FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Ameluz
Croatian: Moguće nuspojave Kako čuvati Ameluz
English: Before PDT (%) 12 months after PDT (%)
Croatian: 12 mjeseci poslije fotodinamske terapije (%)
English: Clinical efficacy was maintained during the follow-up periods of 6 and 12 months after the last photodynamic therapy.
Croatian: Klinička djelotvornost bila je održana tijekom razdoblja praćenja od 6 i 12 mjeseci nakon zadnje fotodinamske terapije.
English: Biofrontera Pharma GmbH sucursal en España Tel: 900 974943 ameluz-es@biofrontera.com
Croatian: Tel: 900 974943 ameluz-es@biofrontera.com
English: No occlusive dressing is necessary.
Croatian: Nije potrebna primjena zavoja.
English: Not at application site: Chills, feeling hot, pyrexia, pain, fatigue, ulcer
Croatian: Izvan mjesta primjene: zimica, osjećaj vrućine, vrućica, bol, umor, vrijed
English: Table 1: Summary of related adverse drug reactions (ADRs) reported in patients treated with photodynamic therapy with 5-aminolaevulinic acid System organ class
Croatian: Sažetak povezanih nuspojava prijavljenih u bolesnika liječenih fotodinamskom terapijom s
English: Ameluz contains
Croatian: Ameluz sadrži
English: Lesions of mild severity were cleared by 99.1 % vs. 49.2 %, those of moderate severity by 91.7 % vs. 24.1 % for treatment with Ameluz and placebo, respectively.
Croatian: Lezije blage težine bile su uklonjene u 99,1% naspram 49,2% slučajeva, a one umjerene težine u 91,7%
English: Prior to the decision to undergo photodynamic therapy it should be taken into consideration that the probability of a subject to be completely cleared 12 months after the last treatment was 67.5% or 46.8% for treatment with Ameluz with narrow spectrum lamps or all lamp types, respectively.
Croatian: Prije odluke o provođenju fotodinamskog liječenja mora se uzeti u obzir da je vjerojatnost da se ispitanik potpuno očisti od lezija 12 mjeseci nakon zadnjeg liječenja bila 67,5% ili
English: Ameluz 78 mg/g gel 5-aminolaevulinic acid
Croatian: Ameluz 78 mg/g gel
English: After only 1 PDT complete patient clearance resulted in 61.8 % vs. 9.4 %, and complete lesion clearance in 84.2 % vs. 22.0 % for Ameluz and placebo treatment, respectively.
Croatian: slučajeva, a potpuno uklanjanje lezija postignuto je u 84,2% naspram 22,0% slučajeva kod liječenja lijekom Ameluz odnosno placebom.
English: • ulcer
Croatian: • mjehur
English: Therefore, it is recommended to include application site hypersensitivity as an adverse drug reaction (ADR) in section 4.8 of the SmPC.
Croatian: Stoga se kao nuspojavu u dijelu 4.8 sažetka opisa svojstava lijeka preporučuje uključiti preosjetljivost na mjestu primjene.
English: Treatment of lesions and fields of actinic keratoses with daylight
Croatian: Liječenje lezija i područja aktiničke keratoze pod danjim svjetlom Uvjeti koje treba uzeti u obzir prije liječenja
English: Of the BCC lesions, 94.6% were cleared with Ameluz, 92.9% with MAL. For nodular BCC, 89.3% of the lesions were cleared with Ameluz, 78.6% with MAL.
Croatian: Ispitivanje je dokazalo neinferiornost lijeka Ameluz u usporedbi s kremom MAL [97,5% -tni interval pouzdanosti -6,5]. 94,6% lezija bazocelularnog karcinoma povuklo se uz Ameluz, a njih 92,9% uz MAL.
English: - pustules
Croatian: suhoća/
English: STATEMENT OF ACTIVE SUBSTANCE(S) One gram contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).
Croatian: Jedan gram sadrži 78 mg 5-aminolevulinatne kiseline (u obliku klorida).
English: burning) - irritation - itching - tissue swelling caused by excess fluid - scab - scaling of the skin - hardening - abnormal sensation, such as pricking, tingling or numbness
Croatian: − otvrdnuće − neuobičajeni osjet, kao što je bockanje, trnci ili utrnulost
English: burning pain), irritation, pruritus, oedema, scab, exfoliation, induration, paraesthesia
Croatian: Na mjestu primjene: eritem, bol (uključujući žareći bol), nadraženost, pruritus, edem, krasta,
English: EXP
Croatian: np np
English: a) Considerations before treatment: Daylight treatment should only be used if the conditions are suitable to stay comfortably outdoors for two hours (with temperatures > 10 °C).
Croatian: Liječenje AK-a i područja zloćudne transformacije pod danjim svjetlom: a) Uvjeti koje treba uzeti u obzir prije liječenja: Liječenje pod danjim svjetlom smije se primijeniti samo ako postoje prikladni uvjeti za ugodan boravak vani tijekom dva sata (uz temperature > 10 °C).
English: MAL Full patient clearance n (%)
Croatian: MAL Uklanjanje svih lezija u bolesnika n (%)
English: Lot
Croatian: MAL
English: Apply Ameluz to form a thin layer to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula.
Croatian: Nanošenje gela Vrhovima prstiju, zaštićenih rukavicama, ili špatulom nanesite Ameluz u tankom sloju na cijele lezije ili cijela područja i približno 5 mm okolnog područja.
English: Ameluz Full patient clearance n (%)
Croatian: Ameluz Uklanjanje svih lezija u bolesnika n (%)
English: Total
Croatian: Ostali
English: - swelling
Croatian: Ameluza.
English: rinsing with water is recommended.
Croatian: U slučaju nehotičnog dodira, preporučuje se ispiranje vodom.
English: Pregnancy and breast-feeding
Croatian: − nadraženost − svrbež
English: Common: may affect up to 1 in 10 people
Croatian: Često: mogu se javiti u manje od 1 na 10 osoba • reakcije na mjestu nanošenja
English: The probability to require only one treatment with Ameluz and remain completely cleared 12 months later was 34.5% on average with all lamps.
Croatian: Vjerojatnost da bolesnik treba samo jedno liječenje lijekom Ameluz a da ostane potpuno očišćen 12
English: 1 Data from post-marketing
Croatian: • vrijed 1 Podaci iz razdoblja nakon stavljanja lijeka u promet.
English: • if you are elderly and your dose needs to be increased.
Croatian: • ako ste starija osoba i potrebno Vam je povećati dozu.
English: *Based on patient weight of 50 kg
Croatian: *Na temelju težine bolesnika od 50 kg.
English: Date of latest renewal: 20 August 2015
Croatian: Datum posljednje obnove odobrenja: 20. kolovoza 2015.
English: Cumulative urinary excretion is <1 % of dose.
Croatian: Kumulativna urinarna ekskrecija je < 1 % doze.
English: It is important that you take Twynsta every day until your doctor tells you otherwise.
Croatian: Važno je uzimati Twynstu svaki dan, dok Vam liječnik drugačije ne propiše.
English: Absolute bioavailability has been estimated to be between 64 and 80 %.
Croatian: Apsolutna bioraspoloživost je procijenjena na između 64 i 80 %.
English: If you take more Twynsta than you should
Croatian: Ako uzmete više Twynste nego što biste trebali
English: This applies especially to the medicines listed below:
Croatian: Ovo se osobito odnosi na u nastavku navedene lijekove:
English: Therefore, the combination should be administered with caution, especially in the elderly.
Croatian: Stoga se kombinacija treba primjenjivati s oprezom, osobito kod starijh osoba.
English: Children and adolescents Twynsta is not recommended in children and adolescents up to the age of 18 years.
Croatian: Djeca i adolescenti Primjena Twynste se ne preporučuje kod djece i adolescenata do 18 godina starosti.
English: This medicinal product is indicated for long term treatment.
Croatian: Ovaj lijek je indiciran za dugotrajno liječenje.
English: • Diltiazem (cardiac medicine).
Croatian: • Diltiazem (lijek za srce).
English: • if you suffer from heart failure after a heart attack.
Croatian: • ako patite od zatajenja srca nakon srčanog udara.
English: Some side effects can be serious and need immediate medical attention:
Croatian: Neke nuspojave mogu biti ozbiljne te zahtijevati trenutno medicinsko zbrinjavanje:
English: Your doctor may need to change the dose of these other medicines or take other precautions.
Croatian: Liječnik će Vam možda morati promijeniti dozu i/ili primijeniti druge mjere opreza.
English: The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 - 7%, with a maximum of 15%.
Croatian: Udio majčine doze koju primi dojenče procijenjen je na interkvartilni raspon od 3 do 7 %, uz maksimalnu vrijednost od 15 %.
English: You must tell your doctor if you think you might be pregnant or are planning to have a baby.
Croatian: Nužno je obavijestiti liječnika ako mislite da biste mogli biti trudni ili planirate trudnoću.
English: Clinical monitoring and dose adjustment may thus be required.
Croatian: Stoga mogu biti potrebni klinički nadzor i prilagodba doze.
English: PHARMACEUTICAL FORM AND CONTENTS 90 tablets
Croatian: OBLIK I SADRŽAJ 90 tableta
English: Twynsta is used to treat high blood pressure
Croatian: Twynsta se primjenjuje u liječenju visokog krvnog tlaka
English: • Dantrolene (infusion for severe body temperature abnormalities).
Croatian: • Dantrolen (infuzija zbog teških abnormalnosti tjelesne temperature).
English: Component of a multipack, can't be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se odvojeno prodavati.
English: If you have the impression that the effect of Twynsta is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako imate dojam da je učinak Twynste prejak ili preslab, posavjetujte se s liječnikom ili ljekarnikom.
English: Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Croatian: Telmisartan se u velikoj mjeri veže na proteine plazme (> 99,5 %), uglavnom albumin i alfa-1 kiseli glikoprotein.
English: What Twynsta is and what it is used for
Croatian: Što je Twynsta i za što se koristi
English: In two corresponding open-label long-term follow up studies performed over a further 6 months the effect of Twynsta was maintained over the trial period.
Croatian: U dvjema podudarnim, otvorenim, dugotrajnim studijama praćenja, provođenim tijekom daljnjih 6 mjeseci, učinak Twynste bio je održavan tijekom razdoblja ispitivanja.
English: It is recommended to take Twynsta with some liquid.
Croatian: Preporučuje se uzimati Twynstu s malo tekućine.
English: 14 tablets 28 tablets 30 x 1 tablets 56 tablets 90 x 1 tablets 98 tablets
Croatian: 14 tableta 28 tableta 30x1 tableta 56 tableta 90x1 tableta 98 tableta
English: Cmax and to a lesser extent AUC increase disproportionately at doses above 40 mg.
Croatian: Cmax i, u manjoj mjeri, AUC se disproporcionalno povećavaju pri dozama iznad 40 mg.
English: Twynsta is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Croatian: Twynsta se ne preporučuje u ranoj trudnoći, te se ne smije primjenjivati kada ste trudni dulje od 3 mjeseca, jer može ozbiljno naškoditi djetetu kada se primjenjuje nakon trećeg mjeseca trudnoće.
English: In vitro studies have shown that approximately 97.5 % of circulating amlodipine is bound to plasma proteins in hypertensive patients.
Croatian: In vitro studije su pokazale da se oko 97,5 % amlodipina u cirkulaciji veže na proteine plazme kod hipertenzivnih bolesnika.
English: Telmisartan has been studied in a large outcome study in 25,620 patients with high cardiovascular risk (ONTARGET).
Croatian: Telmisartan je ispitivan u velikoj studiji ishoda na 25 620 ispitanika s visokim kardiovaskualrnim rizikom (ONTARGET).
English: • if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
Croatian: • ako imate suženje aortnog zaliska (aortnu stenozu) ili kardiogeni šok (stanje u kojem srce ne može dostaviti tijelu dovoljno krvi).
English: Serious syncope may occur rarely (less than 1 case per 1,000 patients).
Croatian: Rijetko može doći do pojave ozbiljne sinkope (manje od 1 slučaja na 1000 bolesnika).
English: Amlodipine is a weak CYP3A inhibitor.
Croatian: Amlodipin je slab inhibitor enzima CYP3A.
English: Other medicines and Twynsta
Croatian: Drugi lijekovi i Twynsta
English: Clinical data are insufficient regarding the potential effect of amlodipine on fertility.
Croatian: Klinički podaci nisu dostatni u pogledu potencijalnog učinka amlodipina na plodnost.
English: Both of these substances help to control your high blood pressure:
Croatian: Obje ove tvari pomažu u kontroli visokog krvnog tlaka:
English: The antihypertensive effect of Twynsta was similar irrespective of age and gender, and was similar in patients with and without diabetes.
Croatian: Antihipertenzivni učinak Twynste bio je sličan, bez obzira na dob i spol, te je bio sličan kod bolesnika sa i bez dijabetesa.
English: Therefore, the dose of simvastatin in patients on amlodipine should be limited to 20 mg daily.
Croatian: Stoga, doza simvastatina za bolesnike na amlodipinu mora biti ograničena na 20 mg dnevno.
English: Rare cystitis sepsis including fatal outcome
Croatian: Rijetko cistitis sepsa uključujući smrtni ishod
English: Talk to your doctor before taking Twynsta:
Croatian: Obratite se svom liječniku prije nego uzmete Twynstu:
English: You can take Twynsta with or without food.
Croatian: Možete uzimati Twynstu sa ili bez hrane.
English: Concomitant use requiring caution
Croatian: Istodobna primjena koja zahtijeva oprez
English: The safety and efficacy of telmisartan/amlodipine in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost kombinacije telmisartan/amlodipin u djece u dobi ispod 18 godina starosti nisu ustanovljene.
English: The safety and tolerability of Twynsta has been evaluated in five controlled clinical studies with over 3,500 patients, over 2,500 of whom received telmisartan in combination with amlodipine.
Croatian: Sigurnost i podnošljivost Twynste su ocjenjivane u pet kontroliranih kliničkih studija na više od 3500 bolesnika, od kojih je preko 2500 primalo telmisartan u kombinaciji s amlodipinom.
English: No data from controlled clinical studies with the fixed dose combination or with the individual components are available.
Croatian: Nisu dostupni podaci iz kontroliranih kliničkih studija s fiksnom kombinacijom niti s individualnim komponentama.
English: Rare depression, anxiety, insomnia confusion
Croatian: Rijetko depresija, anksioznost, nesanica konfuzija
English: The European Medicines Agency has waived the obligation to submit the results of studies with Twynsta in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Twynsta u svim podskupinama pedijatrijske populacije u hipertenziji (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Very rare pancreatitis, gastritis
Croatian: Vrlo rijetko pankreatitis, gastritis
English: Amlodipine is extensively (approximatively 90 %) metabolised by the liver to inactive metabolites.
Croatian: Amlodipin se u velikoj mjeri (oko 90 %) metabolizira u jetri u neaktivne metabolite.
English: By 3 hours after administration, plasma concentrations are similar whether telmisartan is taken fasting or with food.
Croatian: 3 sata nakon primjene, koncetracije u plazmi su slične, bez obzira je li telmisartan primjenjivan sa ili bez hrane.
English: Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Croatian: Prijavljena je izražena i vjerojatno produljena sistemska hipotenzija, uključujući i šok sa smrtnim ishodom.
English: Such conditions should be corrected before the administration of telmisartan.
Croatian: Ovakva stanja moraju biti korigirana prije početka primjene telmisartana.
English: Talk to your doctor before taking Twynsta if you are suffering or have ever suffered from any of the following conditions or illnesses:
Croatian: Obratite se svom liječniku prije nego uzmete Twynstu ako imate ili ste imali neko od sljedećih stanja ili bolesti:
English: Not known toxic epidermal necrolysis
Croatian: Nepoznato toksična epidermalna nekroliza
English: After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Croatian: Nakon peroralne (i intravenske) primjene telmisartan se gotovo isključivo izlučivao fecesom, uglavnom u nepromijenjenom obliku.
English: Your doctor will normally advise you to stop taking Twynsta before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Twynsta.
Croatian: Liječnik će Vam savjetovati prekid primjene Twynste prije početka trudnoće ili čim saznate da ste trudni, te će Vam preporučiti drugi lijek umjesto Twynste.
English: What Twynsta is and what it is used for What you need to know before you take Twynsta How to take Twynsta
Croatian: Što je Twynsta i za što se koristi Što morate znati prije nego počnete uzimati Twynstu Kako uzimati Twynstu
English: Twynsta can be taken with or without food.
Croatian: Twynsta se može uzimati sa ili bez hrane.
English: The reduction in diastolic blood pressure <90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3 % of patients respectively.
Croatian: Sniženje dijastoličkog krvnog tlaka < 90 mmHg bilo je postignuto kod 71,6 %, 74,8 %, 82,1 %, 85,3 % bolesnika, po istom redoslijedu.
English: • Amlodipine belongs to a group of substances called “calcium channel blockers”.
Croatian: • Amlodipin pripada skupini lijekova koji se nazivaju „blokatori kalcijevih kanala“.
English: The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/m2 basis) was close to the maximum tolerated dose for mice but not for rats.
Croatian: Najviša doza (za miševe slična, a za štakore dvaput* viša od maksimalne preporučene kliničke doze od 10 mg na temelju mg/m2) bila je blizu maksimalnoj podnošljivoj dozi za miševe, ali ne i za štakore.
English: If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere ili ako Vam je dijagnosticirano nasljedno nepodnošenje fruktoze, rijetki nasljedni poremećaj kod kojeg bolesnik ne može razgraditi fruktozu, obratite se liječniku prije nego uzmete ili primite ovaj lijek.
English: Ten per cent of original amlodipine and 60 % of amlodipine metabolites are excreted in urine.
Croatian: Deset posto originalnog amlodipina i 60 % metabolita amlodipina se izlučuje putem urina.
English: This is confirmed by trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.
Croatian: Ovo je potvrđeno odnosom minimalnih i maksimalnih vrijednosti stalno iznad 80 %, a koje su zabilježene nakon doza od 40 i 80 mg telmisartana u placebom kontroliranim kliničkim ispitivanjima.
English: Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication particularly with strong CYP3A4 inducers (e.g. rifampicin, hypericum perforatum).
Croatian: Stoga je potrebno pratiti krvni tlak i razmotriti reguliranje doze tijekom i nakon istodobnog liječenja, osobito s jakim induktorima CYP3A4 (npr. rifampicin, gospina trava).
English: The overall incidence of adverse reactions with Twynsta in the clinical trial programme was low with only 12.7 % of patients on treatment experiencing adverse reactions.
Croatian: Ukupna incidencija nuspojava uz Twynstu u kliničkim ispitivanjima je bila niska, samo 12,7 % bolesnika koji su liječeni Twynstom je imalo nuspojave.
English: In case of surgery or anaesthesia, you should tell your doctor that you are taking Twynsta.
Croatian: U slučaju kiruškog zahvata ili anestezije, potrebno je obavijestiti liječnika da uzimate Twynstu.
English: • Medicines used to alter the way your immune system works (e.g. sirolimus, temsirolimus and everolimus).
Croatian: • Lijekovi koji mijenjaju funkcioniranje imunološkog sustava (npr. sirolimus, temsirolimus i everolimus).
English: Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su razvrstane prema učestalosti uz uporabu sljedeće konvencije: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000; vrlo rijetko (<1/10 000); nije poznato (ne može se utvrditi iz dostupnih podataka).
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Croatian: Bolesnici se moraju odgovarajuće hidrirati, treba razmotriti praćenje bubrežne funkcije nakon početka istodobne terapije i povremeno nakon toga.
English: Limited experience is available in patients with severe renal impairment or haemodialysis.
Croatian: Ograničeno iskustvo dostupno je za bolesnike s teškim oštećenjem bubrega ili bolesnike na hemodijalizi.
English: In some patients treated by calcium channel blockers, reversible biochemical changes in the head of spermatozoa have been reported.
Croatian: U nekih bolesnika liječenih blokatorima kalcijevih kanala prijavljene su reverzibilne biokemijske promjene glave spermija.
English: This medicinal product has moderate influence on the ability to drive and use machines.
Croatian: Ovaj lijek umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Rare malaise influenza-like illness
Croatian: Rijetko malaksalost bolest nalik gripi
English: • Angiotensin II receptor antagonists.
Croatian: • Antagonisti receptora angiotenzina II.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 4 packs, each containing 90 x 1 tablets
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje s 4 pakiranja, od kojih svako sadrži 90 x 1 tabletu.
English: The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC), increase disproportionately with dose.
Croatian: Maksimalne koncentracije u plazmi (Cmax), i u manjoj mjeri površina ispod krivulje-vrijeme (AUC) povećavaju se disporporcionalno s dozom.
English: When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg dose).
Croatian: Kada se telmisartan uzima s hranom, smanjenje u površini pod krivuljom (AUC0-00) telmisartana varira od približno 6 % (doza od 40 mg) do približno 19 % (doza od 160 mg).
English: Experimental data indicate that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites.
Croatian: Eksperimentalni podaci ukazuju da se amlodipin veže na dihidropiridinska i nedihidropiridinska vezna mjesta.
English: Amlodipine should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose.
Croatian: Stoga je primjenu amlodipina potrebno započeti u nižim vrijednostima iz raspona doziranja te je potreban oprez i kod početka liječenja i kod povećanja doze.
English: Not known (frequency cannot be estimated from the available data): Severe allergic reactions with blistering eruptions of the skin and mucous membranes (toxic epidermal necrolysis).
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): Teške alergijske reakcije s izbijanjem mjehurića po koži i sluznicama (toksična epidermalna nekroliza).
English: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 D-59320 Ennigerloh Germany
Croatian: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 D-59320 Ennigerloh Njemačka
English: Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary.
Croatian: Pri istodobnoj primjeni poznatih induktora CYP3A4, koncentracija amlodipina u plazmi može varirati.