FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP is of the opinion that the data from the MAH's study and that reported by Belew (1999) do not support the concept of habituation in cats in terms of blood pressure measurements.
Slovenian: CVMP meni, da podatki iz študije imetnika dovoljenja za promet z zdravilom in podatki, o katerih je poročal Belew (1999), ne podpirajo koncepta prilagoditve pri mačkah z vidika meritev krvnega tlaka.
English: As many of the clinical signs are non-specific, and are cardiovascular in nature, an escape therapy could be possible and more than adequate in addressing those signs.
Slovenian: Ker je mnogo kliničnih znakov nespecifičnih in kardiovaskularne narave, bi bila terapija izogiba možna in kar najbolj ustrezna pri obravnavanju teh znakov.
English: the CVMP concluded that the absence of a negative control group (placebo group) in the pivotal clinical field trial was considered unacceptable,
Slovenian: CVMP je sklenil, da je odsotnost negativne kontrolne skupine (skupine, nadzorovane s placebom) v ključnem kliničnem terenskem preskušanju nesprejemljiva.
English: The MAH stated that their finding was in agreement with that reported previously by Belew
Slovenian: Imetnik dovoljenja za promet z zdravilom je navedel, da so bili njegovi rezultati v skladu z rezultati, o katerih je predhodno poročal Belew
English: The measurement error of the apparatus used for the measurement of the blood pressure of cats
Slovenian: 2.4 Merilna napaka naprave, uporabljene za merjenje krvnega tlaka pri mačkah
English: Spontaneous feline hypertension: Clinical and echocardiographic abnormalities, and survival rate.
Slovenian: Spontaneous feline hypertension: Clinical and echocardiographic abnormalities, and survival rate (Spontana hipertenzija pri mačkah: Klinične in ehokardiografske nepravilnosti ter stopnja preživetja).
English: the CVMP concluded that it is not clear, if the recorded reduction in systolic blood pressure and clinical signs in hypertensive cats following treatment with Vasotop P was a true treatmentrelated effect,
Slovenian: CVMP je sklenil, da ni jasno, ali je ugotovljeno zmanjšanje sistoličnega krvnega tlaka in kliničnih znakov pri mačkah s hipertenzijo po zdravljenju z zdravilom Vasotop P resnično posledica zdravljenja.
English: The MAH provided data to show that of the 82 % of cats showing at least one clinical sign, 46 % had two clinical signs or more.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil podatke, iz katerih je razvidno, da je imelo 82 % mačk najmanj en klinični znak, 46 % pa dva klinična znaka ali več.
English: Around 33 % of the cases were between 160 and 180 mm Hg systolic blood pressure (risk category III) and 67 % ≥ 180 mm Hg systolic blood pressure (risk category IV) at inclusion.
Slovenian: V približno 33 % primerov je bil sistolični krvni tlak med 160 in 180 mm Hg (kategorija tveganja III), v 67 % primerov pa je bil sistolični krvni tlak ≥ 180 mm Hg (kategorija tveganja IV) ob vključitvi.
English: Whilst fully accepting the scientific validity of requiring control groups in clinical studies, the CVMP is of the opinion that a significant proportion of placebo-control cats suffering from moderate-tosevere hypertension (i.e. systolic blood pressure >180 mm Hg) would be at risk of developing target organ damage if left untreated over a potential period of 63 days.
Slovenian: CVMP se sicer popolnoma strinja z znanstvenim vidikom potrebe po kontrolnih skupinah v kliničnih študijah, pa vendarle meni, da bi bilo pri velikem deležu mačk iz skupine, nadzorovane s placebom, ki imajo zmerno do hudo hipertenzijo (tj. sistolični krvni tlak > 180 mm Hg), prisotno tveganje okvare ciljnega organa, če bi ostale nezdravljene v potencialnem obdobju 63 dni.
English: The MAH presented data from their own study and the literature to refute the possibility that the improvement in systolic blood pressure measurements was related to habituation to the “white coat effect”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil podatke iz svoje lastne študije in literature, da bi ovrgel možnost, da je izboljšanje vrednosti sistoličnega krvnega tlaka posledica prilagoditve na „učinek bele halje“.
English: • Some recent studies report low median survival times for hypertension in cats - 4-7 months if untreated (Chetboul et al., 2003) and approximately 9 months even with treatment.
Slovenian: • Rezultati nekaterih nedavnih študij so pokazali nizko mediano časov preživetja pri hipertenziji pri mačkah - 4-7 mesecev brez zdravljenja (Chetboul
English: The MAH provided information on the two Doppler machines employed to measure systolic blood pressure in the pivotal field study.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil podatke o dveh Dopplerjevih napravah, ki sta bili uporabljeni za merjenje sistoličnega krvnega tlaka v uvodni terenski študiji.
English: The CVMP considers that a notable decrease in blood pressure measurements was evident between pre-treatment and post-treatment values.
Slovenian: CVMP meni, da je bilo opaziti bistveno zmanjšanje vrednosti krvnega tlaka ob primerjavi vrednosti pred zdravljenjem in po njem.
English: Comments on whether it is possible to devise and conduct a trial with a placebo control where an escape therapy is identified at certain points in the study period The MAH submitted argumentation which covered the following grounds:
Slovenian: 2.6 Komentarji glede tega, ali je mogoče oblikovati in izvesti preskušanje s skupino, nadzorovano s placebom, kjer je v določenih točkah obdobja študije določena terapija izogiba
English: A multicentre field trial with Vasotop P for the treatment of hypertension in cats
Slovenian: 2.2 Multicentrično terensko preskušanje z zdravilom Vasotop P za zdravljenje hipertenzije pri mačkah
English: the CVMP considered the referral made under Article 6(12) of Commission Regulation EC No 1084/2003, for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg, tablets for dogs and associated names (see Annex I), all the overall submitted data in writing and in the oral explanations,
Slovenian: CVMP je upošteval napotitev v skladu s členom 6(12) Uredbe Komisije ES št. 1084/2003 za Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg, tablete za pse in povezana imena (glejte Dodatek I), vse predložene pisne podatke in ustna pojasnila.
English: The other 12 cats had a >20 mm Hg decrease in systolic blood pressure at Day 63 (mean decrease of 36.6 mm Hg, range 20 mm Hg to 57.8 mm Hg) but were still above the normotensive limit of 160 mm Hg.
Slovenian: Pri drugih 12 mačkah je bil sistolični krvni tlak na 63. dan manjši za > 20 mm Hg (povprečno zmanjšanje za 36,6 mm Hg, v razponu od 20 mm Hg do 57,8 mm Hg), vendar je bil še vedno nad mejo normalnega krvnega tlaka 160 mm Hg.
English: From these 26 cats, 14 cats were normotensive by Day 63.
Slovenian: 14 od teh 26 mačk je imelo na 63. dan normalen krvni tlak.
English: In addition the MAH was requested to submit a further clarification in relation to the percentage of severely hypertensive cats (i.e. systolic blood pressure > 180 mm Hg) that subsequently became normotensive or had a >20 mm Hg decrease in systolic blood pressure following treatment.
Slovenian: Poleg tega je bil imetnik dovoljenja za promet z zdravilom pozvan, naj predloži dodatne podatke o deležu mačk s hudo hipertenzijo (tj. sistoličnim krvnim tlakom > 180 mm Hg), pri katerih se je pozneje vzpostavil normalen krvni tlak ali pri katerih se je po zdravljenju sistolični krvni tlak zmanjšal za > 20 mm Hg.
English: Thus, the finding that 63 % of severely affected cats became normotensive or had a >20 mm Hg reduction in systolic blood pressure following treatment with Vasotop P is noted; whilst it is accepted that 12/26 cats did not become normotensive, a mean reduction of 37 mm Hg in systolic blood pressure in severely hypertensive cats has also been noted.
Slovenian: Ugotovljeno je bilo, da se je pri 63 % hudo prizadetih mačk po zdravljenju z zdravilom Vasotop P vzpostavil normalen krvni tlak ali se je pri njih sistolični krvni tlak zmanjšal za > 20 mm Hg; sprejemljivo je, da se pri 12 od 26 mačk ni vzpostavil normalen krvni tlak, poleg tega je bilo pri mačkah s hudo hipertenzijo opaziti povprečno zmanjšanje sistoličnega krvnega tlaka za 37 mm Hg.
English: The MAH submitted data where 53 % (40 out of 76) of included cats had urea concentrations above the upper limit of the reference range.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil podatke, iz katerih je bilo razvidno, da je imelo 53 % (40 od 76) proučevanih mačk raven sečnine nad zgornjo mejo referenčnega razpona.
English: The MAH also considered if the mean decrease in systolic blood pressure measurements could have been attributable to other non-treatment related factors in the study.
Slovenian: Imetnika dovoljenja za promet z zdravilom je tudi zanimalo, ali je povprečno zmanjšanje vrednosti sistoličnega krvnega tlaka mogoče pripisati drugim z zdravljenjem nepovezanim dejavnikom v študiji.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VASOTOP P 0.625 MG, TABLET FOR DOGS AND CATS, VASOTOP P 1.25 MG, TABLET FOR DOGS AND CATS AND VASOTOP P 2.5 MG, TABLET FOR DOGS AND CATS
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA VASOTOP P 0,625 MG, TABLETA ZA PSE IN MAČKE, VASOTOP P 1,25 MG, TABLETA ZA PSE IN MAČKE, TER VASOTOP P 2,5 MG, TABLETA ZA PSE IN MAČKE
English: The MAH submitted data where ramipril (active substance of Vasotop P) produced a marked decrease of systolic blood pressure in mildly to severely hypertensive cats.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil podatke o primerih, v katerih je ramipril (zdravilna učinkovina zdravila Vasotop P) prispeval k občutnemu znižanju sistoličnega krvnega tlaka pri mačkah z blago do resno hipertenzijo.
English: The MAH clarified that the mean decrease in the severely affected group (systolic blood pressure > 180 mm Hg) was of -25.5 mm Hg (while it was of -18.3 mm Hg in the moderately affected group (systolic blood pressure between 160 mm Hg and 180 mm Hg).
Slovenian: Imetnik dovoljenja za promet z zdravilom je pojasnil, da je bilo povprečno zmanjšanje v hudo prizadeti skupini (sistolični krvni tlak > 180 mm Hg) -25,5 mm Hg, medtem ko je bilo v zmerno prizadeti skupini (sistolični krvni tlak med 160 mm in 180 mm Hg) -18,3 mm Hg.
English: Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets are veterinary medicinal products those contain the active ingredient ramipril at concentrations of 0.625 mg, 1.25 mg and 2.5 mg respectively.
Slovenian: Tablete Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg so zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino ramipril v koncentraciji 0,625 mg, 1,25 mg oz. 2,5 mg. Ramipril je zaviralec angiotenzinske konvertaze (ACE).
English: Luxemburg Intervet International B.V. P.O.
Slovenian: Luksemburg Intervet International B.V.
English: The Netherlands Intervet International B.V. P.O.
Slovenian: Nizozemska Intervet International B.V.
English: From the 43 cats belonging to the severe group at Day 0, 26 cats in total (60.5 %) became normotensive or had a >20 mm Hg decrease in systolic blood pressure at Day 63.
Slovenian: Izmed 43 mačk, ki so bile na 0. dan v hudo prizadeti skupini, se je na 63. dan pri skupno 26 mačkah (60,5 %) vzpostavil normalen krvni tlak oz. se je pri njih sistolični krvni tlak zmanjšal za > 20 mm Hg.
English: Three strengths of tablet are covered by the current application as follows; Vasotop P 0.625 mg tablet, Vasotop P 1.25 mg tablet and Vasotop P 2.5 mg tablet.
Slovenian: Trenutna vloga obsega tri jakosti tablet: tablete Vasotop P 0,625 mg, tablete Vasotop P 1,25 mg in tablete Vasotop P 2,5 mg.
English: Belew A.M., Barlett T., Brown S.A.
Slovenian: Belew A.M., Barlett T., Brown S.A. Evaluation of the white-coat effect in cats (Ocena učinka bele halje pri mačkah).
English: The Marketing Authorisation Holder (MAH) Intervet International B.V. submitted applications for Type II variation subject to Mutual Recognition Procedures (MRP) 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:
Slovenian: je predložil vloge za spremembo tipa II v skladu s postopki z medsebojnim priznavanjem za zdravilo 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, ki se glasi:
English: Belgium Intervet International B.V. P.O.
Slovenian: Portugalska Intervet International B.V.
English: 20 October 2009
Slovenian: 20. oktober 2009
English: The patients were treated for at least 24 weeks.
Slovenian: Bolnike so zdravili vsaj 24 tednov.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Luveniq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote za zdravilo Luveniq je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The evaluation had finished and the CHMP had given a negative opinion.
Slovenian: Postopek vrednotenja je bil zaključen in CHMP je izrazil negativno mnenje.
English: The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew the application.
Slovenian: Družba je zahtevala ponoven pregled negativnega mnenja, ki pa še ni bil zaključen, ko je družba podala zahtevek za umik.
English: It is called ‘non-infectious' when it is caused by the body's own immune system (the body's natural defences) attacking the uvea.
Slovenian: Imenuje se „neinfektivni“, ker je posledica napada lastnega imunskega sistema telesa (naravna obramba telesa) na uveo.
English: The effects of Luveniq were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Luveniq so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The company informed the CHMP that there are no consequences for patients included in ongoing clinical trials.
Slovenian: Družba je CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih.
English: Withdrawal of the marketing authorisation application for Luveniq (voclosporin) EMA/CHMP/835463/2011
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Luveniq (voklosporin) EMA/CHMP/835463/2011
English: It belongs to the class of calcineurin inhibitors.
Slovenian: Spada v skupino zaviralcev kalcinevrina.
English: The main measure of effectiveness was how the inflammation of the eye improved after 16 weeks and 24 weeks of treatment, measured by looking at the change in the amount of vitreous haze (clouding of the vitreous humour, the clear gel between the lens and the retina of the eyeball).
Slovenian: Glavno merilo učinkovitosti je bilo izboljšanje vnetja očesa po 16 in 24 tednih zdravljenja, izmerjeno na osnovi spremembe motnosti (motnosti steklovine, bistrega gela med lečo in mrežnico v očesnem zrklu).
English: Luveniq also caused side effects which are known to occur with this type of immunosuppressive medicine, including hypertension (high blood pressure).
Slovenian: Zdravilo Luveniq je povzročilo neželene učinke, ki so znani za tovrstna imunosupresivna zdravila, vključno s hipertenzijo (zvišan krvni tlak).
English: The application was supported by one main study involving 218 patients with non-infectious uveitis which compared Luveniq with placebo.
Slovenian: Družba je vlogo podprla z eno glavno študijo z 218 bolniki z neinfektivnim uveitisom, v kateri so zdravilo Luveniq primerjali s placebom.
English: Withdrawal of the marketing authorisation application for Luveniq (voclosporin)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Luveniq (voklosporin)
English: It targets T-cells, a type of white blood cell in the immune system that is particularly active in inflammation.
Slovenian: Učinkuje na celice T, vrsto levkocitov imunskega sistema, ki so še posebej aktivni pri vnetju.
English: Luveniq is an immunosuppressive agent, which means that it reduces the activity of the immune system.
Slovenian: Zdravilo Luveniq je imunosupresivno sredstvo, kar pomeni, da zmanjša aktivnost imunskega sistema.
English: What is Luveniq?
Slovenian: Kaj je zdravilo Luveniq?
English: Luveniq was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 14 September 2007 for the treatment of chronic non-infectious uveitis.
Slovenian: Zdravilo Luveniq je bilo dne 14. septembra 2007 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje kroničnega neinfektivnega uveitisa.
English: Luveniq is a medicine that contains the active substance voclosporin.
Slovenian: Luveniq je zdravilo, ki vsebuje zdravilno učinkovino voklosporin.
English: Therefore, the CHMP was of the opinion that the benefits of Luveniq had not been shown to outweigh its risks and recommended that it be refused marketing authorisation.
Slovenian: CHMP je menil, da ni bilo dokazano, da koristi zdravila Luveniq odtehtajo z njim povezana tveganja, zato je priporočil zavrnitev vloge za pridobitev dovoljenja za promet.
English: What was Luveniq expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Luveniq uporabljalo?
English: It was expected to decrease the inflammation seen in uveitis by blocking an enzyme called calcineurin which is involved in activating Tcells.
Slovenian: Zdravilo naj bi zmanjšalo vnetje pri uveitisu z blokiranjem encima, imenovanega kalcinevrin, ki sodeluje pri aktivaciji celic T.
English: On 13 October 2011, Lux Biosciences GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Luveniq, for the treatment of chronic active non-infectious uveitis involving the intermediate or posterior segments of the eye.
Slovenian: Družba Lux Biosciences GmbH je dne 13. oktobra 2011 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Luveniq, namenjenim zdravljenju kroničnega aktivnega neinfektivnega uveitisa, ki je zajel vmesni in zadajšnji očesni prekat.
English: What did the company present to support its application?
Slovenian: Katero dokumentacijo je družba predložila CHMP v podporo svoji vlogi?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had previously given a negative opinion in June 2011 recommending that the marketing authorisation be refused for Luveniq for the treatment of chronic active non-infectious uveitis involving the intermediate or posterior segments of the eye.
Slovenian: Na podlagi pregleda podatkov je Odbor v času umika vloge junija 2011 izrazil negativno mnenje in priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Luveniq za zdravljenje kroničnega aktivnega neinfektivnega uveitisa, ki je zajel vmesni in zadajšnji očesni prekat.
English: How is Luveniq expected to work?
Slovenian: Kako naj bi zdravilo Luveniq delovalo?
English: Only one main study supported the application and the results did not show in a robust way that Luveniq was more effective than placebo at reducing eye inflammation, while no difference was seen in the patients' eyesight compared with placebo.
Slovenian: Njeni rezultati niso pokazali na robusten način, da je zdravilo Luveniq učinkovitejše od placeba pri zmanjšanju vnetja očesa.
English: Luveniq was expected to be used to treat chronic active non-infectious uveitis involving the intermediate or posterior segments of the eye. Uveitis is inflammation of the uvea (the middle layer of the eye) which can lead to loss of vision.
Slovenian: Zdravilo Luveniq naj bi se uporabljalo za zdravljenje kroničnega aktivnega neinfektivnega uveitisa, ki je zajel vmesni in zadajšnji očesni prekat.
English: At the time of the negative opinion, the CHMP was not convinced that the benefits of Luveniq had been shown to outweigh the risks as a treatment for chronic non-infectious uveitis.
Slovenian: Zato je CHMP v času umika menil, da koristi zdravila Luveniq za zdravljenje kroničnega neinfektivnega uveitisa ne odtehtajo z njim povezanih tveganj.
English: Pharmaceutical Form
Slovenian: Jakost Farmacevtska oblika Pot uporabe
English: EU/1/11/742/001
Slovenian: 90 (3 x 30 x 1) tablet (enoodmerni pretisni omot) (zloženka: škatla)
English: Invented name
Slovenian: Ime
English: The patient should take one tablet once a day with a light meal, preferably at the same time each day.
Slovenian: Bolnik mora vzeti eno tableto sočasno z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem času.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasilamlo on 14 April 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Rasilamlo, veljavno po vsej Evropski uniji, izdala 14. aprila 2011.
English: The full EPAR for Rasilamlo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rasilamlo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Rasilamlo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rasilamlo?
English: This is a summary of the European public assessment report (EPAR) for Rasilamlo.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rasilamlo.
English: Rasilamlo aliskiren / amlodipine
Slovenian: Rasilamlo aliskiren/amlodipin
English: It should not be taken together with fruit juice or drinks containing plant extracts such as herbal teas.
Slovenian: Zdravila se ne sme jemati skupaj s sadnim sokom ali pijačami, ki vsebujejo rastlinske izvlečke, kot so na primer zeliščni čaji.
English: The main measure of effectiveness was the change in the average diastolic blood pressure (blood pressure measured between two heartbeats) measured when the patients were seated.
Slovenian: Glavno merilo učinkovitosti je bila sprememba povprečnega diastoličnega krvnega tlaka (krvnega tlaka, merjenega med dvema utripoma srca), izmerjenega pri bolniku v sedečem položaju.
English: Other information about Rasilamlo
Slovenian: Druge informacije o zdravilu Rasilamlo
English: A risk management plan has been developed to ensure that Rasilamlo is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Rasilamlo je bil pripravljen načrt obvladovanja tveganj.
English: What benefit has Rasilamlo shown during the studies?
Slovenian: Kakšne koristi je zdravilo Rasilamlo izkazalo med študijami?
English: The CHMP decided that Rasilamlo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Rasilamlo večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rasilamlo.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: For more information about treatment with Rasilamlo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Rasilamlo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In three main studies involving 2,212 patients Rasilamlo was compared with aliskiren or amlodipine taken alone for eight or six weeks.
Slovenian: V treh glavnih študijah, v katere je bilo vključenih 2 212 bolnikov, so zdravilo Rasilamlo osem ali šest tednov primerjali z aliskirenom ali amlodipinom kot samostojnima zdraviloma.