FrancophonIA/ELRC3.0 huggingface dataset:
English: Some of the studies looked at Repatha taken on its own, while others studied Repatha in combination with other fat-lowering medicines, including patients on the maximum recommended doses of statins.
Slovenian: V nekaterih študijah so zdravilo Repatha proučevali kot samostojno zdravilo, v drugih pa v kombinaciji z drugimi zdravili za zniževanje ravni maščob, vključno z bolniki, ki so jemali največji priporočeni odmerek statinov.
English: Atherosclerotic heart disease
Slovenian: Aterosklerozna srčna bolezen
English: In primary hypercholesterolaemia and mixed dyslipidaemia, Repatha was studied in 9 main studies involving around 7,400 adult patients, including patients with heterozygous familial disease.
Slovenian: Zdravilo Repatha so pri primarni hiperholesterolemiji in mešani dislipidemiji proučevali v devetih glavnih študijah, v katere je bilo vključenih približno 7 400 odraslih bolnikov, vključno z bolniki s heterozigotno družinsko boleznijo.
English: How does Repatha work?
Slovenian: Kako zdravilo Repatha deluje?
English: How is Repatha used?
Slovenian: Kako se zdravilo Repatha uporablja?
English: Repatha also helps to reduce other fatty substances from blood in patients with mixed dyslipidaemia.
Slovenian: Zdravilo Repatha pri bolnikih z mešano dislipidemijo prav tako pomaga zniževati druge maščobe v krvi.
English: Some specific preparations may be used in children between 4 and 12 years of age.
Slovenian: Nekateri posebni pripravki se lahko uporabljajo pri otrocih, starih od 4 do 12 let.
English: Primula veris L. and/or Primula elatior (L.) Hill, radix
Slovenian: Primula veris L. in/ali Primula elatior (L.) Hill, radix
English: Primula root EMA/424238/2016
Slovenian: EMA/424238/2016
English: Most primula root preparations should only be used in adults and adolescents over the age of 12 years.
Slovenian: Večina pripravkov, ki vsebujejo korenino jegliča, se sme uporabljati samo pri odraslih in mladostnikih, starejših od 12 let.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/424238/2016
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.
English: What is primula root?
Slovenian: Kaj je korenina jegliča?
English: longer than one week or worsen during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Slovenian: simptomi med uporabo zdravila trajajo več kot en teden ali se poslabšajo, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
English: This summary is not intended to provide practical advice on how to use medicines containing primula root.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo korenino jegliča.
English: The HMPC conclusions only cover primula root preparations which are obtained by drying and comminuting (reducing into tiny pieces) the underground parts or using a technique to extract compounds by putting the plant material in a solvent (such as ethanol or methanol) to dissolve compounds and form a liquid extract.
Slovenian: Zaključki odbora HMPC zajemajo samo pripravke s korenino jegliča, ki se pridobivajo s sušenjem in drobljenjem (zmanjševanjem na majhne delce) podzemnih delov ali z uporabo tehnike, s katero se spojine ekstrahirajo tako, da se rastlinski material najprej namoči v topilo (npr. etanol ali metanol), v katerem se raztopijo spojine in se pridobi tekoči ekstrakt.
English: Primula root is the common name for the underground parts of the plant Primula veris L. and/or Primula elatior (L.) Hill.
Slovenian: Korenina jegliča je splošno ime za podzemne dele rastline Primula veris L. in/ali Primula elatior (L.) Hill.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of primula root.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo korenine jegliča.
English: There are no clinical studies with preparations containing primula root only.
Slovenian: Kliničnih študij s pripravki, ki bi vsebovali samo korenino jegliča, ni.
English: The solvent is then either fully or partially evaporated to obtain a dry or soft extract.
Slovenian: Topilo se nato v celoti ali delno odpari, s čimer se pridobi suhi ali gosti ekstrakt.
English: The HMPC conclusions on the use of these primula root medicines for coughs are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo korenino jegliča, za zdravljenje kašlja temeljijo na njihovi „tradicionalni uporabi“.
English: Herbal medicines containing these primula root preparations are usually available as herbal tea to be drunk and in liquid or solid forms to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo te pripravke s korenino jegliča, so navadno na voljo kot zdravilni čaj, ki se popije, in v tekoči ali trdni obliki za jemanje skozi usta.
English: Further information on the risks associated with these primula root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih s temi zdravili, ki vsebujejo korenino jegliča, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Primula root preparations may also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Pripravki s korenino jegliča so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing primula root.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo korenino jegliča.
English: Information on the use and licensing of primula root medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo korenino jegliča, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: How are primula root medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo korenino jegliča, odobrena v EU?
English: Any applications for the licensing of medicines containing primula root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo korenino jegliča, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: Further information on the HMPC assessment of primula root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo korenino jegliča, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: In its assessment, the HMPC considered laboratory studies which showed primula root increased production of airway secretions, making phlegm less thick and easier to expel.
Slovenian: V svoji oceni je odbor HMPC upošteval študije z laboratorijskimi preskusi, ki so pokazale, da je korenina jegliča povečala izločanje sluzi v dihalih, zaradi česar je sluz manj gosta in jo je laže izkašljati.
English: The HMPC concluded that, on the basis of its long-standing use, these primula root preparations can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko ti pripravki s korenino jegliča uporabljajo kot ekspektoransi (zdravila za lažje izkašljevanje sluzi) pri kašlju, povezanem s prehladom.
English: What evidence supports the use of primula root medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo korenino jegliča?
English: Detailed instructions on how to take primula root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo korenino jegliča, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: Other information about primula root medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo korenino jegliča
English: For more information about treatment with primula root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo korenino jegliča, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with primula root medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo korenino jegliča?
English: For practical information about using primula root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: If symptoms last
Slovenian: Če
English: Date of first authorisation: 17 January 2007 Date of latest renewal: 22 November 2011
Slovenian: Datum prve odobritve: 17. januar 2007 Datum zadnjega podaljšanja: 22. november 2011
English: (It is also better to avoid Exforge in early pregnancy, see Pregnancy section).
Slovenian: (Zdravilu Exforge se je bolje izogibati tudi v zgodnji nosečnosti, glejte poglavje Nosečnost).
English: After the transitional period of 2 years, a limit for NDMA of maximum 0.03 ppm should be implemented.
Slovenian: Po dveletnem prehodnem obdobju je treba za NDMA uvesti mejo največ 0,03 ppm.
English: In two long-term follow-up studies the effect of Exforge was maintained for over one year.
Slovenian: V dveh dolgoročnih spremljevalnih študijah se je učinek zdravila Exforge ohranil več kot eno leto.
English: See also information under the heading “Do not take Exforge”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Exforge”.
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Slovenian: Starost, spol, rasa ali indeks telesne mase (≥30 kg/m2, <30 kg/m2) niso vplivali na odziv na zdravilo
English: Exforge is not recommended in early pregnancy (first 3 months), 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: Jemanje zdravila Exforge v zgodnjem obdobju nosečnosti (v prvih 3 mesecih) ni priporočljivo, če pa ste noseči več kot 3 mesece, ga ne smete jemati, ker lahko uporaba po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.
English: Your doctor will normally advise you to stop taking Exforge before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge.
Slovenian: Zdravnik vam bo praviloma svetoval, da prenehate z jemanjem zdravila Exforge še preden zanosite oziroma takoj, ko ugotovite da ste noseči in vam bo svetoval jemanje drugega zdravila namesto zdravila Exforge.
English: Children and adolescents The use of Exforge in children and adolescents is not recommended (aged below 18 years old).
Slovenian: Otroci in mladostniki Zdravila Exforge ni priporočljivo uporabljati pri otrocih in mladostnikih (starih manj kot 18 let).
English: Exforge and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Slovenian: Zdravilo Exforge in starejši ljudje (stari 65 let ali več) Zdravnik mora biti pri zviševanju vašega odmerka previden.
English: N-nitrosodimethylamine (NDMA)
Slovenian: N-nitrozodimetilamin (NDMA)
English: What Exforge is and what it is used for
Slovenian: Kaj je zdravilo Exforge in za kaj ga uporabljamo
English: Exforge with food and drink
Slovenian: Zdravilo Exforge skupaj s hrano in pijačo
English: The safety of Exforge has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Slovenian: Varnost zdravila Exforge so ocenjevali v petih kontroliranih kliničnih študijah s 5.175 bolniki, od katerih jih je 2.613 prejemalo valsartan v kombinaciji z amlodipinom.
English: Do not take Exforge if you are allergic to amlodipine or to any other calcium channel blockers.
Slovenian: Ne jemljite zdravila Exforge če ste alergični na amlodipin ali na katerikoli zaviralec kalcijevih kanalčkov.
English: Patients taking Exforge and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Slovenian: Bolniki, ki jemljejo zdravilo Exforge in vozijo motorna vozila ali uporabljajo stroje, morajo upoštevati, da se lahko občasno pojavi omotica ali utrujenost.
English: Stopping your treatment with Exforge may cause your disease to get worse.
Slovenian: Če prenehate jemati zdravilo Exforge, se lahko vaša bolezen poslabša.
English: The safety and efficacy of Exforge in children aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Exforge pri otrocih, starih manj kot 18 let, nista bili dokazani.
English: The usual dose of Exforge is one tablet per day.
Slovenian: Običajni odmerek zdravila Exforge je ena tableta na dan.
English: Other medicines and Exforge
Slovenian: Druga zdravila in zdravilo Exforge
English: It is recommended to take Exforge with some water.
Slovenian: Zdravilo Exforge je priporočljivo vzeti z malo vode.
English: If you think you may be allergic, talk to your doctor before taking Exforge.
Slovenian: Če domnevate, da bi lahko bili alergični, se posvetujte z zdravnikom, preden vzamete zdravilo Exforge.
English: To date there is no experience of the safe use of Exforge in patients who have had a recent kidney transplantation.
Slovenian: Doslej ni izkušenj glede varnosti uporabe zdravila Exforge pri bolnikih, ki jim je bila nedavno presajena ledvica.
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Exforge containing the same component doses.
Slovenian: Zaradi praktičnosti je možno bolnike, ki dobivajo valsartan in amlodipin v ločenih tabletah/kapsulah, prevesti na zdravilo Exforge, ki vsebuje enaka odmerka sestavin.
English: Abrupt withdrawal of Exforge has not been associated with a rapid increase in blood pressure.
Slovenian: Nenadna prekinitev zdravila Exforge ni povezana s hitrim zvišanjem krvnega tlaka.
English: The recommended dose of Exforge is one tablet per day.
Slovenian: Priporočeni odmerek zdravila Exforge je ena tableta na dan.
English: What you need to know before you take Exforge
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Exforge
English: You should never take Exforge again.
Slovenian: V tem primeru zdravila Exforge nikoli več ne smete več jemati.
English: If you have taken too many tablets of Exforge, or if someone else has taken your tablets, consult a doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Exforge, kot bi smeli Če ste vzeli preveč tablet zdravila Exforge, ali je vaše tablete vzel kdo drug, se takoj posvetujte z zdravnikom.
English: No drug-drug interaction studies have been performed with Exforge and other medicinal products.
Slovenian: Študij medsebojnega delovanja z zdravilom Exforge in drugimi zdravili niso izvedli.
English: • Concomitant use of Exforge with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Slovenian: • Sočasna uporaba zdravila Exforge in zdravil, ki vsebujejo aliskiren, je kontraindicirana pri bolnikih s sladkorno boleznijo ali z okvaro ledvic (GFR <60 ml/min/1,73m2) (glejte poglavji 4.5 in 5.1).
English: Other possible side effects of Exforge:
Slovenian: Drugi možni neželeni učinki zdravila Exforge:
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Exforge.
Slovenian: Če je uporabljen tudi diuretik, uporaba zdravila Exforge predvidoma poveča toksične učinke litija.
English: Exforge is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Slovenian: Zdravilo Exforge je na voljo v pakiranjih, ki vsebujejo 7, 14, 28, 30, 56, 90, 98 ali 280 tablet in v skupnih pakiranjih s 4 škatlami, od katerih vsaka vsebuje 70 tablet, ali z 20 škatlami, od katerih vsaka vsebuje 14 tablet.
English: Exforge was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Slovenian: Zdravilo Exforge so raziskali tudi v študiji, kontrolirani z učinkovino, pri 130 bolnikih s hipertenzijo, ki so imeli srednji diastolični krvni tlak sede ≥110 mm Hg in <120 mm Hg.
English: Exforge has not been studied in any patient population other than hypertension.
Slovenian: Zdravilo Exforge ni raziskano pri nobeni drugi populaciji razen pri bolnikih s hipertenzijo.
English: The amlodipine component of Exforge inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Slovenian: Amlodipin v zdravilu Exforge zavira transmembranski vstop kalcijevih ionov v srčne in žilne gladke mišice.
English: If you get these symptoms, stop taking Exforge and contact your doctor straight away.
Slovenian: Če opazite navedene simptome, takoj prenehajte jemati zdravilo Exforge in obvestite svojega zdravnika.
English: Exforge combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Slovenian: Zdravilo Exforge vsebuje dve antihipertenzivni učinkovini s komplementarnima mehanizmoma delovanja za obvladanje krvnega tlaka pri bolnikih z esencialno hipertenzijo: amlodipin spada med zaviralce kalcijevih kanalčkov, valsartan pa med antagoniste angiotenzina II.
English: Frequency Exforge Amlodipine Valsartan
Slovenian: Pogostnost Exforge Amlodipin Valsartan
English: Do not take Exforge with grapefruit or grapefruit juice.
Slovenian: Zdravila Exforge ne zaužijte skupaj z grenivko ali z grenivkinim sokom.
English: The rate and extent of absorption of Exforge are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Slovenian: Hitrost in obseg absorpcije zdravila Exforge sta enakovredna biološki uporabnosti valsartana in amlodipina, uporabljenih v ločenih tabletah.
English: If you forget to take Exforge
Slovenian: Če ste pozabili vzeti zdravilo Exforge
English: If hypotension occurs with Exforge, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Slovenian: Če se med uporabo zdravila Exforge pojavi hipotenzija, je treba bolnika poleči in mu, če je potrebno, dati intravensko infuzijo fiziološke raztopine.
English: Correction of this condition prior to administration of Exforge or close medical supervision at the start of treatment is recommended.
Slovenian: Priporočljivo je, da pred začetkom uporabe zdravila Exforge, popravite to stanje ali bolniku zagotovite natančen zdravniški nadzor na začetku zdravljenja.
English: Clinically significant hypotension due to Exforge overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Slovenian: Klinično značilna hipotenzija zaradi prevelikega odmerka zdravila Exforge zahteva srčnožilno podporo, vključno s pogostim nadziranjem delovanja srca in dihal, dviganjem udov ter kontrolo krožečega volumna tekočine in izločanja urina.
English: What Exforge is and what it is used for What you need to know before you take Exforge How to take Exforge
Slovenian: Kaj je zdravilo Exforge in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Exforge Kako jemati zdravilo Exforge Možni neželeni učinki
English: Exforge is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Slovenian: Če želite dojiti, bo zdravnik za vas izbral drugo zdravilo, še posebno če je vaš otrok še novorojenček ali je bil rojen prezgodaj.
English: Exforge can be used with or without food.
Slovenian: Zdravilo Exforge lahko vzamete s hrano ali brez nje.
English: Particular caution should be exercised when administering Exforge to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Slovenian: Posebna previdnost je potrebna v primeru uporabe zdravila Exforge pri bolnikih z blago do zmerno okvaro jeter ali z obstruktivnimi biliarnimi boleznimi.
English: Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Exforge as well, even if not observed in clinical trials or during the post-marketing period.
Slovenian: Dodatne informacije o posameznih zdravilnih učinkovinah Neželeni učinki, opisani za katero od obeh zdravilnih učinkovin (za amlodipin ali valsartan), so lahko tudi neželeni učinki zdravila Exforge, tudi če niso bili ugotovljeni v kliničnih preskušanjih ali v obdobju po prihodu zdravila na trg.
English: This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Exforge.
Slovenian: Grenivka in grenivkin sok lahko namreč povzročita zvišanje koncentracije zdravilne učinkovine amlodipina v krvi, kar lahko pripelje do nepredvidljivega povečanja učinka zdravila Exforge pri zniževanju krvnega tlaka.
English: If you stop taking Exforge
Slovenian: Če ste prenehali jemati zdravilo Exforge
English: In this study (baseline blood pressure 171/113 mmHg), an Exforge regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Slovenian: V tej študiji (izhodiščni krvni tlak 171/113 mm Hg) je shema odmerjanja zdravila Exforge 5 mg/160 mg, titrirana do 10 mg/160 mg, znižala krvni tlak sede za 36/29 mm Hg; v primerjavi s tem je shema odmerjanja lizinoprila/hidroklorotiazida 10 mg/12,5 mg, titrirana do 20 mg/12,5 mg, znižala krvni tlak za 32/28 mm Hg.
English: Caution should be exercised when administering Exforge to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Slovenian: Previdnost je potrebna pri uporabi zdravila Exforge pri bolnikih z okvaro jeter ali obstruktivno biliarno boleznijo (glejte poglavje 4.4).
English: If any of these apply to you, tell your doctor before taking Exforge.
Slovenian: Če kaj od naštetega velja za vas, morate to povedati zdravniku, preden vzamete zdravilo Exforge.
English: How to take Exforge
Slovenian: Kako jemati zdravilo Exforge