natgillin/translations-raw huggingface dataset:
1.6 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene). 
1,6 ml raztopine v vložku (steklo tipa 1) z batom (bromobutil) in gumijasto zaporko (bromobutil/poliizopren).
PumpCart). 
NovoRapid PumpCart),
This may lead to inaccurate dosing that can make your blood sugar level too high or too low. 
To lahko povzroči netočno odmerjanje, posledično pa se lahko koncentracija krvnega sladkorja preveč zviša ali preveč zniža.
Your NovoRapid FlexTouch pen is a pre-filled insulin pen. 
Vaš injekcijski peresnik NovoRapid FlexTouch je napolnjen insulinski peresnik.
NovoRapid InnoLet is only suitable for injecting under the skin. 
Zdravilo NovoRapid InnoLet je primerno samo za injiciranje pod kožo.
A drop of insulin will appear at the needle tip. 
Na konici igle se bo pojavila kapljica insulina.
METHOD OF ADMINISTRATION FlexTouch 
POSTOPEK UPORABE FlexTouch
• Always prime InnoLet before you inject. 
• Pred injiciranjem vedno odstranite zrak z injekcijskega peresnika InnoLet.
► NovoRapid PumpCart is only suitable for injecting under the skin (subcutaneously) using a pump. 
► Zdravilo NovoRapid PumpCart je primerno samo za injiciranje pod kožo (subkutana uporaba) s črpalko.
Instructions on how to use NovoRapid solution for injection in FlexPen. 
Navodila za uporabo zdravila NovoRapid raztopina za injiciranje v injekcijskem peresniku FlexPen
• Connect the infusion set with NovoRapid PumpCart by attaching the adapter onto your pump. 
• Povežite komplet za infundiranje z zdravilom NovoRapid PumpCart, tako da namestite nastavek na insulinsko črpalko.
3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene). 
3 ml raztopine v vložku (steklo tipa 1) z batom (bromobutil) in gumijasto zaporko (bromobutil/poliizopren).
Each cartridge contains 300 units of insulin aspart in 3 ml solution for injection. 
300 enot insulina aspart v 3 ml raztopine za injiciranje.
► NovoRapid Penfill is only suitable for injecting under the skin using a reusable pen. 
► Zdravilo NovoRapid Penfill je primerno samo za injiciranje pod kožo z injekcijskim peresnikom za večkratno uporabo.
Read carefully the instructions on how to use NovoRapid PumpCart included in this package leaflet. 
Natančno preberite napotke za uporabo vložka NovoRapid PumpCart, ki se nahajajo na koncu tega navodila za uporabo.
Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control. 
Za doseganje optimalne urejenosti glikemije je priporočljivo spremljanje koncentracije glukoze v krvi in prilagajati odmerek insulina.
During use or when carried as a spare: Store below 30°C. 
Med uporabo in ko se zdravilo uporablja kot rezerva: shranjujte pri temperaturi do 30 °C.
Start by checking your pen to make sure that it contains NovoRapid 100 units/ml, then look at the illustrations to the right to get to know the different parts of your pen and needle. 
Začnite tako, da preverite injekcijski peresnik in se tako prepričate, da vsebuje zdravilo NovoRapid 100 enot/ml.
PumpCart - without blue box) 
ŠKATLA V NOTRANJOSTI SKUPNEGA PAKIRANJA (VLOŽEK PumpCart - brez modrega okenca)
What NovoRapid contains 
Kaj vsebuje zdravilo NovoRapid
You must use the pen as described in the instructions on how to use NovoRapid FlexTouch. 
Injekcijski peresnik morate uporabljati, kot je opisano v navodilih za uporabo injekcijskega peresnika NovoRapid FlexPen.
NovoRapid PumpCart is a pre-filled cartridge ready for use directly in the pump. 
Zdravilo NovoRapid PumpCart je na voljo v obliki napolnjenega vložka, pripravljenega za neposredno uporabo v črpalki.
• If you get any side effects, talk with your doctor, nurse or pharmacist. 
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
NovoRapid Penfill is only suitable for injecting under the skin using a reusable pen. 
Zdravilo NovoRapid Penfill je primerno samo za injiciranje pod kožo z injekcijskim peresnikom za večkratno uporabo.
If necessary, NovoRapid can be administered intravenously which should be carried out by physicians or other healthcare staff. 
Če je potrebno, je mogoče zdravilo NovoRapid aplicirati tudi intravensko, vendar ga sme tako aplicirati samo zdravstveni delavec.
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.