natgillin/translations-raw huggingface dataset:
Always use your insulin and adjust your basal (all-day) and bolus (meal time) doses exactly as your doctor has told you.
Pri uporabi insulina in prilagajanju bazalnega odmerka (odmerka za čez ves dan) in bolusnih odmerkov (odmerkov ob obrokih) natančno upoštevajte zdravnikova navodila.
NovoRapid FlexPen is only suitable for subcutaneous injections.
Zdravilo NovoRapid FlexPen je primerno samo za subkutano injiciranje.
• Follow the instructions in the pump user manual to remove an empty NovoRapid PumpCart cartridge from your pump.
• Upoštevajte navodila za uporabo, ki ste jih prejeli z insulinsko črpalko, da boste iz nje odstranili prazen vložek NovoRapid PumpCart.
NovoRapid InnoLet is a pre-filled disposable pen containing insulin aspart.
Ravnanje z injekcijskim peresnikom NovoRapid InnoLet NovoRapid InnoLet je napolnjen injekcijski peresnik za enkratno uporabo, ki vsebuje insulin aspart.
When NovoRapid is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Zdravilo NovoRapid začne delovati v 10 do 20 minutah po subkutani injekciji.
Keep the vial/cartridge in the outer carton in order to protect from light.
Vialo/vložek shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
NovoRapid FlexTouch is only suitable for subcutaneous injections.
Zdravilo NovoRapid FlexTouch je primerno samo za subkutano injiciranje.
See c)
PRILOGA I
NovoRapid vial can also be used if intravenous administration of insulin aspart, by physicians or other healthcare staff, is applicable.
Če je potrebno, lahko zdravnik ali drugo zdravstveno osebje uporabi vialo zdravila NovoRapid tudi za intravensko aplikacijo insulina aspart.
Pack sizes of 1 (with or without needles) or 5 (without needles) or a multipack with 2 x 5 (without needles) pre-filled pens of 3 ml.
Pakiranja z 1 (z iglami ali brez), s 5 (brez igel) ali skupno pakiranje z 2 x 5 (brez igel) napolnjenimi injekcijskimi peresniki po 3 ml. Na trgu morda ni vseh navedenih pakiranj.
► NovoRapid should never be mixed with any other medicinal product including other insulin products when used in a pump.
► Če zdravilo NovoRapid uporabljate v črpalki, ga nikoli ne smete mešati z nobenim drugim zdravilom (tudi z drugimi insulini ne).
MARKETING AUTHORISATION NUMBER EU/1/99/119/015 5 packs of 1 x 10 ml vial
EU/1/99/119/015 5 kompletov po 1 x 10 ml viala
NovoRapid Penfill is only suitable for subcutaneous injections from a reusable pen.
Zdravilo NovoRapid Penfill je primerno samo za subkutano injiciranje z injekcijskimi peresniki za večkratno uporabo.
MARKETING AUTHORISATION NUMBERS EU/1/99/119/001 1 vial of 10 ml EU/1/99/119/008 5 vials of 10 ml
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/99/119/001 1 viala z 10 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK (VIAL - with blue box)
NALEPKA ZUNANJEGA OVOJA PAKIRANJA Z VEČ VIALAMI - z modrim okencem
► NovoRapid PumpCart is only for use with a pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
► Zdravilo NovoRapid PumpCart je namenjeno uporabi z insulinskimi črpalkami, ki so zasnovane za uporabo s tem vložkom, kot npr. Accu-Chek Insight in YpsoPump.
Always keep the cartridge in the outer carton when you are not using it in order to protect it from light.
Kadar vložka ne uporabljate, ga vedno shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
During use or when carried as a spare: The product may be stored for a maximum of 4 weeks.
Med uporabo in ko zdravilo uporabljate kot rezervo: zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 30 °C.
To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen.
Za zagotovitev pravilnega odmerjanja se zdravila NovoRapid PumpCart ne sme uporabiti v injekcijskem peresniku.
Check the name and coloured label on your NovoRapid FlexTouch pen to make sure that it contains the type of insulin you need.
Preverite ime in barvno nalepko in se tako prepričajte, da vaš injekcijski peresnik NovoRapid FlexTouch vsebuje pravo vrsto insulina.
Inserting a new NovoRapid PumpCart cartridge in your pump
Vstavljanje novega vložka NovoRapid PumpCart v insulinsko črpalko
Please refer to the package leaflet where detailed instructions for use are provided.
Za podrobne napotke o uporabi glejte navodilo za uporabo.
NovoRapid PumpCart 100 units/ml solution for injection in cartridge Insulin aspart
NovoRapid PumpCart 100 enot/ml raztopina za injiciranje v vložku insulin aspart
Posology
NovoRapid
Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi glicerol fenol metakrezol cinkov klorid natrijev hidrogenfosfat dihidrat natrijev klorid klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
Other medicines and NovoRapid PumpCart
Shranjevanje zdravila NovoRapid PumpCart
NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
Zdravilo NovoRapid PumpCart je namenjeno uporabi z insulinskimi črpalkami, ki so zasnovane za uporabo s tem vložkom, kot npr. insulinski črpalki Accu-Chek Insight in YpsoPump.
• Always keep your pen and needles out of sight and reach of others, especially children.
• Injekcijski peresnik in igle hranite nedosegljivo drugim osebam, še posebno otrokom.
NovoRapid PumpCart is presented as a solution for injection.
Zdravilo NovoRapid PumpCart je namenjeno za uporabo v črpalki.
NovoRapid FlexTouch is only suitable for injecting under the skin.
Zdravilo NovoRapid FlexTouch je primerno samo za injiciranje pod kožo.
NovoRapid FlexPen is only suitable for injecting under the skin.
Zdravilo NovoRapid FlexPen je primerno samo za injiciranje pod kožo.
Now turn over for information on how to use your FlexPen.
Zdaj na hrbtni strani preberite, kako uporabljati injekcijski peresnik FlexPen.
Keep the vial in the outer carton in order to protect it from light.
Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Read carefully the instructions on how to use NovoRapid FlexTouch included in this package leaflet.
Natančno preberite navodila za uporabo injekcijskega peresnika NovoRapid FlexPen, ki jih vključuje to navodilo za uporabo.
► NovoRapid FlexTouch is only suitable for injecting under the skin.
► Zdravilo NovoRapid FlexTouch je primerno samo za injiciranje pod kožo.
Read carefully the instructions on how to use NovoRapid InnoLet included in this package leaflet.
Natančno preberite navodila za uporabo injekcijskega peresnika NovoRapid InnoLet, ki jih vključuje to navodilo za uporabo.
► Discard the needle after each injection.
► Po vsakem injiciranju iglo zavrzite.
► NovoRapid FlexPen is only suitable for injecting under the skin.
► Zdravilo NovoRapid FlexPen je primerno samo za injiciranje pod kožo.
Your FlexPen is a pre-filled dial-a-dose insulin pen.
Vaš injekcijski peresnik FlexPen je napolnjen insulinski peresnik z gumbom za nastavitev odmerka.
Do not use this medicine after the expiry date which is stated on the InnoLet label and carton, after ‘EXP'.
Zdravila ne uporabljajte po preteku roka uporabnosti, ki je naveden na nalepki injekcijskega peresnika InnoLet in škatli, za “EXP”.
NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen Insulin aspart
NovoRapid FlexPen 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin aspart
NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen Insulin aspart
NovoRapid InnoLet 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin aspart
Always use the dose scale and the dose selector to see how many units you have selected before injecting the insulin.
Pred injiciranjem vedno uporabite merilo odmerka in izbirnik odmerka , da boste preverili koliko enot ste nastavili.
NovoRapid Penfill 100 units/ml solution for injection in cartridge Insulin aspart
NovoRapid Penfill 100 enot/ml raztopina za injiciranje v vložku insulin aspart
NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen Insulin aspart
NovoRapid FlexTouch 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin aspart
Always keep the pen cap on your InnoLet when you are not using it in order to protect it from light.
Kadar injekcijskega peresnika InnoLet ne uporabljate, naj bo vedno pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
NovoRapid has a shorter duration of action compared to soluble human insulin after subcutaneous injection.
Po subkutani injekciji je delovanje zdravila NovoRapid kratkotrajnejše kot delovanje topnega humanega insulina.
What to do in case of pump failure
Kaj storiti, če črpalka odpove?
Before opening: NovoRapid PumpCart that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Pred odprtjem: zdravilo NovoRapid PumpCart, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
Please read these instructions carefully before using your NovoRapid PumpCart.
Pred uporabo zdravila NovoRapid PumpCart natančno preberite ta navodila.
INFORMATION IN BRAILLE NovoRapid
PODATKI V BRAILLOVI PISAVI
A randomised, double-blind cross-over PK/PD trial comparing insulin aspart with soluble human insulin was performed in elderly patients with type 2 diabetes (19 patients aged 65-83 years, mean age 70 years).
Pri starejših bolnikih s sladkorno boleznijo tipa 2 (19 bolnikov, starih od 65 do 83 let, povprečna starost 70 let) so opravili randomizirano, dvojno slepo navzkrižno preskušanje farmakokinetike/farmakodinamike, med katerim so insulin aspart primerjali s topnim humanim insulinom.
Making the injection
Nameščanje injekcijske igle
MARKETING AUTHORISATION HOLDER Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
NovoNordisk A/S Novo Allé DK-2880 Bagsvaerd Danska
Do not use this medicine after the expiry date which is stated on the vial label and carton, after ‘EXP'.
Zdravila ne uporabljajte po preteku roka uporabnosti, ki je naveden na nalepki viale in škatli za “EXP”.
Before opening: NovoRapid Penfill that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Pred odprtjem: zdravilo NovoRapid Penfill, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
SC use
uporabo
Always keep the pen cap on your FlexPen when you are not using it in order to protect it from light.
Kadar injekcijskega peresnika FlexPen ne uporabljate, naj bo vedno pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
Before opening: NovoRapid FlexPen that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Pred odprtjem: zdravilo NovoRapid FlexPen, ki ni v uporabi, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (CARTRIDGE.
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (NAPOLNJEN INJEKCIJSKI PERESNIK FlexTouch)
How to handle NovoRapid InnoLet
NALEPKA (NAPOLNJEN INJEKCIJSKI PERESNIK InnoLet)
Before opening: NovoRapid InnoLet that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Pred odprtjem: zdravilo NovoRapid InnoLet, ki ni v uporabi, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
Do not use this medicine after the expiry date which is stated on the FlexTouch label and carton, after ‘EXP'.
Zdravila ne uporabljajte po preteku roka uporabnosti, ki je naveden na nalepki injekcijskega peresnika FlexPen in škatli, za “EXP”.
► Do not refill the cartridge.
► Vložka ne smete znova polniti.
FlexTouch - without blue box)
ŠKATLA V NOTRANJOSTI SKUPNEGA PAKIRANJA (NAPOLNJEN INJEKCIJSKI PERESNIK FlexTouch - brez modrega okenca)
Before opening: NovoRapid FlexTouch that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Pred odprtjem: zdravilo NovoRapid FlexTouch, ki ni v uporabi, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK (PRE-FILLED PEN.
NALEPKA ZUNANJEGA OVOJA SKUPNEGA PAKIRANJA (NAPOLNJEN INJEKCIJSKI PERESNIK FlexTouch - z modrim okencem)
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens of 3 ml.
Pakiranja z 1 (z iglami ali brez), s 5 (brez igel) in z 10 (brez igel) napolnjenimi injekcijskimi peresniki po 3 ml. Na trgu morda ni vseh navedenih pakiranj.
Hold the dose button down until the dose counter returns to 0 after the injection.
Potisni gumb držite pritisnjen, dokler števec odmerka po injiciranju ne pokaže 0.
What NovoRapid PumpCart contains
Kaj vsebuje zdravilo NovoRapid PumpCart
NAME OF THE MEDICINAL PRODUCT NovoRapid 100 units/ml solution for injection Insulin aspart
NovoRapid 100 enot/ml raztopina za injiciranje insulin aspart
The plunger goes in first.
Zdravilo NovoRapid začne delovati hitro.
OTHER SPECIAL WARNINGS, IF NECESSARY Use solution only if clear and colourless
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
Invented name Strength Pharmaceutical form Route of administration Packaging Content
Številka EU Zaščiteno ime Jakost Farmacevtska oblika Pot uporabe
1 vial
1viala
It was to be available as a suspension for injection into a joint.
Na voljo naj bi bilo v obliki suspenzije za injiciranje v sklep.
Finally, the Committee had concerns about the way the medicine was manufactured and its quality ensured.
Poleg tega je imel pomisleke o načinu izdelave in zagotavljanja kakovosti zdravila.
Osteoarthritis is a condition that causes swelling and pain in the joints and which is often associated with lameness.
Osteoartritis je bolezen, ki povzroča otekanje in bolečine v sklepih ter je pogosto povezana s šepavostjo.
Following a request from the European Commission, the CVMP revised part of its opinion concerning compliance with Good Manufacturing Practice (GMP).
Na zahtevo Evropske komisije je odbor CMVP pregledal del svojega mnenja glede skladnosti z dobro proizvodno prakso.
The way that mesenchymal stem cells work has not been clearly established but published studies indicate that they have an anti-inflammatory action and may have an effect in regenerating tissue.
Način delovanja mezenhimskih matičnih celic še ni jasno ugotovljen, vendar objavljene študije kažejo, da imajo protivnetno delovanje in morda učinkujejo pri regeneraciji tkiva.
The CVMP noted that there were problems with the way the main study was designed and carried out, and concluded that the effectiveness of the medicine had not been sufficiently demonstrated.
Odbor CVMP je opozoril na težave z zasnovo in izvedbo glavne študije ter zaključil, da učinkovitost zdravila ni bila zadostno dokazana.
The main measure of effectiveness was a reduction in 1 or more grades of lameness using a scoring system that runs from 1 to 5.
Glavno merilo učinkovitosti je bilo zmanjšanje šepavosti za eno stopnjo ali več po petstopenjskem sistemu ocenjevanja.
The Committee removed its previous objection that the company did not comply with GMP but all other concerns remained.
Umaknil je svoj predhodni ugovor, da podjetje ne ravna v skladu z dobro proizvodno prakso, vendar so vsi drugi pomisleki ostali.
This was expected to help control the inflammation and joint damage associated with osteoarthritis in horses, and so reduce lameness.
To naj bi pomagalo nadzorovati vnetje in poškodbe sklepov, povezane z osteoartritisom pri konjih, in tako zmanjšati šepavost.
Horse Allo 20 was developed as a novel therapy medicine containing cells that have been manipulated so that they can be used to repair, regenerate or replace tissue.
Zdravilo Horse Allo 20 je bilo razvito kot novo zdravilo, ki vsebuje celice, spremenjene tako, da se lahko uporabljajo za obnovitev, regeneracijo ali nadomeščanje tkiva.
The CVMP was also concerned about the high number of side effects reported in the field study.
Izrazil je tudi zaskrbljenost zaradi velikega števila neželenih učinkov, o katerih so poročali v terenski študiji.
The applicant presented data from a field study involving horses from 2 years of age with osteoarthritis, where 37 horses were treated with Horse Allo 20 while 33 horses received a dummy treatment.
Predlagatelj je predložil podatke iz terenske študije, ki je vključevala konje z osteoartritisom, starejše od dveh let, pri čemer so 37 konjev zdravili z zdravilom Horse Allo 20, 33 konjev pa je prejemalo zdravilo brez učinkovine.
On 24 January 2019, the CVMP revised part of its opinion but confirmed its recommendation to refuse the marketing authorisation.
Odbor CVMP je 24. januarja 2019 pregledal del svojega mnenja, vendar je potrdil svoje priporočilo za zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom.
On 21 June 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Horse Allo 20, intended for the treatment of lameness in adult horses with osteoarthritis.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je v svojem negativnem mnenju z dne 21. junija 2018 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Horse Allo 20, namenjenim zdravljenju šepavosti pri odraslih konjih z osteoartritisom.
The company that applied for authorisation is Centauri Biotech SL.
Vlogo za pridobitev dovoljenja za promet z zdravilom je predložilo podjetje Centauri Biotech SL.
What is Horse Allo 20?
Kaj je zdravilo Horse Allo 20?
What were the CVMP's main concerns that led to the refusal?
Kateri so bili glavni zadržki, zaradi katerih je odbor CVMP predlagal zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom?
The CVMP was therefore of the opinion that the benefits of Horse Allo 20 did not outweigh its risks and recommended that it be refused marketing authorisation.
Posledično je menil, da koristi zdravila Horse Allo 20 ne odtehtajo z njim povezanih tveganj, in priporočil, da se vloga za pridobitev dovoljenja za promet z njim zavrne.
Horse Allo 20 was expected to be used to treat lameness in adult horses with osteoarthritis.
Zdravilo Horse Allo 20 naj bi se uporabljalo za zdravljenje šepavosti pri odraslih konjih z osteoartritisom.
What was Horse Allo 20 expected to be used for?
Za kaj naj bi se zdravilo Horse Allo 20 uporabljalo?
Horse Allo 20 is a veterinary medicine that contains allogeneic equine mesenchymal stem cells as active substance.
Horse Allo 20 je zdravilo za uporabo v veterinarski medicini, ki kot učinkovino vsebuje konjske alogenske mezenhimske matične celice.
How does Horse Allo 20 work?
Kako zdravilo Horse Allo 20 deluje?
The European Commission granted a marketing authorisation valid throughout the European Union for Betmiga on 20 December 2012.
Evropska komisija je dovoljenje za promet z zdravilom Betmiga, veljavno po vsej Evropski uniji, izdala 20. decembra 2012.
The potential risk of hypersensitivity (allergic reactions) and effects on the heart has been adequately addressed in the product information.
Morebitno tveganje preobčutljivosti (alergijskih reakcij) in učinkov na srce je ustrezno obravnavano v informacijah o zdravilu.
What measures are being taken to ensure the safe and effective use of Betmiga?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Betmiga?
It is available as prolonged-release tablets (25 mg, 50 mg).
Na voljo je v obliki tablet s podaljšanim sproščanjem (25 mg, 50 mg).
‘Prolonged-release' means that mirabegron is released slowly from the tablet over a few hours.
„Podaljšano sproščanje“ pomeni, da se mirabegron iz tablete sprošča počasi več ur.
The main measure of effectiveness was the change in the number of urinations and incontinence episodes per day after 3 months of treatment.
Glavno merilo učinkovitosti je bila sprememba števila dnevnih uriniranj in inkontinenčnih epizod po treh mesecih zdravljenja.
Serious but uncommon side effects include atrial fibrillation (cardiac rhythm disorder).
Med resne vendar redke neželene učinke spada atrijska fibrilacija (motnja srčnega ritma).
This is a summary of the European public assessment report (EPAR) for Betmiga.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Betmiga.
It is used to treat certain symptoms of the condition: urgency (sudden urge to urinate), increased urinary frequency (the need to urinate frequently) and urge incontinence (involuntary leakage of urine from the bladder when a sudden strong need to urinate is felt).
Uporablja se za zdravljenje določenih simptomov te bolezni: urgentnosti mokrenja (nenadne močne potrebe po uriniranju), povečane pogostosti mokrenja (potrebe po pogostem uriniranju) in urgentne inkontinence (nehotenega uhajanja urina iz mehurja ob pojavu nenadne močne potrebe po uriniranju).
The recommended dose of Betmiga is 50 mg once a day.
Priporočeni odmerek zdravila Betmiga je 50 mg enkrat na dan.
Other information about Betmiga
Druge informacije o zdravilu Betmiga
In patients who have reduced kidney or liver function the doctor may need to prescribe a lower dose or avoid the use of Betmiga, especially in patients taking certain other medicines.
Pri bolnikih z zmanjšanim delovanjem ledvic ali jeter bo zdravnik morda moral predpisati manjši odmerek zdravila Betmiga ali se izogniti njegovi uporabi, zlasti pri bolnikih, ki jemljejo še določena druga zdravila.
A risk management plan has been developed to ensure that Betmiga is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Betmiga je bil pripravljen načrt obvladovanja tveganj.
Betmiga has been studied in three main studies involving 4,611 patients with overactive bladder syndrome.
Zdravilo Betmiga so proučevali v treh glavnih študijah, ki so zajele 4 611 bolnikov s sindromom čezmerno aktivnega sečnega mehurja.
The most common side effects with Betmiga are tachycardia (rapid heartbeat) seen in just over 1 person in 100, and urinary tract infection (infection of the structures that carry urine) seen in just under 3 people in 100.
Najpogostejša neželena učinka zdravila Betmiga sta tahikardija (hitro bitje srca), ki je bila opažena pri nekaj več kot eni osebi od 100, in okužba sečil (okužba struktur, po katerih se pretaka urin), ki je bila opažena pri nekaj manj kot treh osebah od 100.
Regarding its safety, most side effects are comparable to those of other medicines used for treating overactive bladder syndrome.
Kar zadeva varnost zdravila, je bila večina neželenih učinkov primerljivih s tistimi, ki so značilni za druga zdravila, ki se uporabljajo za zdravljenje sindroma prekomerno aktivnega sečnega mehurja.
Treatment with 50 mg a day of Betmiga was shown to be effective in reducing the number of urination and incontinence episodes.
Zdravljenje s 50-miligramskim odmerkom zdravila Betmiga na dan se je izkazalo kot učinkovito pri zmanjševanju števila uriniranj in inkontinenčnih epizod.
What benefit has Betmiga shown during the studies?
Kakšne koristi je zdravilo Betmiga izkazalo med študijami?
The CHMP therefore decided that Betmiga's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zato zaključil, da so koristi zdravila Betmiga večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Patients received Betmiga (25 mg, 50 mg or 100 mg) or placebo (a dummy treatment) every day for 3 months.
Bolniki so tri mesece vsak dan prejemali bodisi zdravilo Betmiga (25 mg, 50 mg ali 100 mg) bodisi placebo (zdravilo brez zdravilne učinkovine).
Betmiga must not be used in people who have hypertension (high blood pressure) that is severe and uncontrolled.
Zdravila Betmiga ne smejo uporabljati bolniki s hudo in nenadzorovano hipertenzijo (visokim krvnim tlakom).
The active substance in Betmiga, mirabegron, is a beta-3-adrenergic-receptor agonist.
Zdravilna učinkovina v zdravilu Betmiga, mirabegron, je agonist adrenergičnih receptorjev beta-3.