natgillin/translations-raw huggingface dataset:
Results showed that it was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Ivabradine Anpharm died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Rezultati so pokazali, da je bilo to zdravilo učinkovitejše od placeba pri preprečevanju smrti zaradi bolezni srca ali ožilja ali hospitalizacije zaradi poslabšanja srčnega popuščanja: 24,5 % (793 od 3 241) bolnikov, zdravljenih z zdravilom Ivabradine Anpharm, je umrlo ali je bilo hospitaliziranih zaradi poslabšanja srčnega popuščanja v primerjavi z 28,7 % (937 od 3 264) bolnikov, ki so prejemali placebo.
What measures are being taken to ensure the safe and effective use of Ivabradine Anpharm?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ivabradine Anpharm?
The Agency decided that Ivabradine Anpharm's benefits are greater than its risks and it can be authorised for use in the EU.
Zato je zaključila, da so koristi zdravila Ivabradine Anpharm večje od z njim povezanih tveganj, in da se lahko odobri za uporabo v EU.
In a fourth study in 889 patients, Ivabradine Anpharm was more effective than placebo when both were added to atenolol.
V četrti študiji z 889 bolniki je bilo zdravilo Ivabradine Anpharm učinkovitejše od placeba, pri čemer so oba dodajali atenololu.
Ivabradine Anpharm therefore reduces or prevents the symptoms of angina.
Zdravilo Ivabradine Anpharm tako zmanjša ali prepreči simptome angine pektoris.
As for all medicines, data on the use of Ivabradine Anpharm are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ivabradine Anpharm stalno spremljajo.
Ivabradine Anpharm must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Zdravila Ivabradine Anpharm ne smejo jemati bolniki, ki imajo srčni utrip med mirovanjem nižji od 70 udarcev na minuto, zelo nizek krvni tlak, razne vrste obolenj srca (npr. kardiogeni šok, motnje ritma, srčni napad, nestabilno ali akutno (nenadno) srčno popuščanje in nestabilno angino pektoris) ali hude težave z jetri.
The most common side effect with Ivabradine Anpharm (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Najpogostejši neželeni učinek zdravila Ivabradine Anpharm (ki se lahko pojavi pri več kot 1 bolniku od 10) so pojav svetlikanja ali „fosfeni“ (prehodno povečanje svetlosti v vidnem polju).
For more information about using Ivabradine Anpharm, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Ivabradine Anpharm glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The European Medicines Agency concluded that Ivabradine Anpharm was shown to be effective in longterm angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta blockers or whose disease is not controlled with them.
Evropska agencija za zdravila je zaključila, da je bilo za zdravilo Ivabradine Anpharm dokazano, da je učinkovito pri zdravljenju kronične angine pektoris in ima zadosten varnostni profil za nadomestno zdravljenje bolnikov, ki ne morejo jemati zaviralcev receptorjev beta oziroma katerih bolezen ni urejena z njimi.
An overview of Ivabradine Anpharm and why it is authorised in the EU
Pregled zdravila Ivabradine Anpharm in zakaj je odobreno v EU
In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Ivabradine Anpharm compared with placebo (3.4% vs 2.9% yearly incidence rates).
V tej študiji je pri posebni podskupini bolnikov s simptomatsko angino pektoris, zdravljenih z zdravilom Ivabradine Anpharm, prišlo do majhnega, vendar pomembnega povečanja združenega tveganja smrti zaradi srčno-žilne bolezni ali srčnega napada brez smrtnega izida v primerjavi s placebom (letni delež pogostnosti 3,4 % v primerjavi z 2,9 %).
The medicine is used in patients who have a normal heart rhythm and whose heart rate is at least 70 beats per minute.
Zdravilo se uporablja pri bolnikih z normalnim srčnim ritmom, ki ne sme biti manjši od 70 utripov na minuto.
Ivabradine Anpharm is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).
Ivabradine Anpharm je zdravilo za srce, ki se uporablja za zdravljenje simptomov kronične stabilne angine pektoris (bolečine v prsnem košu, čeljusti in hrbtu zaradi telesnega napora) pri odraslih z boleznijo koronarnih arterij (boleznijo srca, ki jo povzroča zamašitev krvnih žil, ki dovajajo kri v srčno mišico).
A sixth study compared Ivabradine Anpharm with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
V šesti študiji so zdravilo Ivabradine Anpharm primerjali s placebom pri 19 102 bolnikih z boleznijo koronarnih arterij brez kliničnega srčnega popuščanja.
It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients.
V študiji z 939 bolniki je bilo enako učinkovito kot atenolol (zaviralec receptorjev beta), v študiji s 1 195 bolniki pa enako učinkovito kot amlodipin (drugo zdravilo, ki se uporablja za zdravljenje angine pektoris).
Ivabradine Anpharm is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute.
Zdravilo Ivabradine Anpharm se uporablja tudi pri bolnikih s kroničnim srčnim popuščanjem (kadar srce ne more črpati dovolj krvi po telesu), ki imajo sicer normalen srčni ritem, a je njihov srčni utrip najmanj 75 udarcev na minuto.
Why is Ivabradine Anpharm authorised in the EU?
Zakaj je bilo zdravilo Ivabradine Anpharm odobreno v EU?
Other information about Ivabradine Anpharm
Druge informacije o zdravilu Ivabradine Anpharm
What is Ivabradine Anpharm and what is it used for?
Kaj je zdravilo Ivabradine Anpharm in za kaj se uporablja?
What benefits of Ivabradine Anpharm have been shown in studies?
Kakšne koristi zdravila Ivabradine Anpharm so se pokazale v študijah?
Ivabradine Anpharm was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Zdravilo Ivabradine Anpharm so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili v petih glavnih študijah, v katere je bilo vključenih več kot 4 000 odraslih s kronično stabilno angino pektoris.
By lowering the heart rate, Ivabradine Anpharm reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Zdravilo Ivabradine Anpharm z upočasnitvijo srčnega utripa zmanjša obremenitev srca ter upočasni napredovanje srčnega popuščanja in ublaži simptome.
Ivabradine Anpharm was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Zdravilo Ivabradine Anpharm so primerjali s placebom v eni glavni študiji, v katero je bilo vključenih več kot 6 500 bolnikov s kroničnim zmernim do hudim srčnim popuščanjem.
Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people).
(upočasnjen srčni utrip) je pogosta (pojavi se lahko pri največ 1 bolniku od 10).
It also concluded that Ivabradine Anpharm was effective in long-term heart failure with an acceptable safety profile.
Prav tako je zaključila, da je zdravilo Ivabradine Anpharm učinkovito pri zdravljenju kroničnega srčnega popuščanja in ima zadosten varnostni profil.
What are the risks associated with Ivabradine Anpharm?
Kakšna tveganja so povezana z zdravilom Ivabradine Anpharm?
The active substance in Ivabradine Anpharm, ivabradine, works by blocking the ‘If currents' in the sinus node, the natural ‘pacemaker' that controls the heart's contractions and regulates the heart rate.
Zdravilna učinkovina v zdravilu Ivabradine Anpharm, ivabradin, deluje tako, da zavira „tokove If“ v sinusnem vozlu, tj. naravnem spodbujevalniku srca, ki nadzoruje krčenje srca in uravnava srčni utrip.
Ivabradine Anpharm contains the active substance ivabradine.
Zdravilo Ivabradine Anpharm vsebuje zdravilno učinkovino ivabradin.
For the full list of all side effects reported with Ivabradine Anpharm, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ivabradine Anpharm, glejte navodilo za uporabo.
For the full list of restrictions with Ivabradine Anpharm, see the package leaflet.
Za celoten seznam omejitev pri uporabi zdravila Ivabradine Anpharm glejte navodilo za uporabo.
How is Ivabradine Anpharm used?
Kako se zdravilo Ivabradine Anpharm uporablja?
How does Ivabradine Anpharm work?
Kako zdravilo Ivabradine Anpharm deluje?
ATCvet code: QI01AD07.
Oznaka ATCvet: QI01AD07
Date of last renewal: 21/05/2008.
Datum zadnjega podaljšanja: 21/05/2008.
Simultaneous use of both vaccines increases the risk of recombination of viruses and potential emergence of new variants.
Sočasna uporaba obeh cepiv povečuje tveganje ponovne kombinacije virusov in možen pojav novih variant.
Each container should be used immediately and completely after opening.
Vsako merico je treba po odprtju porabiti takoj in v celoti.
Where the number of chickens is between the standard dosages, the next higher dosage should be used.
Če je število piščancev med standardnimi odmerki, uporabimo naslednji večji odmerek.
Store in a refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2 °C -8 °C).
The safety parameters of the mixed vaccines are not different from those described for the vaccines administered separately.
Varnostni parametri mešanih cepiv se ne razlikujejo od tistih, ki so opisani za cepiva, ki se dajejo ločeno.
In laboratory studies and field trials:
V laboratorijskih študijah in študijah na terenu:
Vaccination programme The veterinarian should determine the optimum vaccination schedule according to the local situation.
Program cepljenja Veterinar določi optimalno shemo cepljenja glede na lokalne razmere.
A sufficient number of water containers to provide adequate drinking space is essential.
Zadostno število posod za vodo, ki zagotovijo ustrezno velik prostor za pitje, je ključnega pomena.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti in učinkovitosti tega cepiva ob uporabi s katerimkoli drugim zdravilom za uporabo v veterinarski medicini.
Ensure that all the vaccine suspension is consumed within 1-2 hours.
Poskrbeti je treba, da živali popijejo vso suspenzijo cepiva v 1 do 2 urah.
In case of the latter presentation the cups may contain 3 up to 100 spheres depending on the required dosages and production yields.
V primeru slednje oblike merice lahko vsebujejo 3 do 100 kroglic odvisno od potrebnih odmerkov in proizvodnih donosov.
After reconstitution the suspension looks clear.
Po rekonstiotuciji je suspenzija bistra.
Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati to zdravilo za uporabo v veterinarski medicini, se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, ker so te dejavnosti lahko prepovedane v državi članici v celoti ali v delu njenega ozemlja.
Care should be taken to avoid the introduction of the variant strain into an area where it is not present.
Paziti je treba, da variantnega seva ne bi prenesli na območje, kjer se še ni pojavil.
For prolonged immunity, chickens should be revaccinated every 6 weeks after the initial administration.
Za podaljšano imunost je treba cepljenje ponavljati vsakih 6 tednov po prvem dajanju.
For heavy breeds, or in hot weather, the quantity of water may be increased up to 40 litres per 1,000 doses.
Pri težkih pasmah ali v vročem vremenu lahko količino vode povečamo do 40 litrov na 1000 odmerkov.
In both cases mix the water containing the vaccine well before use.
V obeh primerih vodo, v kateri je cepivo, dobro premešamo.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC, so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št.
Do not use this veterinary medicinal product after the expiry date stated on the label.
Tega zdravila za uporabo v veterinarski medicini ne uporabljajte po izteku roka uporabnosti, ki je naveden na nalepki.
Wash and disinfect hands and equipment after vaccinating to avoid spread of the virus.
Po cepljenju si umijte in razkužiti roke in opremo, da bi se izognili širjenju virusa.
This will vary according to the age of the chickens being vaccinated and the management system, but 250 to 400 ml of water per 1,000 doses is suggested.
Količina vode se lahko razlikuje glede na starost piščancev in sistem reje, vendar je priporočena količina 250 do 400 ml vode za 1000 odmerkov.
These should be clean and free from traces of detergents and disinfectants.
Posode morajo biti čiste in ne smejo vsebovati sledi detergentov in razkužil.
In post marketing experience: In very rare cases mild respiratory signs of disease are reported.
V zelo redkh primerih poročajo o blagih respiratornih znakih bolezni.
Dissolve the vaccine in physiological saline solution or sterile distilled water (usually 30 ml per 1,000 doses, 75 ml per 2,500 doses) and administer by means of a standardized dropper.
Cepivo raztopimo v fiziološki raztopini soli ali sterilni destilirani vodi (običajno 30 ml za 1000 odmerkov, 75 ml za 2500 odmerkov) in ga dajemo s standardizirano kapalko.
Only skimmed milk should be used, since fat in whole milk may block the automatic drinking systems as well as reduce vaccine virus efficacy.
Uporabiti smete samo posneto mleko, ker lahko maščoba v polnomastnem mleku zamaši avtomatični sistem za napajanje in zmanjša učinkovitost virusnega cepiva.
Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of spray administration, personal protective equipment consisting of masks with eye protection should be worn when handling the veterinary medicinal product.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Pri dajanju s pršilom je treba nositi osebno zaščitno opremo, ki sestoji iz maske z zaščito za oči, kadar delate z zdravilom za uporabo v veterinarski medicini.
Pharmacotherapeutic group: Immunologicals for Aves, domestic fowl, live viral vaccine, avian infectious bronchitis virus.
Farmakoterapevtska skupina: imunološka zdravila za ptice, domačo perutnino, živa virusna vakcina, virus kužnega bronhitisa perutnine
Vaccination with Nobilis IB 4-91 may very commonly induce mild respiratory signs of disease which may persist for a few days depending on the health and condition of the chickens.
Cepljenje s cepivom Nobilis IB 4-91 lahko zelo pogosto povzroči blage respiratorne znake bolezni, ki lahko trajajo nekaj dni, odvisno od zdravstvenega in splošnega stanja piščancev.
The instructions on reconstitution of both lyophilisates and the subsequent application are to be followed as outlined above for spray and intranasal/ocular administration.
Ravnati se je treba po navodilih o rekonstituciji obeh liofilizatov in nadaljnji uporabi, kot je opisano zgoraj za dajanje z razprševanjem in intranazalno/okularno dajanje.
Date of first authorisation: 09/06/1998.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja: 09/06/1998.
The same volumes as for the single product should be used.
Uporabiti je treba iste količine kot za posamezno zdravilo.
However, the chance of a hazard occurring has been estimated very low and is minimized by routinely vaccinating all chickens on the premise at the same time and cleaning and disinfection after each production round.
Vendar pa je tveganje ocenjeno kot zelo nizko in zmanjšano z rutinskim cepljenjem vseh piščancev v obratu istočasno in s čiščenjem in razkuževanjem po vsakem turnusu.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 zdravljenih živali) - pogosti (pri več kot 1 toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1 toda manj kot 10 živalih od 1000 zdravljenih živali) - redki (pri več kot 1 toda manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključujoč posamezne primere)
Do not mix with any other veterinary medicinal product, except Nobilis IB Ma5 recommended for use with the veterinary medicinal product.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini razen s cepivom Nobilis IB Ma5, ki je priporočeno za uporabo z zdravilom za uporabo v veterinarski medicini.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica skladno z nacionalno zakonodajo prepove izdelavo, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da: a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročilo težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
The vaccine should be given in the early morning as this is the main period of water intake or during the cool period on a hot day.
Cepivo dajemo v zgodnjih jutranjih urah, ker živali takrat popijejo največ vode, ali v hladnejšem delu vročega dneva.
Guideline when the product is used with Nobilis IB Ma5
Smernice, kadar se cepivo uporablja s cepivom Nobilis IB Ma5
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se je treba za uporabo tega cepiva pred uporabo katerega koli drugega zdravila za uporabo v veterinarski medicini odločiti od primera do primera.
Feed should be available when vaccinating.
Med cepljenjem naj bo živalim hrana na voljo.
By adding skimmed milk to the drinking water the vaccine virus retains its activity longer.
Z dodajanjem posnetega mleka v pitno vodo podaljšamo aktivnost virusnega cepiva.
Drinking water
Voda za pitje:
Shelf life of the veterinary medicinal product in aluminium laminate cups as packaged for sale: 24 months.
Rok uporabnosti zdravila za uporabo v veterinarski medicini v mericah iz aluminijevega laminata v pakiranju za prodajo: 24 mesecev.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALECZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
The vaccine suspension should be spread evenly over the correct number of chickens, at a distance of 30-40 cm using a coarse spray, preferably when the chickens are sitting together in dim light.
Suspenzijo cepiva je treba z razpršilnikom z večjimi kapljicami enakomerno razpršiti po ustreznem številu piščancev z razdalje 30 do 40 cm, najbolje takrat, ko sedijo in so zbrani na enem mestu ter pri šibkejši svetlobi.
At least 3.6 log10 EID50 (1 dose) per animal by coarse spray, drinking water or intranasal/ocular administration.
Najmanj 3,6 log 10 EID50 (1 odmerek) na eno žival z razprševanjem, z dajanjem cepiva v vodi za pitje ali z intranazalnim/okularnim dajanjem.
The volume of water for reconstitution should be sufficient to ensure an even distribution when sprayed onto the chickens.
Vode za rekonstitucijo cepiva mora biti dovolj, da se pri škropljenju piščancev zagotovi enakomerna porazdelitev pripravka.
EU/2/98/006/001-014
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/98/006/001-014
Since the stability of IBV in suspension may be low due to sensitivity to high temperatures and impurities, water used for dissolving the freeze-dried vaccine should be cool and of good quality.
Zaradi slabše stabilnosti suspenzije virusa kužnega bronhitisa pri visoki temperaturi in v prisotnosti nečistoč mora biti voda, ki jo uporabimo za raztapljanje liofiliziranega cepiva, hladna in dobre kakovosti.
In case of the product presented in cups, do not use the product if the contents are brownish and stick to the container as this indicates that the integrity of the container has been breached.
V primeru, da je cepivo v mericah, ga ne uporabite, če je vsebina rjavkasta in se lepi na merico, ker to kaže, da je merica poškodovana.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke ali druge učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo, obvestite svojega veterinarja.
1,000 doses (3-100 spheres) 2,500 doses (3-100 spheres) 5,000 doses (3-100 spheres) 10,000 doses (3-100 spheres)
1.000 odmerkov (3-100 kroglic) 2.500 odmerkov (3-100 kroglic) 5.000 odnerkov (3-100 kroglic) 10.000 odmerkov (3-100 kroglic)
Chickens should be vaccinated against other prevalent IBV serotypes (e.g. Massachusetts) according to the local IB vaccination programme.
Piščance je treba cepiti proti drugim razširjenim serotipom kužnega bronhitisa perutnine (npr. Massachussetts) v skladu z lokalnim programom cepljenja proti bronhitisu perutnine.
Shelf life of the veterinary medicinal product in glass vials as packaged for sale: 9 months.
Rok uporabnosti zdravila za uporabo v veterinarski medicini v steklenih vialah v pakiranju za prodajo: 9 mesecev.