natgillin/translations-raw huggingface dataset:
• To refer to the Ranexa SPC prior to prescribing any medications to the patient, as there are potential drug interactions which should be taken into consideration.
• Enne ravimite määramist patsiendile tutvuge Ranexa ravimi omaduste kokkuvõttega, sest tuleb võtta arvesse ravimite võimalikke koostoimeid.
• Caution should be exercised when prescribing Ranexa to patients:
• Ettevaatlik peab olema Ranexa määramisel patsientidele:
• With certain other risk factors listed in the product information
• kellel on teatavaid teisi ravimi omaduste kokkuvõttes loetletud riskitegureid
• Liver problems
• teil on maksaprobleemid
Health Care Professional information The PAC should include the following information for the healthcare professional information regarding Ranexa:
Patsiendi hoiatuskaart peab sisaldama Ranexa kohta järgmist informatsiooni tervishoiutöötajale:
• That the card should be shown to any doctor involved in their treatment
• Näidake seda kaarti igale teid ravivale arstile
• To refer to the Ranexa package leaflet for more information.
• Lisateavet Ranexa kohta lugege pakendi infolehelt.
• Call their doctor if they feel dizzy or sick, become sick or experience any unexpected symptoms after starting Ranexa.
• peab arstile teatama, kui tal tekib pärast ravi alustamist Ranexaga pearinglus, iiveldus või oksendamine või ootamatuid sümptomeid.
• To ensure to take a list of all their other medicines with them at any visit to the health care professional.
• Pidage meeles võtta igale arstivisiidile kaasa loetelu kõikidest teistest ravimitest, mida kasutate.
• Taking certain other drugs mentioned in the product information
• kes kasutavad teatavaid teisi ravimi omaduste kokkuvõttes loetletud ravimeid
• Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than Amiodarone
• Ia klassi (nt kinidiin) või III klassi (nt dofetiliid, sotalool) antiarütmikume, välja arvatud amiodarooni.
The Pharmacist should be requested to distribute a PAC to each patient at the time Ranexa is dispensed.
Apteegil tuleb paluda Ranexa müümisel patsiendile alati patsiendi hoiatuskaart kaasa anda.
• Moderate CYP3A4 inhibitors (e.g. diltiazem, erythromycin, fluconazole)
• mõõdukad CYP3A4 inhibiitorid (nt diltiaseem, erütromütsiin, flukonasool) • P-gp inhibiitorid (nt tsüklosporiin, verapamiil)
• That prior to Ranexa treatment the patient should tell their doctor if they have any of the following:
• Enne ravi alustamist Ranexaga rääkige arstile, kui:
Patient information The PAC should include the following information for the patient:
Patsiendi hoiatuskaardil peab olema järgmine oluline teave:
• Potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone)
• tugevaid CYP3A4 inhibiitoreid (nt itrakonasool, ketokonasool, vorikonasool,
• That during treatment with Ranexa the patient should:
• Ravi ajal Ranexaga patsient:
• Is taking the herbal remedy St John's Wort
• te kasutate taimset ravimit naistepuna
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member States shall agree the details of a Patient Alert Card (PAC) with the MAH, who must provide this PAC directly to the pharmacy with each Ranexa shipment.
Liikmesriigid peavad patsiendi hoiatuskaardi üksikasjad kokku leppima müügiloa hoidjaga,
50 ml (16 mg/ml) 1 vial
50 ml (16 mg/ml)
800 mg Concentrate for solution for infusion
800 mg Infusioonilahuse kontsentraat
Intravenous use Vial (glass)
Intravenoosne klaasviaal
The evening dose should be taken two to three hours before bedtime.
Õhtune annus tuleb manustada kaks kuni kolm tundi enne magamaminekut.
The European Commission granted a marketing authorisation valid throughout the European Union for Bronchitol on 13 April 2012.
Euroopa Komisjon andis Bronchitoli müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 13. aprillil
FEV1 is the maximum volume of air a person can breathe out in one second.
FEV1 näitab maksimaalset õhu hulka, mida inimene on suuteline ühe sekundi jooksul kopsudest välja puhuma.
What measures are being taken to ensure the safe use of Bronchitol?
Mis meetmeid võetakse, et tagada Bronchitoli kasutamise ohutus?
Some patients also received additional treatment with rhDNase (another treatment for cystic fibrosis).
Mõned patsiendid said veel ravi rhDNasega (teine tsüstilise fibroosi ravim).
In order to obtain further information on effectiveness and safety of Bronchitol in children and adolescents with cystic fibrosis the CHMP requested the company to carry out a study in this patient group.
Lisateabe saamiseks Bronchitoli efektiivsuse ja ohutuse kohta tsüstilise fibroosiga lastel ja noorukitel nõudis inimravimite komitee ettevõttelt uuringu korraldamist selles patsiendirühmas.
The recommended dose is 400 mg (which requires the inhalation of the content of 10 capsules loaded individually into the inhaler) twice a day in the morning and in the evening.
Soovitatav annus on 400 mg (selleks on vaja inhaleerida 10 kapsli sisu, mis tuleb ükshaaval inhaleerimisseadmesse laadida) kaks korda ööpäevas (hommikul ja õhtul).
The most common side effect with Bronchitol (seen in more than 1 patient in 10) is cough.
Bronchitoli kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) on köha.
Bronchitol was tested in two main studies involving 642 patients between six and 56 years of age with mild or moderate cystic fibrosis.
Bronchitoli uuriti kahes põhiuuringus, milles osales kokku 642 patsienti vanuses 6-56 eluaastat, kellel oli kerge kuni mõõduka raskusega tsüstiline fibroos.
The summary of the opinion of the Committee for Orphan Medicinal Products for Bronchitol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Harvikravimite komitee arvamuse kokkuvõte Bronchitoli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
The full EPAR for Bronchitol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Euroopa avaliku hindamisaruande täistekst Bronchitoli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Bronchitol
Muu teave Bronchitoli kohta
It is available as capsules (40 mg) containing a dry powder for inhalation using an inhaler device.
Seda turustatakse kapslitena (40 mg), mis sisaldavad kuiva pulbrit sissehingamiseks koos vastava inhaleerimisseadmega.
The exact way in which Bronchitol works in cystic fibrosis is not known.
Bronchitoli täpne toimemehhanism tsüstilise fibroosi korral ei ole teada.
For more information about treatment with Bronchitol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Bronchitoliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
The main measure of effectiveness was based on the improvement in patients' forced expiratory volume in one second (FEV1) adjusted for the patients age, height and sex, measured over 26 weeks in both studies.
Efektiivsuse põhinäitaja uuringutes oli patsientide esimese sekundi forsseeritud ekspiratoorse mahu (FEV1) paranemine, mida kohandati patsientide vanuse, pikkuse ja soo suhtes ning mõõdeti 26 nädala vältel.
This is a summary of the European public assessment report (EPAR) for Bronchitol.
See on ravimi Bronchitol Euroopa avaliku hindamisaruande kokkuvõte.
This first dose of 400 mg Bronchitol should only be given under the supervision of a qualified healthcare professional in a setting where the patient's breathing can be properly monitored and facilities for resuscitation are available.
Esimene 400 mg Bronchitoli annus tuleb manustada vastava väljaõppe saanud tervishoiutöötaja järelevalve all ja tingimustes, kus patsiendi hingamist saab kohaselt jälgida ja on olemas elustamisvõimalused.
In both studies the patients received either 400 mg of inhaled Bronchitol twice daily or 50 mg of inhaled Bronchitol twice daily (which was considered ineffective and hence intended as placebo (dummy treatment)).
Mõlemas uuringus inhaleerisid patsiendid kas 400 mg Bronchitoli kaks korda ööpäevas või 50 mg Bronchitoli kaks korda ööpäevas (viimast loeti mittetoimivaks annuseks ja seda kasutati uuringus platseebo ehk toimeta ravimina).
After being inhaled, Bronchitol is believed to cause the inflow of fluid into the airway secretions in the lungs, making them less viscous and therefore easier to be cleared away.
Arvatakse, et pärast inhaleerimist soodustab Bronchitol vedeliku tungimist hingamisteedes olevasse sekreeti ja muudab selle vähem viskoosseks ning seetõttu ka kergemini välja köhitavaks.
This leads to problems with the digestion and absorption of food, resulting in poor growth, and long-term infection and inflammation of the lungs because of excess mucus not being cleared away.
See takistab toidu seedimist ja imendumist, mille tagajärjeks on kasvupeetus ning pikaajalised infektsioonid ja põletik kopsudes, sest hingamisteedest ei saa ülemäärast lima eemaldada.
Bronchitol must not be used in people who are hypersensitive (allergic) to mannitol.
Bronchitoli ei tohi kasutada inimesed, kes on ülitundlikud (allergilised) mannitooli suhtes.
Regarding the safety of Bronchitol, the CHMP considered that sufficient measures have been proposed by the company to reduce the risks of bronchospasm and haemoptysis.
Bronchitoli ohutuse osas leidis inimravimite komitee, et ettevõte on välja pakkunud piisavad meetmed bronhospasmi ja veriköha riski vähendamiseks.
Bronchitol is a medicine that contains the active substance mannitol.
Bronchitol on ravim, mis sisaldab toimeainena mannitooli.
This means that it can promote osmosis (the flow of liquid across a membrane).
See tähendab, et mannitool soodustab osmoosi (vedeliku voolamist läbi membraani).
Patients who show bronchial hyperresponsiveness must not be treated with Bronchitol.
Patsiente, kellel esineb bronhide ülitundlikkus, ei tohi Bronchitoliga ravida.
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 Bronchitol.
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
Because the number of patients with cystic fibrosis is low, the disease is considered ‘rare', and Bronchitol was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November
Et tsüstilise fibroosiga patsientide arv on väike ja see haigus esineb harva, nimetati Bronchitol 7. novembril 2005 harvikravimiks.
Cystic fibrosis is an inherited disease that affects the cells in the lungs and the glands in the gut and pancreas that secrete fluids such as mucus and digestive juices.
Tsüstiline fibroos on pärilik haigus, mis kahjustab kopsurakke ning soole- ja pankreasenäärmeid, mis eritavad vedelikke, nagu lima ja seedemahlu.
Patients overall showed an improvement of approximately 2-3% in FEV1 adjusted for age, height and sex when compared with placebo over 26 weeks of treatment with Bronchitol.
Üldiselt paranes patsientide vanuse, pikkuse ja soo suhtes kohandatud FEV1-väärtus pärast 26-nädalast ravi Bronchitoliga platseeboga võrreldes ligikaudu 2-3%.
The Committee took the view that although the improvement in FEV1 shown by the studies was small Bronchitol may be of benefit in patients with cystic fibrosis if used in addition to best standard of care.
Inimravimite komitee oli arvamusel, et ehkki FEV1 paranemine uuringutes oli tagasihoidlik, võib Bronchitoli kasutamisest standardravi kõrval olla tsüstilist fibroosi põdevatele haigetele kasu.
The company that makes Bronchitol must ensure that all healthcare professionals expected to prescribe the medicine are provided with important safety information including information on the risk of narrowing of the airways in the lungs and the coughing of blood and how to manage this risk.
Bronchitoli tootja tagab kõikidele ravimit määravatele arstidele ravimi ohutusteabe, sealhulgas hingamisteede ahenemise ja veriköha riski ning nende tekkevõimaluse vähendamise kohta.
The active substance in Bronchitol, mannitol, is a naturally occurring polyol (a sugar alcohol) that is widely used as an osmotic agent.
Bronchitoli toimeaine mannitool on looduslik polüool (suhkuralkohol), mida kasutatakse laialdaselt osmootse toimega ainena.
Why has Bronchitol been approved?
Miks Bronchitol heaks kiideti?
In cystic fibrosis these fluids become thick and viscous, blocking the airways and the flow of digestive juices.
Tsüstilise fibroosi korral muutuvad need vedelikud tihkeks ja viskoosseks, blokeerides hingamisteed ning pärssides seedemahlade voolamist sooles.
What is Bronchitol?
Mis on Bronchitol?
The CHMP therefore concluded that the benefits of Bronchitol in addition to best standard of care outweigh its risks for adult patients with cystic fibrosis and recommended that it be granted marketing authorisation.
Seetõttu otsustas inimravimite komitee, et Bronchitoli kasulikkus ravimi kasutamisel standardravi kõrval on tsüstilise fibroosiga täiskasvanud patsientidel suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
EPAR summary for the public
Kokkuvõte üldsusele mannitool
For the full list of all side effects reported with Bronchitol, see the package leaflet.
Bronchitoli kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
Bronchitol is inhaled using the inhaler device provided.
Bronchitoli inhaleeritakse kaasasoleva inhaleerimisseadme abil.
What is the risk associated with Bronchitol?
Mis riskid Bronchitoliga kaasnevad?
The most serious side effect with Bronchitol is bronchospasm (narrowing of the airways of the lung) during the initiation dose assessment and haemoptysis (coughing of blood) during treatment with Bronchitol.
Bronchitoli kõige tõsisem kõrvalnäht algannuse hindamise ajal on bronhospasm (hingamisteede ahenemine) ja ravi ajal hemoptüüs (veriköha).
Bronchitol is used for the treatment of cystic fibrosis in adults in addition to best standard of care.
Bronchitoli kasutatakse täiskasvanud patsientidel tsüstilise fibroosi raviks standardravi kõrval.
For more information on how to use Bronchitol, see the instructions in the package leaflet.
Lisateave Bronchitoli kasutamise kohta on pakendi infolehel.
The effects of Bronchitol were first tested in experimental models before being studied in humans.
Enne inimuuringuid kontrolliti Bronchitoli toimet muude katsetega.
What benefit has Bronchitol shown during the studies?
Milles seisneb uuringute põhjal Bronchitoli kasulikkus?
Bronchitol must also not be used in patients with bronchial hyperresponsiveness.
Samuti ei tohi Bronchitoli kasutada patsiendid, kellel esineb bronhide ülitundlikkus mannitoolile.
Before initiating treatment with Bronchitol, patients need to undergo an initiation dose assessment during which they are challenged with an increasing dose of Bronchitol up to 400 mg in total to detect bronchial hyperresponsiveness (a state in which the airways of the lungs narrow easily).
Patsientidele manustatakse Bronchitoli suurenevaid annuseid kuni annuseni 400 mg, et teha kindlaks patsiendi bronhide võimalik ülitundlikkus mannitoolile (seisund, mille korral hingamisteed ahenevad ülemäära).
How does Bronchitol work?
Kuidas Bronchitol toimib?
How is Bronchitol used?
Kuidas Bronchitoli kasutatakse?
What is Bronchitol used for?
Milleks Bronchitoli kasutatakse?
How has Bronchitol been studied?
Kuidas Bronchitoli uuriti?
The capsules must never be swallowed.
Bronchitoli kapsleid ei tohi neelata.
The vaccine should be given according to official recommendations.
Vaktsiini määratakse vastavalt ametlikele soovitustele.
This summary was last updated in 12-2010.
Kokkuvõtte viimane uuendus: 12-2010
The full EPAR for Pumarix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Euroopa avaliku hindamisaruande täistekst Pumarixi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Dosing recommendations are only available for adults.
Annustamissoovitused kehtivad ainult täiskasvanud patsientidele.
The European Commission granted a marketing authorisation valid throughout the European Union for Pumarix to GlaxoSmithKline Biologicals s.a. on 4 March 2011.
Euroopa Komisjon andis Pumarixi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele GlaxoSmithKline Biologicals 4. märtsil 2011.
It should only be used once a flu pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU).
Seda tohib kasutada ainult Maailma Terviseorganisatsiooni või Euroopa Liidu poolt ametlikult välja kuulutatud gripipandeemia korral.
Adults should be given a dose of 0.5 ml followed by a second dose after an interval of at least three weeks.
Täiskasvanud patsientidele manustatakse 0,5 ml annus ning seejärel teine annus vähemalt kolm nädalat hiljem.
The vaccine contains a flu strain called ‘A/Indonesia/05/2005 PR8-IBCDCRG2' (H5N1).
Vaktsiin sisaldab gripiviiruse tüve A/Indonesia/05/2005 PR8-IBCDC-RG2 (H5N1).
The virus has first been inactivated so that it does not cause any disease.
Kõigepealt viirus inaktiveeritakse (hävitatakse), et see ei põhjustaks haigust.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because very few people have been exposed to it, and to which very few people are immune.
Selle asemel on võimalik valmistada vaktsiin, mis sisaldab spetsiaalselt valitud gripiviiruse tüve, millega on kokku puutunud vähesed inimesed ja mille suhtes on immuunsed väga vähesed inimesed.
For more information about treatment with Pumarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Pumarixiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole..
In the second main study, 4,560 adults were given either Pumarix or placebo (a dummy vaccine).
Teises põhiuuringus, manustati 4560 täiskasvanud patsiendile kas Pumarixi või platseebot (näiv ravim).
This means that, because the vaccine is a mock up and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine.
See tähendab, et kuna see on imitatsioonvaktsiin ega sisalda veel pandeemiat põhjustava gripiviiruse tüve, ei ole lõpliku pandeemiavaktsiini kohta olnud võimalik hankida ammendavat teavet.
When the company that makes the vaccine includes in it the flu strain responsible for a pandemic, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Kui vaktsiini tootja lisab vaktsiini pandeemiat põhjustava gripitüve, kogub ta teavet lõpliku pandeemiavaktsiini ohutuse ja efektiivsuse kohta ning esitab selle hindamiseks inimravimite komiteele.
Other information about Pumarix
Muu teave Pumarixi kohta
One main study involving 680 adults compared Pumarix given as two doses three weeks apart with Pandemrix H5N1 (another pandemic influenza vaccine) and also compared Pumarix given with and without an adjuvant.
Ühes põhiuuringus, milles osales 680 täiskasvanud patsienti, võrreldi Pumarixi manustatuna kahe annusena, mille vahele jäi kolm nädalat, vaktsiiniga Pandemrix H5N1 (samuti pandeemilise gripi vaktsiin) ning Pumarixi koos adjuvandiga ja ilma.
The CHMP decided that the vaccine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Pumarixi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimile müügiloa.
The vaccine is given by injection into muscle, preferably into shoulder or thigh muscle.
Vaktsiini süstitakse lihasesse, eelistatult õlavarre või reielihasesse.
It contains parts of influenza (flu) viruses that have been inactivated (killed).
See sisaldab inaktiveeritud (hävitatud) gripiviiruste osi.
Pumarix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde and sodium deoxycholate.
Pumarixi ei tohi manustada patsientidele, kellel on tekkinud anafülaktiline reaktsioon (raske allergiline reaktsioon) vaktsiini mis tahes komponendi või aine suhtes, mida vaktsiin mikrokogustes sisaldab, näiteks muna- või kanavalk, ovalbumiin (munavalge valk), formaldehüüd ja naatriumdeoksükolaat.
They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
Vaktsiini saab seejärel katsetada, et näha inimeste reaktsiooni, ning see võimaldab prognoosida reaktsiooni, kui vaktsiini lisatakse pandeemiat põhjustav gripitüvi.
The main measure of effectiveness in both studies was the ability to trigger the production of antibodies against the flu virus (‘immunogenicity') after six weeks.
Efektiivsuse põhinäitaja mõlemas uuringus oli vaktsiini võime tekitada gripivastaseid antikehi kuus nädalat hiljem.
However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Pandeemia ajal võib olla vaja manustada vaktsiini ka neile patsientidele tingimusel, et on võimalik kasutada elustamisvõimalusi.
This is a summary of the European public assessment report (EPAR) for Pumarix.
Käesolev dokument on ravimi Pumarix Euroopa avaliku hindamisaruande kokkuvõte.
What is Pumarix?
Mis on Pumarix?
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 Pumarix.
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
The study also showed that Pumarix triggered the production of more antibodies when given with an adjuvant than when given without.
Uuring näitas samuti, et Pumarix manustatuna koos adjuvandiga tekitas rohkem antikehi kui manustatuna ilma adjuvandita.
The emulsion contains the ‘adjuvant' to enhance the immune response.
Emulsioon sisaldab parema immuunvastuse saamiseks ka adjuvanti.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Gripipandeemia tekib, kui ilmub uus gripiviiruse tüvi, mis võib kergesti levida inimeselt inimesele, sest selle vastu puudub immuunsus (kaitse).
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Pumarix pandeemilise gripi vaktsiin (H5N1) (inaktiveeritud purustatud viirus, adjuveeritud)
Why has Pumarix been approved?
Miks Pumarix heaks kiideti?
The most common side effects with Pumarix (seen in more than 1 patient in 10) are headache, joint pain, muscle ache, pain at injection site and fatigue (tiredness).
Pumarixi kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on peavalu, liigesevalu, lihasvalu süstekoha valulikkus ja väsimus.
Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with an emulsion.
Vaktsiin valmistatakse enne kasutamist, segades omavahel viiruseosakesi sisaldava suspensiooni ja emulsiooni.