natgillin/translations-raw huggingface dataset:
The fifth study compared buccal midazolam with intravenous diazepam, where the measure of effectiveness was the treatment's ability to stop the seizure within 5 minutes.
Viiendas uuringus võrreldi suuõõnde manustatavat midasolaami intravenoosse diasepaamiga ning efektiivsuse põhinäitaja oli see, kas ravi peatas krambihoo 5 minuti jooksul.
The active substance in Buccolam is midazolam, a benzodiazepine, which acts as an anti-convulsant medicine.
Buccolami toimeaine midasolaam on bensodiasepiin, mis toimib krambivastase ravimina.
In four of these studies, oromucosal midazolam was compared with rectal diazepam and the measure of effectiveness was the treatment's ability to stop the seizure within 10 minutes.
Neist uuringutest neljas võrreldi oromukosaalset midasolaami rektaalse diasepaamiga ning efektiivsuse põhinäitaja oli see, kas ravi peatas krambihoo 10 minuti jooksul.
It is available as ‘oromucosal solution' (a solution given in the side of the mouth, into the space between the gum and the cheek) in prefilled syringes.
Seda turustatakse suuõõnelahusena (suuõõnde, igeme ja põse vahelisse ruumi manustatav lahus) eeltäidetud süstaldes.
What benefit has Buccolam shown during the studies?
Milles seisneb uuringute põhjal Buccolami kasulikkus?
What is Buccolam used for?
Milleks Buccolami kasutatakse?
How is Buccolam used?
Kuidas Buccolami kasutatakse?
How has Buccolam been studied?
Kuidas Buccolami uuriti?
How does Buccolam work?
Kuidas Buccolam toimib?
Invented name
Ravimi väljamõeld ud nimetus
Invented name
Müügiloa nr Euroopa Liidus Ravimi väljamõeldud nimetus
What is Joicela?
Mis on Joicela?
The studies looked at measurements of pain and disease activity after 13 weeks of treatment.
Uuringutes vaadeldi valu ja haiguse aktiivsuse näitajaid pärast 13nädalast ravi.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Ettevõtte kiri, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, on avaldatud jaotises „All documents″.
The Committee was not convinced that screening patients for the DQA1*0102 gene variant sufficiently reduced this risk.
Komitee ei olnud kindel, et patsientide kontrollimine geenivariandi DQA1*0102 suhtes vähendab seda riski piisavalt.
Withdrawal of the marketing authorisation application for Joicela (lumiracoxib) EMA/917506/2011
Müügiloa taotluse tagasivõtmise teave: Joicela (lumirakoksiib) EMA/917513/2011
Two of the studies involved 3,235 patients with knee osteoarthritis while the third study involved 1,262 patients with hip osteoarthritis.
Kahes uuringus osales 3235 põlve osteoartriidiga patsienti ning kolmandas uuringus 1262 puusa osteoartriidiga patsienti.
It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
See blokeerib COX-2 ensüümi, mille tulemusena väheneb põletikuprotsessis osalevate ainete prostaglandiinide teke.
It was to be available as filmcoated tablets.
Seda kavatseti turustada õhukese polümeerikattega tablettidena.
Joicela is a medicine that contains the active substance lumiracoxib.
Joicela on ravim, mis sisaldab toimeainena lumirakoksiibi.
The company informed the CHMP that no clinical trials or compassionate use programmes are currently on-going with Joicela.
Ettevõte teatas inimravimite komiteele, et seoses ravimiga Joicela ei toimu praegu kliinilisi uuringuid või eriloaga kasutamise programme.
Withdrawal of the marketing authorisation application for Joicela (lumiracoxib)
Müügiloa taotluse tagasivõtmise teave: Joicela (lumirakoksiib)
By reducing the production of prostaglandins, Joicela helps to reduce the symptoms of inflammation, such as pain, seen in osteoarthritis.
Prostaglandiinide tekke vähendamisega aitab Joicela vähendada osteoartriidi puhul esinevaid põletiku sümptomeid, näiteks valu.
DQA1*0102 is thought to increase the risk of liver toxicity in patients taking Joicela.
Arvatakse, et DQA1*0102 suurendab Joicelat võtvatel patsientidel maksatoksilisuse riski.
At the time of the withdrawal, the CHMP was of the view that the benefits of Joicela did not outweigh its risks, particularly its risk of liver toxicity.
Inimravimite komitee oli müügiloa taotluse tagasivõtmise ajal arvamusel, et ravimi Joicela kasulikkus ei ole suurem kui sellega kaasnevad riskid, eriti maksatoksilisuse risk.
The effects of Joicela were first tested in experimental models before being studied in humans.
Enne inimuuringuid kontrolliti Joicela toimet muude katsetega.
What was Joicela expected to be used for?
Milleks kavatseti Joicelat kasutada?
Joicela was compared with celecoxib (another medicine used in osteoarthritis) and placebo (a dummy treatment) in three main studies.
Kolmes põhiuuringus võrreldi Joicelat tselekoksiibi (samuti osteoartriidi puhul kasutatav ravim) ning platseeboga (näiv ravim).
Based on the review of the data and the company's response to the CHMP's lists of questions, the CHMP had some concerns and was of the provisional opinion that Joicela could not have been approved for the symptomatic treatment of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults who are not carriers of DQA1*0102.
Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Joicela kasutamist põlve ja puusa osteoartriidi sümptomaatiliseks raviks (liigeste tursed ja valu) patsientidel, kellel ei esine geenivarianti DQA1*0102, ei ole võimalik heaks kiita.
The active substance in Joicela, lumiracoxib, is a selective ‘non-steroidal anti-inflammatory drug' (NSAID) that belongs to the group ‘cyclo-oxygenase 2 (COX-2) inhibitors'.
Joicela toimeaine lumirakoksiib on tsüklooksügenaas-2 (COX-2) inhibiitorite rühma kuuluv selektiivne mittesteroidne põletikuvastane ravim.
Joicela was expected to be used to relieve the symptoms of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults who are not carriers of a gene variant called ‘DQA1*0102'.
Joicelat kavatseti kasutada põlve ja puusa osteoartriidi sümptomite (liigeste tursed ja valu) leevendamiseks patsientidel, kellel ei esine geenivarianti DQA1*0102.
On 15 April 2011, Novartis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Joicela for the symptomatic relief in the treatment of osteoarthritis of the knee and hip in patients who are not carriers of the DQA1*0102 allele.
Novartis teatas 15. aprillil 2011 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Joicela müügiloa taotlus.
How is Joicela expected to work?
Milline on Joicela eeldatav toime?
27 January 2010
27. jaanuaril 2010
on 14 September 2009.
14. septembril 2009.
Committee for Medicinal Products for Veterinary Use (CVMP)
VETERINAARRAVIMITE KOMITEE (CVMP)
The final opinion was converted into a Decision by the European Commission on 27 January 2010.
Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 27. jaanuaril 2010
The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was Slovakia and the Concerned Member States were Poland and Spain.
Taotlus esitati muudetud direktiivi 2001/82/EÜ artikli 32 kohaselt; viiteliikmesriik oli Slovakkia ning asjaomased liikmesriigid Poola ja Hispaania.
The Mutual Recognition Procedure started on 3 April 2008.
Vastastikuse tunnustamise menetlus algas 3. aprillil 2008.
Written explanations were provided by the Marketing Authorisation Holder on 14 January 2009 and supplementary information was submitted on 22 April 2009.
Müügiloa hoidja esitas kirjalikud selgitused 14. jaanuaril 2009 ja lisateavet 22. aprillil 2009.
The Committee appointed Dr Anna-Maria Brady as rapporteur and Dr Frédéric Descamps as co-rapporteur.
Komitee määras ettekandjaks dr Anna-Maria Brady ja kaasettekandjaks dr Frédéric Descampsi.
APPM Respipharm is a multi-component formaldehyde inactivated whole-cell bacterial vaccine containing three strains of Actinobacillus pleuropneumoniae (Serotypes 2, 9 and 11) and one strain of Pasteurella multocida (Serotype A).
APPM Respipharm on formaldehüüdiga inaktiveeritud täisrakuline bakteriaalne mitmekomponentne vaktsiin, mis sisaldab kolme Actinobacillus pleuropneumoniae tüve (serotüübid 2, 9 ja 11) ning ühte Pasteurella multocida tüve (serotüüp A).
Due to concerns raised by Spain during the Mutual Recognition Procedure that APPM Respipharm may pose a potentially serious risk to human or animal health or to the environment with respect to quality and efficacy of the product, the Reference Member State, Slovakia, referred the matter to the Agency on 7 October 2008 under Article 33(4) of Directive 2001/82/EC.
Kuna vastastikuse tunnustamise menetluse käigus tõstatas Hispaania küsimuse võimalikust riskist inimeste või loomade tervisele või keskkonnale vaktsiini APPM Respipharm kvaliteedi ja efektiivsuse tõttu, tegi viiteliikmesriik Slovakkia 7. oktoobril 2008 direktiivi 2001/82/EÜ artikli 33 lõike 4 alusel Euroopa Ravimiametile esildise.
On 28 July 2009, Pharmagal Bio s.r.o.
28. juulil 2009 teatas Pharmagal Bio s.r.o.
The re-examination procedure started on 15 September 2009.
Arvamuse läbivaatamist alustati 15. septembril 2009.
The product is indicated for use in pigs (sows and weaned piglets) from 6 weeks of age, intended to induce active immunisation of sows and piglets against pleuropneumonia caused by Actinobacillus pleuropneumoniae and against secondary infection by Pasteurella multocida.
Vaktsiin on ette nähtud kasutamiseks sigadel (emistel ja võõrutatud põrsastel) alates kuuendast elunädalast aktiivseks immuniseerimiseks Actinobacillus pleuropneumoniae põhjustatud pleuropneumoonia ning Pasteurella multocida põhjustatud sekundaarse infektsiooni vastu.
The detailed grounds for the re-examination were submitted by Pharmagal Bio s.r.o.
Üksikasjalikud põhjendused otsuse läbivaatamise toetuseks esitas Pharmagal Bio s.r.o.
Background information
TAUSTTEAVE
Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that its opinion of 15 July 2009 should not be revised, and therefore adopted an opinion on 11 November 2009 recommending the suspension of the existing Marketing Authorisation and the refusal of the granting of the Marketing Authorisations for APPM Respipharm.
Lähtudes ettekandja hinnangust kättesaadavate andmete kohta, leidis veterinaarravimite komitee, et tema 15. juuli 2009. aasta otsust ei ole vaja läbi vaadata, ning võttis seetõttu 11. novembril 2009 vastu arvamuse, milles soovitas tühistada vaktsiini APPM Respipharm kehtiva müügiloa ja keelduda andmast vaktsiinile uusi müügilube.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Teaduslikud järeldused on esitatud II lisas.
notified the Agency of its intention to request the reexamination of the CVMP opinion of 15 July 2009.
Euroopa Ravimiametile, et soovib veterinaarravimite komitee 15. juuli 2009. aasta arvamuse läbivaatamist.
Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the application does not satisfy the criteria for authorisation in respect of efficacy.
Lähtudes ettekandja hinnangust kättesaadavate andmete kohta, leidis veterinaarravimite komitee, et vaktsiini efektiivsuse poolest ei vasta taotlus müügiloa andmise kriteeriumitele.
Therefore, the Committee adopted an opinion on 15 July 2009 recommending the suspension of the existing Marketing Authorisation and the refusal of the granting of the Marketing Authorisations for APPM Respipharm.
Seetõttu võttis komitee 15. juulil 2009 vastu arvamuse, milles soovitas tühistada vaktsiini APPM Respipharm kehtiva müügiloa ja keelduda andmast vaktsiinile uusi müügilube.
During its 15-17 September 2009 meeting, the CVMP appointed Dr Kristina Lehmann as rapporteur and Prof. Tibor Soós as co-rapporteur for the re-examination of the abovementioned opinion.
Eespool osutatud arvamuse läbivaatamiseks määras veterinaarravimite komitee oma 15.17. septembri 2009. aasta koosolekul ettekandjaks dr Kristina Lehmanni ja kaasettekandjaks prof Tibor Soósi.
The Marketing Authorisation Holder, Pharmagal Bio s.r.o., submitted an application via mutual recognition for APPM Respipharm, on the basis of the marketing authorisation granted by Slovakia.
esitas müügiloa taotluse vastastikuse tunnustamise menetluse kaudu, võttes aluseks Slovakkias antud müügiloa.
What is Pioglitazone ratio?
Mis on Pioglitazone ratio?
On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratio, for the treatment of type 2 diabetes.
3. veebruaril 2012 teatas ratiopharm GmbH ametlikult inimravimite komiteele, et soovib tagasi võtta II tüüpi diabeedi raviks ette nähtud ravimi Pioglitazone ratio müügiloa taotluse.
Because Pioglitazone ratio is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Et Pioglitazone ratio on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati ravimi bioekvivalentsust võrdlusravimiga Actos.
Pioglitazone ratio was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Ravimit Pioglitazone ratio kavatseti kasutada ka koos insuliiniga patsientidel, kellele üksnes insuliini manustamine ei mõju rahuldavalt ja kes ei saa kasutada metformiini.
Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratio for the treatment of type 2 diabetes.
Taotluse tagasivõtmise ajal oli inimravimite komitee andnud seetõttu positiivse arvamuse ning soovitas anda ravimile Pioglitazone ratio II tüüpi diabeedi raviks müügiloa.
The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratio had been shown to have comparable quality and to be bioequivalent to Actos.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Pioglitazone ratio võrdväärne kvaliteet ja bioekvivalentsus ravimiga Actos.
This means that Pioglitazone ratio is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
See tähendab, et Pioglitazone ratio on sarnane võrdlusravimiga Actos, millel juba on Euroopa Liidus müügiluba.
Pioglitazone ratio is a medicine that contains the active substance pioglitazone.
Pioglitazone ratio on ravim, mis sisaldab toimeainena pioglitasooni.
Pioglitazone ratio was developed as a ‘generic medicine'.
Pioglitazone ratio töötati välja geneerilise ravimina.
Pioglitazone ratio, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Pioglitazone ratio toimeaine pioglitasoon suurendab rakkude (rasva-, lihas- ja maksarakud) tundlikkust insuliini suhtes, mis
Pioglitazone ratio was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Ravimit Pioglitazone ratio kavatseti kasutada eelkõige ülekaaluliste täiskasvanud patsientide II tüüpi diabeedi raviks Seda kavatseti kasutada koos dieedi ja füüsilise koormusega.
Pioglitazone ratio was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Ravimit Pioglitazone ratio kavatseti kasutada ainsa ravimina patsientidel, kellele ei sobi metformiin (samuti diabeediravim).
How is Pioglitazone ratio expected to work?
Milline on ravimi Pioglitazone ratio eeldatav toime?
What was Pioglitazone ratio expected to be used for?
Milleks kavatseti ravimit Pioglitazone ratio kasutada?
The European Commission granted a marketing authorisation valid throughout the European Union for Zyclara on 23 August 2012.
Euroopa Komisjon andis Zyclara müügiloa, mis kehtib kogu Euroopa Liidus, 23. augustil 2012.
Some other side effects, including headache and tiredness, were also reported.
Teatati ka teistest kõrvalnähtudest, sealhulgas peavalu ja väsimus.
Zyclara imiquimod
Zyclara imikvimood
Other information about Zyclara
Muu teave Zyclara kohta
What measures are being taken to ensure the safe and effective use of Zyclara?
Mis meetmed võetakse, et tagada Zyclara ohutu ja efektiivne kasutamine?
The full EPAR for Zyclara can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst Zyclara kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The patient's response to treatment should be evaluated 8 weeks after the end of treatment, and a third 2-week course may be considered if needed.
Patsiendi ravivastust tuleb hinnata 8 nädala möödudes ravi lõpetamisest ning vajaduse korral võib kaaluda kolmandat 2-nädalast ravikuuri.
It contains the active substance imiquimod at 3.75% strength (100 mg cream contains 3.75 mg imiquimod).
See sisaldab toimeainena imikvimoodi tugevusega 3,75% (100 mg kreemi sisaldab 3,75 mg imikvimoodi).
The Agency therefore decided that Zyclara's benefits are greater than its risks and recommended that it be given marketing authorisation.
Amet otsustas seetõttu, et Zyclara kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
What is Zyclara and what is it used for?
Mis on Zyclara ja milleks seda kasutatakse?
Why is Zyclara approved?
Miks Zyclara heaks kiideti?
This is followed by a 2-week break without treatment and then a further 2 weeks of treatment.
Sellele järgneb 2 ravivaba nädalat ja seejärel veel 2 nädalat ravi.
This means that it is similar to a ‘reference medicine' containing the same active substance, but Zyclara is available in a different strength.
See tähendab, et Zyclara on sarnane võrdlusravimiga, mis sisaldab sama toimeainet, kuid Zyclarat turustatakse teise tugevusega.
The reference medicine for Zyclara is Aldara, which contains imiquimod at 5% strength.
Zyclara võrdlusravim on Aldara, mis sisaldab imikvimoodi tugevusega 5%.
In addition, its lower strength allows it to be used across larger areas of the skin and thereby treat more of the affected skin.
Lisaks võimaldab Zyclara väiksem tugevus kasutada seda suurematel nahapindadel ja seega ravida kahjustunud nahka ulatuslikumalt.
This means that it uses the immune system to bring about its effect.
See tähendab, et see toimib immuunsüsteemi kaudu.
The cream should remain on the skin overnight (for about 8 hours) before being washed off. Daily treatment should continue for 2 weeks.
Kreem peab olema nahal terve öö (ligikaudu 8 tundi), enne kui see maha pestakse.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zyclara have been included in the summary of product characteristics and the package leaflet.
Zyclara ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
If actinic keratosis is cleared after two 2-week courses but then it comes back, it can be treated again with one or two 2-week treatment courses provided these are given after a break of at least 12 weeks from the original treatment.
Kui kiirguskeratoos on pärast kaht 2-nädalast ravikuuri paranenud, kuid taastub, tohib teha veel ühe või kaks 2-nädalast ravikuuri, tingimusel et algsest ravist on möödunud vähemalt 12 nädalat.
It is not intended to provide practical advice on how to use Zyclara.
Hindamisaruandes ei anta Zyclara kasutamise praktilisi nõuandeid.
These substances help to kill the abnormal cells in the skin that lead to keratosis.
Need ained aitavad hävitada keratoosi põhjustavaid ebanormaalseid naharakke.
Zyclara is used to treat adults whose immune system (the body's natural defences) is working normally when other skin treatments for actinic keratosis cannot be used or are less appropriate.
Zyclarat kasutatakse normaalselt toimiva immuunsüsteemiga (organismi looduslik kaitsemehhanism) täiskasvanutel, kui teisi kiirguskeratoosi naharaviprotseduure ei saa kasutada või need on vähem sobivad.
If actinic keratosis does not improve enough with Zyclara, a different treatment should be tried.
Kui kiirguskeratoos ei allu piisavalt Zyclara ravile, tuleb proovida muud ravi.
Most patients using Zyclara experience side effects on the skin where the medicine was applied (most commonly redness, scab formation, dryness and shedding of the skin).
Enamikul Zyclarat kasutavatel patsientidel tekivad kõrvalnähud nahapiirkonnas, millele ravimit on kantud (kõige sagedamini punetus, korbad, kuivus ja ketendus nahal).
The European Medicines Agency concluded that Zyclara 3.75% cream has been shown to be effective at clearing actinic keratosis from the skin and that its use did not raise significant safety concerns.
Inimravimite komitee järeldas, et Zyclara 3,75% kreem oli kiirguskeratoosi eemaldamisel nahalt efektiivne ja et selle kasutamine ei tekitanud olulisi ohutusprobleeme.
Zyclara is a ‘hybrid medicine'.
Zyclara on hübriidravim.
What are the risks associated with Zyclara?
Mis riskid Zyclaraga kaasnevad?
This is a summary of the European public assessment report (EPAR) for Zyclara.
See on ravimi Zyclara Euroopa avaliku hindamisaruande kokkuvõte.
Two doses of Zyclara (2.5% and 3.75%) were compared with placebo (a dummy treatment) in these studies, and the main measure of effectiveness was the number of patients whose skin was completely cleared of the actinic keratosis after treatment.
Kahte Zyclara annust (2,5% ja 3,75%) võrreldi nendes uuringutes platseeboga (näiva ravimiga) ja efektiivsuse põhinäitaja oli nende patsientide osakaal, kellel oli pärast ravi lõppu nahk kiirguskeratoosist täielikult puhas.
How does Zyclara work?
Kuidas Zyclara toimib?
Zyclara is available as a 3.75% cream in individual sachets.
Zyclarat turustatakse 3,75% kreemina eraldi kotikestes.
Zyclara has been shown to be effective in clearing actinic keratosis from the skin in two main studies involving 479 patients with actinic keratosis on the face and scalp.
Zyclara efektiivsust kiirguskeratoosi eemaldamisel nahalt tõendati kahes põhiuuringus, milles osales 479 näopiirkonna ja peanaha kiirguskeratoosiga patsienti.
About 11% of patients in studies with Zyclara required treatment to be interrupted due to this kind of side effect on the skin.
Ligikaudu 11%-l Zyclara uuringutes osalenud patsientidest oli nahal avaldunud kõrvalnähtude tõttu vaja ravi katkestada.
Zyclara at a lower strength (2.5%) had a lower clearance rate than the 3.75% strength.
Väiksema tugevuse (2,5%) korral oli Zyclaraga puhastumuse määr väiksem kui 3,75% tugevuse juures.
For the full list of side effects and restrictions with Zyclara, see the package leaflet.
Zyclara kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
One or two sachets of Zyclara are applied in a thin layer to the affected areas of the face or balding scalp once a day before bedtime.
Üks või kaks kotikest Zyclara kreemi kantakse õhukese kihina kahjustatud piirkondadele näol ja kiilaneval peanahal üks kord ööpäevas enne magamaminekut.
For practical information about using Zyclara, patients should read the package leaflet or contact their doctor or pharmacist.
Kui vajate Zyclara kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
For more information about treatment with Zyclara, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Zyclaraga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
Actinic keratosis is a precancerous, abnormal skin growth that develops after too much exposure to sunlight.
Kiirguskeratoos on vähieelne ebanormaalne nahapaksenemus, mis tekib pärast liigset kokkupuudet päikesekiirgusega.