natgillin/translations-raw huggingface dataset:
The most frequently reported side effects are skin reactions at the application site of Picato, including erythema (reddening of the skin), flaking or scaling, crusting, swelling, vesiculation or pustulation (blisters), and erosion or ulceration (wearing away of outer skin layer or open sore of the skin). 
Najpogostejši neželeni učinki, o katerih so poročali, so kožne reakcije na mestu nanosa zdravila Picato, vključno z eritemom (pordelostjo kože), luščenje ali luskavica, tvorjenje krast, otekanje, mehurjenje ali tvorba pustul (mehurjev) in erozija ali ulceracija (lupljenje zunanje kožne plasti ali odprte razjede kože).
This is a summary of the European public assessment report (EPAR) for Picato. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Picato.
For more information about treatment with Picato, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Picato preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefit has Picato shown during the studies? 
Kakšne koristi je zdravilo Picato izkazalo med študijami?
Following the application of Picato, most patients (more than 95%) experienced one or more local skin responses. 
Po nanosu zdravila Picato je večina bolnikov (več kot 95 %) opazila enega ali več lokalnih kožnih odzivov.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Picato. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Picato, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The exact way Picato works is not fully understood. 
Natančen način delovanja zdravila Picato ni v celoti znan.
It is available as a gel in two strengths (150 micrograms/g and 500 micrograms/g). 
Na voljo je v obliki gela dveh jakosti (150 mikrogramov/g in 500 mikrogramov/g).
It is thought that the active substance in Picato, ingenol mebutate, works in two different ways. 
Predvideva se, da zdravilna učinkovina v zdravilu Picato, ingenol mebutat, deluje na dva različna načina.
Actinic keratosis is a skin lesion that develops after too much exposure to sunlight. 
Aktinična keratoza je kožna lezija, ki se razvije po čezmerni izpostavljenosti sončni svetlobi.
In all four studies, Picato was compared with vehicle (a gel without active substance). 
V vseh štirih študijah so zdravilo Picato primerjali z vehiklom (gelom brez zdravilne učinkovine).
Picato must not be used in people who are hypersensitive (allergic) to ingenol mebutate or any of the other ingredients. 
Zdravila Picato ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) ingenol mebutat ali katero koli drugo sestavino zdravila.
There were no major safety concerns with Picato and the side effects seen were mostly local skin reactions which, although they affected most patients, usually resolved within two to four weeks of treatment depending on the location. 
V zvezi z zdravilom Picato niso opazili pomembnejših varnostnih zadržkov, opaženi neželeni učinki pa so bili večinoma lokalne kožne reakcije, ki so kljub temu, da so prizadele večino bolnikov, izzvenele v dveh do štirih tednih zdravljenja, odvisno od mesta zdravljenja.
Once applied and absorbed by the skin cells, ingenol mebutate has a direct toxic effect on the cell as well as promoting an inflammatory response. 
Ko nanesemo ingenol mebutat in ga kožne celice absorbirajo, ima ta učinkovina neposreden toksičen učinek na celico in obenem spodbuja vnetni odziv.
Together, these actions lead to the death of the cells affected by actinic keratosis. 
Oba učinka skupaj povzročita odmrtje celic, ki jih je prizadela aktinična keratoza.
The CHMP noted that treatment with Picato has a beneficial effect. 
CHMP je zaključil, da ima zdravljenje z zdravilom Picato ugoden učinek.
The main measure of effectiveness was the number of patients whose skin was completely cleared of the actinic keratosis eight weeks after treatment. 
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila v osmih tednih po zdravljenju koža povsem brez aktiničnih keratoz.
Picato is used when the outer layer of the skin affected by actinic keratosis is not thickened or raised. 
Zdravilo Picato se uporablja, kadar zunanja plast kože, ki jo je prizadela aktinična keratoza, ni odebeljena ali dvignjena.
A new tube of Picato gel should be used for each application. 
Za vsak nanos je treba uporabiti novo tubo gela Picato.
In addition, the CHMP considered the fact that Picato can be self-applied and that treatment is of short duration as an advantage. 
Poleg tega je CHMP kot prednost upošteval dejstvo, da lahko zdravilo Picato bolnik nanaša sam in da je zdravljenje kratkotrajno.
Picato was shown to be effective in clearing actinic keratosis from the skin. 
Zdravilo Picato se je izkazalo za učinkovito pri odstranjevanju aktiničnih keratoz s kože.
The CHMP therefore decided that Picato's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zaključil je, da so koristi zdravila Picato večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Why has Picato been approved? 
Zakaj je bilo zdravilo Picato odobreno?
For the full list of all side effects reported with Picato, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Picato, glejte navodilo za uporabo.
Picato is used to treat adults with actinic keratosis. 
Zdravilo Picato se uporablja za zdravljenje odraslih bolnikov z aktinično keratozo.
Picato is a medicine containing the active substance ingenol mebutate. 
Picato je zdravilo, ki vsebuje zdravilno učinkovino ingenol mebutat.
Picato (500 microgram/g) has been studied in two studies involving 458 adults with actinic keratosis affecting the trunk and extremities, where it was applied once a day for two consecutive days. 
Zdravilo Picato (500 mikrogramov/g) so proučevali v dveh študijah, ki sta vključevali 458 odraslih bolnikov z aktinično keratozo, ki je prizadela trup in ude, kamor so zdravilo nanašali dva zaporedna dneva enkrat dnevno.
Picato gel is applied to the affected skin areas. 
Gel Picato se nanese na prizadete dele kože.
EPAR summary for the public ingenol mebutate 
Picato ingenol mebutat
Picato (150 microgram/g) has been studied in two main studies involving 547 adults with actinic keratosis affecting the face and scalp, where it was applied once a day for three consecutive days. 
Zdravilo Picato (150 mikrogramov/g) so proučevali v dveh glavnih študijah, ki sta vključevali 547 odraslih bolnikov z aktinično keratozo, ki je prizadela obraz in lasišče, kamor so zdravilo nanašali tri zaporedne dni enkrat dnevno.
When the affected areas are the face, scalp and upper part of the neck, Picato (150 micrograms/g) should be applied once a day for three consecutive days. 
Če so prizadeta območja na obrazu, lasišču ali zgornjem delu vratu, je treba zdravilo Picato (150 mikrogramov/g) nanašati tri zaporedne dni po enkrat dnevno.
When the affected areas are the trunk, extremities and lower part of the neck, the higher strength Picato (500 micrograms/g) should be applied once a day for two consecutive days. 
Če so prizadeta območja na trupu, udih ali spodnjem delu vratu, je treba zdravilo Picato močnejše jakosti (500 mikrogramov/g) nanašati dva zaporedna dneva po enkrat dnevno.
For further information on how to use Picato see the package leaflet. 
Za nadaljnje informacije o uporabi zdravila Picato glejte navodilo za uporabo.
In the second study, the skin cleared in 42% (42 out of 100) of patients treated with Picato, compared with 5% (5 out of 103) of patients treated with placebo. 
V drugi študiji se je koža povsem očistila pri 42 % (42 od 100) bolnikov, zdravljenih z zdravilom Picato, v primerjavi s 5 % (5 od 103) bolnikov, zdravljenih s placebom.
Infection at the application site was also reported when treating the face and scalp. 
Pri zdravljenju obraza in lasišča so poročali tudi o okužbi na mestu nanosa.
How has Picato been studied? 
Kako je bilo zdravilo Picato raziskano?
In the second study the skin completely cleared in 37% (50 out of 135) of patients treated with Picato, compared with 2% (3 out of 134) of patients treated with placebo. 
V drugi študiji se je koža povsem očistila pri 37 % (50 od 135) bolnikov, zdravljenih z zdravilom Picato, v primerjavi z 2 % (3 od 134) bolnikov, zdravljenih s placebom.
For actinic keratosis affecting the face and scalp, the first study showed that the skin completely cleared in 47% (67 out of 142) of patients treated with Picato, compared with 5% (7 out of 136) of patients treated with placebo. 
Za aktinično keratozo, ki prizadene obraz in lasišče, je prva študija pokazala, da se je koža povsem očistila pri 47 % (67 od 142) bolnikov, zdravljenih z zdravilom Picato, v primerjavi s 5 % (7 od 136) bolnikov , zdravljenih s placebom.
For actinic keratosis of the trunk and extremities, the first study showed that the skin cleared completely in 28% (35 out of 126) of patients treated with Picato, compared with 5% (6 out of 129) of patients treated with placebo. 
Za aktinično keratozo, ki prizadene trup in ude, je prva študija pokazala, da se je koža povsem očistila pri 28 % (35 od 126) bolnikov, zdravljenih z zdravilom Picato, v primerjavi s 5 % (6 od 129) bolnikov, zdravljenih s placebom.
What is Picato used for? 
Za kaj se zdravilo Picato uporablja?
What is Picato? 
Kaj je zdravilo Picato?
How is Picato used? 
Kako se zdravilo Picato uporablja?
How does Picato work? 
Kako zdravilo Picato deluje?
Stomach problems may occur. 
Lahko se pojavijo težave z želodcem.
Thymus vulgaris L. and Thymus zygis L., herba 
Thymus vulgaris L. in Thymus zygis L., herba
Most thyme preparations should only be used in adults and adolescents over the age of 12 years, but a few can also be used in children above 4 years. 
Večina pripravkov z zeljo vrtne materine dušice se sme uporabljati le pri odraslih in mladostnikih, starejših od 12 let, nekaj pa jih je mogoče uporabljati tudi pri otrocih, starejših od 4 let.
Although no significant difference was observed between thyme and bromhexine in treating the cough, there were shortcomings in the study such as the small number of patients and lack of details of the thyme preparation, so firm conclusions could not be drawn. 
Čeprav med zeljo vrtne materine dušice in bromheksinom pri zdravljenju kašlja niso opazili značilne razlike, je študija vsebovala pomanjkljivosti, kot sta majhno število bolnikov in pomanjkanje podrobnosti o pripravku z zeljo vrtne materine dušice, zato trdnih zaključkov ni bilo možno sprejeti.
In its assessment, the HMPC also considered clinical studies in both adults and children. 
V svoji oceni je odbor HMPC prav tako upošteval klinične študije, ki so vključevale odrasle in otroke.
If symptoms last longer than one week or worsen during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted. 
Če simptomi med uporabo zdravila trajajo več kot en teden ali se poslabšajo, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
The HMPC conclusions only cover thyme preparations which are obtained by drying and comminuting (reducing into tiny pieces) the leaves and flowers, by expressing the juice of the leaves and flowers or as dry, liquid and soft extracts. 
Zaključki odbora HMPC zajemajo samo pripravke z zeljo vrtne materine dušice, ki se pridobivajo s sušenjem in drobljenjem (zmanjševanjem na majhne delce) listov in cvetov, z iztiskanjem soka iz listov in cvetov ter kot suhi, tekoči ali gosti ekstrakti.
Further information on the risks associated with these thyme 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 s temi zdravili, ki vsebujejo zel vrtne materine dušice, 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 summary is not intended to provide practical advice on how to use medicines containing thyme. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo zel vrtne materine dušice.
Thyme is the common name for the leaves and flowers of the plants Thymus vulgaris L. or Thymus zygis L. 
Zel vrtne materine dušice je splošno ime za liste in cvetove rastline Thymus vulgaris L. ali Thymus zygis L.
Herbal medicines containing these thyme preparations are usually available as herbal tea to be drunk or in liquid or solid forms to be taken by mouth. 
Zdravila rastlinskega izvora, ki vsebujejo te pripravke z zeljo vrtne materine dušice, so navadno na voljo kot zdravilni čaj, ki se popije, ali v tekoči ali trdni obliki za jemanje skozi usta.
The solvent is then partially or completely evaporated to obtain a soft or dry extract. 
Topilo se nato delno ali v celoti odpari, s čimer se pridobi gosti ali suhi ekstrakt.
Information on the use and licensing of thyme medicines in EU Member States should be obtained from the relevant national authorities. 
Za informacije o uporabi in registraciji zdravil, ki vsebujejo zel vrtne materine dušice, v državah članicah EU se obrnite na pristojni nacionalni organ.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of thyme. 
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo zeli vrtne materine dušice.
Any applications for the licensing of medicines containing thyme 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 zel vrtne materine dušice, 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.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing thyme. 
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo zel vrtne materine dušice.
Further information on the HMPC assessment of thyme 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 zel vrtne materine dušice, 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.
A clinical study involving 60 adults with productive cough treated either with a thyme preparation or bromhexine, an established treatment for productive coughs. 
V klinični študiji, ki je vključevala 60 odraslih s produktivnim kašljem, je bil produktivni kašelj zdravljen s pripravkom z zeljo vrtne materine dušice ali bromheksinom, uveljavljenim zdravilom za produktivni kašelj.
Thyme preparations may also be found in combination with other herbal substances in some herbal medicines. 
Pripravki z zeljo vrtne materine dušice so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
The HMPC concluded that, on the basis of its long-standing use, these thyme preparations can be used for productive (chesty) coughs associated with colds. 
Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko ti pripravki, ki vsebujejo zel vrtne materine dušice uporabljajo za produktivni (mokri) kašelj, povezan s prehladom.
How are thyme medicines approved in the EU? 
Kako so zdravila, ki vsebujejo zel vrtne materine dušice, odobrena v EU?
The HMPC conclusions on the use of these thyme medicines for productive coughs are based on their ‘traditional use'. 
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo zel vrtne materine dušice, pri produktivnem kašlju temeljijo na njihovi „tradicionalni uporabi“.
Detailed instructions on how to take thyme 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 zel vrtne materine dušice, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
What evidence supports the use of thyme medicines? 
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo zel vrtne materine dušice?
For practical information about using thyme 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 thyme 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 zel vrtne materine dušice, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
Thyme medicines must not be used in patients who are allergic to thyme or to other plants of the Lamiaceae (Labiatae) family. 
Zdravila, ki vsebujejo zel vrtne materine dušice, se ne smejo uporabljati pri bolnikih, ki so alergični na zel vrtne materine dušice ali druge rastline iz družine ustnatic.
What are the risks associated with thyme medicines? 
Kakšna tveganja so povezana z zdravili, ki vsebujejo zel vrtne materine dušice?
Other information about thyme medicines 
Druge informacije o zdravilih, ki vsebujejo zel vrtne materine dušice
Therefore, the HMPC conclusions on the use of these thyme medicines are based on their longstanding use. 
Zaključki odbora HMPC v zvezi z uporabo teh zdravil, ki vsebujejo zel vrtne materine dušice, zato temeljijo na njihovi dolgotrajni uporabi.
What is thyme? 
Kaj je zel vrtne materine dušice?
It is unlikely that you will not be given the medicine as it has been prescribed. 
Ni verjetno, da ne bi dobili zdravila tako, kot vam je bilo predpisano.
Always ask if you are not sure why you are getting a dose of medicine. 
Vedno vprašajte, če niste prepričani, zakaj prejemate zdravilo.
Children and Teenagers This medicine must not be given to children or teenagers. 
Otroci in najstniki Tega zdravila otroci in najstniki ne smejo jemati.
(See sections 4.2 Elderly, 4.5, 4.8, and 4.9). 
(glejte poglavja 4.2 Starejši, 4.5, 4.8 in 4.9).
These effects are normally mild or moderate and often disappear after a short time. 
Ti učinki so po navadi blagi do zmerni in pogosto po kratkem času izzvenijo.
Do not have this medicine if any of the above applies to you. 
Ne jemljite tega zdravila, če karkoli od zgoraj navedenega velja za vas.
5% glucose injection. 
5 % injekcija glukoze.
It is presented in glass bottle. 
Na voljo je v steklenicah.
Protect your skin from sunlight 
Zaščita kože pred soncem
The time to switch from intravenous to oral treatment depends on the clinical situation but is normally 2 to 4 days. 
Čas prehoda z intravenoznega na oralno zdravljenje je odvisen od kliničnega stanja in običajno znaša 2-4 dni.
Given the bioequivalence of the parenteral and oral forms, the same dosage can be used. 
Ker sta parenteralna in peroralna oblika bioekvivalentni, je mogoče uporabiti isti odmerek.
• Attacks of porphyria in people who already have porphyria (a very rare metabolic disease) 
• Napadi porfirije pri osebah, ki že imajo porfirijo (zelo redko presnovno bolezen)
If it is stopped too soon, your condition may get worse or the bacteria may become resistant to the medicine. 
Če se z jemanjem zdravila prehitro preneha, se lahko vaše zdravstveno stanje poslabša ali postane bakterija odporna na zdravilo.
From a microbiological point of view, the solution for infusion should be used immediately. 
Z mikrobiološkega stališča je treba zdravilo porabiti takoj.
Your doctor or nurse will continue giving you Tavanic, even if you feel better. 
Zdravnik ali medicinska sestra bosta nadaljevala z dajanjem zdravila Tavanic tudi, če se boste počutili bolje.
Frequencies in this table are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data). 
Neželeni učinki so navedeni glede na organske sisteme in razvrščeni po pogostnosti v skladu z MeDRA terminologijo: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1000 do <1/100); redki (≥1/10000 do <1/1000); zelo redki (<10000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The risk of tendinitis and tendon rupture is increased in patients aged over 60 years, inpatients receiving daily doses of 1000 mg and in patients using corticosteroids. 
Tveganje za tendinitis in pretrganje tetive je večje pri bolnikih starejših od 60 let, pri bolnikih, ki dobivajo dnevni odmerek 1000 mg, in pri bolnikih, ki uporabljajo kortikosteroide.
• Seeing or hearing things that are not there (hallucinations, paranoia), change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions 
• Videnje ali slišanje stvari, ki jih ni (halucinacije, paranoja), spremembe mnenj in razmišljanj (psihotične reakcije) z možnostjo samomorilnega razmišljanja ali ravnanja
swelling of your lips, face, throat, or tongue. 
oteklost ustnic, obraza, žrela ali jezika.
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Če ni porabljeno takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo.
Interference with laboratory test 
Vpliv na laboratorijske teste
1 Treatment duration includes intravenous plus oral treatment. 
1Trajanje zdravljenja vključuje tako oralno kot intravenozno zdravljenje.
Streptococcus A, B, C, G 
Streptococcus A,B,C,G ≤1 mg/l
• Reactions at the site of infusion 
• Reakcije na mestu infundiranja
OTHER SPECIAL WARNING(S), IF NECESSARY Use as directed by your doctor. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Uporabiti v skladu z navodili zdravnika.
For incompatibilities see section 6.2 and compatibility with other infusion solutions see section 6.6. 
Za inkompatibilnosti glejte poglavje 6.2, za kompatibilnost z drugimi infuzijskimi raztopinami glejte poglavje 6.6.
Penetration into tissues and body fluids: 
Prodiranje v tkiva in telesne tekočine:
2.5% glucose in Ringer solution. 
2,5 % glukoza v Ringerjevi raztopini.
Clear greenish-yellow isotonic solution with pH of 4.3 to 5.3 and osmolarity of 282 - 322 mOsm/litre. 
Bistra zeleno rumena izotonična raztopina s pH od 4,3 do 5,3 in osmolarnostjo od 282322 mOsm/liter.
This medicine is authorised in the Member States of the EEA under the following name: Tavanic 
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Tavanic
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: [To be completed nationally] Date of last renewal: [To be completed nationally] 
Datum prve odobritve: [Izpolni država članica] Datum zadnjega podaljšanja: [Izpolni država članica]
Mixture with other solutions for infusion: 
Mešanje z drugimi raztopinami za infundiranje: