natgillin/translations-raw huggingface dataset:
Short-acting beta-agonists work by stimulating a receptor on the surface of cells called the ‘beta-2 adrenergic receptor', which brings about smooth muscle relaxation.
Kratkodelujoči agonisti beta-adrenergičnih receptorjev delujejo tako, da spodbujajo receptorje na površini celic, imenovane „beta-2 adrenergični receptorji“, kar povzroča sproščanje gladkih mišic.
In countries where injectable forms are also authorised for external cephalic version (a method for moving the baby into the right position for birth) and emergency use in specific conditions, the PRAC
V državah, kjer so oblike za injiciranje odobrene tudi za zunanji obrat (metodo za premik otroka v pravilni položaj za
These recommendations follow a review of available cardiovascular safety data on the medicines fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline when used in obstetric indications.
Ta priporočila upoštevajo pregled razpoložljivih kardiovaskularnih varnostnih podatkov o fenoterolu, heksoprenalinu, izoksuprinu, ritodrinu, salbutamolu in terbutalinu, kadar se uporabljajo pri porodniških indikacijah.
These recommendations follow a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which looked into the known risk of cardiovascular side effects (problems affecting the heart and blood vessels) with high doses of short-acting beta-agonists when used as tocolytics (medicines that suppress labour contractions).
Ta priporočila upoštevajo pregled, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila in s katerim so preučili znana tveganja za kardiovaskularne neželene učinke (težave, ki prizadenejo srce in krvne žile) pri velikih odmerkih kratkodelujočih agonistov beta-adrenergičnih receptorjev, če se uporabljajo kot tokolitiki (zdravila, ki zavirajo porodne popadke).
In addition to oral medicines and suppositories, this review also covered injectable short-acting betaagonists used as tocolytics.
Poleg peroralnih zdravil in svečk je ta pregled vključeval tudi kratkodelujoče agoniste betaadrenergičnih receptorjev za injiciranje, ki se uporabljajo kot tokolitiki.
Given the cardiovascular risk and the very limited data on the effectiveness of the oral and suppository forms of these medicines, the PRAC concluded that their benefit-risk balance is not favourable and these medicines should no longer be used in obstetric indications.
Na podlagi kardiovaskularnega tveganja in zelo omejenih podatkov o učinkovitosti peroralnih oblik teh zdravil ter svečk je odbor PRAC sklenil, da razmerje med tveganji in koristmi ni ugodno, zato se ta zdravila ne smejo več uporabljati pri porodniških indikacijah.
They are available as tablets, oral solutions, solutions for injection or infusion, and suppositories.
Na voljo so v obliki tablet, peroralnih raztopin, raztopin za injiciranje ali infundiranje in svečk.
• Parenteral short-acting beta-agonists are effective in the short-term and they can still be used in all authorised obstetric indications (inhibition of premature labour, external cephalic version, emergency use in specified conditions).
• Parenteralni kratkodelujoči agonisti beta-adrenergičnih receptorjev so učinkoviti pri kratkotrajnem zdravljenju, zato se lahko še vedno uporabljajo pri vseh odobrenih porodniških indikacijah (zaviranju prezgodnjega poroda, zunanjem obratu, urgentni uporabi pri posebnih pogojih).
• Parenteral short-acting beta-agonists should not be used in women with a history of heart disease or significant risk factors for heart disease or when prolongation of the pregnancy is hazardous to mother or fetus.
• Parenteralni kratkodelujoči agonisti beta-adrenergičnih receptorjev se ne smejo uporabljati pri ženskah s srčno boleznijo v anamnezi ali pomembnimi dejavniki tveganja za srčno bolezen ali kadar je podaljšanje nosečnosti nevarno za mater ali plod.
• Given the identified cardiovascular adverse reaction profile and the very limited data supporting the benefits of oral forms and suppositories as short or long-term tocolytics, these formulations should no longer be used in any obstetric indication.
• Glede na ugotovljeni profil kardiovaskularnih neželenih učinkov in zelo omejene podatke, ki podpirajo koristi peroralnih oblik ter svečk kot kratko- ali dolgotrajnih tokolitikov, se te formulacije ne smejo več uporabljati pri nobenih porodniških indikacijah.
The PRAC concluded that there was a risk of serious cardiovascular side effects to both the mother and unborn baby when high-dose short-acting beta-agonists are used in obstetric indications, with the data suggesting these mostly occur with prolonged use.
Odbor PRAC je sklenil, da je prisotno tveganje za resne kardiovaskularne neželene učinke na mater in nerojenega otroka, kadar se veliki odmerki kratkodelujočih agonistov beta-adrenergičnih receptorjev uporabljajo pri porodniških indikacijah, pri čemer podatki kažejo, da se ti večinoma pojavijo pri dolgotrajni uporabi.
• Because of a risk of problems affecting the heart and circulation to both the mother and unborn baby with high-dose short-acting beta-agonists, these medicines must not be used by mouth or as suppositories to suppress premature labour in pregnant women.
• Zaradi tveganja za težave, ki prizadenejo srce in ožilje pri materi in nerojenem otroku, pri velikih odmerkih kratkodelujočih agonistov beta-adrenergičnih receptorjev se ta zdravila v peroralni obliki ali v obliki svečk ne smejo uporabljati za zaviranje prezgodnjega poroda pri nosečnicah.
The CMDh is a medicines regulatory body representing the European Union (EU) Member States recommended that they remain authorised in these indications.
CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU).
• High-dose short-acting beta-agonists are associated with a risk of serious adverse cardiovascular events to both the mother and the fetus, particularly when used for a prolonged period of time.
• Veliki odmerki kratkodelujočih agonistov beta-adrenergičnih receptorjev so povezani s tveganjem za resne kardiovaskularne neželene učinke na mater in plod, predvsem če se uporabljajo dolgotrajno.
• Although these medicines are also used for the treatment of asthma, they are usually given at lower doses for this condition; if you are being treated with short-acting beta-agonists and have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Če se zdravite s kratkodelujočimi agonisti beta-adrenergičnih receptorjev in imate kakršna koli vprašanja ali pomisleke glede zdravljenja, se posvetujte z zdravnikom ali farmacevtom.
Content (concentration)
Izmišljeno ime ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija) velikost pakiranja
Similar results were seen in adults and in children.
Pri odraslih in otrocih so bili opaženi podobni rezultati.
It contains the active substance emedastine (0.5 mg/ml).
Vsebuje zdravilno učinkovino emedastin (0,5 mg/ml).
Its effects have not been studied beyond six weeks.
Učinkov zdravila niso preučevali v preizkušanjih, daljših od šest tednov.
The results of the allergen challenge tests supported these results.
Rezultati testov izpostavljenosti alergenom so te zaključke potrdili.
These symptoms include itching, redness and swelling.
Ti simptomi vključujejo srbenje, pordelost in otekanje.
The European Commission granted a marketing authorisation valid throughout the European Union for Emadine on 27 January 1999.
Evropska komisija je dovoljenje za promet z zdravilom Emadine, veljavno po vsej Evropski uniji, izdala 27. januarja 1999.
The main measure of effectiveness was the reduction in itching and redness, measured on a nine-point scale over up to six weeks.
Glavno merilo učinkovitosti je bilo zmanjšanje srbenja in pordelosti, ocenjeno na 9-točkovni lestvici v obdobju šestih tednov.
This is a test where patients with an allergy who are not currently showing any allergic symptoms receive a defined dose of an allergen (the substance that they are allergic to) to trigger an allergic reaction.
Gre za test, pri katerem bolniki z alergijo, ki trenutno ne kažejo simptomov alergije, prejmejo določeno dozo alergena (snovi, na katero so alergični), da bi se sprožila alergijska reakcija.
Emadine is not recommended for patients older than 65 years or in patients who have problems with their liver or kidneys.
Zdravilo Emadine ni priporočljivo za bolnike, starejše od 65 let ali za bolnike, ki imajo težave z jetri ali ledvicami.
The full EPAR for Emadine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Emadine je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Emadine is used in adults and children aged three years and older.
Zdravilo Emadine se uporablja pri odraslih in otrocih, starejših od treh let.
This is a summary of the European public assessment report (EPAR) for Emadine.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Emadine.
Other information about Emadine
Druge informacije o zdravilu Emadine
For more information about treatment with Emadine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Emadine preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.
Če so receptorji blokirani, histamin ne more učinkovati, zaradi česar se simptomi alergije zmanjšajo.
The bottle form of Emadine contains benzalkonium chloride, which is known to discolour soft contact lenses.
Steklenička zdravila Emadine vsebuje benzalkonijev klorid, za katerega je znano, da razbarva mehke kontaktne leče.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Emadine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
If more than one type of eye treatment is being used, each one should be given at least 10 minutes apart and any eye ointments should be given last.
Če bolnik uporablja več vrst zdravil za oči, jih je treba uporabiti v razmiku vsaj desetih minut.
The Committee recommended that Emadine be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Emadine izda dovoljenje za promet.
Emadine is given as one drop in the affected eye(s) twice a day.
Odmerek zdravila Emadine je ena kapljica v prizadeto oko (očesi) dvakrat na dan.
The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an ‘allergen challenge'.
Družba je prav tako predstavila dognanja študij, v katerih so bolniki prejemali zdravilo Emadine, levokabastin ali placebo (zdravilo brez zdravilne učinkovine), preden so jih izpostavili alergenom.
What benefit has Emadine shown during the studies?
Kakšne koristi je zdravilo Emadine izkazalo med študijami?
The active substance in Emadine, emedastine, is an antihistamine.
Zdravilna učinkovina zdravila Emadine, emedastin, je antihistaminik.
The most common side effects with Emadine (which may affect between 1 and 2 patients in 100) are eye pain, eye pruritus (itchy eye) and conjunctival hyperaemia (increased blood flow to the eye, leading to redness).
Najpogostejši neželeni učinki pri zdravilu Emadine (opaženi pri 1 do 2 bolnikih od 100) so bolečine v očeh, očesni pruritus (srbenje v očesu) in konjunktivna hiperemija (zvišan dotok krvi v oko, kar povzroči njegovo pordelost).
In both groups of patients, itching scores fell from around 5.1 at the start of the study, to around 3.8 after five minutes and around 2.7 after two hours.
Pri obeh skupinah bolnikov se je ocena srbenja znižala s približno 5,1 na začetku študije na približno 3,8 po petih minutah in 2,7 po dveh urah.
For the full list of all side effects and restrictions with Emadine, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Emadine glejte navodilo za uporabo.
For redness, the scores fell from around 2.7 to 0.5 for Emadine and to 1.1 for levocabastine.
Ocene pordelosti so z 2,7 padle na 0,5 za zdravilo Emadine in na 1,1 za levokabastin.
The Committee for Medicinal Products for Human Use (CHMP) decided that Emadine's benefits are greater than its risks for the symptomatic treatment of seasonal allergic conjunctivitis.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Emadine pri simptomatskem zdravljenju sezonskega alergijskega konjunktivitisa večje od z njim povezanih tveganj.
What is the risk associated with Emadine?
Kakšna tveganja so povezana z zdravilom Emadine?
Emadine is used to treat the symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Zdravilo Emadine se uporablja za zdravljenje simptomov sezonskega alergijskega konjunktivitisa (vnetja oči, ki ga pri bolnikih s senenim nahodom povzroča cvetni prah).
Similar reductions in redness scores were seen, falling from 4.5 to 3.7 after five minutes and 2.7 after two hours.
Podobno zmanjšanje je bilo opaziti pri pordelosti, ki je bila na začetku ocenjena s 4,5, po petih minutah s 3,7 in po dveh urah 2,7.
In the long term, the itching scores fell from an average of around 3.9 on the first day, falling to 0.8 for Emadine and 2.0 for levocabastine after six weeks.
Dolgoročno se je povprečna ocena srbenja, ki je v prvem dnevu znašala 3,9, po šestih tednih znižala na 0.8 pri uporabi zdravila Emadine in na 2,0 pri uporabi levokabastina.
Emadine was as effective as levocabastine in reducing symptoms of seasonal conjunctivitis.
Zdravilo Emadine se je pri zmanjševanju simptomov sezonskega konjunktivitisa izkazalo kot enako učinkovito kot levokabastin.
Why has Emadine been approved?
Zakaj je bilo zdravilo Emadine odobreno?
Emadine is available in a bottle and in single-dose containers.
Na voljo je v stekleničkah in vsebnikih z enim odmerkom.
Emadine is a clear eye drop solution.
Zdravilo Emadine je bistra raztopina za kapljice za oči.
What is Emadine used for?
Za kaj se zdravilo Emadine uporablja?
How has Emadine been studied?
Kako je bilo zdravilo Emadine raziskano?
What is Emadine?
Kaj je zdravilo Emadine?
How is Emadine used?
Kako se zdravilo Emadine uporablja?
It works by blocking the receptors that histamine normally attaches to. Histamine is a substance in the body that causes allergic symptoms.
Histamin je snov v telesu, ki povzroča alergijske simptome.
Emadine has been compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis aged four years and over.
V glavni študiji, v katero je bilo vključenih 222 bolnikov, starejših od štirih let, s sezonskim konjunktivitisom, so zdravilo Emadine primerjali z levokabastinom (drugi antihistaminik).
How does Emadine work?
Kako zdravilo Emadine deluje?
The bottles are packed individually in a carton box.
Stekleničke so pakirane posamezno v zloženkah.
The duration of protection is 6 months.
Zaščita traja 6 mesecev.
4.8 Interaction with other medicinal product and other forms of interaction
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council, Member States prohibit or/ may prohibit the import, sale, supply and/or use of Porcilis Pesti on the whole or part of their territory if it is established that:
V skladu z 71. členom Direktive 2001/82/ES evropskega parlamenta in Sveta države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo Porcilisa Pesti na celotnem svojem ozemlju ali delu ozemlja, če se ugotovi, da:
Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMA) http://www.ema.europa.eu/.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Zdravilna učinkovina, ki je biološkega izvora in je namenjena za vzbujanje aktivne imunosti, ni zajeta v Uredbi (ES) št. 470/2009.
If you notice any serious side effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
Avoid the introduction of contamination.
Pazite, da ne bi prišlo do kontaminacije.
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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Za pomožne snovi (vključno z dodatki), navedene v poglavju 6.1 SPC, 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. 470/2009.
However, the use of vaccines may be authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordance with Community Legislation on control and eradication of classical swine fever;
Vendar se uporaba cepiv lahko odobri v sklopu načrta za cepljenje v izrednih razmerah, ki ga po potrditvi bolezni izvede pristojni organ v državi članici v skladu z zakonodajo Skupnosti o nadzoru in izkoreninjenju klasične prašičje kuge;
The onset of protection is 2 weeks.
Zaščita se razvije v 2 tednih.
After administration of an overdose, local reactions at the injection site may be more pronounced.
Po vnosu prevelikega odmerka so lahko lokalne reakcije na mestu vboda izrazitejše.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C to 8°C).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C do 8 °C).
Manufacturer of the biological active substance:
Izdelovalec biološke zdravilne učinkovine:
Shelf-life after first broaching the bottle: 3 hours.
Rok uporabnosti po prvem odpiranju stekleničke: 3 ure.
b) The storage, supply, distribution and sale of classical swine fever vaccines must be carried out under the control of and in accordance with the eventual instructions established by the competent authority of the Member State;
b) Skladiščenje, oskrbo, distribucijo in prodajo cepiv proti klasični prašičji kugi je treba izvajati pod nadzorstvom pristojnega organa v državi članici in v skladu z morebitnimi navodili, ki jih ta organ uvede;
According to Community Legislation on Classical swine fever (Council Directive 80/217/EEC, as amended), in the European Union:
Zakonodaja Skupnosti, ki obravnava klasično prašičjo kugo (Direktiva Sveta 80/217/EEG, z vsemi spremembami) v Evropski uniji določa:
Excipients: For a full list of excipients, see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.,
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International B.V.
Administer one dose (2 ml) by deep intramuscular injection in the neck area behind the ear.
Injicirajte en odmerek (2 ml)globoko intramuskularno v vrat v predel za ušesom
MARKETING AUTHORISATION NUMBER(S) EU/2/99/016/001 - EU/2/99/016/006
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/99/016/001 - EU/2/99/016/006
Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati zdravilo za uporabo v veterinarski medicini, mora imeti pooblastilo pristojnega organa v državi članici.
SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous
POSEBNA OPOZORILA, ČE SO POTREBNA Nenamerno injiciranje je nevarno.
Shelf life of the veterinary medicinal product as packaged for sale: 12 months Shelf life after first broaching the bottle: 3 hours.
Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 12 mesecev Rok uporabnosti po prvem odpiranju stekleničke: 3 ure.
The product contains Classical Swine Fever virus E2 immunogen incorporated in an emulsion in order to prolong stimulation of the immune system of the target species.
Izdelek vsebuje imunogen E2 virusa klasične prašičje kuge, vgrajen v emulzijo, kar podaljša stimulativni učinek na imunski sistem ciljne živalske vrste.
Classical Swine Fever vaccine, ATC vet code: QI09AA06
Cepivo proti klasični prašičji kugi, oznaka ATCvet: QI09AA06
a) The use of classical swine fever vaccines is prohibited.
a) Uporaba cepiv proti klasični prašičji kugi je prepovedana.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJE, ČE STA RAZLIČNA
MARKETING AUTHORISATION NUMBER(S) EU/2/99/016/001-006
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/99/016/001-006
The active substance stimulates active immunity against Classical Swine Fever (CSF).
Zdravilna učinkovina spodbudi aktivno imunost proti klasični prašičji kugi (KPK).
c) Special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the marking of pig meat from vaccinated pigs.
c) Premike prašičev z območij, kjer uporabljajo ali so uporabljali cepivo proti klasični prašičji kugi, ter označevanje mesa cepljenih prašičev urejajo posebne določbe.
Re-vaccination: Every 6 months, using a single dose.
Revakcinacija: enkratni odmerek vsakih 6 mesecev.
a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and elimination of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the product is intended to confer immunity is largely absent from the territory.
a) bi uporaba izdelka pri živalih ovirala izvajanje nacionalnih programov diagnosticiranja, nadzora ali zatiranja živalskih bolezni ali da bi povzročila težave pri zagotavljanju, da ne bi prišlo do okužbe živih živali, živil ali drugih proizvodov, ki izvirajo iz zdravljenih živali.
Basic vaccination: Inject one dose per pig followed by a second injection 4 weeks after the first injection.
Osnovno cepljenje: en odmerek za enega prašiča, nato drugi odmerek 4 tedne po prvem.
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 odločiti za uporabo tega cepiva pred nekim drugim zdravilom za uporabo v veterinarski medicini ali po njem v vsakem primeru posebej.
Before use, allow the vaccine to reach room temperature.
Cepivo naj se pred uporabo ogreje na sobno temperaturo.
The import, sale, supply and/or use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended).
Uvoz, prodaja, oskrba ali uporaba tega zdravila za uporabo v veterinarski medicini so dovoljeni samo pod določenimi pogoji, ki jih predpisuje zakonodaja Evropske skupnosti za nadzor nad KPK (Direktiva Sveta 80/217/EGS, z vsemi spremembami).