FrancophonIA/ELRC3.0 huggingface dataset:
English: Any applications for the licensing of medicines containing caraway fruit 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.
Bulgarian: Всички заявления за разрешаване за употреба на лекарства, съдържащи плод от ким, трябва да се подават до националните органи, отговорни за лекарствените продукти, които оценяват заявлението за растителното лекарство и вземат предвид научните заключения на HMPC.
English: Further information on the HMPC assessment of caraway fruit 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.
Bulgarian: Допълнителна информация относно оценката на HMPC за лекарствата, съдържащи плод от ким, включително подробности за заключенията на Комитета, може да се намерят в папка „All documents“ на уебсайта на Агенцията: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Herbal medicines containing whole or comminuted (reduced into tiny pieces) caraway fruit are usually available as a herbal tea to be drunk.
Bulgarian: Растителните лекарства, съдържащи цял или стрит (раздробен на малки части) плод от ким обикновено са налични като растителен чай за пиене.
English: Further information on the risks associated with caraway fruit 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.
Bulgarian: Допълнителна информация относно рисковете, свързани с лекарствата, съдържащи плод от ким, включително подходящи предпазни мерки за безопасната им употреба, могат да се намерят в монографията, в папка „All documents,“ на уебсайта на Агенцията: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC concluded that, on the basis of its long-standing use, caraway fruit medicines can be used for the relief of problems of the digestive system such as bloating and flatulence.
Bulgarian: HMPC заключи, че въз основа на дългогодишната употреба лекарствата, съдържащи плод от ким, могат да се използват за облекчаване на проблеми на храносмилателната система като подуване и газове.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of caraway fruit.
Bulgarian: Настоящият документ представлява резюме на научните заключения на Комитета по растителните лекарствени продукти (HMPC) за употребата на плода от ким в медицината.
English: Detailed instructions on how to take caraway fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Bulgarian: Подробни указания как се приемат лекарствата, съдържащи плод от ким, както и кой може да ги използва, могат да се намерят в листовката към лекарството.
English: Other information about caraway fruit medicines
Bulgarian: Допълнителна информация за лекарствата, съдържащи плод от ким
English: What is caraway fruit?
Bulgarian: Какво представлява плодът от ким?
English: What are the HMPC conclusions on its medicinal uses?
Bulgarian: Какви са заключенията на HMPC за употребата на плод от ким в медицината?
English: How are caraway fruit medicines approved in the EU?
Bulgarian: Как се одобряват лекарствата, съдържащи плод от ким, в ЕС?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Bulgarian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 октомври 2015 г.
English: For practical information about using caraway fruit medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Bulgarian: За практическа информация относно употребата на лекарства, съдържащи плод от ким, пациентите трябва да прочетат листовката към лекарството или да попитат своя лекар или фармацевт.
English: For more information about treatment with caraway fruit medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Bulgarian: За повече информация относно лечението с лекарствата, съдържащи плод от ким, прочетете листовката към лекарството или попитайте Вашия лекар или фармацевт.
English: What are the risks associated with caraway fruit medicines?
Bulgarian: Какви са рисковете, свързани с лекарствата, съдържащи плод от ким?
English: What evidence supports the use of caraway fruit medicines?
Bulgarian: Какви са доказателствата, които подкрепят употребата на лекарствата, съдържащи плод от ким?
English: Caraway fruit is the common name for the fruit of the plant Carum carvi L. The plant is cultivated or gathered to obtain the fruit for medicinal use.
Bulgarian: Растението се отглежда или събира, за да се набави плодът за медицинска употреба.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing caraway fruit.
Bulgarian: При оценяване на заявленията за разрешаване за употреба на растителни лекарства, съдържащи плод от ким, държавите членки вземат предвид заключенията на HMPC.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is
Bulgarian: Това означава, че въпреки че доказателствата от клинични изпитвания са недостатъчни, ефективността на тези растителни лекарства е приемлива и има доказателства, че те се използват безопасно по този начин от поне 30 години (включително от поне 15 години в ЕС).
English: You do not need to stay in a darkened room.
Bulgarian: Ni vam treba ostati v zatemnjenem prostoru.
English: If more than this is required, the system should be checked.
Bulgarian: Če se zahteva več kot toliko, je treba preveriti sistem.
English: Use Before or After Radiotherapy
Bulgarian: Uporaba pred ali po radioterapiji
English: The potential risk for humans is unknown.
Bulgarian: Morebitno tveganje za zdravje ljudi ni znano.
English: The following key elements should be included in the educational materials:
Bulgarian: Naslednji ključni elementi morajo biti priloženi izobraževalnemu gradivu:
English: From a microbiological point of view, the product should be used immediately.
Bulgarian: Z mikrobiološkega stališča je treba zdravilo takoj uporabiti.
English: If you have liver problems, this period might be longer.
Bulgarian: Če imate težave z jetri, bo to obdobje morda trajalo dlje.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at 23°C.
Bulgarian: Kemično in fizikalno stabilnost med uporabo so dokazovali 3 ure pri 23°C.
English: Frequencies are defined as: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); not known (cannot be estimated from the available data).
Bulgarian: Pogostost je opredeljena kot: zelo pogosti (>1/10); pogosti (>1/100, <1/10); občasni (>1/1000, <1/100); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Therefore, you should take liquid food only for a few days (in some cases up to 4 weeks).
Bulgarian: Zato morate uživati tekočo hrano le nekaj dni (v nekaterih primerih pa do 4 tedne).
English: Do not use other diluents.
Bulgarian: Ne uporabljajte drugih razredčil.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Bulgarian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: − When new information is received that may impact on the current Safety Specification,
Bulgarian: − Če se ugotovijo novi podatki, ki vplivajo na trenutne varnostne lastnosti in zahteve,
English: The objective is to expose and treat all areas of HGD and the entire length of BO.
Bulgarian: Cilj je osvetliti in zdraviti vsa področja HGD ter celotno dolžino BP.
English: Such pain may be of sufficient intensity to warrant the shortterm prescription of opiate analgesics.
Bulgarian: Tovrstna bolečina je lahko dovolj močna, da upraviči kratkotrajno predpisovanje opiatnih analgetikov.
English: There are no human data available to support or rebut these possibilities.
Bulgarian: Podatkov pri ljudeh, ki bi podprli ali ovrgli te možnosti, ni na voljo.
English: The tissue around the eyes may be more sensitive, and therefore, it is not recommended that the face be used for testing.
Bulgarian: Tkivo v okolici oči je morda bolj občutljivo, zato ni priporočljivo, da se za preskušanje uporablja obraz.
English: Gender had no effect on pharmacokinetic parameters except for tmax, which was approximately 1.5 hours in women and 0.17 hours in men.
Bulgarian: Spol ni imel nobenega vpliva na farmakokinetične parametre, razen na tmax, ki je bil približno 1,5 ure pri ženskah in 0,17 ur pri moških.
English: For most patients (up to 75 kg) two vials of PhotoBarr 75 mg will suffice.
Bulgarian: Pri večini bolnikov (do 75 kg) zadostujeta dve viali PhotoBarra 75 mg.
English: In case of an allergic reaction, appropriate measures (standard of care) should be taken and the PDT treatment should not be repeated.
Bulgarian: V primeru alergijske reakcije je treba ustrezno ukrepati (standardna oskrba) in zdravljenje PDT se ne
English: Physicians should be trained in the use of PDT.
Bulgarian: Zdravnike je treba usposobiti za uporabo PDT.
English: Using other medicines
Bulgarian: Uporaba drugih zdravil
English: Pack size: 1 vial.
Bulgarian: Velikost pakiranja: 1 viala.
English: Tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Bulgarian: svojega zdravnika ali farmacevta, če uporabljate ali ste pred kratkim uporabljali katero koli zdravilo, tudi če ste ga dobili brez recepta.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 March 2004
Bulgarian: Datum prve pridobitve dovoljenja za promet: 25. marec 2004
English: frequency cannot be estimated from the available data.
Bulgarian: pogostosti na podlagi obstoječih podatkov ni možno oceniti
English: Therefore, patients should be advised to receive liquid food during the first days (up to 4 weeks) after the laser light application.
Bulgarian: Zato je treba bolnikom svetovati, da uživajo tekočo hrano v prvih dneh (do 4 tedne) po uporabi laserske svetlobe.
English: It is important to avoid contact with the eyes and skin during preparation and/or administration.
Bulgarian: Pomembno je, da se med pripravo in/ali uporabo izogibate stiku z očmi in kožo.
English: Eight percent were severe, requiring multiple (6 - >10) dilatations.
Bulgarian: Osem odstotkov jih je bilo hudih in je bila zanje potrebna večkratna (6 - >10) razširitev.
English: Research in animals and in cell culture has suggested that many active substances could influence the effects of PDT, possible examples of which are described below.
Bulgarian: ter raziskave celične kulture so pokazale, da lahko številne aktivne snovi vplivajo na učinke PDT, katerih možni primeri so opisani spodaj.
English: if you notice a change in your eyesight.
Bulgarian: - če opazite spremembe vida.
English: If you realise that you have missed your appointment for the laser treatment, contact your doctor immediately.
Bulgarian: Če ugotovite, da ste zamudili obisk za zdravljenje z lasersko svetlobo, se takoj posvetujte z zdravnikom.
English: The serum decay was bi-exponential, with a slow distribution phase and a very long elimination phase that started approximately 24 hours after injection.
Bulgarian: Razgradnja v serumu je bila bieksponenčna, s počasno fazo porazdelitve ter zelo dolgo fazo izločanja, ki se je začela približno 24 ur po injiciranju.
English: 4.6 Fertility, Pregnancy and lactation
Bulgarian: 4.6 Plodnost, nosečnost in dojenje
English: At the time of intended photoactivation 40-50 hours after injection, the pharmacokinetic profiles of porfimer sodium in men and women were very similar.
Bulgarian: V času načrtovane fotoaktivacije 40-50 ur po injiciranju so bili farmakokinetični profili porfimer-natrija pri moških in ženskah zelo podobni.
English: 6.5 Nature and contents of container
Bulgarian: 6.5 Vrsta ovojnine in vsebina
English: No studies on the effects on the ability to drive and use machines have been performed.
Bulgarian: Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: Some other medicines may increase the risk for photosensitivity reactions for example antibiotics or antidiabetic medicines.
Bulgarian: Nekatera zdravila lahko povečajo tveganje za preobčutljivostne reakcije na svetlobo, na primer antibiotiki ali antidiabetična zdravila.
English: Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development (see section 5.3).
Bulgarian: Študije na živalih ne zadoščajo, kar zadeva vplive na nosečnost, razvoj zarodka/plodu, porod in razvoj otroka po rojstvu (glejte poglavje 5.3).
English: For the PDT procedure, sedation may be required, and consequently caution should be taken.
Bulgarian: s PDT je morda potrebna sedacija, zato je potrebna previdnost.
English: However, to speed up the natural process of inactivating the medicine in your body, it is good to expose the skin to normal levels of indoor light.
Bulgarian: Da bi pospešili naravni proces deaktiviranja zdravila v telesu, je dobro izpostaviti kožo običajni jakosti notranje svetlobe.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Bulgarian: V razvrstitvah pogostosti so neželeni učinki navedeni po padajoči resnosti.
English: Only a solution without particles should be used and without visible signs of deterioration.
Bulgarian: Uporabiti je dovoljeno le raztopino brez delcev in brez vidnih znakov kvarjenja.
English: • OTHER CONDITIONS
Bulgarian: DRUGI POGOJI
English: As per the CHMP Guideline on Risk Management Systems for medicinal products of human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Bulgarian: s smernicami Odbora za zdravila za humano medicino (CHMP) glede sistema upravljanja tveganja za uporabo zdravil za humano medicino, je potrebno posodobljen RPM priložiti sočasno z naslednjim rednim poročilom o varnosti zdravila (PSUR, periodic safety
English: Subsequent free radical reactions can form superoxide and hydroxyl radicals.
Bulgarian: Zaradi poznejših reakcij prostih radikalov lahko nastanejo superoksid in radikali hidroksila.
English: All incidences of strictures were considered associated with treatment of which 1% was considered serious.
Bulgarian: Vsi primeri striktur bi naj bili povezani z zdravljenjem, od tega je 1% veljal za hude.
English: Name and address of the manufacturer responsible for batch release Axcan Pharma SAS
Bulgarian: Ime in naslov izdelovalca, odgovornega za sproščanje serije Axcan Pharma SAS
English: 5.3 Preclinical safety data
Bulgarian: 5.3 Predklinični podatki o varnosti
English: 4.9 Overdose
Bulgarian: 4.9 Preveliko odmerjanje
English: If extravasation does occur, the area should be protected from light for a minimum of 90 days.
Bulgarian: Če pride do izliva, je treba to področje zaščititi pred svetlobo najmanj 90 dni.
English: The level of photosensitivity will vary for different areas of the body, depending on the extent of previous exposure to light.
Bulgarian: Stopnja občutljivosti na svetlobo se spreminja glede na različne dele telesa, odvisno od stopnje predhodne izpostavljenosti svetlobi.
English: Therefore, adequate and rigorous surveillance should be continued despite possible endoscopic partial or complete restitution of the normal squamous mucosa.
Bulgarian: Zato je treba nadaljevati z ustreznim in strogim nadzorom navkljub morebitni endoskopski delni ali popolni obnovi normalne
English: In the PDT + OM group, 133 patients were treated.
Bulgarian: s PDT + OM, je bilo 133 bolnikov.
English: If PDT is to be used before or after radiotherapy, sufficient time should be allowed between the therapies to ensure that the inflammatory reaction produced by the first treatment has subsided prior to commencement of the second treatment.
Bulgarian: Če naj se PDT uporablja pred ali po radioterapiji, je potrebno dovolj časa med zdravljenji, da se zagotovi, da se je vnetna reakcija, ki jo je povzročilo prvo zdravljenje, umirila pred začetkom drugega
English: In the case of a previously treated oesophageal segment, if it has not sufficiently healed and/or histological assessment of biopsies is not clear, the subsequent course of PDT may be delayed for an additional 1-2 months.
Bulgarian: V primeru predhodno zdravljenega segmenta požiralnika, kadar ni bil dovolj ozdravljen, in/ali če histološka ocena opravljenih biopsij ni jasna, se lahko naslednja epizoda PDT prestavi še za 1-2 meseca.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/272/002
Bulgarian: EU/1/04/272/001
English: o Patients should be aware of potential risk factors (skin phototype and hepatic impairment).
Bulgarian: o Bolniki morajo biti seznanjeni z možnimi nevarnostmi (fototip kože in okvare jeter).
English: Like all medicines, PhotoBarr can cause side effects, although not everybody gets them.
Bulgarian: Kot vsa zdravila, ima lahko tudi zdravilo PhotoBarr neželene učinke, ki pa se ne pojavijo pri vseh
English: Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam The Netherlands
Bulgarian: Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam Nizozemska
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Bulgarian: Pogoji shranjevanja pripravljenega zdravila so navedeni v razdelku 6.3.
English: Reproductive toxicology studies were insufficient to support the safety of porfimer sodium during pregnancy, as no light activation had been used.
Bulgarian: Raziskave toksičnosti na reprodukcijo so bile nezadostne, da bi podpirale varnost porfimer-natrija med nosečnostjo, ker ni bila uporabljena aktivacija svetlobe.
English: Not known:
Bulgarian: Ni znano:
English: Do not mix PhotoBarr with other medicinal products in the same solution.
Bulgarian: Ne mešajte PhotoBarra z drugimi medicinskimi izdelki v isti
English: Adverse reactions reported are listed below in Table 5 by organ class and frequency.
Bulgarian: Neželeni učinki, o katerih so poročali, so našteti spodaj v Preglednici 5 glede na vrsto organskega sistema in njihovo pogostost.
English: In these studies foetotoxicity, but not teratogenicity, occurred in rats and rabbits only at evaluated intravenous doses (greater than of equal to 4 mg/kg) and at greater frequency (daily) compared in the clinical use.
Bulgarian: V teh raziskavah je nastala toksičnost za zarodek, ne pa tudi teratogenost, pri podganah in kuncih le pri ocenjenih intravenskih odmerkih (večjih ali enakih 4 mg/kg) in pri klinični uporabi pri večji primerjani pogostosti (dnevno).
English: The photosensitivity is due to residual photoactive substances, which will be present in all parts of the skin.
Bulgarian: Občutljivost na svetlobo je posledica preostalih fotoaktivnih snovi, ki bodo prisotne na vseh delih kože.
English: Whenever possible, the segment selected for the first light application should include all the areas of HGD.
Bulgarian: Kadar je možno, naj izbrani segment za prvo uporabo svetlobe zajema vsa področja HGD.
English: Therefore, patients should not stay in a darkened room during this period and should be encouraged to expose their skin to ambient indoor light.
Bulgarian: Zato v tem času bolniki ne smejo ostati v zatemnjenem prostoru, treba pa jih je tudi spodbujati, da izpostavljajo kožo okoliški svetlobi v prostoru.
English: PhotoBarr is neither a primary ocular irritant nor a primary dermal irritant.
Bulgarian: PhotoBarr ni niti primarni okularni iritant niti primarni dermalni iritant.
English: Photosensitivity reactions are very common side effects of PhotoBarr (affecting more than 2 users in 3).
Bulgarian: Fotosenzitivne reakcije so zelo pogost neželeni učinek PhotoBarra (prizadenejo več kot 2 bolnika od 3).
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Bulgarian: so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: Therefore, care should be taken to prevent extravasation at the injection site.
Bulgarian: Zato je treba paziti, da se prepreči izliv (ekstravazacija) na mestu injiciranja.
English: − Within 60 days of an important (pharmacovigilance or risk minimisation) milestone
Bulgarian: − V roku 60 dni od doseganja pomembnega mejnika (na področju farmakovigilance ali
English: There is no known benefit from injecting the extravasation site with another substance.
Bulgarian: Ni znane koristi od vbrizgavanja druge snovi na mesto ekstravazacije.
English: A small area of skin should be exposed to sunlight for 10 minutes.
Bulgarian: Majhen predel kože je treba izpostaviti sončni svetlobi za 10 minut.
English: Cellular damage caused by porfimer sodium PDT is a consequence of the propagation of free radical reactions.
Bulgarian: Okvara celic, ki jo povzroči porfimer-natrij PDT, je posledica širjenja reakcij prostih radikalov.
English: Porfimer sodium is a mixture of porphyrin units, which are linked together in chains of two to eight units.
Bulgarian: Porfimer-natrij je mešanica enot porfirina, ki se med seboj vežejo v verigah po dve do osem enot.
English: If no photosensitivity reaction (erythema, oedema, blistering) occurs within 24 hours, the patient can gradually resume normal outdoor activities, initially continuing to exercise caution and gradually allowing increased exposure.
Bulgarian: Če ni fotosenzitivne reakcije v 24 urah (rdečina, edem, mehurčki), lahko bolnik postopoma spet začne opravljati običajna opravila na prostem, pri čemer naj bo v začetku previden, postopoma pa si lahko dovoli čedalje večjo izpostavljenost.
English: You should visit your eye specialist.
Bulgarian: Obiščite specialista za očesne bolezni.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Bulgarian: - Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: As a result of PDT treatment, patients may complain of substernal chest pain because of inflammatory responses within the area of treatment.
Bulgarian: Posledica zdravljenja s PDT je, da se lahko bolniki pritožujejo nad bolečino v prsih pod grodnico zaradi vnetnih reakcij v področju zdravljenja.
English: The pharmacokinetics of porfimer sodium have been studied in 12 patients with endobronchial cancer and 23 healthy subjects (11 men and 12 women), given 2 mg/kg porfimer sodium through slow intravenous injection.
Bulgarian: Farmakokinetiko porfimer-natrija so preučevali pri 12 bolnikih z endobronhialnim rakom in 23 zdravih osebah (11 moških in 12 ženskah), ki so prejeli 2 mg/kg porfimer-natrija s počasnim intravenskim injiciranjem.
English: During your light treatment you may receive sedation.
Bulgarian: V času zdravljenja s svetlobo lahko dobite sedative.
English: To increase your response rate, you may need up to three PDT courses, separated by at least 90 days.
Bulgarian: Da bi povečali vašo stopnjo odzivnosti, boste morda potrebovali do tri cikluse PDT v razmaku najmanj 90
English: As with therapeutic overdose, any accidentally overexposed person must be protected from bright light.'
Bulgarian: Kot v primeru terapevtskega prekomernega odmerka, je treba osebo, ki je bila izdelku izpostavljena nenamerno, zaščititi pred močno svetlobo.
English: In this case, you should avoid any activities that require mental alertness such as driving a car or using any machine.
Bulgarian: V tem primeru se morate izogibati vsem aktivnostim, ki zahtevajo vašo pozornost, kot je na primer vožnja ali upravljanje