natgillin/translations-raw huggingface dataset:
10 ml glass vial containing either 3ml or 6 ml
10-mililitrska steklena viala vsebuje 3 ml ali 6 ml razpršilnik za 50 µl
Veterinary medicinal product subject to prescription
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE
CARTON
Presnova
90 (3 x 30) tablets (multipack)
90 (3 × 30) filmsko obloženih tablet (skupno pakiranje)
30 x 1 tablets (unit dose)
30 x 1 tableta (enojno pakiranje)
Invented name Strength Pharmaceutical Form Route of Administration
Farmacevtska oblika
It contains inactivated (killed) whole virus of two equine influenza (flu) strains (‘A/equine-2/South Africa/4/03' and ‘A/equine-2/Newmarket/2/93').
Vsebuje inaktivirana (uničena) cela virusa dveh sevov influence (gripe) konj („A/konjski-2/Južna Afrika/4/03“ in „A/konjski-2/Newmarket/2/93“).
The swelling is expected to decrease within two days.
Oteklina naj bi izginila v dveh dneh.
In very rare cases fever may occur for one day, and up to three days in exceptional circumstances.
V zelo redkih primerih se lahko pojavi povišana telesna temperatura, ki traja en dan, oziroma izjemoma do tri dni.
Equine influenza is a highly contagious disease that is very common in horses but that rarely causes death.
Influenca konj je zelo nalezljiva bolezen, ki je pri konjih zelo pogosta, vendar redko povzroči pogin.
These equine influenza viruses have been inactivated so that they can no longer cause disease.
Ti virusi so bili inaktivirani, tako da ne morejo povzročiti bolezni.
This should be followed by a third vaccination five months later, and afterwards by yearly revaccinations.
Temu sledi tretje cepljenje pet mesecev kasneje, nato pa obnovitveno cepljenje vsako leto.
The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza on 8 July 2005.
Evropska komisija je dovoljenje za promet z zdravilom Equilis Prequenza, veljavno po vsej Evropski uniji, odobrila dne 8. julija 2005.
The duration of protection was five months after primary vaccination and 12 months after the first revaccination.
Zaščita je trajala pet mesecev po osnovnem cepljenju in 12 mesecev po prvem ponovnem cepljenju.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided led to the recommendations on the conditions of use.
Njegov namen je pojasniti, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi katere je oblikoval priporočila glede uporabe zdravila.
Vaccines work by ‘teaching' the immune system how to defend itself against diseases.
Cepiva delujejo tako, da imunski sistem „naučijo“, kako naj se brani pred boleznimi.
The effectiveness of the current formulation of the vaccine has been assessed in additional laboratory studies.
Učinkovitost trenutne formulacije je bila raziskana v dodatnih laboratorijskih študijah.
The studies also compared the clinical signs and virus excretion of a group of vaccinated animals with those of a control group, i.e. which did not receive the vaccine.
V študijah so primerjali tudi klinične znake in izločanje virusa pri cepljenih živalih in živalih iz kontrolne skupin, tj. tistih, ki niso prejele cepiva.
Pain at the injection site can occur rarely.
Na mestu injiciranja se lahko redko pojavi bolečina.
A hard or soft swelling may occur at the injection site.
Na mestu injiciranja se lahko pojavi trda ali mehka oteklina.
When a horse is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against them.
Ko konj prejme cepivo, imunski sistem prepozna virus kot „tujek“ in proti njim tvori protitelesa.
The main measure of effectiveness was the production of protective levels of antibodies against the influenza components.
Glavno merilo učinkovitosti tvorjenje zaščitnih ravni protiteles proti sestavinam influence.
Other information about Equilis Prequenza:
Druge informacije o zdravilu Equilis Prequenza:
The vaccine is given as an injection into a muscle.
Cepivo se daje z injiciranjem v mišico.
Horses should receive a primary vaccination, consisting of two injections given four weeks apart.
Konji potrebujejo osnovno cepljenje, ki vključuje dve injiciranji, ki se izvedeta v razmiku štirih tednov.
The vaccine is available as a suspension for injection.
Cepivo je na voljo v obliki suspenzije za injiciranje.
The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption or before the milk can be used for human consumption.
Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje, meso ali mleko pa uporabi za prehrano ljudi.
The vaccine also contains an ‘adjuvant' to enhance the immune response.
Cepivo vsebuje tudi adjuvans za povečanje imunskega odziva.
Horses developed protection two weeks after primary vaccination.
Pri konjih so se zaščitne ravni razvile dva tedna po osnovnem cepljenju.
Equilis Prequenza is a vaccine for use in horses.
Equilis Prequenza je cepivo, ki se uporablja pri konjih.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza exceed the risks for the approved indications and recommended that Equilis Prequenza be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva Equilis Prequenza večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The current formulation of Equine Prequenza has been shown to produce similar results to those shown in the initial studies.
Za trenutno formulacijo cepiva Equilis Prequenza je bilo dokazano, da ima podobne rezultate, kot so bili doseženi v prvotnih študijah.
The effectiveness of Equilis Prequenza was initially studied in several trials under laboratory and field conditions.
Učinkovitost zdravila Equilis Prequenza so prvotno raziskali v več preskušanjih, izvedenih v laboratorijskih in terenskih pogojih.
The safety of the initial formulation of Equilis Prequenza was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age.
Varnost zdravila prvotne formulacije cepiva Equilis Prequenza so raziskovali v več študijah, izvedenih v laboratorijskih in terenskih pogojih na številnih konjih, starejših od dveh mesecev.
The vaccine reduces the signs of equine influenza and the excretion (shedding) of the virus after infection.
Cepivo zmanjšuje znake influence in izločanje virusa po okužbi.
Equilis Prequenza contains inactivated whole virus of the influenza strains against which the vaccine is indicated.
Zdravilo Equilis Prequenza vsebuje inaktivirane cele viruse sevov influence, za katere je cepivo indicirano.
The initial studies showed that Equilis Prequenza is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, in horses from 6 months of age.
Študije so pokazale, da je zdravilo Equilis Prequenza učinkovito cepivo proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi pri konjih, starejših od šest mesecev.
The viruses included in the current formulation of Equilis Prequenza are grown in mammalian cells, unlike those in the initial formulation, which were grown in hens' eggs.
Viruse, ki so vključeni v trenutno formulacijo cepiva Equilis Prequenza, gojijo v celicah sesalcev, virusi v prvotni formulaciji cepiva pa so bili gojeni v kokošjih jajcih.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains.
Ko bo imunski sistem naslednjič izpostavljen kateremu od teh virusnih sevov, bo lahko hitreje tvoril protitelesa.
The withdrawal period for Equilis Prequenza for meat and milk is zero days.
Karenca za cepivo Equilis Prequenza za meso in mleko je nič dni.
What benefit has Equilis Prequenza shown during the studies?
Kakšne koristi je zdravilo Equilis Prequenza izkazalo med študijami?
Most of the studies used Equilis Prequenza Te, a vaccine which protects against tetanus as well as the strains of equine influenza included in Equilis Prequenza.
V večini študij je bilo uporabljeno cepivo Equilis Prequenza Te, ki ščiti tako pred tetanusom in pred sevi virusov influence konj, ki so vključeni v cepivo Equilis Prequenza.
The antibodies will then help to protect against the disease caused by these strains of the equine influenza virus.
Ta mu bodo pomagala pri obrambi pred boleznijo, ki jo ti sevi virusa influence konj povzročajo.
Why has Equilis Prequenza been approved?
Zakaj je bilo zdravilo Equilis Prequenza odobreno?
Equilis Prequenza is used to vaccinate horses from six months of age against equine influenza.
Cepivo Equilis Prequenza se uporablja za cepljenje konj, ki so starejši od šestih mesecev, proti influenci konj.
What is the risk associated with Equilis Prequenza?
Kakšna tveganja so povezana s cepivom Equilis Prequenza?
How has Equilis Prequenza been studied?
Kako je bilo zdravilo Equilis Prequenza raziskano?
How does Equilis Prequenza work?
Kako zdravilo Equilis Prequenza deluje?
What is Equilis Prequenza?
Kaj je zdravilo Equilis Prequenza?
What is Equilis Prequenza used for?
Za kaj se zdravilo Equilis Prequenza uporablja?
Equine influenza vaccine
Equilis Prequenza cepivo proti influenci konj
Although a possible effect in these conditions was observed, several shortcomings were identified.
Čeprav je bil zaznan možen učinek pri teh stanjih, je bilo ugotovljenih več pomanjkljivosti.
1 Dry extract (DER 3-7.4:1), extraction solvent: ethanol 40-70% (V/V).
1 Suhi ekstrakt (DER 3-7,4:1), ekstrakcijsko topilo: etanol 40-70 % (v/v).
This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
To pomeni, da obstajajo podatki iz literature z znanstvenimi dokazi o njegovi učinkovitosti in varnosti pri uporabi na navedeni način, ki zajemajo obdobje vsaj 10 let v EU.
This means that, although there is insufficient evidence from clinical studies, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
To pomeni, da je kljub pomanjkljivim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi, da so se na navedeni način varno uporabljala že vsaj 30 let (najmanj 15 let tudi v EU).
Results showed improvements in the time it takes to fall asleep and sleep quality.
Rezultati so pokazali izboljšanje v smislu časa, potrebnega za uspavanje, in kakovosti spanja.
Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have baths with valerian root medicines.
Bolniki z odprtimi ranami, težavami s kožo, zelo povišano telesno temperaturo, hudimi okužbami ter resnimi težavami s srcem in prekrvavitvijo se ne smejo kopati v kopelih z zdravili, ki vsebujejo korenino zdravilne špajke.
DER or drug extract ratio is the ratio between the amount of herbal substance used and the quantity of extract obtained.
DER ali razmerje med rastlinsko drogo in ekstraktom je razmerje med uporabljeno količino rastlinske snovi in količino pridobljenega ekstrakta.
Valerian root medicines should be used only in adults and adolescents over the age 12 years.
Zdravila, ki vsebujejo korenino zdravilne špajke, se smejo uporabljati samo pri odraslih in mladostnikih, starejših od 12 let.
Valerian root is the common name for the underground parts of the plant Valeriana officinalis L.
Korenina zdravilne špajke je splošno ime za podzemne dele rastline Valeriana officinalis L.
This summary is not intended to provide practical advice on how to use medicines containing valerian root.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo korenino zdravilne špajke.
When used for the relief of mild nervous tension and sleep disorders, if symptoms persist or worsen after 2 weeks of continued use with the medicine, a doctor should be consulted.
Kadar se zdravilo uporablja za lajšanje blage živčne napetosti in motenj spanja in simptomi po dveh tednih neprekinjene uporabe zdravila ne izginejo ali se poslabšajo, se je treba posvetovati z zdravnikom.
These include nausea and abdominal cramps.
Ti vključujejo slabost in trebušne krče.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of valerian root.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo korenine zdravilne špajke.
The other herbal preparations of valerian root are available in solid or liquid form to be taken by mouth.
Drugi pripravki rastlinskega izvora s korenino zdravilne špajke so na voljo v trdni ali tekoči obliki za jemanje skozi usta.
The way valerian root medicines work is not fully known, but from some experiments it is thought that effects on the brain leading to relaxation and sleepiness might play a role.
Način delovanja zdravil s korenino zdravilne špajke ni v celoti znan, vendar nekateri poskusi kažejo, da morda vplivajo na možgane ter povzročajo sprostitev in zaspanost.
How does valerian root work as a medicine?
Kako korenina zdravilne špajke deluje kot zdravilo?
Further information on the risks associated with valerian root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o tveganjih, povezanih s temi zdravili, ki vsebujejo korenino zdravilne špajke, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
The HMPC conclusions only cover valerian root preparations which are obtained by drying and comminuting (reducing into tiny pieces) or powdering the underground parts of the plant, by expressing the juice of the fresh root, and as dry or liquid extracts.
Zaključki odbora HMPC zajemajo samo pripravke s korenino zdravilne špajke, ki se pridobivajo s sušenjem in drobljenjem (zmanjševanjem na majhne delce) ali z drobljenjem podzemnih delov rastline v prah, z iztiskanjem soka iz sveže korenine in kot suhi ali tekoči ekstrakti.
In its assessment, the HMPC also considered clinical studies involving patients with mild symptoms of mental stress and insomnia (difficulty sleeping).
V svoji oceni je odbor HMPC prav tako upošteval klinične študije, ki so vključevale bolnike z blagimi simptomi stresa in nespečnosti (težav s spanjem).
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing valerian root.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo korenino zdravilne špajke.
Any applications for the licensing of medicines containing valerian root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo korenino zdravilne špajke, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
Further information on the HMPC assessment of valerian root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o oceni zdravil, ki vsebujejo korenino zdravilne špajke, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
Herbal medicines containing comminuted valerian root are usually available as herbal tea to be drunk or as bath additives.
Zdravila rastlinskega izvora, ki vsebujejo zdrobljeno korenino zdravilne špajke, so navadno na voljo kot zdravilni čaj, ki se popije, ali kot dodatek kopeli.
Information on the use and licensing of valerian root medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in registraciji zdravil, ki vsebujejo korenino zdravilne špajke, v državah članicah EU se obrnite na pristojni nacionalni organ.
Extracts are prepared using a technique to extract compounds by putting the plant material in a solvent (such as ethanol, methanol or water) to dissolve compounds and form a liquid extract.
Ekstrakti se pripravljajo z uporabo tehnike, s katero se spojine ekstrahirajo tako, da se rastlinski material najprej namoči v topilo (npr. etanol, metanol ali vodo), v katerem se raztopijo spojine in se pridobi tekoči ekstrakt.
How are valerian root medicines approved in the EU?
Kako so zdravila, ki vsebujejo korenino zdravilne špajke, odobrena v EU?
Valerian root preparations may also be found in combination with other herbal substances in some herbal medicines.
Pripravki s korenino zdravilne špajke so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
Detailed instructions on how to take valerian root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o jemanju zdravil, ki vsebujejo korenino zdravilne špajke, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
What evidence supports the use of valerian root medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo korenino zdravilne špajke?
The HMPC conclusions on the use of other valerian medicines for relief of mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Zaključki odbora HMPC o uporabi drugih zdravil, ki vsebujejo zdravilno špajko, za lajšanje blagih simptomov stresa in kot pomoč pri spanju temeljijo na njihovi „tradicionalni uporabi“.
For more information about treatment with valerian root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo korenino zdravilne špajke, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
Other information about valerian root medicines
Druge informacije o zdravilih, ki vsebujejo korenino zdravilne špajke
The HMPC also concluded that, on the basis of its long-standing use, the other valerian root preparations described above can be used for relief of mild symptoms of mental stress and to aid sleep.
Odbor HMPC je na podlagi dolgotrajne uporabe prav tako zaključil, da se lahko drugi zgoraj opisani pripravki s korenino zdravilne špajke uporabljajo za lajšanje blagih simptomov stresa in kot pomoč pri spanju.
Therefore, the HMPC conclusions on these uses of valerian root medicines are based on their long-standing use.
Zaključki odbora HMPC v zvezi s tovrstno uporabo zdravil, ki vsebujejo korenino zdravilne špajke, zato temeljijo na njihovi dolgotrajni uporabi.
What are the risks associated with valerian root medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo korenino zdravilne špajke?
The HMPC considered that clinical studies with dry ethanol extracts support its use for relief of mild nervous tension and in sleep disorders.
Odbor HMPC je presodil, da klinične študije s suhimi etanolnimi ekstrakti podpirajo njegovo uporabo za lajšanje blage živčne napetosti in motenj spanja.
For practical information about using valerian root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
The HMPC concluded that a specific valerian root preparation obtained as dry ethanol extract1 can be used for the relief of mild nervous tension and sleep disorders.
Odbor HMPC je zaključil, da se lahko poseben pripravek s korenino zdravilne špajke, pridobljen kot suhi etanolni ekstrakt1, uporablja za lajšanje blage živčne napetosti in motenj spanja.
The HMPC conclusions on the use of a specific valerian root preparation obtained as dry ethanol extract for the relief of mild nervous tension and sleep disorders are based on their ‘well-established use'.
Zaključki odbora HMPC v zvezi z uporabo posebnega pripravka s korenino zdravilne špajke, pridobljenega kot suhi etanolni ekstrakt, za lajšanje blage živčne napetosti in motenj spanja temeljijo na njegovi „dobro uveljavljeni medicinski uporabi“.
What is valerian root?
Kaj je korenina zdravilne špajke?
For dry extracts, the solvent is then evaporated off.
Topilo se nato odpari, s čimer se pridobi suhi ekstrakt.
A doctor or healthcare practitioner should be consulted if symptoms persist during treatment for mental stress and to aid sleep.
Če simptomi med lajšanjem stresa in kot pomoč pri spanju ne izginejo, se je treba posvetovati z zdravnikom ali zdravstvenim delavcem.
Side effects have been reported with valerian root.
Pri uporabi korenine zdravilne špajke so poročali o neželenih učinkih.
1 MU: Million Units
*ME: Milijonov Enot
EU - Number
EU številka
Pharmaceutical
Farmacevtska oblika
The European Commission granted a marketing authorisation valid throughout the European Union for Dynastat on 22 March 2002.
Evropska komisija je dovoljenje za promet z zdravilom Dynastat, veljavno po vsej Evropski uniji, odobrila dne 22. marca 2002.
• a history of serious allergic reactions to medicines, especially skin reactions;
• anamnezo hudih alergijskih reakcij na zdravila, še zlasti kožnih reakcij;
It was generally more effective than placebo and as effective as other painkillers.
Na splošno je bilo učinkovitejše od placeba in enako učinkovito kot druga zdravila proti bolečinam.
This means that it is converted to valdecoxib in the body.
To pomeni, da se v telesu pretvori v valdekoksib.
Other information about Dynastat:
Druge informacije o zdravilu Dynastat:
Dynastat parecoxib
Dynastat parekoksib
This document is a summary of the European public assessment report (EPAR) for Dynastat.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dynastat.
The main measures of effectiveness were changes in pain scores as rated by the patients.
Glavno merilo učinkovitosti so bile spremembe rezultatov v zvezi z bolečino, kot so jo ocenili bolniki.
Dynastat must not be used in patients with:
Zdravila Dynastat ne smejo uporabljati bolniki z:
What benefit has Dynastat shown during the studies?
Kakšne koristi je zdravilo Dynastat izkazalo med študijami?
The CHMP decided that Dynastat's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Dynastat večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Dynastat can be given at the same time as opioid painkillers (medicines that are related to morphine).
Zdravilo Dynastat se lahko daje sočasno z opioidnimi protibolečinskimi zdravili (zdravili, ki so povezana z morfinom).
It must not be used after coronary bypass surgery.
Ne sme se uporabljati po obvodni operaciji koronarnih arterij.
Dynastat must not be given to women during the last three months of pregnancy or to breast-feeding women.
Zdravilo Dynastat se ne sme dajati nosečnicam v zadnjem trimesečju ali doječim materam.