natgillin/translations-raw huggingface dataset:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Ena filmsko obložena tableta vsebuje 10 mg memantinijevega klorida, kar ustreza 8,31 mg memantina.
NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets
Memantin LEK 20 mg filmsko obložene tablete
In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
(skupna ocena KPSS ob vključitvi 11 do 23), v katero je bilo zajeto 470 bolnikov, so bili bolniki randomizirani.
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two 10 mg tablets once a day) as described above.
Starejši: Na podlagi kliničnih študij je priporočen odmerek za bolnike nad 65 let starosti 20 mg na dan,
If you take more Memantine LEK than you should - In general, taking too much Memantine LEK should not result in any harm to you.
- Na splošno zaužitje večjega odmerka zdravila Memantin LEK ne sme imeti škodljivih posledic.
OUTER PACKING
Način jemanja
NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets memantine hydrochloride
Memantin LEK 10 mg filmsko obložene tablete memantinijev klorid
Elevated liver function test Hepatitis
Bolezni jeter, žolčnika in žolčevodov Pogosti zvišane vrednosti testov jetrne funkcije
Dizziness Balance disorders Gait abnormal Seizures
Pogosti motnje ravnotežja
BATCH NUMBER Lot
ŠTEVILKA SERIJE Serija{številka}
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Ena filmsko obložena tableta vsebuje 20 mg memantinijevega klorida (kar ustreza 16,62 mg memantina).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Ena filmsko obložena tableta vsebuje 20 mg memantinijevega klorida, kar ustreza 16,62 mg memantina.
28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets
filmsko obložena tableta 28 filmsko obloženih tablet.
Continue to take Memantine LEK as long as it is of benefit to you.
Jemljite zdravilo Memantin LEK tako dolgo, kot vam pomaga in se ne pojavijo neželeni učinki, ki jih ne prenašate.
Uncommon (may affect up to 1 in 100 people):
zasoplost, visok krvni tlak in preobčutljivost za zdravilo Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
Memantine LEK is for oral use.
Zdravilo Memantin LEK deluje na receptorje
Pharmacokinetic/pharmacodynamic relationship
nevroleptiki (zdravila za zdravljenje duševnih motenj) peroralni antikoagulanti
Iron oxide yellow (E 172) Iron oxide red (E 172)
Obloga tablete: polivinilalkohol makrogol 3350 titanov dioksid (E 171) smukec rumeni železov oksid (E 172) rdeči železov oksid (E 172)
Tablet coat
PRETISNI OMOT ZA TABLETE
Week 1 (day 1-7): The patient should take 5 mg per day for 7 days.
1. teden (1.-7. dan): Bolnik mora sedem dni jemati eno 5 mg filmsko obloženo tableto na dan.
Reporting of side effects
PODATKI NA ZUNANJI OVOJNINI
Week 3 (day 15-21): The patient should take 15 mg per day for 7 days.
3. teden (15.-21. dan): Bolnik mora sedem dni jemati eno 15 mg filmsko obloženo tableto na dan.
08 October 2012
8. oktober 2012
The European Commission issued a decision on 08 October 2012.
Evropska komisija je sklep izdala dne 8. oktobra 2012.
In addition, there were concerns over the methodology used to analyse these in vitro results.
Poleg tega so se pojavili pomisleki glede metodologije, ki je bila uporabljena za analizo teh rezultatov študij in vitro.
However, the Member States were not able to reach an agreement, and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 23 February 2012.
Vendar pa države članice niso uspele doseči soglasja, zato je španska regulatorna agencija za zdravila 23. februarja 2012 zadevo napotila na CHMP v arbitražo.
This is a procedure where one Member State (the ‘reference Member State', in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Norway).
To je postopek, v katerem ena od držav članic („referenčna država članica“, v tem primeru Nizozemska) oceni zdravilo, da bi odobrila dovoljenja za promet z njim, ki bo veljavno v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru Belgija, Češka republika, Danska, Estonija, Finska, Francija, Nemčija, Grčija, Madžarska, Italija, Luksemburg, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Španija, Švedska, Združeno kraljestvo in Norveška.
On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Mometasone Furoate Sandoz.
Evropska agencija za zdravila je 19. julija 2012 zaključila postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Mometasone Furoate Sandoz.
This means that it is similar to a ‘reference medicine' already authorised in the EU that contains the same active substance, but which is given using a different type of nasal spray device.
To pomeni, da je podobno „referenčnemu zdravilu“, že odobrenemu v EU, ki vsebuje isto zdravilno učinkovino, vendar se daje z drugačno vrsto nosnega pršilnika.
The Spanish agency therefore considered that the results from the in vitro studies could not be used to predict how well the medicine would work in patients.
Španska agencija je zato menila, da rezultatov študij in vitro ni mogoče uporabiti za predvidevanje, kako dobro bo zdravilo učinkovalo na bolnike.
It works by attaching to receptors in various types of immune cells, leading to a reduction in the release of substances that are involved in the inflammation process, and thereby reducing the symptoms of allergy.
Deluje tako, da se veže na receptorje v različnih vrstah celic imunskega sistema, kar vodi do zmanjšanega sproščanja snovi, ki sodelujejo v vnetnem procesu, s čimer se zmanjšajo simptomi alergije.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Mometasone Furoate Sandoz outweigh its risks, and that the marketing authorisation can be granted in the Netherlands and in the following Member States of the EU: Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Norway.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Mometasone Furoate Sandoz odtehtajo njegova tveganja in da se lahko odobri dovoljenje za promet na Nizozemskem in v naslednjih državah članicah EU: Belgiji, Češki republiki, na Danskem, v Estoniji, na Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, v Italiji, Luksemburgu, na Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji, na Švedskem, v Združenem kraljestvu in na Norveškem.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP recognised some of the concerns of the Spanish agency, but concluded that overall it was sufficiently demonstrated that possible differences between Mometasone Furoate Sandoz and the reference medicine would not affect the benefit-risk balance of the product, taking into account all the in vitro data.
CHMP je na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v okviru Odbora priznal nekatere pomisleke španske agencije, vendar je zaključil, da je bilo na splošno zadovoljivo dokazano, da morebitne razlike med zdravilom Mometasone Furoate Sandoz in referenčnim zdravilom ne bi vplivale na razmerje med koristmi in tveganji zdravila, ob upoštevanju vseh podatkov in vitro.
It is also used to prevent moderate to severe symptoms of seasonal allergic rhinitis before the pollen seasons starts.
Uporablja se tudi za preprečevanje zmernih do hudih simptomov sezonskega alergijskega rinitisa pred pričetkom sezone pojavljanja cvetnega prahu.
The CHMP therefore concluded that the benefits of Mometasone Furoate Sandoz outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Odbor je zato zaključil, da so koristi zdravila Mometasone Furoate Sandoz večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet v zadevnih državah članicah.
Mometasone Furoate Sandoz is used in adults and children from six years of age to treat the symptoms of seasonal allergic or perennial rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever, or which occurs throughout the year).
Zdravilo Mometasone Furoate Sandoz se uporablja pri odraslih in otrocih, starih šest let ali več, za zdravljenje simptomov sezonskega alergijskega ali celoletnega rinitisa (vnetja nosnih poti, ki ga povzroči alergija, kot je seneni nahod, ali takšnega, ki se pojavlja skozi vse leto).
The ‘reference medicine' for Mometasone Furoate Sandoz is called Nasonex.
“Referenčno zdravilo” za zdravilo Mometasone Furoate Sandoz se imenuje Nasonex.
The grounds for the referral were concerns over the type of in vitro (experimental) studies carried out to demonstrate that Mometasone Furoate Sandoz is comparable to Nasonex (that it produces the same levels of the active substance in the nose as Nasonex).
Razlog za napotitev so bili pomisleki glede vrste (poskusnih) študij in vitro, ki so bile izvedene zato, da se dokaže, da je zdravilo Mometasone Furoate Sandoz primerljivo z zdravilom Nasonex (tj, da vzpostavlja enake ravni zdravilne učinkovine v nosu kot zdravilo Nasonex).
Why was Mometasone Furoate Sandoz reviewed?
Zakaj je bilo zdravilo Mometasone Furoate Sandoz pregledano?
The active substance, mometasone furoate, belongs to the group ‘glucocorticoids'.
Zdravilna učinkovina, momentazonfuroat, spada v skupino „glukokortikoidov“.
Mometasone Furoate Sandoz is a medicine that contains the active substance mometasone furoate.
Mometasone Furoate Sandoz je zdravilo, ki vsebuje zdravilno učinkovino mometazonfuroat.
In addition, it is used in adults to treat the symptoms of nasal polyps (growths in the lining of the nose).
Poleg tega se uporablja za zdravljenje simptomov nosnih polipov (tvorb na nosni sluznici) pri odraslih.
Mometasone Furoate Sandoz is a ‘hybrid medicine'.
Zdravilo Mometasone Furoate Sandoz je „hibridno zdravilo“.
What is Mometasone Furoate Sandoz?
Kaj je zdravilo Mometasone Furoate Sandoz?
Also, data from a clinical study provided additional evidence that Mometasone Furoate Sandoz nasal spray works as well as Nasonex nasal spray in patients.
Poleg tega so podatki iz klinične študije še dodatno dokazali, da pršilo za nos Mometasone Furoate Sandoz pri bolnikih deluje enako dobro kot pršilo za nos Nasonex.
Sandoz B.V. submitted an application for Mometasone Furoate Sandoz to the Dutch medicines regulatory agency for a decentralised procedure.
je nizozemski medicinski regulatorni agenciji za zdravila predložila vlogo za decentralizirani postopek za zdravilo Mometasone Furoate Sandoz.
It can be used in the following situations:
Lahko se uporablja v naslednjih primerih:
Generally one kit is sufficient.
Običajno zadostuje en komplet.
• patients who are still growing;
• pri bolnikih, ki še rastejo;
The European Commission granted a marketing authorisation valid throughout the European Union for Inductos on 9 September 2002.
Evropska komisija je dovoljenje za promet z zdravilom Inductos, veljavno po vsej Evropski uniji, izdala 9. septembra 2002.
What measures are being taken to ensure the safe and effective use of Inductos?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Inductos?
The full EPAR for Inductos 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 Inductos je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
After two years, 57% of the patients treated with Inductos (69 out of 122) had responded to treatment, compared with 59% of the patients treated with a bone graft (78 out of 133).
Po dveh letih se je na zdravljenje odzvalo 57 % (69 od 122) bolnikov, zdravljenih z zdravilom Inductos, v primerjavi z 59 % (78 od 133) bolnikov, ki so bili zdravljeni s kostnim presadkom.
In addition, the company that markets Inductos will make sure that educational material is available in all Member States for all healthcare professionals expected to use the medicine.
Poleg tega bo družba, ki izdeluje zdravilo Inductos, poskrbela, da bo v vseh državah članicah na voljo izobraževalno gradivo za zdravstvene delavce, ki naj bi uporabljali zdravilo.
Other information about Inductos
Druge informacije o zdravilu Inductos
• patients diagnosed with or being treated for cancer;
• pri bolnikih, pri katerih je bil diagnosticiran rak ali se zdravijo zaradi raka;
This is a summary of the European public assessment report (EPAR) for Inductos.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Inductos.
• patients with an active infection at the surgery site;
• pri bolnikih z aktivno okužbo na mestu kirurškega posega;
Inductos must not be used in the following situations:
Zdravilo Inductos se prav tako ne sme uporabljati v naslednjih primerih:
For more information about treatment with Inductos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Inductos preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Inductos 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) pri agenciji je zaključil, da so koristi zdravila Inductos večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
A risk management plan has been developed to ensure that Inductos is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Inductos je bil pripravljen načrt obvladovanja tveganj.
What benefit has Inductos shown during the studies?
Kakšne koristi je zdravilo Inductos izkazalo med študijami?
The newly formed bone grows into the matrix, which then degrades.
Novonastala kost zraste v matriks, ki se nato razgradi.
Inductos is made up into a solution before use, applied to the matrix and left for at least 15 minutes (but no more than two hours).
Zdravilo Inductos se pred uporabo pripravi v obliki raztopine ter nanese na matriks, nakar je treba počakati najmanj 15 minut (vendar ne več kot dve uri).
Dibotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Dibotermin alfa se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celice prejmejo gen (DNK), s katerim lahko tvorijo dibotermin alfa.
It is a copy of a protein called bone morphogenetic protein 2 (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Učinkovina je kopija beljakovine, imenovane beljakovina za morfogenezo kosti 2 (BMP-2), ki se naravno tvori v telesu in pomaga pri tvorbi novega kostnega tkiva.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Inductos, 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.
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 Inductos.
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.
The most common side effects with Inductos (seen in more than 1 patient in 10) are radiculopathic events (problems occurring at or near the root of the nerve, along the spine, resulting in pain, weakness, numbness, or difficulty controlling specific muscles) when used in spine surgery, and localised infection when used in tibia fracture surgery.
Najpogostejši neželeni učinki zdravila Inductos (opaženi pri več kot 1 bolniku od 10) so radikulopatski dogodki (težave, ki se pojavljajo na korenini živca ali blizu nje vzdolž hrbtenice, kar povzroča bolečino, šibkost,odrevenelost ali oteženo nadziranje določenih mišic), kadar se uporabi pri kirurškem posegu na hrbtenici, ali lokalizirana okužba, kadar se uporabi pri kirurškem posegu za zdravljenje zloma golenice.
What is the risk associated with Inductos?
Kakšna tveganja so povezana z zdravilom Inductos?
The main measure of effectiveness was fusion of the vertebrae confirmed by X-ray, and improvement in the pain and disability reported by the patient, measured two years after surgery.
Glavno merilo učinkovitosti je bila fuzija vretenc, potrjena z rentgenskim slikanjem, ter raven zmanjšanja bolečine in invalidnosti, o kateri je poročal bolnik dve leti po kirurškem posegu.
In this type of surgery, Inductos can be used instead of an autogenous bone graft (bone taken from one part of a person's body and placed in another part of the body).
Pri tej vrsti kirurškega posega se lahko zdravilo Inductos uporablja namesto avtogenega kostnega presadka (kosti, odvzete iz enega dela telesa in presajene v drug del istega telesa).
Of the patients in the standard care group, 46% needed a further intervention within a year to repair their fracture, while the proportion was 26% for those also receiving Inductos.
V skupini bolnikov, ki so prejemali zgolj standardno oskrbo, je v prvem letu potrebovalo nadaljnje posege za zdravljenje zloma 46 % bolnikov, medtem ko je bilo v skupini bolnikov, ki so prejemali tudi zdravilo Inductos, takih bolnikov 26 %.
The matrix is then cut, if needed, to the correct size before use.
Pred vsaditvijo se matriks po potrebi odreže na ustrezno velikost.
This material will include information on the risk of heterotopic ossification and the potential risk of medication errors and incorrect use of Inductos.
V gradivu bodo navedene informacije o tveganju za pojav heterotopičnega kostenenja in možnih tveganjih zaradi napak pri predpisovanju ali uporabi zdravila Inductos.
Inductos is used in adults who have been treated for at least six months for back pain due to a damaged disc but have not had an operation.
Zdravilo Inductos se uporablja pri odraslih, ki so bili vsaj šest mesecev zdravljeni zaradi bolečin v hrbtenici, ki jo povzroča poškodovana medvretenčna ploščica, a še niso bili operirani;
Inductos has been studied in 279 patients having lower back spine fusion.
Zdravilo Inductos so proučevali pri 279 bolnikih, pri katerih je bila izvedena fuzija v ledvenem delu hrbtenice.
Additional studies and analysis of data from the published literature showed that Inductos was more effective than bone graft at inducing fusion of the lower back vertebrae, irrespective of the surgical technique or the type of approved medical device used to hold the bone in position.
Dodatne študije in analiza podatkov iz objavljene literature so pokazali, da je bilo zdravilo Inductos pri sprožanju fuzije vretenc v ledvenem delu hrbtenice učinkovitejše od kostnega presadka, ne glede na uporabljeno kirurško tehniko ali vrsto odobrenega medicinskega pripomočka za učvrstitev položaja kosti.
Patients undergoing treatment with Inductos may be at risk of heterotopic ossification (the growth of bone in abnormal places like soft tissue); this risk is considered to be manageable with the proposed risk minimisation measures.
Pri bolnikih, ki se zdravijo z zdravilom Inductos, obstaja nevarnost za heterotopično kostenenje (tvorbo kosti na neobičajnih mestih, kot so mehka tkiva); ta nevarnost je obvladljiva skupaj s predlaganimi ukrepi za zmanjševanje tveganj.
For lower back spine fusion, the damaged disc between the vertebrae is removed and replaced with one or more medical devices and Inductos.
Pri fuziji v ledvenem delu hrbtenice se odstrani poškodovana medvretenčna ploščica med vretenci ter nadomesti z enim ali več medicinskimi pripomočki in zdravilom Inductos.
Inductos has been studied in 450 patients with a fractured tibia.
Zdravilo Inductos so proučevali pri 450 bolnikih z zlomom golenice.
Inductos is used in addition to standard treatment and care.
Zdravilo Inductos se uporablja kot dodatek k standardnemu zdravljenju in oskrbi.
It is only used when the nail to fix the bone does not need ‘reaming' (drilling to make room for nail placement).
Uporablja se samo, kadar za namestitev vijaka za pritrditev kosti ni potrebno vrtanje (vrtanje vijačne odprtine).
Inductos is used together with approved medical devices that correct the position of the spine.
Zdravilo Inductos se uporablja skupaj s odobrenim medicinskim pripomočkom, ki popravi položaj hrbtenice.
The CHMP considered that Inductos is effective in single-level lumbar spine fusion as a substitute for autogenous bone graft and for the treatment of acute tibia fractures in adults, as an adjunct to standard care.
Menil je, da je zdravilo Inductos učinkovito pri enonivojski fuziji ledvene hrbtenice kot nadomestilo za avtogeni kostni presadek ter zdravljenje akutnih zlomov golenice pri odraslih kot dodatek k standardni oskrbi.
Inductos should be used by a qualified surgeon.
Zdravilo Inductos lahko uporablja le ustrezno usposobljeni kirurg.
When implanted, dibotermin alfa stimulates the bone tissue around the matrix to make new bone.
Po vsaditvi dibotermin alfa spodbuja kostno tkivo okrog matriksa k tvorbi nove kosti.
• patients with an inadequate blood supply at the fracture site;
• pri bolnikih, ki na mestu zloma nimajo ustrezne prekrvavitve;
This is a type of surgery used to relieve back pain due to a damaged disc where the disc between two vertebrae (the bones in the spine) is removed and the vertebrae are fused (joined) together.
Gre za kirurški poseg, ki se uporablja za lajšanje bolečine v hrbtenici zaradi poškodovane medvretenčne ploščice, pri katerem se ploščica med dvema vretencema (kostema hrbtenice) odstrani, vretenci pa se nato spojita.
Spinal fusion using Inductos was compared with fusion using a bone graft removed from the hip during surgery.
Fuzijo hrbtenice ob uporabi zdravila Inductos so primerjali s fuzijo ob uporabi kostnega presadka, odvzetega iz kolka med kirurškim posegom.
The active substance in Inductos, dibotermin alfa, acts on the bone structure.
Zdravilna učinkovina v zdravilu Inductos, dibotermin alfa, deluje na zgradbo kosti.
The most severe side effect is localised oedema (swelling at the surgery site) when used in upper spine (neck) surgery.
Najresnejši neželeni učinek je lokalizirani edem (otekanje na operiranem mestu) pri kirurškem posegu v zgornjem (vratnem) delu hrbtenice.
The medical devices fix the position of the vertebrae, and Inductos encourages bone to grow between the two vertebrae to join them permanently in the correct position.
Medicinski pripomoček učvrsti položaj hrbtenice, zdravilo Inductos pa spodbudi rast kosti med vretencema, tako da se trajno spojita v pravilni položaj.