FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on PK modelling the recommended waiting time in patients with mild or moderate renal impairment for re-use of 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium after routine reversal with sugammadex should be 24 hours.
Slovenian: Na osnovi farmakokinetičnega modeliranja je pri bolnikih z blago ali zmerno ledvično okvaro priporočeni časovni presledek pred ponovno uporabo 0,6 mg/kg rokuronija ali 0,1 mg/kg vekuronija po rutinski prekinitvi blokade s sugamadeksom 24 ur.
English: Bridion 100 mg/mL solution for injection
Slovenian: Bridion 100 mg/ml raztopina za injiciranje
English: Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade.
Slovenian: (glejte poglavje 4.8) Bolnike je treba med in po prekinitvi blokade živčnomišičnega prenosa skrbno opazovati glede hemodinamičnih sprememb.
English: The time to recovery from succinylcholine-induced neuromuscular blockade (1 mg/kg) was compared with sugammadex (16 mg/kg, 3 minutes later) - induced recovery from rocuronium-induced neuromuscular blockade (1.2 mg/kg).
Slovenian: Čas do prekinitve živčnomišične blokade, sprožene s sukcinilholinom (1 mg/kg), so primerjali s časom, ki je potreben, da sugamadeks (v odmerku 16 mg/kg, ki so ga dali čez 3 minute) odpravi živčnomišično blokado, sproženo z rokuronijem (v odmerku 1,2 mg/kg).
English: Procedural complication
Slovenian: POSTOPEK UPORABE
English: Interactions potentially affecting the efficacy of other medicinal products (capturing interactions): Due to the administration of sugammadex, certain medicinal products could become less effective due to a lowering of the (free) plasma concentrations.
Slovenian: Pri uporabi sugamadeksa se lahko zmanjša učinkovitost določenih zdravil zaradi znižanja koncentracije njihove proste (nevezane) frakcije v plazmi.
English: Neostigmine (70 mcg/kg)
Slovenian: neostigmin (70 mcg/kg)
English: The incidence of adjudicated hypersensitivity was 1.3%, 6.6% and 9.5% in the placebo, sugammadex 4 mg/kg and sugammadex 16 mg/kg groups, respectively.
Slovenian: Pojavnost tako ocenjene preobčutljivosti je bila v skupini, ki je prejemala placebo, 1,3 %, v skupini, ki je prejemala sugamadeks v odmerku 4 mg/kg, 6,6 % in v skupini, ki je prejemala sugamadeks v odmerku 16 mg/kg, 9,5 %.
English: What Bridion is
Slovenian: Kaj je zdravilo Bridion
English: This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Slovenian: To vodi do prekinitve živčnomišične blokade, ki smo jo dosegli z rokuronijem ali vekuronijem.
English: • if you have fluid retention (oedema).
Slovenian: • če vam zastaja tekočina v telesu (edem),
English: After the last dose of rocuronium or vecuronium, at 1-2 PTCs, 4 mg/kg sugammadex or 70 mcg/kg neostigmine was administered in a randomised order.
Slovenian: Po dajanju zadnjega odmerka rokuronija ali vekuronija pri odčitku 1-2 PTC so bolnikom dali 4 mg/kg sugamadeksa ali 70 mcg/kg neostigmina, glede na naključno razporeditev v skupino.
English: Exposure was 2-fold and 5-fold higher in subjects with moderate and severe renal impairment, respectively.
Slovenian: Izpostavljenost je bila 2-krat večja pri bolnikih z zmerno okvaro ledvic in 5-krat večja pri bolnikih s hudo okvaro ledvic.
English: Moderate 15 11 (22) Severe 5 3 (22)
Slovenian: 23 kg zmerno 15 11 (22) hudo 5
English: Bridion contains the active substance sugammadex.
Slovenian: Zdravilo Bridion vsebuje učinkovino sugamadeks.
English: A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium or vecuronium induced blockade.
Slovenian: Sugamadeks v odmerku 2 mg/kg priporočamo, če pride do spontanega popuščanja z rokuronijem ali vekuronijem povzročene živčnomišične blokade, pri čemer pride vsaj do ponovnega pojava T2.
English: In this situation the patient must be ventilated.
Slovenian: V primeru, da bolnik prejema takšno zdravilo v infuziji, je treba dajanje tega zdravila prekiniti.
English: For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no dose adjustments are required.
Slovenian: Pri bolnikih z blago do zmerno jetrno okvaro ni potrebna prilagoditev odmerka, ker se sugamadeks izloča predvsem skozi ledvice.
English: Bridion 100 mg/mL may be diluted to 10 mg/mL to increase the accuracy of dosing in the paediatric population (see section 6.6).
Slovenian: Za povečanje natančnosti odmerjanja pri pediatričnih bolnikih se zdravilo Bridion 100 mg/ml lahko redči na 10 mg/ml (glejte poglavje 6.6).
English: Sugammadex concentrations were no longer detectable beyond 7 days post-dose in subjects with severe renal insufficiency.
Slovenian: Pri bolnikih s hudo ledvično insuficienco koncentracije sugamadeksa niso bile več zaznavne po 7 dneh po prejemu odmerka.
English: Routine reversal - moderate neuromuscular blockade:
Slovenian: Rutinska prekinitev živčnomišične blokade - zmerna živčnomišična blokada:
English: Elderly patients:
Slovenian: Posebne skupine bolnikov:
English: Sugammadex exhibits linear kinetics in the dosage range of 1 to 16 mg/kg when administered as an IV bolus dose.
Slovenian: Pri dajanju v obliki intravenskega bolusnega odmerka ima sugamadeks linearno kinetiko v razponu odmerkov od 1 do 16 mg/kg.
English: If neuromuscular blockade is required before the recommended waiting time has passed, a nonsteroidal neuromuscular blocking agent should be used.
Slovenian: Če se izkaže, da je pri bolniku potrebna ponovna živčnomišična blokada, še preden mine celoten priporočeni časovni presledek, je treba uporabiti nesteroidni mišični relaksant.
English: Neostigmine (50 mcg/kg)
Slovenian: neostigmin (50 mcg/kg)
English: Bridion 100 mg/mL injection sugammadex
Slovenian: Bridion 100 mg/ml raztopina za injiciranje sugamadeks
English: How Bridion is given
Slovenian: Kako se daje zdravilo Bridion
English: Drug hypersensitivity reactions:
Slovenian: Preobčutljivostne reakcije na zdravilo:
English: In another pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Slovenian: V neki drugi ključni študiji uporabe zdravila so bolnike naključno razvrstili bodisi v skupino, ki je prejela rokuronij, ali pa v skupino, ki je prejela vekuronij.
English: The time from start of administration of sugammadex or neostigmine to recovery of the T4/T1 ratio to 0.9 was:
Slovenian: Čas od začetka dajanja sugamadeksa ali neostigmina bolniku do povrnitve razmerja T4/T1 na vrednost 0,9 je znašal:
English: Impaired Mild 26 19 (22)
Slovenian: 7 let okvarjeno blago 26 19 (22)
English: Anaesthetic complications, indicative of the restoration of neuromuscular function, include movement of a limb or the body or coughing during the anaesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube.
Slovenian: Med zaplete pri anesteziji, ki kažejo na povrnitev živčnomišičnega delovanja, sodijo gibanje udov ali telesa in kašelj med anestezijo ali med kirurškim posegom ter grimase ali sesanje dihalne cevke (glejte poglavje 4.4, Plitva anestezija).
English: Re-administration of rocuronium or vecuronium after sugammadex: For waiting times for re-administration of rocuronium or vecuronium after reversal with sugammadex, see section 4.4.
Slovenian: Za časovne presledke pred ponovno uporabo rokuronija ali vekuronija po prekinitvi blokade s sugamadeksom glejte poglavje 4.4.
English: Reversal by sugammadex of the neuromuscular blockade induced by rocuronium was compared to the reversal by neostigmine of the neuromuscular blockade induced by cis-atracurium.
Slovenian: Prekinitev živčnomišične blokade, povzročene z rokuronijem, s pomočjo sugamadeksa so primerjali z odpravo živčnomišične blokade, povzročene s cisatrakurijem, s pomočjo neostigmina.
English: Neither sugammadex nor the complex of sugammadex and rocuronium binds to plasma proteins or erythrocytes, as was shown in vitro using male human plasma and whole blood.
Slovenian: In vitro poskusi z uporabo moške plazme in polne krvi so pokazali, da se niti sugamadeks niti kompleks sugamadeksa in rokuronija ne vežeta na plazemske proteine ali na eritrocite.
English: Rocuronium
Slovenian: Rokuronij
English: What Bridion is used for
Slovenian: Za kaj uporabljamo zdravilo Bridion
English: Routine reversal - deep neuromuscular blockade:
Slovenian: Rutinska prekinitev živčnomišične blokade - globoka živčnomišična blokada:
English: Sugammadex has not been investigated in patients receiving rocuronium or vecuronium in the ICU setting.
Slovenian: Sugamadeksa pri bolnikih, pri katerih je bil uporabljen rokuronij ali verkuronij na oddelkih za intenzivno nego, niso proučevali.
English: Impaired Mild 48 44 (23)
Slovenian: mladostnik normalno 15 let okvarjeno blago 48 44 (23)
English: Drug hypersensitivity reactions (see section 4.4)
Slovenian: Bolezni imunskega sistema občasni preobčutljivostne reakcije na zdravilo (glejte poglavje 4.4)
English: → Tell your anaesthetist if this applies to you.
Slovenian: → Če to velja za vas, morate to povedati anesteziologu.
English: Anaesthetic complication:
Slovenian: Zapleti pri anesteziji:
English: Sugammadex provided faster reversal of neuromuscular blockade induced by rocuronium compared to neostigmine reversal of neuromuscular blockade induced by cis-atracurium:
Slovenian: S sugamadeksom so dosegli hitrejšo prekinitev živčnomišične blokade, povzročene z rokuronijem, kot z neostigminom pri prekinitvi s cisatrakurijem povzročene živčnomišične blokade:
English: Time (minutes) from administration of rocuronium and sugammadex or succinylcholine to recovery of the T1 10%
Slovenian: Čas (v minutah) od dajanja rokuronija in sugamadeksa ali sukcinilholina do povrnitve T1 na 10% Mišični relaksant
English: Delayed recovery:
Slovenian: Upočasnjeno popuščanje blokade:
English: Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade:
Slovenian: Sugamadeks lahko uporabljamo za prekinitev različnih globin mišične relaksacije, dosežene z rokuronijem ali vekuronijem:
English: Treatment regimen Rocuronium and sugammadex (16 mg/kg)
Slovenian: Shema zdravljenja rokuronij in sugamadeks (16 mg/kg)
English: In a pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Slovenian: V ključni študiji uporabe zdravila so bolnike naključno razvrstili bodisi v skupino, ki je prejela rokuronij, ali pa v skupino, ki je prejela vekuronij.
English: Due to the administration of certain medicinal products after sugammadex, theoretically rocuronium or vecuronium could be displaced from sugammadex.
Slovenian: Pri dajanju nekaterih zdravil po sugamadeksu bi lahko ta teoretično izrinila rokuronij ali vekuronij iz kompleksa s sugamadeksom in bi prišlo do ponovitve živčnomišične blokade.
English: • If you get any side effects, talk to your anaesthetist or other doctor.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z anesteziologom ali z drugim zdravnikom.
English: In a pooled analysis the following recovery times for 16 mg/kg sugammadex after 1.2 mg/kg rocuronium bromide were reported:
Slovenian: V združeni analizi so dobili naslednje vrednosti časa, ki je bil potreben za prekinitev živčnomišične blokade, sprožene z 1,2 mg/kg rokuronijevega bromida, s pomočjo 16 mg/kg sugamadeksa:
English: Impaired Mild 50 51 (24)
Slovenian: starostnik normalno 75 let okvarjeno blago 50 51 (24)
English: If you get any side effects, talk to your anaesthetist or other doctor.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z anesteziologom ali drugim zdravnikom.
English: Sugammadex has only been administered as a single bolus injection in clinical trials.
Slovenian: V kliničnih preskušanjih so sugamadeks uporabljali samo v obliki enkratnih bolusnih injekcij.
English: Impaired Mild 50 51 (22)
Slovenian: 40 let okvarjeno blago 50 51 (22)
English: Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular blockade.
Slovenian: Obvezna je uporaba umetnega predihavanja, dokler po prekinitvi živčnomišične blokade bolnik ne začne spet samostojno dihati.
English: After the last dose of rocuronium or vecuronium, at the reappearance of T2, 2 mg/kg sugammadex or 50 mcg/kg neostigmine was administered in a randomised order.
Slovenian: Po dajanju zadnjega odmerka rokuronija ali vekuronija so pri ponovnem pojavu T2 bolnikom dali bodisi 2,0 mg/kg sugamadeksa ali pa 50 mcg/kg neostigmina, glede na naključno razporeditev v skupino.
English: At the reappearance of T2 a dose of 2 mg/kg sugammadex or 50 mcg/kg neostigmine was administered.
Slovenian: Ob ponovnem pojavu T2 so bolnikom dali sugamadeks v odmerku 2 mg/kg ali neostigmin v odmerku 50 mcg/kg.
English: Treatment regimen Sugammadex (4 mg/kg)
Slovenian: Shema zdravljenja sugamadeks (4 mg/kg)
English: How to store Bridion
Slovenian: Shranjevanje zdravila Bridion
English: Use for reversal of neuromuscular blocking agents other than rocuronium or vecuronium: Sugammadex should not be used to reverse block induced by nonsteroidal neuromuscular blocking agents such as succinylcholine or benzylisoquinolinium compounds.
Slovenian: Sugamadeksa ne smete uporabljati za prekinitev blokade živčnomišičnega prenosa, povzročene z nesteroidnimi mišičnimi relaksanti, kot so spojine sukcinilholina ali benzilizokinolina.
English: These reactions varied from isolated skin reactions to serious systemic reactions (i.e. anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex.
Slovenian: anafilaksija, anafilaktični šok) in so se pojavile tudi pri bolnikih, ki pred tem še niso prejeli sugamadeksa.
English: Time (minutes) from administration of sugammadex at 3 minutes after rocuronium to recovery of the T4/T1 ratio to 0.9, 0.8 or 0.7
Slovenian: Čas (v minutah) od dajanja sugamadeksa 3 minute za rokuronijem do povrnitve razmerja T4/T1 na vrednost 0,9, 0,8 ali 0,7 Povrnitev vrednosti T4/T1 na 0,9
English: VIAL LABEL, 10 x 5 mL vials
Slovenian: OZNAČEVANJE NA VIALI, 10 vial po 5 ml
English: Re-administration of rocuronium or vecuronium after routine reversal (up to 4 mg/kg sugammadex):
Slovenian: Časovni presledki pred ponovno uporabo mišičnih relaksantov po prekinitvi blokade s sugamadeksom: Ponovna uporaba rokuronija ali vekuronija po rutinski prekinitvi blokade (do 4 mg/kg sugamadeksa):
English: Treatment regimen Sugammadex (2 mg/kg)
Slovenian: Shema zdravljenja sugamadeks (2 mg/kg)
English: However, it may affect the results of a blood test for a hormone called progesterone.
Slovenian: Zdravilo Bridion na splošno ne vpliva na laboratorijske preiskave, lahko pa vpliva na izvide krvnih preiskav za določanje hormona progesterona.
English: Each vial of 5 mL contains 500 mg sugammadex (as sugammadex sodium).
Slovenian: Ena 5-mililitrska viala vsebuje 500 mg sugamadeksa (v obliki natrijevega sugamadeksata).
English: • your weight
Slovenian: • vaše telesne mase,
English: 1 mL contains 100 mg sugammadex (as sugammadex sodium).
Slovenian: 1 ml vsebuje 100 mg sugamadeksa (v obliki natrijevega sugamadeksata).
English: Treatment regimen Rocuronium and sugammadex (2 mg/kg)
Slovenian: Shema zdravljenja rokuronij in sugamadeks (2 mg/kg)
English: Time (minutes) from administration of sugammadex or neostigmine at deep neuromuscular blockade (1-2 PTCs) after rocuronium or vecuronium to recovery of the T4/T1 ratio to 0.9 Neuromuscular blocking agent
Slovenian: Čas (v minutah) od dajanja sugamadeksa ali neostigmina pri globoki živčnomišični blokadi (1-2 PTC), doseženi z rokuronijem ali vekuronijem, do povrnitve razmerja T4/T1 na vrednost 0,9 Mišični relaksant
English: VIAL LABEL, 10 x 2 mL vials
Slovenian: OZNAČEVANJE NA VIALI, 10 vial po 2 ml
English: 1 mL solution for injection contains sugammadex sodium equivalent to 100 mg sugammadex.
Slovenian: 1 ml raztopine za injiciranje vsebuje 100 mg sugamadeksa v obliki natrijevega sugamadeksata.
English: Bridion is administered concomitantly with neuromuscular blocking agents and anaesthetics in surgical patients.
Slovenian: Zdravilo Bridion se pri kirurških bolnikih uporablja sočasno z mišičnimi relaksanti in anestetiki, zato je težko oceniti vzročno povezanost neželenih učinkov.
English: Vecuronium
Slovenian: Vekuronij
English: It is unknown whether sugammadex is excreted in human breast milk.
Slovenian: Ni znano, ali se sugamadeks izloča v materino mleko pri človeku, študije pri živalih pa so potrdile izločanje zdravila v mleko samic.
English: Airway Complication of Anaesthesia:
Slovenian: Zapleti v dihalnih poteh pri anesteziji:
English: Each vial of 2 mL contains 200 mg sugammadex (as sugammadex sodium).
Slovenian: Ena 2-mililitrska viala vsebuje 200 mg sugamadeksa (v obliki natrijevega sugamadeksata).
English: Light anaesthesia:
Slovenian: Plitva anestezija:
English: Please refer to the package leaflet of rocuronium or vecuronium for a list of the specific medicinal products which potentiate neuromuscular blockade.
Slovenian: Prosimo, glejte seznam zdravil, ki okrepijo živčnomišično blokado, v navodilu za uporabo rokuronija ali vekuronija.
English: Each vial of 5 mL contains sugammadex sodium equivalent to 500 mg sugammadex.
Slovenian: Ena viala s 5 ml raztopine vsebuje 500 mg sugamadeksa v obliki natrijevega sugamadeksata.
English: Procedural Complication:
Slovenian: S posegom povezani zapleti:
English: Adolescent
Slovenian: Dojenje
English: The onset of neuromuscular blockade may be prolonged up to approximately 4 minutes, and the duration of neuromuscular blockade may be shortened up to approximately 15 minutes after readministration of rocuronium 1.2 mg/kg within 30 minutes after sugammadex administration.
Slovenian: Pri ponovni uporabi 1,2 mg/kg rokuronija v času 30 minut po uporabi sugamadeksa se lahko začetek delovanja živčnomišične blokade podaljša do približno 4 minute in čas trajanja živčnomišične blokade skrajša do približno 15 minut.
English: Time (minutes) from administration of sugammadex or neostigmine at reappearance of T2 after rocuronium or vecuronium to recovery of the T4/T1 ratio to 0.9
Slovenian: Čas (v minutah) od dajanja sugamadeksa ali neostigmina pri ponovnem pojavu T2 po uporabi rokuronija ali vekuronija do povrnitve razmerja T4/T1 na vrednost 0,9 Mišični relaksant
English: Time (minutes) from administration of sugammadex or neostigmine at reappearance of T2 after rocuronium or cis-atracurium to recovery of the T4/T1 ratio to 0.9
Slovenian: Čas (v minutah) od dajanja sugamadeksa ali neostigmina pri ponovnem pojavu T2 po uporabi rokuronija ali cisatrakurija do povrnitve razmerja T4/T1 na vrednost 0,9 Mišični relaksant
English: Each vial of 2 mL contains sugammadex sodium equivalent to 200 mg sugammadex.
Slovenian: Ena viala z 2 ml raztopine vsebuje 200 mg sugamadeksa v obliki natrijevega sugamadeksata.
English: In preclinical and clinical studies no metabolites of sugammadex have been observed and only renal excretion of the unchanged product was observed as the route of elimination.
Slovenian: Med načini izločanja zdravila pa so opazili le ledvično izločanje v nespremenjeni obliki.
English: 1 mL contains sugammadex sodium equivalent to 100 mg sugammadex.
Slovenian: 1 ml raztopine vsebuje 100 mg sugamadeksa v obliki natrijevega sugamadeksata.
English: Talk to your anaesthetist before Bridion is given
Slovenian: Preden dobite zdravilo Bridion, se posvetujte z anesteziologom:
English: A dose of 4 mg/kg sugammadex is recommended if recovery has reached at least 1-2 post-tetanic counts (PTC) following rocuronium or vecuronium induced blockade.
Slovenian: Če je po blokadi živčnomišičnega prenosa z rokuronijem ali vekuronijem izmerjena stopnja mišične relaksacije najmanj 1-2 PTC (post-tetanic counts) po tetanični stimulaciji, priporočamo odmerek sugamadeksa 4 mg/kg.
English: 30 ml (10 mg/ml)
Slovenian: 300 mg koncentrat za pripravo raztopine za infundiranje intravenska uporaba viala (steklena) 30 ml (10 mg/ml) 1 viala
English: Packaging
Slovenian: velikost pakiranja
English: Strength Pharmaceutical Form
Slovenian: Jakost Farmacevtska oblika Pot uporabe ovojnina
English: 13 July 2011
Slovenian: 13. julij 2011
English: The final opinion was converted into a Decision by the European Commission on 13 July 2011.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 13. julija 2011.
English: The referral procedure started on 14 July 2010.
Slovenian: Napotitveni postopek se je začel 14. julija 2010.
English: Written explanations were provided by the applicant/marketing authorisation holder on 29 October 2010 and 8 March 2011.
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom je 29. oktobra 2010 in 8. marca 2011 predložil pisna pojasnila.
English: The Committee appointed Mrs Ruth Kearsley as rapporteur and Dr Jiří Bureš as co-rapporteur.
Slovenian: Odbor je za poročevalko imenoval Ruth Kearsley, za soporočevalca pa dr. Jiříja Bureša.
English: Doxycycline is a semi-synthetic tetracycline antibiotic.
Slovenian: Doksiciklin je polsintetični tetraciklinski antibiotik.
English: International non-proprietary name (inn): doxycycline hyclate
Slovenian: Mednarodno nelastniško ime (INN): doksiciklinijev hiklat
English: Due to divergent national decisions taken by Member States regarding the target species, indications, amounts to be administered and withdrawal periods concerning the authorisation of Doxycycline 50% WSP and associated names, on 18 June 2010 the United Kingdom referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised summary of product characteristics across the European Union.
Slovenian: Zaradi različnih nacionalnih odločitev držav članic glede ciljnih vrst, indikacij, odmerjanja in karence v zvezi z odobritvijo zdravila Doxycycline 50 % WSP in povezanih imen je Združeno kraljestvo dne 18. junija 2010 zadevo napotilo na CVMP v skladu s členom 34(1) Direktive 2001/82/ES, da bi se odpravile razlike med nacionalno odobrenimi povzetki glavnih značilnosti zdravila v Evropski uniji.
English: Doxycycline 50% WSP and associated names is a powder for use in drinking water containing the active substance doxycycline hyclate 500 mg/g.
Slovenian: Zdravilo Doxycycline 50 % WSP in povezana imena je prašek za uporabo v pitni vodi, ki vsebuje zdravilno učinkovino doksiciklinijev hiklat 500 mg/g.
English: Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the rapporteurship.
Slovenian: Po odstopu Ruth Kearsley z mesta članice odbora CVMP je bila kot njena zamenjava imenovana Helen Jukes, ki je prevzela tudi poročanje.
English: Tetracyclines have broad spectrum activity inhibiting Gram-positive and Gram-negative bacteria, mycoplasmas, chlamydiae, rickettsias and some protozoa.
Slovenian: Tetraciklini imajo širok spekter delovanja ter zavirajo grampozitivne in gramnegativne bakterije, mikoplazme, klamidije, rikecije in nekatere protozoje.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit/risk profile for Doxycycline 50% WSP and associated names remains positive subject to variation of the marketing authorisations in accordance with the summary of product characteristics, and therefore adopted a positive opinion on 4 May 2011.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov, ki so jo opravili poročevalci, je CVMP menil, da razmerje med koristmi in tveganji za zdravilo Doxycycline 50 % WSP in povezana imena ostaja pozitivno pod pogojem, da se dovoljenja za promet z zdravilom spremenijo v skladu s povzetkom glavnih značilnosti zdravila, zato je dne 4. maja 2011 sprejel pozitivno mnenje.
English: In pigs and pre-ruminant calves the product is indicated for the treatment of certain infections of the respiratory tract.
Slovenian: Pri prašičih in teletih neprežvekovalcih je zdravilo indicirano za zdravljenje nekaterih okužb dihal.
English: Opinion following an Article 34 referral for Doxycycline 50% WSP and associated names
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 34 za zdravilo Doxycycline 50 % WSP in povezana imena
English: In chickens the product is indicated for named infections of the respiratory tract and the alimentary tract.
Slovenian: Pri piščancih je zdravilo indicirano za navedene okužbe dihal in prebavil.