natgillin/translations-raw huggingface dataset:
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Booster vaccination:
Suspenzija za injiciranje
This summary was last updated in June 2013.
Povzetek je bil nazadnje posodobljen 06-2013.
It is used to treat patients with moderate to severe Alzheimer's disease.
Uporablja se za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
To prevent side effects, the dose of Memantine ratiopharm is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Da se preprečijo neželeni učinki, se odmerek zdravila Memantine ratiopharm v prvih treh tednih zdravljenja postopoma povečuje: prvi teden je odmerek 5 mg, drugi teden 10 mg, tretji teden pa 15 mg. Od četrtega tedna naprej je priporočeni vzdrževalni odmerek 20 mg enkrat dnevno.
Memantine ratiopharm should be given once a day at the same time every day.
Zdravilo Memantine ratiopharm se daje enkrat dnevno, vsak dan ob istem času.
Memantine ratiopharm is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) and can only be obtained with a prescription.
Zdravilo Memantine ratiopharm je na voljo v obliki tablet (5 mg, 10 mg, 15 mg in 20 mg) in se izdaja le na recept.
The full EPAR for Memantine ratiopharm 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 Memantine ratiopharm je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Memantine ratiopharm.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Memantine ratiopharm.
This means that Memantine ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Ebixa.
The Committee recommended that Memantine ratiopharm be approved for use in the EU.
Priporočil je, da se zdravilo Memantine ratiopharm odobri za uporabo v EU.
The tolerance and dose should be assessed within three months after starting treatment, and from then on the benefits of continuing treatment with Memantine ratiopharm should be re-assessed on a regular basis.
Prenašanje in odmerek zdravila je treba oceniti v treh mesecih od začetka zdravljenja, od takrat naprej pa je treba koristi zdravljenja z zdravilom Memantine ratiopharm ponovno ocenjevati v rednih intervalih.
What measures are being taken to ensure the safe and effective use of Memantine ratiopharm?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Memantine ratiopharm?
The European Commission granted a marketing authorisation valid throughout the European Union for Memantine ratiopharm on 13 June 2013.
Evropska komisija je dovoljenje za promet z zdravilom Memantine ratiopharm, veljavno po vsej Evropski uniji, odobrila dne 13 junija 2013.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine ratiopharm by the patient.
Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno spremljal bolnikovo jemanje zdravila Memantine ratiopharm.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine ratiopharm has been shown to have comparable quality and to be bioequivalent to Ebixa.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Memantine ratiopharm primerljivo raven kakovosti kot zdravilo Ebixa ter da mu je biološko enakovredno.
Because Memantine ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Memantine ratiopharm generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Other information about Memantine ratiopharm
Druge informacije o zdravilu Memantine ratiopharm
For more information about treatment with Memantine ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Memantine ratiopharm preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What are the benefits and risks of Memantine ratiopharm?
Kakšne so koristi in tveganja, povezani z zdravilom Memantine ratiopharm?
Because Memantine ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa.
Ker je zdravilo Memantine ratiopharm generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Ebixa.
For practical information about using Memantine ratiopharm, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Memantine ratiopharm naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Memantine ratiopharm is a ‘generic medicine'.
Zdravilo Memantine ratiopharm je „generično zdravilo“.
Safety information has been included in the summary of product characteristics and the package leaflet for Memantine ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients.
V povzetek glavnih značilnosti zdravila Memantine ratiopharm in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What is Memantine ratiopharm and what is it used for?
Kaj je zdravilo Memantine ratiopharm in za kaj se uporablja?
Memantine ratiopharm is a medicine that contains the active substance memantine hydrochloride.
Memantine ratiopharm je zdravilo, ki vsebuje zdravilno učinkovino memantinijev klorid.
EPAR summary for the public
Povzetek EPAR za javnost memantinijev klorid
The active substance in Memantine ratiopharm, memantine hydrochloride, is an antidementia medicine.
Zdravilna učinkovina zdravila Memantine ratiopharm, memantinijev klorid, je zdravilo za zdravljenje demence.
It is not intended to provide practical advice on how to use Memantine ratiopharm.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Memantine ratiopharm approved?
Zakaj je bilo zdravilo Memantine ratiopharm odobreno?
How has Memantine ratiopharm been studied?
Kako je bilo zdravilo Memantine ratiopharm raziskano?
How is Memantine ratiopharm used?
Kako se zdravilo Memantine ratiopharm uporablja?
How does Memantine ratiopharm work?
Kako zdravilo Memantine ratiopharm deluje?
This summary was last updated in February 2017.
Povzetek je bil nazadnje posodobljen februarja 2017.
Repeated accidental self-injection may cause an allergic reaction to the medicine.
Ponavljajoče se nenamerno samoinjiciranje lahko povzroči alergijsko reakcijo na zdravilo.
The full EPAR for Cytopoint 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 Cytopoint je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Once the dog's skin becomes damaged by scratching and rubbing, secondary bacterial and yeast infections may develop as well.
Ko pride do poškodbe kože zaradi praskanja in drgnjenja, se lahko razvijejo tudi sekundarne bakterijske in glivične okužbe.
This is a summary of the European public assessment report (EPAR) for Cytopoint.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cytopoint.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Cytopoint'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 Cytopoint večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Cytopoint starts to be effective within eight hours of injection and the effect lasts for up to 28 days.
Zdravilo Cytopoint začne učinkovati v osmih urah po injiciranju, njegov učinek pa traja do 28 dni.
The most common side effects with Cytopoint (which may affect up to 1 in 1,000 animals) are allergic reactions with swelling of the face and itchy rash.
Najpogostejši neželeni učinki zdravila Cytopoint (ki lahko prizadenejo največ 1 žival od 1 000) so alergijske reakcije z otekanjem obraza in srbeč izpuščaj.
It is not intended to provide practical advice on how to use Cytopoint.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Atopic dermatitis is inflammation of the skin that is linked to allergy, often to things in the environment such as house dust mites and pollens.
Atopični dermatitis je vnetje kože, ki je povezano z alergijo, pogosto na dejavnike v okolju, kot so denimo hišne pršice in cvetni prah.
Lokivetmab is a monoclonal antibody (a type of protein) that recognises and attaches to interleukin-31, a protein that plays an important role in triggering atopic dermatitits in dogs.
Lokivetmab je monoklonsko protitelo (vrsta beljakovine), ki prepozna interlevkin-31, tj. beljakovino, ki ima pomembno vlogo pri sprožitvi atopičnega dermatitisa pri psih, in se veže nanj.
Other information about Cytopoint
Druge informacije o zdravilu Cytopoint
Cytopoint is a veterinary medicine used to treat atopic dermatitis in dogs.
Cytopoint je zdravilo za uporabo v veterinarski medicini za zdravljenje atopičnega dermatitisa pri psih.
Cytopoint is available as a solution for injection that is injected under the skin once a month.
Zdravilo Cytopoint je na voljo v obliki raztopine za injiciranje, ki se enkrat na mesec vbrizga v podkožje.
The dose to be used depends on the weight of the dog being treated.
Odmerek, ki ga je treba uporabiti, je odvisen od telesne mase psa, ki se zdravi.
What is Cytopoint and what is it used for?
Kaj je zdravilo Cytopoint in za kaj se uporablja?
By blocking interleukin 31, lokivetmab reduces itchy skin and inflammation.
Lokivetmab z zaviranjem interlevkina-31 zmanjša srbenje kože in vnetje.
Cytopoint was as effective as ciclosporin in treating itchy skin; after 28 days the pruritus score (measurement of itchiness) was reduced by 52% in dogs given Cytopoint and 44% in those given ciclosporin.
Zdravilo Cytopoint je bilo enako učinkovito kot ciklosporin pri zdravljenju srbeče kože; po 28 dneh se je rezultat za pruritus (srbenje) zmanjšal za 52 % pri psih, ki so prejemali zdravilo Cytopoint, in za 44 % pri psih, ki so prejemali ciklosporin.
What benefits of Cytopoint have been shown in studies?
Kakšne koristi je zdravilo Cytopoint izkazalo v študijah?
What are the risks associated with Cytopoint?
Kakšna tveganja so povezana z zdravilom Cytopoint?
In a field study involving dogs with atopic dermatitis, 142 dogs received Cytopoint monthly for 3 months whilst 132 were treated with ciclosporin, another medicine approved for treating atopic dermatitis.
V terenski študiji, ki je zajela pse z atopičnim dermatitisom, je 142 psov mesečno prejemalo zdravilo Cytopoint v obdobju treh mesecev, 132 pa jih je bilo zdravljenih s ciklosporinom, tj. drugim zdravilom, odobrenim za zdravljenje atopičnega dermatitisa.
Why is Cytopoint approved?
Zakaj je bilo zdravilo Cytopoint odobreno?
Safety information has been included in the summary of product characteristics and the package leaflet for Cytopoint, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila Cytopoint in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno z ustreznimi previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
In a follow up study, 81 dogs of the dogs continued Cytopoint treatment for a further six months and the itchy skin score went down further to 14.
V nadaljevanju študije je 81 psov še dalje prejemalo zdravilo Cytopoint nadaljnjih šest mesecev, pri čemer so se rezultati glede srbeče kože še dodatno zmanjšali na vrednost 14.
For more information about treatment with Cytopoint, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Cytopoint naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
The European Commission granted a marketing authorisation valid throughout the EU for Cytopoint on 25 April 2017.
Evropska komisija je dovoljenje za promet z zdravilom Cytopoint, veljavno po vsej EU, odobrila dne
For practical information about using Cytopoint, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Cytopoint naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Over the three months of the study pruritus score went down from a value of 74 at the start to 26 at the end in dogs given Cytopoint.
V treh mesecih izvajanja študije se je rezultat za pruritus pri psih, ki so prejemali zdravilo Cytopoint, zmanjšal s 74 ob začetku študije na 26 ob koncu študije.
How does Cytopoint work?
Kako zdravilo Cytopoint deluje?
How is Cytopoint used?
Kako se zdravilo Cytopoint uporablja?
Cytopoint contains the active substance lokivetmab.
Zdravilo Cytopoint vsebuje zdravilno učinkovino lokivetmab.
Cytopoint must not be given to dogs weighing less than 3 kg. For the full list of restrictions and all side effects reported with Cytopoint, see the package leaflet.
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Cytopoint, glejte navodilo za uporabo.
The recommended dose of Fosavance is one tablet once a week.
Priporočeni odmerek zdravila Fosavance je ena tableta enkrat na teden.
The European Commission granted a marketing authorisation valid throughout the EU for Fosavance on 24 August 2005.
Evropska komisija je dovoljenje za promet z zdravilom Fosavance, veljavno po vsej Evropski uniji, izdala 24. avgusta 2005.
The main measure of effectiveness was the reduction in the number of patients with low vitamin D levels after 15 weeks.
Glavno merilo učinkovitosti je bilo zmanjšanje števila bolnic z nizko ravnjo vitamina D po 15 tednih zdravljenja.
What measures are being taken to ensure the safe and effective use of Fosavance?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fosavance?
The full EPAR for Fosavance 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 Fosavance je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Fosavance.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fosavance.
The CHMP decided that Fosavance's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Fosavance večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins).
Bolnica mora tableto zaužiti s polnim kozarcem vode (vendar ne mineralne), in sicer najmanj 30 minut pred zaužitjem hrane, pijače ali drugih zdravil (vključno z antacidi, dodatki kalcija in vitamini).
For more information about treatment with Fosavance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Fosavance preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Fosavance:
Druge informacije o zdravilu Fosavance:
Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s.
Alendronska kislina je difosfonat, ki se pri zdravljenju osteoporoze uporablja od sredine devetdesetih let prejšnjega stoletja.
A risk management plan has been developed to ensure that Fosavance is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Fosavance je bil pripravljen načrt obvladovanja tveganj.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fosavance, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
for the full list of restrictions, see the package leaflet.
Za celoten seznam omejitev glejte navodilo za uporabo.
Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the European Union (EU), the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.
Ker se alendronska kislina in vitamin D3 ločeno že uporabljata v zdravilih, odobrenih v Evropski uniji (EU), je družba predložila podatke iz starejših študij ter iz objavljene literature o ženskah, ki so že prestale menopavzo in so jemale alendronsko kislino in vitamin D kot ločeni tableti.
What benefit has Fosavance shown during the studies?
Kakšne koristi je zdravilo Fosavance izkazalo med študijami?
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 Fosavance.
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.
Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Fosavance.
Ker bolnice z osteoporozo z izpostavljanjem sončni svetlobi morda ne dobijo dovolj vitamina D3, je ta vključen v zdravilo Fosavance.
It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Zavira delovanje osteoklastov, tj. celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Fosavance was the same as the dose needed to prevent bone loss.
Podatki iz starejših študij in objavljene literature, ki jih je predstavila družba, so pokazali, da je odmerek alendronske kisline v zdravilu Fosavance enak odmerku, ki je potreben za preprečevanje izgube kostne mase.
Fosavance alendronic acid and colecalciferol
Fosavance alendronska kislina in holekalciferol
To avoid irritation of the oesophagus (the tube that leads from the mouth to the stomach), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet.
Da bi preprečili draženje požiralnika (cevke, ki vodi od ust do želodca), bolnica ne sme leči, dokler ne zaužije prvega dnevnega obroka hrane, kar pa ne sme biti prej kot 30 minut po zaužitju tablete.
What is the risk associated with Fosavance?
Kakšna tveganja so povezana z zdravilom Fosavance?
Fosavance reduces the risk of fractures (broken bones) in the spine and the hip.
Zdravilo Fosavance zmanjšuje tveganje za zlome kosti v hrbtenici in kolkih.
Fosavance must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes.
Zdravila Fosavance ne smejo uporabljati bolnice z nepravilnostmi v požiralniku, bolnice s hipokalciemijo (nizkimi ravnmi kalcija v krvi) ali tiste, ki vsaj 30 minut ne morejo vzravnano stati ali sedeti.
For the full list of all side effects reported with Fosavance, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fosavance, glejte navodilo za uporabo.
This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Fosavance 70 mg/2,800 IU on its own or adding another 2,800 IU vitamin D3 (equivalent to using Fosavance 70 mg/5,600 IU).
Ta študija je bila pri 652 bolnicah podaljšana za nadaljnjih 24 tednov, da bi primerjali učinke nadaljevanja zdravljenja samo z zdravilom Fosavance v odmerku 70 mg/2 800 i.e. z učinki dodajanja 2 800 i.e. vitamina D3 (kar je enakovredno uporabi zdravila Fosavance 70 mg/5 600 i.e.).
The most common side effects with Fosavance (seen between 1 and 10 patients in 100) are headache, abdominal pain (stomach ache), dyspepsia (heartburn), constipation, diarrhoea, flatulence (gas),
Najpogostejši neželeni učinki zdravila Fosavance (opaženi pri 1 do 10 bolnikih od 100) so glavobol, bolečine v trebuhu, dispepsija (zgaga), zaprtje, driska, flatulenca (vetrovi), razjede požiralnika, disfagija (težave pri požiranju), napihnjen trebuh, refluks kisline in mišično-skeletne bolečine (bolečine v mišicah, kosteh in sklepih).
Why has Fosavance been approved?
Zakaj je bilo zdravilo Fosavance odobreno?
To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Fosavance's ability to increase vitamin D levels.
V podporo uporabi kombinacije alendronske kisline in vitamina D3 v isti tableti in za pridobitev dokazov, da lahko zdravilo Fosavance poveča ravni vitamina D, je družba opravila študijo s 717 bolnicami z osteoporozo, ki je vključevala 682 žensk, ki so že prestale menopavzo.
Fosavance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Fosavance je zdravilo, ki vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol (vitamin D3).
Fosavance contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Fosavance je vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol (vitamin D3).
Patients received either Fosavance 70 mg/2,800 IU or alendronic acid only once a week.
Bolnice so enkrat tedensko prejemale bodisi zdravilo Fosavance 70 mg/2 800 i.e. bodisi le alendronsko kislino.
Fosavance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels.
Zdravilo Fosavance (ki vsebuje 2 800 ali 5 600 i.e. holekalciferola) se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pomanjkanje vitamina D. Pri bolnicah, ki ne jemljejo dodatkov vitamina D se uporablja zdravilo Fosavance v odmerku 70 mg/5 600 i.e.