral powders to be administered with the feed containing lincomycin and spectinomycin.
Slovenian: V podporo uporabi predmešanic za zdravilno krmno mešanico in peroralnih praškov za dajanje v krmo, ki vsebujejo linkomicin in spektinomicin, so bili predloženi zelo omejeni podatki ali pa jih sploh ni bilo.
English: Piglets, calves, chickens
Slovenian: Micospectone prašički, teleta, piščanci
English: Linco-Spectin 100, 222/444.7 mg/g Powder for Use in Drinking Water for Pigs and Chickens
Slovenian: Linco-Spectin 100, 222/444.7 mg/g Powder for use in drinking water for pigs and chickens prašiči, piščanci
English: Linco-Spectin 100, 222/444.7 mg/g Powder for use in drinking water for pigs and chickens
Slovenian: Linco-Spectin 100, 222/444.7 mg/g Powder for Use in Drinking Water for Pigs and Chickens prašiči, piščanci
English: Zavet
Slovenian: Zavet Bulgaria
English: Calves, piglets, chickens
Slovenian: Pyanosid Pulver prašiči, piščanci
English: End of February
Slovenian: Konec februarja
English: The mechanism of action is multifactorial.
Slovenian: Mehanizem delovanja je multifaktorski.
English: However, the clinical relevance of these findings is unknown.
Slovenian: Vendar klinična pomembnost teh ugotovitev ni znana.
English: Updated analysis from CIBMTR to be submitted by end of December 2020.
Slovenian: CIBMTR je treba predložiti do konca decembra 2020.
English: # median (min-max)
Slovenian: # mediana (min-maks)
English: However, the exact mechanism of action of defibrotide is not fully elucidated.
Slovenian: Vendar natančni mehanizem delovanja defibrotida ni popolnoma pojasnjen.
English: You will receive this treatment four times a day for at least 21 days or until your symptoms resolve.
Slovenian: To zdravljenje boste prejemali štirikrat na dan vsaj 21 dni ali dokler simptomi ne izginejo.
English: Absorption and Distribution
Slovenian: Absorpcija in porazdelitev
English: Almost all renal excretion occurs within the first 4 hours.
Slovenian: Skoraj vse izločanje skozi ledvice nastopi v prvih 4 urah.
English: This can be caused by medicines that are given prior to a stem cell transplantation.
Slovenian: To lahko povzročijo zdravila, ki se dajejo pred presaditvijo matičnih celic.
English: Individual Studies
Slovenian: Posamezne študije
English: Safety information in children are available from the prevention study conducted solely in children.
Slovenian: Varnostni podatki pri otrocih so na voljo iz preventivne študije, ki so jo opravili samo pri otrocih.
English: At an interim analysis of the on-going registry, data from 96 patients with severe VOD were available.
Slovenian: Pri vmesni analizi potekajočega registra so bili na voljo podatki za 96 bolnikov s hudo VOB.
English: Summary of the Safety Profile
Slovenian: Povzetek varnostnega profila
English: It will be slowly injected (over a 2-hour period) into one of your veins.
Slovenian: Počasi vam ga bodo injicirali (v 2 urah) v eno od ven.
English: Data derived from an independent US registry have shown a beneficial effect of Defitelio in routine clinical practice.
Slovenian: Podatki iz neodvisnega registra ZDA so pokazali koristen učinek zdravila Defitelio v rutinski klinični praksi.
English: Historical Control
Slovenian: Zgodovinska kontrola
English: As you will be given this medicine by a doctor or a nurse it is unlikely that a dose will be missed.
Slovenian: Ker vam bo to zdravilo dajal zdravnik ali medicinska sestra, ni verjetno, da bi bil odmerek izpuščen.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded in the patient file.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba ime in številko serije uporabljenega zdravila jasno zapisati v bolnikovo kartoteko.
English: • if you have problems with blood circulation because your body cannot maintain a constant blood pressure.
Slovenian: • če imate težave s krvnim obtokom, ker telo ni zmožno vzdrževati stalnega krvnega tlaka.
English: This is called an ‘intravenous infusion' or drip.
Slovenian: To se imenuje »intravensko infundiranje« ali infuzija.
English: Measure 1
Slovenian: Ukrep 1
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/878/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/878/001
English: In the treatment studies over 50% of the patients were children.
Slovenian: V študijah zdravljenja je bilo več kot 50 % bolnikov otrok.
English: This leaflet was last revised in:
Slovenian: Navodilo je bilo nazadnje revidirano dne :
English: However there was no difference in incidence of serious bleeding or bleeding events with fatal outcome.
Slovenian: Vendar pa ni bilo razlike v pojavnosti resnih dogodkov krvavitve ali krvavitve s smrtnim izidom.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000).
English: Table 1: Treatment Study Results: Complete Response and Survival Rate of Severe VOD at Day+100
Slovenian: Preglednica 1: Rezultati študije zdravljenja: popoln odziv in stopnja preživetja pri hudi VOB po 100.+ dnevu
English: • if you are using other medicines to break down blood clots such as tissue plasminogen activator
Slovenian: • če uporabljate druga zdravila za razgrajevanje krvnih strdkov, kot je tkivni aktivator plazminogena.
English: Date of latest renewal: 26 July 2018
Slovenian: Datum prve odobritve: 18. oktober 2013 Datum zadnjega podaljšanja: 26. julija 2018
English: • if you are allergic to defibrotide or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na defibrotid ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: • severe allergic reaction (you might experience swelling of the hands, face, lips, tongue or throat,
Slovenian: • huda alergijska reakcija (pojavita se lahko otekanje dlani, obraza, ustnic, jezika ali grla in oteženo dihanje).
English: If particles are observed and/or the liquid in the vial is not clear, the vial must not be used.
Slovenian: Če opazite delce in/ali tekočina v viali ni bistra, viale ne smete uporabiti.
English: • if you are taking medicine that increases the risk of bleeding
Slovenian: • če jemljete zdravila, ki povečujejo tveganje za krvavitev;
English: If you are sexually active and you or your partner could become pregnant, you both must use effective contraception during treatment with Defitelio and for 1 week after stopping the treatment.
Slovenian: Če ste spolno dejavni in lahko vi ali vaša partnerka zanosite, morata oba uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Defitelio in 1 teden po prekinitvi zdravljenja.
English: Considering the nature of the medicinal product, a risk to the newborns/infants is not expected.
Slovenian: Glede na naravo zdravila tveganja za novorojenčke/dojenčke ni pričakovati.
English: The report will also reflect on the safety data being collected during prophylactic treatment, and any potential safety differences related to the difference in indication (ie treatment vs prophylactic therapy).
Slovenian: Poročilo bo odražalo tudi podatke o varnosti, ki se zbirajo med profilaktičnim zdravljenjem, in morebitne razlike v varnosti, povezane z razliko v indikaciji (npr. pri zdravljenju v primerjavi s profilaktičnim zdravljenjem).
English: Additional information is shown in the following Table 2.
Slovenian: Dodatni podatki so prikazani v spodnji preglednici 2.
English: PAI-2 is known to be uniquely up-regulated in the placenta.
Slovenian: Znano je, da se raven zaviralca PAI-2 edinstveno viša v placenti.
English: 4.5 Interaction with other medicinal products and other forms of interaction Potential interactions with recombinant t-PA
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Morebitne interakcije z rekombinantnim t-PA
English: The recommended dose in children from one month to 18 years of age is the same as in adults.
Slovenian: Priporočeni odmerek pri otrocih, starih od enega meseca do 18 let, je enak kot pri odraslih.
English: No special precautions are indicated.
Slovenian: Potrebni niso nobeni posebni previdnostni ukrepi.
English: In each of the clinical trials performed in the treatment of VOD, over 50% of patients were under the age of 18 years.
Slovenian: V vseh kliničnih preskušanjih, opravljenih pri zdravljenju VOB, je bilo več kot 50 % bolnikov starih manj kot 18 let.