natgillin/translations-raw huggingface dataset:
General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) per kg bodyweight each day, divided in 2 intakes per day.
Običajni odmerek: med 0,14 ml (14 mg) in 0,42 ml (42 mg) na kg telesne mase vsak dan, razdeljen na dva enaka odmerka na dan.
General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10mg) and 0.3 ml (30mg), per kg bodyweight of the child. (see table below for dose examples).
Običajni odmerek: zdravilo Keppra se jemlje dvakrat na dan v dveh enakih odmerkih, pri čemer vsak posamezni odmerek znaša od 0,1 ml (10 mg) do 0,3 ml (30 mg) na kg telesne mase otroka (za primere odmerkov glejte spodnjo preglednico).
General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day.
Običajni odmerek: med 0,2 ml (20 mg) in 0,6 ml (60 mg) na kg telesne mase vsak dan, razdeljen na dva enaka odmerka na dan.
General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant.
Običajni odmerek: zdravilo Keppra se jemlje dvakrat na dan v dveh enakih odmerkih, pri čemer vsak posamezni odmerek znaša od 0,07 ml (7 mg) do 0,21 ml (21 mg) na kg telesne mase dojenčka (za primere odmerkov glejte spodnjo preglednico).
Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use.
Ob uporabi zdravil, ki vsebujejo metronidazol za sistemsko zdravljenje, so pri bolnikih s Cockaynovim sindromom poročali o primerih resne hepatotoksičnosti/akutne odpovedi jeter, vključno s primeri s smrtnim izidom z zelo hitrim pojavom po začetku zdravljenja.
Monotherapy
Samostojno zdravljenje
For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
Odmerjanje pri dojenčkih (od 1 meseca do manj kot 6 mesecev) Za dojenčke, stare od 1 meseca do manj kot 6 mesecev, ustrezen odmerek izmerite z uporabo 1-mililitrske brizge, vključene v pakiranje.
Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with product containing metronidazole.
Ob uporabi zdravil, ki vsebujejo metronidazol, so pri bolnikih s Cockaynovim sindromom poročali o primerih resne jetrne toksičnosti/akutne odpovedi jeter, vključno s primeri s smrtnim izidom.
For children 6 months to 4 years, measure the appropriate dosage using the 3 ml syringe included in the package.
Za otroke, stare od 6 mesecev do manj kot 4 leta, ustrezen odmerek izmerite z uporabo 3-mililitrske brizge, vključene v pakiranje.
Package leaflet
Dopolnilno zdravljenje
Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.
Odmerjanje pri odraslih in mladostnikih (od 16. leta starosti) Ustrezen odmerek izmerite z uporabo 10-mililitrske brizge, vključene v pakiranje za bolnike, stare 4 leta in več.
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/130)
Izid napotitvenega postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/130)
The European Commission issued a decision on 20 September 2019.
Evropska komisija je sklep izdala 20. septembra 2019.
Tylosin is a macrolide antibiotic used mainly to treat infections caused by bacteria known as Grampositive bacteria.
Tilozin je makrolidni antibiotik, ki se uporablja predvsem za zdravljenje okužb, ki jih povzročajo bakterije, imenovane grampozitivne bakterije.
Why were veterinary medicines containing tylosin reviewed?
Zakaj so bila zdravila za uporabo v veterinarski medicini, ki vsebujejo tilozin, pregledana?
The Committee concluded that the injection should be divided over two injection sites (maximum 2.5 ml injection volume per injection site).
Odbor je sklenil, da je treba injiciranje razdeliti na dve mesti injiciranja (največ 2,5 ml volumna injiciranja na mesto injiciranja).
In addition, cattle may also be treated by injection given slowly into a vein.
Poleg tega se lahko govedo zdravi tudi s počasnim injiciranjem v veno.
The CVMP reviewed available data on residue depletion, which indicates how long a medicine takes to fall below maximum residue limits (MRLs) in the animal's body.
Odbor CVMP je pregledal vse razpoložljive podatke o izločanju ostankov, ki je pokazatelj, kako dolgo traja, da zdravilo pade pod mejno vrednost ostankov (MRL) v telesu živali.
Veterinary medicines containing tylosin are used in adult cattle, calves, pigs, sheep and goats and are given by injection into the muscle.
Zdravila za uporabo v veterinarski medicini, ki vsebujejo tilozin, se uporabljajo pri odraslem govedu, teletih, prašičih, ovcah in kozah ter se dajejo z injiciranjem v mišico.
The full changes made to the product information are detailed in Annex III of the CVMP opinion under 'All documents'.
Vse spremembe v informacijah o zdravilu so opisane v Prilogi III mnenja odbora CVMP pod zavihkom
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that, for 49 out of 50 products, those containing benzyl alcohol and propylene glycol as a non-active ingredient, the withdrawal periods for meat and offal from treated sheep should be 42 days, while the withdrawal periods for milk from treated sheep should be 108 hours.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CVMP je ta zaključil, da bi morala biti pri 49 od 50 proizvodov, ki vsebujejo benzilalkohol in propilenglikol kot neaktivno sestavino, karenca za meso in drobovino zdravljenih ovac 42 dni, karenca za mleko zdravljenih ovac pa 108 ur.
Therefore, the CVMP concluded that the benefit-risk balance for the veterinary medicine Tilocen is not favourable for sheep and recommended a change to its marketing authorisation to remove any reference to use in sheep.
Zato je odbor CVMP zaključil, da razmerje med tveganji in koristmi zdravila Tilocen za uporabo v veterinarski medicini ni ugodno pri ovcah, in priporočil spremembo dovoljenja za promet s tem zdravilom, v katerem je treba odstraniti vsa sklicevanja na uporabo pri ovcah.
The Dutch authority considered that the withdrawal periods for sheep in the EU might not be adequate to ensure consumer safety, noting that withdrawal periods differed across the EU: from 8 to 42 days for sheep meat and offal and from 4 to 7 days for sheep milk.
Ta organ je namreč menil, da karence za ovce v EU naj ne bi bile ustrezne za zagotovitev varstva potrošnikov, saj so se med posameznimi državami EU razlikovale: od 8 do 42 dni za ovčje meso in organe ter od 4 do 7 dni za ovčje mleko.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that for some of these medicines, the maximum injection volume per site and the withdrawal periods for sheep meat, offal and milk should be changed.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je treba za nekatera od teh zdravil spremeniti največjo dovoljeno količino injiciranja na posamezno mesto ter karence za ovčje meso, drobovino in mleko.
For one medicine, Tilocen, which contains the non-active ingredient polyethylene glycol 400, there were no data available that could be used to set adequate withdrawal periods in sheep.
Za zdravilo Tilocen, ki vsebuje neaktivno sestavino polietilen glikol 400, ni bilo na voljo nobenih podatkov, ki bi se lahko uporabili za določitev ustrezne karence pri ovcah.
However, for one medicine, Tilocen, the Committee concluded that there were insufficient data to determine the withdrawal period and that it should therefore no longer be used in sheep.
Pri enem zdravilu, Tilocen, pa je ugotovil, da ni dovolj podatkov za določitev karence in da se to zato ne sme več uporabljati pri ovcah.
On 20 June 2019, the European Medicines Agency completed a review of the withdrawal periods for injectable veterinary medicines containing tylosin when used in sheep.
Evropska agencija za zdravila je 20. junija 2019 končala pregled karenc pri zdravilih za uporabo v veterinarski medicini, ki vsebujejo tilozin za injiciranje, kadar se uporabljajo pri ovcah.
On 28 September 2018, the Dutch medicines authority requested that the CVMP review all available data and recommend withdrawal periods for milk, meat and offal from sheep treated with injectable veterinary medicines containing tylosin.
Nizozemski organ za zdravila je 28. septembra 2018 zahteval, da odbor CVMP pregleda vse razpoložljive podatke in priporoči karenco za mleko, meso in organe ovac, zdravljenih z zdravili za uporabo v veterinarski medicini, ki vsebujejo tilozin za injiciranje.
The CVMP recommended the variation of the marketing authorisations for these veterinary medicines.
Zato je priporočil spremembo dovoljenj za promet s temi zdravili za uporabo v veterinarski medicini.
This summary was last updated in 10-2014
Povzetek je bil nazadnje posodobljen 10-2014.
This medicine is the same as Stalevo, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Stalevo, ki je že odobreno v Evropski uniji (EU).
Corbilta is used when these fluctuations cannot be treated with the standard combination alone.
Zdravilo Corbilta se uporablja, kadar teh fluktuacij ni mogoče zdraviti samo s standardno kombinacijo.
The European Commission granted a marketing authorisation valid throughout the European Union for Corbilta on 11 November 2013.
Evropska komisija je dovoljenje za promet z zdravilom Corbilta, veljavno po vsej Evropski uniji, izdala 11 novembra 2013.
What measures are being taken to ensure the safe and effective use of Corbilta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Corbilta?
Patients then lose their ability to control their movements reliably.
Bolniki nato izgubijo sposobnost zanesljivega nadzora nad svojimi gibi.
Other information about Corbilta
Druge informacije o zdravilu Corbilta
This is a summary of the European public assessment report (EPAR) for Corbilta.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Corbilta.
The use of combinations of levodopa and carbidopa is well established, having being in use since the mid1970s.
Uporaba kombinacij levodope in karbidope je dobro uveljavljena, in sicer od sredine sedemdesetih let prejšnjega stoletja.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Corbilta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Corbilta večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It is not intended to provide practical advice on how to use Corbilta.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The full EPAR for Corbilta 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 Corbilta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Corbilta must not be used in patients with:
Zdravilo Corbilta se ne sme uporabljati pri bolnikih, ki imajo:
The strength of Corbilta that the patient should use is based on the amount of levodopa they need to control their symptoms.
Jakost zdravila Corbilta, ki naj jo bolnik uporablja, temelji na količini levodope, ki jo potrebuje za nadzor nad simptomi.
What benefits of Corbilta have been shown in studies?
Kakšne koristi je zdravilo Corbilta izkazalo v študijah?
They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Povezana so z zmanjšanjem učinka levodope, ko bolnik občuti nenadne prehode med stanjem „on“, ko se lahko premika, in stanjem „off“, ko ima težave z gibanjem.
A risk management plan has been developed to ensure that Corbilta is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Corbilta je bil pripravljen načrt obvladovanja tveganj.
The maximum daily dose of Corbilta is 10 tablets, except for the tablets containing 175 mg levodopa and 43.75 mg carbidopa, for which the maximum daily dose is eight tablets, and those containing 200 mg levodopa and 50 mg carbidopa, for which the maximum daily dose is seven tablets.
Največji dnevni odmerek zdravila Corbilta je deset tablet, razen pri tabletah, ki vsebujejo 175 mg levodope in 43,75 mg karbidope, pri katerih je največji dnevni odmerek osem tablet, ter pri tistih, ki vsebujejo 200 mg levodope in 50 mg karbidope, pri katerih je največji dnevni odmerek sedem tablet.
What are the risks associated with Corbilta?
Kakšna tveganja so povezana z zdravilom Corbilta?
What is Corbilta and what is it used for?
Kaj je zdravilo Corbilta in za kaj se uporablja?
Why is Corbilta approved?
Zakaj je bilo zdravilo Corbilta odobreno?
• a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
• anamnezo nevroleptičnega malignega sindroma (nevarne bolezni živčnega sistema, ki jo običajno povzročijo antipsihotična zdravila) ali rabdomiolize (razgradnje mišičnega tkiva).
All of the active substances in Corbilta work to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Vse zdravilne učinkovine v zdravilu Corbilta delujejo tako, da ponovno vzpostavijo ravni dopamina v tistih delih možganov, ki nadzirajo gibe in koordinacijo.
Corbilta is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Corbilta je zdravilo, ki vsebuje tri zdravilne učinkovine: levodopo, karbidopo in entakapon.
Corbilta is available as a range of tablets in seven strengths, containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa.
Zdravilo Corbilta je na voljo v obliki tablet v sedmih jakostih, ki vsebujejo od 50 do 200 mg levodope in od 12,5 do 50 mg karbidope.
Corbilta must not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Zdravilo Corbilta se ne sme uporabljati skupaj z drugimi zdravili, ki spadajo v skupino, imenovano „zaviralci monoaminooksidaze“ (vrsta antidepresivov).
It is used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Uporablja se za zdravljenje odraslih s Parkinsonovo boleznijo (napredujočo boleznijo možganov, ki povzroča tresenje, počasno gibanje in okorelost mišic).
Serious side effects which have been reported much less often include gastrointestinal haemorrhage (bleeding in the gut) and angioedema (swelling under the skin of face or limbs).
Resni neželeni učinki, o katerih so poročali veliko redkeje, vključujejo gastrointestinalno hemoragijo (krvavitve v črevesju) ter angioedem (podkožne otekline na obrazu in okončinah).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Corbilta, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Corbilta in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The most common side effects with Corbilta (seen in more than 1 patient in 10) are dyskinesia (uncontrollable movements), aggravated Parkinsonism (worsening of Parkinson's disease), nausea (feeling sick) and harmless urine discoloration.
Najpogostejši neželeni učinki zdravila Corbilta (opaženi pri več kot 1 bolniku od 10) so diskinezija (nenadzorovani gibi), poslabšanje parkinsonizma (Parkinsonove bolezni), navzeja (slabost) in neškodljivo razbarvanje urina.
The company that makes Stalevo has agreed that its scientific data can be used for Corbilta (‘informed consent').
Družba, ki proizvaja zdravilo Stalevo, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Corbilta („uporaba dokumentacije s soglasjem“).
The company carried out ‘bioequivalence' studies to show that taking Corbilta produces the same levels of levodopa, carbidopa and entacapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Družba je izvedla študije „biološke enakovrednosti“, da bi dokazala, da so ravni levodope, karbidope in entakapona v krvi pri jemanju zdravila Corbilta enake kot pri jemanju ločenih tablet, ki vsebujejo entakapon ter kombinacijo levodope in karbidope.
For more information about treatment with Corbilta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Corbilta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Corbilta is used in patients who are being treated with a combination of levodopa and an inhibitor of dopa decarboxylase (two standard treatments for Parkinson's disease) but are having ‘fluctuations' towards the end of the period between two doses of their medication.
Zdravilo Corbilta se uporablja pri bolnikih, ki se zdravijo s kombinacijo levodope in zaviralca dopa dekarboksilaze (dveh standardnih zdravil za zdravljenje Parkinsonove bolezni), pri katerih pa se proti koncu obdobja med dvema odmerkoma zdravila pojavijo „fluktuacije“ (nihanja).
Having all three substances in the same tablet can lower the number of tablets patients have to take and help them stick to their treatment.
Ker ena tableta vsebuje vse tri učinkovine, je število tablet, ki jih mora bolnik zaužiti, manjše, zaradi česar se lažje drži režima zdravljenja.
For practical information about using Corbilta, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Corbilta naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of all side effects reported with Corbilta, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Corbilta, glejte navodilo za uporabo.
The company used some of the data from Comtess/Comtan (entacapone) to support the use of Corbilta and presented data from the published literature for the use of the combination of levodopa and carbidopa.
Družba je v podporo uporabi zdravila Corbilta uporabila nekatere podatke o zdravilu Comtess/Comtan (entakapon) in predložila podatke o uporabi kombinacije levodope in karbidope iz objavljene literature.
How is Corbilta used?
Kako se zdravilo Corbilta uporablja?
See the summary of product characteristics (also part of the EPAR) for full instructions on how patients should be switched to Corbilta and on how the dose is adjusted during treatment.
Za celotna navodila o tem, kako naj bolniki preidejo na jemanje zdravila Corbilta in kako je treba prilagajati odmerek med zdravljenjem, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
How does Corbilta work?
Kako zdravilo Corbilta deluje?
This overview was last updated in June 2019.
Ta povzetek je bil nazadnje posodobljen junija 2019.
Further information on Advocate can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/advocate.
Nadaljnje informacije o zdravilu Advocate so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/advocate.
Vomiting has also occurred rarely.
Redko se je pojavilo tudi bruhanje.
Other information about Advocate
Druge informacije o zdravilu Advocate
The European Medicines Agency decided that Advocate's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Advocate večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Advocate received a marketing authorisation valid throughout the EU on 2 April 2003.
Zdravilo Advocate je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 2. aprila 2003.
Advocate should not be used for any other animal species.
Zdravilo se ne sme uporabljati za nobeno drugo živalsko vrsto.
Dogs and cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should only be treated after special consideration by the veterinarian.
Psi in mačke, ki tehtajo manj kot 1 kg, ter beli dihurji, ki tehtajo manj kot 0,8 kg, se lahko zdravijo le po posebni presoji veterinarja.
Advocate (imidacloprid / moxidectin)
Advocate (imidakloprid/moksidektin)
Although no side effects have been confirmed in ferrets, similar side effects could occur rarely.
Čeprav pri belih dihurjih neželeni učinki niso bili opaženi, se lahko v redkih primerih pojavijo podobni neželeni učinki.
An overview of Advocate and why it is authorised in the EU
Pregled zdravila Advocate in zakaj je odobreno v EU
People with a known sensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution.
Osebe z znano občutljivostjo na benzilalkohol, imidakloprid ali moksidektin naj zdravilo uporabljajo previdno.
Subsequently, the efficacy was confirmed in several field studies in cats and dogs, conducted in different European geographical locations.
Zatem je bila potrjena v več terenskih študijah z mačkami in psi, izvedenih na različnih geografskih območjih po Evropi.
What are the risks associated with Advocate?
Kakšna tveganja so povezana z zdravilom Advocate?
Field studies involving heartworm in dogs were conducted both in the USA and Europe.
Terenske študije, ki so vključevale srčne gliste pri psih, so potekale v ZDA in Evropi.
Advocate should not be used in kittens under 9 weeks of age or in puppies under 7 weeks of age.
Zdravilo Advocate se ne sme uporabljati pri mačkah, mlajših od devet tednov, ali psih, mlajših od sedem tednov.
When administering Advocate, the user should not smoke, eat or drink, and should wash their hands thoroughly after use.
Med nanašanjem zdravila Advocate naj uporabnik ne kadi, je ali pije, po uporabi pa naj si temeljito umije roke.
Why is Advocate authorised in the EU?
Zakaj je bilo zdravilo Advocate odobreno v EU?
What is Advocate and what is it used for?
Kaj je zdravilo Advocate in za kaj se uporablja?
What benefits of Advocate have been shown in studies?
Kakšne koristi je zdravilo Advocate izkazalo v študijah?
The effectiveness of the product was measured by the number of live parasites or egg counts in the faeces at various times after treatment.
Učinkovitost zdravila je bila izmerjena s številom živih zajedavcev ali jajčec v blatu ob različnih časih po zdravljenju.
If a cat or dog licks the application area, it might salivate for a short period and might show signs such as a lack of muscular coordination, shaking, abnormal breathing and/or vomiting.
Če mačka ali pes poliže mesto nanosa, se utegne kratek čas močno sliniti in kazati znake, kot so pomanjkljiva mišična koordinacija, tresenje, nenormalno dihanje in/ali bruhanje.
It is very important that the cat products should only be used for cats, and the dog products for dogs.
Zelo pomembno je, da se zdravilo za mačke uporablja le za mačke, zdravilo za pse pa le za pse.
It contains two active substances, imidacloprid and moxidectin.
Vsebuje dve učinkovini, imidakloprid in moksidektin.
Skin contact with the pipette contents should be avoided and animals should not be stroked or groomed until the application site is dry.
Preprečiti je treba stik kože z vsebino merilne kapalke, živali pa se ne sme božati ali negovati, dokler se mesto nanosa ne posuši.
The effectiveness of Advocate against the specified parasites was investigated in laboratory studies in cats, ferrets and dogs.
Učinkovitost zdravila Advocate proti navedenim zajedavcem je bila proučena z laboratorijskimi študijami pri mačkah, belih dihurjih in psih.