FrancophonIA/ELRC3.0 huggingface dataset:
English: In calves, a single subcutaneous injection of 10 times the recommended dose (40 mg/kg body weight) and repeated subcutaneous administration of tildipirosin (on three occasions in intervals of 7 days) at 4, 12 and 20 mg/kg (1, 3 and 5 times the recommended clinical dose) were well tolerated, apart from transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in some animals.
Slovenian: Teleta so dobro prenašala enkratni subkutani odmerek, ki je bil 10-krat večji od priporočenega odmerka (40mg/kg telesne teže) in ponovno subkutano dajanje tildipirozina (trikrat v razmikih po 7 dni) v odmerkih 4, 12 in 20 mg/kg (1-krat, 3-krat in 5-krat priporočeni klinični odmerek), le pri nekaterih živalih so opazili prehodne klinične znake neugodja in otekline na mestu injiciranja, povezane z bolečino.
English: At 20 mg/kg body weight one out of eight animals showed transient generalized body tremors with inability to stand after the first administration and the animal showed transient unsteadiness on its feet after the third administration.
Slovenian: V skupini, ki je dobivala po 20 mg/kg telesne teže, se je pri eni živali od osmih po prvem odmerku pokazal prehoden generaliziran tremor in ni mogla stati, po tretjem odmerku pa so pri njej opazili prehodno nestabilnost.
English: The following tildipirosin breakpoints have been established for bovine respiratory disease (according to CLSI Guideline VET02 A3):
Slovenian: Za govejo respiratorno bolezen (v skladu smernico CLSI VET02 A3) so določene naslednje predlagane preliminarne prelomne točke za tildipirozin:
English: Pathomorphological injection site reactions will largely resolve within 35 days.
Slovenian: Patomorfološke reakcije na mestu injiciranja v glavnem izginejo v 35 dneh.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROSTITEV SERIJE
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega (odgovornih) za sprostitev serije
English: The following tildipirosin breakpoints have been established for swine respiratory disease (according to CLSI Guideline VET02 A3):
Slovenian: Za prašičjo respiratorno bolezen (v skladu s smernico CLSI VET02 A3) so določene naslednje predlagane preliminarne prelomne točke za tildipirozin:
English: Meat and offal: 47 days
Slovenian: Meso in organi: 47 dni
English: Pharmacotherapeutic group: antibacterials for systemic use, macrolides.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij,makrolidni antiobiotiki
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 180 mg/ml of tildipirosin
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI 180 mg/ml tildipirozina
English: Do not administer simultaneously with other macrolides or lincosamides (see section 12)
Slovenian: Ne dajajte istočasno z drugimi makrolidi ali linkozamidi (glejte poglavje 12)
English: Do not administer simultaneously with other macrolides or lincosamides (see section 12).
Slovenian: Ne dajajte istočasno z drugimi makrolidi ali linkozamidi (glejte poglavje 12).
English: Citric acid monohydrate Propylene glycol Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Citronska kislina, monohidrat propilen glikol voda za injekcije
English: Muscle tremors to the hind legs were observed following the first treatment in one pig each from the 12 and 20 mg/kg bodyweight group.
Slovenian: Mišični tremor v zadnjih nogah so opazili po prvem dajanju pri enem pujsku v skupinah, ki sta dobivali po 12 in 20 mg/kg telesne teže
English: Meat and offal: 9 days
Slovenian: Meso in organi: 9 dni
English: For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.
Slovenian: INDIKACIJE Za zdravljenje in preprečevanje respiratorne bolezni goveda (BRD), povzročene z Mannheimia haemolytica, Pasteurella multocida in Histophilus somni, ki so občutljivi za tildipirozin.
English: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin.
Slovenian: INDIKACIJE Zdravljenje in metafilaksa prašičje respiratorne bolezni (SRD), povzročene z Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica in Haemophilus parasuis, ki so občutljivi za tildipirozin.
English: Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid, which far exceed those in blood plasma.
Slovenian: Akumulacija na mestu infekcije respiratornega trakta, ki močno presega koncentracije v krvni plazmi,
English: Type I amber glass vial with a chlorobutyl rubber stopper and an aluminium cap.
Slovenian: Viala iz rjavega stekla tipa I z zamaškom iz klorbutilne gume in aluminijasto zaporko
English: Disease Species
Slovenian: Vrsta bolezni
English: Recommended needle size and diameter per production stage
Slovenian: Priporočena velikost in premer igle glede na kategorija
English: In piglets, intramuscular administration of tildipirosin (on three occasions in intervals of 4 days) at 8, 12 and 20 mg/kg body weight (BW) (2, 3 and 5 times the recommended clinical dose), resulted in transient slightly subdued behaviour in one piglet each from the 8 and 12 mg/kg BW group and 2 piglets from the 20 mg/kg BW group following the first or second injection.
Slovenian: Pri pujskih se je po intramuskularnem dajanju tildipirozina (trikrat v razmikih po 4 dni) v odmerkih 8, 12 in 20 mg/kg telesne teže (2-, 3- in 5-kratni priporočeni klinični odmerek) po prvem ali drugem odmerku pojavilo prehodno rahlo umirjeno vedenje pri enem pujsku v skupinah, ki sta prejemali po 8in 12 mg/kg telesne teže, in pri dveh pujskih iz skupine, ki je prejemala po 20 mg/kg telesne teže.
English: Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid (collected post mortem), which far exceed those in blood plasma.
Slovenian: se kaže z visoko in podaljšano koncentracijo tildipirozina v pljučih in bronhialni tekočini (zbrani post mortem).
English: OTHER INFORMATION Box containing 1 vial of 20 ml, 50 ml, 100 ml or 250 ml.
Slovenian: DRUGE INFORMACIJE Škatla z 1 vialo po 20 ml, 50 ml, 100 ml ali 250 ml. Ni nujno, da so v prometu vsa navedena pakiranja.
English: Vial (20 ml, 50 ml)
Slovenian: Govedo Viala (20 ml, 50 ml)
English: In vitro, the effect of tildipirosin is bacteriostatic against Pasteurella multocida and B. bronchiseptica, and bactericidal for A. pleuropneumoniae and H. parasuis.
Slovenian: B. bronchiseptica, in baktericidno za A. pleuropneumoniae in H. parasuis.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cattle
Slovenian: PODATKI NA ZUNANJI OVOJNINI Govedo
English: Box containing 1 vial of 20 ml, 50 ml, 100 ml or 250 ml.
Slovenian: Škatla z 1 vialo po 20 ml, 50 ml, 100 ml ali 250 ml Ni nujno, da so v prometu vsa navedena pakiranja.
English: MRL
Slovenian: i.m.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/001-004
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/11/124/001-004
English: R S
Slovenian: Rp-Vet.
English: QUANTITY OF THE ACTIVE SUBSTANCE 40 mg/ml of tildipirosin
Slovenian: 40 mg/ml tildipirozina
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pigs
Slovenian: PODATKI NA ZUNANJI OVOJNINI Prašiči
English: PHARMACEUTICAL FORM Solution for injection.
Slovenian: Raztopina za injiciranje
English: Growing-finishing Finishing/sows/boars
Slovenian: Pitanci Pitanci/svinje/merjasci
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Cattle
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: PACKAGE LEAFLET FOR: ZUPREVO 180 mg/ml solution for injection for cattle
Slovenian: NAVODILO ZA UPORABO: ZUPREVO 180 mg/ml, raztopina za injiciranje za govedo
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM Shranjujte nedosegljivo otrokom.
English: PACKAGE LEAFLET FOR: ZUPREVO 40 mg/ml solution for injection for pigs
Slovenian: NAVODILO ZA UPORABO: ZUPREVO 40 mg/ml, raztopina za injiciranje za prašiče
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Pigs
Slovenian: PODATKI, KI MORAJO BITI NA STIČNI OVOJNINI Prašiči
English: Ask your veterinary surgeon/pharmacist how to dispose of medicines no longer required.
Slovenian: Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ZUPREVO 180 mg/ml raztopina za injiciranje za govedo
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
Slovenian: B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: P. multocida
Slovenian: P. multocida H. somni
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle tildipirosin
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ZUPREVO 180 mg/ml, raztopina za injiciranje za govedo
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ZUPREVO 40 mg/ml raztopina za injiciranje za prašiče
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosto (pri več kot 1 živali od 10 živali stranski učinki v času enega zdravljenja) - pogosto (pri več kot 1 živali toda manj kot pri 10 živalih od 100 živali) - občasno (pri več kot 1 živali toda manj kot pri 10 živalih od 1.000 živali) - redko (pri več kot 1 živali toda manj kot pri 10 živalih od 10.000 živali) - zelo redko (pri manj kot 1 živali na 10.000 živali, vključno s posameznimi primeri)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Cattle
Slovenian: PODATKI, KI MORAJO BITI NA STIČNI OVOJNINI Govedo
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs tildipirosin
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ZUPREVO 40 mg/ml, raztopina za injiciranje za prašiče
English: Manufacturer for the batch release: Intervet International GmbH Feldstrasse 1 a
Slovenian: Intervet International GmbH
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/007
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/11/124/007
English: 4.2 Indications for use, specifying the target species
Slovenian: KLINIČNI PODATKI 4.1 Ciljne živalske vrste
English: I
Slovenian: DODATEK I
English: BATCH NUMBER Batch:
Slovenian: ŠTEVILKA SERIJE Serija:
English: SPECIAL WARNINGS Read the package leaflet before use.
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pred uporabo preberite navodilo za uporabo.
English: Muscle Skin+fat Liver Kidney
Slovenian: Raztopina za injiciranje Bistra rumenkasta raztopina
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/003
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/11/124/003
English: Zone diameter (mm) MIC breakpoint (µg/ml) S I
Slovenian: Prelomne točke MIK (µg/ml) O S R O S R
English: Keep out of the sight and reach of children.
Slovenian: Shranjujte Nedosegljivo otrokom.
English: Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Slovenian: Lot ponedeljek torek sreda četrtek petek sobota nedelja
English: • At the request of the EMEA.
Slovenian: • na zahtevo Evropske agencije za zdravila (EMEA).
English: Not known (frequency cannot be estimated from the available data): Kidney problems.
Slovenian: Pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov): težave z ledvicami.
English: It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects.
Slovenian: Zelo pomembno je, da jemljete to zdravilo natančno tako, kot vam naroči zdravnik, da bodo rezultati zdravljenja kar najboljši, možnost stranskih učinkov pa čim manjša.
English: The use of Tekturna in children and adolescents is not recommended.
Slovenian: Uporaba zdravila Tekturna pri otrocih in mladostnikih ni priporočena.
English: hands and feet, eyes, lips and/or tongue).
Slovenian: oči, ustnic in/ali jezika).
English: Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Tekturna.
Slovenian: Preden se namenite upravljati vozilo, uporabljati stroje ali opravljati druge dejavnosti, ki zahtevajo zbranost, morate dobro poznati svoj odziv na učinke zdravila Tekturna.
English: People who have high blood pressure often do not notice any signs of the problem.
Slovenian: Ljudje, ki imajo visok krvni tlak, pogosto ne čutijo težav povezanih s tem.
English: If you forget to take a dose of Tekturna, take it as soon as you remember and then take the next dose at its usual time.
Slovenian: Če pozabite vzeti odmerek zdravila Tekturna, ga vzemite takoj, ko se spomnite nanj in nato vzemite naslednji odmerek ob običajnem času.
English: If you forget to take Tekturna
Slovenian: Če ste pozabili vzeti zdravilo Tekturna
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Slovenian: • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja)
English: Tekturna has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Slovenian: Zdravilo Tekturna so proučevali pri 1.864 bolnikih, starih 65 let ali več, in pri 426 bolnikih, starih 75 let ali več.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
English: However, CYP3A4 inhibitors often also affect P-gp.
Slovenian: Vendar zaviralci CYP3A4 pogosto vplivajo tudi na P-gp.
English: Due to the lack of data a potential interaction between grapefruit juice and aliskiren cannot be excluded.
Slovenian: Zaradi pomanjkanja podatkov medsebojnega delovanja med grenivkinim sokom in aliskirenom ni mogoče izključiti.
English: Tekturna has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Slovenian: Varnost zdravila Tekturna so ocenjevali pri več kot 7.800 bolnikih, med drugim pri več kot 2.300 bolnikih, ki so bili zdravljeni več kot 6 mesecev, in pri več kot 1.200 bolnikih, ki so bili zdravljeni več kot 1 leto.
English: Your doctor may prescribe Tekturna together with other medicines used to treat high blood pressure.
Slovenian: Zdravnik vam lahko predpiše zdravilo Tekturna skupaj z drugimi zdravili za zdravljenje visokega krvnega tlaka.
English: In experimental animals, it has been shown that P-gp is a major determinant of Tekturna bioavailability.
Slovenian: Na poskusnih živalih se je pokazalo, da je P-gp glavna determinanta biološke uporabnosti zdravila Tekturna.
English: Tekturna helps to lower high blood pressure.
Slovenian: Tekturna pomaga zniževati visok krvni tlak.
English: If angioedema occurs, Tekturna should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Slovenian: Če pride do angioedema, je treba zdravljenje z zdravilom Tekturna takoj prekiniti in poskrbeti za ustrezno zdravljenje in spremljanje bolnika, dokler znaki in simptomi niso v celoti in trajno odpravljeni.
English: The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.
Slovenian: Neželeni učinki (preglednica 1) so razvrščeni po skupinah glede na pogostnost, najpogostejši najprej, po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100, <1/10); občasni (≥1/1.000, <1/100); redki (≥1/10.000, <1/1.000); zelo redki (<1/10.000), vključno s posameznimi primeri.
English: If any of these apply to you, tell your doctor before you take Tekturna.
Slovenian: Če kaj od navedenega velja za vas, povejte zdravniku, preden začnete jemati zdravilo Tekturna.
English: Beneficial effects of Tekturna on mortality and cardiovascular morbidity and target organ damage are currently unknown.
Slovenian: Ugodni vplivi zdravila Tekturna na umrljivost, kardiovaskularno obolevnost in prizadetost tarčnih organov trenutno niso znani.
English: Preliminary data suggest that irbesartan may decrease Tekturna AUC and Cmax.
Slovenian: Predhodni podatki nakazujejo, da irbesartan lahko zmanjša AUC in Cmax zdravila Tekturna.
English: The clinical relevance of a reduction in UACR is not established in the absence of an effect on blood pressure.
Slovenian: Kliničnega pomena zmanjšanja UACR niso ugotovili glede na to, da ne vpliva na krvni tlak.
English: If this continues for a long time, it can damage the blood vessels of the brain, heart and kidneys, and may result in a stroke, heart failure, heart attack or kidney failure.
Slovenian: Če to traja dolgo, lahko poškoduje krvne žile v možganih, srcu in ledvicah in lahko povzroči možgansko kap, odpoved srca, srčni infarkt ali odpoved ledvic.
English: Cases of angioedema have also been reported in post-marketing experience (frequency unknown).
Slovenian: Primere angioedema so opisovali tudi na podlagi izkušenj po prihodu zdravila na trg (pogostnost neznana).
English: Tekturna was not teratogenic in rats or rabbits (see section 5.3).
Slovenian: Zdravilo Tekturna ni bilo teratogeno pri podganah ali kuncih (glejte poglavje 5.3).
English: Elderly patients (over 65 years) No adjustment of the initial dose is required for elderly patients.
Slovenian: Starejši bolniki (starejši od 65 let) Starejšim bolnikom ni potrebno prilagajati začetnega odmerka.
English: If symptomatic hypotension should occur, supportive treatment should be initiated.
Slovenian: Če pride do simptomatske hipotenzije, je potrebno uvesti podporno zdravljenje.
English: Food intake Meals with a high fat content have been shown to reduce the absorption of Tekturna substantially.
Slovenian: Pokazalo se je, da obroki z veliko vsebnostjo maščob bistveno zmanjšajo absorpcijo zdravila Tekturna.
English: Tekturna should be taken with a light meal once a day, preferably at the same time each day.
Slovenian: Zdravilo Tekturna je treba jemati z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem času.
English: Do not use Tekturna after the expiry date which is stated on the carton and blister.
Slovenian: Zdravila Tekturna ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
English: Rare (affecting less than 1 in 1,000 patients): Angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
Slovenian: Redki (pojavijo se pri manj kot 1 od 1.000 bolnikov): angioedem (oteženo dihanje in požiranje ali otekanje v obraz, roke in stopala, oči, ustnice in/ali jezik).
English: Like all medicines, Tekturna can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Tekturna neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: In this leaflet: What Tekturna is and what it is used for
Slovenian: KAJ JE ZDRAVILO TEKTURNA IN ZA KAJ GA UPORABLJAMO
English: In the event of any signs suggesting an allergic reaction (in particular difficulties in breathing, or swallowing, or swelling of the face, extremities, eyes, lips and/or tongue) patients should discontinue treatment and contact the physician (see section 4.4).
Slovenian: V primeru znakov, ki bi nakazovali alergično reakcijo (še posebno, če gre za težave z dihanjem ali pri požiranju, otekanje obraza, okončin, oči, ustnic in/ali jezika), mora bolnik prekiniti zdravljenje in se obrniti na zdravnika (glejte poglavje 4.4).
English: As for any medicine that acts directly on the RAS, Tekturna should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Slovenian: Tako kot velja za katerokoli drugo zdravilo, ki deluje neposredno na sistem renin-angiotenzin, tudi zdravila Tekturna ne smete uporabljati v prvem trimesečju nosečnosti oziroma pri ženskah, ki načrtujejo nosečnost, poleg tega je kontraindiciran v drugem in tretjem trimesečju nosečnosti (glejte poglavje 4.3).
English: The MAH must ensure that the system of pharmacovigilance, as described in version 2 (dated 5 July 2006) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2 (z dne 5. junija 2006), predstavljen v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
English: In the event of severe and persistent diarrhoea, Tekturna therapy should be stopped.
Slovenian: V primeru hude ali persistentne driske je treba zdravljenje z zdravilom Tekturna prekiniti.
English: In diabetic hypertensive patients, Tekturna monotherapy was safe and effective.
Slovenian: Pri sladkornih bolnikih s hipertenzijo je bila monoterapija z zdravilom Tekturna varna in učinkovita.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 30 May 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici načrta za obvladovanje tveganja (RMP) z dne 30. maja 2007, predstavljenem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
English: The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Tekturna and placebo, respectively.
Slovenian: Delež bolnikov, ki so imeli UACR zmanjšano za vsaj 50 % od izhodiščne vrednosti, je bil pri zdravilu Tekturna 24,7 %, pri placebu pa 12,5 %.
English: In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Tekturna 150 mg was well tolerated.
Slovenian: V 3-mesečni študiji, ki je vključevala 302 bolnika z blagim, stabilnim srčnim popuščanjem, od katerih so vsi prejemali standardno terapijo pri stabilnem srčnem popuščanju, so bolniki dodajanje zdravila Tekturna v odmerku 150 mg dobro prenašali.
English: Tekturna was secreted in the milk of lactating rats.
Slovenian: Zdravilo Tekturna se je izločalo v mleko doječih podgan.