FrancophonIA/ELRC3.0 huggingface dataset:
English: Sabumalin is a metered dose aerosol inhaler containing a suspension formulation of salbutamol sulphate 100 µg/spray, with HFA 134a as propellant.
Estonian: Selles on suspensioon, mis sisaldab salbutamoolsulfaati annuses 100 µg pihustuse kohta ja propellendiks on HFA 134a.
English: The Applicant should provide in vivo equivalence when the products are used with and their spacers 2.
Estonian: Taotleja peab esitama in vivo ekvivalentsuse tõendid, kui ravimeid kasutatakse koos vahemahutitega.
English: a. Why the comparison of all the individual stages is not more discriminative to detect differences between formulations that may have clinical relevance b. Why the particles of 6 µm or up to 8 µm, which are deposited in stage 1, are considered with regards to safety only.
Estonian: b. Miks arvestatakse etapis 1 ladestuvate osakestega, mille läbimõõt on 6-8 µm, ainult ohutuse seisukohalt?
English: - the CHMP considered that a similar particle size distribution between the test and the reference product was demonstrated,
Estonian: - komitee leidis, et testitava ravimi ja võrdlusravimi puhul näidati sarnast osakeste suurusjaotust,
English: Salbutamol Sandoz 100 mikrogramm Dosieraerosol Druckgas-inhalation, Suspension
Estonian: Salbutamol Sandoz 100 mikrogramm Dosieraerosol Druckgasinhalation, Suspension
English: The particle size is considered to be one of the most significant characteristic influencing deposition in the respiratory tract and can be determined using Cascade Impactor measurements although the in vitro comparison should be performed per impactor stage or justified grouped stages which are relevant to efficacy and safety.
Estonian: Seda saab kindlaks määrata, kui kasutada kaskaadi analüsaatoril teostatud mõõtmisi, kuigi in vitro võrdlus tuleb läbi viia analüsaatori etappide kohta või tõhususe ja ohutuse seisukohalt oluliste etappide rühma kohta.
English: Although the claim of the Applicant that the PK bioequivalence study demonstrated equivalence without spacer was endorsed, the CHMP did not support the assumption that the data with the use of a spacer would provide the same evidence of equivalence and therefore considered that a PK study with a spacer is mandatory.
Estonian: Kuigi toetati taotleja väidet, et farmakokineetilises bioekvivalentsuse uuringus näidati ekvivalentsust ilma vahemahutita, ei toetanud komitee eeldust, et kasutamisel koos vahemahutiga annaks need andmed ekvivalentsuse kohta samasuguseid tõendeid.
English: The Applicant stated that for pharmacokinetic studies, equivalence is conventionally demonstrated by applying a +/- 20% limit for the 90% CI and therefore applied these limits to the FDP comparison, despite the recent EMEA guidance recommending +/- 15% limits for in vitro equivalence and +/- 20% limits for in vivo pharmacokinetic equivalence.
Estonian: Neid piire kasutati seega FDP võrdlemiseks, vaatamata hiljutisele Euroopa Ravimiameti juhisele, kus in vitro ekvivalentsuse puhul soovitati +/15% piiri ja in vivo farmakokineetilise ekvivalentsuse puhul +/-20% piiri.
English: Salbutamol Sandoz 100 mcg/dosis suspensión para inhalación en envase a
Estonian: Salbutamol Sandoz 100 mcg/dosis suspensión para inhalación en envase a presción EFG
English: Single stage comparison revealed that most of the values are within the ± 15 % range (except from stage 0, 1 and filter) and after pooling, all values were within the ± 15 % range.
Estonian: Üksikute etappide võrdlus näitas, et enamik väärtusi on vahemikus ± 15% (v.a etapid 0, 1 ja filtri etapp).
English: The marketing applications were submitted as hybrid applications under Article 10(3) of Directive 2001/83/EC and the EU reference product is Sultanol Dosier-Aerosol 100 µg/dose, Druckgasinhalation, suspension, (GlaxoSmithKline).
Estonian: Euroopa Liidus on võrdlusravimiks Sultanol Dosier-Aerosol 100 μg annuses, Druckgasinhalation, suspensioon (GlaxoSmithKline).
English: The Applicant concluded that the in vitro data and the negligible clinical relevance of the differences detected were supported by the provided in vivo study.
Estonian: Taotleja järeldas, et in vivo uuring toetab in vitro katsetest saadud andmeid ja täheldatud erinevuste ebaolulisust kliinilisest seisukohast.
English: The pharmacokinetic bioequivalence data also confirmed that Sabumalin and the reference product possess the same systemic safety profile since bioequivalence in systemic levels (AUC and Cmax) have been shown, when used with or without a spacer.
Estonian: Farmakokineetilise bioekvivalentsuse andmed kinnitasid samuti, et Sabumalinil ja võrdlusravimil on samasugune süsteemne ohutusprofiil, sest bioekvivalentsust näidati süsteemsetel tasemetel (AUC ja Cmax) nii vahemahutiga kui ka ilma.
English: However, for some substances, clinical efficacy and safety is not represented by a specific stage but a range of stages and therefore, comparison of individual stages cannot detect differences between formulations that may have clinical relevance.
Estonian: Samas ei ole mõnede ainete puhul kliiniline tõhusus ja ohutus esitatud spetsiifilise etapina, vaid etappide vahemikuna.
English: The CHMP noted the position of the Applicant but considered that this oversimplifies the effect of all generated particles on the respiratory and alimentary tract and that it is difficult to define the role of the individual stages in terms of safety and efficacy, effects such as differences in breathing patterns, aerosol velocity in entering the airways and the shape of the plume must be taken into account.
Estonian: Komitee hindas taotleja seisukohta, kuid leidis, et kõigi tekitatud osakeste toimet hingamisteedes ja seedekulglas on liialt lihtsustatud ning ohutuse ja tõhususe seisukohalt on eri etappide osa keeruline määratleda.
English: Salbutamol Sandoz 100 µg túlnyomásos inhalációs szuszpenzió
Estonian: Salbutamol Sandoz 100 µg túlnyomásos
English: The fine particle dose ratio was 1.01 and the corresponding confidence interval was 0.97 - 1.04 and the data therefore clearly demonstrate that the expected spacer effect is identical for test and reference product.
Estonian: Peenikeste osakeste määr oli 1,01 ja sellele vastav usaldusintervall 0,97…1,04.
English: The Applicant also included results from a comparative pharmacokinetic study evaluating systemic safety, which demonstrates equivalence and considered that the equivalence of the Cmax values as identified from the systemic safety study supports the prediction of equivalent lung bioavailability and equivalent lung deposition.
Estonian: Taotleja leidis, et Cmax-i väärtuste ekvivalentsus, mis leiti süsteemse ohutuse uuringus, toetab eeldust ekvivalentsest biosaadavusest kopsus ja ekvivalentsest ladestumisest kopsudesse.
English: In addition, the study demonstrated indirectly the same lung deposition with a trend to a deeper lung deposition based on a higher ratio in Cmax and a shorter Tmax.
Estonian: Lisaks näitas see uuring kaudselt samasugust ladestumist kopsu koos kalduvusega ladestuda sügavamale kopsu, mis põhineb kõrgemal Cmax-i suhtel ja lühemal Cmax-il. Komitee arvates ei ole sellel väikesel erinevusel kliiniliselt olulist toimet ja farmakodünaamika uuringut ei ole vaja.
English: The Applicant provided single issue specific protocols for test and generic products, demonstrating that the approach for demonstration of in vitro equivalence followed a planned and sound concept.
Estonian: In vitro ekvivalentsuse näitamiseks valitud lähenemisel järgiti planeeritud ja kindlat süsteemi.
English: The CHMP requested the Applicant to provide data from a PK study with concomitant use of a spacer.
Estonian: Komitee palus taotlejal esitada vahemahutiga tehtud farmakokineetika uuringu andmed.
English: The
Estonian: Tugevus
English: As stated earlier, the Applicant provided initial repriming studies on the test product which were complemented with a repriming study with the reference product and the CHMP considered that while the data demonstrate the effect of the position of the MDI on the deposited dose, this effect is observed in both the test and the reference product.
Estonian: Komitee leidis, et kuigi esitatud andmed näitavad MDI asendi toimet kohta ladestuvale annusele, täheldatakse seda nii testitava ravimi kui ka võrdlusravimi puhul.
English: The results provided as a whole clearly indicate the non inferiority of the generic product to the reference product and the Applicant considered both products to be fully interchangeable.
Estonian: Esitatud terviktulemused näitavad selgelt, et geneeriline ravim ei ole võrdlusravimist halvem.
English: Particles >4.5 µm are swallowed and contribute by negligible amount to the early systemic bioavailability (as Cmax) and peak adverse events of inhaled salbutamol.
Estonian: Need ei mõjuta varajast süsteemset biosaadavust (Cmax-i) ega inhaleeritud salbutamooli maksimaalseid kõrvaltoimeid olulisel määral.
English: These also included infections caused by MRSA.
Estonian: Infektsioonide hulgas oli ka MRSA põhjustatud infektsioone.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orbactiv on 19 March 2015.
Estonian: Euroopa Komisjon andis Orbactivi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. märtsil
English: Other information about Orbactiv
Estonian: Muu teave Orbactivi kohta
English: A risk management plan has been developed to ensure that Orbactiv is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Orbactivi võimalikult ohutu kasutamine.
English: The full EPAR and risk management plan summary for Orbactiv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Orbactivi kohta on ameti veebilehel: 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 Orbactiv?
Estonian: Mis meetmed võetakse, et tagada Orbactivi ohutu ja efektiivne kasutamine?
English: The study also looked at the number of patients whose infection was cured after treatment.
Estonian: Uuringus vaadeldi ka nende patsientide arvu, kelle infektsioon paranes pärast ravi.
English: The recommended dose is a single infusion of 1,200 mg over three hours.
Estonian: Soovitatav annus on 1200 mg ühekordse infusioonina 3 tunni jooksul.
English: Before using Orbactiv, doctors should consider official guidance on the appropriate use of antibiotics.
Estonian: Enne Orbactivi kasutamist peab arst arvesse võtma antibiootikumide asjakohase kasutamise ametlikke juhiseid.
English: Orbactiv oritavancin
Estonian: Orbactiv oritavantsiin
English: What is Orbactiv and what is it used for?
Estonian: Mis on Orbactiv ja milleks seda kasutatakse?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Orbactiv's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Orbactivi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: It works by preventing certain bacteria from making their own cell walls, thereby killing the bacteria.
Estonian: See takistab teatud bakterite rakuseinte moodustamist, hävitades sellega bakterid.
English: Orbactiv has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work.
Estonian: On tõestatud, et Orbactiv toimib selliste bakterite vastu (näiteks metitsilliiniresistentne Staphylococcus aureus (MRSA), millele standardsed antibiootikumid ei mõju.
English: In both studies, the main measure of effectiveness was the number of patients who responded within 3 days of starting treatment with an improvement in their skin in the infected area, lack of fever and no need for additional antibiotic.
Estonian: Mõlemas uuringus oli efektiivsuse põhinäitaja patsientide arv, kellel tekkis 3 päeva jooksul ravi alustamisest ravivastus: nahainfektsioon leevenes, palavikku ei olnud ning ei olnud vaja lisaantibiootikume.
English: Why is Orbactiv approved?
Estonian: Miks Orbactiv heaks kiideti?
English: This is a summary of the European public assessment report (EPAR) for Orbactiv.
Estonian: See on ravimi Orbactiv Euroopa avaliku hindamisaruande kokkuvõte.
English: Although Orbactiv's safety profile overall is similar to that of other glycopeptides, the CHMP noted that some side effects occurred more frequently such as abscesses and bone infections.
Estonian: Kuigi Orbactivi üldine ohutusprofiil on sarnane teiste glükopeptiidide omale, märkis inimravimite komitee, et teatud kõrvalnähte, näiteks abstsesse ja luuinfektsioone, esines sagedamini.
English: What are the risks associated with Orbactiv?
Estonian: Mis riskid Orbactiviga kaasnevad?
English: In addition, 82.7% of patients treated with Orbactiv in the first study and 79.6% in the second study were cured, compared with 80.5% and 80.0% respectively of patients treated with vancomycin.
Estonian: Lisaks paranes esimeses uuringus Orbactiviga ravitud patsientidest 82,7% ja teises uuringus 79,6%, vankomütsiiniga ravitud patsientidel olid need näitajad vastavalt 80,5% ja 80,0%.
English: The active substance in Orbactiv, oritavancin, is a type of antibiotic called a glycopeptide.
Estonian: Orbactivi toimeaine oritavantsiin on antibiootikumi liik, mida nimetatakse gükopeptiidiks.
English: Orbactiv was at least as effective as vancomycin at treating the infection: 80.1% of patients treated with Orbactiv in the first study and 82.3% in the second study responded to treatment, compared with 82.9% and 78.9% respectively of patients treated with vancomycin.
Estonian: Orbactiv oli infektsiooni ravis vähemalt sama efektiivne kui vankomütsiin: esimeses uuringus tekkis ravivastus 80,1%-l Orbactiviga ravitud patsientidest ja teises uuringus 82,3%-l patsientidest, vankomütsiiniga ravitud patsientide näitajad olid vastavalt 82,9% ja 78,9%.
English: The CHMP considered that Orbactiv, which can be given as a single dose, could be a valuable alternative treatment option for acute bacterial infections of the skin and of skin structures.
Estonian: Inimravimite komitee oli seisukohal, et Orbactiv, mida tohib manustada üheainsa annusena, võib olla naha ja nahastruktuuride ägedate bakterinfektsioonide väärtuslik alternatiivne ravivõimalus.
English: It is not intended to provide practical advice on how to use Orbactiv.
Estonian: Hindamisaruandes ei anta Orbactivi kasutamise praktilisi nõuandeid.
English: For the full list of all side effects and restrictions with Orbactiv, see the package leaflet.
Estonian: Orbactivi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The most common side effects with Orbactiv (which may affect 5 people or more in 100) are nausea (feeling sick), hypersensitivity (allergy) reactions or reactions at the site of infusion and headache.
Estonian: Orbactivi kõige sagedamad kõrvalnähud (võivad esineda vähemalt 5 patsiendil 100st) on iiveldus, ülitundlikkusreaktsioonid (allergia) või reaktsioonid infusioonikohal ja peavalu.
English: Patients who have received Orbactiv must not be given an infusion of unfractionated heparin (a medicine used to prevent blood clots) for 120 hours after the infusion of Orbactiv.
Estonian: Orbactivi saanud patsientidele ei tohi manustada fraktsioneerimata hepariini (verehüüvete moodustumist takistav ravim) infusioonina vähemalt 120 tunni jooksul pärast Orbactivi infusiooni.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Orbactiv, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Orbactivi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: It contains the active substance oritavancin.
Estonian: Ravim sisaldab toimeainena oritavantsiini.
English: The CHMP considered that these side effects were manageable and adequately addressed in the product information.
Estonian: Inimravimite komitee oli seisukohal, et need kõrvalnähud on ohjatavad ja et neid on ravimiteabes asjakohaselt kajastatud.
English: Orbactiv, given as a single infusion, was compared with a 7 to 10-day treatment with vancomycin (another glycopeptide) in two main studies involving a total of around 1,959 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections.
Estonian: Ühekordse infusioonina manustatavat Orbactivi võrreldi 7-10-päevase vankomütsiini (samuti glükopeptiid) raviga kahes põhiuuringus, milles osales kokku ligikaudu 1959 naha ja nahastruktuuride ägedate bakterinfektsioonidega, näiteks tselluliidi, nahamädanike ja haavainfektsioonidega patsienti.
English: The most common side effects that resulted in treatment being stopped were cellulitis and osteomyelitis (bone infection).
Estonian: Kõige sagedamad kõrvalnähud, mille tõttu ravi lõpetati, olid tselluliit ja osteomüeliit (luuinfektsioon).
English: For practical information about using Orbactiv, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Orbactivi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Orbactiv is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Estonian: Orbactiv on antibiootikum, mida kasutatakse naha ja nahastruktuuride (nahaaluskoe) ägedate (lühiajaliste) bakterinfektsioonide, näiteks tselluliidi (naha süvakoe põletiku), nahamädanike ja haavainfektsioonide raviks täiskasvanutel.
English: How is Orbactiv used?
Estonian: Kuidas Orbactivi kasutatakse?
English: How does Orbactiv work?
Estonian: Kuidas Orbactiv toimib?
English: What benefits of Orbactiv have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Orbactivi kasulikkus?
English: For more information about treatment with Orbactiv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Orbactiviga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: A list of bacteria against which Orbactiv is active can be found in the summary of product characteristics (also part of the EPAR).
Estonian: Orbactivi suhtes tundlike bakterite loetelu on ravimi omaduste kokkuvõttes (samuti Euroopa avaliku hindamisaruande osa).
English: Orbactiv is available as a powder to be made up into a solution for infusion (drip) into a vein and can only be obtained with a prescription.
Estonian: Orbactivi turustatakse infusioonilahuse (veeni tilgutatava lahuse) pulbrina.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 21. september 2009
English: Date of latest renewal: 22 May 2014
Estonian: Müügiloa viimase uuendamise kuupäev: 22. mai 2014
English: The optimal duration of treatment has not been formally established.
Estonian: Ravi optimaalset kestust ei ole ametlikult kehtestatud.
English: Do not stop the treatment unless your doctor tells you so.
Estonian: Ärge lõpetage ravi kui arst ei ole seda öelnud.
English: • if you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
Estonian: • kui olete klopidogreeli või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline;
English: Contact your doctor immediately if you experience: fever, signs of infection or extreme tiredness.
Estonian: Võtke otsekohe ühendust oma arstiga, kui teil tekib: palavik, infektsioonhaiguse nähud või väljendunud väsimus.
English: Macrogol 3000 (Polyethyleneglycol)
Estonian: Makrogool 3000 (polüetüleenglükool)
English: The mean age was 71 years, 41.6% of patients were ≥75 years.
Estonian: Keskmine vanus oli 71 aastat; 41,6% patsientidest oli vanuses ≥ 75 aastat.
English: Clopidogrel has been evaluated for safety in more than 44,000 patients, who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Estonian: Klopidogreeli ohutust on uuritud enam kui 44000 kliinilistes uuringutes osalenud patsiendil, kaasa arvatud enam kui 12000 patsienti, keda raviti 1 aasta või kauem.
English: 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.
Estonian: Atsetüülsalitsüülhappe juhupärane kasutamine (vähem kui 1000 mg mistahes 24-tunnise perioodi jooksul) ei tohiks üldiselt probleeme tekitada, kuid pikemaajaliseks kasutamiseks teistel asjaoludel peab arstiga nõu pidama.
English: At Day 14, platelet function testing (PFT) was performed.
Estonian: 14. päeval tehti trombotsüütide funktsiooni uuring (PFT, platelet function testing).
English: Their frequency is defined using the following conventions: common (1/100 to <1/10); uncommon (1/1,000 to < 1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Estonian: Nende esinemissagedus on defineeritud järgmiselt: Sage (1/100 kuni < 1/10); Aeg-ajalt (1/1000 kuni < 1/100); Harv (1/10 000 kuni < 1/1000), teadmata (ei saa hinnata olemasolevate andmete alusel); Väga harv (< 1/10 000).
English: Pregnancy and breast-feeding It is preferable not to take this medicine during pregnancy.
Estonian: Rasedus ja imetamine Seda ravimit ei ole soovitatav võtta kasutada raseduse ajal.
English: Secondary prevention of atherothrombotic events
Estonian: Aterotrombootiliste haigusjuhtude sekundaarne preventsioon
English: Detailed information is available on the European Medicines Agency website: http://www.ema.europa.eu/
Estonian: Täpne teave selle ravimi kohta on Euroopa Ravimiameti kodulehel: http://www.ema.europa.eu/
English: If you experience prolonged bleeding when taking Clopidogrel Mylan If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Estonian: Kui märkate Clopidogrel Mylan'i võtmise ajal veritsusaja pikenemist Kui te endale sisse lõikate või end vigastate, võib veritsuse peatumine võtta pisut rohkem aega kui tavaliselt.
English: The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
Estonian: Aktiivne metaboliit tekib peamiselt CYP2C19 vahendusel, millele aitavad kaasa mitmed teised CYP-ensüümid, k.a CYP1A2, CYP2B6 ja CYP3A4.
English: Your doctor should have prescribed Clopidogrel Mylan plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Estonian: Teie arst peab olema teile määranud Clopidogrel Mylan'it koos atseüülsalitsüülhappega, kui te ei saa võtta suukaudseid antikoagulante ning teil ei ole suure verejooksu ohtu.
English: Some other medicines may influence the use of Clopidogrel Mylan or vice versa.
Estonian: Mõned teised ravimid võivad mõjutada Clopidogrel Mylan'i toimet ja vastupidi.
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Mylan.
Estonian: Kui te arvate, et mõni nendest kehtib teie kohta või kui teil tekib mingeid kahtlusi, konsulteerige enne Clopidogrel Mylan'i võtmist arstiga.
English: The most common side effect reported with Clopidogrel Mylan is bleeding.
Estonian: Kõige sagedamini täheldatud kõrvaltoime Clopidogrel Mylan'i kasutamisel on verejooks.
English: Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg.
Estonian: Kuna ASH suuremaid annuseid seostatakse suurenenud verejooksu riskiga, ei soovitata suuremaid ASH annuseid kui 100 mg.
English: Sverige Mylan AB
Estonian: Mylan AB