FrancophonIA/ELRC3.0 huggingface dataset:
English: Abdominal distension Gastritis Abdominal discomfort Dysphagia Gastro-oesophageal reflux disease (GORD) Tongue discolouration
Slovenian: Napihnjenost trebuha Gastritis Nelagodje v trebuhu Disfagija Gastroezofagealni refluks (GERB) Sprememba barve jezika
English: Velphoro has been administered to over 248 seniors (≥65 years of age) according to the approved dosing regimen.
Slovenian: V skladu z odobrenim režimom odmerjanja so zdravilo Velphoro dajali več kot 248 starostnikom (≥ 65 let).
English: See section 2 for further information on sucrose and starches.
Slovenian: Za več informacij o saharozi in škrobu glejte poglavje 2.
English: Velphoro does not affect guaiac based (Haemoccult) or immunological based (iColo Rectal and Hexagon Obti) faecal occult blood tests.
Slovenian: Zdravilo Velphoro ne vpliva na teste gvajak (Haemoccult) ali imunološke (iColo Rectal in Hexagon Obti) teste krvi v blatu.
English: Child-resistant aluminium/aluminium perforated unit-dose blister, each blister containing 6 chewable tablets.
Slovenian: Aluminijasti pretisni omot/aluminijasti perforiran pretisni omot za enkratni odmerek z otroško zaščito, pri čemer en omot vsebuje 6 žvečljivih tablet.
English: Brown, circular tablets embossed with PA500 on one side.
Slovenian: Rjave, okrogle tablete, ki imajo na eni strani vtisnjeno oznako PA500.
English: If you forget to take Velphoro
Slovenian: Če ste pozabili vzeti zdravilo Velphoro
English: Adult patients with hyperphosphataemia (serum phosphorus levels ≥1.94 mmol/L) were treated with Velphoro at a starting dose of 1,000 mg iron/day followed by an 8-week dose titration period.
Slovenian: Odrasle bolnike s hiperfosfatemijo (raven fosforja v serumu ≥ 1,94 mmol/l) so zdravili z zdravilom Velphoro z začetnim odmerkom 1.000 mg železa/dan, čemur je sledilo 8­tedensko obdobje titriranja odmerka.
English: Pack sizes of 30 or 90 chewable tablets.
Slovenian: Velikost pakiranj: 30 ali 90 žvečljivih tablet.
English: At the end of week 24, 93 patients on hemodialysis whose serum phosphorus levels were controlled (<1.78 mmol/L) with Velphoro in the first part of the study, were re-randomized to continue treatment with either their week 24 maintenance dose (N=44 or a non-effective low dose control 250 mg iron/day, N=49) of Velphoro for a further 3 weeks.
Slovenian: Na koncu 24. tedna so 93 bolnikov na hemodializi, ki so jim v prvem delu študije nadzirali ravni fosforja v serumu (< 1,78 mmol/l) z zdravilom Velphoro, ponovno randomizirali, da so nadaljevali zdravljenje bodisi z vzdrževalnim odmerkom 24. tedna (N = 44) bodisi z neučinkovitim nizkim odmerkom kontrole 250 mg železa/dan, (N = 49) zdravila Velphoro še nadaljnje 3 tedne.
English: 4.7 Effects on ability to drive and use machines Velphoro has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Velphoro nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and a foil induction seal, or in child resistant aluminium blister.
Slovenian: Tablete so pakirane v plastenkah iz polietilena visoke gostote, ki imajo za otroke varen polipropilenski pokrovček in zaporko z indukcijsko zatesnjeno folijo, ali v aluminijastih pretisnih omotih z otroško zaščito.
English: The usual recommended starting dose is the equivalent of 1,500 mg iron per day (3 tablets).
Slovenian: Običajni priporočeni začetni odmerek zdravila je enak 1.500 mg železa na dan (3 tablete).
English: Multipacks are available for the blister packs with 90 chewable tablets (containing 3 individual packs of 30 × 1 chewable tablets each).
Slovenian: Večja pakiranja so na voljo za pakiranja s pretisnimi omoti z 90 žvečljivimi tabletami (vsebujejo 3 posamezna pakiranja po 30 × 1 žvečljivo tableto).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS), PART OF MULTIPACK (WITHOUT BLUE BOX)
Slovenian: ZUNANJOST ŠKATLE - 30 ŽVEČLJIVIH TABLET (5 PRETISNIH OMOTOV S PO 6 ŽVEČLJIVIMI TABLETAMI), DEL VEČJEGA PAKIRANJA (BREZ MODREGA OKENCA)
English: What Velphoro looks like and contents of the pack
Slovenian: Izgled zdravila Velphoro in vsebina pakiranja
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) chewable tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Večje pakiranje: 90 (3 pakiranja po 30) žvečljivih tablet.
English: The maximum recommended dose is 3,000 mg iron (6 tablets) per day.
Slovenian: Največji priporočeni odmerek je 3000 mg železa (6 tablet) na dan.
English: When administering any medicinal product that is already known to interact with iron (like alendronate and doxycycline) or has the potential to interact with Velphoro based only on in vitro studies like levothyroxine, the medicinal product should be administered at least one hour before or two hours after Velphoro.
Slovenian: Pri jemanju katerega koli zdravila, za katerega je znano, da vpliva na železo (kot sta alendronat in doksiciklin), ali pa se je pri študijah in vitro pokazala možnost, da bi zdravilo, kot je levotiroksin, lahko vplivalo na zdravilo Velphoro, je treba to zdravilo jemati vsaj eno uro pred jemanjem zdravila Velphoro ali dve uri po tem.
English: If you stop taking Velphoro
Slovenian: Če ste prenehali jemati zdravilo Velphoro
English: In Study-05A, 1,055 patients on hemodialysis (N=968) or peritoneal dialysis (N=87) with serum phosphorus ≥1.94 mmol/L following a 2 - 4-week phosphate binder washout period, were randomized and treated with either Velphoro, at a starting dose of 1,000 mg iron/day (N=707), or active-control (sevelamer carbonate, N=348) for 24 weeks.
Slovenian: V študiji­05A so 1.055 bolnikov na hemodializi (N = 968) ali peritonealni dializi (N = 87) s fosforjem v serumu ≥ 1,94 mmol/l, ki je sledila 2­ do 4­tedenskemu obdobju brez fosfatnih vezalcev, naključno porazdelili in jih 24 tednov zdravili z zdravilom Velphoro z začetnim odmerkom 1.000 mg železa/dan (N = 707) ali s kontrolo z učinkovino (sevelamerijev karbonat, N = 348).
English: High density polyethylene (HDPE) bottle with child-resistant polypropylene closure and foil induction seal, containing a molecular sieve desiccant and cotton.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE) z za otroke varnim polipropilenskim pokrovčkom in zaporko z indukcijsko zatesnjeno folijo ter sušilnim molekularnim sitom in bombažem.
English: Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).
Slovenian: Zdravilo Velphoro je indicirano za uravnavanje ravni fosforja v serumu pri odraslih s kronično ledvično boleznijo (KLB) in bolnikih na hemodializi (HD) ali peritonealni dializi (PD).
English: Method of administration - Velphoro should only be taken by mouth.
Slovenian: Način uporabe - Zdravilo Velphoro se jemlje samo peroralno (skozi usta).
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Mean serum phosphorus levels were 2.5 mmol/L at baseline and 1.8 mmol/L at week 12 for Velphoro (reduction by 0.7 mmol/L).
Slovenian: Povprečne ravni fosforja v serumu so bile v izhodišču 2,5 mmol/l in 1,8 mmol/l v 12. tednu pri zdravilu Velphoro (zmanjšanje za 0,7 mmol/l).
English: Velphoro contains potato starch and pregelatinised maize starch.
Slovenian: Zdravilo Velphoro vsebuje krompirjev škrob in predgelatinizirani koruzni škrob.
English: Velphoro works by binding phosphorus from food in your digestive tract (stomach and intestines).
Slovenian: Zdravilo Velphoro veže fosfor iz hrane v prebavnem traktu (želodcu in črevesju).
English: Serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption.
Slovenian: Raven fosforja v serumu se zmanjša kot posledica zmanjšane absorbcije fosfata iz prehrane.
English: The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day, divided across the meals of the day.
Slovenian: Priporočeni začetni odmerek zdravila Velphoro je 1500 mg železa (3 tablete) na dan porazdeljeno na dnevne obroke.
English: How to take Velphoro
Slovenian: Kako jemati zdravilo Velphoro
English: PHARMACEUTICAL FORM AND CONTENTS 30 × 1 chewable tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 × 1 žvečljiva tableta
English: LIST OF EXCIPIENTS Contains sucrose, potato starch and pregelatinised maize starch.
Slovenian: Vsebuje saharozo, krompirjev škrob in predgelatinizirani koruzni škrob.
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex France
Slovenian: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex Francija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/001 30 chewable tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/943/001 30 žvečljivih tablet
English: Velphoro is for oral administration only and must be taken with meals.
Slovenian: Zdravilo Velphoro je samo za peroralno uporabo in ga je treba jemati s hrano.
English: Velphoro is a medicine that contains the active substance sucroferric oxyhydroxide, which is made up from iron, sugar (sucrose) and starches.
Slovenian: Velphoro je zdravilo, ki vsebuje učinkovino železov(III) oksihidroksid saharozni kompleks, ki je sestavljena iz železa, sladkorja (saharoza) in škroba.
English: (listed in section 6) - if you have a history of abnormal iron build-up in your organs (haemochromatosis) - if you have any other disorder associated with too much iron.
Slovenian: - če ste alergični na železov(III) oksihidroksid saharozni kompleks ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če se vam je kdaj v preteklosti v organih kopičila prevelika količina železa (hemokromatoza); - če imate drugo motnjo, ki je povezana s preveč železa.
English: Your doctor will advise you whether Velphoro should be used during pregnancy, based on benefit and risk assessment for use during pregnancy.
Slovenian: Vaš zdravnik vam bo na podlagi ocene koristi in tveganj uporabe med nosečnostjo povedal, ali lahko zdravilo Velphoro jemljete med nosečnostjo.
English: There are no available clinical data from the use of sucroferric oxyhydroxide on exposed human pregnancies.
Slovenian: Kliničnih podatkov o uporabi železovega(III) oksihidroksid saharoznega kompleksa pri nosečnicah ni na voljo.
English: In rats, there was a slightly increased incidence of benign C-cell adenoma in the thyroid of male rats given the highest dose of sucroferric oxyhydroxide.
Slovenian: Pri podganjih samcih, ki so dobivali največji odmerek železovega(III) oksihidroksid saharoznega kompleksa, so opazili nekoliko povečan pojav benignega C­celičnega adenoma v ščitnici.
English: Black stools may occur very commonly in patients taking Velphoro.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Velphoro, se lahko zelo pogosto pojavi črno blato.
English: Velphoro contains a mixture of polynuclear iron(III)-oxyhydroxide (pn-FeOOH), sucrose and starches.
Slovenian: Zdravilo Velphoro vsebuje mešanico polinuklearnega železovega(III) oksihidroksida (pn­FeOOH), saharoze in škroba.
English: There are no available clinical data from the use of Velphoro in breast-feeding women.
Slovenian: Kliničnih podatkov o uporabi zdravila Velphoro pri doječih materah ni na voljo.
English: Velphoro contains starches.
Slovenian: Zdravilo Velphoro vsebuje škrob.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Slovenian: Ena žvečljiva tableta vsebuje 500 mg železa v obliki železovega(III) oksihidroksid saharoznega kompleksa (sucroferric oxyhydroxide), ki je znan tudi kot mešanica polinuklearnega železovega(III) oksihidroksida, saharoze in škroba.
English: However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in the clinical studies with Velphoro.
Slovenian: Vendar pa v kliničnih študijah z zdravilom Velphoro niso opazili nobenih okvar jeter ali bistvenih sprememb jetrnih encimov.
English: Pack sizes of 30 × 1 or multipack of 90 (3 packs of 30 × 1) chewable tablets.
Slovenian: Velikost pakiranj: 30 × 1 žvečljiva tableta ali večje pakiranje po 90 žvečljivih tablet (3 pakiranja po 30 × 1).
English: Velphoro can cause black stools.
Slovenian: Zaradi uporabe zdravila Velphoro se lahko blato obarva črno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/943/004
English: In the 55 weeks long term studies, the majority of these diarrhoea adverse reactions were transient, occurred early during treatment initiation and led to treatment discontinuation in 3.1% of the patients.
Slovenian: Pojavili so se kmalu na začetku zdravljenja, pri 3,1 % bolnikov pa je to privedlo do prekinitve zdravljenja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/943/003
English: What Velphoro contains
Slovenian: Kaj vsebuje zdravilo Velphoro
English: No dose-dependent trends were observed in the adverse reaction profile of Velphoro.
Slovenian: V profilu neželenih učinkov zdravila Velphoro ni bilo opaženih učinkov, odvisnih od odmerka.
English: Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in increments of 500 mg iron (1 tablet) per day every 2 - 4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards.
Slovenian: Raven fosforja v serumu je treba spremljati in vsake 2 - 4 tedne povečevati oziroma zmanjševati odmerek zdravila Velphoro v korakih po 500 mg železa (1 tableta) na dan.
English: Neohesperidin-dihydrochalcone Magnesium stearate
Slovenian: Neohesperidin dihidrokalkon
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - BOTTLE OF 30 AND 90 CHEWABLE TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - PLASTENKA S 30 IN 90 ŽVEČLJIVIMI TABLETAMI
English: Any potential bleeding from your digestive tract (stomach and gut) may be hidden by these black stools.
Slovenian: Takšno črno blato lahko prikrije morebitne krvavitve v prebavnem traktu (želodcu in črevesju).
English: Nausea Constipation Vomiting Dyspepsia Abdominal pain Flatulence Tooth discolouration
Slovenian: Navzea Zaprtje Bruhanje Dispepsija Bolečine v trebuhu Flatulenca Sprememba barve zob
English: - The active substance is iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Slovenian: - Učinkovina je železo v obliki železovega(III) oksihidroksid saharoznega kompleksa, ki je znan tudi kot mešanica polinuklearnega železovega(III) oksihidroksida, saharoze in škroba.
English: The active moiety of Velphoro, pn-FeOOH, is not metabolised.
Slovenian: Aktivna sestavina zdravila pn­FeOOH se ne presnavlja.
English: Velphoro can cause discoloured (black) stool.
Slovenian: Zaradi uporabe zdravila Velphoro lahko blato spremeni barvo (se obarva črno).
English: One phase 3 clinical study has been performed in patients with CKD on dialysis to investigate the efficacy and safety of Velphoro in this population.
Slovenian: Da bi preučili učinkovitost in varnost zdravila Velphoro v tej populaciji, so pri bolnikih s KLB na dializi opravili eno klinično študijo v 3 fazah.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACK) - 90 (3 PACKS OF 30) CHEWABLE TABLETS
Slovenian: ZUNANJOST ŠKATLE (VEČJE PAKIRANJE) - 90 (3 PAKIRANJA PO 30) ŽVEČLJIVIH TABLET
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON -30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS)
Slovenian: ZUNANJA ŠKATLA - 30 ŽVEČLJIVIH TABLET (5 PRETISNIH OMOTOV S PO 6 ŽVEČLJIVIMI TABLETAMI)
English: NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets iron as sucroferric oxyhydroxide
Slovenian: Navodilo za uporabo Velphoro 500 mg žvečljive tablete železo v obliki železovega(III) oksihidroksid saharoznega kompleksa (sucroferric oxyhydroxide)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 30 AND 90 CHEWABLE TABLETS
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA - PLASTENKA S 30 IN 90 ŽVEČLJIVIMI TABLETAMI
English: There is no clinical data available with Velphoro in patients with earlier stages of renal impairment.
Slovenian: Pri bolnikih z zgodnejšo fazo okvare ledvic ni na voljo kliničnih podatkov v zvezi z zdravilom Velphoro.
English: How to store Velphoro
Slovenian: Shranjevanje zdravila Velphoro
English: Colloidal anhydrous silica 6.2 Incompatibilities
Slovenian: Brezvodni koloidni silicijev dioksid
English: Diarrhoea* Faeces discoloured
Slovenian: Diareja* Sprememba barve blata
English: Tabulated list of adverse reactions
Slovenian: Povzetek neželenih učinkov v tabeli
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 6 CHEWABLE TABLETS
Slovenian: PRETISNI OMOT S 6 ŽVEČLJIVIMI TABLETAMI
English: Information about sucrose and starches (carbohydrates) Velphoro contains sucrose.
Slovenian: Zdravilo Velphoro vsebuje saharozo in škrob (ogljikovi hidrati)
English: Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide.
Slovenian: Ena žvečljiva tableta vsebuje 500 mg železa v obliki železovega(III) oksihidroksid saharoznega kompleksa.
English: Velphoro contains sucrose and starches (carbohydrates) If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: Discoloured stool
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: 27 April 2010
Slovenian: 27. aprila 2010
English: The final opinion was converted into a Decision by the European Commission on 27 April 2010.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 27. aprila 2010.
English: The referral procedure started on 14 July 2009.
Slovenian: Napotitveni postopek se je začel 14. julija 2009.
English: The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the reference Member State was Germany and the concerned Member States were Austria, Belgium, Denmark, Greece, Spain, Finland, Ireland, Italy, Luxemburg, the Netherlands, Norway, Portugal and Sweden.
Slovenian: Vloga je bila predložena v skladu s členom 6 Uredbe Komisije 1084/2003/ES, pri čemer je bila referenčna država članica Nemčija, zadevne države članice pa Avstrija, Belgija, Danska, Grčija, Španija, Finska, Irska, Italija, Luksemburg, Nizozemska, Norveška, Portugalska in Švedska.
English: EMA/183104/2010 Veterinary Medicines
Slovenian: EMA/183104/2010 Veterinarska zdravila
English: Article 6(12) of Regulation (EC) No 1084/2003.
Slovenian: Člen 6(12) Uredbe (ES) št. 1084/2003.
English: International non-proprietary name (INN): ramipril
Slovenian: Mednarodno nelastniško ime (INN): ramipril
English: The mutual recognition procedures (DE/V/0103/001/II/007, DE/V/0103/002/II/007 and DE/V/0103/004/II/007) started on 3 December
Slovenian: Postopki z medsebojnim priznavanjem (DE/V/0103/001/II/007, DE/V/0103/002/II/007 in DE/V/0103/004/II/007) so se začeli 3. decembra 2008.
English: The rapporteur and co-rapporteur appointed were Dr. R. Breathnach and Dr. M. Holzhauser-Alberti respectively.
Slovenian: Za poročevalca je bil določen dr. R. Breathnach, za soporočevalca pa dr. M. Holzhauser-Alberti.
English: The products are currently authorised for use in dogs for the treatment of congestive heart failure (NYHA classification grade II, III and IV) due to chronic degenerative valvular heart disease or cardiomyopathy, with or without adjunct diuretic (furosemide) or cardiac glycoside (digoxin/methyldigoxin) therapy.
Slovenian: Zdravila so trenutno odobrena za uporabo pri psih za zdravljenje kongestivnega srčnega popuščanja (razreda II, III in IV po klasifikaciji NYHA) zaradi kroničnega obolenja srčnih zaklopk ali kardiomiopatije z dodatnim zdravljenjem z diuretikom (furosemidom) ali srčnim glikozidom (digoksinom/metildigoksinom) ali brez dodatnega zdravljenja.
English: On 2 July 2009 Belgium referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns whether the marketing authorisation should be varied by adding cats as a new target species by considering if a placebo group is deemed necessary in a clinical field trial to assess the efficacy of ramipril in cats to reduce systolic blood pressure.
Slovenian: Dne 2. julija 2009 je Belgija v skladu s členom 39 Direktive 2001/82/ES, kakor je bila spremenjena s sklicevanjem na člen 6(12) Uredbe (ES) št. 1084/2003, zadevo napotila na agencijo zaradi zadržkov glede spremembe dovoljenja za promet z dodatkom mačk kot nove ciljne živalske vrste, da bi ugotovila, ali je za vrednotenje učinkovitosti ramiprila za znižanje sistoličnega krvnega tlaka pri mačkah potrebna placebo skupina v kliničnem terenskem preskušanju.
English: tablet for dogs
Slovenian: za zdravilo Vasotop P tablete za pse
English: Written explanations were provided by the marketing authorisation holder on 17 August 2009.
Slovenian: Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil 17. avgusta 2009, razlage v ustni obliki pa 11. novembra 2009.
English: Further to rapporteurs' assessment of the currently available data, the CVMP adopted on 8 December 2009 an opinion recommending that the variation application for the veterinary medicinal products Vasotop P 0.625 mg tablet for dogs, Vasotop P 1.25 mg tablet for dogs and Vasotop P 2.5 mg tablet for dogs and associated names does not satisfy the criteria for approval in respect of efficacy.
Slovenian: Na podlagi poročevalčeve ocene trenutno razpoložljivih podatkov je CVMP 8. decembra 2009 sprejel mnenje, v katerem priporoča, da vloga za spremembo zdravil za uporabo v veterinarski medicini Vasotop P 0,625 mg tablete za pse, Vasotop P 1,25 mg tablete za pse in Vasotop P 2,5 mg tablete za pse in z njim povezana imena glede učinkovitosti ne izpolnjuje meril za odobritev.
English: Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets are veterinary medicinal products that contain the active ingredient ramipril at concentrations of 0.625 mg, 1.25 mg and 2.5 mg respectively.
Slovenian: Zdravila Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg tablete so zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino ramipril v koncentracijah 0,625 mg, 1,25 mg in 2,5 mg. Ramipril je zaviralec angiotenzinske konvertaze (ACE).
English: The marketing authorisation holder (Intervet International B.V.) submitted applications for a type II variation subject to mutual recognition procedures for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets for dogs in order to include a new indication for cats as follows: For the reduction of elevated systolic blood pressure (between 160 and 230 mm Hg) and the control of associated clinical signs.
Slovenian: je predložil vloge za spremembo tipa II po postopkih z medsebojnim priznavanjem za zdravila Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg tablete za pse, da bi vključil novo indikacijo za mačke: Za znižanje povišanega sistoličnega krvnega tlaka (med 160 in 230 mm Hg) in obvladovanje povezanih kliničnih znakov.
English: Opinion following an Article 6(12) referral for Vasotop P tablet for dogs EMA/183104/2010
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 6(12) za zdravilo Vasotop P tablete za pse
English: Including fatal outcome.
Slovenian: Vključno s smrtnimi izidi.
English: Also tell your doctor if you are taking or have recently taken any other medicines.
Slovenian: Zdravnika obvestite tudi, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
English: Very limited data are available.
Slovenian: Na voljo je zelo malo podatkov.