natgillin/translations-raw huggingface dataset:
Although it was not clear whether such events represented ‘true' anaphylactic reactions or resulted from similar clinical signs due to anaphylactoid or endotoxin-related events, the term ‘anaphylactic-type' is used hereafter to describe the adverse events reported.
Čeprav ni bilo jasno, ali taki dogodki predstavljajo „dejansko“ anafilaktično reakcijo ali pa so posledica podobnih kliničnih znakov zaradi dogodkov, povezanih z anafilaktoidi ali endotoksini, se v nadaljevanju za opisovanje neželenih dogodkov, o katerih so poročali, uporablja izraz „anafilaktični“.
The marketing authorisations in Spain and Italy were suspended by the national competent authorities on 11 and 20 April 2011, respectively.
Nacionalni pristojni organ v Španiji je dovoljenje za promet začasno umaknil 11. aprila 2011, v Italiji pa 20. aprila 2011.
A laboratory trial is currently ongoing, however further investigations will be required to determine the underlying cause(s) of the anaphylactic-type events reported.
Trenutno poteka laboratorijsko preskušanje, vendar bodo potrebne nadaljnje raziskave za določitev osnovnih vzrokov za pojav anafilaktičnih dogodkov, o katerih so poročali.
Scientific conclusions and grounds for suspension of the marketing authorisation(s)
Znanstveni zaključki in podlaga za začasni umik dovoljenj za promet z zdravilom
After evaluation of the adverse events, the French competent authority considered that the benefit-risk balance for the product was unfavourable and suspended the marketing authorisation in France as a precautionary measure until the cause of the adverse events could be identified and corrective measures implemented.
Po oceni neželenih dogodkov je francoski pristojni organ sklenil, da je razmerje med koristmi in tveganji zdravila neugodno in kot previdnosti ukrep začasno umaknil dovoljenje za promet z zdravilom v Franciji, dokler se ne pojasni vzrok neželenih učinkov in sprejmejo ustrezni popravni ukrepi.
The data evaluated indicate an association between vaccination of cattle with HIPRABOVIS PNEUMOS Emulsion for injection for cattle and the occurrence of anaphylactic-type events, which has increased recently in some EU Member States.
Ovrednoteni podatki kažejo na povezavo med cepljenjem goveda z zdravilom HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo in pojavnostjo anafilaktičnih dogodkov, ki se je nedavno v nekaterih državah članicah EU povečala.
The emphasis placed by the marketing authorisation holder on investigation of the role of bovine respiratory syncytial virus infection or vaccination was considered to be pursued to the exclusion of other possible risk factors which may contribute to the adverse events.
Poudarek, ki ga je imetnik dovoljenja za promet z zdravilom namenil preučevanju vloge okužb z govejim respiratornim sincicijskim virusom ali cepiv, naj bi bil namenjen izključitvi drugih možnih dejavnikov tveganja, ki bi lahko vplivali na neželene dogodke.
Although it was considered that it may be useful to revise the SPC text in future to more accurately reflect the frequency and severity of adverse events reported, such a change was not considered to be an adequate measure to address the issue concerning anaphylactic-type events.
Čeprav so menili, da bi bila v prihodnosti koristna sprememba besedila povzetka glavnih značilnosti zdravila, tako da bi natančneje odražalo pogostost in resnost neželenih dogodkov, o katerih so poročali, pa so za take spremembe menili, da niso zadosten ukrep za reševanje težav v zvezi z anafilaktičnimi dogodki.
There are valid alternative therapeutic and management tools available on the EU market to control the diseases caused by Mannheimia haemolytica and Histophilus somni.
Na tržišču EU so na voljo odobrena nadomestna terapevtska sredstva in orodja za obvladovanje bolezni, ki jih povzročata Mannheimia haemolytica in Histophilus somni.
Between 1 April 2010 and 28 February 2011, the overall EU incidence for adverse events reported following use of the product was estimated to be 0.048% (or ‘rare') between 1 April 2010 and 28 February 2011 and the incidence of fatalities was 0.0087% (or ‘very rare').
Med 1. aprilom 2010 in 28. februarjem 2011 je bila skupna pojavnost neželenih dogodkov, o katerih so poročali po uporabi zdravila, ocenjena na 0,048 % (ali „redki“), pojavnost smrtnosti v tem obdobju pa je bila 0,0087 % (ali „zelo redka“).
The principal risks associated with the product relate to the potential for anaphylactic-type events in treated animals, some of which have been fatal.
Glavno tveganje, povezano z uporabo zdravila, je pojav anafilaktičnih dogodkov pri zdravljenih živalih, med katerimi so tudi primeri s smrtnim izidom.
• the underlying cause of the adverse events observed has yet to be determined and consequently no specific measures could be recommended to ensure that the product is not associated with an unacceptable risk of anaphylactic-type events, some of which were fatal, under the authorised conditions of use;
• Osnovni vzrok opaženih neželenih dogodkov še ni bil ugotovljen in zato pri odobrenih pogojih uporabe ni bilo mogoče priporočiti nobenih posebnih ukrepov, ki bi zagotovili, da zdravilo ni povezano s nesprejemljivim tveganjem za anafilaktične dogodke, med katerimi so tudi primeri s smrtnim izidom.
As the underlying cause(s) has not yet been determined, appropriate corrective measures to minimise the risk of such adverse events could not be identified.
Ker osnovni vzroki še niso bili ugotovljeni, ni bilo mogoče določiti ustreznih popravnih ukrepov za zmanjšanje tveganja za pojav teh neželenih dogodkov.
These reports raised concern over a potential association with the use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle.
Ta poročila so sprožila zadržke glede možne povezave z uporabo zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo.
The vaccine is expected to benefit herd health and welfare by reducing the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in cattle.
Cepivo naj bi koristilo zdravju in dobremu počutju črede z zmanjševanjem kliničnih znakov in pljučnih lezij, ki jih pri govedu povzročata Mannheimia haemolytica serotip A1 in Histophilus somni.
One clinical trial investigated the potential role of bovine respiratory syncytial virus vaccines as a potential predisposing factor to the adverse events after use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle.
V enem kliničnem preskušanju so preučevali morebiten vpliv cepiv proti govejemu respiratornemu sincicijskemu virusu kot potencialnih predispozicijskih dejavnikov za neželene dogodke po uporabi zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo.
HIPRABOVIS PNEUMOS Emulsion for injection for cattle is the only vaccine currently authorised in the EU with the combination of active components, Mannheimia haemolytica and Histophilus somni.
Zdravilo HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo je trenutno edino odobreno cepivo v EU, ki vsebuje kombinacijo zdravilnih učinkovin Mannheimia haemolytica in Histophilus somni.
Following the evaluation of the data presented by the marketing authorisation holder, it was considered that there was insufficient information to identify the underlying mechanism for anaphylactic-type events following administration of HIPRABOVIS PNEUMOS Emulsion for injection for cattle, or potential factors that may contribute to such events.
Po oceni podatkov, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, je bilo ugotovljeno, da ni zadostnih informacij za določitev osnovnega mehanizma za anafilaktične dogodke po uporabi zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo ali drugih potencialnih dejavnikov, ki bi lahko vplivali na take dogodke.
Whilst acknowledging the inherent limitations of the pharmacovigilance data and the limited size of the clinical study conducted by the marketing authorisation holder, having evaluated the data available, the CVMP concluded that the above-mentioned findings provide evidence to suggest an association between the anaphylactic-type events observed and administration of HIPRABOVIS PNEUMOS Emulsion for injection for cattle.
Ob upoštevanju omejitev farmakovigilančnih podatkov in omejene velikosti klinične študije, ki jo je izvedel imetnik dovoljenja za promet z zdravilom, je CVMP po oceni razpoložljivih podatkov sklenil, da navedene ugotovitve zagotavljajo dokaz, ki kaže na povezavo med opaženimi anafilaktičnimi dogodki in uporabo zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo.
• anaphylactic-type adverse events, some of which were fatal, reported after the use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle indicates an association with the product;
• Anafilaktični neželeni dogodki, med katerimi so bili tudi primeri s smrtnim izidom in o katerih so poročali po uporabi zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo, kažejo na povezavo z zdravilom.
HIPRABOVIS PNEUMOS Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age.
Zdravilo HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo je inaktivirano cepivo za zmanjšanje kliničnih znakov in pljučnih lezij, ki jih povzročata Mannheimia haemolytica serotip A1 in Histophilus somni, pri teletih od starosti dveh mesecev.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF HIPRABOVIS PNEUMOS EMULSION FOR INJECTION FOR CATTLE AND ASSOCIATED NAMES
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA HIPRABOVIS PNEUMOS EMULZIJA ZA INJICIRANJE ZA GOVEDO IN POVEZANIH IMEN
It was recommended that further investigation of all potential contributory factors be explored further by the marketing authorisation holder.
Priporočeno je bilo, da imetnik dovoljenja za promet z zdravilom podrobneje preuči tudi vse ostale dejavnike, ki bi lahko imeli vpliv.
Grounds for suspension of the marketing authorisations
Podlaga za začasen umik dovoljenj za promet z zdravilom
The Committee considered the measures proposed by the marketing authorisation holder to mitigate the risk of anaphylactic-type events following use of the product.
Odbor je preučil ukrepe, ki jih je predlagal imetnik dovoljenja za promet z zdravilom za zmanjšanje tveganja za pojav anafilaktičnih dogodkov po uporabi zdravila.
The Committee reviewed the ongoing and planned studies supported by the marketing authorisation holder to investigate the potential relation between HIPRABOVIS PNEUMOS Emulsion for injection for cattle and anaphylactic-type adverse events.
Odbor je pregledal potekajoče in načrtovane študije, ki jih podpira imetnik dovoljenja za promet z zdravilom, ker želi s temi študijami raziskati možno povezavo med zdravilom HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo in anafilaktičnimi neželenimi dogodki.
• the CVMP concluded that the benefit-risk balance for HIPRABOVIS PNEUMOS Emulsion for injection for cattle is unfavourable under the authorised conditions of use; therefore, in accordance with Article 83 (1)(a) of Directive 2001/82/EC, the CVMP recommends the suspension of the marketing authorisations for the veterinary medicinal products referred to in Annex I of the CVMP Opinion.
Zato CVMP v skladu s členom 83(1)(a) Direktive 2001/82/ES priporoča začasni umik dovoljenj za promet z veterinarskimi zdravili, navedenimi v Prilogi I mnenja CVMP.
In the absence of an identified underlying cause for the adverse events observed at the time, the changes proposed to the summary of product characteristics (SPC) and product literature were, on the whole, not considered sufficient to minimise the risk of anaphylactic-type events following administration of HIPRABOVIS PNEUMOS Emulsion for injection for cattle under authorised conditions of use.
Ker takrat še ni bil ugotovljen osnovni vzrok za pojav opaženih neželenih dogodkov, je veljalo, da predlagane spremembe povzetka glavnih značilnosti zdravila in literature o zdravilu pri odobrenih pogojih uporabe ne zadostujejo v celoti za zmanjšanje tveganja za anafilaktične dogodke po uporabi zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo.
The CVMP concluded that the overall benefit-risk balance of the product is unfavourable under the authorised conditions of use.
CVMP je sklenil, da pri odobrenih pogojih uporabe skupno razmerje med koristmi in tveganji tega zdravila ni ugodno.
Fortekor Plus is given twice daily approximately one hour before feeding.
Zdravilo Fortekor Plus se daje dvakrat na dan, približno eno uro pred hranjenjem.
The European Commission granted a marketing authorisation valid throughout the European Union for Fortekor Plus on 8 September 2015.
Evropska komisija je dovoljenje za promet z zdravilom Fortekor Plus, veljavno po vsej Evropski uniji, izdala 8. septembra 2015.
The full EPAR for Fortekor Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Fortekor Plus je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Fortekor Plus.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fortekor Plus.
Other information about Fortekor Plus
Druge informacije o zdravilu Fortekor Plus
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) decided that Fortekor Plus' benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Fortekor Plus večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Congestive heart failure is a condition where the heart cannot pump enough blood around the body.
Kongestivno srčno popuščanje je stanje, pri katerem srce ne more črpati dovolj krvi po telesu.
The most common side effects with pimobendan (which may affect more than 1 in 10,000 dogs) are an increase in heart rate and vomiting.
Najpogostejši neželeni učinki pimobendana (ki lahko prizadenejo več kot 1 psa od 10 000) so povišanje srčnega utripa in bruhanje.
The dose is adjusted according to bodyweight.
Odmerek je treba prilagoditi v skladu s telesno maso.
This allows the blood pressure to drop, reducing the load on the heart.
S tem se zniža krvni tlak in zmanjša obremenitev srca.
What are the risks associated with Fortekor Plus?
Kakšna tveganja so povezana z zdravilom Fortekor Plus?
It is not intended to provide practical advice on how to use Fortekor Plus.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Fortekor Plus approved?
Zakaj je bilo zdravilo Fortekor Plus odobreno?
Fortekor Plus is available as tablets (pimobendan 1.25 mg/benazepril hydrochloride 2.5 mg and pimobendan 5 mg/benazepril hydrochloride 10 mg) and can only be obtained with a prescription.
Zdravilo Fortekor Plus je na voljo v obliki tablet (pimobendan 1,25 mg/benazeprilijev klorid 2,5 mg in pimobendan 5 mg/benazeprilijev klorid 10 mg) in se izdaja le na recept.
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Pojasnjuje, kako je agencija ocenila to zdravilo za uporabo v veterinarski medicini, na podlagi česar je priporočila njegovo odobritev v Evropski uniji (EU) in pogoje njegove uporabe.
What is Fortekor Plus and what is it used for?
Kaj je zdravilo Fortekor Plus in za kaj se uporablja?
Pregnant women should take special care to avoid accidentally swallowing Fortekor Plus because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy.
Nosečnice morajo biti posebej previdne, da preprečijo nenamerno zaužitje zdravila Fortekor Plus, saj je bilo ugotovljeno, da zaviralci angiotenzinske konvertaze (ACE) vplivajo na nerojenega otroka med nosečnostjo.
What benefits of Fortekor Plus have been shown in studies?
Kakšne koristi je zdravilo Fortekor Plus izkazalo v študijah?
The most common side effects with benazepril are short-lived episodes of vomiting, incoordination or signs of tiredness.
Najpogostejši neželeni učinki benazeprila so kratkotrajne epizode bruhanja, motnje koordinacije ali znaki utrujenosti.
People who are hypersensitive (allergic) to pimobendan or benazepril hydrochloride should avoid contact with Fortekor Plus.
Ljudje, ki so preobčutljivi za (alergični na) pimobendan ali benazeprilijev klorid, se morajo izogibati stiku z zdravilom Fortekor Plus.
It also must not be given to dogs with low blood pressure, low blood volume, low blood sodium levels or acute (short-term) kidney failure.
Prav tako se ne sme dati psom z nizkim krvnim tlakom, nizkim volumnom krvi, nizkimi ravnmi natrija ali akutno (kratkotrajno) odpovedjo ledvic.
When the production of angiotensin II is lowered, the blood vessels relax and widen.
Z manjšim nastajanjem angiotenzina II se krvne žile sprostijo in razširijo.
Fortekor Plus must not be given to dogs with hypertrophic cardiomyopathy (heart muscle disease where the walls of the heart thicken reducing blood output), clinical conditions where heart output cannot increase because of functional or anatomical reasons (e.g. narrowing of the aorta or pulmonary artery).
Zdravilo Fortekor Plus se ne sme dati psom s hipertrofično kardiomiopatijo (bolezen srčne mišice, pri kateri odebeljene srčne stene zmanjšajo izhodni srčni volumen), ter kliničnimi stanji, pri katerih povečanje izhodnega volumna srca ni mogoče zaradi funkcionalnih ali anatomskih razlogov (npr. zoženja aorte ali pljučne arterije).
The main measure of effectiveness was the total score of exercise intolerance, demeanour, breathing effort, coughing and difficulty of breathing at night.
Glavno merilo učinkovitosti je bilo skupna ocena intolerance za telesno dejavnost, razpoloženja, težav z dihanjem, kašlja in težav z dihanjem ponoči.
Benazepril is a prodrug, a substance that is converted to benazeprilat in the body.
Benazepril je predzdravilo, tj. snov, ki se v telesu pretvori v benazeprilat.
Fortekor Plus is a veterinary medicine used to treat congestive heart failure in dogs.
Fortekor Plus je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zdravljenje kongestivnega srčnega popuščanja pri psih.
For more information about treatment with Fortekor Plus, read the package leaflet (also part of the EPAR) or contact your veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Fortekor Plus preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z veterinarjem ali farmacevtom.
ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Zaviralci ACE zavirajo nastajanje angiotenzina II, ki je močan vazokonstriktor (snov, ki oži krvne žile).
Pimobendan is an inotropic (heart stimulant) substance which increases the strength of the contraction of heart muscle and opens up blood vessels carrying blood to and from the heart, which reduces the work of the heart.
Pimobendan je inotropna učinkovina (srčni stimulans), ki poveča jakost krčenja srčne mišice in razširi krvne žile, po katerih kri potuje v srce in iz njega, s čimer zmanjša napor srca.
For the full list of all restrictions and side effects reported with Fortekor Plus, see the package leaflet.
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Fortekor Plus, glejte navodilo za uporabo.
For practical information about using Fortekor Plus, animal owners/keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Fortekor Plus naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Benazeprilat is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Benazeprilat je zaviralec encima angiotenzinske konvertaze (ACE).
Both pimobendan and benazepril are already authorised for dogs as separate medicines.
Tako pimobendan kot benazepril sta že odobrena za uporabo pri psih v obliki ločenih zdravil.
Pimobendan/benazepril hydrochloride
Fortekor Plus pimobendan/benazeprilijev klorid
In a field study involving 67 dogs with congestive heart failure treatment with Fortekor Plus was compared to pimobendan and benazepril given as separate treatments.
V terenski študiji, ki je vključevala 67 psov s kongestivnim srčnim popuščanjem, so zdravilo Fortekor Plus primerjali s pimobendanom in benazeprilom, danima v obliki ločenih zdravil.
It is only for use in dogs whose heart failure is already being controlled by the same doses of pimobendan and benazepril hydrochloride given as separate medicines.
Namenjeno je le za uporabo pri psih, pri katerih je srčno popuščanje že nadzorovano z enakima odmerkoma pimobendana in benazeprilijevega klorida, danih kot ločeni zdravili.
Safety information has been included in the summary of product characteristics and the package leaflet for Fortekor Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners/keepers.
V povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
The study showed Fortekor Plus to be as effective as pimobendan and benazepril when given as separate treatments.
Študija je pokazala, da je zdravilo Fortekor Plus enako učinkovito kot pimobendan in benazepril, dana v obliki ločenih zdravil.
How is Fortekor Plus used?
Kako se zdravilo Fortekor Plus uporablja?
Fortekor Plus contains two active substances, pimobendan and benazepril hydrochloride.
Zdravilo Fortekor Plus vsebuje dve zdravilni učinkovini, pimobendan in benazeprilijev klorid.
How does Fortekor Plus work?
Kako zdravilo Fortekor Plus deluje?
12 vials Meat and offal: 15 days (cattle), 5 days (pigs, horses)
12 viale Meso in drobovina: 15 dni (govedo), 5 dni (prašiči, konji) Mleko: 5 dni (govedo)
The company withdrew before the European Commission had issued a decision on this opinion.
Družba je umaknila vlogo, preden je Evropska komisija izdala odločbo o tem mnenju.
The virus has first been inactivated so that it does not cause any disease.
Virus so prej inaktivirali, tako da ne povzroča bolezni.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo v rubriki „All documents“ (Vsi dokumenti).
This is a special type of vaccine that is designed to help with the management of a pandemic.
To je posebna vrsta cepiva, ki je zasnovana za pomoč pri obvladovanju pandemije.
The main measure of effectiveness was the level of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Glavno merilo učinkovitosti je bila raven protiteles proti virusu gripe v krvi v različnih obdobjih: pred cepljenjem, na dan druge injekcije (21. dan) in 21 dni pozneje (42. dan).
This is expected to help to protect against the disease caused by the virus.
To naj bi pripomoglo k zaščiti pred boleznijo, ki jo povzroča virus.
The injections were given 21 days apart.
Injekcije so bile dane v razmiku 21 dni.
The vaccine also contains an ‘adjuvant' (a compound containing aluminium), which is expected to stimulate a better response.
Cepivo vsebuje tudi „adjuvans“ (sestavino, ki vsebuje aluminij), ki naj bi spodbudil boljši odziv.
Therefore, the Committee was also concerned that the vaccine's immunogenicity was low, regardless of the strain of virus included, and that the vaccine might not be able to adequately prepare the immune system for future infections.
Odbor je zato izrazil tudi pomislek, da je imunogenost cepiva nizka ne glede na vključeni sev virusa in da cepivo morda ne bo sposobno ustrezno pripraviti imunski sistem na prihodnje okužbe.
Emerflu contains a flu strain called ‘A/Vietnam/1194/2004 NIBRG 14' (H5N1).
Zdravilo Emerflu vsebuje sev gripe, imenovan „A/Vietnam/1194/2004 NIBRG 14“ (H5N1).