natgillin/translations-raw huggingface dataset:
Since this was mainly observed in dogs with an empty stomach, it is recommended to feed a light meal or snack a while before the tablets are given.
Ker so ta učinek opazili predvsem pri psih, ki so tableto dobili na prazen želodec, je priporočljivo, da živali pred prejetjem tablete zaužijejo lahek obrok ali prigrizek.
A very common side effect in cats was evidence of pain from injection under the skin and this may be reduced by injection of the product at refrigerated temperature.
Zelo pogost neželeni učinek pri mačkah so bile bolečine med injiciranjem v podkožje, kar je mogoče zmanjšati z injiciranjem ohlajenega zdravila.
the animal owner can administer the tablets to the dog.
Za nadaljevanje zdravljenja lahko lastnik psu daje tablete.
For dogs, the treatment of vomiting should be started with the injection, since vomiting animals might throw the intact tablet up again.
Zdravljenje bruhanja pri psih je treba začeti z injekcijo, ker bi psi, ki bruhajo, utegnili ponovno izbruhati celo tableto.
The CVMP concluded that the benefits of Cerenia exceed its risks and recommended that Cerenia be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Cerenia večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
In the study looking at the effect of Cerenia before and after surgery, Cerenia was effective at preventing vomiting asociated with the use of morphine.
V študiji, v kateri so proučevali učinek zdravila Cerenia pred kirurškim posegom in po njem, je bilo zdravilo učinkovito pri preprečevanju bruhanja, povezanega z uporabo morfina.
The bioequivalence studies showed that giving the injection under the skin produced the same levels of maropitant in the body as giving the injection into a vein.
Študije biološke enakovrednosti so pokazale, da je z injiciranjem v podkožje raven maropitanta v telesu enaka kot z injiciranjem v veno.
A common side effect of the tablets when used at a high dose of 8 mg/kg in dogs (for motion sickness) was vomiting before the car journey started.
Pogost neželeni učinek tablet, kadar so se uporabljale v visokem odmerku 8 mg/kg pri psih (za preprečevanje slabosti zaradi vožnje), je bilo bruhanje pred začetkom vožnje z avtomobilom.
In case of accidental ingestion or self-injection medical advice should be sought immediately and the package leaflet or the label shown to the physician.
V primeru nenamernega zaužitja ali samoinjiciranja zdravila se je treba nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo zdravila ali nalepko.
Dogs received either Cerenia soluton for injection or placebo 45 minutes before the administration of morphine for sedation and pain relief prior to anaesthesia .
Psi so prejeli bodisi zdravilo Cerenia v obliki raztopine za injiciranje bodisi placebo 45 minut preden so prejeli morfin za sedacijo in lajšanje bolečin pred anestezijo.
In dogs the tablets can be used to prevent vomiting due to motion sickness.
Pri psih se lahko tablete uporabljajo za preprečevanje bruhanja zaradi potovalne slabosti.
What is Cerenia used for?
Za kaj se zdravilo Cerenia uporablja?
Since Cerenia has not been studied in very young dogs or cats, or in pregnant or lactating bitches or queens, use of Cerenia in these animals should be discussed with your veterinarian.
Ker zdravila niso proučevali pri zelo mladih psih ali mačkah niti pri brejih oziroma doječih psicah in mačkah, se je treba o njegovi uporabi v teh primerih posvetovati z veterinarjem.
In cats, treatment of vomiting is with the injection only.
Zdravljenje bruhanja pri mačkah je mogoče samo z injekcijo.
In cats the solution for injection is used to prevent vomiting and to reduce nausea, but is not suitable for motion (travel) sickness.
Pri mačkah se raztopina za injiciranje uporablja za preprečevanje bruhanja in lajšanje slabosti, ni pa primerna za potovalno slabost.
In order to study the effect of Cerenia in motion sickness, dogs prone to vomiting when travelling were taken on car journeys lasting several hours for up to two consecutive days.
Da bi proučili učinek zdravila Cerenia pri slabosti zaradi vožnje, so pse, ki so bili nagnjeni k bruhanju med potovanji, peljali na večurno vožnjo z avtomobilom največ dva dneva zapored.
Cerenia solution for injection is used in dogs both to prevent nausea and vomiting before and after an operation and to improve recovery from general anaesthesia after use of morphine.
Pri psih se raztopina za injiciranje uporablja za preprečevanje slabosti in bruhanja pred operacijo in po njej ter za hitrejše okrevanje po splošni anesteziji, pri kateri je bil uporabljen morfin.
Bioequivalence studies were conducted in both dogs and cats to compare giving the injection under the skin with injection into a vein.
Pri psih in mačkah so bile izvedene študije biološke enakovrednosti, da bi primerjali injiciranje v podkožje z injiciranjem v veno.
A further study involving dogs looked at the prevention of nausea and vomiting before and after surgery.
V dodatni študiji pri psih, so proučevali preprečevanje slabosti in bruhanja pred operacijo in po njej.
For the treatment of vomiting, the effect of Cerenia compared with placebo was examined in sick cats that were vomiting for various reasons.
Za zdravljenje bruhanja so učinke zdravila v primerjavi s placebom proučevali na bolnih mačkah, ki so bruhale iz različnih razlogov.
What is Cerenia?
Kaj je zdravilo Cerenia?
For the prevention of vomiting, Cerenia was studied in cats which received either Cerenia or placebo before another substance known to trigger vomiting was given to them.
Za preprečevanje bruhanja so zdravilo Cerenia proučevali pri mačkah, ki so prejele bodisi zdravilo Cerenia bodisi placebo, preden so jim dali kakšno drugo snov, za katero je znano, da povzroča bruhanje.
How has Cerenia been studied?
Kako je bilo zdravilo Cerenia raziskano?
As injection under the skin causes pain in cats, the animal will need to be restrained when treated.
Ker so za mačke injekcije v podkožje boleče, jih je treba med zdravljenjem imobilizirati.
For the prevention of vomiting, Cerenia was studied in dogs which received either Cerenia or a placebo (a dummy tablet or injection) before another substance known to trigger vomiting (such as certain cancer medicines) was given to them.
Za preprečevanje bruhanja so zdravilo Cerenia proučevali pri psih, ki so prejeli bodisi zdravilo Cerenia bodisi placebo (tableto ali injekcijo brez zdravilne učinkovine), preden so jim dali kakšno drugo snov, za katero je znano, da povzroča bruhanje (na primer nekatera zdravila proti raku).
How does Cerenia work?
Kako zdravilo Cerenia deluje?
For the treatment of vomiting, the effect of Cerenia (or a placebo) was examined in sick dogs that were vomiting for various reasons, for example because of a gastrointestinal infection.
Učinek zdravila Cerenia (ali placeba) za zdravljenje bruhanja so proučevali pri bolnih psih, ki so bruhali iz različnih razlogov, na primer zaradi okužbe prebavil.
Dogs were treated with either 1 mg/kg (injection given under the skin) or 2 mg/kg (tablet) once daily up to five days.
Pse so zdravili z odmerki 1 mg/kg (z injekcijami v podkožje) ali 2 mg/kg (s tabletami) enkrat dnevno za največ pet dni.
Cerenia is used to prevent (tablets and solution for injection) and treat (solution for injecton) nausea caused by chemotherapy in dogs.
Zdravilo Cerenia se uporablja za preprečevanje (s tabletami in raztopino) ali zdravljenje slabosti (z raztopino) zaradi kemoterapije pri psih.
Cats were treated with 1 mg/kg (injection given under the skin) once daily up to five days.
Mačkam so dajali zdravilo v odmerku 1 mg/kg (z injekcijo) enkrat dnevno do pet dni.
Cerenia tablets are given to dogs at a dose of 8 mg maropitant per kg bodyweight once daily to prevent vomiting due to motion sickness for a maximum of two consecutive days.
Tablete zdravila Cerenia se psom dajejo enkrat na dan za največ dva dni zapored v odmerku 8 mg maropitanta na kg telesne mase za preprečevanje bruhanja zaradi vožnje.
Cerenia solution for injection is given to dogs and cats once daily under the skin or into a vein (1 mg per kg bodyweight) for up to five days.
Zdravilo Cerenia se v obliki raztopine psom in mačkam injicira v podkožje enkrat na dan (1 ml na kg telesne mase) za največ pet dni.
The results of the studies showed that Cerenia was more effective than placebo: less vomiting was seen in dogs and cats that received the medicine than in animals that received placebo, both in the treatment or in the prevention of vomiting.
Pri psih in mačkah, ki so prejeli zdravilo, je bilo opaziti manj pogosto bruhanje kot pri tistih, ki so prejeli placebo, in sicer tako pri zdravljenju kot pri preprečevanju bruhanja.
The animals received either Cerenia tablets at a dose of 8 mg/kg bodyweight or a placebo for up to two consecutive days.
Psi so največ dva dneva zapored prejemali tablete zdravila Cerenia v odmerku 8 mg/kg telesne mase ali placebo.
Cerenia is used to treat vomiting in dogs and cats (solution for injection) or to prevent vomiting in dogs (tablets), in combination with other supportive measures.
Zdravilo Cerenia se, skupaj z drugimi podpornimi ukrepi, uporablja za zdravljenje bruhanja pri psih in mačkah (z raztopino za injiciranje) ali preprečevanje bruhanja pri psih (s tabletami).
Cerenia tablets are given to dogs at a dose of 2 mg maropitant per kg bodyweight once daily to prevent or treat vomiting for up to 14 days.
Tablete zdravila Cerenia se psom dajejo za preprečevanje ali zdravljenje bruhanja enkrat na dan v odmerku 2 mg maropitanta na kg telesne mase za največ 14 dni.
Cerenia blocks neurokinin-1 (NK1) receptors, which are found on the surface of certain cells in the part of the brain that controls nausea and vomitingand are activated by the attachment of a chemical in the body called ‘substance P'.
Ti so prisotni na površini nekaterih celic v delu možganov, ki nadzoruje slabost in bruhanje, in se aktivirajo, ko se nanje veže kemična snov v telesu, imenovana snov P. Zdravilo Cerenia preprečuje, da bi se snov P vezala na receptorje, in s tem onemogoči njihovo aktiviranje ter ublaži slabost in bruhanje.
Further information on Dectova can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dectova.
Nadaljnje informacije o zdravilu Dectova so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/dectova.
The recommended dose for adults is 600 mg twice daily for 5 to 10 days while for children the dose is adjusted based on weight.
Priporočeni odmerek pri odraslih je 600 mg dvakrat na dan od 5 do 10 dni, medtem ko se pri otrocih odmerek prilagodi glede na telesno maso.
Treatment is started as soon as possible and usually within 6 days after symptoms start.
Zdravljenje je treba začeti čim prej in običajno v šestih dneh po pojavu simptomov gripe.
Complicated influenza is a severe flu infection that requires hospitalisation of the patient.
Zapletena influenca je huda okužba z gripo, pri kateri je potrebna hospitalizacija bolnika.
The European Medicines Agency therefore decided that Dectova's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Dectova večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Dectova?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dectova?
The main measure of effectiveness was how long it took for patients to leave hospital or for 4 out of the following 5 flu symptoms to resolve: fever, decreased levels of oxygen in the blood, raised breathing rate, raised heart rate and abnormal blood pressure.
Glavno merilo učinkovitosti je bilo, kako dolgo je trajalo, da so bolniki zapustili bolnišnico, ali so izzveneli štirje od naslednjih petih bolezenskih simptomov gripe: zvišana telesna temperatura, nižje ravni kisika v krvi, povečana hitrost dihanja, povečan srčni utrip in nenormalni krvni tlak.
The medicine is used when the virus is resistant to other flu treatments or when other antiviral treatments, including inhaled zanamivir are not suitable for the patient.
Zdravilo se uporablja, kadar je virus odporen proti drugim zdravilom proti gripi ali kadar druga protivirusna zdravila, vključno z zanamivirjem za inhaliranje, niso primerna za bolnika.
When the neuraminidases are blocked, the virus cannot spread.
Ko so nevraminidaze zavrte, se virus ne more več širiti.
Dectova is an antiviral medicine used to treat complicated and potentially life-threatening influenza (flu) caused by either the influenza A or B virus in adults and children from 6 months of age.
Dectova je protivirusno zdravilo ki se uporablja za zdravljenje zapletene in potencialno življenjsko ogrožajoče influence (gripe), ki jo povzročata virus A ali B pri odraslih in otrocih, starejših od šest mesecev.
Further evidence on benefits of Dectova comes from supporting clinical studies and other laboratory studies.
Dodatni dokazi o koristih zdravila Dectova prihajajo iz podpornih kliničnih študij in drugih laboratorijskih študij.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dectova have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Dectova upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Evidence from laboratory and other clinical studies also supported the effectiveness of Dectova.
Dokazi iz laboratorijskih in drugih kliničnih študij prav tako podpirajo učinkovitost zdravila Dectova.
Since Dectova has been authorised under exceptional circumstances, the company that markets the medicine will conduct two observational studies in patients with complicated influenza to obtain further data on the effectiveness.
Ker je zdravilo Dectova pridobilo dovoljenje za promet v izjemnih okoliščinah, bo podjetje, ki ga trži, izvedlo dve opazovalni študiji pri bolnikih z zapletenim potekom gripe, da bo pridobilo dodatne podatke o učinkovitosti zdravila.
Side effects reported with Dectova are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Dectova, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
However, because uncertainties remain about the size of the effect of Tamiflu (and by extension the size of Dectova's effect), Dectova has been authorised under ‘exceptional circumstances'.
Ker pa še vedno obstajajo negotovosti glede obsega učinka zdravila Tamiflu (in s podaljšanjem obsega učinka zdravila Dectova, je zdravilo Dectova pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
As for all medicines, data on the use of Dectova are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Dectova stalno spremljajo.
An overview of Dectova and why it is authorised in the EU
Pregled zdravila Dectova in zakaj je odobreno v EU
Other information about Dectova
Druge informacije o zdravilu Dectova
Although Tamiflu was used as the comparator, there is some uncertainty about how effective this medicine is in complicated influenza as it has not been compared with placebo (a dummy treatment) in hospitalised influenza patients.
Čeprav je bilo zdravilo Tamiflu uporabljeno kot primerjalno zdravilo, je nekaj negotovosti glede tega, kako učinkovito je to zdravilo pri zapletenem poteku gripe, saj ga niso primerjali s placebom (zdravilom brez učinkovine) pri hospitaliziranih bolnikih z gripo.
Dectova is expected to be effective against some flu strains that do not respond to other flu treatments.
Zdravilo Dectova naj bi bilo učinkovito proti nekaterim sevom gripe, ki se ne odzivajo na druga zdravljenja proti gripi.
Lower doses are given to adults and children with reduced kidney function.
Odrasli in otroci z okvaro delovanja ledvic prejmejo nižje odmerke.
For more information about using Dectova, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Dectova glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Dectova, zanamivir, prevents the flu virus from spreading by blocking some of the enzymes on the surface of the virus called neuraminidases.
Učinkovina v zdravilu Dectova, zanamivir, preprečuje širjenje virusa gripe tako, da zavira dejavnost encimov na površini virusa, imenovanih nevraminidaze.
The most common side effects with Dectova (which may affect up to 1 in 10 people) are diarrhoea, raised levels of transaminases (liver enzymes), liver injury and rash.
Najpogostejši neželeni učinki zdravila Dectova (ki lahko prizadenejo največ 1 osebo od 10) so driska, povišane ravni transaminaz (jetrnih encimov), okvara jeter in izpuščaj.
It took around 5.1 days for symptoms to resolve or patients to leave the hospital with Dectova compared with 5.6 days with Tamiflu.
Pri jemanju zdravila Dectova so simptomi izzveneli oziroma so bolniki lahko zapustili bolnišnico v približno 5,1 dnevu, v primerjavi s 5,6 dneva pri jemanju zdravila Tamiflu.
Why is Dectova authorised in the EU?
Zakaj je bilo zdravilo Dectova odobreno v EU?
What is Dectova and what is it used for?
Kaj je zdravilo Dectova in za kaj se uporablja?
The most serious side effect is liver injury.
Najresnejši neželeni učinek je okvara jeter.
What are the risks associated with Dectova?
Kakšna tveganja so povezana z zdravilom Dectova?
What benefits of Dectova have been shown in studies?
Kakšne koristi je zdravilo Dectova izkazalo v študijah?
Its side effects, the most important one being liver injury, are similar to those seen with Tamiflu.
Njegovi neželeni učinki, od katerih je najpomembnejši okvara jeter, so podobni neželenim učinkom, opaženim pri zdravilu Tamiflu.
Dectova contains the active substance zanamivir.
Zdravilo Dectova vsebuje učinkovino zanamivir.
What information is still awaited for Dectova?
Katere informacije o zdravilu Dectova še pričakujemo?
A main study showed that Dectova works as well as Tamiflu, with comparable time to discharge patients from hospital or resolution of most of the influenza symptoms.
V glavni študiji je bilo dokazano, da zdravilo Dectova učinkuje enako dobro kot zdravilo Tamiflu, saj je bil pri obeh zdravilih opazen primerljiv čas do odpusta bolnikov iz bolnišnice ali odprave večine simptomov gripe.
Dectova works on neuraminidases of both influenza A (the most common type) and influenza B viruses.
Zdravilo Dectova deluje na nevraminidaze virusov influence A (najpogostejša vrsta) in influence B.
Dectova is given as an infusion (drip) into a vein.
Zdravilo Dectova se daje z infundiranjem (kapalno infuzijo) v veno.
Dectova can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Dectova je le na recept.
How is Dectova used?
Kako se zdravilo Dectova uporablja?
How does Dectova work?
Kako zdravilo Dectova deluje?
Dectova has been shown to work as well as Tamiflu (the standard of care for complicated flu) in one main study involving 626 patients who had been hospitalised.
V eni glavni študiji, v katero je bilo vključenih 626 bolnikov, ki so bili hospitalizirani, je bilo dokazano, da zdravilo Dectova deluje podobno kot zdravilo Tamiflu (običajno zdravilo za zdravljenje zapletene gripe).
“Paediatric patients
„Pediatrični bolniki
The Member States competent authorities will continue to keep the product under regular review.
Pristojni organi držav članic bodo zdravilo še naprej redno nadzorovali.
A Request for Supplementary Information was adopted on 16 November 2006.
Dne 16. novembra 2006 je bil sprejet zahtevek za dodatne informacije.
Section 4.1 (Indication):
Poglavje 4.1 (indikacije):
The information given in this document and Annexes reflect only the CHMP Opinion dated 14 December 2006.
Informacije, podane v tem dokumentu in dodatkih, odražajo le mnenje CHMP z dne 14. decembra 2006.
This is equivalent to 0.1 ml/kg BW of the 1.0 M solution”.
To je enako kot 0,1 ml/kg BW 1,0 M raztopine“.
BACKGROUND INFORMATION*
OSNOVNI PODATKI*
Gadograf/Gadovist International Non-Proprietary Name (INN): Gadobutrol
Gadograf/Gadovist Mednarodno nelastniško ime (INN): Gadobutrol
The company responded to these points on 30 November 2006.
Družba se je na točke zahtevka odzvala 30. novembra 2006.
The CHMP appointed Dr. Broich (DE) as Rapporteur and Dr. Prieto (ES) as CoRapporteur.
Odbor CHMP je za poročevalca določil dr. Broicha (DE) in za soporočevalca dr. Prieta (ES).
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 36(1) REFERRAL
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI MNENJE NA OSNOVI POSVETOVALNEGA POSTOPKA PO 36(1) ČLENU ZA
The Applicant further agreed to the proposed wording by the CHMP as follows:
Prosilec je privolil tudi v besedilo, ki ga je pripravil CHMP in se glasi:
Having considered the grounds for the referral triggered by Spain, the CHMP, during its May 2006 plenary meeting, adopted a List of Questions and a TT for a referral procedure under Article 36.
Odbor CHMP je po preučitvi razlogov za napotitev, ki ga je sprožila Španija, na plenarnem zasedanju maja 2006 sprejel seznam vprašanj in TT za postopek napotitve v skladu s členom 36.
Gadovist/Gadograf was approved for “Contrast enhancement in cranial and spinal magnetic resonance imaging” in Germany in January 2000 and subsequently in June 2000 in the EU and Norway via the mutual recognition procedure (MRP).
Zdravilo Gadovist/Gadograf je bilo odobreno za „izboljšanje kontrasta pri kranialnem in spinalnem magnetnoresonančnem slikanju“ v Nemčiji januarja leta 2000 ter nato v EU in na Norveškem junija leta 2000 s postopkom medsebojnega priznavanja.
After finalisation of the procedure the Spanish Agency for Medicines and Health Products initiated a referral for arbitration to the CHMP under article 36.1 of Directive 2001/83/EC.
Po finalizaciji postopka je španska agencija za zdravila in medicinske pripomočke v skladu s členom 36.1 Direktive 2001/83/ES pri odboru CHMP sprožila napotitveni postopek za arbitražo.
Concerns were further raised with regards to the Paediatric Indication and the use of the comparator Magnevist.
Nadaljnja vprašanja so se nanašala na pediatrične indikacije in uporabo primerjalnega zdravila Magnevist.
Section 4.2 (Posology):
Poglavje 4.2 (odmerjanje):
Magnevist is not approved "to classify focal lesions [of liver or kidney] as benign or malignant" throughout the EU and it was questioned whether it would support the granting of an indication for which Magnevist has not been approved.
Zdravilo Magnevist ni odobreno za „klasifikacijo žariščnih lezij [jeter ali ledvic] kot benignih ali malignih“ po vsej EU, tako da je bilo vprašljivo, ali bo mogoče podeliti indikacijo, za katero zdravilo Magnevist ni bilo odobreno.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II and the amended Summary of Product Characteristics in Annex III.
Seznam zadevnih imen zdravil je naveden v Dodatku I. Dodatek II vsebuje znanstvene zaključke, Dodatek III pa dopolnjen povzetek glavnih značilnosti zdravila.
A label extension to the indication “Contrast-enhanced Magnetic resonance angiography” (CE-MRA) followed in November
Razširitev oznake za indikacijo „izboljšanje kontrasta pri magnetnoresonančni angiografiji“ (CE-MRA) je sledila novembra leta 2003.
The Applicant was asked to justify the choice of this comparator and the clinical utility of Gadovist/Gadograf with respect to diagnostic thinking, therapeutic management and clinical outcome.
Odbor je prosilca pozval, da utemelji izbiro tega primerjalnega zdravila in klinične uporabnosti zdravila Gadovist/Gadograf v smislu diagnostike, terapevtskega vodenja in kliničnega izida.