FrancophonIA/ELRC3.0 huggingface dataset:
English: How has Potactasol been studied?
Estonian: Kuidas Potactasoli uuriti?
English: (Invented) name
Estonian: (Väljamõel dud) nimetus
English: Immediate Packaging Pack size bister (PCTFE/PVC/alu) 56 tablets
Estonian: Sisepakendi iseloomustus Pakendi suurus
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Estonian: • Ravimi omaduste kokkuvõtte (SPC) ja pakendi infoleht ning märgistus
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Estonian: LIIKMESRIIKIDE POOLT RAKENDATAVAD TINGIMUSED VÕI PIIRANGUD RAVIMI EFEKTIIVSEKS JA OHUTUKS KASUTAMISEKS
English: The Member States shall ensure that the MAH provides all doctors who are expected to prescribe MabCampath with a healthcare professional information pack containing the
Estonian: Liikmesriigid peavad tagama, et müügiloa hoidja varustab kõiki MabCampathit välja kirjutatavatele arstidele arsti infopaki, mis sisaldab järgmist:
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product as described below are implemented:
Estonian: Liikmesriigid peavad tagama, et rakendatakse kõiki tingimusi või piiranguid ravimi efektiivseks ja ohutuks kasutamiseks:
English: • The risk of opportunistic infections, in particular CMV viraemia • Recommendation to avoid vaccination with live vaccines for at least 12 months following o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
Estonian: • Kui reaktsioon on mõõdukas või äge, tuleb annustamist jätkata samal tasemel (st ilma annuse tõusuta) kuni annust talutakse hästi Kui ravi on 7 või rohkem päeva peatatud, tuleb MabCampathi määrata järk-järgulise annuse tõusuga
English: Key elements to be included in the educational brochure
Estonian: Infolehes sisalduvad järgmised võtmesõnad
English: - To agree the details of an educational brochure with the MAH.
Estonian: Müügiloa hoidja nõustub infolehe teabega.
English: This summary was last updated on 30/08/2012.
Estonian: Kokkuvõtte viimane uuendus: 30/08/2012.
English: The marketing authorisation was renewed on 2 August 2007.
Estonian: Müügiluba pikendati 2. augustil 2007.
English: It is a solution for injection (0.1 mg/ml and 0.5 mg/ml).
Estonian: Ravim on süstelahus (0,1 mg/ml ja 0,5 mg/ml).
English: In addition, the blood pressure will increase before returning to normal or below normal.
Estonian: Peale selle tõuseb vererõhk, mis seejärel taastub või jääb normaalsest madalamaks.
English: Dexdomitor dexmedetomidine
Estonian: Dexdomitor deksmedetomidiin
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Dexdomitor on 30 August 2002.
Estonian: Euroopa Komisjon andis Dexdomitori müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 30. augustil 2002.
English: The use of waterproof gloves is advisable.
Estonian: Soovitatav on kasutada veekindlaid kindaid.
English: The duration and depth of sedation and analgesia depend on the dose that is used.
Estonian: Sedatsiooni ja analgeesia kestus ning sügavus sõltuvad kasutatavast annusest.
English: The CVMP concluded that the benefits of Dexdomitor exceed the risks and recommended that it be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et Dexdomitori kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: It is used in non-invasive procedures which do not involve breaking the skin or a body cavity.
Estonian: Ravimit kasutatakse mitteinvasiivsete protseduuride korral, millega ei kaasne naha läbistamist ega kehaõõnsustesse tungimist;
English: Dexdomitor is used to sedate (calm down) dogs and cats in the following situations:
Estonian: Dexdomitori kasutatakse koerte ja kasside rahustamiseks järgmistel juhtudel:
English: As for medetomidine, ‘good' or ‘excellent' analgesia was reached in about 40 to 50 % of the animals, supporting its used in non-invasive mildly to moderately painful procedures.
Estonian: Medetomidiini kasutamisel saavutati ligikaudu 40-50%-l loomadest hea või väga hea analgeesia ning see tõendas ravimi kasutamise efektiivsust kergelt või mõõdukalt valulike mitteinvasiivsete protseduuride korral.
English: In some dogs and cats, there may be a decrease in breathing rate and the mucous membranes may appear pale or with a blue tinge.
Estonian: Mõnel koeral ja kassil võib hingamissagedus väheneda ja limaskestad võivad muutuda kahvatuks või sinakaks.
English: The safety of the use of Dexdomitor has not been studied in puppies below 16 weeks of age or in kittens below 12 weeks of age.
Estonian: Dexdomitori ei tohi kasutada alla 16-nädalastel kutsikatel ega alla 12-nädalastel kassipoegadel.
English: Vomiting may occur five to 10 minutes after injection or at the time of recovery.
Estonian: 5-10 minuti jooksul pärast süstimist või toibumisel võib loom oksendada.
English: Dexdomitor causes a decrease in heart rate and body temperature.
Estonian: Dexdomitor põhjustab südame löögisageduse vähenemist ja kehatemperatuuri alanemist.
English: The studies included dogs and cats of various ages and breeds, which were undergoing procedures requiring sedation or analgesia.
Estonian: Uuringutes osales eri vanuses ja eri tõugudest koeri ja kasse, kellele tehti protseduure, mille jaoks oli vaja sedatsiooni või analgeesiat.
English: If Dexdomitor is accidentally self-injected or taken by mouth, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Estonian: Dexdomitori juhusliku enesele süstimise või suhu sattumise korral tuleb otsekohe pöörduda arsti poole ja näidata ravimi pakendi infolehte või etiketti.
English: It should not be used in animals that have problems with their heart or blood vessels, with severe systemic (whole body) disease, that are moribund (close to death) or that are known to be hypersensitive (allergic) to dexmedetomidine or any of the other ingredients.
Estonian: Ravimit ei tohi kasutada loomadel, kellel on südame või veresoonte häireid, raskekujuline süsteemne (kogu organismi hõlmav) haigus, surmalähedases seisundis loomadel ega loomadel, kes on teadaolevalt deksmedetomidiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Why has Dexdomitor been approved?
Estonian: Miks Dexdomitor heaks kiideti?
English: What is the risk associated with Dexdomitor?
Estonian: Mis riskid Dexdomitoriga kaasnevad?
English: However, the person should not drive due to the risk of sedation and changes in blood pressure.
Estonian: Arsti juurde minekul ei tohi kannatanu sedatsiooni ja vererõhu muutuste riski tõttu ise autot juhtida.
English: Pregnant women should take special care to avoid self-injection.
Estonian: Eriti hoolikalt tuleb vältida iseendale süstimist raseduse ajal.
English: Other information about Dexdomitor:
Estonian: Muu teave Dexdomitori kohta
English: Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.
Estonian: Deksmedetomidiin on väga sarnane teisele loomade sedatsiooniks kasutatavale ainele medetomidiinile, mida on veterinaarias kasutatud aastaid.
English: • For deep sedation and analgesia in dogs in combination with butorphanol (a sedative and analgesic) for procedures including minor surgery.
Estonian: • sügava sedatsiooni ja analgeesia tekitamiseks koertel koos butorfanooliga (rahusti ja valuvaigisti) väikeste kirurgiliste lõikuste korral.
English: The dose depends on the body surface area in dogs (calculated using bodyweight) and bodyweight in cats.
Estonian: Annus sõltub koertel kehapindalast (arvutatakse kehamassi järgi) ja kassidel kehamassist.
English: Dexdomitor also showed adequate effectiveness for deep sedation of dogs in combination with butorphanol, and for premedication in dogs and cats before induction of general anaesthesia, reducing the amount of anaesthetic that the dogs and cats require.
Estonian: Dexdomitor osutus piisavalt efektiivseks ka koertel sügava sedatsiooni tekitamisel koos butorfanooliga ning koerte ja kasside eelravimina enne üldanesteesia manustamist, vähendades koertel ja kassidel anesteetikumi vajadust.
English: Dexdomitor was investigated in studies involving dogs and cats in which its effectiveness was compared with that of medetomidine.
Estonian: Dexdomitori uuriti koerte ja kasside uuringutes, kus seda võrreldi medetomidiiniga.
English: How does Dexdomitor work?
Estonian: Kuidas Dexdomitor toimib?
English: What is Dexdomitor?
Estonian: Mis on Dexdomitor?
English: Muscle tremors (shaking) and corneal opacities (cloudy spots in the cornea, the clear part of the eye in front of the pupil) may occur during sedation.
Estonian: Sedatsiooni ajal võib esineda lihasevärinat ja sarvkesta tuhmumist (ähmased laigud sarvkestal, silma eesmisel läbipaistval osal pupilli ees).
English: Dexdomitor was also compared with medetomidne for premedication (sedation prior to anaesthesia) in cats about to undergo general anaesthesia with ketamine and for deep sedation of dogs in combination with butorphanol.
Estonian: Dexdomitori võrreldi medetomidiiniga ka kasutamisel eelravimina (anesteesiaeelne sedatsioon) kassidel enne üldanesteesiat ketamiiniga ning koerte sügavaks sedatsiooniks koos butorfanooliga.
English: Other side effects can occur when Dexdomitor is used with other medicines.
Estonian: Dexdomitori kasutamisel koos muude ravimitega võib esineda ka muid kõrvalnähte.
English: What is Dexdomitor used for?
Estonian: Milleks Dexdomitori kasutatakse?
English: In cats, it is given by intramuscular injection.
Estonian: Kassidele manustatakse ravimit intramuskulaarse süstina.
English: For a full list of all side effects reported with Dexdomitor, see the package leaflet.
Estonian: Dexdomitori kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: If contact does occur, rinsing with large amounts of water is advised.
Estonian: Kui ravimit sinna siiski satub, peske saastunud kohta rohke veega.
English: The studies showed that Dexdomitor had an equivalent level of effectiveness as medetomidine in inducing sedation and analgesia in dogs and cats.
Estonian: Uuringud näitasid, et Dexdomitor oli koertel ja kassidel sedatsiooni ja analgeesia tekitamisel sama efektiivne kui medetomidiin.
English: In dogs, both intravenous and intramuscular injections of Dexdomitor were studied.
Estonian: Koertel uuriti nii Dexdomitori intravenoosset kui ka intramuskulaarset süstimist.
English: Dexdomitor contains the active substance dexmedetomidine, which belongs to a class of medicines having a psycholeptic (sedative) action.
Estonian: Dexdomitor on ravim, mis sisaldab toimeainena psühholeptikumi (rahustit) deksmedetomidiini.
English: How has Dexdomitor been studied?
Estonian: Kuidas Dexdomitori uuriti?
English: What benefit has Dexdomitor shown during the studies?
Estonian: Milles seisneb uuringute põhjal Dexdomitori kasulikkus?
English: When used in cats, ketamine should be used as the anaesthetic agent.
Estonian: Kassidel tuleb anesteetikumina kasutada ketamiini;
English: • Before inducing general anaesthesia.
Estonian: • enne üldanesteesiat (üldnarkoosi).
English: In dogs, Dexdomitor is given by intravenous or intramuscular injection.
Estonian: Koertele manustatakse ravimit intravenoosse või intramuskulaarse süstina.
English: The dose is chosen according to the species being treated, the use, whether it is given by intravenous (into a vein) or intramuscular (into a muscle) injection and any other medicines that are also being used.
Estonian: Annus valitakse olenevalt ravitavast loomaliigist ja ravimi otstarbest ning olenevalt sellest, kas ravimit süstitakse veeni või lihasesse ning kas kasutatakse ka muid ravimeid.
English: Finally, it was studied as a premedication in dogs and cats prior to induction of general anaesthesia.
Estonian: Uuriti ka ravimi kasutamist koerte ja kasside eelravimina enne üldanesteesiat.
English: • When carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated and made less sensitive to pain (analgesia).
Estonian: • rahustamist või analgeesiat (valu vaigistamist) vajavad kergelt või mõõdukalt valulikud ja liikumatut asendit nõudvad protseduurid ja uuringud koertel ja kassidel.
English: Dexdomitor was at least as effective as medetomidine in inducing general anaesthesia in cats in combination with ketamine.
Estonian: Dexdomitor oli üldanesteesia tekitamisel kassidel koos ketamiiniga vähemalt sama efektiivne kui medetomidiin.
English: People who are known to be hypersensitive to dexmedetomidine or any of the other ingredients should give the medicine with caution.
Estonian: Ravimi manustamisel peavad olema ettevaatlikud inimesed, kes on teadaolevalt deksmedetomidiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Contact with the skin, eyes of mucous (moist body surfaces) should be avoided.
Estonian: Vältige ravimi sattumist nahale, silma või limaskestale.
English: 60 sachets + 2 syringes (1 ml) + 2 syringes (3 ml) + 2 syringes (10 ml) + 2 mixing cups
Estonian: 60 kotikest + 2 süstalt (1 ml) + 2 süstalt (3 ml) + 2 süstalt (10 ml) + 2 segamistopsi
English: Granules for oral suspension sachet (PET/Alu/LLDPE)
Estonian: 100 mg Suukaudse suspensiooni graanulid kotike (PET/Alu/LLDPE)
English: 21 March 2014 EMA/167920/2014 EMEA/H/C/002670
Estonian: 21. märts 2014 EMA/167920/2014 EMEA/H/C/002670
English: What is Masican?
Estonian: Mis on Masican?
English: Refusal of the marketing authorisation for Masican (masitinib) EMA/167920/2014
Estonian: Masicani (masitiniib) müügiloa andmisest keeldumine EMA/167920/2014
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2014.
Estonian: Pärast taotluse põhjenduste kaalumist vaatas inimravimite komitee oma algse arvamuse uuesti läbi ja kinnitas 20. märtsil 2014 müügiloa andmisest keeldumist.
English: The study was a ‘phase II study', an exploratory study designed to see if a medicine is worth investigating further.
Estonian: See oli II faasi uuring ehk uurimuslik uuring, mille eesmärk oli kindlaks teha, kas ravimit on vaja põhjalikumalt uurida.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui osalete kliinilises uuringus või ravimi eriloaga kasutamise programmis ja vajate ravi kohta lisateavet, pöörduge arsti poole, kes teile ravi määras.
English: The main measure of effectiveness was progression-free survival (how long the patients lived without the disease getting worse).
Estonian: Ravimi efektiivsuse põhinäitaja oli progressioonivaba elulemus (kui kaua patsiendid elasid, ilma et vähk oleks progresseerunud).
English: The company that applied for authorisation is AB Science.
Estonian: Müügiluba taotles ettevõte AB Science.
English: Therefore, the Committee concluded that there were insufficient data to establish the benefits of Masican.
Estonian: Seega otsustas komitee, et Masicani kasulikkuse tõendamiseks ei ole piisavalt andmeid.
English: By blocking these receptors, Masican might help in controlling cell division and thereby slow down the growth of the cancer.
Estonian: Nende retseptorite blokeerimisega võib Masican aidata rakkude vohamist piirata ja aeglustada vähi kasvamist.
English: Therefore the CHMP concluded that the benefits of Masican did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Estonian: Seetõttu järeldas inimravimite komitee, et Masicani kasulikkus ei ületa riske ja jäi varasema soovituse juurde keelduda ravimile müügiloa andmisest.
English: During the re-examination, although the medicine's safety was of less concern, the Committee still had major concerns about the medicine's benefits.
Estonian: Kuigi ravimi ohutus oli taasläbivaatamise ajal väiksem probleem, kahtles komitee endiselt ravimi kasulikkuses.
English: On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masican, intended for the treatment of malignant gastrointestinal stromal tumour (GIST).
Estonian: 21. novembril 2013 andis inimravimite komitee negatiivse arvamuse, soovitades pahaloomulise gastrointestinaalse stromaaltuumori (GIST) raviks kasutatava ravimi Masican müügiloa andmisest keelduda.
English: At the time of the initial evaluation, the CHMP was concerned that the study was not designed to compare Masican with sunitinib and that it was difficult to interpret the results.
Estonian: Algse hindamise ajal tekitas inimravimite komiteele probleeme põhiliselt see, et uuringu eesmärk ei olnud võrrelda Masicani sunitiniibiga ning tulemusi oli raske tõlgendada.
English: Masican was expected to be used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, in adults whose cancer cannot be removed surgically or has spread and is getting worse despite treatment with imatinib, another medicine used to treat this cancer.
Estonian: Masicani kavatseti kasutada gastrointestinaalse stromaaltuumori (GIST) - mao- ja soolevähi - raviks täiskasvanutel, kelle vähki ei saa kirurgiliselt eemaldada või kelle vähk on edasi levinud ja kelle seisund halveneb hoolimata ravist imatiniibiga (samuti vähiravim).
English: Refusal of the marketing authorisation for Masican (masitinib)
Estonian: Masicani (masitiniib) müügiloa andmisest keeldumine
English: Although the group of patients treated with Masican appeared to live longer than those treated with sunitinib, the possibility that this was a chance finding could not be ruled out because of the exploratory nature of the study and because other supportive evidence was lacking.
Estonian: Kuigi näis, et Masicaniga ravitud patsiendid elasid kauem kui sunitiniibiga ravitud patsiendid, ei saanud välistada, et see oli juhuslik leid, sest uuring oli uurimuslik ja muid toetavaid tõendeid oli vähe.
English: The applicant presented results of a main study in 44 patients with GIST that could not be removed surgically or that had spread and was resistant to imatinib treatment.
Estonian: Taotleja esitas ühe põhiuuringu tulemused; uuringus osales 44 GIST-iga patsienti, kelle kasvajat ei saanud kirurgiliselt eemaldada või oli see levinud ja imatiniibile resistentne.
English: The study included a group of patients treated with Masican and one group treated with sunitinib, another medicine of the same class.
Estonian: Ühe rühma patsiente raviti Masicaniga ja teise rühma patsiente raviti teise sama klassi ravimiga sunitiniibiga.
English: The CHMP was also concerned that safety data were only available for a few patients treated with Masican at the proposed dose and this did not allow a proper evaluation of the medicine's side effects.
Estonian: Inimravimite komitee ei olnud rahul ka sellega, et ohutusandmed esitati ainult mõnede patsientide kohta, keda raviti soovitatud Masicani annusega, ja seetõttu ei saanud ravimi kõrvalnähtusid nõuetekohaselt hinnata.
English: Finally, there were concerns about the quality control of the medicine during manufacture, which led to uncertainties about the impurities that patients would be exposed to.
Estonian: Pealegi ei olnud lahendatud ka ravimi tootmise kvaliteedikontrolli küsimused, mis tekitasid kahtlusi patsientide kokkupuutest lisanditega.
English: Masican is an anticancer medicine that contains the active substance masitinib.
Estonian: Masican on vähiravim, mille toimeaine on masitiniib.
English: How is Masican expected to work?
Estonian: Milline on Masicani eeldatav toime?
English: In addition, there were still outstanding problems related to quality control during its manufacture.
Estonian: Jätkuvalt olid lahendamata ka ravimi tootmise kvaliteedikontrolli küsimused.
English: What was Masican expected to be used for?
Estonian: Milleks kavatseti Masicani kasutada?
English: The active substance in Masican, masitinib, is a tyrosine-kinase inhibitor.
Estonian: Masicani toimeaine masitiniib on türosiinkinaasiinhibiitor, mis blokeerib teatud ensüüme türosiinkinaase.
English: surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Estonian: Neid ensüüme leidub vähiraku pinnal teatud retseptorites, sealhulgas neis, mis osalevad rakkude vohamise stimuleerimises.
English: Masican was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 21 December 2004 for the treatment of malignant GIST.
Estonian: Masican nimetati 21. detsembril 2004 harvikravimiks, millega ravida pahaaloomulist GIST-i. Lisateave on siin.
English: It is given to newborn calves once a day for one week.
Estonian: Ravimit antakse vastsündinud vasikatele üks kord ööpäevas ühe nädala jooksul.
English: For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of diarrhoea.
Estonian: Kõhulahtisuse ennetamiseks tuleb ravi alustada 24-48 tunni jooksul pärast sündimist; kõhulahtisuse vähendamiseks tuleb ravi alustada 24 tunni jooksul pärast kõhulahtisuse algust.
English: The full EPAR for Halagon can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Halagoni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The company provided data on the quality and manufacture of Halagon.
Estonian: Ettevõte esitas andmed Halagoni kvaliteedi ja tootmise kohta.
English: The infection is known as cryptosporidiosis.
Estonian: Seda infektsiooni nimetatakse krüptosporidioosiks.
English: Halagon should be given after feeding.
Estonian: Halagoni tuleb anda pärast söötmist.
English: The European Commission granted a marketing authorisation valid throughout the EU for Halagon on 13 December 2016.
Estonian: Euroopa Komisjon andis Halagoni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 13/12/2016.
English: Halagon halofuginone
Estonian: Halagon halofuginoon
English: The withdrawal period for meat from newborn calves treated with Halagon is 13 days.
Estonian: Halagoniga ravitud vastsündinud vasikate liha keeluaeg on 13 päeva.
English: What is Halagon and what is it used for?
Estonian: Mis on Halagon ja milleks seda kasutatakse?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Halagon has been shown to have comparable quality to Halocur.
Estonian: Ravimiameti veterinaarravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Halagon sarnane toime ravimiga Halocur.
English: Halagon is a ‘generic medicine'.
Estonian: Halagon on geneeriline ravim.
English: The Committee recommended that Halagon be approved for use in the EU.
Estonian: Komitee soovitas Halagoni kasutamise Euroopa Liidus heaks kiita.
English: The medicine contains the active substance halofuginone.
Estonian: Ravim sisaldab toimeainena halofuginooni.
English: This means that Halagon is similar to a ‘reference medicine' already authorised in the EU called Halocur.
Estonian: See tähendab, et Halagon on sarnane võrdlusravimiga Halocur, millel juba on Euroopa Liidus müügiluba.
English: No additional studies were needed as Halagon is a water based oral solution containing the same active substance and other ingredients as the reference medicine, in the same concentrations.
Estonian: Lisauuringud ei olnud vajalikud, sest Halagon on veepõhine suukaudne lahus, mis sisaldab sama toimeainet ja teisi koostisaineid samas kontsentratsioonis kui võrdlusravim.