natgillin/translations-raw huggingface dataset:
Pigment changes (discolouration) of ocular tissues, including the retina have been reported in longterm clinical studies with retigabine, sometimes but not always in conjunction with pigment changes of the skin, lips or nails (see below paragraph and section 4.8).
V dolgotrajnih kliničnih študijah retigabina so bile opisane pigmentne spremembe (spremembe barve) očesnih tkiv, vključno z mrežnico, včasih - a ne vedno - skupaj s pigmentnimi spremembami na koži, ustnicah ali nohtih (glejte spodnji odstavek in poglavje 4.8).
Each pack contains blisters of 84 or 2 x 84 film-coated tablets.
Vsako pakiranje vsebuje pretisne omote s 84 ali 2 x 84 filmsko obloženimi tabletami.
Your doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are breast-feeding.
Vaš zdravnik bo pretehtal koristi, ki jih jemanje zdravila Trobalt med obdobjem dojenja pomeni za vas, v primerjavi z morebitnim tveganjem za otroka.
The tablets should be swallowed whole, and not chewed, crushed or divided.
Tablete je treba vzeti v treh deljenih odmerkih vsak dan. Bolnik mora tablete zaužiti cele in jih ne sme grizti, drobiti ali lomiti.
21 film-coated tablets 84 film-coated tablets
21 filmsko obloženih tablet 84 filmsko obloženih tablet
Retigabine may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium).
Retigabin lahko podaljša trajanje anestezije z nekaterimi anestetiki (npr. z natrijevim tiopentalom).
The maximum starting dose of Trobalt is 100 mg, taken three times a day (a total of 300 mg a day).
Največji začetni odmerek zdravila Trobalt je 100 mg trikrat na dan (skupaj 300 mg na dan).
If retinal pigment changes, vitelliform maculopathy or vision changes are detected, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.
V primeru ugotovljenih sprememb pigmentacije mrežnice, viteliformne makulopatije ali sprememb vida se sme zdravljenje z zdravilom Trobalt nadaljevati le po skrbni ponovni oceni možnega tveganja v primerjavi s koristmi zdravljenja.
Do not reduce your dose unless your doctor tells you to. To stop taking Trobalt, it is important that the dose is reduced gradually, over at least 3 weeks.
Pri prenehanju jemanja zdravila Trobalt je pomembno odmerek zmanjševati postopoma, v teku vsaj 3 tednov.
Withdrawal seizures
Odtegnitveni napadi
Study 205 (n=396; n=303)
Študija 205 (n = 396, n = 303) Celotna odstotna sprememba pogostnosti parcialnih napadov (mediana)
No dose reduction is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6; see section 5.2).
Bolnikom z blago okvaro jeter (5 do 6 po Child-Pughu; glejte poglavje 5.2) odmerka ni treba zmanjšati.
Confusional state Psychotic disorders Hallucinations Disorientation Anxiety
halucinacije, dezorientiranost, anksioznost
• constipation; feeling sick (nausea); indigestion; dry mouth
• zaprtost, slabost v želodcu (navzea), težave z želodcem, suha usta,
Three multicentre, randomized, double-blind, placebo-controlled studies in a total of 1239 adult patients have been conducted to assess the efficacy of retigabine as adjunctive therapy of partial onset seizures, with or without secondary generalisation.
Klinična učinkovitost dodatnega zdravljenja z retigabinom pri napadih s parcialnim začetkom Za oceno učinkovitosti retigabina kot dodatnega zdravljenja napadov s parcialnim začetkom (s sekundarno generalizacijo ali brez nje) so bile opravljene tri multicentrične, randomizirane, dvojno slepe, s placebom kontrolirane študije, ki so skupaj zajele 1239 odraslih bolnikov.
You must look out for certain symptoms while you are taking Trobalt, to reduce the risk of any problems.
Da boste zmanjšali tveganje za pojav težav, morate biti med uporabo zdravila Trobalt pozorni na določene simptome.
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX21.
Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki.
Retigabine is extensively metabolised in humans.
Presnova retigabina je pri človeku izdatna.
Study 301 (n=305; n=256)
Študija 301 (n = 305, n = 256) Celotna odstotna sprememba pogostnosti parcialnih napadov (mediana)
Increased liver function tests
Bolezni jeter, žolčnika in žolčevodov zvišanje jetrnih funkcijskih testov
The 100 mg and 300 mg tablets also contain indigo carmine aluminium lake (E132) and iron oxide yellow (E172).
100-mg in 300-mg tablete vsebujejo tudi indigotin (E132) in rumeni železov oksid (E172).
During an 8-week baseline period, patients had to experience ≥4 partial onset seizures per 28 days.
tedenskim izhodiščnim obdobjem so se morali bolnikom pojaviti ≥ 4 napadi s parcialnim začetkom v
− The need for comprehensive ophthalmological examinations including visual acuity, slit-lamp examination, dilated fundus photography and macular optical coherence tomography (OCT) imaging at treatment initiation and at least every 6 months thereafter while treatment is ongoing.
- V času zdravljenja je treba na začetku zdravljenja in vsaj vsakih 6 mesecev opraviti izčrpen oftalmološki pregled, vključno z ostrino vida, pregledom s špranjsko svetilko, slikanjem očesnega ozadja ob dilataciji in optično koherentno tomografijo (OCT) makule.
Based on a study conducted in healthy volunteers, therapeutic doses of retigabine (600-1,200 mg/day) resulted in a minor (8-18%) increase in digoxin AUC following a single oral dose of digoxin.
povzročili majhno (8-18%) povečanje AUC digoksina po enem samem peroralnem odmerku digoksina.
Confusional state, psychotic disorders and hallucinations were reported in controlled clinical studies with retigabine (see section 4.8).
V kontroliranih kliničnih študijah z retigabinom so bili opisani stanje zmedenosti, psihotične motnje in halucinacije (glejte poglavje 4.8).
Talk to your doctor about breast-feeding while you are taking Trobalt.
O dojenju med jemanjem zdravila Trobalt se posvetujte z zdravnikom.
Pigment changes (discolouration) of the skin, lips or nails have been reported in long-term clinical studies with retigabine, sometimes but not always in conjunction with pigment changes of ocular tissues (see above paragraph and section 4.8).
kože, ustnic in nohtov, včasih - a ne vedno - skupaj s pigmentnimi spremembami očesnih tkiv (glejte zgornji odstavek in poglavje 4.8).
Each pack contains blisters of 21or 84 film-coated tablets.
Vsako pakiranje vsebuje pretisne omote z 21 ali 84 filmsko obloženimi tabletami.
These may affect up to 1 in 10 people:
Pogosti neželeni učinki Pojavijo se lahko pri največ 1 od 10 oseb:
At retigabine doses of up to 750 mg/day, there was no clinically significant effect of retigabine on the pharmacokinetics of the estrogen (ethinyl estradiol) or progestogen (norethindrone) components of the oral contraceptive pill.
Retigabin v odmerkih do 750 mg/dan ni klinično pomembno vplival na farmakokinetiko estrogenske
A study of cardiac conduction in healthy subjects has demonstrated that retigabine titrated to 1,200 mg/day produced a QT-prolonging effect.
V študiji srčnega prevajanja je retigabin pri zdravih prostovoljcih ob titriranju do 1.200 mg/dan povzročil podaljšanje intervala QT.
• lack of co-ordination; spinning sensation (vertigo); balance problems; problems walking
• pomanjkanje koordinacije, občutek vrtenja (vrtoglavica), težave z ravnotežjem, težave s hojo, • tresenje, nenadno trzanje mišic (mioklonus),
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).
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).
There was no evidence of teratogenicity following administration of retigabine to pregnant animals during the period of organogenesis.
Po uporabi retigabina pri brejih živalih med obdobjem organogeneze niso ugotovili znakov teratogenosti.
Don't stop taking Trobalt without advice Take Trobalt for as long as your doctor recommends.
Ne nehajte jemati zdravila Trobalt, ne da bi vam to naročil zdravnik.
4.9 Overdose
4.9 Preveliko odmerjanje Simptomi in znaki
How to take
Način uporabe
Tell the doctor that you are taking Trobalt, well in advance.
Zdravniku morate dovolj zgodaj povedati, da jemljete zdravilo Trobalt.
Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50” on one side.
Škrlatne, okrogle filmsko obložene tablete velikosti 5,6 mm z oznako "RTG 50" na eni strani.
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Pri bolnikih, ki so zaradi različnih indikacij dobivali antiepileptična zdravila, so opisane samomorilne misli in samomorilno vedenje.
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).
V študiji enega odmerka pri prostovoljcih z blago okvaro jeter (5 do 6 po Child-Pughu) ni bilo pomembnih učinkov na AUC retigabina.
Green, round, film-coated tablets of 7.1 mm, marked with “RTG 100” on one side.
Zelene, okrogle filmsko obložene tablete velikosti 7,1 mm z oznako "RTG 100" na eni strani.
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) .
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).
50 mg tablets:
50-mg tablete:
If at any time you have these thoughts,
• če že imate kakšne težave s srcem,
• If you get any side effects, talk to your doctor or pharmacist.
• Če opazite kateri koli neželeni učinek se posvetujte z zdravnikom ali farmacevtom.
Talk to your doctor before taking Trobalt:
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Trobalt se posvetujte z zdravnikom:
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).
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 %.
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.
Dodatno so poročali o posebni obliki nepravilnosti makule z značilnostmi viteliformne makulopatije (glejte poglavje 4.8).
Adjustment of the Trobalt dose is recommended in patients with moderate or severe hepatic impairment (see section 4.2).
Bolnikom z zmerno do hudo okvaro jeter je priporočljivo prilagoditi odmerek zdravila Trobalt (glejte poglavje 4.2).
• drowsiness
• zaspanost,
Skin rash Hyperhidrosis
hiperhidroza
A blue-grey discolouration of the skin, lips or nails has also been reported in people taking Trobalt for several years (See Section 4).
Pri bolnikih, ki jemljejo zdravilo Trobalt več let so poročali tudi o modro-sivih spremembah barve kože, ustnic ali nohtov (glejte poglavje 4).
Purple, oblong, film-coated tablets of 8.1 mm x 18 mm, marked with “RTG-400” on one side.
Škrlatne, podolgovate filmsko obložene tablete velikosti 8.1 mm x 18 mm z oznako "RTG-400" na eni strani.
INFORMATION IN BRAILLE trobalt 50 mg
PODATKI V BRAILLOVI PISAVI trobalt 50 mg
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).
V kliničnih študijah so bili, zlasti med titriranjem, opisani neželeni učinki, npr. omotica, zaspanost, diplopija in zamegljen vid (glejte poglavje 4.8).
Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Iron oxide yellow (E172).
200-mg tablete: polivinilalkohol titanov dioksid (E171) smukec (E553b) rumeni železov oksid (E172) sojin lecitin ksantanski gumi
Your doctor will monitor you more closely if treatment with Trobalt is continued.
Če boste zdravljenje z zdravilom Trobalt nadaljevali, vas bo zdravnik natančneje nadziral.
Packs containing 21or 84 film-coated tablets.
Pakiranja z 21 ali 84 filmsko obloženimi tabletami.
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).
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 %.
Trobalt 100 mg film-coated tablets are green, round and marked “RTG 100” on one side.
Filmsko obložene tablete Trobalt 100 mg so zelene barve, okrogle in označene z "RTG 100" na eni strani.
Yellow, oblong, film-coated tablets of 7.1 mm x 14 mm, marked with “RTG-200” on one side.
Rumene, podolgovate filmsko obložene tablete velikosti 7.1 mm x 14 mm z oznako "RTG-200" na eni strani.
The active substance is retigabine.
Zdravilna učinkovina je retigabin.
Trobalt 200 mg film-coated tablets are yellow, oblong and marked “RTG-200” on one side.
Filmsko obložene tablete Trobalt 200 mg so rumene barve, podolgovate in označene z "RTG-200" na eni strani.
Green, oblong, film-coated tablets of 7.1 mm x 16 mm, marked with “RTG-300” on one side.
Zelene, podolgovate filmsko obložene tablete velikosti 7.1 mm x 16 mm z oznako "RTG-300" na eni strani.
INFORMATION IN BRAILLE trobalt 200 mg
PODATKI V BRAILLOVI PISAVI trobalt 200 mg
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).
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).
Trobalt contains the active substance retigabine.
Zdravilna učinkovina v zdravilu Trobalt je retigabin.
The steady state volume of distribution of retigabine is 2 to 3 l/kg following intravenous dosing.
Po intravenski uporabi je volumen porazdelitve retigabina v stanju dinamičnega ravnovesja od 2 do 3
Each tablet contains 200 mg retigabine
Ena tableta vsebuje 200 mg retigabina
Trobalt 300 mg film-coated tablets are green, oblong and marked “RTG-300” on one side.
Filmsko obložene tablete Trobalt 300 mg so zelene barve, podolgovate in označene z "RTG-300" na eni strani.
100 mg tablets:
100-mg tablete:
− Caution when using TROBALT in patients with a cardiac disease or those taking medicines concomitantly known to cause QT prolongation
− 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.
INFORMATION IN BRAILLE trobalt 400 mg
PODATKI V BRAILLOVI PISAVI trobalt 400 mg
Each tablet contains 50 mg retigabine
Ena tableta vsebuje 50 mg retigabina.
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).
vendar pri bolnikih z blago okvaro ledvic prilagoditev odmerka zdravila Trobalt ni potrebna (glejte poglavje 4.2).
INFORMATION IN BRAILLE trobalt 300 mg
PODATKI V BRAILLOVI PISAVI trobalt 300 mg
Risk related to antiepileptic medicinal products in general Specialist advice should be given to women who are of childbearing potential.
Tveganje, povezano z antiepileptiki na splošno
Trobalt 400 mg film-coated tablets are purple, oblong and marked “RTG-400” on one side.
Filmsko obložene tablete Trobalt 400 mg so škrlatne barve, podolgovate in označene z "RTG-400" na eni strani.
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).
Študije na živalih so pomankljive v smislu preučevanja toksičnih vplivov na sposobnost razmnoževanja, kajti koncentracija v plazmi,
INFORMATION IN BRAILLE trobalt 100 mg
PODATKI V BRAILLOVI PISAVI trobalt 100 mg
Magnesium stearate
Okvara jeter
Each tablet contains 300 mg retigabine
Ena tableta vsebuje 300 mg retigabina
Each tablet contains 400 mg retigabine
Ena tableta vsebuje 400 mg retigabina
• feeling agitated, aggressive or irritable
• občutek šibkosti ali splošno slabo počutje,
300 mg tablets:
300-mg tablete:
400 mg tablets:
400-mg tablete:
NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets
IME ZDRAVILA Trobalt 50 mg filmsko obložene tablete
NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets
IME ZDRAVILA Trobalt 300 mg filmsko obložene tablete
Metabolism and nutrition disorders
Presnovne in prehranske motnje povečanje telesne mase,
NAME OF THE MEDICINAL PRODUCT Trobalt 400 mg film-coated tablets
IME ZDRAVILA Trobalt 400 mg filmsko obložene tablete
NAME OF THE MEDICINAL PRODUCT Trobalt 200 mg film-coated tablets
IME ZDRAVILA Trobalt 200 mg filmsko obložene tablete
Tell your doctor if any of these applies to you.
Če kaj od tega velja za vas, morate povedati zdravniku.
NAME OF THE MEDICINAL PRODUCT Trobalt 100 mg film-coated tablets
IME ZDRAVILA Trobalt 100 mg filmsko obložene tablete
200 mg tablets:
200-mg tablete:
General disorders and administrative site conditions
Splošne težave in spremembe na mestu aplikacije astenija,
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.
Filmsko obložene tablete Trobalt 50 mg so škrlatne barve, okrogle in označene z "RTG 50" na eni strani.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/007
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/681/007
Each tablet contains 100 mg retigabine
Ena tableta vsebuje 100 mg retigabina.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/011
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/681/011
MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/012
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/681/012
MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/009
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/681/009
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of retigabine.
Ena filmsko obložena tableta vsebuje 50 mg retigabina.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/010
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/681/010
MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/008
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/681/008
Pregnancy
Starejši
MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/004
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/681/004
MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/681/001
NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets retigabine
Trobalt 300 mg filmsko obložene tablete retigabin
Always take this medicine exactly as your doctor has told you to.
Zdravilo Trobalt uporabljajte toliko časa, kot vam svetuje zdravnik.
NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets retigabine
Trobalt 50 mg filmsko obložene tablete retigabin
Rare:
Pogosti
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of retigabine.
Ena filmsko obložena tableta vsebuje 200 mg retigabina.
Nervous system disorders
psihotične motnje,
NAME OF THE MEDICINAL PRODUCT Trobalt 200 mg film-coated tablets retigabine
Trobalt 200 mg filmsko obložene tablete retigabin
3 years
Med 8
NAME OF THE MEDICINAL PRODUCT Trobalt 400 mg film-coated tablets retigabine
Trobalt 400 mg filmsko obložene tablete retigabin
Packaging Content Package size
Vsebina Velikost pakiranja
--1 Porcine circovirus type 2 ORF2 subunit antigen ≥ 2828 AU* Mycoplasma hyopneumoniae inactivated
--1 Cirkovirus prašičev tip 2, antigenska podenota ORF2 ≥ 2828 AU*
≥ 2.69 RPU** * Antigenic Units as determined in the in vitro potency test (ELISA).
Inaktivirana Mycoplasma hyopneumoniae * Enote antigena, določene z in vitro ELISA testom učinkovitosti ** Relativne enote učinkovitosti, določene z referenčnim cepivom
Strength Pharmaceutical form
Izmišljeno ime Jakost Farmacevtska oblika
Strength Pharmaceutical Form Route of Administration
ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Package size l t o r
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
31 May 2016 EMA/269745/2016
31. maj 2016 EMA/269745/2016
For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Za podrobnejše informacije o študijah, ki jih je ocenil odbor HMPC, glejte njegovo poročilo o oceni.
If symptoms last longer than two weeks during the use of the medicine a doctor or qualified healthcare practitioner should be consulted.
Če simptomi med uporabo zdravila trajajo dlje kot dva tedna, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
At the time of the HMPC assessment, no side effects had been reported with these medicines.
V času ocene odbora HMPC v zvezi s temi zdravili ni bilo poročil o neželenih učinkih.
Sandy everlasting is the common name for the flowers of the plant Helichrysum arenarium (L.) Moench.
Cvet peščenega smilja je splošno ime za cvetove rastline Helichrysum arenarium (L.) Moench.
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).
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).
This summary is not intended to provide practical advice on how to use medicines containing sandy everlasting.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo cvet peščenega smilja.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of sandy everlasting.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo cveta peščenega smilja.
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.
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.
The HMPC noted a lack of clinical studies with sandy everlasting.
Odbor HMPC je ugotovil pomanjkanje kliničnih študij s cvetom peščenega smilja.