natgillin/translations-raw huggingface dataset:
This is because it has not been possible to obtain complete information about Brineura due to the rarity of the disease.
Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
In a study in which 23 children (average age of 4 years) were treated with Brineura for almost a year, 20 of them (87%) did not experience the 2-point decline in movement and language skills seen historically in patients not receiving treatment.
V študiji pri 23 otrocih (povprečne starosti 4 leta), ki so se zdravili z zdravilom Brineura skoraj eno leto, 20 otrok (87 %) ni imelo upada za 2 točki pri motoričnih in govornih funkcijah, kot se je pokazalo pri bolnikih, ki zdravila niso prejemali.
The summary of the opinion of the Committee for Orphan Medicinal Products for Brineura can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Brineura je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
With regard to its safety, the data do not reveal any unacceptable concerns.
V zvezi s podatki ni bilo nobenih nesprejemljivih zadržkov glede varnosti zdravila.
Brineura has been authorised under ‘exceptional circumstances'.
Zdravilo Brineura je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Brineura or the infusion may be slowed down.
Za zmanjšanje tveganja za pojav reakcij, povezanih z infuzijo, lahko bolniki pred zdravljenjem z zdravilom Brineura ali med njim prejemajo druga zdravila ali pa se hitrost infundiranja upočasni.
Other information about Brineura
Druge informacije o zdravilu Brineura
The rating was done by doctors who gave patients individual scores for movement and language skills (where 0 means most severe and 3 is normal).
Ocenjevanje so izvedli zdravniki, ki so bolnikom dali posamične ocene za motorične in govorne funkcije (kjer ocena 0 pomeni skrajno resno, ocena 3 pa normalno stanje).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Brineura have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Brineura upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The active substance in Brineura, cerliponase alfa, is a copy of TPP1 and is used as a replacement for the missing enzyme.
Zdravilna učinkovina zdravila Brineura, cerliponaza alfa, je kopija TPP1 in se uporablja kot nadomestilo za manjkajoči encim.
For more information about treatment with Brineura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Brineura preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Since Brineura has been approved under exceptional circumstances, the company that markets it will provide further data from studies on the safety of Brineura, including the risk of allergic reactions when used long-term, and on its long-term effectiveness in delaying or stopping worsening of movement and language skills.
Ker je zdravilo Brineura pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, priskrbela nadaljnje podatke iz študij o varnosti zdravila Brineura, vključno s podatki o tveganju za alergijske reakcije pri dolgotrajni uporabi in o dolgotrajni učinkovitosti pri odložitvi ali zaustavitvi poslabšanja motoričnih in govornih funkcij.
The medicine is infused directly into the brain in order to bypass the blood-brain barrier, a protective barrier that separates the blood stream from the brain, and prevents substances such as medicines, from entering brain tissue.
Zdravilo se infundira neposredno v možgane, da obide krvno-možgansko pregrado, zaščitno pregrado, ki loči krvni obtok od možganov in prepreči snovem, kot so zdravila, da bi prišla v možgansko tkivo.
The most common side effects with Brineura (which may affect more than 1 in 5 people) are fever, low levels of protein in CSF (the fluid in the brain and spinal cord), abnormalities in ECG (a test of the heart's activity), vomiting, upper respiratory tract infections (nose and throat infections), and hypersensitivity (allergic) reactions.
Najpogostejši neželeni učinki zdravila Brineura (ki se lahko pojavijo pri več kot 1 bolniku od 5) so zvišana telesna temperatura, zmanjšana vrednost beljakovin v CSF (cerebrospinalnem likvorju in hrbtenjači), nenormalnosti na EKG (testu aktivnosti srca), bruhanje, okužbe zgornjih dihal (nosu in žrela) in preobčutljivostne (alergijske) reakcije.
It must also not be given to patients who have had a shunt implanted to drain extra fluid from the brain.
Ne sme se dajati tudi bolnikom, ki imajo vsajen šant za odvajanje odvečne tekočine iz možganov.
Because the number of patients with CLN2 is low, the disease is considered ‘rare', and Brineura was designated an ‘orphan medicine' (a medicine used in rare diseases) on 13 March 2013.
Ker je bolnikov s CLN2 malo, velja ta bolezen za redko, zato je bilo zdravilo Brineura 13. marca 2013 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
In a follow-up study the benefits of Brineura lasted for another year, with the results showing the disease could be delayed in the majority of patients.
V kontrolni študiji so koristi zdravila Brineura trajale še eno leto, pri čemer so rezultati pri večini bolnikov kazali na odložitev napredovanja bolezni.
The full EPAR for Brineura 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 Brineura je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The company that markets Brineura will ensure that all healthcare professionals expected to use this medicine are provided with training material on how to use it and how to avoid problems with the device such as infection or blockage.
Družba, ki trži zdravilo Brineura, bo za vse zdravstvene delavce, za katere se pričakuje, da bodo uporabljali to zdravilo, priskrbela izobraževalno gradivo o tem, kako uporabljati zdravilo in kako se izogniti težavam pri uporabi pripomočka, kot sta okužba ali zamašitev.
Why is Brineura approved?
Zakaj je bilo zdravilo Brineura odobreno?
Available data show that Brineura helps slow the decline in movement and language skills in patients with CLN2, a condition for which there are no other treatments.
Razpoložljivi podatki kažejo, da zdravilo Brineura pomaga upočasniti upad motoričnih in govornih funkcij pri bolnikih s CLN2, boleznijo, za katero ni na voljo drugih možnosti zdravljenja.
What are the risks associated with Brineura?
Kakšna tveganja so povezana z zdravilom Brineura?
Brineura is infused directly into the brain.
Zdravilo Brineura se daje z infundiranjem neposredno v možgane.
What benefits of Brineura have been shown in studies?
Kakšne koristi je zdravilo Brineura izkazalo v študijah?
Brineura is a medicine for treating neuronal ceroid lipofuscinosis type 2 (CLN2 disease), an inherited condition in children that leads to progressive brain damage.
Zdravilo Brineura se uporablja za zdravljenje bolnikov z nevronsko ceroidno lipofuscinozo tipa 2 (CLN2), dedno boleznijo pri otrocih, ki povzroči hitro napredujočo okvaro možganov.
For the full list of all side effects reported with Brineura, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Brineura, glejte navodilo za uporabo.
Patients with CLN2 lack an enzyme required for normal brain development called tripeptidyl-peptidase1 (TPP1).
Bolniki s CLN2 imajo pomanjkanje encima, ki se imenuje tripeptidil-peptidaza-1 (TPP1) in je potreben za normalen razvoj možganov.
What is Brineura and what is it used for?
Kaj je zdravilo Brineura in za kaj se uporablja?
What information is still awaited for Brineura?
Katere informacije o zdravilu Brineura še pričakujemo?
For practical information about using Brineura, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Brineura naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Brineura contains the active substance cerliponase alfa.
Zdravilo Brineura vsebuje zdravilno učinkovino cerliponaza alfa.
Brineura must not be given to patients who have experienced life-threatening hypersensitivity (allergic) reactions with Brineura and whose symptoms re-occurred when Brineura was given again.
Zdravilo Brineura se ne sme dajati bolnikom, ki so imeli življenje ogrožajočo alergijsko reakcijo na zdravilo Brineura in pri katerih se simptomi ob ponovni uporabi zdravila Brineura ponovijo.
Finally, patients must not be given Brineura while there are any problems with the device, such as leakage or infection.
Zdravilo Brineura pa se tudi ne sme dajati, kadar imajo bolniki kakršne koli težave s pripomočkom, kot sta puščanje ali okužba.
Before the first infusion, the patient will need to have surgery to implant a device, which runs from the outside of the skull through to the fluid cavity in the brain where the medicine is delivered to.
Pred prvim infundiranjem je treba operativno vsaditi pripomoček, ki poteka od zunanje strani lobanje do prostora z likvorjem v možganih, kamor se daje zdravilo.
Brineura has been shown in early studies to reduce the rate at which the disease worsens as measured with standard rating scale.
V zgodnjih študijah so dokazali, da je zdravilo Brineura upočasnilo poslabšanje bolezni, pri čemer so uporabili standardno klinično ocenjevalno lestvico.
Brineura can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Brineura je le na recept.
How is Brineura used?
Kako se zdravilo Brineura uporablja?
The infusions are given once every two weeks by a healthcare professional knowledgeable about giving medicines into the brain.
Infuzije dajejo zdravniki, ki so usposobljeni za intracerebroventrikularno dajanje zdravil, in sicer enkrat na dva tedna.
This summary was last updated in January 2018.
Povzetek je bil nazadnje posodobljen januarja 2018.
In both cases, treatment is for five consecutive days.
V obeh primerih zdravljenje traja pet zaporednih dni.
As a result, the cells cannot divide and eventually die.
Posledično se celice ne morejo deliti in odmrejo.
In case of skin or eye contact, the affected area should be rinsed immediately with water and any contaminated clothes should be removed.
V primeru stika s kožo ali očmi je treba prizadeto področje nemudoma izprati z vodo, odstraniti pa je treba tudi vsa kontaminirana oblačila.
The medicine is effective against the worms and their eggs.
Zdravilo učinkuje proti črvom in njihovim jajčecem.
The full EPAR for Panacur AquaSol can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Panacur AquaSol je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Panacur AquaSol's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Panacur AquaSol večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It works by interfering with the formation of tube-like structures called ‘microtubules' inside the cells of the worm that are needed to perform vital functions such as growth and cell division.
Deluje tako, da znotraj celic črva zavira tvorbo cevkastih struktur, imenovanih „mikrotubule“, ki so potrebne za opravljanje življenjsko pomembnih funkcij, kot sta rast in delitev celic.
This is a summary of the European public assessment report (EPAR) for Panacur AquaSol.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Panacur AquaSol.
The medicine should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
Zdravilo ne sme priti v vodotoke, ker je škodljivo za vodne organizme.
Before allowing the animals to access the medicated water, the water delivery system should be drained and flushed with the medicated water.
Preden se živalim omogoči dostop do vode z zdravilom, je treba sistem oskrbe z vodo izsušiti in ga oplakniti z vodo, ki ji je dodano zdravilo.
It is also the time required after administration of the medicine before eggs can be used for human consumption.
Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko jajca uporabijo za prehrano ljudi.
The first study included 432 pigs infected with Ascaris suum and the second study included 102 pigs infected with Oesophagostomum species.
Prva je vključevala 432 prašičev, okuženih z Ascaris suum, druga pa 102 prašiča, okužena z vrsto Oesophagostomum.
The person administering Panacur AquaSol should avoid contact with his/her skin, eye and moist body surfaces (mucous membranes) as the medicine may cause reactions, including skin irritation.
Oseba, ki daje zdravilo Panacur AquaSol, se naj izogiba stiku s kožo, očmi in vlažnimi telesnimi površinami (sluznico), saj lahko zdravilo povzroči reakcije, vključno z draženjem kože.
After treatment with Panacur AquaSol, the number of Trichuris suis eggs was reduced by 90%.
Po zdravljenju z zdravilom Panacur AquaSol se je število jajčec Trichuris suis zmanjšalo za 90 %.
The European Commission granted a marketing authorisation valid throughout the EU, for Panacur AquaSol on 09/12/2011.
Evropska komisija je dovoljenje za promet z zdravilom Panacur AquaSol, veljavno po vsej Evropski uniji, izdala 9. decembra 2011.
Panacur AquaSol is available as an oral suspension (200 mg/ml) for use in drinking water and can only be obtained with a prescription.
Zdravilo Panacur AquaSol je na voljo v obliki peroralne suspenzije (200 mg/ml) za dajanje v vodo za pitje, izdaja pa je le na recept.
In both studies, animals received either treatment with Panacur AquaSol or no treatment at all.
V obeh študijah so živali prejemale bodisi zdravilo Panacur AquaSol ali niso prejemale nobenega zdravila.
In a third study, 254 pigs infected with Trichuris suis were treated either with Panacur AquaSol or received no treatment.
V tretji študiji je bilo 254 prašičev, okuženih s Trichuris suis, zdravljenih bodisi z zdravilom Panacur AquaSol bodisi niso prejemali nobenega zdravila.
There are currently no known side effects associated with Panacur AquaSol.
Trenutno niso znani nobeni neželeni učinki, povezani z zdravilom Panacur AquaSol.
A further field study involved chickens bred for laying and broiler breeders (chickens producing parent stock for chickens bred for meat), infected with Capillaria worms.
Naslednja terenska študija je vključevala piščance, ki so jih redili za nesnice, in starševske pitovne piščance (piščance, ki bodo starševska jata za piščance, rejene za meso), okužene s črvi Capillaria.
Repeated use of Panacur AquaSol or a similar anthelmintic may result in resistance.
Ob večkratni uporabi zdravila Panacur AquaSol ali podobnega antihelmintika se lahko razvije odpornost nanj.
After treatment with Panacur AquaSol, no Ascaris suum or Oesophagostomum eggs could be detected in the faeces of the pigs.
Po zdravljenju z zdravilom Panacur AquaSol v iztrebkih prašičev niso odkrili jajčec Ascaris suum ali Oesophagostomum.
Other information about Panacur AquaSol
Druge informacije o zdravilu Panacur AquaSol
The active substance in Panacur AquaSol, fenbendazole, is a well-known anthelmintic, a substance that is active against helminths (parasitic worms).
Zdravilna učinkovina v zdravilu Panacur AquaSol, fenbendazol, je dobro znan antihelmintik, tj. snov, ki učinkuje proti črevesnim glistam (zajedavcem).
The withdrawal period is the time required after administration of the medicine before the animal can be slaughtered and the meat used for human consumption.
Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso uporabi za prehrano ljudi.
What are the risks associated with Panacur AquaSol?
Kakšna tveganja so povezana z zdravilom Panacur AquaSol?
The effectiveness of Panacur AquaSol was also investigated in a field study involving chickens bred for laying and chickens bred for meat, infected with Ascaridia galli or Heterakis gallinarum.
Učinkovitost zdravila Panacur AquaSol so raziskali tudi v terenski študiji, ki je vključevala piščance za vzrejo nesnic, in piščance, ki so jih redili za meso, okužene z Ascaridia galli ali Heterakis gallinarum.
Panacur AquaSol may be toxic if ingested by humans.
Zdravilo Panacur AquaSol je lahko za ljudi strupeno, če ga zaužijejo.
Pregnant women must take extra precautions when handling Panacur AquaSol as effects on the developing baby cannot be excluded.
Še zlasti previdno morajo z zdravilom Panacur AquaSol ravnati nosečnice, saj ni mogoče izključiti učinkov zdravila na nerojenega otroka.
The amount added is based on the combined weight of all the pigs to be treated, with 2.5 mg added for each kg bodyweight on each treatment day (two or three consecutive days respectively).
Dodana količina temelji na skupni telesni masi vseh prašičev, ki jih je treba zdraviti, pri čemer se odmerek vsak dan zdravljenja (dva oziroma tri dni zapored) povišuje za 2,5 mg na kg telesne mase.
The withdrawal period for eggs is zero days.
Karenca za jajca je nič dni.
For more information about treatment with Panacur AquaSol, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Panacur AquaSol naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
What benefits of Panacur AquaSol have been shown in studies?
Kakšne koristi je zdravilo Panacur AquaSol izkazalo v študijah?
For practical information about using Panacur AquaSol, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Panacur AquaSol naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Treatment with Panacur Aquasol at 1 mg/kg for 5 days in chickens reduced intestinal worm counts by 91% for Ascaridia galli and 98% for Heterakis gallinarum.
Petdnevno zdravljenje piščancev z zdravilom Panacur AquaSol v odmerku 1 mg/kg je v prebavilih zmanjšalo število črvov za 91 % pri okužbi z Ascaridia galli in za 98 % pri okužbi z Heterakis gallinarum.
• Oesophagostomum worms (adult stages);
• črvi Oesophagostomum (odrasli stadiji);
What is Panacur AquaSol and what is it used for?
Kaj je zdravilo Panacur AquaSol in za kaj se uporablja?
Panacur AquaSol is used for the treatment and control of three types of roundworm infections in the gut of pigs:
Zdravilo Panacur AquaSol se uporablja za zdravljenje in nadzor treh vrst okužb z valjastimi črvi v črevesju prašičev:
Panacur AquaSol treatment at 2 mg/kg for 5 days reduced worm counts by 100%.
Petdnevno zdravljenje z zdravilom Panacur AquaSol v odmerku 2 mg/kg je zmanjšalo število črvov za 100 %.
Panacur AquaSol is also used for the treatment of three types of roundworm infections in the gut of chickens:
Zdravilo Panacur AquaSol se uporablja tudi za zdravljenje treh vrst okužb z valjastimi črvi v črevesju piščancev:
Protective gloves must be worn at all times whilst handling the product and cleaning the measuring device.
Pri ravnanju z zdravilom in čiščenju merilne priprave je treba ves čas nositi zaščitne rokavice.
Why is Panacur AquaSol approved?
Zakaj je bilo zdravilo Panacur AquaSol odobreno?
The withdrawal period for chicken meat and offal is six days for the 1 mg fenbendazole/kg dose and nine days for the 2 mg fenbendazole/kg dose.
Karenca za meso in drobovino piščancev je šest dni pri odmerku fenbendazola 1 mg/kg in devet dni pri odmerku fenbendazola 2 mg/kg.
For chickens, Panacur AquaSol is added to their drinking water in a quantity that aims to supply each chicken 1 mg fenbendazole per kg bodyweight daily for treating Ascaridia galli and Heterakis gallinarum and 2 mg fenbendazole per kg bodyweight daily for Capillaria infections.
Za piščance se zdravilo Panacur AquaSol dodaja pitni vodi v količini, ki vsakega piščanca dnevno oskrbi z 1 mg fenbendazola na kg telesne mase za zdravljenje okužb z Ascaridia galli in Heterakis gallinarum ter 2 mg fenbendazola na kg telesne mase za zdravljenje okužb s Capillaria.
• Ascaris suum (adult intestinal and migrating larval stages);
• Ascaris suum (odrasli, intestinalni in migrirajoči larvalni stadiji);
Panacur AquaSol was tested in three field studies involving pigs.
Zdravilo Panacur AquaSol so pri prašičih preskusili v treh terenskih študijah.
It is not intended to provide practical advice on how to use Panacur AquaSol.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How does Panacur AquaSol work?
Kako zdravilo Panacur AquaSol deluje?
• Heterakis gallinarum (L5 larvae and adult stages);
• Heterakis gallinarum (larvalni stadij L5 in odrasli stadiji);
• Ascaridia galli (L5 larvae and adult stages);
• Ascaridia galli (larvalni stadij L5 in odrasli stadiji);
The withdrawal period for Panacur AquaSol for pig meat and offal is four days.
Karenca za meso in drobovino prašičev, zdravljenih z zdravilom Panacur AquaSol, je štiri dni.
• Capillaria worms (L5 larvae and adult stages).
• črvi Capillaria (larvalni stadij L5 in odrasli stadiji).
How is Panacur AquaSol used?
Kako se zdravilo Panacur AquaSol uporablja?
For pigs, Panacur AquaSol is added to their drinking water in a quantity that aims to supply each pig 2.5 mg fenbendazole per kg bodyweight daily; this is done for two consecutive days for treatment and control of Ascaris suum and Oesophagostomum infections, and for three consecutive days to treat and control Trichuris suis.
Zdravilo se dodaja dva dni zapored za zdravljenje in nadzor okužb z Ascaris suum in Oesophagostomum ter tri dni zapored za zdravljenje in nadzor okužbe s Trichuris suis.
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
PRILOGA I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Richter Gedeon nyrt.
Madžarska Richter Gedeon nyrt.
S.C. TERAPIA S.A. Str. Fabricii nr. 124, Cluj Napoca, România
Str. Fabricii nr. 124, Cluj Napoca, România
TOLPERISON 50 mg coated tablet oral use
TOLPERISON 50 mg obložena tableta peroralna uporaba
Tablets oral use
Tableta
Other information about Inflacam
Druge informacije o zdravilu Inflacam
Further information on Inflacam can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports Information on the reference medicine can also be found on the Agency's website.
Nadaljnje informacije o zdravilu Inflacam so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports Informacije o referenčnem zdravilu so prav tako na voljo na spletni strani agencije.
Inflacam received a marketing authorisation valid throughout the EU on 9 December 2011.
Zdravilo Inflacam je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 9. decembra 2011.
What are the benefits and risks of Inflacam?
Kakšne so koristi in tveganja, povezani z zdravilom Inflacam?
Injections may be into a vein, muscle or under the skin.
Injekcije se dajejo v veno, mišico ali pod kožo.
An overview of Inflacam and why it is authorised in the EU
Pregled zdravila Inflacam in zakaj je odobreno v EU