FrancophonIA/ELRC3.0 huggingface dataset:
English: Any applications for the licensing of medicines containing matricaria oil 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 eterično olje prave kamilice, 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: Information on the use and licensing of matricaria oil 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 eterično olje prave kamilice, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Further information on the HMPC assessment of matricaria oil 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 eterično olje prave kamilice, 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: Matricaria oil medicines must not be used in patients who are allergic to matricaria oil or other plants of the same family (Asteraceae (Compositae)).
Slovenian: Zdravila, ki vsebujejo eterično olje prave kamilice, se ne smejo uporabljati pri bolnikih, ki so alergični na eterično olje prave kamilice ali druge rastline iz družine nebinovk - Asteraceae (Compositae).
English: Although observational data with matricaria oil medicines as a bath additive for irritation of the skin are available, they were too limited to be used as evidence.
Slovenian: Čeprav so podatki iz opazovalnih študij za zdravila, ki vsebujejo eterično olje prave kamilice in se uporabljajo kot dodatek kopelim pri razdraženosti kože, na voljo, so nezadostni, da bi jih lahko uporabili kot dokaz učinkovitosti.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing matricaria oil.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo eterično olje prave kamilice.
English: Patients with severe heart and circulation problems should not have full baths with matricaria oil.
Slovenian: Bolniki z resnimi težavami s srcem in krvnim obtokom ne smejo uporabljati kopeli celega telesa z eteričnim oljem prave kamilice.
English: Matricaria oil is the common name for the essential oil of the flower heads of the plant Matricaria recutita L. (also known as chamomile).
Slovenian: Eterično olje prave kamilice je splošno ime za eterično olje cvetne glavice rastline Matricaria recutita L. (kamilice).
English: Matricaria oil can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Eterično olje prave kamilice je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: The HMPC concluded that, on the basis of its long-standing use, matricaria oil medicines can be used as add-on treatment of irritation of the skin and areas around the anus and genitals, once serious conditions have been excluded by a medical doctor.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe eteričnega olja prave kamilice zaključil, da se lahko zdravila, ki vsebujejo eterično olje prave kamilice, uporabljajo kot dodatek pri zdravljenju razdraženosti kože in predelov okoli anusa (zadnjika) in spolovil, ko zdravnik izključi resne bolezni.
English: Matricaria oil medicines should only be used in adults and adolescents (above 12 years of age).
Slovenian: Zdravila, ki vsebujejo eterično olje prave kamilice, se lahko uporabljajo samo pri odraslih in mladostnikih, starejših od 12 let.
English: Allergic reactions, sometimes severe, have been reported following contact of liquid chamomile preparations with internal moist surfaces such as the lining of the mouth.
Slovenian: Tekoči kamilični pripravki lahko pri stiku z notranjimi vlažnimi površinami, kot je sluznica v ustih, povzročijo alergijske reakcije, ki so včasih resne.
English: Herbal medicines containing matricaria oil are usually available in liquid forms to be used as bath additives.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo eterično olje prave kamilice, so navadno na voljo v tekočih oblikah za dodajanje kopelim.
English: What evidence supports the use of matricaria oil medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo eterično olje prave
English: For practical information about using matricaria oil 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: Therefore, the HMPC conclusions on the use of matricaria oil medicines are based on their long-standing use.
Slovenian: Ugotovitve odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo eterično olje prave kamilice, zato temeljijo na njihovi dolgotrajni uporabi.
English: What are the risks associated with matricaria oil medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo eterično olje prave
English: For more information about treatment with matricaria oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: zdravljenju z zdravili, ki vsebujejo eterično olje prave kamilice, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: What is matricaria oil?
Slovenian: Kaj je eterično olje prave kamilice?
English: A doctor or a qualified healthcare practitioner should be consulted if symptoms persist for more than one
Slovenian: Če simptomi pri zdravljenju trajajo dlje kot teden dni, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
English: Other information about matricaria oil medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo eterično olje prave kamilice
English: Detailed instructions on how to take matricaria oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: zdravil, ki vsebujejo eterično olje prave kamilice, in o tem, kdo sme ta zdravila jemati, so v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: Matricaria oil
Slovenian: Podrobna navodila o jemanju
English: Date of first authorisation: 04 April 2008 Date of latest renewal: 20 February 2013
Slovenian: Datum prve odobritve: 04. april 2008 Datum zadnjega podaljšanja: 20. februar 2013
English: • You have a head injury.
Slovenian: • Imate poškodovano glavo.
English: • Information on the correct indication and the risk for abuse
Slovenian: • Informacijah o pravilni indikaciji in tveganju zlorabe
English: Seek URGENT medical advice if:
Slovenian: Poiščite NUJEN zdravniški nasvet, če:
English: The rate of development of tolerance varies widely among individuals.
Slovenian: Stopnja razvoja tolerance se med posamezniki razlikuje.
English: Accidental use in children
Slovenian: Naključna uporaba pri otrocih
English: The reason of this difference is unknown.
Slovenian: Vzrok za to razliko ni znan.
English: Tolerance, dependence
Slovenian: Toleranca, odvisnost
English: This may occur within the recommended dose.
Slovenian: Pojavi se lahko znotraj priporočenega odmerka.
English: These differences continued to be significant at each subsequent time point in each individual study.
Slovenian: Te razlike so bile pomembne tudi ob vsakem naslednjem merjenju v vsaki individualni študiji.
English: Each tablet contains either:
Slovenian: Ena tableta vsebuje bodisi:
English: Patients should be carefully monitored until an effective dose is reached.
Slovenian: Bolnike je treba skrbno nadzirati, dokler ni dosežen učinkovit odmerek.
English: It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above.
Slovenian: V pomoč vam je lahko, da prijatelje ali sorodnike obvestite o zgornjih znakih in simptomih.
English: • You are over 65 years old - you may need a lower dose and any dose increase will be reviewed very carefully by your doctor.
Slovenian: • Ste stari več kot 65 let - morda boste potrebovali manjši odmerk; vsako povečanje odmerka bo zdravnik zelo skrbno proučil.
English: Because of this, concomitant use should only be considered when other treatment options are not possible.
Slovenian: Zaradi tega je treba o sočasni uporabi razmisliti le, ko druge možnosti zdravljenja niso možne.
English: Higher doses may be necessary.
Slovenian: Morda bodo potrebni višji odmerki.
English: Any change in dosage must be prescribed and monitored by your doctor.
Slovenian: Vsako spremembo odmerka mora predpisati in nadzirati zdravnik.
English: Do not give this medicine to children and adolescents below18 years of age.
Slovenian: Tega zdravila ne smete dati otrokom in mladostnikom, starim manj kot 18 let.
English: • Risk of interactions with other medications
Slovenian: • Tveganje medsebojnega delovanja z drugimi zdravili
English: Try to keep the person awake until emergency help arrives.
Slovenian: Osebo poskušajte ohranjati budno, dokler ne pride urgentna zdravniška pomoč.
English: The primary efficacy variable was the patient's assessment of pain intensity.
Slovenian: Variabla primarne učinkovitosti je bila ocena intenzivnosti bolnikove bolečine.
English: * Based on venous blood samples (plasma).
Slovenian: * Na podlagi vzorcev venske krvi (plazma).
English: In general, the effective concentration and the concentration at which toxicity occurs increase with increasing tolerance to opioids.
Slovenian: Na splošno učinkovita koncentracija in koncentracija, pri kateri se pojavi toksičnost, narašča z večanjem tolerance na opioide.
English: • Possible side effects (the most likely ones, how to recognise them and when to alert physicians)
Slovenian: • Možni neželeni učinki (najbolj verjetni, kako jih prepoznati in kdaj obvestiti zdravnika)
English: Sometimes, your doctor may tell you to place the tablet under your tongue instead.
Slovenian: Morda vam bo zdravnik naročil, da namesto tega tableto vstavite pod jezik.
English: Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.
Slovenian: Vaš zdravnik bo ocenil, ali potrebujete zdravilo za zmanjšanje ali izničenje odtegnitvenih simptomov
English: This product should only be used by patients already taking other opioids.
Slovenian: Zdravilo lahko uporabljajo samo bolniki, ki že jemljejo druge opioide.
English: • How to use EFFENTORA (how to take it, how to reach the effective dose during the titration process)?
Slovenian: • Kako uporabljati zdravilo EFFENTORA (kako ga jemati, kako med postopkom titriranja doseči učinkoviti odmerek)?
English: The differences observed were not clinically significant.
Slovenian: Opažene razlike niso bile statistično značilne.
English: <1/1,000), not known (cannot be estimated from the available data); within each frequency group, undesirable effects are presented in order of decreasing seriousness:
Slovenian: neznana (ni mogoče oceniti iz razpoložljivih podatkov); v vsaki skupini pogostnosti so neželeni učinki predstavljeni v padajočem vrstnem redu po resnosti:
English: Dosage increase should be done with caution.
Slovenian: Odmerek je treba povečati previdno.
English: • The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics.
Slovenian: • Tveganje neželenih učinkov se poveča, če jemljete zdravila, kot so nekateri antidepresivi ali antipsihotiki.
English: A Q&A document, providing answers to potential questions on the following topics:
Slovenian: Dokument z vprašanji in odgovori, kjer so odgovori na možna vprašanja na naslednje teme:
English: Doses above 800 micrograms were not evaluated in clinical studies.
Slovenian: Odmerkov nad 800 mikrogramov v kliničnih študijah niso ocenjevali.
English: • Patients without maintenance opioid therapy as there is an increased risk of respiratory depression.
Slovenian: • Bolniki brez vzdrževalne opioidne terapije, saj obstaja povišano tveganje respiratorne depresije.
English: The plasma protein binding of fentanyl is 80% to 85%.
Slovenian: Vezava fentanila na plazemske beljakovine je 80 % do 85 %.
English: The main pharmacokinetic parameters are shown in the following table.
Slovenian: Glavni farmakokinetični parametri so prikazani v spodnji tabeli.
English: • lack of sex hormones (androgen deficiency)
Slovenian: • pomanjkanje spolnih hormoneov (pomanjkanje androgena)
English: • Educational material for the patients
Slovenian: • Izobraževalno gradivo za bolnike
English: • What is Breakthrough pain?
Slovenian: • Kaj je prebijajoča bolečina?
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder or call the following number:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom ali pokličite naslednjo številko:
English: Physicians should keep in mind the potential of abuse of fentanyl.
Slovenian: Zdravniki morajo upoštevati možnost zlorabe fentanila.
English: In the further course of treatment your requirement for analgesic therapy may change.
Slovenian: V nadaljevanju zdravljenja se lahko vaše zahteve po analgetičnem zdravljenju spremenijo.
English: • Medicines called monoamine-oxidase (MAO) inhibitors (used for severe depression) or have done so in the past 2 weeks.
Slovenian: • Zdravila, imenovana zaviralci monamin-oksidaze (MAO) (uporabljajo se za hudo depresijo), če ste jih jemali v prejšnjih 2 tednih.
English: Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, rare (≥1/10,000 to
Slovenian: Neželeni učinki so našteti spodaj po sistemu MedDRA glede na organske sisteme in pogostnost (pogostnost je opredeljena kot: zelo pogosti ≥1/10, pogosti ≥1/100 do <1/10, občasni ≥1/1.000 do <1/100, redki (≥1/10.000 do <1/1.000),
English: If you have not been using these medicines you must not use Effentora, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
Slovenian: Če niste uporabljali teh zdravil, ne smete uporabljati zdravila Effentora, saj lahko poviša tveganje, da postane dihanje nevarno počasno in/ali plitko ali se celo ustavi.
English: Aluminium laminated blister of PVC/Al foil/Polyamide/PVC with paper/polyester lidding.
Slovenian: Plastificiran aluminijev pretisni omot PVC/Al folija/poliamid/PVC s pokrovom iz papirja/poliestra.
English: Following the intravenous administration of fentanyl, less than 7% of the administered dose is excreted unchanged in the urine, and only about 1% is excreted unchanged in the faeces.
Slovenian: Po intravenski aplikaciji fentanila se manj kot 7 % apliciranega odmerka nespremenjenega izloči v urinu in samo približno 1 % se izloči nespremenjenega v blatu.
English: You must let your doctor know immediately if you are using Effentora more than four times per day, as a change may be required to your treatment regimen.
Slovenian: Zdravnika morate nemudoma obvestiti, če uporabljate zdravilo Effentora več kot štirikrat na dan, saj bo morda potrebna sprememba pri vašem režimu zdraviljenja.
English: ** Data for Tmax presented as median (range).
Slovenian: ** Podatki za Tmax, predstavljeni kot mediana (razpon).
English: • You experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine as prescribed by your doctor.
Slovenian: • Imate bolečino ali zvečano občutljivost za bolečino (hiperalgezijo), ki se ne odziva na večje odmerke zdravila, ki vam jih predpiše zdravnik.
English: A document explaining the titration process and the dosing recommendations after treatment initiation
Slovenian: Dokument z razlago postopka titriranja in priporočil za odmerjanje po uvedbi zdravljenja
English: Your doctor will decide if your dose needs to be changed.
Slovenian: Zdravnik se bo odločil, ali je treba odmerek spremeniti.
English: The educational material for healthcare professionals shall consist of four items: • Opioid prescribing guide
Slovenian: Izobraževalno gradivo za zdravstvene delavce mora vsebovati naslednje štiri postavke: • Vodnika za predpisovanje opioidov
English: • disturbance in thinking, movements disturbance
Slovenian: • motnje v razmišljanju, motnje v gibanju
English: Pharmacotherapeutic group: analgesics; opioids; ATC code N02AB03.
Slovenian: Farmakoterapevtska skupina: analgetiki; opioidi; oznaka ATC N02AB03.
English: Any used or unused but no longer required medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Vso uporabljeno ali neuporabljeno zdravilo ali odpadni material, ki ga ne uporabljate več, zavrzite v skladu z lokalnimi predpisi.
English: The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent.
Slovenian: Glavna vezna beljakovina je alfa-1 kisli glikoprotein, do neke mere pa sodelujeta tudi albumin in lipoproteini.
English: As with all opioids, there is a risk of clinically significant respiratory depression associated with the use of fentanyl.
Slovenian: Kot z vsemi opioidi obstaja tveganje klinično pomembne respiratorne depresije, povezane z uporabo fentanila.
English: OTFC (normalized to 400 mcg)
Slovenian: OTFC (normalizirano na 400 mcg)
English: Effentora with food, drink and alcohol
Slovenian: Zdravilo Effentora skupaj s hrano, pijačo in alkoholom
English: This can occur if your dose of Effentora is too high or if you take too much Effentora.
Slovenian: To se lahko pojavi, če je vaš odmerek zdravila Effentora previsok ali če ste vzeli preveč zdravila Effentora.
English: Sixty-seven percent of the patients were able to be titrated to an effective dose.
Slovenian: Sedeminšestdeset odstotkov bolnikov je bilo možno titrirati na učinkovit odmerek.
English: • Some muscle relaxants - such as baclofen, diazepam (see also section “Warnings and precautions”.
Slovenian: • Nekateri mišični relaksanti, kot sta baklofen in diazepam (glejte tudi poglavje »Opozorila in previdnostni ukrepi«).
English: There are no adequate data from the use of fentanyl in pregnant women.
Slovenian: Ni ustreznih podatkov za uporabo fentanila pri nosečnicah.
English: • You have liver or kidney problems, as these organs have an effect on the way in which your system breaks down the medicine.
Slovenian: • Imate težave z jetri ali ledvicami, saj ti organi vplivajo na način, na katerega vaš organizem razgrajuje zdravilo.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
English: Patients who identified an effective dose entered the double-blind phase of the study.
Slovenian: Bolniki, pri katerih je bil učinkovit odmerek ugotovljen, so bili uvrščeni v dvojno slepo fazo študije.
English: Patients receiving Effentora concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time.
Slovenian: Bolnike, ki prejemajo zdravilo Effentora hkrati z zmernimi ali močnimi zaviralci CYP3A4, je treba daljše časovno obdobje skrbno nadzirati.
English: Your doctor will tell you whether Effentora is suitable for you.
Slovenian: Vaš zdravnik vam bo povedal, ali je zdravilo Effentora za vas primerno.
English: Your doctor may change the treatment for your persistent pain; when your persistent pain is controlled, your doctor may need to change the dose of Effentora.
Slovenian: Zdravnik bo morda spremenil vaše zdravilo za zdravljenje stalne bolečine; ko je vaša stalna bolečina pod nadzorom, bo morda zdravnik moral še enkrat spremeniti odmerek zdravila Effentora.
English: Patients and their carers must be instructed that Effentora contains an active substance in an amount that can be fatal, especially to a child.
Slovenian: Bolnike in njihove skrbnike je treba opozoriti, da vsebuje zdravilo Effentora učinkovino v količini, ki je lahko smrtna, posebej za otroke.
English: It may harm them,
Slovenian: bolečina dlesni,
English: The dose and duration of concomitant use should be limited (see section 4.4).
Slovenian: Odmerek in trajanje sočasne uporabe je treba omejiti (glejte poglavje 4.4).
English: • drug dependence (addiction)
Slovenian: • odvisnost od zdravil (zasvojenost)
English: Transient pH changes accompanying the effervescent reaction may optimise dissolution (at a lower pH) and membrane permeation (at a higher pH).
Slovenian: Prehodne spremembe v pH, ki spremljajo efervescentno reakcijo, lahko optimirajo raztapljanje (ob nižjem pH) in prepustnost membrane (pri višjem pH).
English: Its primary therapeutic actions are analgesia and sedation.
Slovenian: Njegova primarna terapevtska učinka sta analgetični in pomirjevalni.
English: You should take this into consideration if you are on a controlled sodium diet and seek advice from your doctor.
Slovenian: To upoštevajte, če ste na dieti z nadzorovanim vnosom natrija, in prosite zdravnika za nasvet.
English: A condition in which the adrenal glands do not produce enough hormones.
Slovenian: To je stanje, pri katerem nadledvične žleze ne ustvarijo dovolj hormonov.
English: Please tell your doctor about all sedative medicines you are taking (such as sleeping pills, medicines to treat anxiety, some medicines to treat allergic reactions (antihistamines), or tranquillisers) and follow your doctor's dose recommendation closely.
Slovenian: Zdravniku povejte za vsa sedativna zdravila, ki jih jemljete (kot so uspavalne tablete, zdravila za zdravljenje anksioznosti, nekatera zdravila za zdravljenje alergijskih reakcij (antihistaminiki) ali pomirjevala) in natančno upoštevajte zdravnikova priporočila za odmerek.
English: Absolute bioavailability Fraction absorbed transmucosally Tmax (minute) ** Cmax (ng/ml)
Slovenian: Absolutna biološka razpoložljivost Frakcije, absorbirane transmukozno Tmax (minuta) ** Cmax (ng/ml)
English: If this occurs, please seek immediate medical assistance.
Slovenian: V takem primeru nemudoma poiščite zdravniško pomoč.
English: If you begin to feel very dizzy, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away.
Slovenian: Če ste zelo omotični ali zelo zaspani, preden se tableta povsem razkroji, sperite usta z vodo in preostanke takoj izpljunite v umivalnik ali stranišče.
English: Patients with xerostomia
Slovenian: Bolniki s kserostomijo
English: In order to minimise the risks of opioid-related undesirable effects and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
Slovenian: Za zmanjšanje tveganja neželenih učinkov, povezanih z jemanjem opioidov, in za opredelitev učinkovitega odmerka je nujno, da bolnike med postopkom titriranja skrbno nadzira zdravstveni delavec.
English: When you place a tablet in your mouth, it dissolves and the medicine is absorbed through the lining of your mouth, into the blood system.
Slovenian: Ko tableto vstavite v usta, se raztopi in zdravilo se preko ustne sluznice absorbira v krvni sistem.