FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Mylan.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih načinih uporabe so že bile izvedene z referenčnim zdravilom Lyrica, zato jih ni treba ponoviti za zdravilo Pregabalin Mylan.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Mylan has been shown to have comparable quality and to be bioequivalent to Lyrica.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pregabalin Mylan primerljivo raven kakovosti kot zdravilo Lyrica ter da mu je biološko enakovredno.
English: What are the benefits and risks of Pregabalin Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Pregabalin Mylan?
English: The active substance in Pregabalin Mylan, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Slovenian: Zdravilna učinkovina v zdravilu Pregabalin Mylan, pregabalin, ima podobno strukturo kot telesu lastni „živčni prenašalec“ gama-aminomaslena kislina (GABA), vendar ima bistveno drugačne biološke učinke.
English: The Committee recommended that Pregabalin Mylan be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Pregabalin Mylan odobri za uporabo v EU.
English: As for every medicine, the company provided studies on the quality of Pregabalin Mylan.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Pregabalin Mylan.
English: This means that Pregabalin Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Lyrica.
English: After three to seven days, the dose can be increased to 300 mg per day.
Slovenian: Po treh do sedmih dneh se lahko odmerek poveča na 300 mg na dan. Odmerki se lahko povečajo, dokler ni dosežen najučinkovitejši odmerek.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Slovenian: Opravila je tudi študije, ki so pokazale, da je zdravilo biološko enakovredno referenčnemu zdravilu.
English: Because Pregabalin Mylan 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.
Slovenian: Ker je zdravilo Pregabalin Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: For more information about treatment with Pregabalin Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pregabalin Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Mylan have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pregabalin Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For practical information about using Pregabalin Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Pregabalin Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: What is Pregabalin Mylan and what is it used for?
Slovenian: Kaj je zdravilo Pregabalin Mylan in za kaj se uporablja?
English: To stop treatment with Pregabalin Mylan the dose should be reduced gradually, over at least a week.
Slovenian: Največji odmerek je 600 mg na dan. Pred prenehanjem zdravljenja z zdravilom Pregabalin Mylan mora zmanjševanje odmerka potekati postopno in trajati najmanj en teden.
English: Pregabalin Mylan is a ‘generic medicine'.
Slovenian: Zdravilo Pregabalin Mylan je „generično zdravilo“.
English: Other information about Pregabalin Mylan
Slovenian: Druge informacije o zdravilu Pregabalin Mylan
English: Therefore, the CHMP's view was that, as for Lyrica, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Lyrica odtehtajo znana tveganja.
English: It is not intended to provide practical advice on how to use Pregabalin Mylan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Pregabalin Mylan approved?
Slovenian: Zakaj je bilo zdravilo Pregabalin Mylan odobreno?
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Slovenian: • nevropatsko bolečino (bolečino zaradi poškodbe živcev), vključno s periferno nevropatsko bolečino,
English: How has Pregabalin Mylan been studied?
Slovenian: Kako je bilo zdravilo Pregabalin Mylan raziskano?
English: How is Pregabalin Mylan used?
Slovenian: Kako se zdravilo Pregabalin Mylan uporablja?
English: Pregabalin Mylan contains the active substance pregabalin.
Slovenian: Zdravilo Pregabalin Mylan vsebuje zdravilno učinkovino pregabalin.
English: How does Pregabalin Mylan work?
Slovenian: Kako zdravilo Pregabalin Mylan deluje?
English: --1 Live myxoma vectored rabbit haemorrhagic disease (RHD) virus: Strain 009: ≥103.0 and ≤105.8 FFU* Strain MK1899: ≥103.0 and ≤105.8 FFU* *Focus Forming Units
Slovenian: --1 Miksoma virus, živi vektorski RHD virus: Sev 009: ≥103.0 i ≤105.8 FFU* Sev MK1899: ≥103.0 i ≤105.8 FFU*
English: Invented name
Slovenian: Izmišlje no ime
English: Solvent: 10 vials
Slovenian: Topilo: 10 vials
English: Lyophilisate: 10 vials, In cardboard box:
Slovenian: V kartonski škatli: Liofilizat: 10 vials, V kartonskoj škatli:
English: EU (MA) number
Slovenian: EU številka
English: Lyophilisate: 50 doses, solvent: 10 ml
Slovenian: 50 odmerkov, topilo: 10 ml
English: Immediate packaging
Slovenian: Ovojnina Vsebina
English: The European Commission granted a marketing authorisation valid throughout the EU for Aclasta on 15 April 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Aclasta, veljavno po vsej Evropski uniji, izdala 15. aprila 2005.
English: The effect of each infusion lasts for a year or more.
Slovenian: Učinki posamezne infuzije trajajo eno leto ali dlje.
English: The full EPAR for Aclasta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Aclasta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Aclasta?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aclasta?
English: This is a disease where the normal process of bone growth is changed.
Slovenian: To je bolezen, pri kateri je normalen proces rasti kosti spremenjen.
English: Aclasta is given as an infusion lasting at least 15 minutes.
Slovenian: Zdravilo Aclasta se daje kot infuzija v trajanju vsaj 15 minut.
English: Other information about Aclasta:
Slovenian: Druge informacije o zdravilu Aclasta:
English: A risk management plan has been developed to ensure that Aclasta is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Aclasta je bil pripravljen načrt obvladovanja tveganj.
English: What benefit has Aclasta shown during the studies?
Slovenian: Kakšne koristi je zdravilo Aclasta izkazalo med študijami?
English: Osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) has been reported rarely (seen in between 1 and 10 patients in 10,000).
Slovenian: Osteonekroza čeljusti (poškodbe čeljustnih kosti, kar lahko povzroči bolečino, rane v ustih ali zrahljanost zob) je bila opažena le redko (pri 1 do 10 bolnikih od 10 000).
English: Aclasta zoledronic acid
Slovenian: Aclasta zoledronska kislina
English: For more information about treatment with Aclasta, read the Package Leaflet (also part of the EPAR).
Slovenian: Za več informacij o zdravljenju z zdravilom Aclasta preberite navodilo za uporabo (ki je prav tako del EPAR).
English: Patients must have adequate fluids before and after treatment, and should receive adequate supplements of vitamin D and calcium.
Slovenian: Bolniki morajo pred zdravljenjem in po njem popiti zadostne količine tekočin ter prejemati ustrezne dodatke vitamina D in kalcija.
English: After six months, around 96% of patients had responded to treatment in the two studies, compared with around 74% of the patients who received risedronate.
Slovenian: Po šestih mesecih se je v dveh študijah na zdravljenje odzvalo približno 96 % bolnikov v primerjavi s 74 % bolnikov, ki so prejemali rizedronat.
English: Because zoledronic acid has been authorised in the EU as Zometa for a number of years, the company presented the results of some studies carried out with Zometa, which were taken into account when assessing Aclasta.
Slovenian: Ker je zoledronska kislina v EU že vrsto let odobrena kot zdravilo Zometa, je družba predstavila rezultate nekaterih študij, opravljenih s tem zdravilom, ki so bili upoštevani pri ocenjevanju zdravila Aclasta.
English: For Paget's disease, only one infusion of Aclasta is usually given, but additional infusions can be considered if the patient's disease comes back.
Slovenian: Pri Pagetovi bolezni se običajno daje samo ena infuzija zdravila Aclasta, lahko pa se razmisli o dodatnih infuzijah, če se bolezen ponovi.
English: Gradually, the bones become thin and fragile, and more likely to fracture.
Slovenian: Kosti se tako postopoma redčijo in postajajo bolj krhke ter posledično bolj lomljive.
English: This document is a summary of the European Public Assessment Report (EPAR) for Aclasta.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aclasta.
English: Zoledronic acid has also been authorised in the European Union (EU) as Zometa since March 2001 for the prevention of bone complications in patients with cancer that is affecting the bone, and for the treatment of hypercalcaemia (high blood calcium levels) caused by tumours.
Slovenian: Zoledronska kislina je v Evropski uniji (EU) odobrena že od marca 2001 kot zdravilo Zometa za preprečevanje z okostjem povezanih zapletov pri bolnikih z rakom, ki prizadene kosti, ter za zdravljenje hiperkalciemije (visokih ravni kalcija v krvi), ki jo povzročajo tumorji.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aclasta, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: 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.
English: Aclasta should not be used in patients with severe kidney problems.
Slovenian: Zdravilo Aclasta se ne sme uporabljati pri bolnikih s hudimi ledvičnimi težavami.
English: In the treatment of Paget's disease of the bone, Aclasta must only be used by a doctor who has experience in the treatment of the disease.
Slovenian: Pri zdravljenju Pagetove bolezni kosti sme zdravilo Aclasta uporabljati samo zdravnik, ki ima izkušnje z zdravljenjem te bolezni.
English: Most side effects with Aclasta tend to occur within the first three days after infusion, becoming less common with repeated infusions.
Slovenian: Večina neželenih učinkov zdravila Aclasta se pojavi v prvih treh dneh po infundiranju in so po naslednjih infuzijah manj pogosti.
English: In these studies, the patients could take other medicines for osteoporosis, but not other bisphosphonates.
Slovenian: V vseh treh študijah so bolniki lahko jemali druga zdravila za zdravljenje osteoporoze, vendar ne drugih difosfonatov.
English: The patients received one infusion of Aclasta or they took risedronate once a day for two months.
Slovenian: Bolniki so prejeli infuzijo zdravila Aclasta ali dva meseca prejemali rizedronat enkrat na dan.
English: 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 Aclasta.
Slovenian: 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.
English: What is the risk associated with Aclasta?
Slovenian: Kakšna tveganja so povezana z zdravilom Aclasta?
English: In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Slovenian: Pri ženskah je osteoporoza pogostejša v obdobju po menopavzi, ko upade količina ženskega hormona estrogena.
English: Aclasta is also used to treat Paget's disease of the bone in adults.
Slovenian: Zdravilo Aclasta se uporablja tudi za zdravljenje Pagetove bolezni kosti pri odraslih.
English: Patients will also be provided with a reminder card on the risk of osteonecrosis of the jaw, instructing patients to contact their doctor if they experience symptoms.
Slovenian: Bolniki bodo prejeli tudi opozorilno kartico o tveganju za osteonekrozo čeljusti z navodilom, naj stopijo v stik z zdravnikom, če opazijo simptome.
English: In Paget's disease, the bone breaks down more quickly, and when it grows back, it is weaker than normal.
Slovenian: Pri Pagetovi bolezni se kost hitreje zlomi, ko pa se zaraste, je šibkejša kot običajno.
English: Patients who have broken their hip should not receive Aclasta any earlier than two weeks after the operation to repair the fracture.
Slovenian: Bolniki z zlomljenim kolkom ne smejo prejeti zdravila Aclasta prej kot dva tedna po operaciji, da se zlom zaceli.
English: The main measure of effectiveness was the number of patients who responded to treatment, defined as blood levels of serum alkaline phosphatase (an enzyme involved in the breakdown of bone) returning to normal or falling at least three-quarters of the way back to normal.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so se odzvali na zdravljenje, kar se je ugotavljalo na podlagi tega, če so se ravni serumske alkalne fosfataze (encima, ki sodeluje pri razgradnji kosti) v krvi vrnile na običajno raven ali padle za vsaj 75 % na poti k običajnim ravnem.
English: Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment.
Slovenian: Osteoporoza se lahko pri obeh spolih pojavi tudi kot neželeni učinek zdravljenja z glukokortikoidi.
English: It is used in patients who are at risk of fractures (broken bones) including those who have recently broken their hip in a minor trauma such as a fall, and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).
Slovenian: Uporablja se pri bolnikih, pri katerih obstaja tveganje za zlome kosti, vključno pri tistih z nedavnim zlomom kolka po lažji nezgodi, kot je padec, ter pri bolnikih, pri katerih je osteoporoza povezana z dolgotrajnim zdravljenjem z glukokortikoidi (vrsto steroidov).
English: Using paracetamol or ibuprofen (anti-inflammatory medicines) shortly after Aclasta can reduce symptoms such as fever, muscle pain, influenza (flu)-like symptoms, joint pain and headache in the three days following the infusion.
Slovenian: Uporaba paracetamola ali ibuprofena (zdravil proti vnetju) kmalu po zaužitju zdravila Aclasta lahko v treh dneh po infuziji zmanjša simptome, kot so povišana telesna temperatura, bolečine v mišicah, gripi podobni simptomi, bolečine v sklepih in glavobol.
English: Aclasta must not be used in patients with severe kidney problems, hypocalcaemia (low blood calcium levels), or in pregnant or breastfeeding women.
Slovenian: Zdravilo Aclasta se ne sme uporabljati pri bolnikih s hudimi ledvičnimi težavami, hipokalciemijo (nizkimi ravnmi kalcija v krvi) ali pri nosečih ali doječih ženskah.
English: The CHMP decided that Aclasta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Aclasta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: The company that makes Aclasta will provide educational packs in each Member State for doctors who prescribe Aclasta for osteoporosis, reminding them how the medicine should be used.
Slovenian: Družba, ki izdeluje zdravilo Aclasta, bo v vsaki državi članici za zdravnike, ki bodo predpisovali zdravilo Aclasta za osteoporozo, pripravila izobraževalno gradivo z informacijami o uporabi zdravila.
English: This leads to less bone loss in osteoporosis and less disease activity in Paget's disease.
Slovenian: Zaradi tega je pri osteoporozi izguba kostne mase manjša, pri Pagetovi bolezni pa je bolezen manj aktivna.
English: The most common side effect with Aclasta (seen in more than 1 patient in 10) is fever.
Slovenian: Najpogostejši neželeni učinek zdravila Aclasta (opažen pri več kot 1 bolniku od 10) je povišana telesna temperatura.
English: Why has Aclasta been approved?
Slovenian: Zakaj je bilo zdravilo Aclasta odobreno?
English: Aclasta must not be used in people who are hypersensitive (allergic) to zoledronic acid, to other bisphosphonates or to any of the other ingredients.
Slovenian: Zdravila Aclasta ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zoledronsko kislino, druge difosfonate ali katero koli drugo sestavino zdravila.
English: This can be repeated once a year in patients being treated for osteoporosis.
Slovenian: Pri bolnikih, ki se zdravijo zaradi osteoporoze, se lahko ponovi enkrat na leto.
English: It will also provide an information pack for patients to explain the medicine's side effects, remind them of the need for adequate calcium and vitamin D supplementation, and when patients should contact their doctor.
Slovenian: Prav tako bo pripravila informativno gradivo za bolnike, v katerem bodo razloženi neželeni učinki, poudarjena potreba zadostnega nadomeščanja kalcija in vitamina D ter navodilo, kdaj morajo poiskati pomoč zdravnika.
English: Aclasta is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid.
Slovenian: Zdravilo Aclasta je raztopina za infundiranje (kapalno infuzijo) v veno, ki vsebuje zdravilno učinkovino zoledronska kislina.
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Slovenian: Do osteoporoze pride, ko rast nove kostnine ni več zadostna, da bi nadomestila naravno razgradnjo kostne mase.
English: There was a 41% risk reduction in hip fractures, when comparing all women taking Aclasta (with or without other osteoporosis medicines) with those taking placebo.
Slovenian: Tveganje za zlom kolka je bilo manjše za 41 %, ko so primerjali vse ženske, ki so prejemale zdravilo Aclasta (z drugimi zdravili za zdravljenje osteoporoze ali brez njih), s tistimi, ki so jemale placebo.
English: For the full list of all side effects reported with Aclasta, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Aclasta, glejte navodilo za uporabo.
English: The active substance in Aclasta, zoledronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina zdravila Aclasta, zoledronska kislina, je difosfonat.
English: For Paget's disease, Aclasta has been compared with risedronate in a total of 357 adults in two studies lasting six months.
Slovenian: Pri Pagetovi bolezni so zdravilo Aclasta proučevali pri skupno 357 bolnikih v dveh študijah, v katerih so ga šest mesecev primerjali z rizedronatom.
English: Aclasta is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men.
Slovenian: Zdravilo Aclasta se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah v obdobju po menopavzi in pri moških.
English: In the study of men and women who had broken their hip, 9% of the patients receiving Aclasta had a fracture (92 out of 1,065), compared with
Slovenian: V študiji pri moških in ženskah, ki so si zlomili kolk, je do zloma prišlo pri 9 % (92 od 1 065) bolnikov, ki so prejemali zdravilo Aclasta , v primerjavi s 13 % (139 od 1 062) bolnikov, ki so prejemali placebo.
English: In Paget's disease, Aclasta was more effective than risedronate.
Slovenian: Pri Pagetovi bolezni je bilo zdravilo Aclasta učinkovitejše od rizedronata.
English: How has Aclasta been studied?
Slovenian: Kako je bilo zdravilo Aclasta raziskano?
English: What is Aclasta used for?
Slovenian: Za kaj se zdravilo Aclasta uporablja?
English: How does Aclasta work?
Slovenian: Kako zdravilo Aclasta deluje?
English: In the study of elderly women, the risk of fractures in the spine was reduced by 70% in patients taking Aclasta (without any other medicines for osteoporosis) over three years when compared with those taking placebo.
Slovenian: Pri osteoporozi je bilo zdravilo Aclasta učinkovitejše od primerjalnih zdravil: v študiji pri starejših ženskah je v treh letih prišlo do 70-odstotnega zmanjšanja tveganja za zlom hrbtenice pri bolnicah, ki so jemale zdravilo Aclasta (brez drugih zdravil za zdravljenje osteoporoze), v primerjavi s tistimi, ki so jemale placebo.
English: How is Aclasta used?
Slovenian: Kako se zdravilo Aclasta uporablja?
English: Finally, Aclasta was more effective than risedronate at increasing spine bone density over a year's treatment in patients taking glucocorticoids.
Slovenian: Pri bolnikih, ki so jemali glukokortikoide, je bilo zdravilo Aclasta pri povečevanju gostote kosti hrbtenice po enoletnem zdravljenju učinkovitejše od rizedronata.
English: What is Aclasta?
Slovenian: Kaj je zdravilo Aclasta?
English: The third compared one infusion of Aclasta with daily treatment with risedronate (another bisphosphonate) in 833 men and women with osteoporosis caused by glucocorticoids, and looked at the change in the density of the bones in the spine over a year.
Slovenian: Zdravilo Aclasta so za zdravljenje osteoporoze proučevali v treh glavnih študijah: v prvi so zdravilo Aclasta primerjali s placebom (zdravilom brez zdravilne učinkovine) pri skoraj 8 000 starejših ženskah z osteoporozo, in sicer so beležili število zlomov hrbtenice in kolka v obdobju treh let; v drugi so zdravilo Aclasta primerjali s placebom pri 2 127 moških in ženskah z osteoporozo, ki so si nedavno zlomili kolk, in beležili število zlomov v obdobju do pet let; v tretji pa so primerjali enojno infuzijo zdravila Aclasta z dnevnim odmerjanjem rizedronata (drugega difosfonata) pri 833 moških in ženskah z osteoporozo, ki so jo povzročili glukokortikoidi, ter opazovali spremembe v gostoti kosti hrbtenice v enem letu.
English: Strength Pharmaceutical Form Route of Administration
Slovenian: izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: 2 vials + 1 vial
Slovenian: 2 viali + 1 viala
English: Solution: 5 ml (30 mg/ml) + Flushing solution 5ml
Slovenian: raztopina: 5 ml (30 mg/ml) + raztopina za izpiranje 5 ml
English: Intracerebroventr icular use vial (glass)
Slovenian: 150 mg raztopina za infundiranje intracerebroventri kularna uporaba viala (steklena)