FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalisation, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
Slovenian: Pri bolnikih, ki so prejemali peroralne difosfonate, so poročali o neželenih učinkih, kot so ezofagitis, razjede požiralnika in erozije požiralnika; le-ti so bili v nekaterih primerih hudi in so zahtevali hospitalizacijo, redko so jih spremljale krvavitve ali posledična striktura ali perforacija požiralnika.
English: Do not pass it on to others.
Slovenian: Ne dajajte si jih sami.
English: Relative risk reduction New morphometric vertebral fractures
Slovenian: Zmanjšanje relativnega tveganja za nove zlome vretenc (določeno morfometrično)
English: Rare (may affect up to 1 in 1000 people): • hives
Slovenian: Redki (pojavijo se pri največ 1 od 1.000 bolnikov): • koprivnica.
English: Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bondenza 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Slovenian: Pri teh bolnikih je bila incidenca neželenih učinkov v zgornjem delu prebavil podobna pri tistih, ki so se zdravili z zdravilom Bondenza 150 mg enkrat na mesec ali ibandronsko kislino 2,5 mg vsak dan.
English: Each prefilled syringe contains 3 ml of solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 3 ml raztopine.
English: Furthermore, Bondenza 3 mg injection every 3 months was proven superior to oral ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p<0.001, and at two years, p<0.001.
Slovenian: Zdravilo Bondenza 3 mg v obliki injekcije, dane vsake 3 mesece, se je izkazalo za boljše kakor peroralno dana ibandronska kislina 2,5 mg enkrat na dan v povišanju MKG ledvene hrbtenice v prospektivno načrtovani analizi po enem letu, p < 0,001, in dveh letih, p < 0,001.
English: At one year, 83.5 % (p= 0.006) of patients receiving Bondenza 150 mg once monthly and 73.9 % of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease ≥50 % from baseline).
Slovenian: Po enem letu je bilo odzivnih 83,5 % bolnikov (p = 0,006), ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec, in 73,9 % bolnikov, ki so jemali ibandronsko kislino 2,5 mg enkrat na dan, odzivnost so definirali kot ≥ 50 % zmanjšanje od izhodišča.
English: - The active substance is ibandronic acid.
Slovenian: - Zdravilna učinkovina je ibandronska kislina.
English: Posology
Slovenian: BESEDILO NALEPK
English: At one year (primary analysis), 91.3 % (p=0.005) of patients receiving Bondenza 150 mg once monthly had a lumbar spine BMD increase above or equal to baseline (BMD responders), compared with 84.0 % of patients receiving ibandronic acid 2.5 mg daily.
Slovenian: Po enem letu (primarna analiza) se je 91,3 % (p = 0,005) bolnikom, ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec, MKG lumbalne hrbtenice povišala ali ostala enaka izhodiščni vrednosti (bolniki, odzivni na povišanje MKG) v primerjavi s 84,0 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg na dan.
English: Both bioavailability and BMD gains are reduced when food or beverage is taken less than 60 minutes after ibandronic acid is ingested.
Slovenian: Če zaužijemo hrano ali pijačo, preden je minilo 60 minut od jemanja ibandronske kisline, sta zmanjšana biološka uporabnost in porast MKG.
English: Angioedema, Facial swelling/oedema, Urticaria
Slovenian: Bolezni kože in podkožja angioedem, otekanje obraza/edem, urtikarija
English: In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of Bondenza 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
Slovenian: V ključni dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16550) je bila celokupna varnost zdravila Bondenza 3 mg v obliki intravenske injekcije, dane vsake 3 mesece, in ibandronske kisline 2,5 mg, dane peroralno enkrat na dan, podobna.
English: Based on the results of study BM 16550, Bondenza 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Slovenian: Glede na rezultate študije BM 16550 pričakujemo, da je zdravilo Bondenza 3 mg v obliki intravenske injekcije, ki jo dajemo vsake 3 mesece, najmanj enako učinkovito v preprečevanju zlomov kakor peroralno odmerjena ibandronska kislina 2,5 mg enkrat na dan.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/003 1 film-coated tablet EU/1/03/266/004 3 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/03/266/003 1 filmsko obložena tableta
English: Continuing to receive Bondenza
Slovenian: Nadaljevanje jemanja zdravila Bondenza
English: Therefore dose adjustment is not necessary in patients with hepatic impairment.
Slovenian: Za bolnike z jetrno okvaro prilagajanje odmerkov ni potrebno.
English: The pharmacokinetics of ibandronic acid was not assessed in patients with end-stage renal disease managed by other than hemodialysis.
Slovenian: Farmakokinetike ibandronske kisline pri bolnikih s končno ledvično odpovedjo, ki jih niso zdravili s hemodializo, niso proučevali.
English: Bondenza is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see section 4.4 and section 5.2).
Slovenian: Uporaba zdravila Bondenza pri bolnikih s kreatininskim očistkom pod 30 ml/min zaradi malo kliničnih izkušenj ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: There is no relevant use of Bondenza in children below 18 years, and Bondenza was not studied in this population.
Slovenian: Uporaba zdravila Bondenza pri otrocih, mlajših od 18 let, ni smotrna.
English: When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Slovenian: Če upoštevamo strožji kriterij, ki združuje MKG ledvene hrbtenice in kolka, je bilo po enem letu odzivnih 83,9 % (p < 0,001) bolnikov, ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec, in 65,7 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg na dan.
English: You should not be given Bondenza if you are pregnant, or if there is a possibility you may become pregnant.
Slovenian: Če ste noseči ali če obstaja možnost, da bi lahko zanosili, ne smete prejemati zdravila Bondenza.
English: Absorption Not applicable
Slovenian: Napake pri aplikaciji
English: Cases of serious, sometimes fatal, allergic reaction have been reported in patients treated with intravenous ibandronic acid.
Slovenian: Pri bolnikih zdravljenih z intravensko ibandronsko kislino so poročali o primerih resnih, včasih smrtnih, alergijskih reakcij.
English: Bondenza 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Slovenian: Dajanje zdravila Bondenza 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi: Bondenza 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi se daje intravensko 15 do 30 sekund.
English: After intravenous administration of 0.5 mg, total, renal, and non-renal clearances decreased by 67 %, 77 % and 50 %, respectively, in subjects with severe renal failure but there was no reduction in tolerability associated with the increase in exposure.
Slovenian: Po intravenskem dajanju odmerka 0,5 mg se je pri bolnikih s hudo ledvično okvaro celokupni očistek zmanjšal za 67 %, ledvični očistek za 77 %, neledvični očistek pa za 50 %.
English: One tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg ibandronske kisline (v obliki natrijevega monohidrata).
English: Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Slovenian: Peroralni difosfonati lahko povzročijo lokalno draženje sluznice zgornjega dela prebavil.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: There was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats at an extrapolated exposure of at least 35 times above human exposure.
Slovenian: Pri ekstrapolaciji izpostavljenosti, ki je 35-krat presegala izpostavljenost pri človeku, na razvoj F1 potomcev podgan niso opazili škodljivih vplivov.
English: Most cases of adverse reactions did not lead to cessation of therapy
Slovenian: V večini primerov prekinitev terapije zaradi neželenih učinkov ni bila potrebna.
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05-BA06
Slovenian: Oznaka ATC: M05BA06
English: One pre-filled syringe contains 3 mg of ibandronic acid in 3 ml of solution (as sodium monohydrate).
Slovenian: Ena napolnjena injekcijska brizga vsebuje 3 mg ibandronske kisline v 3 ml raztopine (v obliki natrijevega monohidrata).
English: Anaphylactic reaction/shock*†
Slovenian: Bolezni imunskega sistema preobčutljivostna reakcija anafilaktična reakcija/šok*†
English: The dose of Bondenza is one tablet once a month.
Slovenian: NAČRTOVANJE JEMANJA ZDRAVILA BONDENZA Odmerek zdravila Bondenza je ena tableta enkrat na mesec.
English: ibandronic acid 2.5 mg daily (N=977)
Slovenian: ibandronska kislina 2,5 mg enkrat na dan (n = 977)
English: At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Slovenian: Po dveh letih je 87,1 % (p < 0,001) bolnikov, ki so prejemali 150 mg enkrat na mesec, in 70,5 % bolnikov, ki so prejemali 2,5 mg na dan, zadostilo kriterijem za odzivnost.
English: You may develop low levels of calcium, phosphorus or magnesium in the blood.
Slovenian: Če so vam dali večji odmerek zdravila Bondenza, kot bi smeli To lahko povzroči nizke koncentracije kalcija, fosforja ali magnezija v krvi.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bondenza 3 mg solution for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Bondenza 3 mg raztopina za injiciranje ibandronska kislina
English: • muscle cramps, stiffness of your joints and limbs
Slovenian: • mišični krči, togost v sklepih ali okončinah.
English: How to take Bondenza
Slovenian: Kako jemati zdravilo Bondenza
English: At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Slovenian: Po dveh letih je bilo odzivnih 93,5 % bolnikov (p = 0,004), ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec, in 86,4 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg enkrat na dan.
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Slovenian: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Nemčija
English: What Bondenza is and what it is used for What you need to know before you receive Bondenza How to receive Bondenza
Slovenian: Kaj je zdravilo Bondenza in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Bondenza Kako prejemati zdravilo Bondenza Možni neželeni učinki
English: Table 1: Adverse reactions occurring in postmenopausal women receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM16549 and MF4411 and in postmarketing experience.
Slovenian: Preglednica 1: Neželeni učinki, ki so se pojavili pri postmenopavznih ženskah, ki so v študijah faze III BM16549 in MF4411 ter po prihodu zdravila na trg prejemale zdravilo Bondenza 150 mg enkrat na mesec ali ibandronsko kislino 2,5 mg na dan.
English: For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen.
Slovenian: Razlik v incidenci neželenih učinkov v zgornjem delu prebavil pri teh bolnikih glede na jemanje 150 mg enkrat na mesec ali 2,5 mg enkrat na dan ni bilo.
English: .Table 1: Adverse reactions occurring in postmenopausal women receiving Bondenza 3 mg injection every 3 months or ibandronic acid 2.5 mg daily in the phase III studies BM16550 and MF 4411, and in post-marketing experience.
Slovenian: Preglednica 1: Neželeni učinki, ki so se pojavili pri postmenopavznih ženskah, ki so v študijah faze III BM16550 in MF4411 ter po prihodu zdravila na trg prejemale zdravilo Bondenza 3 mg v obliki injekcije vsake 3 mesece ali ibandronsko kislino 2,5 mg na dan.
English: If you get any of the side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
English: An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with Bondenza 3 mg injection.
Slovenian: Tudi dveletno zdravljenje s 3-mg injekcijo zdravila Bondenza je pokazalo pričakovano zmanjšanje kostne premene, normalno kakovost kosti in odsotnost motenj mineralizacije.
English: No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/min.
Slovenian: Pri bolnikih z blago do zmerno ledvično okvaro, ki imajo očistek kreatinina enak ali večji kot 30 ml/min, prilagajanje odmerkov ni potrebno.
English: BMD - mean change relative to baseline lumbar spine at year 3 BMD - mean change relative to baseline total hip at year 3
Slovenian: MKG - povprečna sprememba glede na izhodiščno vrednost za ledveno hrbtenico po 3 letih MKG - povprečna sprememba glede na izhodiščno vrednost za kolk po 3 letih
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/005 1 pre-filled syringe EU/1/03/266/006 4 pre-filled syringes
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/03/266/005 1 napolnjena injekcijska brizga
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 150 mg ibandronske kisline (v obliki natrijevega monohidrata).
English: Vascular disorders Gastrointestinal disorders
Slovenian: Bolezni prebavil gastritis, dispepsija,
English: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Slovenian: Drugi neželeni učinki ibandronske kisline v študijah vplivov na sposobnost razmnoževanja pri podganah so bili pričakovano značilni za to skupino zdravil (difosfonati).
English: dosing regimen, there was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in rats and rabbits.
Slovenian: Pri podganah in kuncih, ki so peroralno prejemali ibandronsko kislino, niso opazili neposrednih škodljivih vplivov na plod ali teratogenega delovanja.
English: System Organ Class Common
Slovenian: Organski sistem Pogosti
English: Ocular inflammation
Slovenian: NAPOLNJENA INJEKCIJSKA BRIZGA
English: Check with your doctor or pharmacist if you are not sure.
Slovenian: Obvestite svojega zdravnika, če to ni mogoče.
English: General disorders and administration site conditions reactions, Asthenia
Slovenian: Splošne težave in spremembe na mestu aplikacije bolezen, podobna gripi*
English: ibandronic acid 2.5 mg daily (N=294)
Slovenian: ibandronska kislina 2,5 mg enkrat na dan (n = 334)
English: For total hip BMD, 90.0 % (p<0.001) of patients receiving Bondenza 150 mg once monthly and 76.7 % of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline at one year.
Slovenian: MKG kolka se je po enem letu povišala ali ostala enaka izhodiščni vrednosti pri 90,0 % (p < 0,001) bolnikov, ki so prejemali 150 mg enkrat na mesec, in 76,7 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg na dan.
English: So be especially careful if you take painkillers or anti-inflammatories while you're taking Bondenza.
Slovenian: Če jemljete zdravila proti bolečini ali protivnetna zdravila med zdravljenjem z zdravilom Bondenza, bodite še posebno previdni.
English: ibandronic acid 2.5 mg daily
Slovenian: ibandronska kislina 2,5 mg enkrat na dan
English: *See further information below †Identified in post-marketing experience.
Slovenian: *Za nadaljnje informacije glejte spodnje besedilo.
English: Musculoskeletal and , connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice†
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA06
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati.
English: General disorders and administration site conditions *See further information below †Identified in post-marketing experience.
Slovenian: utrujenost *Za nadaljnje informacije glejte spodnje besedilo.
English: Musculoskeletal and connective tissue disorders
Slovenian: Žilne bolezni flebitis/ tromboflebitis
English: Lumbar spine L2-L4 BMD 3.9 [3.4, 4.3]
Slovenian: MKG ledvene hrbtenice L2-L4
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 3 mg ibandronske kisline (v obliki natrijevega monohidrata) v 3 ml raztopine.
English: Lactose monohydrate Povidone
Slovenian: Atipičen zlom stegnenice
English: - You should take calcium and vitamin-D supplements while receiving Bondenza.
Slovenian: - Med zdravljenjem z zdravilom Bondenza morate jemati dodatke kalcija in vitamina D.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do
English: Continuing to take Bondenza
Slovenian: PRETISNI OMOT
English: Angioedema, Face oedema, Urticaria
Slovenian: slaba prebava, slabost, driska,
English: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints.
Slovenian: občutjem neugodja, utrujenostjo, bolečino v kosteh in bolečimi mišicami ter sklepi.
English: Roche Farma, S.A. Tel: +34 - 94 481 83 00
Slovenian: Tel: +34 - 94 481 83 00
English: At two years 93.4 % (p<0.001) of patients receiving Bondenza 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Slovenian: Po dveh letih se je MKG kolka povišala ali ostala enaka izhodiščni vrednosti pri 93,4 % bolnikov (p < 0,001), ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec, in 78,4 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg enkrat na dan.
English: Titanium dioxide (E 171)
Slovenian: Obloga tablete hipromeloza titanov dioksid (E171) smukec makrogol 6000
English: Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Slovenian: Pri bolnikih, zdravljenih z difosfonati, so poročali o osteonekrozi čeljustnic.
English: There is no relevant use of Bondenza in children below 18 years, and Bondenza was not studied in this population (see section 5.1 and 5.2).
Slovenian: Zdravila Bondenza pri tej populaciji bolnikov niso proučevali (glejte poglavji 4.4 in 5.2).
English: Ocular inflammation*†
Slovenian: Bolezni prebavil* ezofagitis,
English: • dizziness
Slovenian: • koprivnica.
English: At two years 78.7 % (p=0.002) and 65.6 % of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
Slovenian: (p = 0,002), ki so prejemali 150 mg enkrat na mesec, in 65,6 % bolnikov, ki so jemali 2,5 mg enkrat na dan.
English: The Reference Member State was Ireland and the Concerned Member States were Austria, Bulgaria, Denmark, Spain, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia and Sweden.
Slovenian: Referenčna država članica je bila Irska, zadevne države članice pa Avstrija, Bolgarija, Danska, Španija, Finska, Francija, Madžarska, Islandija, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovenija in Švedska.
English: During the procedure, there was disagreement between the Reference Member State and Concerned Member States on the data presented to support the environmental risk assessment.
Slovenian: Med postopkom je prišlo do nesoglasja med referenčno državo članico in zadevnimi državami članicami glede podatkov, predloženih v podporo oceni tveganja za okolje.
English: The parent drug accounted for 79% of the total radioactive faecal residue.
Slovenian: Matično zdravilo je predstavljalo 79 % celotnega radioaktivnega ostanka v blatu.
English: • During this referral procedure in Ireland the marketing authorisation of the reference product
Slovenian: • Med napotitvenim postopkom na Irskem je bilo dovoljenje za promet z referenčnim zdravilom
English: The product has claims for persistent efficacy ranging from 21 to 49 days.
Slovenian: Učinek zdravila naj bi trajal v razponu od 21 do 49 dni.
English: 1 During the decentralised procedure it was agreed that the authorisation of the generic product under the name "Dectomax" will not be issued until the reference product under the name "Dectomax" has either been withdrawn or renamed.
Slovenian: 1 Med decentraliziranim postopkom je bilo dogovorjeno, da dovoljenje za promet generičnega zdravila z imenom „Dectomax“ ne bo izdano, dokler referenčno zdravilo z imenom „Dectomax“ ne bo umaknjeno ali preimenovano.
English: The following two changes to the initial application that were made during the decentralised procedure and the CVMP referral procedure should be noted:
Slovenian: Opozoriti je treba na naslednji dve spremembi prvotne vloge, do katerih je prišlo med decentraliziranim postopkom in napotitvenim postopkom pri CVMP:
English: INN/Strength Animal species
Slovenian: INN/Jakost Živalska vrsta
English: In general terms, as for the benefits, that except for the risks identified in particular by the referral (ERA) all other risks are expected to be the same as for the reference product and have not been discussed in any detail by CVMP.
Slovenian: Na splošno velja, tako kot pri koristih, da so z izjemo tveganj, ki so bila posebej opredeljena v napotitvenem postopku (ocena tveganja za okolje), vsa druga tveganja po pričakovanjih enaka kot pri referenčnem zdravilu, CVMP pa o njih ni podrobno razpravljal.
English: After refinement of PECsw using the FOCUS model as recommended by CVMP guideline CVMP/ERA/418282/2005, the RQ remains above 1 for Daphnia.
Slovenian: Po izboljšavi PKOpovršinske vode z modelom FOCUS, kot priporoča smernica CVMP/ERA/418282/2005, količnik tveganja ostaja nad 1 za organizem Daphnia.
English: Two Concerned Member States (the Netherlands and France) considered that the authorisation of Dectomax 5 mg/ml pour-on solution for cattle may present a potential serious risk to the environment.
Slovenian: Dve zadevni državi članici (Nizozemska in Francija) sta menili, da utegne odobritev zdravila Dectomax 5 mg/ml, raztopina za kožni poliv za govedo, predstavljati možno resno tveganje za okolje.