natgillin/translations-raw huggingface dataset:
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta Rok uporabnosti po prvem odpiranju vsebnika: 6 mesecev.
Halofuginone lactate (RU 38788) is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Halofuginon laktat (RU 38788) je sol, katere učinek proti protozojem in
Intervet Productions SA Rue de Lyons F-27460 Igoville France
F-27460 Igoville
Avoid skin, eye or mucosal contact with the product.
Pazite, da zdravilo ne pride v stik s kožo, očmi ali sluznico.
To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Zaradi natančnega odmerjanja je zdravilo treba dajati z brizgo ali ustrezno napravo za peroralno dajanje.
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
Marketing authorisation holder: Intervet International B.V. Wim de Körverstraat 35
IMETNIK(I) DOVOLJENJ(A) ZA PROMET Intervet International B.V.
High-density polyethylene portable bottle of 500 ml containing 490 ml of the oral solution.
Prenosna 500 ml plastenka iz polietilena visoke gostote s 490 ml peroralne raztopine.
HALOCUR 0.5 mg/ml oral solution for calves
HALOCUR 0,5 mg/ml, peroralna raztopina za teleta
PACKAGE LEAFLET: HALOCUR 0.5 mg/ml oral solution for calves
NAVODILO ZA UPORABO HALOCUR 0,5 mg/ml, peroralna raztopina za teleta
High-density polyethylene portable bottle of 1000 ml containing 980 ml of the oral solution.
Prenosna 1000 ml plastenka iz polietilena visoke gostote z 980 ml peroralne raztopine.
EXP: month/year Once broached, use within 6 months.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: mesec/leto
New born calves
Novorojena teleta
The veterinary medicinal product is a canary yellow oral solution.
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Zdravilo za uporabo v veterinarski medicini je peroralna raztopina kanarsko rumene barve.
500 ml bottle containing 490 ml of oral solution 1000 ml bottle containing 980 ml of oral solution
500 ml plastenka s 490 ml peroralne raztopine
Tartrazine (E 102)
1,00 mg/ml tartrazin (E 102)
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
BESEDILO “ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
Name and address of the manufacturer responsible for batch release
A. PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega (odgovornih) za sproščanje serij Intervet Productions SA
Immediate Packaging Content (concentratio n)
Vsebina (koncentracija)
1 blister (7 tablets)
7 tablet 1 pretisni omot (7 tablet)
Subcutaneous or intravenous use (dogs), subcutaneous use (cats)
psi in mačke subkutana ali intravenska uporaba (psi), subkutana uporaba (mačke)
Intramuscular use (pigs)
Subkutana intravenska uporaba (goveda), intramuskularna uporaba (prašiči), intravenska uporaba (konji)
Oral suspension Horses
navedba smiselno ni potrebna konji
Oral suspension Pigs
mačke subkutana uporaba mačke subkutana uporaba prašiči prašiči
20 February 2014 EMA/108603/2014
20. februar 2014 EMA/108603/2014
In the EU, acipimox-containing medicines are currently marketed in Austria, Belgium, Denmark, Hungary, Italy, Luxembourg, the Netherlands and the United Kingdom.
V EU se zdravila, ki vsebujejo acipimoks, trenutno tržijo v Avstriji, Belgiji, na Danskem, Madžarskem, v Italiji, Luksemburgu, na Nizozemskem in v Združenem kraljestvu.
• Patients who have any questions should ask their doctor or pharmacist.
• Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo s svojim zdravnikom ali farmacevtom.
2 More information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Referrals/Tredaptive, Pelzont and Trevaclyn.
2 Več informacij je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Referrals/Tredaptive, Pelzont and Trevaclyn.
This was endorsed by the CMDh.
To je odobrila skupina CMDh.
1 The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
1 Skupina CMDh je organ, ki zastopa države članice EU in je odgovoren za zagotovitev enotnih varnostnih standardov za zdravila, ki so v EU odobrena po nacionalnih postopkih.
• Most patients taking acipimox are already using it in this way, but the product information is being updated to clarify the recommended use.
• Večina bolnikov, ki jemljejo acipimoks, ga že uporablja na ta način, vendar so bile posodobljene tudi informacije o zdravilu, tako da pojasnjujejo priporočeno uporabo.
Medicines containing nicotinic acid or related substances have been authorised in the EU via national procedures since the mid-1950s.
Zdravila, ki vsebujejo nikotinsko kislino ali sorodne učinkovine, so v EU z nacionalnimi postopki odobrena od sredine petdesetih let 20. stoletja.
The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Priporočila Odbora PRAC so bila posredovana koordinacijski skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
• Acipimox is a medicine used to treat disorders related to high levels of fat in the blood.
• Acipimoks je zdravilo, ki se uporablja za zdravljenje motenj, povezanih z visokimi ravnmi maščob v krvi.
These recommendations were originally made by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 5-8 November 2013.
Ta priporočila je Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri agenciji pripravil na svoji seji, ki je potekala od 5. do 8. novembra 2013.
In higher doses, it reduces the levels of fat in the blood.
V večjih odmerkih zniža ravni maščob v krvi.
Acipimox-containing medicines should be used when changes in lifestyle, including diet and exercise, and treatment with other medicines are not adequate.
Zdravila, ki vsebujejo acipimoks, se smejo uporabiti, kadar spremembe življenjskega sloga, vključno z dieto in telesno vadbo, ter zdravljenje z drugimi zdravili niso zadostni.
Nicotinic acid is a naturally occurring substance used in low doses as a vitamin (known as niacin or vitamin B3).
Nikotinska kislina je naravno prisotna snov, ki se v majhnih odmerkih uporablja kot vitamin (znan pod imenom niacin ali vitamin B3).
As a result, the European Medicines Agency recommended the suspension of medicines containing the combination of nicotinic acid and laropiprant across the EU2.
Posledično je Evropska agencija za zdravila priporočila umik zdravil, ki vsebujejo kombinacijo nikotinske kisline in laropipranta, v celotni EU2.
The review of nicotinic acid and its related substances acipimox and xantinol nicotinate was initiated on 27 February 2013 at the request of the Danish Health and Medicines Authority, under Article 31 of Directive 2001/83/EC.
Presoja nikotinske kisline in sorodnih učinkovin, acipimoksa ter ksantinolnikotinata, je bila skladno s členom 31 Direktive 2001/83/ES sprožena 27. februarja 2013 na zahtevo danskega organa za zdravje in zdravila.
As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.
Ker je skupina CMDh stališče sprejela z večino glasov, je bilo posredovano Evropski komisiji, ki ga je potrdila in dne 20. februarja 2014 izdala pravno zavezujoč sklep, ki velja za celotno EU.
Laropiprant has no effect on cholesterol but it reduces flushing, which is a known side effect of nicotinic acid.
Laropiprant nima učinka na holesterol, vendar zmanjša zardevanje, ki je znan neželeni učinek nikotinske kisline.
In addition, the PRAC consulted an ad-hoc expert group of European experts on the use of acipimox.
Poleg tega se je odbor PRAC o uporabi acipimoksa posvetoval z začasno strokovno skupino evropskih strokovnjakov.
Nicotinic acid was also authorised in combination with laropiprant.
Nikotinska kislina je bila odobrena tudi v kombinaciji z laropiprantom.
On 18 December 2013, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 confirmed by majority that medicines containing acipimox should have their marketing authorisations amended to ensure that they are used across the European Union only as an additional or alternative treatment in type IIb and type IV hyperlipoproteinaemia.
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh)1 je 18. decembra 2013 večinsko potrdila, da je treba dovoljenja za promet z zdravili, ki vsebujejo acipimoks, spremeniti, tako da bi zagotovili, da se ta zdravila v Evropski uniji uporabljajo samo kot dodatno ali alternativno zdravljenje hiperlipoproteinemije tipa IIb in IV.
The CMDh endorsed the PRAC recommendations by majority at its meeting of 16-18 December 2013 and its position was sent to the European Commission which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.
Skupina CMDh je na svoji seji od 16. do 18. decembra 2013 večinsko podprla priporočila odbora PRAC, njeno mnenje je bilo posredovano Evropski komisiji, ki ga je potrdila in 20. februarja 2014 izdala pravno zavezujočo odločbo, ki velja za celotno EU.
• Based on the available data, the indications for acipimox should be restricted to alternative or adjunct treatment in patients who have not responded adequately to other treatments such as statin or fibrate treatment.
• Glede na razpoložljive podatke je treba indikacije za acipimoks omejiti na alternativno ali dodatno zdravljenje pri bolnikih, ki se niso zadostno odzvali na druge oblike zdravljenja, kot je zdravljenje s statinom ali fibratom.
The PRAC concluded that the benefit-risk balance of acipimox-containing products remains favourable under normal conditions of use, subject to the agreed changes to the product information.
Odbor PRAC je zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo acipimoks, v običajnih pogojih uporabe še naprej ugodno pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu.
The study showed that adding this combination to treatment with statins (another class of medicines used to treat lipid disorders) did not lead to additional benefits in reducing the risk of major vascular events such as heart attack and stroke, but did result in a higher frequency of non-fatal but serious side effects.
Študija je pokazala, da dodajanje te kombinacije k zdravljenju s statini (drugim razredom zdravil za zdravljenje motenj lipidov) ni ustvarilo dodatnih koristi pri zmanjševanju tveganja velikih žilnih dogodkov, kot so srčna in možganska kap, vendar je povzročilo večjo pogostnost nesmrtnih, a resnih neželenih učinkov.
The review of acipimox was based on the limited available efficacy and safety data on acipimox as well as data from the scientific literature relating to the structurally related compound nicotinic acid.
Presoja acipimoksa je temeljila na omejenih razpoložljivih podatkih o učinkovitosti in varnosti acipimoksa ter podatkih iz znanstvene literature, povezanih s strukturno sorodno učinkovino, nikotinsko kislino.
Its uses and safety have been reviewed because of a study showing that a related medicine, nicotinic acid, increased the side effects and gave no additional benefit when it was taken together with other treatments for these disorders.
Presoja njegove uporabe in varnosti je bila opravljena, ker je študija pokazala, da je sorodno zdravilo, nikotinska kislina, povečalo neželene učinke, pri tem pa ni izkazalo nobene dodatne koristi, kadar se je uporabljalo skupaj z drugimi oblikami zdravljenja teh motenj.
• Having reviewed the available safety data, including data on nicotinic acid obtained from HPS2THRIVE, the PRAC considered the safety profile of acipimox to be well characterised.
• Po pregledu razpoložljivih podatkov o varnosti, vključno s podatki o nikotinski kislini iz študije HPS2-THRIVE, je odbor PRAC menil, da je varnostni profil acipimoksa dobro opredeljen.
After looking at the available data on acipimox, including evidence from the literature, spontaneous reports of adverse effects and advice from a group of experts in the treatment of lipid disorders, as well as data from HPS2-THRIVE, the PRAC concluded that acipimox continues to have a role as an additional or alternative treatment to reduce triglycerides in those forms of hyperlipoproteinaemia that involve high triglyceride levels (with or without increased cholesterol), in patients in whom lifestyle changes and use of other medicines such as fibrates and statins are not adequate.
Po pregledu razpoložljivih podatkov o acipimoksu, vključno z dokazi iz literature, spontanimi poročili o neželenih učinkih in nasveti skupine strokovnjakov za zdravljenje motenj lipidov, ter podatkov iz študije HPS2-THRIVE je odbor PRAC sklenil, da ima acipimoks še vedno vlogo pri dodatnem ali alternativnem zdravljenju za zniževanje ravni trigliceridov pri oblikah hiperlipoproteinemije, ki vključujejo visoke ravni trigliceridov (s povišano vrednostjo holesterola ali brez nje), pri bolnikih, pri katerih spremembe življenjskega sloga in uporaba drugih zdravil, kot so fibrati in statini, niso
Patients receiving acipimox should have their treatment reviewed at their next regular appointment.
Pri bolnikih, ki jemljejo acipimoks, je treba pri naslednjem rednem obisku ponovno oceniti zdravljenje.
Because acipimox was related to nicotinic acid and was marketed for lipid disorders in the EU, its benefit-risk balance was also then reviewed.
Ker je acipimoks soroden nikotinski kislini in se je v EU tržil za zdravljenje motenj lipidov, se je opravila tudi presoja razmerja med njegovimi tveganji in koristmi.
These are conditions involving hypertriglyceridaemia (high levels of triglycerides, a type of fat, in the blood), with or without increased cholesterol.
Gre za stanja, ki vključujejo hipertrigliceridemijo (visoke ravni trigliceridov, vrste maščob, v krvi) s povišano ravnijo holesterola ali brez nje.
• The review has shown that acipimox can be useful as an additional or alternative treatment to lower high levels of triglycerides (a particular type of fat) in the blood of patients with high levels of these fats (with or without high cholesterol), who cannot be treated by means such as diet, exercise, or other medicines.
• Presoja je pokazala, da je lahko acipimoks koristen kot dodatno ali alternativno zdravljenje za zniževanje visoke ravni trigliceridov (vrste maščob) v krvi pri bolnikih z visokimi ravnmi teh maščob (s povišano ravnijo holesterola ali brez nje), ki jih ni mogoče zdraviti z ukrepi, kot so dieta, telesna vadba ali druga zdravila.
It was noted that acipimox was of particular use in patients who either do not tolerate statin or fibrates or who do not achieve triglyceride goals with statin or fibrate therapy alone and could therefore be used as an alternative or adjunct treatment to reduce triglyceride levels in these patients.
Ugotovili so, da je acipimoks zlasti učinkovit pri bolnikih, ki ne prenašajo statinov ali fibratov ali pri monoterapiji s statinom ali fibratom ne dosežejo ciljnih ravni trigliceridov, zato bi se lahko uporabljal kot alternativno ali dodatno zdravljenje za zniževanje ravni trigliceridov pri teh bolnikih.
However, findings from the HPS2-THRIVE study were used to expand the warnings in the acipimox product information concerning a possible increased risk of painful muscle damage when acipimox is used together with a statin.
Vendar so se ugotovitve študije HPS2-THRIVE uporabile za razširitev opozoril v informacijah o zdravilu za acipimoks v zvezi z morebitnim povečanim tveganjem boleče mišične poškodbe, kadar se acipimoks uporablja skupaj s statinom.
• Acipimox is indicated for the treatment of hypertriglyceridaemia with or without hypercholesterolaemia (Fredrickson type IIb or type IV hyperlipoproteinaemia).
• Acipimoks je indiciran za zdravljenje hipertrigliceridemije s hiperholesterolemijo ali brez nje (hiperlipoproteinemija Fredricksonovega tipa IIb ali IV).
Flushing, rash and gastrointestinal effects (nausea, dyspepsia, diarrhoea and upper abdominal pain) are the most frequently reported adverse effects for acipimox and are listed in the acipimox product information, together with pruritus, erythema, urticaria and angioedema.
Najpogosteje poročani neželeni učinki acipimoksa so zardevanje, izpuščaj in učinki na prebavila (navzeja, dispepsija, driska ter bolečina v zgornjem delu trebuha) in so navedeni v informacijah o zdravilu skupaj s srbenjem, eritemom, urtikarijo in angioedemom.
Acipimox is a substance closely related to nicotinic acid that has been available since 1984 as Olbetam and other trade names for the treatment of lipid disorders.
Acipimoks je učinkovina, zelo podobna nikotinski kislini, ki je od leta 1984 pod lastniškim imenom Olbetam in drugimi imeni na voljo za zdravljenje motenj lipidov.
The PRAC considered that the available data did not identify any new safety information which impacts the benefit-risk balance of acipimox, with the exception of a potential risk of muscle toxicity associated with the concomitant use of acipimox with statins, which was addressed by adding a warning to the product information.
Odbor PRAC je menil, da razpoložljivi podatki niso razkrili nobenih novih varnostnih podatkov, ki bi vplivali na razmerje med tveganji in koristmi acipimoksa, z izjemo morebitnega tveganja za toksične učinke na mišice, povezanega s sočasno uporabo acipimoksa in statinov, v zvezi s katerim so v informacije o zdravilu vključili opozorilo.
• Although the review of acipimox-containing medicines was originally triggered by concerns arising from the HPS2-THRIVE study, the extended release nicotinic acid/laropiprant combination used in that study cannot be regarded as the same as mono-component acipimox and the concerns can therefore not be extrapolated to acipimox, in particular due to the possible confounding effect of laropiprant.
• Čeprav so presojo zdravil, ki vsebujejo acipimoks, prvotno opravili zaradi pomislekov, ki izhajajo iz študije HPS2-THRIVE, kombinacije nikotinske kisline/laropipranta s podaljšanim sproščanjem, ki je bila uporabljena v tej študiji, ni mogoče obravnavati kot enake samostojni učinkovini, acipimoksu, zato pomislekov ni mogoče prenesti na acipimoks, predvsem zaradi morebitnih dodatnih učinkov laropipranta.
The original reason for the review of acipimox was HPS2-THRIVE, a large study which looked at the long-term effect of the combination of nicotinic acid (a substance related to acipimox) and another medicine, laropiprant, in treating lipid disorders.
Prvotni razlog za presojo acipimoksa je bila velika študija HPS2-THRIVE, ki je proučevala dolgotrajne učinke kombinacije nikotinske kisline (snovi, sorodne acipimoksu) in drugega zdravila, laropipranta, pri zdravljenju motenj lipidov.
In July 2013 it was established that nicotinic acid and the related substance xantinol nicotinate were not currently marketed in the EU to treat lipid disorders (xantinol nicotinate is authorised in some EU countries for oral use as a vasodilator, a medicine that widens the blood vessels used to treat blood circulation problems) and the review was therefore restricted to acipimox only.
EU trenutno ne tržita za zdravljenje motenj lipidov (ksantinolnikotinat je v nekaterih državah EU odobren za peroralno uporabo kot vazodilatator, zdravilo, ki razširi krvne žile in se uporablja za zdravljenje težav s krvnim obtokom), zato je bila presoja omejena samo na acipimoks.
• Patients taking acipimox should have their treatment re-evaluated at their next regular appointment.
• Pri bolnikih, ki jemljejo acipimoks, mora zdravnik pri naslednjem rednem obisku ponovno oceniti zdravljenje.
CMDh endorses PRAC recommendation
Skupina CMDh je podprla priporočilo odbora PRAC.
• Acipimox was considered to be efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and significantly superior to placebo in patients with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia).
• Menili so, da je acipimoks učinkovit pri zniževanju ravni trigliceridov pri bolnikih s hipertrigliceridemijo (hiperlipoproteinemijo tipa IV po Fredricksonu) in pomembno superioren v primerjavi s placebom pri bolnikih s hiperholesterolemijo ter hipertrigliceridemijo (hiperlipoproteinemijo tipa IIb po Fredricksonu).
• However, based on the results from HPS2-THRIVE and the chemical similarity of acipimox and nicotinic acid, prescribers should be aware of the potential increased risk of myopathy when acipimox is used in combination with a statin.
• Rezultati študije HPS2-THRIVE in kemijsko podobne značilnosti acipimoksa ter nikotinske kisline pa kažejo, da morajo biti predpisovalci seznanjeni z morebitnim povečanim tveganjem miopatije, kadar se acipimoks uporablja v kombinaciji s statinom.
The results from HPS2-THRIVE could not be applied directly to acipimox since the study investigated the effect of the combination with laropiprant, whose effects were not established, and possible differences between
Rezultatov študije HPS2-THRIVE ni mogoče neposredno prenesti na acipimoks, saj je študija preiskovala učinek kombinacije z laropiprantom, pri katerem učinki niso bili ugotovljeni, prav tako pa so odkrili morebitne razlike med nikotinsko kislino in acipimoksom.
• Based on the available data, the PRAC noted a number of clinical differences between acipimox and nicotinic acid, with acipimox having a longer duration of action and non-clinical studies showing that acipimox is consistently less potent than nicotinic acid as an agonist of the HCA2 receptor.
• Na podlagi razpoložljivih podatkov je odbor PRAC izpostavil številne klinične razlike med acipimoksom in nikotinsko kislino: delovanje acipimoksa je daljše, predklinične študije pa so pokazale, da je acipimoks kot agonist receptorja HCA 2 šibkejši kot nikotinska kislina.
• The main role of acipimox is to prevent the non-cardiovascular complications of hypertriglyceridaemia and acipimox should not be used for the prevention of cardiovascular disease in the absence of convincing LDL-C or outcome data.
Acipimoks se ne sme uporabljati za preprečevanje kardiovaskularne bolezni, če niso prisotni prepričljivi podatki o holesterolu LDL ali drugih izidih.
The marketing authorisation was renewed on 19 July 2001 and on 19 July 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano 19. julija 2001 in 19. julija 2006.
The additional studies showed that starting vaccination at six weeks was adequate, and that a booster dose is needed in the second year of life in order to maintain protection.
Dodatne študije so pokazale, da je začetek cepljenja pri šestih tednih primeren ter da je potreben obnovitveni odmerek v drugem letu starosti, da se zaščita ohrani.
The active substances in Tritanrix HepB have been available in the European Union (EU) for a number of years in other vaccines.
Zdravilne učinkovine v cepivu Tritanrix HepB so bile na voljo v Evropski uniji (EU) že več let v drugih cepivih.
The recommended vaccination schedule consists of three doses within the first six months of life, with at least four weeks between each dose.
Priporočena shema cepljenja je sestavljena iz treh odmerkov, ki se jih daje v prvih šestih mesecih življenja s časovnimi presledki najmanj 4 tedne.
A booster dose is recommended before the end of the second year of life.
Priporočljivo je obnovitveno cepljenje pred zaključkom drugega leta življenja.
This means that the toxoids and the parts of the hepatitis B virus are fixed onto aluminium compounds, to stimulate a better immune response.
To pomeni, da sta toksoida in deli virusa hepatitisa B fiksirani na aluminijeve spojine za boljšo stimulacijo imunskega odziva.