FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effect with HorStem (which may affect more than 1 in 10 horses) is short-lived synovitis (inflammation of the joint lining) with severe lameness, joint effusion (increased fluid in the joint) and pain on palpation 24 hours after injection.
Slovenian: Najpogostejši neželeni učinki zdravila HorStem (ki lahko prizadenejo več kot 1 konja od 10) so akutni sinovitis (vnetje sklepne ovojnice) s hudo šepavostjo, efuzija sklepa (povečana količina tekočine v sklepu) in bolečina ob palpaciji v 24 urah po injiciranju.
English: It is not clear exactly how HorStem works in horses with osteoarthritis.
Slovenian: Natančen način delovanja zdravila HorStem pri konjih z osteoartritisom ni znan.
English: HorStem is given only by a veterinarian as a single injection into the affected joint.
Slovenian: Zdravilo HorStem mora dati izključno veterinar v obliki enkratne injekcije v prizadeti sklep.
English: In a field study of horses with mild to moderate osteoarthritis, 16 horses received an injection of HorStem into the affected joint and 17 horses received a placebo (dummy) injection.
Slovenian: V terenski študiji s konji z blagim do zmernim osteoartritisom je 16 konjev prejelo injekcijo zdravila HorStem v prizadeti sklep, 17 konjev pa je prejelo placebo injekcijo (injekcijo brez učinkovine).
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: HorStem is a veterinary medicine used to treat lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
Slovenian: HorStem je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zdravljenje šepavosti, povezane z blago do zmerno degenerativno boleznijo sklepov (osteoartritisom) pri konjih.
English: Care should be taken to avoid accidental self-injection.
Slovenian: Da bi se izognili samoinjiciranju, je potrebna previdnost.
English: It contains the active substance equine umbilical cord mesenchymal stem cells.
Slovenian: Vsebuje učinkovino konjskih popkovničnih mezenhimskih matičnih celic.
English: How does HorStem work?
Slovenian: Kako zdravilo HorStem deluje?
English: HorStem (equine umbilical cord mesenchymal stem cells)
Slovenian: HorStem (konjske popkovnične mezenhimske matične celice)
English: How is HorStem used?
Slovenian: Kako se zdravilo HorStem uporablja?
English: This summary was last updated in 05-2016.
Slovenian: Povzetek je bil nazadnje posodobljen 05-2016.
English: These materials have been inactivated where necessary so that they do not cause any disease.
Slovenian: Ta material je bil po potrebi inaktiviran, tako da ne povzroča bolezni.
English: Although no data are available in children older than 2 years, there is no indication that older children would respond differently.
Slovenian: Čeprav za otroke, starejše od dveh let, ni podatkov, prav tako ni znamenj, ki bi kazala, da bi se starejši otroci odzvali drugače.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hexacima on 17 April 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Hexacima, veljavno po vsej Evropski uniji, izdala 17. aprila 2013.
English: Vaccination with Hexacima should be carried out according to official recommendations.
Slovenian: Cepljenje s cepivom Hexacima je treba izvajati v skladu z uradnimi priporočili.
English: Reactions may be more likely after the first dose than later doses.
Slovenian: Reakcije so bolj verjetne po prvem odmerku kot pri naslednjih.
English: What measures are being taken to ensure the safe and effective use of Hexacima?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hexacima?
English: Other information about Hexacima
Slovenian: Druge informacije o zdravilu Hexacima
English: The full EPAR for Hexacima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Hexacima je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used in babies and toddlers aged from six weeks to protect against the following infectious diseases:
Slovenian: Uporablja se pri dojenčkih in otrocih, starejših od šest mesecev, za zaščito proti naslednjim nalezljivim boleznim:
English: This means that some of the active substances are fixed onto aluminium compounds, to stimulate a better response.
Slovenian: To pomeni, da so nekatere zdravilne učinkovine vezane na aluminijeve spojine, kar spodbudi boljši odziv.
English: The two-dose vaccination schedule was investigated in an additional main study involving 554 children.
Slovenian: Shema cepljenja z dvema odmerkoma je bila raziskana v dodatni glavni študiji s 554 otroki.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hexacima'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 humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Hexacima večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani proti boleznim.
English: This is a summary of the European public assessment report (EPAR) for Hexacima.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Hexacima.
English: The main measure of effectiveness was the production of antibody levels known to be protective against those diseases.
Slovenian: Glavno merilo učinkovitosti je bila tvorba ravni protiteles, za katere je znano, da ščitijo pred temi boleznimi.
English: The effects were compared with a combination of separate vaccines designed to protect against the diseases included in Hexacima.
Slovenian: Učinke so primerjali s kombinacijo ločenih cepiv, namenjenih za zaščito pred boleznimi, ki so vključene v cepivo Hexacima.
English: • invasive diseases (such as meningitis) caused by H. influenzae type b bacteria.
Slovenian: • invazivnim boleznim (kot je meningitis), ki jih povzročajo bakterije H. influenzae tipa b.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hexacima have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo cepiva, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: • hepatitis B (a viral liver infection);
Slovenian: • hepatitisu B (virusni okužbi jeter);
English: It is not intended to provide practical advice on how to use Hexacima.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Hexacima is a vaccine.
Slovenian: Zdravilo Hexacima je cepivo.
English: It must not be used in children who have an uncontrolled or severe illness affecting the brain or nervous system, such as uncontrolled epilepsy, unless the condition has stabilised with treatment and the benefit clearly outweighs the risk.
Slovenian: Ne sme se uporabljati pri otrocih, ki imajo nenadzorovana ali resna obolenja možganov ali živčnega sistema, kot je nenadzorovana epilepsija, razen če se je stanje z zdravljenjem ustalilo in so koristi cepljenja veliko večje od tveganj.
English: Regarding safety, the CHMP considered that Hexacima's overall safety profile is similar to other vaccines, although Hexacima is more likely than similar vaccines to cause reactions (mainly at the injection site).
Slovenian: Kar zadeva varnost, je CHMP mnenja, da je celotni varnostni profil cepiva Hexacima podoben drugim cepivom, čeprav je bolj verjetno, da bo cepivo Hexacima povzročilo reakcije (večinoma na mestu injiciranja), kot druga cepiva.
English: Hexacima contains small amounts of materials derived from the bacteria and viruses it protects against.
Slovenian: Zdravilo Hexacima vsebuje majhne količine materiala, pridobljenega iz bakterij in virusov, proti katerim ščiti.
English: A booster dose should be given at least six months after the last of these initial doses.
Slovenian: Obnovitveni odmerek je treba dati vsaj šest mesecev po zadnjem od začetnih odmerkov.
English: What are the risks associated with Hexacima?
Slovenian: Kakšna tveganja so povezana z zdravilom Hexacima?
English: What benefits of Hexacima have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Hexacima izkazalo v študijah?
English: The recommended initial vaccination schedule is either two doses, given two months apart or three doses, given at least one month apart.
Slovenian: Priporočeni začetni režim cepljenja je bodisi dva odmerka v razmiku dveh mesecev ali trije odmerki v razmiku vsaj enega meseca.
English: • diphtheria (a highly contagious disease that affects the throat and skin, and can cause damage to the heart and other organs);
Slovenian: • davici (zelo nalezljivi bolezni, ki prizadene grlo in kožo in lahko poškoduje srce in druge organe);
English: For more information about treatment with Hexacima, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Hexacima preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Hexacima and what is it used for?
Slovenian: Kaj je zdravilo Hexacima in za kaj se uporablja?
English: Five of these studies examined the effect of giving a booster dose at least 6 months after the initial vaccination schedule in 1,511 children.
Slovenian: V petih od teh študij so proučevali učinke obnovitvenega odmerka, ki ga je 1 511 otrok prejelo vsaj šest mesecev po začetni shemi cepljenja.
English: Hexacima has been studied in several countries worldwide in 12 main studies involving over 3,400 children between six weeks and two years of age who were given three doses of the vaccine during their first six months of life according to different local vaccination schedules.
Slovenian: Cepivo Hexacima je bilo proučevano v različnih državah sveta v 12 glavnih študijah, ki so vključevale več kot 3 400 otrok, starih od šest tednov do dveh let, in ki so v skladu z različnimi lokalnimi shemami cepljenja prejeli tri odmerke cepiva v prvih šestih mesecih življenja.
English: Hexacima must not be used in children who have ever had an allergic reaction to Hexacima or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin).
Slovenian: Cepivo Hexacima se ne sme uporabljati pri otrocih, ki so v preteklosti imeli alergijsko reakcijo nanj ali cepivo, ki vsebuje enake sestavine, vključno s snovmi, ki se uporabljajo med procesom izdelave cepiva in ki so lahko prisotne v zelo majhnih količinah (kot sta antibiotika neomicin ali streptomicin).
English: Why is Hexacima approved?
Slovenian: Zakaj je bilo zdravilo Hexacima odobreno?
English: For practical information about using Hexacima, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Hexacima naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The most common side effects with Hexacima include pain and redness at the site of injection, irritability and crying.
Slovenian: Najpogostejši neželeni učinki cepiva Hexacima vključujejo bolečino in rdečico na mestu injiciranja, razdražljivost in jok.
English: Vaccination with Hexacima should be postponed if a child has a moderate to severe fever.
Slovenian: Cepljenje s cepivom Hexacima je treba odložiti, če ima otrok srednje ali zelo povišano telesno temperaturo.
English: It must not be used in children who have ever had encephalopathy (a brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components in the past.
Slovenian: Ne sme se uporabljati pri otrocih, ki so v preteklosti preboleli encefalopatijo (obolenje možganov) neznanega vzroka v sedmih dneh po prejemu cepiva, ki je vsebovalo komponente oslovskega kašlja.
English: Hexacima or an appropriate combination of other vaccines can be used for the booster dose.
Slovenian: Za poživitveni odmerek se lahko uporabi cepivo Hexacima ali ustrezna kombinacija drugih cepiv.
English: When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
Slovenian: Ko otrok prejme cepivo, imunski sistem prepozna dele bakterij in virusov kot tujek in proti njim razvije protitelesa.
English: • tetanus (lockjaw, usually caused by infection of a wound);
Slovenian: • tetanusu (mrtvičnemu krču, ki ga navadno povzroči okužba rane);
English: Hexacima is available as a suspension for injection in vials and prefilled syringes.
Slovenian: Cepivo Hexacima je na voljo kot suspenzija za injiciranje v vialah in napolnjenih injekcijskih brizgah.
English: • poliomyelitis (polio, a disease that affects the nerves and can lead to muscle weakness or paralysis);
Slovenian: • otroški paralizi (bolezni, ki prizadene živce in lahko povzroči oslabelost mišic ali paralizo;
English: The studies showed that protective antibody levels against the various diseases developed in between 90 and 100% of children after the first three doses of Hexacima; protection was maintained or improved when a booster dose was given.
Slovenian: Študije so pokazale, da so se zaščitne ravni protiteles, ki ščitijo pred različnimi boleznimi, razvile pri 90 do 100 % otrok po prvih treh odmerkih cepiva Hexacima.
English: For the full list of all side effects reported with Hexacima, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Hexacima, glejte navodilo za uporabo.
English: These studies showed that Hexacima produces similar antibody profiles over time to comparable vaccines, and that the vaccine can be given at the same time as Prevenar and Rotarix.
Slovenian: Te študije so pokazale, da so po določenem času profili protiteles, ustvarjeni s cepivom Hexacima, podobni tistim, ki jih ustvarijo primerjalna cepiva, in da se sme cepivo uporabljati sočasno s cepivoma Prevenar in Roatrix.
English: Hexacima is given by deep injection into a muscle, normally in the upper thigh or the shoulder.
Slovenian: Cepivo Hexacima se daje običajno z injekcijo globoko v stegensko ali ramensko mišico.
English: Hexacima is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type b bacteria, the hepatitis B virus, and inactivated polioviruses.
Slovenian: Zdravilo Hexacima je cepivo, ki vsebuje zdravilne učinkovine, pridobljene iz bakterij davice, tetanusa, oslovskega kašlja in Haemophilus influenzae tipa b, virusa hepatitisa B in neaktiviranih poliovirusov.
English: The CHMP noted that Hexacima has been shown to produce protective antibody levels against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and H. influenzae type b infections in children between six weeks and two years of age regardless of ethnicity.
Slovenian: Ugotovil je, da je bilo dokazano, da cepivo Hexacima ustvari zaščitne ravni protiteles proti davici, tetanusu, oslovskemu kašlju, virusu hepatitisa B, otroški paralizi in okužbam, ki jih povzročajo bakterije H. influenzae tipa b pri otrocih, starih od šest mesecev do dveh let, ne glede na njihovo etnično pripadnost.
English: The immune system will then be able to produce antibodies quickly when the person is naturally exposed to the bacteria or viruses.
Slovenian: Posledično bo imunski sistem ob ponovni izpostavitvi bakterijam ali virusom sposoben hitro tvoriti protitelesa.
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Slovenian: Hexacima konjugirano (adsorbirano) cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rDNK), otroški paralizi (inaktivirano) in bakteriji Haemophilus influenzae tipa b
English: How does Hexacima work?
Slovenian: Kako zdravilo Hexacima deluje?
English: How is Hexacima used?
Slovenian: Kako se zdravilo Hexacima uporablja?
English: A subsequent study involving 455 children looked at the longer-term persistence of protective antibodies up to 3 years after a booster dose with Hexacima, and another study in 1,336 children evaluated the response to different lots of the vaccine and what happened when it was given with vaccines for infections caused by the bacterium Streptococcus pneumoniae (Prevenar) and rotavirus (Rotarix).
Slovenian: V drugi študiji so pri 1 336 otrocih proučevali odziv na različne skupine cepiv in kaj se zgodi, če se cepivo daje sočasno s cepivi za okužbe, ki jih povzročata bakterija Streptococcus pneumoniae (Prevenar) in rotavirus (Rotarix).
English: In the study, children who received Hexacima produced a similar antibody response to those who received a comparator vaccine (Infanrix hexa), when given as a two-dose schedule followed by a booster 6 months later.
Slovenian: Študija je pokazala, da so se pri otrocih, ki so prejeli cepivo Hexacima v dveh odmerkih, ki mu je čez šest mesecev sledil obnovitveni odmerek, ustvarile primerljive ravni protiteles, kot pri tistih, ki so prejeli primerjalno cepivo (Infanrix hexa).
English: • pertussis (whooping cough);
Slovenian: • oslovskemu kašlju;
English: 1 morning, 2 evening 2 morning, 2 evening
Slovenian: 1 zjutraj, 2 zvečer 2 zjutraj, 2 zvečer
English: 2220 Heist op den Berg Belgium
Slovenian: 2220 Heist op den Berg Belgija
English: Overall Population*
Slovenian: Celotna populacija*
English: This should be discussed with your doctor.
Slovenian: O tem se pogovorite z zdravnikom.
English: In those patients the SVR was 12 %.
Slovenian: Pri teh bolnikih je vrednost SVR znašala 12 %.
English: Male patients and their female partners
Slovenian: Moški bolniki in njihove partnerke
English: Overall Response a (n = 118)
Slovenian: Skupni odziv a (n = 118)
English: 3 years After first opening: the medicinal product should be used within one month.
Slovenian: 3 leta Po prvem odprtju: Zdravilo porabite v roku enega meseca.
English: If you have too much or too little, try again until you have the correct amount.
Slovenian: Če imate v brizgi preveč ali premalo raztopine, poskusite ponovno, dokler ne boste imeli pravilne količine raztopine.
English: Date of first authorisation: 25 January 2005 Date of latest renewal: 23 April 2009
Slovenian: Datum prve odobritve: 25. januar 2005 Datum zadnjega podaljšanja: 23. april 2009
English: This medicine can be very damaging to your unborn baby (embryo).
Slovenian: To zdravilo je lahko zelo škodljivo za nerojenega otroka (plod).
English: Date of first authorisation: 07 May 1999 Date of latest renewal: 23 April 2009
Slovenian: Datum prve odobritve: 07. maj 1999 Datum zadnjega podaljšanja: 23. april 2009
English: • had a serious heart problem during the past 6 months.
Slovenian: • če ste imeli resne težave s srcem v zadnjih 6 mesecih,
English: Response week 12 % (n/N)
Slovenian: Odziv v 12. tednu % (n/N)
English: 3 capsules
Slovenian: 3 kapsule
English: This should be discussed with your doctor (see section “Do not take Rebetol”).
Slovenian: O tem se pogovorite z zdravnikom (glejte poglavje "Ne jemljite zdravila Rebetol").
English: If you are pregnant, you must not take this medicine.
Slovenian: Če ste noseči, ne smete jemati tega zdravila.
English: A patient may be missing or have had a different result for week 4 or week 12.
Slovenian: Možno je, da manjka en bolnik oziroma da je imel v 4. tednu in v 12. tednu različna rezultata.
English: If the syringe has touched the inside of the mouth, rinse it with water before inserting it in the bottle again.
Slovenian: Če se brizga vseeno dotakne notranjosti ust, brizgo sperite z vodo, preden jo boste spet vstavili v stekleničko.
English: Paediatric population No data are available in children below 3 years of age.
Slovenian: Pediatrična populacija Podatkov pri otrocih, mlajših od 3 let, ni na voljo.
English: The use of Rebetol is contraindicated during pregnancy.
Slovenian: Uporaba zdravila Rebetol je kontraindicirana med nosečnostjo.
English: Talk to your doctor if you or the child you are caring for:
Slovenian: Zdravniku povejte, če ste vi ali otrok, za katerega skrbite:
English: If it gets worse, your doctor will decide whether or not your Rebetol treatment needs to be changed.
Slovenian: Če se poslabša, se bo zdravnik odločil, ali je pri vas potrebna sprememba zdravljenja z zdravilom Rebetol ali ne.
English: Positive
Slovenian: Pozitivna
English: Reduce Rebetol dose* if:
Slovenian: Odmerek zdravila Rebetol zmanjšajte*, če:
English: What Rebetol is and what it is used for
Slovenian: Kaj je zdravilo Rebetol in za kaj ga uporabljamo
English: Long-term efficacy data - Adults
Slovenian: Dolgoročni podatki o učinkovitosti - Odrasli bolniki
English: Elderly patients ( 65 years of age)
Slovenian: Starejši bolniki ( 65 let starosti)
English: In all three treatment groups, sustained virologic response rates were similar.
Slovenian: V vseh treh terapevtskih skupinah so bile pogostnosti trajnega virološkega odziva podobne.
English: Ninety-four of 107 children enrolled in the 5 year long-term follow-up trial.
Slovenian: Štiriindevetdeset od 107 otrok je bilo vključenih v 5-letno dolgoročno spremljevalno preskušanje.
English: Although not all of these unwanted effects may occur, they may need medical attention if they do occur.
Slovenian: Čeprav ni nujno, da se bodo pojavili vsi ti neželeni učinki, če pa se, boste morda potrebovali zdravniško pomoč.
English: If an entire day has gone by, check with your doctor.
Slovenian: Če je minil že ves dan, se posvetujte z zdravnikom.
English: Once the bottle has been opened, the oral solution can be used for 1 month.
Slovenian: Po odprtju stekleničke lahko peroralno raztopino uporabljate 1 mesec.
English: The side effect profile was also similar at the lower incidences.
Slovenian: Profil neželenih učinkov je bil podoben tudi pri nižjih pojavnostih.
English: Depending on the genotype of the hepatitis C virus that you have, your doctor may choose to treat you with a combination of this medicine with other medicines.
Slovenian: Odvisno od genotipa virusa hepatitisa C, ki ga imate, bo zdravnik morda izbral zdravljenje s kombinacijo tega zdravila z drugimi zdravili.
English: Caucasian patients had a higher sustained virologic response rate compared to the African Americans.
Slovenian: Kavkazijci so imeli večje pogostnosti trajnega virološkega odziva kot Afroameričani.
English: - Depending upon the results of these tests, your doctor may change/adjust the number of hard capsules you or the child you are caring for take, prescribe a different pack size of this medicine, and/or change the length of time to take this treatment.
Slovenian: - Glede na izvide teh preiskav bo zdravnik lahko spremenil/prilagodil število trdih kapsul, ki jih vi ali otrok, za katerega skrbite, jemljete, in vam predpisal drugo velikost pakiranja tega zdravila in/ali spremenil dolžino zdravljenja.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can also help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.