FrancophonIA/ELRC3.0 huggingface dataset:
English: − Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia) and in the latter proposed indication ‘symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia'.
Slovenian: − ni ugodno za simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence) in kasneje predlagano indikacijo „simptomatsko zdravljenje kognitivne okvare pri starejših, izključujoč Alzheimerjevo bolezen in demenco“,
English: However, the presented studies assessed oral dihydroergotoxine in very heterogeneous vein diseases: peripheral and cerebrovascular insufficiency, chronic varicose eczema, ulcus cruris, varicose veins, venous insufficiency, cerebral vascular lesions, thrombophlebitis of the superficial veins, post-thrombophlebitis syndromes.
Slovenian: Vendar pa so v predloženih študijah ocenjevali peroralni dihidroergotoksin pri zelo raznovrstnih venskih boleznih: periferni in cerebrovaskularni insuficienci, kroničnem varikoznem ekcemu, golenji razjedi, varikoznih venah, venskem popuščanju, cerebrovaskularnih lezijah, površinskem tromboflebitisu in potrombotičnih sindromih.
English: The CHMP considered the MAHs proposals for risk minimisation measures.
Slovenian: CHMP je obravnaval predloge imetnikov dovoljenj za promet z zdravili glede ukrepov za zmanjšanje tveganja.
English: The data from the reported cases of fibrosis (n=9) are limited in order to draw firm conclusions, however, the capacity of dihydroergotoxine to induce fibrotic reactions, localised in the retroperitoneal, pulmonary and cardiac area cannot be excluded notably based on the absence of any other aetiology for some of the assessed cases and the mechanism of action of ergot derivatives.
Slovenian: Podatki o primerih fibroze, o katerih so poročali (n = 9), so preveč omejeni, da bi omogočali trdne zaključke, vendar pa predvsem zaradi odsotnosti drugih vzrokov za nekatere pregledane primere in mehanizma delovanja derivatov ergot-alkaloidov ni mogoče izključiti možnosti, da lahko dihidroergotoksin izzove fibrotične reakcije v retroperitonealnem prostoru, predelu pljuč in predelu srca.
English: On the efficacy side for the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”, data were presented by the MAH by sub-areas of the cognitive function diseases: cerebrovascular impairment with arteriosclerosis, cerebrovascular insufficiency and stroke; and other causes with elderly/senile impairment, primary or not otherwise specified impairment, and organic brain syndrome.
Slovenian: Za oceno učinkovitosti pri indikaciji „simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)“, je imetnik dovoljenja za promet z zdravilom predložil podatke za posamezne podkategorije motenj kognitivnih funkcij: prizadetost možganskega žilja z arteriosklerozo, cerebrovaskularna insuficienca in možganska kap; ter drugi vzroki za starostno/senilno okvaro, primarno okvaro ali nikjer drugje opredeljeno okvaro in organski možganski sindrom.
English: The CHMP noted that the incidence of adverse events (i.e. retroperitoneal fibrosis, pulmonary fibrosis, cardiac valvulopathy, ergotism) reported by the MAH with dihydroergotoxine is low.
Slovenian: CHMP je upošteval, da je incidenca neželenih dogodkov (retroperitonealne fibroze, pljučne fibroze, srčne valvulopatije in ergotizma), o katerih je poročal imetnik dovoljenja za promet z zdravilom, pri uporabi dihidroergotoksina majhna.
English: The CHMP took note of the risk minimisation measures proposed by the MAH.
Slovenian: CHMP je upošteval ukrepe za zmanjšanje tveganja, ki jih je predlagal imetnik dovoljenja za promet z zdravilom.
English: The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergotoxine in the proposed indication “symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia” is very limited.
Slovenian: Odbor meni, da so dokazi o klinično pomembni učinkovitosti dihidroergotoksina pri predlagani indikaciji „simptomatsko zdravljenje kognitivne okvare pri starejših, izključujoč Alzheimerjevo bolezen in demenco,“ zelo omejeni.
English: The CHMP was therefore of the opinion that no conclusion on the efficacy of dihydroergotoxine as “Adjuvant symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)” or in another indication could be drawn.
Slovenian: CHMP je zato menil, da ni mogoče podati zaključka o učinkovitosti dihidroergotoksina pri indikaciji „adjuvantno simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)“ ali drugi indikaciji.
English: − Prophylaxis of migraine headache.
Slovenian: − preprečevanje migrenskega glavobola,
English: − Symptomatic treatment of veno-lymphatic insufficiency.
Slovenian: • simptomatsko zdravljenje veno-limfatične insuficience.
English: During the review, the MAH has suggested to restrict the indication to ‘symptomatic treatment of chronic cognitive impairment in elderly (excluding Alzheimer's disease and other dementia)'.
Slovenian: Med pregledom je imetnik dovoljenja za promet z zdravilom predlagal omejitev indikacije na „simptomatsko zdravljenje kronične kognitivne okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)“.
English: The scope of the re-examination focused on the re-evaluation of the benefit-risk balance of dihydroergotoxine in the restricted indication proposed by the MAH which is “symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia”.
Slovenian: V okviru ponovnega pregleda so se osredotočili na ponovno oceno tveganja med tveganji in koristmi dihidroergotoksina pri omejeni indikaciji, ki jo je predlagal imetnik dovoljenja za promet z zdravilom, tj. „simptomatsko zdravljenje kognitivne okvare pri starejših, izključujoč Alzheimerjevo bolezen in demenco“.
English: − Is not favourable for ancillary treatment of Raynaud's syndrome.
Slovenian: − ni ugodno za dodatno zdravljenje Raynaudovega sindroma,
English: In view of the above, the Committee considered that there is a risk for rare but severe fibrotic reactions and ergotism associated with dihydroergotoxine treatment.
Slovenian: Na podlagi zgoraj navedenega je odbor menil, da je zdravljenje z dihidroergotoksinom povezano s tveganjem za redke, vendar hude fibrotične reakcije in ergotizem.
English: Thus, the Committee concluded that the benefit-risk balance of dihydroergotoxine containing products in “symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia” is not favourable.
Slovenian: Posledično je odbor zaključil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo dihidroergotoksin, pri indikaciji „simptomatsko zdravljenje kognitivne okvare pri starejših, izključujoč Alzheimerjevo bolezen in demenco,“ ni ugodno.
English: − Ancillary treatment of Raynaud's syndrome.
Slovenian: − dodatno zdravljenje Raynaudovega sindroma,
English: − Is not favourable for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Slovenian: − ni ugodno za dodatno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora,
English: − Is not favourable for symptomatic treatment of veno-lymphatic insufficiency.
Slovenian: − ni ugodno za preprečevanje migrenskega glavobola; − ni ugodno za simptomatsko zdravljenje veno-limfatične insuficience.
English: • Ancillary treatment of Raynaud's syndrome
Slovenian: • dodatno zdravljenje Raynaudovega sindroma;
English: The SAG further considered that the evidence presented by the MAH was of poor quality.
Slovenian: Znanstveno svetovalna skupina je prav tako menila, da je kakovost podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, slaba.
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Slovenian: − dodatno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora,
English: − Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Slovenian: − simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših
English: Woody nightshade stem preparations are obtained by comminuting (reducing into tiny pieces) the stems of two- to three-year old plants, harvested in spring before the leaves develop, or in late autumn after the leaves have dropped.
Slovenian: Pripravki, ki vsebujejo grenkoslad, se izdelujejo z drobljenjem (zmanjševanjem na drobne delce) stebel rastlin, starih od dve do tri leta in nabranih spomladi, preden se razvijejo listi, ali konec jeseni, ko listi odpadejo.
English: Woody nightshade stem should only be used in adults and should not be used if symptoms last for longer than two weeks without seeking advice from a qualified healthcare practitioner.
Slovenian: Steblo grenkoslada se lahko uporablja samo pri odraslih in se ne sme uporabljati brez posveta z usposobljenim zdravstvenim delavcem, če simptomi trajajo več kot dva tedna.
English: Woody nightshade stem EMA/HMPC/261736/2013
Slovenian: Steblo grenkoslada EMA/HMPC/261736/2012
English: Woody nightshade stem is the common name for the stems of the plant Solanum dulcamara L. The plant is cultivated or gathered to obtain the stems for medicinal use.
Slovenian: Steblo grenkoslada je splošno ime za stebla rastline Solanum dulcamara L. Rastlina se goji ali nabira za pridobivanje stebel za uporabo v medicinske namene.
English: The HMPC concluded that, on the basis of its long-standing use, woody nightshade stem can be used for the relief of the symptoms of repeated episodes of mild eczema (itchy, red rash).
Slovenian: Odbor HMPC je zaključil, da se na podlagi njegove dolgotrajne uporabe steblo grenkoslada lahko uporablja za lajšanje simptomov ponavljajočih se pojavov blažjega ekcema (srbečega, rdečega izpuščaja).
English: Further information on the risks associated with woody nightshade stem 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 steblo grenkoslada, 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: Woody nightshade may be harmful if taken by mouth, and such use is not covered by the Committee's conclusions.
Slovenian: Peroralna uporaba (zaužitje skozi usta) grenkoslada je lahko nevarno, zato tovrstna uporaba v zaključkih Odbora ni obravnavana.
English: This summary is not intended to provide practical advice on how to use medicines containing woody nightshade stem.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo steblo grenkoslada.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of woody nightshade stem.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo stebla grenkoslada.
English: Herbal medicines containing comminuted woody nightshade stem are usually available for soaking in water (infusion or decoction) to produce a liquid to be applied to the skin.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo zdrobljena stebla grenkoslada, so navadno na voljo za pripravo vodnega izvlečka (poparek ali prevretek) v obliki tekočine, ki se jo nanese na kožo.
English: The HMPC took into account the well documented use of woody nightshade stem for this indication.
Slovenian: Odbor HMPC je upošteval izčrpno dokumentirano uporabo stebla grenkoslada za omenjeno indikacijo.
English: Further information on the HMPC assessment of woody nightshade stem 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 steblo grenkoslada, 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: Any applications for the licensing of medicines containing woody nightshade stem 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 steblo grenkoslada, 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: The HMPC conclusions on the use of woody nightshade stem medicines for mild eczema are based on their ‘traditional use' in this condition.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo steblo grenkoslada, za lajšanje blažjega ekcema temeljijo na „tradicionalni uporabi“ pri tem stanju.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing woody nightshade stem.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo steblo grenkoslada.
English: Information on the use and licensing of woody nightshade stem medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo steblo grenkoslada, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: For more information about treatment with woody nightshade stem 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 steblo grenkoslada, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: How are woody nightshade stem medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo steblo grenkoslada, odobrena v EU?
English: Detailed instruction on how to use woody nightshade stem medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobne informacije o uporabi zdravil, ki vsebujejo steblo grenkoslada, in o tem, kdo jih lahko uporablja, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: EMA/HMPC/261736/2013
Slovenian: EMA/HMPC/261736/2012 Odbor za zdravila rastlinskega izvora (HMPC)
English: What is woody nightshade stem?
Slovenian: Kaj je steblo grenkoslada?
English: What evidence supports the use of woody nightshade stem medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo steblo grenkoslada?
English: What are the risks associated with woody nightshade stem medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo steblo grenkoslada?
English: For practical information about using woody nightshade stem 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: Woody nightshade stem
Slovenian: Steblo grenkoslada
English: Other information about woody nightshade stem medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo steblo grenkoslada
English: It is infused over 30 minutes.
Slovenian: Infundiranje traja 30 minut.
English: It is used in adults and children aged over 3 months to treat the following infections:
Slovenian: Uporablja se pri odraslih in otrocih, starejših od treh mesecev, za zdravljenje naslednjih okužb:
English: What measures are being taken to ensure the safe and effective use of Invanz?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Invanz?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Invanz on 18 April 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Invanz, veljavno po vsej Evropski uniji, izdala 18. aprila 2002.
English: The full EPAR for Invanz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Invanz je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Invanz also has an effect on some blood tests.
Slovenian: Zdravilo Invanz vpliva tudi na rezultate nekaterih krvnih testov.
English: The studies examined if the infection was cured after 7 to 28 days of treatment, depending on the type of infection.
Slovenian: V študijah so proučevali, ali se lahko okužba odpravi po sedmih do 28 dnevih zdravljenja, odvisno od vrste okužbe.
English: This is a summary of the European public assessment report (EPAR) for Invanz.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Invanz.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Invanz's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Invanz večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: What benefits of Invanz have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Invanz izkazalo v študijah?
English: Effectiveness was measured as absence of infection 4 weeks after treatment, which involved 952 adults.
Slovenian: Učinkovitost so merili kot odsotnost okužbe v obdobju štiri tedne po zdravljenju, v študijo pa je bilo vključenih 952 odraslih.
English: It attaches to certain proteins on the bacteria cells.
Slovenian: Ertapenem se pripoji na določene beljakovine na površini bakterijskih celic.
English: What is Invanz and what is it used for?
Slovenian: Kaj je zdravilo Invanz in za kaj se uporablja?
English: It must also not be used in patients who are severely allergic to other types of antibiotics, such as penicillins and cephalosporins.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih, ki imajo hudo alergijo na druge vrste antibiotikov, kot so pencilini in cefalosporini.
English: Invanz is an antibiotic.
Slovenian: Zdravilo Invanz je antibiotik.
English: Infection was absent in about 60% patients given Invanz compared with 49% of patients given cefotetan.
Slovenian: Odsotnost okužbe je bila ugotovljena pri okoli 60 % bolnikov, ki se prejeli zdravilo Invanz, v primerjavi z 49 % bolnikov, ki so prejemali cefotetan.
English: This upsets the essential functions that keep the cells alive, and so kills the bacteria.
Slovenian: S tem ovira funkcije, ki so bistvenega pomena za preživetje teh celic, kar posledično uniči bakterije.
English: Other information about Invanz
Slovenian: Druge informacije o zdravilu Invanz
English: What are the risks associated with Invanz?
Slovenian: Kakšna tveganja so povezana z zdravilom Invanz?
English: In children, Invanz was as effective as the comparator antibiotics and had similar effectiveness to that in adults.
Slovenian: Pri otrocih je bilo zdravilo Invanz enako učinkovito kot primerjalni antibiotiki, njegova učinkovitost pa je bila primerljiva s tisto pri odraslih.
English: Treatment of infections
Slovenian: Zdravljenje okužb
English: Why is Invanz approved?
Slovenian: Zakaj je bilo zdravilo Invanz odobreno?
English: Before using Invanz, doctors should consider official guidance on the appropriate use of antibiotics.
Slovenian: Preden zdravnik predpiše zdravilo Invanz, mora upoštevati uradne smernice za ustrezno uporabo antibiotikov.
English: It is not intended to provide practical advice on how to use Invanz.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Invanz have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Prevention of infections after colorectal surgery
Slovenian: Preprečevanje okužb po kolorektalni operaciji
English: Invanz is given at a dose of 1 g once a day in adults and adolescents.
Slovenian: Zdravilo Invanz se odraslim in mladostnikom daje v odmerku 1 g enkrat na dan.
English: For preventing infection after colorectal surgery in adults, a single dose of Invanz is given within 1 hour before the operation.
Slovenian: Za preprečevanje okužb po korektalni operaciji pri odraslih se daje en odmerek zdravila Invanz eno uro pred posegom.
English: The active substance in Invanz, ertapenem, belongs to the group of antibiotics known as ‘carbapenems'.
Slovenian: Zdravilna učinkovina v zdravilu Invanz, ertapenem, spada v skupino antibiotikov, imenovanih „karbapenemi“.
English: For more information about treatment with Invanz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Invanz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Invanz can work on a range of different bacteria, which are listed in the summary of product characteristics (also part of the EPAR).
Slovenian: Zdravilo Invanz deluje proti vrsti različnih bakterij, ki so navedene v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Invanz must not be used in people who are hypersensitive (allergic) to ertapenem or to other antibiotics of the same group (carbapenems).
Slovenian: Zdravila Invanz ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) ertapenem ali katere koli druge antibiotike iz iste skupine (karbapenemi).
English: The most common side effects with Invanz (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea (feeling sick), vomiting, rash (including nappy rash in children), itching, and problems around the area where the medicine is infused (including pain and inflammation of the vein).
Slovenian: Najpogostejši neželeni učinki zdravila Invanz (ki lahko prizadenejo največ 1 osebo od 10) so glavobol, driska, slabost, bruhanje, izpuščaji (vključno s pleničnim izpuščajem pri otrocih), srbenje in težave na mestu infundiranja (vključno z bolečinami in vnetjem vene).
English: For practical information about using Invanz, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Invanz naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.