natgillin/translations-raw huggingface dataset:
Linseed is the common name for the seeds of the plant Linum usitatissimum L. The dried, ripe seeds for medicinal use are obtained from plants that have been cultivated.
Seme navadnega lana je splošno ime za seme rastline Linum usitatissimum L. Posušena, zrela semena se za medicinsko uporabo pridobivajo iz rastlin, ki so bile gojene.
Further information on the risks associated with linseed 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 seme navadnega lana, 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.
This helps to make the stool softer and pass through the gut more easily.
To prispeva k temu, da je blato mehkejše in se lažje izloči skozi črevo.
Linseed can also be found in combination with other herbal substances in some herbal medicines.
Seme navadnega lana je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
Information on the use and licensing of linseed medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo seme navadnega lana, v državah članicah EU se obrnite na pristojni nacionalni organ.
It should also not be used in patients with abnormal constriction or blockage of the digestive tract, paralysis in the gut, or abnormal widening of the large intestine, or with diseases of the oesophagus (the tube between mouth and stomach).
Prav tako se ne sme uporabljati pri bolnikih z nenormalnim zoženjem ali zaporo prebavil, paralizo črevesja, nenormalno razširitvijo debelega črevesa ali z boleznimi požiralnika (cevi, ki povezuje usta z želodcem).
How does linseed work as a medicine?
Kako seme navadnega lana deluje kot zdravilo?
In its assessment, the HMPC considered a number of clinical studies showing linseed's effect on constipation and hard stool.
V svoji oceni je odbor HMPC upošteval več kliničnih študij, ki so pokazale učinek semena navadnega lana na zaprtost in trdo blato.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing linseed.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo seme navadnega lana.
Any applications for the licensing of medicines containing linseed 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.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo seme navadnega lana, 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.
Common side effects (seen between 1 and 10 patients in 100) have been reported with linseed.
Pri uporabi semena navadnega lana so poročali o pogostih neželenih učinkih (opaženih pri 1 do 10 bolnikih od 100).
How are linseed medicines approved in the EU?
Kako so zdravila, ki vsebujejo seme navadnega lana, odobrena v EU?
What evidence supports the use of linseed medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo seme navadnega lana?
Further information on the HMPC assessment of linseed 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.
Dodatne informacije o oceni zdravil, ki vsebujejo seme navadnega lana, 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.
For treating constipation, linseed must not be used in patients with a sudden change in bowel habit that persists for more than 2 weeks, or undiagnosed bleeding from the anus, or if constipation is not relieved despite the use of a laxative.
Seme navadnega lana se ne sme uporabljati za zdravljenje zaprtosti pri bolnikih z nenadnimi spremembami pri odvajanju blata, ki trajajo več kot dva tedna, pri bolnikih z nediagnosticiranimi krvavitvami iz anusa (zadnjika) ali v primeru, da se zaprtost kljub uporabi odvajala ne izboljša.
Other information about linseed medicines
Druge informacije o zdravilih, ki vsebujejo seme navadnega lana
The HMPC conclusions on the use of linseed for treating constipation are based on ‘well-established use'.
Zaključki odbora HMPC o uporabi semena navadnega lana za zdravljenje zaprtosti temeljijo na „dobro uveljavljeni medicinski uporabi“.
The HMPC concluded that linseed can be used to treat habitual constipation or in conditions requiring the stool to be softer so it can pass more easily.
Odbor HMPC je zaključil, da se seme navadnega lana lahko uporablja za zdravljenje habitualne (ponavljajoče) zaprtosti ali v primerih, ko je potrebno, da je blato mehkejše in se tako lažje izloči.
The HMPC conclusions on the use of linseed medicines for the relief of mild gastrointestinal discomfort are based on their ‘traditional use' in this condition.
Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo seme navadnega lana, za zdravljenje blagega nelagodja v prebavilih temeljijo na njihovi „tradicionalni uporabi“ pri tem stanju.
Detailed instructions on how to take linseed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o jemanju zdravil, ki vsebujejo seme navadnega lana, in o tem, kdo sme ta zdravila jemati, so v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
The studies demonstrated that linseed reduced habitual constipation.
Študije so dokazale, da seme navadnega lana zmanjšuje habitualno (ponavljajočo) zaprtost.
What are the risks associated with linseed medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo seme navadnega lana?
It is likely that linseed mucilage coats the lining of the digestive tract and thus protects it from irritation.
Verjetno je, da sluz semena navadnega lana tvori sloj, ki prekrije sluznico prebavil in jih tako ščiti pred draženjem.
For practical information about using linseed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
For more information about treatment with linseed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo seme navadnega lana, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
Linseed swells with water in the gut to form a thick jelly-like substance (mucilage).
Seme navadnega lana nabrekne z vodo v črevesju in tvori gosto, želatini podobno snov (sluz).
The HMPC also concluded that, on the basis of its long-standing use, linseed can be used to relieve mild gastrointestinal (stomach and gut) discomfort.
Na podlagi njegove dobro uveljavljene uporabe je odbor HMPC prav tako zaključil, da se seme navadnega lana lahko uporablja za zmanjšanje blagega nelagodja v prebavilih (želodcu in črevesju).
Also, the swelling effect of linseed widens the gut and this stretching effect speeds up passage of the stool through the gut.
Zaradi nabrekanja seme navadnega lana prav tako povzroči raztezanje črevesa, ta učinek pa pospeši izločanje blata skozenj.
What is linseed?
Kaj je seme navadnega lana?
Herbal medicines containing linseed, also known as Lini semen, are to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo seme navadnega lana, se jemljejo peroralno (uživajo skozi usta).
Linseed
Seme navadnega lana
Advice should be taken from a doctor or a qualified healthcare professional if constipation persists after 3 days of using linseed or if mild gastrointestinal discomfort persists after 7 days of using linseed.
Če se po uporabi semena navadnega lana zaprtost ne izboljša v treh dneh, blago nelagodje v prebavilih pa ne po sedmih dneh, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
Czech Republic BAXTER CZECH spol.
Češka Republika BAXTER CZECH spol.
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for Numeta G13%E and Numeta G16%E emulsions for infusion
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
16 May 2013
16. maj 2013
The decentralised procedure (DE/V/0122/002/DC) started on 12 November 2010.
Decentralizirani postopek (DE/V/0122/002/DC) se je začel 12. novembra 2010.
The reconsidered opinion was converted into a Decision by the European Commission on 16 May 2013.
Novo mnenje je bilo spremenjeno v Odločbo Evropske komisije z dne 16. maja 2013.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisation in Annex III.
Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s pogoj za preklic začasnega umika dovoljenj za promet z zdravilom v Prilogi III.
On 27 September 2012 a plenary meeting of the Standing Committee on Veterinary Medicinal Products took place and on 3 October 2012 the European Commission sent a letter to the CVMP requesting a reconsideration of the opinion adopted on 13 June 2012.
27. septembra 2012 je potekalo plenarno zasedanje Stalnega odbora za zdravila za uporabo v veterinarski medicini, 3. oktobra 2012 pa je Evropska komisija v dopisu pozvala CVMP, naj ponovno preuči mnenje, ki ga je sprejel dne 13. junija 2012.
Therefore the CVMP recommended the refusal of the granting of the marketing authorisations and the suspension of the existing marketing authorisations.
Zato je CVMP priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom in začasen umik obstoječih dovoljenj.
On 7 February 2013 the CVMP adopted a reconsidered opinion, concluding that the application does not comply with Article 13 of Directive 2001/82/EC, and consequently does not satisfy the criteria for authorisation in respect of efficacy.
CVMP je 7. februarja 2013 sprejel novo mnenje, v katerem je zaključil, da vloga ni v skladu s členom 13 Direktive 2001/82/ES in posledično ne izpolnjuje meril za odobritev na podlagi učinkovitosti.
Potential serious risks were identified during the decentralised procedure by Denmark regarding the cumulative failure rate observed in the pivotal clinical field trial and potential for development of antimicrobial resistance to florfenicol.
Med decentraliziranim postopkom je Danska ugotovila morebitna resna tveganja, povezana s kumulativno stopnjo neuspešnosti zdravljenja, ki so jo zabeležili med ključno klinično terensko študijo, ter nevarnostjo za razvoj odpornosti mikrobov proti florfenikolu.
The reconsideration procedure started on 10 October 2012.
Postopek ponovne preučitve mnenja se je začel 10. oktobra 2012.
The referral procedure started on 10 January 2012.
Napotitveni postopek se je začel 10. januarja 2012.
Oral explanations were given by the applicant on 10 January 2013.
Predlagatelj je 10. januarja 2013 podal ustna pojasnila.
The Committee re-appointed Prof Christian Friis as rapporteur and Dr Cornelia Ibrahim as co-rapporteur for the reconsideration procedure.
Odbor je za poročevalca in soporočevalko v postopku ponovno imenoval prof. Christiana Friisa in dr. Cornelio Ibrahim.
Day 60 of the CMD(v) procedure was on 15 December 2011, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Ker na 60. dan postopka CMD(v), 15. decembra 2011, zadevne države članice še vedno niso dosegle soglasja v zvezi z zdravilom, je bil postopek napoten na CVMP.
Nuflor Swine Once 450 mg per ml solution for injection contains florfenicol as active ingredient and is intended for use in pigs for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae, Haemophilus parasuis and Pasteurella multocida susceptible to florfenicol.
Zdravilo Nuflor Swine Once 450 mg/ml raztopina za injiciranje vsebuje zdravilno učinkovino florfenikol in je namenjeno zdravljenju prašičev z okužbami dihal, ki jih povzročajo sevi za florfenikol občutljivih bakterij Actinobacillus pleuropneumoniae, Haemophilus parasuis in Pasteurella multocida.
On 19 December 2011, the reference Member State, Germany, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Referenčna država članica, Nemčija, je 19. decembra 2011 obvestila Evropsko agencijo za zdravila, da Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)) ni dosegla soglasja v zvezi z zdravilom, in zadevo napotila na CVMP skladno s členom 33(4) Direktive 2001/82/ES.
The proposed dose is 30 mg florfenicol per kg bodyweight given by intramuscular administration as a single injection.
Predlagani odmerek je 30 mg florfenikola na kg telesne mase, ki se daje intramuskularno z enkratnim injiciranjem.
This was a ‘hybrid application' according to Article 13(3) Directive 2001/82/EC, as amended, referring to the reference product, Nuflor Swine 300 mg/ml solution for injection (FR/V/0118/001).
V skladu s členom 13(3) dopolnjene Direktive 2001/82/ES je šlo za „hibridno vlogo‟, ki se nanaša na referenčno zdravilo Nuflor Swine Once 300 mg/ml raztopina za injiciranje (FR/V/0118/001).
On 31 August 2012, the Netherlands submitted an objection to the opinion adopted by CVMP on 13 June 2012 during the written phase of the Standing Committee procedure.
Nizozemska je med pisnim delom postopka stalnega odbora, 31. avgusta 2012 vložila ugovor zoper mnenje, ki ga je 13. junija 2012 sprejel CVMP.
Based on the evaluation of the available data, the CVMP adopted, on 13 June 2012, an opinion recommending the granting of marketing authorisations for Nuflor Swine Once 450 mg/ml solution for injection, subject to certain conditions.
Na podlagi ocene razpoložljivih podatkov je CVMP dne 13. junija 2012 sprejel mnenje, v katerem je priporočil odobritev dovoljenja za promet z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje pod določenimi pogoji.
Nuflor Swine Once 450 mg/ml solution for injection differs from the reference veterinary medicinal product by a higher concentration of active substance, single administration, a change in therapeutic indication but also by a different co-solvent.
Zdravilo Nuflor Swine Once 450 mg/ml raztopina za injiciranje se od referenčnega zdravila za uporabo v veterinarski medicini razlikuje po večji koncentraciji zdravilne učinkovine, enkratni aplikaciji, spremenjeni terapevtski indikaciji in po drugačnem pomožnem topilu.
Written explanations were provided by the applicant on 20 March 2012.
Predlagatelj je 20. marca 2012 predložil pisna pojasnila ter 15. maja 2012 še ustna pojasnila.
The applicant, Intervet International BV, submitted an application for a decentralised procedure for Nuflor Swine Once 450 mg/ml solution for injection.
Predlagatelj, Intervet International BV, je predložil vlogo za pridobitev dovoljenja za promet z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje po decentraliziranem postopku.
On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures
Ker ta vprašanja na 210. dan še vedno niso bila rešena, je bila zadeva 17. oktobra 2011 v skladu s členom 33(1) Direktive 2001/82/ES napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
Article 33(4) of Directive 2001/82/EC, as amended
Mnenje v zvezi z napotitvijo v skladu s členom 33(4)
Opinion following an Article 33(4)1 referral for Nuflor Swine Once 450 mg/ml solution for injection
za zdravilo Nuflor Swine Once 450 mg/ml raztopina za injiciranje
Opinion following an Article 33(4)0F referral for Nuflor Swine Once 450 mg/ml solution for injection
Mnenje v zvezi z napotitvijo v skladu s členom 33(4)0F za zdravilo Nuflor Swine Once
12-16 hours
12-16 ur
Date of first authorisation: 23 November 2007 Date of latest renewal: 20 July 2012
Datum prve odobritve: 23. november 2007 Datum zadnjega podaljšanja: 20. julij 2012
It depends on how serious the poisoning is.
To je odvisno od tega, kako resna je zastrupitev.
The survival rate of 41% depended very much on the clinical situation.
Stopnja preživetja, 41 %, je bila v veliki meri odvisna od klinične situacije.
Documentation on efficacy is available for 54 paediatric patients.
Dokumentacija učinkovitosti je na voljo za 54 pediatričnih bolnikov.
Repeat this procedure if necessary with the second vial.
Po potrebi postopek ponovite z drugo vialo.
24 hours with the exception of bilirubin (up to 4 days)
24 ur, razen pri bilirubinu (do 4 dni)
You may need one or two infusions.
Morda boste infundiranje potrebovali enkrat ali dvakrat.
Survival at Hour 4, N (%) 7 (41) Survival at Day 14, N (%) 3 (18)
Preživetje po 4 urah, N (%) 7 (41) Preživetje po 14 dneh, N (%) 3 (18)
This red colouration has no other consequences on your body.
Rdeča barva nima nikakršnega vpliva na vaše telo.
The following side effects may be expected (frequency cannot be estimated from the available data):
Pričakujete lahko naslednje neželene učinke (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
Results may vary considerably from one analyser to another, therefore, caution is required when reporting and interpreting laboratory results.
Rezultati se pri različnih analizatorjih lahko precej razlikujejo, zato je pri poročanju in interpretaciji laboratorijskih rezultatov potrebna previdnost.
Due to ethical considerations, no controlled human efficacy studies have been performed.
Zaradi etičnih razlogov nadzorovane študije učinkovitosti pri človeku niso bile opravljene.
From a microbiological point of view, the medicinal product should be used immediately.
Z mikrobiološkega vidika je treba zdravilo uporabiti takoj.
Tell your doctor as soon as possible if you were pregnant or think you may have been pregnant during treatment with Cyanokit.
Svojemu zdravniku čim prej povejte, da ste noseči ali mislite, da ste morda bili noseči med zdravljenjem z zdravilom Cyanokit.
It can be administered during pregnancy and breast-feeding.
Lahko se uporablja med nosečnostjo in dojenjem.
Initial dose in g in mL
Začetni odmerek v g v ml
If overdose occurs, treatment is directed to the management of symptoms.
Če pride do prevelikega odmerjanja, je zdravljenje usmerjeno k obravnavanju simptomov.
Read all of this leaflet carefully before using this medicine because it contains important information for you.
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Cyanide is a highly poisonous chemical.
Cianid je zelo strupena kemikalija.
• altered mental status
• spremenjeno duševno stanje.
No dose adjustment is required in these patients.
Prilagoditev odmerka pri teh bolnikih ni potrebna.
Cyanokit may modify the results of these tests.
Zdravilo Cyanokit lahko spremeni rezultate teh preiskav.
Tell your doctor immediately if you have the following symptoms during or after this treatment:
Zdravniku takoj povejte, če imate med zdravljenjem ali po njem naslednje simptome:
Tell your doctor or other health care professional if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali drugo zdravstveno osebje, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
However, because of the limitations of the available data, it is not possible to apply frequency estimations:
Vendar pa zaradi omejenih podatkov, ki so na voljo, ni mogoče dati ocene pogostnosti.
The effects on these tests typically last 48 hours after a 5 g dose, but may persist for longer periods.
Učinki na te teste navadno trajajo 48 ur po 5-gramskem odmerku, vendar lahko vztrajajo daljše obdobje.
• swelling around the eyes, lips, tongue, throat or hands
• otekanje okrog oči, ustnic, jezika, grla ali rok
There are no adequate data from the use of hydroxocobalamin in pregnant women and the potential risk for humans is unknown.
Ni zadostnih podatkov o uporabi hidroksokobalamina pri nosečnicah in možno tveganje za ljudi ni znano.
Activated partial thromboplastin time (aPTT)
Aktivirani parcialni tromboplastinski čas (aPTT)
• that you have been treated with Cyanokit if you need to have the following: - any blood or urine tests.
• da so vas zdravili z zdravilom Cyanokit, če vam morajo opraviti naslednje: preiskave krvi ali urina.
Of the 213 patients in whom the outcome was known the survival was 58%.
Pri 213 bolnikih, pri katerih je izid bil znan, je bilo preživetje 58-odstotno.
Dark red crystalline powder.
Temno rdeč kristaliničen prašek.
• if you are allergic to hydroxocobalamin or vitamin B12.
• če ste alergični na hidroksokobalamin ali vitamin B12.
Cyanokit may lead to shut down of haemodialysis machines until it is eliminated from the blood (at least 5.5 to 6.5 days).
Zdravilo Cyanokit lahko povzroči ustavitev aparatov za hemodializo, dokler se ne izloči iz krvi (vsaj 5,5 do 6,5 dni).
However findings were only seen at exposure levels considered being higher than the maximum human exposure, indicating limited relevance to clinical use.
Vendar so te učinke opazili samo pri izpostavljenosti, ki je večja od največje izpostavljenosti pri človeku, kar kaže na omejen pomen za klinično uporabo.
The rate of intravenous infusion for the second dose ranges from 15 minutes (for patients extremely unstable) to 2 hours based on patient condition.
Razpon hitrosti intravenske infuzije za drugi odmerek je od 15 minut (za izjemno nestabilne bolnike) do 2 uri, kar je odvisno od bolnikovega stanja.
Animal studies have shown teratogenic effects following daily exposure throughout organogenesis (see section 5.3).
Študije na živalih so pokazale teratogene učinke po dnevni izpostavljenosti ves čas trajanja organogeneze (glejte poglavje 5.3).
Caution is required in the interpretation of urinary colorimetric tests for as long as chromaturia is present.
Pri interpretaciji urinskih kolorimetričnih testov je potrebna previdnost, dokler je prisotna kromaturija.
• exposure to fire smoke in an enclosed area
• izpostavljenost dimu zaradi požara v zaprtem prostoru;
The dose of 150 mg/kg approximately corresponds to the maximum recommended human dose.
Odmerek 150 mg/kg približno ustreza največjemu priporočenemu odmerku za ljudi.
• problems with memory
• težave s spominom
Limited data on children (0 to 18 years old) treated with hydroxocobalamin did not show any difference in the safety profile of hydroxocobalamin between adults and children.
Omejeni podatki pri otrocih (0 do 18 let starosti), zdravljenih s hidroksokobalaminom, niso pokazali razlike v varnostnem profilu hidroksokobalamina med odraslimi in otroci.
Increase in blood pressure
Zvišanje krvnega tlaka
• inflammation in the part of the body where the medicine was infused.
• vnetje mesta na telesu, kjer so zdravilo infundirali