FrancophonIA/ELRC3.0 huggingface dataset:
English: Manufacturer [To be completed nationally]
Slovenian: [izpolni država članica]
English: Chest pain, asthenia
Slovenian: • bolečine v prsnem košu
English: Bleeding time prolonged, thrombocythaemia
Slovenian: Psihiatrične motnje občasni tesnoba
English: Posology
Slovenian: Italija
English: You should check with your doctor or pharmacist if you are not sure.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom.
English: After 12 weeks, as compared to placebo, <Cilostazol-containing medicinal product> 100 mg b.i.d.
Slovenian: < Läkemedel som innehåller cilostazol > 100 mg tabletter
English: Investigations
Slovenian: Španija
English: The following side effects have been reported for <Cilostazol-containing medicinal product>.
Slovenian: Z <zdravilom, ki vsebuje cilostazol>, so poročali o naslednjih neželenih učinkih.
English: LABELLING
Slovenian: FARMACEVTSKI PODATKI
English: Anxiety Nervous system disorders Very common Headache Common
Slovenian: Bolezni imunskega sistema občasni alergijske reakcije
English: Do not take <Cilostazol-containing medicinal product> if you are allergic (hypersensitive) to cilostazol or any of the other ingredients of <Cilostazolcontaining medicinal product>.
Slovenian: • če ste alergični na cilostazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: This summary was last updated in March 2016.
Slovenian: Povzetek je bil nazadnje posodobljen marca 2016.
English: These signs disappear without further treatment.
Slovenian: Ti znaki izzvenijo brez dodatnega zdravljenja.
English: Profender emodepside / praziquantel
Slovenian: Profender emodepsid/prazikvantel
English: The European Commission granted a marketing authorisation valid throughout the EU for Profender on 27 July 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Profender, veljavno po vsej Evropski uniji, izdala 27. julija 2005.
English: The person giving the dose should not smoke, eat or drink, and should wash their hands thoroughly after use.
Slovenian: Oseba, ki nanaša zdravilo, ne sme kaditi, jesti ali piti, po uporabi pa naj si temeljito umije roke.
English: The full EPAR for Profender can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Profender je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Profender's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Profender večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Profender.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Profender.
English: Other information about Profender:
Slovenian: Druge informacije o zdravilu Profender:
English: Profender should not be used in young animals (cats under 8 weeks of age or weighing less than 0.5 kg, or puppies under 12 weeks of age or weighing less than 1 kg).
Slovenian: Zdravilo Profender naj se ne uporablja pri mladih živalih (mačkah, mlajših od 8 tednov ali težkih manj kot 0,5 kg, ali psih, mlajših od 12 tednov ali težkih manj kot 1 kg).
English: No side effects have been reported in dogs.
Slovenian: Pri psih neželeni učinki niso bili opaženi.
English: Profender should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Slovenian: Zdravilo Profender ne sme priti v vodotoke, ker je lahko škodljivo za vodne organizme.
English: For lungworms two treatments are needed two weeks apart.
Slovenian: Za zdravljenje okužbe s pljučnimi črvi se dajeta dva odmerka v razmiku dveh tednov.
English: If accidental exposure occurs, the eyes should be rinsed with water or the skin washed with soap and water.
Slovenian: V primeru nenamerne izpostavitve je treba oči izprati z vodo oziroma kožo umiti z vodo in milom.
English: Profender is an antiparasitic medicine that contains two active substances, emodepside and praziquantel.
Slovenian: Profender je antiparazitsko zdravilo, ki vsebuje dve zdravilni učinkovini, emodepsid in prazikvantel.
English: The laboratory study showed Profender to reduce the worm count in the lungs by more than 99%.
Slovenian: Laboratorijska študija je pokazala, da zdravilo Profender zniža število črvov v pljučih za več kot 99 %.
English: Over 90% of cats and 99% of dogs had no roundworm or tapeworm infection after treatment with Profender.
Slovenian: Več kot 90 % mačk in 99 % psov po zdravljenju z zdravilom Profender ni bilo več okuženih z glistami ali trakuljami.
English: The effectiveness was measured by looking at the number of worm eggs or parts of tapeworms passed out in the animal's faeces after treatment.
Slovenian: Učinkovitost je bila merjena z ugotavljanjem števila jajčec ali delov trakulje, izločenih z blatom po zdravljenju.
English: What are the risks associated with Profender?
Slovenian: Kakšna tveganja so povezana z zdravilom Profender?
English: It is not intended to provide practical use on how to use Profender.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Emodepside interferes with certain specific receptors in the nervous systems of roundworms, which results in their subsequent paralysis and death.
Slovenian: Emodepsid ovira določene specifične receptorje v živčnem sistemu glist, kar posledično povzroči njihovo paralizo in smrt.
English: What is Profender and what is it used for?
Slovenian: Kaj je zdravilo Profender in za kaj se uporablja?
English: The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Profender was as effective as the comparator medicine.
Slovenian: Rezultati laboratorijskih in terenskih študij so pokazali, da je zdravilo Profender pri mačkah in psih enako učinkovito kot primerjalno zdravilo.
English: What benefits of Profender have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Profender izkazalo v študijah?
English: The two active substances in Profender interact with different parts of the parasites systems.
Slovenian: Zdravilni učinkovini v zdravilu Profender vplivata na različne dele parazitskih sistemov.
English: The solvent in Profender spot-on solution may stain certain materials including leather, fabrics, plastics and finished surfaces, so contact between the product and such surfaces should be avoided.
Slovenian: Topilo v zdravilu Profender za kožni nanos lahko pusti madeže na nekaterih materialih, vključno z usnjem, tkaninami, plastiko in lakiranimi površinami, zato preprečite stik zdravila s takimi površinami.
English: The correct number of tablets or half tablets to use is calculated based on the dog's weight.
Slovenian: Število potrebnih tablet ali polovičk tablet se določi na podlagi telesne mase psa.
English: Why is Profender approved?
Slovenian: Zakaj je bilo zdravilo Profender odobreno?
English: Mild and short-lived signs relating to the nervous system such as ataxia (inability to co-ordinate muscle movements) or tremor (shaking) may occur in very rare cases.
Slovenian: Prav tako se v zelo redkih primerih lahko pojavijo kratkotrajni neželeni učinki na živčni sistem, kot sta ataksija (nezmožnost usklajenega gibanja mišic) ali tresavica.
English: When giving Profender spot-on solution, skin contact with the pipette contents should be avoided and animals should not be stroked, groomed or allow to groom each other, until the application site is dry.
Slovenian: Kot previdnostni ukrep je treba preprečiti stik kože z vsebino kapalke, živali pa se ne sme božati ali negovati, niti dovoliti, da se živali medsebojno negujejo, dokler se mesto nanosa ne posuši.
English: Profender is a medicine used to treat cats and dogs that have, or are at risk of catching, “mixed” (caused by more than one parasite) parasitic infections.
Slovenian: Zdravilo Profender se uporablja za zdravljenje mačk in psov, ki imajo „mešano“ (ki jo povzroča več parazitov) parazitsko okužbo ali pri katerih obstaja tveganje za pojav takšne okužbe.
English: In each of the field studies, animals of various breeds, age groups and different weights that were naturally infected with roundworms or tapeworms in their guts, were treated either with Profender or another approved worming medicine (selamectin in cats, and milbemycin oxime and praziquantel in dogs).
Slovenian: V vsaki od študij na terenu so bile živali različnih pasem, starosti in telesne mase, ki so bile okužene z gastrointestinalnimi glistami ali trakuljami, zdravljene bodisi z zdravilom Profender ali z drugim odobrenim protiparazitskim zdravilom (mačke s selamektinom, psi pa z milbemicin oksimom in prazikvantelom).
English: For lungworms in cats a laboratory study together with a field study showed Profender to reduce the number of larvae passed in the animal's faeces by more than 99%.
Slovenian: Pri mačkah, okuženih s pljučnimi črvi, je laboratorijska študija skupaj s študijo na terenu pokazala, da zdravilo Profender zniža število ličink v izločkih za več kot 99 %.
English: In cats, in very rare cases, the cat might salivate or vomit after treatment.
Slovenian: V zelo redkih primerih se lahko pri mačkah po zdravljenju pojavi slinjenje ali bruhanje.
English: The effectiveness of each of the products against the specified roundworms and tapeworms was investigated in both laboratory studies and in large field studies (one for the spot-on for cats and another for the tablets for dogs) carried out at several different places across Europe.
Slovenian: Učinkovitost vsake učinkovine proti določenim vrstam glist in trakulj je bila proučena v različnih delih Evrope v laboratorijskih študijah in obsežnih študijah na terenu (ena za kožni nanos pri mačkah in druga za tablete pri psih).
English: Profender tablets are available in three different strengths to cover a range of dog weights (small, medium or large dogs).
Slovenian: Tablete zdravila Profender so na voljo v treh različnih jakostih, ki ustrezajo različno težkim psom (majhnim, srednje velikim in velikim psom).
English: For more information about treatment with Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Profender naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Profender works for infections caused by certain types of roundworms, tapeworms, as well as lungworms in cats.
Slovenian: Zdravilo Profender deluje proti okužbam z določenimi vrstami glist in trakulj, pri mačkah pa tudi s pljučnimi črvi.
English: For practical information about using Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Profender naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Praziquantel damages the skin-like outer layer of tapeworms, leading to their paralysis and death.
Slovenian: Prazikvantel poškoduje povrhnjico trakulje, kar povzroči paralizo in pogin.
English: Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 sizes of pipette for different cat weights) and as a multidose bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application.
Slovenian: Zdravilo Profender je pakirano v kapalkah za kožni nanos, ki so že napolnjene z ustrezno količino zdravila, potrebnega za zdravljenje ene mačke (tri različne velikosti kapalk za različno težke mačke), in v večodmernih stekleničkah za uporabo samo pri veterinarskih kirurških posegih, kjer veterinar pred posegom odmeri natančno količino zdravila Profender, ki je potrebna za posamezno mačko.
English: Profender is available as a solution for use on cats, and as modified release tablets for dogs.
Slovenian: Profender je na voljo v obliki raztopine za uporabo pri mačkah in tablet s prilagojenim sproščanjem za uporabo pri psih.
English: Dogs are treated using Profender modified-release tablets, which are given by mouth when the dog is fasting.
Slovenian: Za zdravljenje psov se uporabljajo tablete zdravila Profender s prilagojenim sproščanjem, ki jih psi zaužijejo peroralno, ko so tešči.
English: The appropriate quantity of Profender (either the contents of one full pipette or the volume measured by the vet) is applied onto the cat's skin, after parting the fur on the back of its neck at the base of its head.
Slovenian: Ustrezno količino zdravila Profender (vsebino ene polne kapalke ali količino, ki jo odmeri veterinar) je treba nanesti mački na zatilje in sicer je treba razmakniti dlako, da je vidna koža.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: As with other products of this type, Profender should be used on sick or ill cats or dogs only after a risk-benefit assessment by the vet. Profender should not be used for any other animal species.
Slovenian: Kot pri drugih podobnih zdravilih se tudi zdravilo Profender pri bolnih in oslabljenih živalih uporablja le v skladu z veterinarjevo oceno razmerja med koristmi in tveganji.
English: How is Profender used?
Slovenian: Kako se zdravilo Profender uporablja?
English: What is Profender?
Slovenian: Kaj je zdravilo Profender?
English: How does Profender work?
Slovenian: Kako zdravilo Profender deluje?
English: Profender is given as a single treatment for roundworms and tapeworms.
Slovenian: Zdravilo Profender se za zdravljenje okužbe z glistami in trakuljami daje v enkratnem odmerku.
English: Users should also wash their hands after giving Profender as tablets to a dog.
Slovenian: Tudi po dajanju tablet Profender psom si je treba temeljito umiti roke.
English: In very rare cases there might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the cat's skin.
Slovenian: Zelo redko se lahko na mestu nanosa zdravila pri mački pojavi prehodno srbenje, vnetje ali izpadanje dlak.
English: Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 sizes of pipette for different cat weights) and as a multidose
Slovenian: Zdravilo Profender je pakirano v kapalkah za kožni nanos, ki so že napolnjene z ustrezno količino zdravila, potrebnega za zdravljenje ene mačke (tri različne velikosti kapalk za različno težke mačke), in v večodmernih stekleničkah za uporabo pri veterinarskih kirurških posegih, kjer veterinar pred posegom odmeri natančno količino zdravila Profender, ki je potrebna za posamezno mačko.
English: These effects are thought to occur as a result of the cat licking the application site straight after treatment.
Slovenian: Domneva se, da se to zgodi, če mačka takoj po nanosu zdravila poliže mesto nanosa.
English: Cats are treated using the Profender spot-on solution range.
Slovenian: Za zdravljenje mačk se uporablja serija raztopin zdravila Profender za kožni nanos.
English: Profender can only be obtained with a prescription.
Slovenian: Izdaja zdravila je le na recept.
English: Instructions for Use
Slovenian: Navodila za uporabo
English: The frequency of these types of events is not known (cannot be estimated from available data).
Slovenian: Pogostost teh vrst dogodkov ni znana (je ni mogoče oceniti na podlagi razpoložljivih podatkov).
English: Adopted at the 30 November - 3 December 2015 PRAC
Slovenian: Sprejeto na zasedanju odbora PRAC, ki je potekalo od 30. novembra do 3. decembra 2015
English: BEFORE YOU TAKE X
Slovenian: PREDEN BOSTE VZELI ZDRAVILO X
English: Talk to your doctor if you have any concerns.
Slovenian: Če imate kakršne koli skrbi, se posvetujte s svojim zdravnikom.
English: BEFORE YOU TAKE DUVAVIVE
Slovenian: PREDEN BOSTE VZELI ZDRAVILO DUVAVIVE
English: For tibolone containing products
Slovenian: Za zdravila, ki vsebujejo tibolon
English: TACHOSIL (Human fibrinogen, human thrombin)Intestinal obstruction (EPITT no 18373)
Slovenian: TACHOSIL (humani fibrinogen, humani trombin)obstrukcija črevesja (EPITT št. 18373)
English: What you need to know before TachoSil is used Warnings and precautions
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo TachoSil Opozorila in previdnostni ukrepi
English: Hormone replacement therapy (HRT) medicinal products, which are not pharmaceutical forms for vaginal use, containing oestrogens or combined oestrogens-progestagens (tibolone containing products also concerned); DUAVIVE (bazedoxifene, oestrogens conjugated) - Increased risk of ovarian cancer (EPITT no 18258)
Slovenian: Zdravila za hormonsko nadomestno zdravljenje (HNZ), ki niso v farmacevtski obliki za vaginalno uporabo, ki vsebujejo estrogene ali kombinacijo estrogenov in progestagenov (prav tako zdravila, ki vsebujejo tibolon); zdravilo DUAVIVE (bazedoksifen, konjugirani estrogeni) - povečano tveganje za raka jajčnikov (EPITT št. 18258)
English: Ovarian cancer is rare - much rarer than breast cancer.
Slovenian: Rak jajčnikov je redek - bistveno redkejši od raka dojke.
English: Pressure is applied with moistened gloves or a moist pad.
Slovenian: Pritisk vršite z navlaženimi rokavicami ali vlažno blazinico.
English: A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56).
Slovenian: Pri metaanalizi 52 epidemioloških študij so poročali o povečanem tveganju za raka jajčnikov pri ženskah, ki trenutno uporabljajo HNZ, v primerjavi z ženskami, ki niso nikoli uporabljale HNZ (RR 1,43, 95 % CI 1,31-1,56).
English: To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the desired application area are adequately cleansed before administration of TachoSil (see section 6.6).
Slovenian: Za preprečevanje lepljenja tkiv na neželenih mestih se prepričajte, da so predeli tkiv zunaj želenega območja nanosa pred nanosom zdravila TachoSil primerno očiščeni (glejte poglavje 6.6).
English: Summary of product characteristics (SmPC) section 4.4: Special warnings and precautions for use
Slovenian: Povzetek glavnih značilnosti zdravila, poglavje 4.4: Posebna opozorila in previdnostni ukrepi
English: After pressing TachoSil to the wound, the glove or the pad must be removed carefully.
Slovenian: Po končanem pritiskanju zdravila TachoSil na rano morate rokavico ali blazinico pazljivo odstraniti.
English: Frequency ‘unknown': Intestinal obstruction (in abdominal surgeries) General disorders and administration site conditions: Frequency ‘unknown': Adhesions
Slovenian: Neznana pogostnost: obstrukcija črevesja (pri abdominalnih operacijah) Splošne težave in spremembe na mestu aplikacije:
English: For DUAVIVE product
Slovenian: Za zdravilo DUAVIVE
English: Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments, or gloves or adjacent tissues covered with blood.
Slovenian: Zaradi močne afinitete kolagena do krvi, se lahko zdravilo TachoSil prime tudi na kirurške instrumente, ali rokavice ali sosednja tkiva, na katerih je kri.
English: After abdominal surgery and if TachoSil sticks to nearby tissues, it is possible that scar tissues can develop in the operated area.
Slovenian: Če se po operaciji trebušne votline zdravilo TachoSil prilepi na bližnja tkiva, lahko na operiranem območju nastane zabrazgotinjeno tkivo.
English: To avoid TachoSil from being pulled loose it may be held in place at one end, e.g. with a pair of forceps.
Slovenian: Da zdravila TachoSil ne potegnete z rane, ga lahko na enem koncu pritrdite na mestu, npr. s pinceto.
English: Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Slovenian: Epidemiološki podatki iz obširne metaanalize kažejo rahlo zvečano tveganje pri ženskah, ki uporabljajo samo estrogensko ali kombinacijo estrogenskega in progestagenskega HNZ, kar postane očitno po petih letih uporabe in se po prenehanju sčasoma počasi zmanjšuje.
English: Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Slovenian: Epidemiološki podatki iz obširne metaanalize kažejo rahlo zvečano tveganje pri ženskah, ki uporabljajo samo estrogensko HNZ, kar postane očitno po petih letih uporabe in se po prenehanju sčasoma počasi zmanjšuje.
English: In the Million Women Study, taking 5 years of HRT tibolone resulted in 1 extra case per 2500 users (see Section 4.4).
Slovenian: V študiji Million Women Study je 5-letna uporaba HRT tibolona povzročila en dodaten primer na 2 500 uporabnic (glej poglavje 4.4).
English: Events of adhesions to gastrointestinal tissues leading to gastrointestinal obstruction have been reported with use in abdominal surgery carried out in proximity to the bowel.
Slovenian: Pri uporabi zdravila v abdominalni kirurgiji v bližini črevesa so poročali o primerih lepljenja na gastrointestinalna tkiva, kar je povzročilo gastrointestinalno obstrukcijo.
English: Your surgeon will make sure to clean the operating area when applying TachoSil to reduce this risk.
Slovenian: Vaš kirurg bo za zmanjšanje tveganja pred nanosom zdravila TachoSil očistil območje, ki ga bo operiral.
English: Scar tissues can cause surfaces in your bowel to stick together, which can lead to blockage of the bowel.
Slovenian: To lahko povzroči, da se površine v črevesu zlepijo skupaj, kar lahko privede do zapore črevesa.
English: In the Million Women Study, it was shown that the relative risk for ovarian cancer with use of tibolone was similar to the risk associated with use of other types of HRT.
Slovenian: Študija Million Women Study je pokazala, da je relativno tveganje za raka jajčnikov pri uporabi tibolona podobno tveganju, povezanemu z uporabo drugih vrst HNZ.
English: This study showed that the relative risk for ovarian cancer with tibolone was similar to the risk with other types of HRT.
Slovenian: Ta študija je pokazala, da je relativno tveganje za raka jajčnikov pri uporabi tibolona podobno tveganju, povezanemu z uporabo drugih vrst HNZ.
English: Scar tissues may develop in some patients after surgery and use of TachoSil.
Slovenian: Pri nekaterih bolnikih lahko po operaciji in uporabi zdravila TachoSil nastane zabrazgotinjeno tkivo.
English: For oestrogen only and combined oestrogen-progestagen HRT products
Slovenian: Za zdravila za HNZ s samo estrogenskim ali kombinacijo estrogenskega in progestagenskega zdravljenja
English: TachoSil may stick to surgical instruments, or gloves or adjacent tissues covered with blood.
Slovenian: Zdravilo TachoSil se lahko prime na kirurške instrumente in, rokavice ali sosednja tkiva, na katerih je kri.
English: It is important to note that failure to adequately clean adjacent tissues may cause adhesions (see section 4.4).
Slovenian: Upoštevajte, da lahko do lepljenja pride, če nezadostno očistite sosednja tkiva (glejte poglavje 4.4).
English: This can be avoided by cleansing surgical instruments, and gloves and adjacent tissues before application.
Slovenian: Temu se lahko izognete tako, da očistite kirurške instrumente, rokavice in sosednja tkiva pred nanosom.