natgillin/translations-raw huggingface dataset:
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mvasi have 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 Mvasi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Mvasi has been shown to have a comparable quality, safety and effectiveness to Avastin.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Mvasi po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Avastin.
In addition, a study involving 642 patients with advanced non-small cell lung cancer showed that Mvasi was as effective as Avastin when given with the cancer medicines carboplatin and paclitaxel.
Poleg tega so v študiji, ki je vključevala 642 bolnikov z napredovalim nedrobnoceličnim rakom pljuč, pokazali, da je zdravilo Mvasi enako učinkovito kot zdravilo Avastin, če se daje v kombinaciji z drugima zdraviloma proti raku, in sicer karboplatinom in paklitakselom.
The reference medicine for Mvasi is Avastin.
Referenčno zdravilo za zdravilo Mvasi je zdravilo Avastin.
As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours.
Zaradi tega se rakave celice ne morejo več oskrbovati s krvjo ter dobivajo premalo kisika in hranil, kar pripomore k upočasnjeni rasti tumorjev.
Mvasi must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies.
Zdravila Mvasi ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) bevacizumab ali katero koli drugo sestavino zdravila, na pripravke iz celic jajčnika kitajskega hrčka ali druga rekombinantna protitelesa.
The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain.
Najpogostejši neželeni učinki bevacizumaba (ki se lahko pojavijo pri več kot 1 bolniku od 10) so hipertenzija (povišan krvni tlak), utrujenost ali astenija (šibkost), driska in bolečine v trebuhu.
For practical information about using Mvasi, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Mvasi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Therefore, the Agency's view was that, as for Avastin, the benefit outweighs the identified risk.
Zato je menila, da njegove koristi enako kot pri zdravilu Avastin odtehtajo znana tveganja.
The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries).
Najresnejši neželeni učinki so gastrointestinalne perforacije (preluknjanje črevesja), krvavitve in arterijska trombembolija (krvni strdki v arterijah).
The active substance in Mvasi, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Zdravilna učinkovina v zdravilu Mvasi, bevacizumab, je monoklonsko protitelo (vrsta beljakovine), zasnovano tako, da prepozna endotelijski rastni faktor v žilah (VEGF), tj. beljakovino, ki kroži po krvi in omogoča rast krvnih žil, in se veže nanj.
• a type of lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery, including cases where the cancer cells have a mutation
• vrste pljučnega raka, ki se imenuje nedrobnocelični rak pljuč, če ta napreduje ali se razširi ali ponovi in če ga ni mogoče zdraviti operativno, vključno s primeri, ko imajo rakave celice mutacijo (spremembo) v genu za beljakovino, imenovano EGFR.
Because Mvasi is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Mvasi.
Zdravilo Mvasi je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti bevacizumaba, izvedenih z zdravilom Avastin, z zdravilom Mvasi ni treba ponavljati.
Mvasi can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.
Predpisovanje in izdaja zdravila Mvasi je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
• breast cancer that has spread to other parts of the body;
• raka dojk, ki se je razširil na druge dele telesa;
• cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb or the peritoneum, the membrane that lines the abdomen);
• raka jajčnikov ali povezanih struktur (jajcevoda, ki prenaša jajčece iz jajčnika v maternico, ali potrebušnice, tj. mrene v trebušni votlini);
Mvasi is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Zdravilo Mvasi je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
The Agency recommended that Mvasi be given marketing authorisation.
Priporočila je, da se za zdravilo Mvasi izda dovoljenje za promet.
For the full list of all side effects reported with Mvasi, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Mvasi, glejte navodilo za uporabo.
How does Mvasi work?
Kako zdravilo Mvasi deluje?
Studies have also shown that giving Mvasi produces similar levels of the active substance in the body to giving Avastin.
Študije so pokazale tudi, da zdravilo Mvasi vzpostavi podobne ravni zdravilne učinkovine v telesu kot zdravilo Avastin.
Mvasi contains the active substance bevacizumab and is a ‘biosimilar medicine'.
Zdravilo Mvasi vsebuje zdravilno učinkovino bevacizumab in je „podobno biološko zdravilo“.
• cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
• raka ledvic (karcinoma ledvičnih celic), ki je napredoval ali se je razširil po telesu;
Laboratory studies comparing Mvasi with Avastin have shown that the active substance in Mvasi is highly similar to that in Avastin in terms of structure, purity and biological activity.
Laboratorijske študije, v katerih so zdravilo Mvasi primerjali z zdravilom Avastin, so pokazale, da je zdravilna učinkovina v zdravilu Mvasi po zgradbi, čistosti in biološkem delovanju zelo podobna zdravilni učinkovini v zdravilu Avastin.
How is Mvasi used?
Kako se zdravilo Mvasi uporablja?
• cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or spread to other parts of the body.
• raka materničnega vratu, pri katerem je bolezen prisotna tudi po zaključenem primarnem zdravljenju ali se je ponovila ali razširila na druge dele telesa.
• cancer of the colon (large bowel) or the rectum, when it has spread to other parts of the body;
• raka črevesja (debelega črevesa) ali danke, ki se je razširil na druge dele telesa;
By attaching to VEGF, Mvasi stops it having an effect.
Zdravilo Mvasi z vezavo na endotelijski rastni faktor v žilah zaustavi njegovo delovanje.
The European Commission granted a marketing authorisation valid throughout the European Union for Tivicay on 16 January 2014.
Evropska komisija je dovoljenje za promet z zdravilom Tivicay, veljavno po vsej Evropski uniji, izdala 16. januarja 2014.
Tivicay is available as tablets (10, 25 and 50 mg).
Zdravilo Tivicay je na voljo v obliki tablet (10, 25 in 50 mg).
What measures are being taken to ensure the safe and effective use of Tivicay?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tivicay?
The full EPAR and risk management plan summary for Tivicay 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) in povzetek načrta obvladovanja tveganj za zdravilo Tivicay sta 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 Tivicay.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tivicay.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tivicay'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) pri agenciji je zaključil, da so koristi zdravila Tivicay 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 Tivicay.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The results indicated that similar levels of the medicine were produced in children to those seen in adults and adolescents, which should result in similar effectiveness.
Rezultati so pokazali, da so bile pri otrocih proizvedene podobne ravni zdravila, kot so bile opažene pri odraslih in mladostnikih, kar naj bi povzročilo podobno učinkovitost.
Other information about Tivicay
Druge informacije o zdravilu Tivicay
The main measure of effectiveness in all the studies was the response rate, which was the proportion of patients with a reduction of the levels of virus (viral load) in the blood to fewer than 50 copies of HIV-1 RNA per ml.
Glavno merilo učinkovitosti v vseh študijah je bila stopnja odziva, opredeljena kot delež bolnikov, pri katerih se je koncentracija virusa (virusno breme) v krvi zmanjšala na manj kot 50 kopij HIV-1 RNK na ml.
It is used together with other medicines to treat adults and children from 6 years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje odraslih in mladostnikov, starejših od 12 let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tivicay 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 Tivicay upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Tivicay was demonstrated to be effective against HIV-1 in four main studies in adults.
Zdravilo Tivicay se je v štirih glavnih študijah izkazalo za učinkovito proti virusu HIV-1 pri odraslih.
The company subsequently presented available results in 23 children from 6 to less than 12 years of age, who were given doses of Tivicay based on their body weight.
Družba je zato predstavila razpoložljive izide pri 23 otrocih, starih od šest do manj kot 12 let, ki so prejeli odmerke zdravila Tivicay glede na njihovo telesno maso.
Supportive data from an ongoing study in children and adolescents indicated that adolescents could be given the adult dose of Tivicay.
Podporni podatki iz potekajoče študije pri otrocih in mladostnikih so pokazali, da je mladostnikom mogoče dati odmerek zdravila Tivicay za odrasle.
What benefits of Tivicay have been shown in studies?
Kakšne koristi je zdravilo Tivicay izkazalo v študijah?
What are the risks associated with Tivicay?
Kakšna tveganja so povezana z zdravilom Tivicay?
The most common side effects with Tivicay (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea, and headache.
Najpogostejši neželeni učinki zdravila Tivicay (ki lahko prizadenejo več kot 1 osebo od 10) so navzeja (slabost), driska in glavobol.
The Committee concluded that the medicine had demonstrated its effectiveness in both untreated and previously treated patients, including those with resistance to integrase inhibitors.
Odbor je zaključil, da se je zdravilo izkazalo za učinkovito tako pri predhodno nezdravljenih bolnikih kot tistih, ki so se že zdravili in med katerimi so bili tudi bolniki, odporni proti zaviralcem integraze.
This is an antiviral medicine that blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
To je protivirusno zdravilo, ki zavira encim, imenovan integraza, ki ga virus HIV potrebuje za to, da se v telesu lahko razmnožuje.
The medicine was generally well tolerated, although the CHMP noted the possible risk of infrequent but severe hypersensitivity reactions.
Bolniki so zdravilo na splošno dobro prenašali, je pa odbor CHMP izpostavil možno tveganje za občasne, vendar hude preobčutljivostne reakcije.
Although Tivicay can normally be taken with or without food, patients whose virus is resistant to this class of medicines should take Tivicay with food as it helps the medicine to get absorbed.
Čeprav se zdravilo Tivicay običajno lahko jemlje s hrano ali brez nje, ga morajo bolniki z virusom, ki je odporen proti zdravilom iz te skupine, jemati skupaj s hrano, saj ga bo telo tako lažje absorbiralo.
When it is given with other medicines, Tivicay helps to prevent the spread of HIV and keep the amount of the virus in the blood at a low level.
Zdravilo Tivicay tako v kombinaciji z drugimi zdravili pomaga preprečiti širjenje virusa HIV in ohranjati količino virusa v krvi na nizki ravni.
What is Tivicay and what is it used for?
Kaj je zdravilo Tivicay in za kaj se uporablja?
Two studies involved patients who had not previously been treated for HIV:
V dveh študijah so proučevali bolnike, ki se pred tem še niso zdravili zaradi virusa HIV:
Tivicay does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Tivicay ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
Patients were treated with a combination of HIV medicines that included either Tivicay or raltegravir.
Bolnike so zdravili s kombinacijo zdravil proti virusu HIV, med katerimi je bilo bodisi zdravilo Tivicay ali raltegravir.
For more information about treatment with Tivicay, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Tivicay preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
More serious adverse effects that have been reported include an uncommon but severe hypersensitivity (allergic) reaction with rash and possible effects on the liver.
Med resnejšimi neželenimi učinki, o katerih so poročali, so bile občasne, vendar hude preobčutljivostne (alergijske) reakcije z izpuščaji in možno prizadetostjo jeter.
Two other studies looked at the effectiveness of Tivicay in patients whose previous HIV treatment had stopped working:
V dveh drugih študijah so proučevali učinkovitost zdravila Tivicay pri bolnikih, pri katerih predhodno zdravljenje virusa HIV ni bilo več učinkovito:
Why is Tivicay approved?
Zakaj je bilo zdravilo Tivicay odobreno?
• The first of these involved 715 patients whose previous treatment had not included an integrase inhibitor and whose infection was therefore not expected to be resistant to this class of medicines.
• v prvi je sodelovalo 715 bolnikov, ki med predhodnim zdravljenjem niso bili izpostavljeni zaviralcu integraze in torej ni verjetno, da bi bila okužba pri njih odporna proti zdravilom iz te skupine.
For practical information about using Tivicay, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Tivicay naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Tivicay must not be given together with dofetilide, a medicine for disturbances of heart rhythm, as it may cause serious side effects.
Zdravilo Tivicay se ne sme uporabljati sočasno z zdravilom za motnje srčnega ritma, imenovanim dofetilid, saj se lahko pojavijo resni neželeni učinki.
Tivicay is an antiviral medicine containing the active substance dolutegravir.
Tivicay je protivirusno zdravilo, ki vsebuje zdravilno učinkovino dolutegravir.
In addition, the dose of Tivicay may need to be adjusted if certain medicines are taken at the same time.
Poleg tega je pri sočasnem jemanju določenih zdravil včasih treba prilagoditi odmerek zdravila Tivicay.
Tivicay can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
Predpisovanje in izdaja zdravila Tivicay je le na recept, predpisati pa ga mora zdravnik z izkušnjami z zdravljenjem okužb z virusom HIV.
• The second study in previously treated patients involved 183 patients with infection resistant to previous treatment that had involved an integrase inhibitor (i.e. their infection was resistant to several classes of medicine, including previous integrase inhibitors): adding Tivicay twice daily to other treatment resulted in a response rate of 69% after 24 weeks of therapy.
• v drugi študiji s predhodno zdravljenimi bolniki je sodelovalo 183 bolnikov z okužbo, odporno proti predhodnemu zdravljenju, ki je vključevalo zaviralec integraze (kar pomeni, da je bila okužba pri njih odporna proti zdravilom iz več skupin, vključno proti zaviralcem integraze, ki so jih v preteklosti prejemali): po 24 tednih zdravljenja z zdravilom Tivicay, ki so ga dvakrat na dan dodajali k drugemu zdravilu, je bila stopnja odziva 69-odstotna.
• The second study involved 833 patients given either a combination of Tivicay with two NRTIs or a different three-drug combination (Atripla) that did not include an integrase inhibitor.
• v drugi študiji je sodelovalo 833 bolnikov, ki so prejemali bodisi zdravilo Tivicay v kombinaciji z dvema nukleozidnima zaviralcema reverzne transkriptaze bodisi drugo kombinacijo treh zdravil (Atripla), ki ni vključevala zaviralca integraze.
For the full list of all side effects reported with Tivicay, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tivicay, glejte navodilo za uporabo.
The response rate at 48 weeks was 88% (364 of 414 patients) in those given Tivicay-based treatment compared with 81% (338 of 419 patients) in those given Atripla.
Po 48 tednih so odziv zabeležili pri 88 % (364 od 414) bolnikov, ki so prejeli kombinacijo z zdravilom Tivicay, in pri 81 % (338 od 419) bolnikov, ki so jemali zdravilo Atripla.
• In the first of these, involving 822 patients, Tivicay once daily was compared with raltegravir (another integrase inhibitor), both given in combination with two other HIV medicines of a different class (known as nucleoside reverse transcriptase inhibitors or NRTIs): 88% (361 of 411 patients) given Tivicay and 85% (351 of 411) given raltegravir responded after 48 weeks of treatment.
• v prvi, v kateri je sodelovalo 822 bolnikov, so zdravilo Tivicay pri odmerjanju enkrat na dan primerjali z raltegravirjem (še enim zaviralcem integraze), pri čemer so obe zdravili dajali v kombinaciji z dvema drugima zdraviloma proti virusu HIV iz druge skupine (t.i. nukleozidni zaviralci reverzne transkriptaze): po 48 tednih zdravljenja so odziv zabeležili pri 88 % (361 od 411) bolnikov, ki so jemali zdravilo Tivicay, in pri 85 % (351 od 411) bolnikov, ki so prejemali raltegravir;
The adult dose depends on whether the infection is known or suspected to be resistant to medicines of the class to which Tivicay belongs (integrase inhibitors).
Odmerek pri odraslih je odvisen od tega, ali je okužba odporna proti zdravilom iz skupine, v katero spada tudi zdravilo Tivicay (zaviralci integraze), oziroma bi to lahko domnevno bila.
Response rate at 48 weeks was 71% in patients given treatment based on Tivicay, and 64% in those given treatment based on raltegravir.
Po 48 tednih so odziv zabeležili pri 71 % bolnikov, ki so jih zdravili s kombinacijo z zdravilom Tivicay, in pri 64 % bolnikov, ki so prejemali kombinacijo z raltegravirjem;
The active substance in Tivicay, dolutegravir, is an integrase inhibitor.
Zdravilna učinkovina v zdravilu Tivicay, dolutegravir, je zaviralec integraze.
How is Tivicay used?
Kako se zdravilo Tivicay uporablja?
The dose for children 6 to 12 years old depends on the weight of the child; for those aged 12 and over it is usually one 50-mg tablet a day.
Za tiste, ki so starejši od 12 let, je odmerek običajno ena 50-miligramska tableta na dan.
How does Tivicay work?
Kako zdravilo Tivicay deluje?
• In patients whose virus is not resistant to integrase inhibitors, the usual dose is one 50-mg tablet a day; however, when given with certain medicines that decrease the effectiveness of Tivicay the dose is increased to one 50 mg tablet twice a day.
• Pri bolnikih z virusom, ki ni odporen proti zaviralcem integraze, je običajen odmerek ena 50-miligramska tableta na dan.
• The dose is one 50-mg tablet twice a day in patients whose virus is known or suspected to be resistant to integrase inhibitors; in these patients, giving Tivicay with medicines that decrease its effectiveness should be avoided.
• Odmerek pri bolnikih z virusom, ki je ali bi lahko bil odporen proti zaviralcem integraze, je ena 50-miligramska tableta dvakrat na dan.
1 bottle + 1 cap adapter
1 steklenica + 1 zamašek z nastavkom za brizgo
Oral liquid Oral or gastroenteral use bottle (glass) 25 ml
Peroralna tekočina Peroralna ali gastroenteralna uporaba steklenica
EU (MA) Number (Invented) name
(Izmišljeno) ime
Strength Pharmaceuti cal Form
Jakost Farmacevtska oblika
Some other medicines may influence the use of Zyllt or vice versa.
Nekatera druga zdravila lahko vplivajo na uporabo zdravila Zyllt in obratno.
Date of first authorisation: 28/9/2009 Date of latest renewal: 14 May 2014
Datum prve odobritve: 28. september 2009 Datum zadnjega podaljšanja:
You should take Zyllt for as long as your doctor continues to prescribe it.
Zdravilo Zyllt morate jemati, dokler vam ga vaš zdravnik predpisuje.
An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
priložnostna uporaba acetilsalicilne kisline (ne več kot 1000 mg v kateremkoli 24-urnem obdobju) na splošno ne bi smela povzročati težav, vendar pa se morate o daljši uporabi v drugih okoliščinah posvetovati s svojim zdravnikom.
Excipients with known effect: Each film-coated tablet contains 108.125 mg lactose.
Pomožni snovi z znanim učinkom: Ena filmsko obložena tableta vsebuje 108,125 mg laktoze.
Other medicines and Zyllt
Druga zdravila in zdravilo Zyllt
Zyllt with food and drink Zyllt may be taken with or without food.
Zdravilo Zyllt skupaj s hrano in pijačo Zdravilo Zyllt lahko jemljete s hrano ali brez nje.
What Zyllt is and what it is used for
Kaj je zdravilo Zyllt in za kaj ga uporabljamo
7 film-coated tablets: EU/1/09/553/001 14 film-coated tablets: EU/1/09/553/002 28 film-coated tablets: EU/1/09/553/003 30 film-coated tablets: EU/1/09/553/004 50 film-coated tablets: EU/1/09/553/005 56 film-coated tablets: EU/1/09/553/006 60 film-coated tablets: EU/1/09/553/007 84 film-coated tablets: EU/1/09/553/008 90 film-coated tablets: EU/1/09/553/009 100 film-coated tablets: EU/1/09/553/010
7 filmsko obloženih tablet: EU/1/09/553/001 14 filmsko obloženih tablet: EU/1/09/553/002 28 filmsko obloženih tablet: EU/1/09/553/003 30 filmsko obloženih tablet: EU/1/09/553/004 50 filmsko obloženih tablet: EU/1/09/553/005 56 filmsko obloženih tablet: EU/1/09/553/006 60 filmsko obloženih tablet: EU/1/09/553/007 84 filmsko obloženih tablet: EU/1/09/553/008 90 filmsko obloženih tablet: EU/1/09/553/009 100 filmsko obloženih tablet: EU/1/09/553/010