FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Trobalt in paediatric patients aged 0 to below 2 years with Lennox Gastaut Syndrome (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila (EMA) je odstopila od zahteve za predložitev rezultatov študij z zdravilom Trobalt pri pediatričnih bolnikih v starosti od 0 do manj kot 2 leti z Lennox-Gastautovim sindromom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: There was no evidence of teratogenicity following administration of retigabine to pregnant animals during the period of organogenesis.
Slovenian: Po uporabi retigabina pri brejih živalih med obdobjem organogeneze niso ugotovili znakov teratogenosti.
English: Don't stop taking Trobalt without advice Take Trobalt for as long as your doctor recommends.
Slovenian: Ne nehajte jemati zdravila Trobalt, ne da bi vam to naročil zdravnik.
English: Common:
Slovenian: Občasni:
English: 4.9 Overdose
Slovenian: 4.9 Preveliko odmerjanje Simptomi in znaki
English: How to take
Slovenian: Način uporabe
English: Tell the doctor that you are taking Trobalt, well in advance.
Slovenian: Zdravniku morate dovolj zgodaj povedati, da jemljete zdravilo Trobalt.
English: Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50” on one side.
Slovenian: Škrlatne, okrogle filmsko obložene tablete velikosti 5,6 mm z oznako "RTG 50" na eni strani.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Slovenian: Pri bolnikih, ki so zaradi različnih indikacij dobivali antiepileptična zdravila, so opisane samomorilne misli in samomorilno vedenje.
English: In a single-dose study, there were no clinically significant effects on retigabine AUC in volunteers with mild hepatic impairment (Child-Pugh score 5 to 6).
Slovenian: V študiji enega odmerka pri prostovoljcih z blago okvaro jeter (5 do 6 po Child-Pughu) ni bilo pomembnih učinkov na AUC retigabina.
English: Green, round, film-coated tablets of 7.1 mm, marked with “RTG 100” on one side.
Slovenian: Zelene, okrogle filmsko obložene tablete velikosti 7,1 mm z oznako "RTG 100" na eni strani.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trobalt in paediatric patients aged 2 to below 18 years with Lennox Gastaut Syndrome, and in paediatric patients aged 0 to below 18 years with partial onset seizures (see section 4.2 for information on paediatric use) .
Slovenian: Evropska agencija za zdravila (EMA) je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Trobalt pri pediatričnih bolnikih v starosti od 2 do manj kot 18 let, ki imajo LennoxGastautov sindrom, in pri pediatričnih bolnikih v starosti od 0 do manj kot 18 let, ki imajo napade s parcialnim začetkom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: 50 mg tablets:
Slovenian: 50-mg tablete:
English: If at any time you have these thoughts,
Slovenian: • če že imate kakšne težave s srcem,
English: Dysphagia
Slovenian: Dojenje
English: • If you get any side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite kateri koli neželeni učinek se posvetujte z zdravnikom ali farmacevtom.
English: Talk to your doctor before taking Trobalt:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Trobalt se posvetujte z zdravnikom:
English: A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe renal impairment (creatinine clearance <50 ml/min; see section 5.2).
Slovenian: Bolnikom z zmerno ali hudo okvaro ledvic (očistek kreatinina < 50 ml/min; glejte poglavje 5.2) je priporočljivo začetni in vzdrževalni odmerek zdravila Trobalt zmanjšati za 50 %.
English: In addition a distinct form of macular abnormality with features of vitelliform maculopathy (see section 4.8) has also been identified, in most cases diagnosed with optical coherence tomography (OCT) imaging.
Slovenian: Dodatno so poročali o posebni obliki nepravilnosti makule z značilnostmi viteliformne makulopatije (glejte poglavje 4.8).
English: Adjustment of the Trobalt dose is recommended in patients with moderate or severe hepatic impairment (see section 4.2).
Slovenian: Bolnikom z zmerno do hudo okvaro jeter je priporočljivo prilagoditi odmerek zdravila Trobalt (glejte poglavje 4.2).
English: • drowsiness
Slovenian: • zaspanost,
English: Skin rash Hyperhidrosis
Slovenian: hiperhidroza
English: A blue-grey discolouration of the skin, lips or nails has also been reported in people taking Trobalt for several years (See Section 4).
Slovenian: Pri bolnikih, ki jemljejo zdravilo Trobalt več let so poročali tudi o modro-sivih spremembah barve kože, ustnic ali nohtov (glejte poglavje 4).
English: ГлаксоСмитКлайн ЕООД Teл.
Slovenian: България ГлаксоСмитКлайн ЕООД
English: Purple, oblong, film-coated tablets of 8.1 mm x 18 mm, marked with “RTG-400” on one side.
Slovenian: Škrlatne, podolgovate filmsko obložene tablete velikosti 8.1 mm x 18 mm z oznako "RTG-400" na eni strani.
English: INFORMATION IN BRAILLE trobalt 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI trobalt 50 mg
English: 4.7 Effects on ability to drive and use machines Adverse reactions such as dizziness, somnolence, diplopia and blurred vision were reported in controlled clinical studies, particularly during titration (see section 4.8).
Slovenian: V kliničnih študijah so bili, zlasti med titriranjem, opisani neželeni učinki, npr. omotica, zaspanost, diplopija in zamegljen vid (glejte poglavje 4.8).
English: Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Iron oxide yellow (E172).
Slovenian: 200-mg tablete: polivinilalkohol titanov dioksid (E171) smukec (E553b) rumeni železov oksid (E172) sojin lecitin ksantanski gumi
English: Your doctor will monitor you more closely if treatment with Trobalt is continued.
Slovenian: Če boste zdravljenje z zdravilom Trobalt nadaljevali, vas bo zdravnik natančneje nadziral.
English: Packs containing 21or 84 film-coated tablets.
Slovenian: Pakiranja z 21 ali 84 filmsko obloženimi tabletami.
English: A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe hepatic impairment (Child-Pugh score ≥7; see section 5.2).
Slovenian: Bolnikom z zmerno ali hudo okvaro jeter (≥ 7 po Child-Pughu; glejte poglavje 5.2) je priporočljivo začetni in vzdrževalni odmerek zdravila Trobalt zmanjšati za 50 %.
English: Trobalt 100 mg film-coated tablets are green, round and marked “RTG 100” on one side.
Slovenian: Filmsko obložene tablete Trobalt 100 mg so zelene barve, okrogle in označene z "RTG 100" na eni strani.
English: Yellow, oblong, film-coated tablets of 7.1 mm x 14 mm, marked with “RTG-200” on one side.
Slovenian: Rumene, podolgovate filmsko obložene tablete velikosti 7.1 mm x 14 mm z oznako "RTG-200" na eni strani.
English: The active substance is retigabine.
Slovenian: Zdravilna učinkovina je retigabin.
English: Trobalt 200 mg film-coated tablets are yellow, oblong and marked “RTG-200” on one side.
Slovenian: Filmsko obložene tablete Trobalt 200 mg so rumene barve, podolgovate in označene z "RTG-200" na eni strani.
English: Green, oblong, film-coated tablets of 7.1 mm x 16 mm, marked with “RTG-300” on one side.
Slovenian: Zelene, podolgovate filmsko obložene tablete velikosti 7.1 mm x 16 mm z oznako "RTG-300" na eni strani.
English: INFORMATION IN BRAILLE trobalt 200 mg
Slovenian: PODATKI V BRAILLOVI PISAVI trobalt 200 mg
English: Česká republika GlaxoSmithKline s.r.o.
Slovenian: GlaxoSmithKline s.r.o.
English: Discolouration of parts of the eye, including the retina (inside the back of the eye) has been reported in people taking Trobalt for several years (see Section 4).
Slovenian: Pri bolnikih, ki jemljejo zdravilo Trobalt več let, so poročali o spremenjeni barvi delov očesa, vključno z mrežnico (na zadnji notranji strani očesa) (glejte poglavje 4).
English: Trobalt contains the active substance retigabine.
Slovenian: Zdravilna učinkovina v zdravilu Trobalt je retigabin.
English: The steady state volume of distribution of retigabine is 2 to 3 l/kg following intravenous dosing.
Slovenian: Po intravenski uporabi je volumen porazdelitve retigabina v stanju dinamičnega ravnovesja od 2 do 3
English: Each tablet contains 200 mg retigabine
Slovenian: Ena tableta vsebuje 200 mg retigabina
English: Trobalt 300 mg film-coated tablets are green, oblong and marked “RTG-300” on one side.
Slovenian: Filmsko obložene tablete Trobalt 300 mg so zelene barve, podolgovate in označene z "RTG-300" na eni strani.
English: 100 mg tablets:
Slovenian: 100-mg tablete:
English: − Caution when using TROBALT in patients with a cardiac disease or those taking medicines concomitantly known to cause QT prolongation
Slovenian: − Potrebna je previdnost pri uporabi zdravila TROBALT pri srčnih bolnikih ali pri tistih, ki sočasno jemljejo zdravila, za katera je znano, da podaljšajo interval QT. − Bolnike je treba obvestiti, da se lahko pri uporabi zdravila TROBALT pojavijo stanje zmedenosti, halucinacije in psihotične motnje, zato naj se držijo titracije odmerka, da bi čim bolj zmanjšali ta tveganja.
English: INFORMATION IN BRAILLE trobalt 400 mg
Slovenian: PODATKI V BRAILLOVI PISAVI trobalt 400 mg
English: Each tablet contains 50 mg retigabine
Slovenian: Ena tableta vsebuje 50 mg retigabina.
English: Adjustment of the Trobalt dose is recommended in patients with moderate to severe renal impairment but no adjustment of the Trobalt dose is recommended in patients with mild renal impairment (see section 4.2).
Slovenian: vendar pri bolnikih z blago okvaro ledvic prilagoditev odmerka zdravila Trobalt ni potrebna (glejte poglavje 4.2).
English: INFORMATION IN BRAILLE trobalt 300 mg
Slovenian: PODATKI V BRAILLOVI PISAVI trobalt 300 mg
English: Risk related to antiepileptic medicinal products in general Specialist advice should be given to women who are of childbearing potential.
Slovenian: Tveganje, povezano z antiepileptiki na splošno
English: Trobalt 400 mg film-coated tablets are purple, oblong and marked “RTG-400” on one side.
Slovenian: Filmsko obložene tablete Trobalt 400 mg so škrlatne barve, podolgovate in označene z "RTG-400" na eni strani.
English: Animal studies are insufficient with respect to reproductive toxicity because the plasma levels achieved in these studies were less than those reached in humans at recommended doses (see section 5.3).
Slovenian: Študije na živalih so pomankljive v smislu preučevanja toksičnih vplivov na sposobnost razmnoževanja, kajti koncentracija v plazmi,
English: INFORMATION IN BRAILLE trobalt 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI trobalt 100 mg
English: Magnesium stearate
Slovenian: Okvara jeter
English: Each tablet contains 300 mg retigabine
Slovenian: Ena tableta vsebuje 300 mg retigabina
English: Each tablet contains 400 mg retigabine
Slovenian: Ena tableta vsebuje 400 mg retigabina
English: • feeling agitated, aggressive or irritable
Slovenian: • občutek šibkosti ali splošno slabo počutje,
English: 300 mg tablets:
Slovenian: 300-mg tablete:
English: 400 mg tablets:
Slovenian: 400-mg tablete:
English: NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets
Slovenian: IME ZDRAVILA Trobalt 50 mg filmsko obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets
Slovenian: IME ZDRAVILA Trobalt 300 mg filmsko obložene tablete
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje povečanje telesne mase,
English: NAME OF THE MEDICINAL PRODUCT Trobalt 400 mg film-coated tablets
Slovenian: IME ZDRAVILA Trobalt 400 mg filmsko obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Trobalt 200 mg film-coated tablets
Slovenian: IME ZDRAVILA Trobalt 200 mg filmsko obložene tablete
English: Tell your doctor if any of these applies to you.
Slovenian: Če kaj od tega velja za vas, morate povedati zdravniku.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 100 mg film-coated tablets
Slovenian: IME ZDRAVILA Trobalt 100 mg filmsko obložene tablete
English: 200 mg tablets:
Slovenian: 200-mg tablete:
English: General disorders and administrative site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija,
English: What Trobalt looks like and contents of the pack Trobalt 50 mg film-coated tablets are purple, round and marked “RTG 50” on one side.
Slovenian: Filmsko obložene tablete Trobalt 50 mg so škrlatne barve, okrogle in označene z "RTG 50" na eni strani.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/007
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/681/007
English: Each tablet contains 100 mg retigabine
Slovenian: Ena tableta vsebuje 100 mg retigabina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/011
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/681/011
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/012
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/681/012
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Slovenian: Tel: + 39 (0)45 9218 111
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/009
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/681/009
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of retigabine.
Slovenian: Ena filmsko obložena tableta vsebuje 50 mg retigabina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/010
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/681/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/681/008
English: Pregnancy
Slovenian: Starejši
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/681/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/681/001
English: NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets retigabine
Slovenian: Trobalt 300 mg filmsko obložene tablete retigabin
English: Always take this medicine exactly as your doctor has told you to.
Slovenian: Zdravilo Trobalt uporabljajte toliko časa, kot vam svetuje zdravnik.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets retigabine
Slovenian: Trobalt 50 mg filmsko obložene tablete retigabin
English: Rare:
Slovenian: Pogosti
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of retigabine.
Slovenian: Ena filmsko obložena tableta vsebuje 200 mg retigabina.
English: Nervous system disorders
Slovenian: psihotične motnje,
English: NAME OF THE MEDICINAL PRODUCT Trobalt 200 mg film-coated tablets retigabine
Slovenian: Trobalt 200 mg filmsko obložene tablete retigabin
English: 3 years
Slovenian: Med 8
English: NAME OF THE MEDICINAL PRODUCT Trobalt 400 mg film-coated tablets retigabine
Slovenian: Trobalt 400 mg filmsko obložene tablete retigabin
English: Packaging Content Package size
Slovenian: Vsebina Velikost pakiranja
English: --1 Porcine circovirus type 2 ORF2 subunit antigen ≥ 2828 AU* Mycoplasma hyopneumoniae inactivated
Slovenian: --1 Cirkovirus prašičev tip 2, antigenska podenota ORF2 ≥ 2828 AU*
English: ≥ 2.69 RPU** * Antigenic Units as determined in the in vitro potency test (ELISA).
Slovenian: Inaktivirana Mycoplasma hyopneumoniae * Enote antigena, določene z in vitro ELISA testom učinkovitosti ** Relativne enote učinkovitosti, določene z referenčnim cepivom
English: Strength Pharmaceutical form
Slovenian: Izmišljeno ime Jakost Farmacevtska oblika
English: Strength Pharmaceutical Form Route of Administration
Slovenian: ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: Package size l t o r
Slovenian: EU/1/11/675/008 Leflunomid Teva 20 mg filmsko obložena tableta peroralna uporaba pretisni omot (OPA/alu/PVC) 28 tablet EU/1/11/675/009 Leflunomid Teva 20 mg filmsko obložena tableta peroralna uporaba pretisni omot (OPA/alu/PVC) 30 tablet EU/1/11/675/010 Leflunomid Teva 20 mg filmsko obložena tableta peroralna uporaba pretisni omot (OPA/alu/PVC) 100 tablet o ā
English: 31 May 2016 EMA/269745/2016
Slovenian: 31. maj 2016 EMA/269745/2016
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Slovenian: Za podrobnejše informacije o študijah, ki jih je ocenil odbor HMPC, glejte njegovo poročilo o oceni.
English: If symptoms last longer than two weeks during the use of the medicine a doctor or qualified healthcare practitioner should be consulted.
Slovenian: Če simptomi med uporabo zdravila trajajo dlje kot dva tedna, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Slovenian: V času ocene odbora HMPC v zvezi s temi zdravili ni bilo poročil o neželenih učinkih.
English: Sandy everlasting is the common name for the flowers of the plant Helichrysum arenarium (L.) Moench.
Slovenian: Cvet peščenega smilja je splošno ime za cvetove rastline Helichrysum arenarium (L.) Moench.
English: In its assessment, the HMPC considered studies in laboratory tests which supported an effect in increasing the flow of bile (a fluid produced in the liver which helps to break down fats) and reducing muscle contractions of the gall bladder (a small organ where bile is stored).
Slovenian: V svoji oceni je odbor HMPC upošteval študije z laboratorijskimi preskusi, ki podpirajo učinek pri pospeševanju pretoka žolča (tekočine, ki nastaja v jetrih in pomaga pri razgradnji maščob) in zmanjševanju mišičnih krčev žolčnika (majhnega organa, kjer se shranjuje žolč).
English: This summary is not intended to provide practical advice on how to use medicines containing sandy everlasting.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo cvet peščenega smilja.
English: Sandy everlasting EMA/269745/2016
Slovenian: EMA/269745/2016
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of sandy everlasting.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo cveta peščenega smilja.
English: Further information on the risks associated with these sandy everlasting 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 z zdravili, ki vsebujejo cvet peščenega smilja, 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: The HMPC noted a lack of clinical studies with sandy everlasting.
Slovenian: Odbor HMPC je ugotovil pomanjkanje kliničnih študij s cvetom peščenega smilja.
English: Herbal medicines containing this sandy everlasting preparation is usually available as herbal teas to be drunk.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo ta pripravek s cvetom peščenega smilja, so navadno na voljo kot zdravilni čaj, ki se popije.
English: Further information on the HMPC assessment of sandy everlasting 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 cvet peščenega smilja, 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: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing sandy everlasting.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo cvet peščenega smilja.
English: Any applications for the licensing of medicines containing sandy everlasting 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 cvet peščenega smilja, 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: Sandy everlasting preparations may also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Pripravki s cvetom peščenega smilja so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Sandy everlasting medicines should only be used in adults.
Slovenian: Zdravila, ki vsebujejo cvet peščenega smilja, se smejo uporabljati samo pri odraslih.
English: The HMPC conclusions on the use of this sandy everlasting medicine for digestive disorders with a feeling of fullness and bloating are based on its ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravila, ki vsebuje cvet peščenega smilja, za prebavne motnje, ki jih spremlja občutek polnosti in napihnjenosti, temeljijo na njihovi „tradicionalni uporabi“.
English: The HMPC conclusions only cover a sandy everlasting preparation, which is obtained by drying and comminuting (reducing into tiny pieces) the flowers.
Slovenian: Zaključki odbora HMPC zajemajo samo pripravek s cvetom peščenega smilja, ki se pridobiva s sušenjem in drobljenjem (zmanjševanjem na majhne delce) cvetov.
English: Information on the use and licensing of sandy everlasting medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo cvet peščenega smilja, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: How are Sandy everlasting medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo cvet peščenega smilja, odobrena v EU?
English: The HMPC concluded, that on the basis of its long-standing use, this sandy everlasting preparation can be used for digestive disorders with a feeling of fullness and bloating.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko ta pripravek, ki vsebuje cvet peščenega smilja, uporablja za prebavne motnje, ki jih spremlja občutek polnosti in napihnjenosti.
English: Detailed instructions on how to take sandy everlasting 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 cvet peščenega smilja, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: For more information about treatment with sandy everlasting 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 cvet peščenega smilja, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Sandy everlasting?
Slovenian: Kaj je cvet peščenega smilja?
English: For practical information about using sandy everlasting 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: What are the risks associated with Sandy everlasting medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo cvet peščenega