FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials with Ameluz, local skin reactions at the application site were observed in most of the subjects treated for actinic keratosis and basal cell carcinoma.
Slovenian: V kliničnih študijah z zdravilom Ameluz pri večini bolnikov, zdravljenih zaradi aktinične keratoze in bazalnoceličnega karcinoma, niso opazili lokalne reakcije na koži na mestu nanosa.
English: b) Application of the gel: Ameluz should be applied to the lesion area or entire cancerized fields of about 20 cm2, using glove protected fingertips or a spatula.
Slovenian: b) Nanašanje gela: zdravilo Ameluz je treba s prsti, zaščitenimi z rokavico, ali z lopatico nanesti na celotno površino lezij ali celotno polje kancerizacije velikosti približno 20 cm2.
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.
Slovenian: Pri nodularni BCC je z zdravilom Ameluz izginilo 89,3 % lezij, z MAL pa 78,6 %.
English: Marketing Authorisation Holder Biofrontera Bioscience GmbH Hemmelrather Weg 201
Slovenian: Imetnik dovoljenja za promet z zdravilom Biofrontera Bioscience GmbH Hemmelrather Weg 201
English: Breast-feeding should be interrupted for 12 hours after application of Ameluz.
Slovenian: Po nanosu zdravila Ameluz je treba za 12 ur prekiniti dojenje.
English: Ameluz is applied to form a film of about 1 mm thickness to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula.
Slovenian: Nanašanje gela Zdravilo Ameluz se nanese tako, da tvori približno 1 mm debel sloj na celotni površini lezij ali polj in približno 5 mm okoli njih, s prsti, zaščitenimi z rokavico, ali z lopatico.
English: In vitro dermal absorption into human skin was studied using Ameluz containing radiolabelled 5-aminolaevulinic acid (ALA).
Slovenian: Z zdravilom Ameluz, ki je vsebovalo radioaktivno označeno 5-aminolevulinsko kislino (ALA), so preučevali dermalno absorpcijo v človeško kožo in vitro.
English: No experience exists for the use of Ameluz in patients taking immunosuppressants.Therefore, the use of immunosuppressants during treatment with Ameluz is not recommended.
Slovenian: Zato se uporaba imunosupresivov med zdravljenjem z zdravilom Ameluz ne priporoča.
English: Table 2a: Efficacy and adverse reactions (transient pain and erythema) occurring at the application site during photodynamic therapy with different light sources for the treatment of AK Light source
Slovenian: Preglednica 2a: učinkovitost in neželeni učinki (v obliki prehodne bolečine in eritema), ki so se pojavili na mestu nanosa med fotodinamičnim zdravljenjem z različnimi viri svetlobe za zdravljenje
English: burning pain), irritation, pruritus, oedema, scab, exfoliation, induration, paraesthesia
Slovenian: Na mestu uporabe: eritem, bolečina (vključno s skelenjem), draženje, pruritus, edem, krastavost, luščenje, induracija, parastezija
English: Ameluz is not recommended during pregnancy, due to insufficient knowledge.
Slovenian: Zaradi nezadostnega znanja uporaba zdravila Ameluz pri nosečnicah ni priporočljiva.
English: Table 2b: Efficacy and adverse reactions (transient pain and erythema) occurring at the application site during photodynamic therapy with different light sources for the treatment of AK Light source
Slovenian: Preglednica 2b: učinkovitost in neželeni učinki (v obliki prehodne bolečine in eritema), ki so se pojavila na mestu nanosa med fotodinamičnim zdravljenjem z različnimi viri svetlobe za zdravljenje
English: At application site: Pustules Not at application site: Rash pustular
Slovenian: Na mestu uporabe: pustule
English: Name and address of the manufacturer responsible for batch release
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca,odgovornega za sproščanje serij
English: Email: ameluz@biofrontera.com
Slovenian: ameluz@pelpharma.at
English: How to store Ameluz
Slovenian: Shranjevanje zdravila Ameluz
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.
Slovenian: Pri zdravljenju z zdravilom Ameluz je izginilo 99,1 % blagih lezij v primerjavi z 49,2 % pri placebu in 91,7 % zmernih lezij v primerjavi s 24,1 % pri placebu.
English: The gel should be allowed to dry for approximately 10 minutes, before a light-tight dressing is placed over the treatment site.
Slovenian: Počakajte, da se gel suši okoli 10 minut, in nato na mesto zdravljenja namestite povoj, ki ne prepušča svetlobe.
English: A light-tight dressing is not necessary.
Slovenian: Uporaba povoja, ki ne prepušča svetlobe, ni potrebna.
English: Then wipe the application area with an alcohol-soaked cotton pad to degrease the skin.
Slovenian: Področje nanosa natančno obrišite z bombažno blazinico, namočeno v alkohol, za razmastitev kože.
English: • eyelid swelling caused by excess fluid, blurred vision or visual impairment
Slovenian: • otekanje vek zaradi odvečne tekočine, zamegljeni vid ali okvara vida • neprijeten, neobičajen občutek za otip
English: 51377 Leverkusen, Germany Tel: +49 214 87632 66, Fax: +49 214 87632 90 Email: ameluz@biofrontera.com
Slovenian: Tel.: +49 214 87632 66, faks: +49 214 87632 90 E-pošta: ameluz@biofrontera.com
English: An entire tube of placebo and Ameluz followed by PDT was applied in a fixed sequence design with a washout period of 7 days to evaluate baseline and Ameluz dependent plasma concentrations of ALA and PpIX.
Slovenian: Študijo FK pri največji uporabi so izvedli pri 12 bolnikih, ki so imeli na obrazu ali čelu vsaj 10 blagih do zmernih AK. Z zasnovo fiksnega zaporedja in obdobjem izpiranja 7 dni so nanesli celotno tubo placeba in zdravila Ameluz, ki mu je sledila PDT, da bi ocenili izhodiščne in od zdravila Ameluz odvisne koncentracije ALA in PpIX v plazmi.
English: Ameluz does not increase 5-aminolaevulinic acid or protoporphyrin IX plasma levels following topical application.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravilo Ameluz ne povečuje koncentracije 5-aminolevulinske kisline ali protoporfirina IX v plazmi po lokalni uporabi.
English: - pustules
Slovenian: − mehurčki
English: • medicines to increase water output through your kidneys with active substance names mostly ending in “thiazide” or “tizide”, such as hydrochlorothiazide
Slovenian: • grizeofulvin: zdravilo za zdravljenje glivičnih okužb • zdravila za povečanje izločanja vode skozi ledvice z učinkovinami, katerih imena se večinoma končajo s „tiazid“ ali „tizid“, kot je hidroklorotiazid • nekatera zdravila za zdravljenje sladkorne bolezni, kot so glibenklamid, glimepirid
English: 1 g Ameluz contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).
Slovenian: 1 g zdravila Ameluz vsebuje 78 mg 5-aminolevulinske kisline (v obliki klorida).
English: Ameluz Full patient clearance n (%)
Slovenian: Zdravilo Ameluz Popolna odstranitev pri bolniku n (%)
English: Severity
Slovenian: Atrofija
English: An unsatisfactory or impaired cosmetic outcome was judged for 3.8% of the subjects in the Ameluz group and in 22.5% of the subjects in the placebo group.
Slovenian: Nezadovoljiv ali neustrezen kozmetični izid je bil ugotovljen pri 3,8 % bolnikov v skupini, zdravljeni z zdravilom
English: Clinical efficacy was maintained during the follow-up periods of 6 and 12 months after the last photodynamic therapy.
Slovenian: Klinična učinkovitost se je v šest- in dvanajstmesečnem obdobju spremljanja po zadnjem fotodinamičnem zdravljenju ohranila.
English: Treatment of lesions and fields of actinic keratoses with daylight
Slovenian: Zdravljenje lezij in polj z aktinično keratozo
English: The application area is first wiped with an alcohol-soaked cotton pad to degrease the skin.
Slovenian: Predel nanosa je treba obrisati z bombažno blazinico, navlaženo z alkoholom, za razmastitev kože.
English: • reactions at the application site - skin reddening - pain (incl.
Slovenian: − pordečitev kože − bolečina (vključno s skelenjem)
English: Broad spectrum Ameluz
Slovenian: Ameluz spekter
English: Ameluz contains soybean phosphatidylcholine and should not be applied to patients known to be allergic to peanut or soya (see section 4.3).
Slovenian: Tveganje alergijskih reakcij Zdravilo Ameluz vsebuje sojin fosfatidilholin in se ne sme uporabljati pri bolnikih, za katere je znano,
English: Scales and crusts should be removed accurately and all lesion surfaces roughened gently.
Slovenian: Luske in kraste je treba odstraniti in vse površine lezij nežno podrgniti.
English: Preparation of the lesions
Slovenian: Priprava lezij
English: MAL Full patient clearance n (%)
Slovenian: MAL Popolna odstranitev pri bolniku n (%)
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 53.1% or 47.2% for treatment with Ameluz and 40.8% or 36.3% for MAL treatment with narrow spectrum lamps or all lamp types, respectively.
Slovenian: mesecev po zadnjem zdravljenju očiščen, 53,1- ali 47,2-odstotna pri zdravljenju z zdravilom Ameluz ter 40,8- ali 36,3-odstotna pri zdravljenju z MAL s svetilkami ozkega spektra oziroma s svetilkami vseh vrst.
English: Total
Slovenian: Široki
English: MAL Full lesion clearance n (%)
Slovenian: MAL Ameluz Popolna odstranitev lezij n (%)
English: n.a.
Slovenian: PRILOGA I
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One gram (g) gel contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).
Slovenian: En gram (g) gela vsebuje 78 mg 5-aminolevulinske kisline (v obliki klorida).
English: Roughness/ dryness/ scaliness
Slovenian: Hrapavost/ suhost/ luskavost
English: The remaining gel is wiped off.
Slovenian: Obrišite preostanek gela.
English: Hot flush
Slovenian: Vročinski obliv
English: The side effects listed below have been reported when using Ameluz with a red-light lamp.
Slovenian: Po uporabi zdravila Ameluz s svetilko z rdečo svetlobo so poročali o spodaj navedenih neželenih učinkih.
English: PC: {number} [product code]
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC: {številka} [koda zdravila]
English: Total patient clearance (%)
Slovenian: Zdravilo Skupna stopnja odstranitve lezij pri bolnikih (%)
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov • reakcije na mestu uporabe
English: • nervousness
Slovenian: • bolečina • živčnost
English: Carefully removed scales and crusts and gently roughen all lesion surfaces.
Slovenian: Kožo, ki se lušči, in kraste previdno odstranite in nežno podrgnite vse površine lezije.
English: Any UV-therapy should be discontinued before treatment.
Slovenian: Zdravilo Ameluz prehodno povečuje fototoksičnost Pred zdravljenjem je treba prekiniti kakršnokoli zdravljenje z UV-žarki.
English: • The other ingredients are: disodium phosphate dihydrate, isopropyl alcohol, polysorbate 80, propylene glycol, purified water, sodium benzoate (E211), sodium dihydrogen phosphate dihydrate, soybean phosphatidylcholine, triglycerides medium-chain, xanthan gum.
Slovenian: natrijev benzoat (E211), natrijev dihidrogenfosfat dihidrat, sojin fosfatidilholin, srednjeverižni trigliceridi, ksantanski gumi.
English: • feeling hot, fever, hot flush
Slovenian: • občutek vročine, zvišana telesna temperatura, vročinski obliv • začasna izguba spomina1
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.
Slovenian: Zdravilo Ameluz s prsti, zaščitenimi z rokavico, ali z lopatico nanesite na celotno površino lezij ali celoten predel ter približno 5 mm okoli njega.
English: Superficial (only) Nodular (only) Others (including mixed s/nBCCs) Thickness >1mm n.a.
Slovenian: (vključno z mešanim p/nBCC) debelina > 1 mm se ne uporablja se ne uporablja se ne uporablja se ne uporablja
English: - ulcer
Slovenian: − izcedek
English: STATEMENT OF ACTIVE SUBSTANCE(S) One gram contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).
Slovenian: En gram vsebuje 78 mg 5-aminolevulinske kisline (v obliki klorida).
English: 0 none no AK lesion present, neither visible nor palpable
Slovenian: 0 brez ni lezij aktinične keratoze, niso vidne niti otipljive
English: - inflammation
Slovenian: Bolezni živčevja
English: The gel should cover the lesions or entire fields and approximately 5 mm of the surrounding area with a film of about 1 mm thickness.
Slovenian: Lezije ali celotna polja in približno 5 mm okoliškega območja je treba premazati z gelom v debelini okoli 1 mm. Gel naj se suši približno 10 minut, nato pa se na mesto zdravljenja namesti povoj, ki ne prepušča svetlobe.
English: Type of skin impairment
Slovenian: • izcedek iz rane • utrujenost
English: Scales and crusts should be removed carefully and all lesion surfaces roughened gently.
Slovenian: Kožo, ki se lušči, in kraste je treba previdno odstraniti in vso površino lezije nežno podrgniti.
English: At application site: Vesicles, discharge, erosion, reaction, discomfort, hyperalgesia, haemorrhage, warmth
Slovenian: reakcija, nelagodje, hiperalgezija, krvavitev,
English: Before administration of Ameluz, all lesions should be carefully wiped with an ethanol or isopropanol-soaked cotton pad to ensure degreasing of the skin.
Slovenian: Pred uporabo zdravila Ameluz je treba vse lezije natančno obrisati z bombažno blazinico,
English: Efficacy and safety of Ameluz for the treatment of basal cell carcinoma (BCC) with a thickness of <2mm has been evaluated in 281 patients enrolled in a phase III clinical trial.
Slovenian: < 2 mm so ocenili pri 281 bolnikih, vključenih v klinično preskušanje faze III.
English: - to bleeding lesions
Slovenian: − povečana občutljivost na bolečino
English: Mild
Slovenian: Blaga
English: • fatigue
Slovenian: − odrgnine
English: Skin and subcutaneous disorders Uncommon
Slovenian: Bolezni kože in podkožja
English: Not at application site: Chills, feeling hot, pyrexia, pain, fatigue, ulcer
Slovenian: Splošne težave, ki se ne pojavljajo na mestu uporabe: mrazenje, občutek vročine, pireksija,
English: Fax: +49-214-87632-90
Slovenian: Nemčija tel.: +49-214-87632-66 faks: +49-214-87632-90 e-pošta: ameluz@biofrontera.com
English: What Ameluz looks like and contents of the pack Ameluz is a white to yellowish gel.
Slovenian: Izgled zdravila Ameluz in vsebina pakiranja
English: Ameluz contains the active substance 5-aminolaevulinic acid.
Slovenian: Kaj je zdravilo Ameluz in za kaj ga uporabljamo Zdravilo Ameluz vsebuje učinkovino 5-aminolevulinsko kislino.
English: The complete patient clearance rate for Ameluz was 93.4%, compared to 91.8% for the comparator MAL.
Slovenian: Cilj študije je bila popolna odstranitev lezij pri bolnikih 12 tednov po zadnjem fotodinamičnem zdravljenju Stopnja popolne odstranitve lezij za zdravilo Ameluz je bila 93,4 % v primerjavi z 91,8 % za MAL v obliki kreme.
English: At application site: Discoloration, ulcer, swelling, inflammation, hypersensitivity*1
Slovenian: Na mestu uporabe: mehurčki, izcedek, erozija,
English: Wound secretion
Slovenian: Izcedek iz rane
English: This applies especially to the medicines listed below:
Slovenian: To velja zlasti za spodaj našteta zdravila:
English: • if you are elderly and your dose needs to be increased.
Slovenian: • če ste starejši in vam je treba povečati odmerek.
English: It is important that you take Twynsta every day until your doctor tells you otherwise.
Slovenian: Pomembno je, da jemljete zdravilo Twynsta vsak dan, dokler vam zdravnik ne naroči drugače.
English: This medicinal product is indicated for long term treatment.
Slovenian: To zdravilo je indicirano za dolgotrajno zdravljenje.
English: *Based on patient weight of 50 kg
Slovenian: *Na podlagi bolnikove telesne mase 50 kg.
English: Absolute bioavailability has been estimated to be between 64 and 80 %.
Slovenian: Ocenjena absolutna biološka uporabnost je med 64 in 80 %.
English: Carcinogenesis, mutagenesis
Slovenian: Karcinogeneza, mutageneza
English: You must tell your doctor if you think you might be pregnant or are planning to have a baby.
Slovenian: Zdravniku morate povedati, če mislite, da bi lahko bili noseči ali če načrtujete nosečnost.
English: (It is also better to avoid Twynsta in early pregnancy - see Pregnancy section.)
Slovenian: (Bolje je, da zdravila Twynsta tudi v zgodnji nosečnosti ne uporabljate - glejte odstavek Nosečnost);
English: Amlodipine is a weak CYP3A inhibitor.
Slovenian: Amlodipin je šibak zaviralec CYP3A.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2010
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 7. oktober 2010 Datum zadnjega podaljšanja: 20. avgust 2015
English: Children and adolescents Twynsta is not recommended in children and adolescents up to the age of 18 years.
Slovenian: Otroci in mladostniki Zdravila Twynsta ne priporočamo pri otrocih in mladostnikih do 18. leta.
English: • Simvastatin to treat elevated levels of cholesterol.
Slovenian: • simvastatin, za zdravljenje zvišanih ravni holesterola;
English: This medicinal product has moderate influence on the ability to drive and use machines.
Slovenian: To zdravilo ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
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.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravilo Twynsta prenehate jemati, preden boste zanosili ali takoj ko boste vedeli, da ste noseči, in vam svetoval, da namesto zdravila Twynsta jemljete drugo zdravilo.
English: 14 tablets 28 tablets 30 x 1 tablets 56 tablets 90 x 1 tablets 98 tablets
Slovenian: 14 tablet 28 tablet 30 x 1 tableta 56 tablet 90 x 1 tableta 98 tablet
English: • if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na telmisartan ali amlodipin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
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.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev ali če so pri vas ugotovili dedno intoleranco za fruktozo, redko genetsko bolezen, pri kateri ne morete razgraditi fruktoze, se posvetujte z zdravnikom, preden vzamete ali dobite to zdravilo.
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.
Slovenian: Zdravila Twynsta v zgodnji nosečnosti ne priporočajo; ne smete pa ga jemati, ko boste noseči več kot 3 mesece, ker lahko po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
English: If you have the impression that the effect of Twynsta is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila Twynsta premočan ali prešibak, se pogovorite z zdravnikom ali farmacevtom.
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Twynsta pri hipertenziji za vse podskupine pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: PHARMACEUTICAL FORM AND CONTENTS 90 tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 90 tablet
English: Reproductive toxicology
Slovenian: Reproduktivna toksikologija
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).
Slovenian: • če imate zoženo aortno srčno zaklopko (aortna stenoza) ali kardiogeni šok (stanje, ko vaše srce ne črpa dovolj krvi za oskrbovanje telesa);
English: The safety and efficacy of telmisartan/amlodipine in children aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost telmisartana/amlodipina pri otrocih, ki so mlajši od 18 let, še nista dokazani.
English: Therefore, patients with heart failure should be treated with caution.
Slovenian: Zato je treba bolnike s srčnim popuščanjem zdraviti previdno.
English: • Medicines used to alter the way your immune system works (e.g. sirolimus, temsirolimus and everolimus).
Slovenian: • zdravila, ki spreminjajo delovanje vašega imunskega sistema (npr. sirolimus, temsirolimus in everolimus),
English: Rare cystitis sepsis including fatal outcome
Slovenian: Redki cistitis sepsa, tudi s smrtnim izidom
English: Rare back pain, pain in extremity (leg pain)
Slovenian: Redki bolečina v hrbtu, bolečina v okončini (bolečina v nogi)
English: The clinical translation of these PK variations may be more pronounced in the elderly.
Slovenian: Klinične posledice teh farmakokinetičnih sprememb so lahko izrazitejše pri starejših.
English: Rare malaise influenza-like illness
Slovenian: Redki slabo počutje gripi podobna bolezen
English: In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine.
Slovenian: Pri zdravih prostovoljcih je uporaba oglja v roku 2 ur po uporabi amlodipina 10 mg zmanjšala stopnjo absorpcije amlodipina.
English: Very rare pancreatitis, gastritis
Slovenian: Zelo redki pankreatitis, gastritis
English: Not known toxic epidermal necrolysis
Slovenian: Neznana toksična epidermalna nekroliza
English: The antihypertensive effect of Twynsta was similar irrespective of age and gender, and was similar in patients with and without diabetes.
Slovenian: Antihipertenzivni učinek zdravila Twynsta je bil podoben pri bolnikih ne glede na starost in spol ter pri bolnikih s sladkorno boleznijo in brez nje.
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).
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): hude alergijske reakcije z nastajanjem mehurjev na koži in sluznicah (toksična epidermalna nekroliza).
English: Telmisartan/amlodipine should therefore be used with caution in these patients.
Slovenian: Telmisartan/amlodipin je treba pri teh bolnikih previdno uporabljati.
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1
Slovenian: • preobčutljivost na učinkovini, derivate dihidropiridina ali katero koli pomožno snov, navedeno v poglavju 6.1,
English: Component of a multipack, can't be sold separately.
Slovenian: Del skupinskega pakiranja, ni za posamično prodajo.
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.
Slovenian: Zato je treba amlodipin uvesti v manjših odmerkih, potrebna pa je tudi previdnost, tako na začetku zdravljenja kot tudi pri povečanju odmerka.
English: Twynsta is used to treat high blood pressure
Slovenian: Zdravilo Twynsta je namenjeno zdravljenju visokega krvnega tlaka:
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.
Slovenian: V dveh odprtih, dolgotrajnih, nadaljevalnih študijah, ki sta potekali nadaljnjih 6 mesecev, je bil učinek zdravila Twynsta nespremenjen ves čas preskušanja.
English: What Twynsta is and what it is used for
Slovenian: Kaj je zdravilo Twynsta in za kaj ga uporabljamo