FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION PROCYSBI 25 mg hard capsule
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA PROCYSBI 25 mg trda kapsula
English: How to take PROCYSBI
Slovenian: Kako jemati zdravilo PROCYSBI
English: If you are allergic to cysteamine (also known as mercaptamine) or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila PROCYSBI: če ste alergični na cisteamin (imenovan tudi merkaptamin) ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če ste alergični na penicilamin; če dojite.
English: In cases of patients with kidney transplants, anti-rejection treatments have been used with cysteamine.
Slovenian: Pri bolnikih s presajenimi ledvicami so se skupaj s cisteaminom uporabljala tudi zdravila za preprečevanje zavrnitvene reakcije.
English: The targeted maintenance dose of 1.3 g/m2/day can be approximated according to the following table, which takes surface area as well as weight into consideration.
Slovenian: Pediatrična populacija z na novo diagnosticirano boleznijo Odmerek, ki približno ustreza ciljnemu vzdrževalnemu odmerku 1,3 g/m2/dan, je mogoče določiti s pomočjo spodnje preglednice, kjer sta upoštevani tako površina kot telesna masa.
English: 400 mL white HDPE bottle containing 250 capsules with one 2-in-1 desiccant cylinder and two oxygen absorber cylinders, with a child resistant polypropylene closure.
Slovenian: 400 ml bela plastenka iz polietilena visoke gostote, ki vsebuje 250 kapsul, skupaj z enim sušilnim valjčkom 2 v 1 in dvema valjčkoma za absorpcijo kisika, ter ima polipropilensko zaporko, varno za otroke.
English: Cysteamine therapy should be initiated promptly after confirmation of the diagnosis of cystinosis to achieve maximum benefit.
Slovenian: Za dosego maksimalnega učinka je treba zdravljenje s cisteaminom uvesti takoj po potrditvi diagnoze cistinoze.
English: Uncommon: Somnolence, convulsions Very common: Vomiting, nausea, diarrhoea Common: Abdominal pain, breath odour, dyspepsia, gastroenteritis
Slovenian: Organski sistem MedDRA Pogostnost: neželeni učinek Zelo pogosti: bruhanje, slabost, driska Pogosti: bolečine v trebuhu, ustni zadah, dispepsija, gastroenteritis
English: The other ingredients are: o In the capsules: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer
Slovenian: Druge sestavine zdravila so: o v kapsulah: mikrokristalna celuloza, kopolimer metakrilne kisline in etilakrilata (1:1),
English: Normal individuals and persons heterozygous for cystinosis have white blood cell cystine levels of < 0.2 and usually below 1 nmol hemicystine/mg protein, respectively, when measured using the mixed leukocyte assay.
Slovenian: Pri zdravih posameznikih je koncentracija cistina v belih krvnih celicah < 0,2, pri osebah, heterozigotnih za cistinozo, pa je običajno nižja od 1 nmol hemicistina/mg beljakovin, izmerjeno z uporabo testa mešanih levkocitov.
English: It is important to dose PROCYSBI in relation to food intake in a consistent and reproducible way over time (see section 5.2) In paediatric patients who are at risk of aspiration, aged approximately 6 years and under, the hard capsules should be opened and the content sprinkled on food or liquid listed below.
Slovenian: Pri pediatričnih bolnikih do približno 6. leta starosti, pri katerih obstaja nevarnost aspiracije, je treba trde kapsule odpreti in vsebino stresti na spodaj navedeno hrano ali tekočino.
English: Frequency: adverse reaction
Slovenian: Občasni: anafilaktična reakcija
English: The mixture must be administered within 2 hours after preparation and may be refrigerated from the time of preparation to the time of administration.
Slovenian: Pripravljeno mešanico je treba dati v 2 urah in se jo lahko po pripravi do uporabe hrani v hladilniku.
English: There have been reports of serious skin lesions in patients treated with high doses of immediaterelease cysteamine bitartrate or other cysteamine salts that have responded to cysteamine dose reduction.
Slovenian: Pri bolnikih, zdravljenih z velikimi odmerki cisteaminijevega bitartrata s takojšnjim sproščanjem ali drugimi cisteaminovimi solmi, so poročali o resnih kožnih lezijah, ki so se izboljšale po zmanjšanju odmerka cisteamina.
English: The adverse reactions profile for healthy subjects was similar to the adverse reactions profile in patients relative to GI disorders (diarrhoea and abdominal pain).
Slovenian: Profil neželenih učinkov, povezanih z boleznimi prebavil (driska in bolečine v trebuhu), pri zdravih posameznikih je bil podoben kot pri bolnikih.
English: Bone disorders reported were genu valgum, leg pain and hyperextensive joints, osteopenia, compression fractures, and scoliosis.
Slovenian: Kostne bolezni, o katerih so poročali, so bile genu valgum, bolečine v spodnjih udih in hiperekstenzija sklepov, osteopenija, kompresijske frakture in skolioza.
English: What PROCYSBI contains
Slovenian: Kaj vsebuje zdravilo PROCYSBI
English: Uncommon: Joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture, scoliosis.
Slovenian: Občasni: hiperekstenzija sklepov, bolečine v spodnjih udih, genu valgum, osteopenija, kompresijska fraktura, skolioza
English: What PROCYSBI looks like and contents of the pack PROCYSBI 25 mg is presented as blue gastro-resistant hard capsules.
Slovenian: Izgled zdravila PROCYSBI in vsebina pakiranja Zdravilo PROCYSBI 25 mg je na voljo v obliki modrih gastrorezistentnih trdih kapsul.
English: 50 mL white HDPE bottle containing 60 capsules with one 2-in-1 desiccant cylinder and one oxygen absorber cylinder, with a child resistant polypropylene closure.
Slovenian: 50 ml bela plastenka iz polietilena visoke gostote, ki vsebuje 60 kapsul, skupaj z enim sušilnim valjčkom 2 v 1 in enim valjčkom za absorpcijo kisika, ter ima polipropilensko zaporko, varno za otroke.
English: A few cases of Ehlers-Danlos-like syndrome on elbows have been reported in children chronically treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/m2/day.
Slovenian: Pri otrocih, kronično zdravljenih z velikimi odmerki različnih oblik cisteamina (cisteaminijev klorhidrat ali cistamin ali cisteaminijev bitartrat), večinoma večjimi od maksimalnega odmerka 1,95 g/m2/dan, so poročali o nekaj primerih sindroma, podobnega Ehlers-Danlosovemu, na komolcih.
English: The dose should be raised if there is adequate tolerance and the WBC cystine level remains > 1 nmol hemicystine/mg protein (when measured using the mixed leukocyte assay).
Slovenian: Odmerek je treba povečati, če je prenašanje primerno dobro in koncentracija cistina v belih krvnih celicah vztraja pri vrednosti > 1 nmol hemicistina/mg beljakovin (izmerjeno z uporabo testa mešanih levkocitov).
English: The cysteamine dose can be increased to a maximum of 1.95 g/m2/day to achieve this level.
Slovenian: Za zagotovitev te vrednosti se lahko odmerek cisteamina poveča do največ 1,95 g/m2/dan.
English: Patients should not engage in potentially hazardous activities until the effects of cysteamine on mental performance are known (see section 4.7).
Slovenian: Dokler se ne ugotovi, kakšni so vplivi cisteamina na bolnikove umske sposobnosti, se mora ta izogniti dejavnostim, ki bi lahko bile nevarne (glejte poglavje 4.7).
English: • The risk of teratogenicity and relevant risk minimisation advice: Women of childbearing potential should be informed about the risk of teratogenicity; For women of child-bearing potential a negative pregnancy test should be confirmed before starting treatment;
Slovenian: ženske v rodni dobi je treba seznaniti s tveganjem za teratogenost; ženske v rodni dobi morajo pred začetkom zdravljenja opraviti test nosečnosti, ki mora biti negativen; ženskam v rodni dobi je treba svetovati, naj med zdravljenjem uporabljajo primerno kontracepcijsko metodo; ženske v rodni dobi je treba opozoriti, da morajo v primeru zanositve v času zdravljenja o tem obvestiti svojega zdravnika;
English: bone fragility hair discolouration fits nervousness hallucination effect on the kidney manifested by swelling of the extremities and weight gain
Slovenian: Občasni neželeni učinki: bolečine v spodnjih udih skolioza (deformacija hrbtenice) krhkost kosti sprememba barve las krči živčnost halucinacije prizadetost ledvic, ki je razvidna iz oteklih okončin in porasta telesne mase
English: The target values provided in the SmPC are obtained from using the mixed leucocyte assay.
Slovenian: Ciljne vrednosti, ki so navedene v povzetku glavnih značilnosti zdravila, so bile pridobljene s pomočjo testa mešanih levkocitov.
English: Specific studies with cysteamine did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test. A bacterial reverse mutation assay study (“Ames test”) was performed with the cysteamine bitartrate used for PROCYSBI and cysteamine bitartrate did not show any mutagenic effects in this test.
Slovenian: Opravljen je bil bakterijski test povratnih mutacij (»Amesov test«) s cisteaminijevim bitartratom, ki se uporablja za zdravilo PROCYSBI, v katerem cisteaminijev bitartrat ni pokazal mutagenega učinka.
English: Cysteamine therapy must be initiated promptly once the diagnosis is confirmed (i.e., increased WBC cystine) to achieve maximum benefit.
Slovenian: Za zagotovitev maksimalnega učinka je treba zdravljenje s cisteaminom uvesti takoj po potrditvi diagnoze (tj. povišana koncentracija cistina v belih krvnih celicah).
English: For example the therapeutic goal is to maintain a WBC cysteine level < 1 nmol hemicystine/mg protein (when measured using the mixed leukocyte assay), 30 min after dosing For patients adherent to a stable dose of PROCYSBI, and who do not have easy access to an adequate facility for measuring their WBC cystine, the goal of therapy should be to maintain plasma cysteamine concentration > 0.1 mg/L, 30 min after dosing.
Slovenian: Pri bolnikih, ki jemljejo stalen odmerek zdravila PROCYSBI in ki ne morejo preprosto dostopati do primerne zdravstvene ustanove, kjer bi jim izmerili cistin v belih krvnih celicah, je cilj zdravljenja ohraniti koncentracijo cisteamina v plazmi > 0,1 mg/l 30 minut po zaužitju odmerka.
English: The cylinders may be discarded with the bottle after use.
Slovenian: Po uporabi lahko valjčke odvržete skupaj s plastenko.
English: Patients being transferred from immediate-release cysteamine bitartrate to PROCYSBI should have their WBC cystine levels measured in 2 weeks, and thereafter every 3 months to assess optimal dose as described above.
Slovenian: Za določitev omenjenega optimalnega odmerka je treba bolnikom, ki preidejo s cisteaminijevega bitartrata s takojšnjim sproščanjem na zdravilo PROCYSBI, izmeriti vrednosti cistina v belih krvnih celicah po 2 tednih in nato še vsake 3 mesece.
English: • Breast-feeding.
Slovenian: • Dojenje.
English: Healthcare professionals should refer to the assay-specific therapeutic targets provided by individual testing laboratories when making decisions regarding diagnosis and PROCYSBI dosing for cystinosis patients.
Slovenian: Pri bolnikih s cistinozo morajo zdravstveni delavci pri odločanju glede diagnoze in odmerjanja zdravila PROCYSBI upoštevati terapevtske ciljne vrednosti specifičnega testa, ki jih zagotovijo posamezni testni laboratoriji.
English: Skin lesions, bone lesions, and joint problems: Treatment with high doses of cysteamine can cause skin lesions to develop.
Slovenian: Občasni neželeni učinki (ki lahko prizadenejo največ 1 bolnika od 100 bolnikov): kožne lezije, kostne lezije in težave s sklepi: zdravljenje z velikimi odmerki cisteamina lahko povzroči razvoj kožnih lezij.
English: Administration of cysteamine in neonate rats induced cataracts.
Slovenian: Cisteamin je pri novorojenih podganah povzročil nastanek sive mrene.
English: Azoospermia has been reported in male cystinosis patients.
Slovenian: Pri moških bolnikih s cistinozo so poročali o azoospermiji.
English: Symptoms such as seizures, tiredness, sleepiness, depression, and brain disorders (encephalopathy) can occur with cysteamine.
Slovenian: Pri uporabi cisteamina se lahko pojavijo simptomi, kot so epileptični napadi, utrujenost, zaspanost, depresija in bolezni možganov (encefalopatija).
English: PROCYSBI 75 mg hard capsule
Slovenian: PROCYSBI 75 mg trda kapsula
English: Common: Asthenia
Slovenian: Pogosti: oslabelost
English: 0.08 ± 0.03; 0.01 to 0.15; <0.0001 All Evaluable Patients (ITT) Population (N=41) Immediate-release cysteamine bitartrate
Slovenian: 0,08 ± 0,03; 0,01 do 0,15; < 0,0001
English: The active substance is cysteamine (as mercaptamine bitartrate).
Slovenian: Učinkovina je cisteamin (v obliki merkaptaminijevega bitartrata).
English: These mainly involve the gastrointestinal and central nervous systems.
Slovenian: Neželeni učinki običajno prizadenejo prebavila in osrednje živčevje.
English: Please keep the three cylinders in each bottle during the use of the bottle.
Slovenian: Med uporabo naj vsi trije valjčki ostanejo v posamezni plastenki.
English: If this is not possible, you can eat a small amount (about 100 grams) of food (preferably carbohydrates e.g. bread, pasta, fruits) during the hour before and after taking PROCYSBI.
Slovenian: Če to ni mogoče, lahko v eni uri pred in po jemanju zdravila PROCYSBI pojeste majhno količino (približno 100 gramov) hrane (po možnosti ogljikove hidrate, npr. kruh, testenine, sadje).
English: GI ulceration and bleeding have been reported in patients receiving immediate-release cysteamine bitartrate.
Slovenian: Pri bolnikih, ki so prejemali cisteaminijev bitartrat s takojšnjim sproščanjem, so poročali o razjedah in krvavitvah v prebavilih.
English: PROCYSBI 25 mg hard capsule
Slovenian: PROCYSBI 25 mg trda kapsula
English: PROCYSBI 75 mg is presented as blue gastro-resistant hard capsules.
Slovenian: Zdravilo PROCYSBI 75 mg je na voljo v obliki modrih gastrorezistentnih trdih kapsul.
English: Stomach and intestinal (gastrointestinal) problems: Patients taking cysteamine have developed ulcers and bleeding.
Slovenian: Če opazite te simptome, se posvetujte z zdravnikom; želodčne in črevesne (prebavne) težave: pri bolnikih, ki so jemali cisteamin, so se pojavile razjede in krvavitve.
English: * Higher dose may be required to achieve target WBC cystine concentration.
Slovenian: * Za doseganje ciljne koncentracije cistina v belih krvnih celicah bo morda potreben večji odmerek.
English: CNS symptoms such as seizures, lethargy, somnolence, depression, and encephalopathy have been associated with cysteamine.
Slovenian: S cisteaminom so povezani simptomi osrednjega živčevja, kot so epileptični napadi, letargija, somnolenca, depresija in encefalopatija.
English: Single doses of the drug inhibit prolactin secretion in animals.
Slovenian: Enkratni odmerki zdravila pri živalih zavirajo izločanje prolaktina.
English: Please keep the two cylinders in each bottle during the use of the bottle.
Slovenian: Med uporabo naj oba valjčka ostaneta v posamezni plastenki.
English: Patients with renal impairment Dose adjustment is not normally required; however, WBC cystine levels should be monitored.
Slovenian: Prilagajanje odmerka običajno ni potrebno; treba pa je spremljati koncentracije cistina v belih krvnih celicah.
English: A closer monitoring of the WBC cystine levels is recommended in these patients.
Slovenian: Pri teh bolnikih je priporočljivo še skrbneje spremljati koncentracije cistina v belih krvnih celicah.
English: Nervous system disorders
Slovenian: Osrednje živčevje
English: Light blue size 0 hard capsules imprinted “75 mg” in white ink and a dark blue cap imprinted with “PRO” in white ink.
Slovenian: Svetlomodre trde kapsule velikosti 0 z odtisnjeno belo oznako »75 mg« in temnomoder pokrovček, na katerem je z belim črnilom odtisnjen logotip družbe Raptor.
English: Each hard capsule contains 25 mg of cysteamine (as mercaptamine bitartrate).
Slovenian: Ena trda kapsula vsebuje 25 mg cisteamina (v obliki merkaptaminijevega bitartrata).
English: Each hard capsule contains 75 mg of cysteamine (as mercaptamine bitartrate).
Slovenian: Ena trda kapsula vsebuje 75 mg cisteamina (v obliki merkaptaminijevega bitartrata).
English: Light blue size 3 hard capsules imprinted “25 mg” in white ink and a light blue cap imprinted with “PRO” in white ink.
Slovenian: Svetlomodre trde kapsule velikosti 3 z odtisnjeno belo oznako »25 mg« in svetlomoder pokrovček, na katerem je z belim črnilom odtisnjen logotip družbe Raptor.
English: Other intestinal symptoms including nausea, vomiting, anorexia and stomach ache can occur with cysteamine.
Slovenian: Pri uporabi cisteamina se lahko pojavijo tudi drugi prebavni simptomi, ki vključujejo siljenje na bruhanje, bruhanje, anoreksijo in bolečine v želodcu.
English: Cysteamine excretion in human milk is unknown.
Slovenian: Ni znano, ali se cisteamin izloča v materino mleko.
English: You should contact your doctor or the hospital emergency department immediately if you have taken more PROCYSBI than you should.
Slovenian: Če ste vzeli večji odmerek zdravila PROCYSBI, kot bi smeli Če ste vzeli večji odmerek zdravila PROCYSBI, kot bi smeli, se nemudoma posvetujte z zdravnikom ali urgentnim oddelkom bolnišnice.
English: GI tract symptoms including nausea, vomiting, anorexia and abdominal pain have been associated with cysteamine.
Slovenian: Prebavni simptomi, ki so jih povezali s cisteaminom, vključujejo navzeo, bruhanje, anoreksijo in bolečine v trebuhu.
English: Administering through feeding tubes
Slovenian: Dajanje zdravila po sondi za hranjenje
English: If fasting during this period is not possible, it is acceptable to eat only a small amount ( 100 grams) of food (preferentially carbohydrates) during the hour before and after PROCYSBI administration.
Slovenian: Če to ni mogoče, lahko v uri pred in po uporabi zdravila PROCYSBI zaužijejo majhno količino hrane ( 100 gramov in po možnosti ogljikove hidrate).
English: How to store PROCYSBI
Slovenian: Shranjevanje zdravila PROCYSBI
English: If the rash is severe, your doctor may discontinue cysteamine treatment.
Slovenian: V primeru hudih izpuščajev lahko zdravnik prekine zdravljenje s cisteaminom; krvni testi kažejo nenormalno delovanje jeter.
English: Please keep the cylinders in each bottle during the use of the bottle.
Slovenian: Med uporabo naj valjčki ostanejo v posamezni plastenki.
English: PROCYSBI 25 mg gastro-resistant hard capsules PROCYSBI 75 mg gastro-resistant hard capsules
Slovenian: PROCYSBI 25 mg gastrorezistentne trde kapsule PROCYSBI 75 mg gastrorezistentne trde kapsule
English: The Safety Checklist should highlight the following:
Slovenian: V varnostnem kontrolnem seznamu mora biti izpostavljeno naslednje: • tveganje za teratogenost in pomembni ukrepi za zmanjšanje tveganja:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/861/002
Slovenian: EU/1/13/861/002
English: o In the capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132).
Slovenian: hipromeloza, smukec, trietilcitrat, natrijev lavrilsulfat; o v ovoju kapsul: želatina, titanov dioksid (E171), indigotin (E132); o v črnilu za tisk: šelak, povidon (K-17), titanov dioksid (E171).
English: The dark blue cap is imprinted with “PRO” in white ink and the light blue body is imprinted with “75 mg” in white ink.
Slovenian: Na temnomodrem pokrovčku je z belim črnilom odtisnjen logotip družbe Raptor, na svetlomodrem osrednjem delu pa je odtisnjena bela oznaka »75 mg«.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/861/001
Slovenian: EU/1/13/861/001
English: The light blue cap is imprinted with “PRO” in white ink and the light blue body is imprinted with “25 mg” in white ink.
Slovenian: Na svetlomodrem pokrovčku je z belim črnilom odtisnjen logotip družbe Raptor, na svetlomodrem osrednjem delu pa je odtisnjena bela oznaka »25 mg«.
English: NAME OF THE MEDICINAL PRODUCT PROCYSBI 75 mg gastro-resistant hard capsules cysteamine
Slovenian: PROCYSBI 75 mg gastrorezistentne trde kapsule cisteamin
English: NAME OF THE MEDICINAL PRODUCT PROCYSBI 25 mg gastro-resistant hard capsules cysteamine
Slovenian: PROCYSBI 25 mg gastrorezistentne trde kapsule cisteamin
English: Treatment effect (LS mean ± SE; 95.8% CI; p-value)
Slovenian: Vrednost cistina v belih krvnih celicah (povprečje najmanjših kvadratov ± SN) v nmol hemicistina/mg beljakovin* Učinek zdravljenja (povprečje najmanjših kvadratov ± SN; 95,8-odstotni IZ; p-vrednost)
English: Manufacturer Chiesi Farmaceutici S.p.A.
Slovenian: Chiesi Pharmaceuticals B.V.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 25 mg of cysteamine (as mercaptamine bitartrate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 25 mg cisteamina (v obliki merkaptaminijevega bitartrata).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 75 mg of cysteamine (as mercaptamine bitartrate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 75 mg cisteamina (v obliki merkaptaminijevega bitartrata).
English: NAME OF THE MEDICINAL PRODUCT PROCYSBI 25 mg gastro-resistant hard capsules PROCYSBI 75 mg gastro-resistant hard capsules
Slovenian: PROCYSBI 25 mg gastrorezistentne trde kapsule PROCYSBI 75 mg gastrorezistentne trde kapsule cisteamin (merkaptaminijev bitartrat)
English: Newly diagnosed paediatric population
Slovenian: Bolniki z ledvično okvaro
English: These studies were conducted at least 25 years ago.
Slovenian: Te študije so bile opravljene pred več kot 25 leti.
English: Susceptibility tests with isolates outside of the EU were submitted.
Slovenian: Predložile so se preiskave občutljivosti z izolati zunaj EU.
English: Add, to all products: 4.4 Special warnings for each target species
Slovenian: Dodajte vsem zdravilom: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto
English: The field studies are more than 20 years old and are limited in their reporting.
Slovenian: Terenske študije so stare več kot 20 let, njihovo poročanje pa je omejeno.
English: Romania CEVA SANTE ANIMALE ZI Très le Bois - BP 372
Slovenian: Romunija CEVA SANTE ANIMALE ZI Très le Bois - BP 372
English: 13 Drlica, K., and X. Zhao.
Slovenian: 13 Drlica, K., in X. Zhao.
English: ATCvet Code: QJ01MA90.
Slovenian: oznaka ATC vet: QJ01MA90.
English: A margin of at least five times the recommended dose was safe.
Slovenian: Odmerki, ki so bili vsaj petkrat večji od priporočenega odmerka, so bili varni.
English: • Correction factors based on the determined accuracy of the analytical method have been used in some cases and not in others;
Slovenian: • korekcijski faktorji, ki temeljijo na določeni natančnosti analitične metode, so se v nekaterih primerih uporabili, v drugih pa ne;
English: Decreased susceptibility varied from approximately 10-50%.
Slovenian: Razpon zmanjšane občutljivosti je bil od 10 do 50 %.
English: The CVMP's conclusion on the benefit-risk balance will be revisited in line with the provisions in these conditions.
Slovenian: Zaključek odbora CVMP glede razmerja med koristmi in tveganji se bo ponovno preučil skladno z določbami v teh pogojih.
English: This dose rate controlled the signs of disease.
Slovenian: S tem odmerjanjem so se nadzorovali znaki bolezni.
English: The conditions of the Marketing Authorisations are described in annex IV.
Slovenian: Pogoji dovoljenj za promet z zdravilom so opisani v Prilogi IV.
English: Although methods cannot be directly compared, there is evidence of reduced susceptibility emerging over time.
Slovenian: Čeprav metod ni mogoče neposredno primerjati, obstajajo dokazi, da se občutljivost s časom zmanjšuje.
English: Add, to all products and delete the existing text:
Slovenian: Dodajte vsem zdravilom in izbrišite obstoječe besedilo:
English: The abovementioned data should be provided to the CVMP for assessment not later than 3 years after the Commission Decision on this referral procedure.
Slovenian: Zgoraj navedene podatke je treba predložiti v oceno odboru CVMP najpozneje 3 leta po sklepu Komisije o tem napotitvenem postopku.
English: Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms.
Slovenian: Zdravljenje od 3 do 5 zaporednih dni; 5 zaporednih dni pri mešanih okužbah in kroničnih naprednih oblikah.