natgillin/translations-raw huggingface dataset:
Xolair is also used to treat chronic (long-term) spontaneous urticaria (itchy rash).
Zdravilo Xolair se uporablja tudi za zdravljenje kronične (dolgotrajne) spontane urtikarije (srbečega izpuščaja).
Over the first 28 or 52 weeks of treatment in the first three studies, there were around 0.5 exacerbations per year in the Xolair group and around one per year in the placebo group.
V prvih treh študijah je bilo v prvih 28 ali 52 tednih zdravljenja v skupini, ki je jemala zdravilo Xolair, okoli 0,5 izbruha na leto, v skupini, ki je prejemala placebo, pa približno eden na leto.
In patients with chronic spontaneous urticaria, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are sinusitis (inflammation of the sinuses), headache, arthralgia (joint pain), injection site reactions and upper respiratory tract infection (colds).
Pri bolnikih s kronično spontano urtikarijo so najpogostejši neželeni učinki zdravila Xolair (opaženi pri 1 do 10 bolnikih od 100) sinuzitis (vnetje sinusov), glavobol, artralgija (bolečine v sklepih), reakcije na mestu injiciranja in okužbe zgornjih dihal (prehladi).
In all of the studies, Xolair was compared with placebo, when they were added to the patients' existing treatment.
V vseh študijah so zdravilo Xolair primerjali s placebom, ki so ju dodajali bolnikovemu obstoječemu zdravljenju.
In the treatment of asthma, Xolair is intended for long-term use.
Zdravilo Xolair je pri zdravljenju astme namenjeno dolgoročni uporabi.
In patients with allergic asthma aged 12 years and over, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are headache and injection site reactions, including swelling, redness, pain and itching.
Pri bolnikih z alergijsko astmo, starejših od 12 let, so najpogostejši neželeni učinki zdravila Xolair (opaženi pri 1 do 10 bolnikih od 100) glavobol in reakcije na mestu injiciranja, vključno z otekanjem, rdečino, bolečino in srbenjem.
In children aged between six and 12 years, the most common side effects (seen in more than 1 patient in 10) are headache and pyrexia (fever).
Pri otrocih, starih od šest do 12 let, sta bila najpogostejša neželena učinka (opažena pri več kot 1 bolniku od 10) glavobol in povišana telesna temperatura.
In all of the studies, Xolair was compared with placebo (a dummy treatment), when they were added to the patients' existing treatment.
V vseh študijah so zdravilo Xolair primerjali s placebom (zdravilom brez zdravilne učinkovine), ki so ju dodajali bolnikovemu obstoječemu zdravljenju.
In the studies in patients with allergic asthma aged 12 years or over, Xolair reduced the number of exacerbations by around half.
V študijah, v katerih so sodelovali bolniki z alergijsko astmo, starejši od 12 let, je zdravilo Xolair zmanjšalo število izbruhov za približno polovico.
What is Xolair used for?
Za kaj se zdravilo Xolair uporablja?
What is Xolair?
Kaj je zdravilo Xolair?
How has Xolair been studied?
Kako je bilo zdravilo Xolair raziskano?
How is Xolair used?
Kako se zdravilo Xolair uporablja?
How does Xolair work?
Kako zdravilo Xolair deluje?
This summary was last updated on 25 January 2008.
Povzetek je bil nazadnje posodobljen 25. januarja 2008.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če želite več informacij, ki temeljijo na priporočilih CVMP, preberite znanstveno razpravo (ki je prav tako del
The vaccine should not be handled by people with a weak immune system.
S cepivom ne smejo ravnati osebe z oslabljenim imunskim sistemom.
If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Če potrebujete več informacij o zdravstvenem stanju ali zdravljenju vaše živali, se posvetujte z veterinarjem.
If the cat has high levels of antibodies inherited from the mother, the first vaccination should be delayed until 12 weeks of age.
Če ima mačka večjo količino protiteles, ki jih je podedovala od matere, je treba prvo cepljenje začeti pri 12. tednih starosti.
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCCh to MERIAL on 23 February 2005.
Evropska komisija je dovoljenje za promet z zdravilom Purevax RCCh, veljavno po vsej Evropski uniji, odobrila družbi MERIAL dne 23. februarja 2005.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) „naučijo“ obrambe pred boleznimi.
This document is a summary of the European Public Assessment Report.
Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
The antibodies will help to protect against the diseases caused by these viruses or bacteria.
Protitelesa mu bodo pomagala pri zaščiti pred boleznimi, ki jih povzročajo ti virusi in bakterije.
The benefit-risk balance may be found in module 6 of this EPAR.
Razmerje med koristmi in tveganji najdete v modulu 6 tega evropskega javnega poročila o oceni zdravila (EPAR).
It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Porasta ravni protiteles proti C. felis ni bilo mogoče zaznati zaradi visokih ravni protiteles pri mačkah na začetku študije.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘foreign' and makes antibodies against them.
Ko mačko cepimo, imunski sistem prepozna oslabljene ali uničene viruse in oslabljene bakterije kot „tuje“ ter proti njim tvori protitelesa.
The first injection should be given in cats aged at least eight weeks, with a second injection three to four weeks later.
Prva injekcija se daje mačkam od osmega tedna starosti naprej, druga injekcija pa 3 do 4 tedne pozneje.
The cat should be revaccinated for all components one year after the first vaccination course, then every year for rhinotracheitis, calicivirosis and chlamydiosis.
Mačko je treba ponovno cepiti za vse sestavine cepiva eno leto po prvem cepljenju in nato vsako leto za rinotraheitis, kalicivirozo in klamidiozo.
They included young and adult cats of various breeds, but not young kittens.
V študije so vključili mlade in odrasle mačke različnih pasem, ne pa muck.
The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine.
Glavno merilo učinkovitosti je bila raven protiteles v krvi proti virusoma in bakteriji iz cepiva.
There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks.
Na mestu injiciranja se lahko pojavi lokalna reakcija z rahlimi bolečinami ob dotiku, srbečico ali edemom (oteklino), ki ponavadi izgine v enem do dveh tednih.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCCh exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCCh be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Purevax RCCh za aktivno imunizacijo mačk, starejših od osem tednov, proti zgoraj navedenim boleznim večje od tveganj, in priporočil odobritev dovoljenja za promet z zdravilom Purevax RCCh.
• attenuated Chlamydophila felis (905 strain).
• atenuirano bakterijo Chlamydophila felis (sev 905).
In the field, the studies of Purevax RCCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
V študijah zdravila Purevax RCCh na terenu so preverili osnovni cepilni program (2 injekciji 3-4 tedne narazen) in obnovitveno cepljenje (samo ena injekcija).
Other information about Purevax RCCh:
Druge informacije o zdravilu Purevax RCCh:
In laboratory conditions Purevax RCCh was demonstrated to provide protection against the diseases listed above.
V laboratorijskih pogojih je zdravilo Purevax RCCh dokazalo, da nudi zaščito proti zgoraj navedenim boleznim.
Purevax RCCh contains small amounts of weakened or killed viruses and bacteria that cause the diseases listed above.
Zdravilo Purevax RCCh vsebuje majhne količine oslabljenih oblik ali uničenih virusov in bakterij, ki povzročajo zgoraj navedene bolezni.
Purevax RCCh is used to vaccinate cats from the age of 8 weeks against the following diseases:
Zdravilo Purevax RCCh se uporablja za cepljenje mačk od 8. tedna starosti naprej proti naslednjim boleznim:
After Purevax RCCh has been made up, 1 ml is injected under the skin.
Ko zdravilo Purevax RCCh pripravimo, ga 1 ml injiciramo pod kožo.
The effectiveness of Purevax RCCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or C. felis.
Učinkovitost zdravila Purevax RCCh so proučili v več preskušanjih v laboratorijih, kjer so mačke cepili in okužili z virulentnim herpesvirusom, kalicivirusom ali C. felis.
Purevax RCCh is a vaccine.
Zdravilo Purevax RCCh je cepivo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREVAX RCCH EPAR summary for the public
PUREVAX RCCH Povzetek EPAR za javnost
For a full list of the side-effects reported with Purevax RCCh, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Purevax RCCh, glejte navodilo za uporabo.
In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Če ste si to zdravilo nenamerno injicirali, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali ovojnino.
What benefit has Purevax RCCh shown during the studies?
Kakšne koristi je zdravilo Purevax RCCh izkazalo med študijami?
Purevax RCCh should not be used in pregnant cats.
Zdravilo Purevax RCCh se ne sme uporabljati za breje mačke.
Purevax RCCh is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Zdravilo Purevax RCCh je v obliki liofilizata (pelete, posušene v zamrznjenem stanju) in vehikla, iz katerih se pripravi suspenzija za injiciranje.
If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.
Če si takšna oseba zdravilo nenamerno injicira, morate zdravniku povedati, da je prišlo do nenamernega injiciranja živega klamidijskega cepiva.
It also helps to reduce viral excretion in case of calicivirus infection.
Cepivo tudi zmanjša izločanje virusov pri kalicivirozi.
Purevax RCCh is a vaccine containing the following active substances:
Zdravilo Purevax RCCh je cepivo, ki vsebuje naslednje zdravilne učinkovine:
• chlamydiosis (a flu-like illness caused by the bacterium C. felis).
• klamidiozi (gripi podobni bolezni, ki jo povzroča bakterija C. felis).
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and C. felis remained stable at a high level or increased slightly.
V študiji obnovitvenega cepljenja so ugotovili, da so ravni protiteles proti herpesvirusu rinotraheitisa mačk, kalicivirusu mačk in C. felis ostale stabilne na visoki vrednosti ali pa so se zvišale.
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection.
V terenski študiji osnovnega cepljenja so ugotovili zvišanje ravni protiteles proti herpesvirusu rinotraheitisa mačk in kalicivirusu mačk.
• feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
• kalicivirozi mačk (gripi podobni bolezni z vnetjem ust, ki jo povzroča kalicivirus),
What is the risk associated with Purevax RCCh?
Kakšna tveganja so povezana z zdravilom Purevax RCCh?
• inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
• atenuirani (oslabljeni) herpesvirus rinotraheitisa mačk (sev FHV F2), • inaktivirane (uničene) antigene kalicivirusa mačk (seva FCV 431 in G1),
Why has Purevax RCCh been approved?
Zakaj je bilo zdravilo Purevax RCCh odobreno?
Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Občasno se lahko pri mački pojavi začasna apatija (izguba interesa za okolico) in anoreksija
• feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
• virusnemu rinotraheitisu mačk (gripi podobni bolezni, ki jo povzroča herpesvirus),
What is Purevax RCCh?
Kaj je zdravilo Purevax RCCh?
How has Purevax RCCh been studied?
Kako je bilo zdravilo Purevax RCCh raziskano?
What is Purevax RCCh used for?
Za kaj se zdravilo Purevax RCCh uporablja?
How does Purevax RCCh work?
Kako zdravilo Purevax RCCh deluje?
Organ/System (Frequency)
Organ/Sistem (pogostnost)
Just take your next capsule at the usual time, then go on as before.
Vzemite naslednjo kapsulo ob običajnem času, nato nadaljujte kot prej.
Any new behavioural sign or symptom requires careful and immediate evaluation.
Vsak novi vedenjski znak ali simptom zahteva natančno in neposredno oceno.
Sleeping problems do not usually last long, and most people only need a short course of treatment.
Težave s spanjem običajno ne trajajo dolgo in večina ljudi potrebuje le kratkotrajno zdravljenje.
Psychic dependence may occur.
Lahko se pojavi psihična odvisnost.
Date of latest renewal: 12 March 2009
Datum zadnjega podaljšanja: 12. marec 2009
Frequencies are defined as
Pogostnosti so definirane kot:
• Rare cases of severe allergic reactions have been reported.
• Poročali so o redkih primerih težkih alergijskih reakcij.
The duration of treatment should usually vary from a few days to two weeks.
Zdravljenje naj bi običajno trajalo od nekaj dni do dveh tednov.
Further, stabilization of circulatory function and intensive monitoring may be required.
Potrebna sta lahko tudi stabilizacija delovanja obtočil in intenzivno spremljanje.
hepatotoxicity (mostly described as transaminase increased)
hepatotoksičnost (večinoma opisana kot povišanje transminaz)
Alcohol can increase the undesirable effects of any medicine taken to help you sleep.
Alkohol lahko okrepi neželene učinke vsakega zdravila, ki ga vzamete za pomoč pri spanju.
Be aware that such combinations may cause you to feel drowsy the next day.
Bodite pozorni na to, da lahko takšne kombinacije povzročijo zaspanost naslednji dan.
Patients should be advised not to drive or operate machinery until it is established that their performance is not impaired.
Bolnikom je treba svetovati, naj ne vozijo ali upravljajo s stroji, dokler se ne ugotovi, ali je njihova opravilna sposobnost zmanjšana.
These occur most often up to several hours after ingesting the product.
Le-te se največkrat pojavijo več ur po zaužitju zdravila.
Alcohol and medicinal product abuse
Zloraba alkohola in zdravila
As with sleep-driving, patients usually do not remember these events.
Podobno kot pri vožnji v polsnu se bolniki teh aktivnosti navadno ne spominjajo.
Sonata will help you to sleep.
Zdravilo Sonata vam bo pomagalo zaspati.
Sonata with food, drink and alcohol
Zdravilo Sonata skupaj s hrano, pijačo in alkoholom
Swallow the capsule(s) with a small glass of water.
Kapsulo/kapsule pogoltnite z majhnim kozarcem vode.
• if you have myasthenia gravis (very weak or tired muscles).
• če imate miastenijo gravis (zelo šibke ali utrujene mišice).
The duration of treatment should be as short as possible (see section 4.2), and should not exceed two weeks.
Zdravljenje mora biti čim krajše (glejte poglavje 4.2), ne več od dveh tednov.
Some patients have required medical therapy in the emergency department.
Pri nekaterih bolnikih je bilo potrebno zdravljenje na urgentnem oddelku.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 March 1999
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 12. marec 1999
Specific patient groups
Specifične skupine bolnikov
At least 71% of the orally-administered dose is absorbed.
Absorbira se najmanj 71% peroralno zaužitega odmerka.
The extent of exposure to zaleplon was similar among all groups.
Izpostavljenost zaleplonu je bila v vseh skupinah podobna.
See also below under Depression and Psychiatric and “paradoxical” reactions
Glejte tudi spodaj pod Depresija in Psihiatrične in »paradoksne« reakcije.
For adults, the recommended dose is 10 mg.
Priporočeni odmerek za odrasle je 10 mg.
• if you are allergic to zaleplon or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na zaleplon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If you still have problems sleeping after you have finished your capsules, contact your doctor again.
Če imate težave s spanjem tudi potem, ko ste porabili kapsule, ponovno obiščite svojega zdravnika.
This includes medicines that can be bought without a prescription.
To velja tudi za zdravila, ki se dobijo brez recepta.
These reactions are more likely to occur in the elderly.
Verjetnost za pojav teh reakcij je večja pri starejših osebah.
Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).
Med zdravljenjem z zdravilom Sonata nikoli ne pijte alkohola (glejte odstavek »Opozorila in previdnostni ukrepi«).
Children and adolescents (under 18 years of age)
Otroci in mladostniki (mlajši od 18 let)
The usual dose for adults is 10 mg just before going to bed, or after you have gone to bed and you are having difficulty falling asleep.
Običajni odmerek za odrasle je 10 mg tik pred spanjem ali če ste že šli v posteljo in ne morete zaspati.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V vsaki skupini pogostnosti so neželeni učinki razporejeni po padajoči resnosti.
In these studies, patients were diagnosed with primary (psychophysiological) insomnia.
V te študije so bili vključeni bolniki s primarno (psihofiziološko) nespečnostjo.
To reduce the risk, patients should not undertake activities requiring psychomotor co-ordination until 4 hours or more after taking Sonata (see section 4.7).
Za zmanjšanje tveganja bolniki ne bi smeli opravljati aktivnosti, ki zahtevajo psihomotorično koordinacijo do 4 ure ali več po zaužitju zdravila Sonata (glej poglavje 4.7).
If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased.
V primeru nezadostnega spanja se poveča možnost zmanjšane budnosti.
Treatment should be as short as possible with a maximum duration of two weeks.
Zdravljenje mora biti čim krajše in lahko traja največ dva tedna.
It is important that patients be aware of the possibility of rebound phenomena, thereby minimising anxiety should such symptoms develop when the medicinal product is discontinued.
Pomembno je, da so bolniki seznanjeni z možnostjo pojava ponovnih simptomov in tako zmanjšate tesnobo, če bi se takšni simptomi pojavili ob prenehanju jemanja zdravila.
• Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to.
• Zdravila Sonata ali drugih uspaval ne jemljite dlje, kot vam je predpisal vaš zdravnik.
It may be useful to inform the patient when treatment is started that it will be of limited duration.
Morda je dobro, da bolniku ob začetku zdravljenja poveste, da bo zdravljenje časovno omejeno.
Induced vomiting is not recommended.
Izzivanje bruhanja ni priporočeno.
Anterograde amnesia may occur using recommended therapeutic dosages, the risk increasing at higher dosages.
Anterogradna amnezija se lahko pojavi pri uporabi priporočenih terapevtskih odmerkov, tveganje pa se poveča pri večjih odmerkih.
Psychiatric and “paradoxical” reactions
Psihiatrične in »paradoksne« reakcije
It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
Indicirano je le, kadar je motnja huda in osebo onesposobi ali ji povzroča izjemno neugodje.
They are packed in blisters.
Pakirane so v pretisnih omotih.
When Sonata is taken with other medicines that act on the brain, the combination may make you more drowsy than it should.
Kadar zdravilo Sonata jemljete z drugimi zdravili, ki učinkujejo na možgane, vas lahko kombinacija naredi bolj zaspane, kot bi vas smela.
Respiratory insufficiency
Respiratorna insuficienca
Although animal studies have shown no teratogenic or embryotoxic effects, insufficient clinical data are available on Sonata to assess its safety during pregnancy and breastfeeding.
Čeprav študije na živalih niso pokazale teratogenih ali embriotoksičnih učinkov, za zdravilo Sonata ni na voljo dovolj kliničnih podatkov, da bi lahko ocenili njegovo varnost v času nosečnosti in dojenja.
The risk of dependence increases with dose and duration of treatment and is greater with patients having a history of alcohol and medicinal product abuse.
Tveganje za pojav odvisnosti se povečuje z odmerkom in trajanjem zdravljenja in je večje pri bolnikih, ki imajo v anamnezi zlorabo alkohola in zdravil.
Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines the next day.
Sedacija, amnezija, slabša koncentracija in slabša mišična funkcija lahko neugodno vplivajo na sposobnost vožnje in upravljanja s stroji naslednji dan.
6.6 Special precautions for disposal and other handling No special requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev.
Concomitant intake with alcohol is not recommended.
Sočasno uporaba z alkoholom ni priporočljiva.
• If you are taking any medicines belonging to the sleep inducing group, including Sonata, there is a possibility that you may become dependent on them.
• Če jemljete katero koli zdravilo, ki spada v skupino uspaval, vključno z zdravilom Sonata, obstaja nevarnost, da se razvije odvisnost.
Zaleplon is a pyrazolopyrimidine hypnotic that is structurally different from benzodiazepines and other hypnotics.
Zaleplon je pirazolopirimidinski hipnotik, ki se strukturno razlikuje od benzodiazepinov in drugih hipnotikov.
The total daily dose of Sonata should not exceed 10 mg in any patient.
Celotni dnevni odmerek zdravila Sonata pri nobenem bolniku ne sme presegati 10 mg.
Results from the 2- and 4week studies showed that no pharmacological tolerance developed with any dose of Sonata.
Rezultati iz 2 in 4-tedenskih raziskav kažejo, da se pri nobenem odmerku zdravila Sonata ni razvila farmakološka toleranca.
If you notice any of the following, or any other changes in your health, do tell your doctor as soon as possible.
Če opazite katerega od spodaj navedenih ali kakršnokoli drugo spremembo glede svojega zdravja, o tem čim prej obvestite svojega zdravnika.
You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or erythromycin (an antibiotic).
Obvestite svojega zdravnika ali farmacevta, če jemljete cimetidin (zdravilo za želodec) ali eritromicin
This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication or if you are already taking another central nervous system depressant or if you are drinking alcohol (see ‘other medicines and Sonata').
Vse to je lahko še slabše, če ste po zaužitju zdravila spali manj kot 7 do 8 ur, če že jemljete druge zaviralce osrednjega živčevja ali če uživate alkohol (glejte odstavek »Druga zdravila in zdravilo Sonata«).
This medicinal product does not require any special temperature storage conditions.
Za shranjevanje zdravila ni posebnih temperaturnih omejitev.
Other medicines and Sonata
Druga zdravila in zdravilo Sonata
Pharmacotherapeutic Group: Benzodiazepine related drugs, ATC Code N05CF03
Farmakoterapevtska skupina: benzodiazepinom sorodna zdravila, oznaka ATC: N05CF03