natgillin/translations-raw huggingface dataset:
Zinbryta should now only be used in patients who have had an inadequate response to at least two disease modifying therapies (DMTs) and cannot be treated with any other DMTs.
Zdravilo Zinbryta se sme zdaj uporabljati samo pri bolnikih, ki so se nezadostno odzvali na vsaj dve zdravili, ki spreminjata potek bolezni (DMT), in se ne morejo zdraviti z nobenim drugim zdravilom DMT.
− It is recommended that you stop treatment in patients with ALT or AST levels more than 3 times the ULN regardless of bilirubin levels.
− priporočljivo je, da pri bolnikih z vrednostmi ALT ali AST, ki so večje od trikratnika ULN, zdravljenje ukinete, ne glede na vrednosti bilirubina;
− Exercise caution in patients taking other medicinal products with known hepatotoxic potential, including non-prescription products and herbal supplements.
− pri bolnikih, ki jemljejo tudi druga zdravila z znanim hepatotoksičnim potencialom, vključno z zdravili, ki se izdajajo brez recepta, in zeliščnimi dodatki, bodite previdni;
The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment.
S pregledom so ugotovili, da se med zdravljenjem in še šest mesecev po koncu zdravljenja z zdravilom Zinbryta lahko pojavijo nepredvidljive in morebitno usodne imunsko posredovane poškodbe jeter.
− Monitor patients' serum transaminase and bilirubin levels at least monthly and as close as possible before each administration, and for up to 6 months after stopping treatment.
− vsaj enkrat mesečno in čim krajši čas pred vsakim odmerkom ter še do šest mesecev po koncu zdravljenja spremljajte vrednosti transaminaz in bilirubina v bolnikovem serumu;
− Screen patients for hepatitis B or C infection before starting treatment in new patients and refer those who test positive to a liver specialist.
− pred uvedbo zdravljenja nove bolnike preglejte glede prisotnosti okužbe s hepatitisom B ali C, v primeru pozitivnega rezultata pa jih napotite k hepatologu;
This overview was last updated in March 2018.
Povzetek je bil nazadnje posodobljen marca 2018.
This is normal and will generally resolve within a couple of days.
To je normalno in navadno izzveni v nekaj dneh.
These effects usually resolve without treatment.
Ti učinki običajno izzvenijo brez zdravljenja.
People should not eat, drink or smoke while handling the medicine.
Uporabniki ne smejo jesti, piti ali kaditi, ko rokujejo z zdravilom.
Further information on Activyl Tick Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Activyl Tick Plus so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Fleas, ticks and sand flies might still be able to transmit any diseases which they may be carrying.
Bolhe, klopi in peščene muhe lahko morda še vedno prenašajo bolezni, s katerimi so okužene.
Activyl Tick Plus received a marketing authorisation valid throughout the EU on 9 January 2012.
Zdravilo Activyl Tick Plus je pridobilo dovoljenje za promet, veljavno po vsej EU, 9. januarja 2012.
The European Medicines Agency decided that Activyl Tick Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila Activyl Tick Plus večje od z njim povezanih tveganj, in da se lahko odobri za uporabo v EU.
For larger dogs, the content can be applied in two (medium dogs), three (large dogs), or four (very large dogs) different spots along the back from the shoulders to the base of the tail.
Pri večjih psih se vsebina kapalke nanese na dveh (srednje veliki psi), treh (veliki psi) ali štirih (zelo veliki psi) različnih mestih vzdolž hrbta od ramenskega predela do korena repa.
The medicine is highly flammable and should be kept away from possible sources of ignition.
Zdravilo je zelo vnetljivo in ga je treba hraniti ločeno od možnih virov vžiga.
To protect children, the medicine should be kept in its sachet until use, and the used pipette should be disposed of immediately.
Za zaščito otrok je treba zdravilo do uporabe hraniti v njegovi vrečki, uporabljeno kapalko pa je treba takoj zavreči.
Both treatments reduced flea and tick numbers to almost zero by the end of the study period.
Obe zdravljenji sta do konca trajanja študije zmanjšali število bolh in klopov skoraj na nič.
On the day of treatment, children must not handle treated dogs and the dogs should not be allowed to sleep with their owners, especially children.
Preprečiti je treba, da bi otroci na dan, ko je bilo zdravilo nanešeno, prišli v stik z živaljo, prav tako pa zdravljene živali ne smejo spati skupaj z lastniki, še zlasti ne z otroki.
One field study involved 230 dogs where Activyl Tick Plus was compared with fipronil (another ectoparasiticide), where the medicines were given every four weeks for 12 weeks.
V terenski študiji, ki je zajela 230 psov, so zdravilo Activyl Tick Plus primerjali s fipronilom (drugim ektoparaziticidom), pri čemer so ga psom dajali vsake štiri tedne v dvanajsttedenskem obdobju.
If Activyl Tick Plus is accidentally spilled into eyes, it should be rinsed off with water.
Če pride zdravilo Activyl Tick Plus nenamerno v oči, ga je treba sprati z vodo.
Activyl Tick Plus (indoxacarb / permethrin)
Activyl Tick Plus (indoksakarb/permetrin)
It must not be used in dogs which are known to be hypersensitive (allergic) to indoxacarb, permethrin or to any of the other ingredients.
Ne sme se uporabljati pri psih, ki so preobčutljivi za (alergični na) indoksakarb, permetrin ali katero koli drugo sestavino zdravila.
For very small and small dogs, the full content of a pipette appropriate for the dog's weight is applied to the skin between the shoulder blades, after parting the fur.
Pri zelo majhnih in majhnih psih se nanese celotna vsebina kapalke, ki ustreza njihovi telesni masi, na kožo med lopaticama, potem ko razmaknemo dlako na tem predelu.
Together, the active form of indoxacarb and permethrin interfere with the parasites' nervous system, causing paralysis and death.
Aktivna oblika indoksakarba in permetrin delujeta na živčni sistem zajedavcev in povzročita paralizo in smrt.
The main measure of effectiveness was the repellent effect against sand flies as measured by the number of fed female sand flies.
Glavno merilo učinkovitosti je bila stopnja repelentnega učinka zoper peščene muhe, kar so merili s številom samic peščene muhe, ki so zaužile kri.
Activyl Tick Plus can also be used as a repellent (a substance that deters insects from approaching and settling) against sand flies (Phlebotomus perniciosus) that is active for up to 3 weeks.
Zdravilo Activyl Tick Plus se lahko uporablja tudi kot repelent (snov, ki odvrača žuželke od približevanja in naselitve na živali) proti peščenim muham (Phlebotomus perniciosus), ki učinkuje do tri tedne.
Why is Activyl Tick Plus authorised in the EU?
Zakaj je zdravilo Activyl Tick Plus odobreno v EU?
The effectiveness of Activyl Tick Plus against sand flies was shown in two laboratory studies.
Učinkovitost zdravila Activyl Tick Plus proti peščenim muham je bila potrjena v dveh laboratorijskih študijah.
The effectiveness of Activyl Tick Plus against fleas and ticks was investigated in laboratory studies and in three field studies.
Učinkovitost zdravila Activyl Tick Plus proti bolham in klopom so proučevali v laboratorijskih študijah in treh terenskih študijah.
People who are known to be hypersensitive to indoxacarb or permethrin should avoid contact with the product.
Ljudje z znano preobčutljivostjo za indoksakarb ali permetrin naj se izogibajo stiku s tem zdravilom.
If adverse reactions occur, medical advice should be sought and the package leaflet shown to the doctor.
Če se pojavijo neželeni učinki, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo.
What is Activyl Tick Plus and what is it used for?
Kaj je zdravilo Activyl Tick Plus in za kaj se uporablja?
Other information about Activyl Tick Plus:
Druge informacije o zdravilu Activyl Tick Plus
What benefits of Activyl Tick Plus have been shown in studies?
Kakšne koristi je zdravilo Activyl Tick Plus izkazalo v študijah?
An overview of Activyl Tick Plus and why it is authorised in the EU
Pregled zdravila Activyl Tick Plus in zakaj je odobreno v EU
Permethrin also acts as a repellent and so helps prevent sand flies from settling and taking a blood meal.
Permetrin istočasno deluje kot repelent in tako preprečuje, da bi se peščene muhe naselile na žival in sesale kri.
Activyl Tick Plus is a veterinary medicine used in dogs to treat flea and tick infestations.
Activyl Tick Plus je zdravilo za uporabo v veterinarski medicini, ki se uporablja pri psih za zdravljenje infestacij z bolhami in klopi.
Activyl Tick Plus must not be used in cats as adverse reactions and even death can occur.
Zdravilo Activyl Tick Plus se ne sme uporabljati pri mačkah, saj lahko izzove neželene učinke in celo pogin.
What are the risks associated with Activyl Tick Plus?
Kakšna tveganja so povezana z zdravilom Activyl Tick Plus?
The active substances in Activyl Tick Plus, indoxacarb and permethrin, are ectoparasiticides, which kill parasites such as fleas and ticks that may be found on the skin or in the fur of animals.
Zdravilni učinkovini v zdravilu Activyl Tick Plus, indoksakarb in permetrin, sta ektoparaziticida, ki uničujeta zajedavce, kot so bolhe in klopi, ki se nahajajo na koži ali v dlaki živali.
The solution is supplied in pipettes filled with the appropriate amounts of indoxacarb and permethrin for dogs of various weights.
Raztopina je na voljo v kapalkah, napolnjenih z ustrezno količino indoksakarba in permetrina za pse z različno telesno maso.
The most common side effects seen with Activyl Tick Plus (which may affect up to 1 in 10 animals) are transitory scratching, erythema (reddening of the skin) and hair loss at the application site.
Najpogostejši neželeni učinki zdravila Activyl Tick Plus (ki lahko prizadenejo največ 1 žival od 10) so prehodno praskanje, eritem (pordela koža) in izpadanje dlake na mestu nanosa.
The application of Activyl Tick Plus may produce a temporary oily appearance or hair clumping at the application site, or a dry white residue.
Uporaba zdravila Activyl Tick Plus lahko izzove kratkotrajen oljni videz ali zlepljanje dlake na mestu nanosa ali suh, bel ostanek.
Hands should be washed immediately after use and any product in contact with the skin should be washed off immediately with soap and water.
Takoj po uporabi zdravila je treba umiti roke in z milom in vodo sprati kožo, ki pride v stik z zdravilom.
In the other study, Activyl Tick Plus showed repellant activity of 98% at 2 days after treatment falling to 86% at 3 weeks.
V drugi študiji je zdravilo Activyl Tick Plus dva dni po nanosu pokazalo 98-odstotni repelentni učinek, ta učinek pa je po treh tednih po nanosu padel na 86 %.
The medicine, available as a spot-on solution, is given as a single application to the dog's skin.
Zdravilo, ki je na voljo v obliki raztopine za nanos, se daje z enkratnim nanosom na kožo psa.
After application, indoxacarb and permethrin are ingested by the fleas and ticks (indoxacarb is converted in their gut into an active form).
Bolhe in klopi po nanosu zdravila zaužijejo indoksakarb in permetrin (indoksakarb se v njihovih prebavilih pretvori v aktivno obliko).
The medicine should be applied in a well-ventilated area and treated dogs should not be handled until the application site is dry.
Zdravilo je treba nanašati v dobro prezračenih prostorih in se izogibati stiku s psom, ki je prejel zdravilo, dokler se mesto nanosa ne posuši.
In one study, Activyl Tick Plus showed repellant activity of above 95% at 1 day after treatment, falling to 92% at 3 weeks after treatment.
V prvi študiji je zdravilo Activyl Tick Plus en dan po nanosu zdravila pokazalo 95-odstotni repelentni učinek, ta učinek pa je po treh tednih po nanosu zdravila padel na 92 %.
For more information about using Activyl Tick Plus, see the package leaflet or contact your veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Activyl Tick Plus naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
How is Activyl Tick Plus used?
Kako se zdravilo Activyl Tick Plus uporablja?
The effectiveness was measured by counting the number of fleas and ticks at fortnightly intervals.
Učinkovitost so merili s štetjem števila bolh in klopov v dvotedenskih razmakih.
Activyl Tick Plus contains the active substances indoxacarb and permethrin.
Zdravilo Activyl Tick Plus vsebuje zdravilni učinkovini indoksakarb in permetrin.
Protective gloves should be worn when handling or applying Activyl Tick Plus to dogs.
Ob nanašanju zdravila Activyl Tick Plus ali rokovanju z njim je treba nositi zaščitne rokavice.
How does Activyl Tick Plus work?
Kako zdravilo Activyl Tick Plus deluje?
The incidence is about 5-9 %.
Pogostost teh pojavov je okoli 5 do 9 %.
This summary was last updated in April 2008.
Povzetek je bil nazadnje posodobljen 04-2008.
The majority of bitches involved in the studies responded positively: they became continent, and remained that way in the long term.
Večina psic, sodelujočih v študijah, se je odzvala pozitivno: pojavila se je kontinenca in se ohranila dolgo časa.
In very rare cases development of alopecia (loss of hair) has also been observed.
V zelo redkih primerih so opazili razvoj alopecije (izguba dlake).
Other information about Incurin:
Druge informacije o zdravilu Incurin:
Animals showing a polyuria-polydipsia (excessive water intake and consequent excretion of a large volume of urine) should also not be treated with this product.
Živali s poliurijo-polidipsijo (pretiran vnos vode in posledično izločanje velikih količin urina) se prav tako ne sme zdraviti s tem zdravilom.
Information on the prescription status of this product may be found on the label/outer package.
Podatki o predpisovanju tega zdravila so navedeni na etiketi/zunanji ovojnini.
The studies also established that there is no apparent relationship between the dosage and the body weight of the dog - therefore the dosing has to be decided on an individual basis.
Študije so pokazale tudi, da ni očitne povezave med odmerjanjem in telesno maso psice - zato je treba odmerek določiti posamezno.
In rare cases vaginal bleeding occurred.
V nekaterih redkih primerih se je pojavila krvavitev iz nožnice.
This condition is accompanied with a decrease of the endogenous oestrogen production.
To stanje spremlja zmanjšanje endogenega proizvajanja estrogena.
Incurin has been studied in bitches in three large field trials.
Zdravilo Incurin so preučevali pri psicah v treh velikih študijah na terenu.
These effects are reversible after lowering the dose.
Našteti učinki minejo, če se odmerek zmanjša.
What benefit has Incurin shown during the studies?
Kakšne koristi je zdravilo Incurin izkazalo med študijami?
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) INCURIN EPAR summary for the public
EMEA/V/C/047 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) INCURIN Povzetek EPAR za javnost
Oestrogen receptors can be found in the urethral sphincter, where oestrogens induce a full response, this way improving urethral closure and bladder storage.
Estrogenski receptorji se nahajajo v uretralnem sfinkterju, kjer estrogeni spodbujajo celovit odziv in na ta način izboljšajo zapiranje sečnice in skladiščno sposobnost mehurja.
The term urinary incontinence is used to describe the condition of involuntary leakage of urine.
Izraz urinska inkontinenca se uporablja za opis nehotenega uhajanja urina.
What is the risk associated with Incurin?
Kakšna tveganja so povezana z zdravilom Incurin?
No special precautions are necessary when administering Incurin.
Pri dajanju zdravila Incurin ni posebnih previdnostnih opozoril.
Estriol contained in Incurin is a short-acting natural oestrogen which binds to the oestrogen receptor.
Estriol, vsebovan v zdravilu Incurin, je kratkodelujoči naravni estrogen, ki se veže na estrogenski receptor.
During the studies repeated administration of up to 2mg estriol per dog produced beneficial effects in bitches showing involuntary leakage of urine.
Med študijami je ponavljajoče dajanje do 2 mg estriola na eno psico izkazalo korist pri psicah z znaki nehotenega uhajanja urina.
The European Commission granted a marketing authorisation valid throughout the European Union for Incurin to Intervet International B.V. on 24 March 2000 and renewed in it 2005.
Evropska komisija je dovoljenje za promet z zdravilom Incurin, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
As the sensitivity of incontinent dogs to estriol is variable, the dose has to be determined on an individual basis.
Občutljivost inkontinečnih psov na estriol ni pri vseh enaka, zato je treba odmerek določiti posamezno.
Why has Incurin been approved?
Zakaj je bilo zdravilo Incurin odobreno?
It is known to occur in bitches, with the incidence being highest after ovariectomy.
Znano je, da se pojavlja pri psicah, in sicer najbolj po ovariektomiji.
Scientific findings strongly suggest a relationship between the incidence of urinary incontinence and oestrogen depletion.
Znanstveni izsledki nakazujejo povezanost med pojavom urinske incontinence ter izločanjem estrogena.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Incurin excede the risks for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches, and recommended that Incurin be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je odločil, da so koristi zdravila Incurin pri zdravljenju od hormona odvisne urinske kontinence zaradi nepravilnega delovanja sfinkterskega mehanizma pri psicah po ovariohisterektomiji večje od njim povezanih tveganj, in je priporočil odobritev dovoljenja za promet za zdravilo Incurin.
For advise on dosing please see the Package Leaflet.
Za priporočilo glede odmerjanja glejte navodilo za uporabo.
The results show that Incurin is efficient and safe to use against urinary incontinence due to SMI in ovariohysterectomised dogs.
Rezultati kažejo, da je zdravilo Incurin učinkovito in varno za uporabo proti urinski inkontinenci zaradi nepravilnega delovanja sfinkterskega mehanizma pri psicah po ovariohisterektomiji.
Incurin is a tablet containing the natural hormone estriol as active substance.
Zdravilo Incurin so tablete, ki kot zdravilno učinkovino vsebujejo naravni hormon estriol.
Incurin is used for the treatment of hormone-dependent urinary incontinence resulting from sphincter mechanism incompetence (SMI) in ovariohysterectomised bitches (i.e. in dogs having had the ovaries and uterus removed surgically).
Zdravilo Incurin se uporablja za zdravljenje hormonsko odvisne urinske inkontinence, ki je posledica nepravilnega delovanja sfinkterskega mehanizma pri psicah po ovariohisterektomiji (tj. pri psicah, ki so jim kirurško odstranili jajčnike in maternico).
Incurin is not to be used in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches.
Zdravilo Incurin se ne sme uporabiti pri psicah, pri katerih ovariohisterektomija ni bila opravljena, saj je bila učinkovitost dokazana samo pri psicah po ovariohisterektomiji.
What is Incurin used for?
Za kaj se zdravilo Incurin uporablja?
How has Incurin been studied?
Kako je bilo zdravilo Incurin raziskano?
What is Incurin?
Kaj je zdravilo Incurin?
How does Incurin work?
Kako zdravilo Incurin deluje?
Effects typical to oestrogens such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog.
Po dajanju največjega priporočenega odmerka, ki je 2 mg na eno psico, so bili opaženi učinki, značilni za estrogen, kot so nabrekla zunanja spolovila, nabrekle mlečne žleze, privlačnost za samca in bruhanje.
No changes were introduced.
Vključene niso bile nobene spremembe.
Labelling The labelling was reviewed during this procedure.
Označevanje Označevanje je bilo med postopkom pregledano.
The European and Asian development plans have been conducted independently in the two different populations.
Evropski in azijski načrt razvoja so izvedli ločeno pri dveh različnih populacijah.
These doses were therefore used in all the major controlled trials.
Ta dva odmerka so zato uporabili v vseh večjih kontroliranih preskušanjih.
Be careful to avoid nitrate tolerance (Class IIb, level of evidence C).
Pazite, da preprečite nitratno toleranco (razred IIb, raven dokazov C).
The results of the IONA study were summarised following the same wording for both groups of products.
Rezultati študije IONA so bili povzeti z enakim besedilom za obe skupini zdravil.
However this was based on limited evidence via literature10 (Ekanayaka, 2014).
Vendar pa je ta kontraindikacija temeljila na omejenih dokazih iz literature10 (Ekanayaka, 2014).
They are also available in the EU under other trade names: Adancor, Angicor and Nicorandil Zentiva.
V EU sta na voljo tudi pod drugimi trgovskimi imeni: Adancor, Angicor in Nicorandil Zentiva.
Ikorel and Dancor medicinal products are registered and marketed in the following EU Members States: Austria, Denmark, France, Ireland, the Netherlands, Portugal and United Kingdom.
Zdravili Ikorel in Dancor imata dovoljenje za promet in se tržita v naslednjih državah članicah EU: v Avstriji, na Danskem, v Franciji, na Irskem, Nizozemskem, Portugalskem in v Združenem kraljestvu.
The results of this PASS are awaited in Q1 2015.
Rezultati študije PASS se pričakujejo v prvi četrtini leta 2015.
However, strong uncertainties regarding this preventive effect do not allow any recommendation and cannot support such an indication.
Vendar pa je s tem preventivnim učinkom povezanih veliko negotovosti, zaradi katerih ni mogoče podati nobenega priporočila niti podpreti takšne indikacije.
Section 4.1 - Therapeutic indications i. Angina pectoris
Poglavje 4.1 - Terapevtske indikacije i. Angina pektoris
The following phrase was recommended regarding the paediatric populations:
Za pediatrično populacijo je bila predlagana naslednja navedba:
The information/education to gain a knowledge that allows this diagnosis is the best risk minimisation measure identified so far.
Informiranje/izobraževanje za pridobitev znanja, ki omogoča takšno diagnozo, je zaenkrat najboljši ukrep za zmanjšanje tveganja, ki ga poznamo.
In addition, this study is limited by the enrolled population with low revascularisation.
Poleg tega je ta študija omejena, saj je v njej sodelovala populacija z nizko stopnjo revaskularizacije.
The European Commission notified the European Medicines Agency/ Committee for Medicinal Products for Human Use (EMA/CHMP) secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product information (PI) for the above-mentioned products and thus to harmonise them across the EU.
Evropska komisija je sekretariat Evropske agencije za zdravila/Odbora za zdravila za uporabo v humani medicini (EMA/CHMP) obvestila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, z namenom odprave razlik med nacionalno odobrenimi informacijami o zdravilu za zgoraj navedena zdravila in uskladitve teh informacij po vsej EU.
<Invented name> is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
Uporaba zdravila <izmišljeno ime> se ne priporoča pri pediatričnih bolnikih, saj varnost in učinkovitost zdravila pri tej skupini bolnikov nista bili dokazani.
The CHMP noted that the daily dose in Asiatic patients is below the one defined in European patients.
Odbor CHMP je ugotovil, da je dnevni odmerek pri azijskih bolnikih manjši od odmerka, določenega za evropske bolnike.
Therefore, the CHMP is of opinion that this indication is not supported due to lack of appropriate data.
Odbor CHMP je zato menil, da ta indikacija ni utemeljena zaradi pomanjkanja ustreznih podatkov.
Therefore the 20 mg daily dose could not be generalised.
Dnevnega odmerka 20 mg zato ni bilo mogoče posplošiti.