natgillin/translations-raw huggingface dataset:
Keep NovoRapid PumpCart in the blister until use to protect it from damage. 
Prije primjene čuvati NovoRapid PumpCart u blisteru radi zaštite od oštećenja.
METHOD AND ROUTES OF ADMINISTRATION Read the package leaflet before use Subcutaneous use 
NAČIN I PUTEVI PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
Instructions on how to use NovoRapid PumpCart pre-filled cartridge. 
Upute za uporabu napunjenog uloška NovoRapid PumpCart
A drop of insulin will appear at the needle tip. 
Na vrhu igle pojavit će se kapljica inzulina.
Setting the dose 
Odmjeravanje doze
5 x 1.6 ml cartridges. 
5 uložaka od 1,6 ml.
Basal (all-day) insulin requirements: When you use NovoRapid PumpCart in a pump, your insulin will be constantly delivered to cover your basal need for insulin. 
Bazalne (cjelodnevne) potrebe za inzulinom: kada primijenjujete NovoRapid PumpCart u pumpi,
Dose selector 
Pokazivač doze
You must use the pen as described in the instructions on how to use NovoRapid FlexPen. 
Brizgalicom morate rukovati na način opisan u uputama za uporabu brizgalice NovoRapid FlexPen.
D Pull off the inner needle cap and dispose of it. 
D Skinite unutarnji zatvarač igle i bacite ga u otpad.
Read carefully the instructions on how to use NovoRapid PumpCart included in this package leaflet. 
Pažljivo pročitajte upute za uporabu uloška NovoRapid PumpCart sadržane u ovoj uputi o lijeku.
Getting started 
Novo Allé
► Needles and NovoRapid FlexPen must not be shared. 
► Igle i NovoRapid FlexPen ne smiju se dijeliti s drugim osobama.
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens. 
Veličine pakiranja: 1 (sa ili bez igala), 5 (bez igala) i 10 (bez igala) napunjenih brizgalica.
How to handle NovoRapid FlexPen 
Kako rukovati brizgalicom NovoRapid FlexPen
Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 x 5 (without needles) pre-filled pens of 3 ml. 
Veličine pakiranja: 1 (sa ili bez igala), 5 (bez igala) ili višestruko pakiranje od 2 x 5 (bez igala) napunjenih brizgalica od 3 ml.
Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark Now turn over for information on how to use your InnoLet. 
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Danska Okrenite stranicu radi informacija o uporabi brizgalice InnoLet.
See c) 
Dodatku V.
NovoRapid has a faster onset and a shorter duration of action than soluble human insulin. 
NovoRapid počinje djelovati brže i djeluje kraće od otopine humanog inzulina.
• Follow the instructions in the pump user manual to remove an empty NovoRapid PumpCart cartridge from your pump. 
• Slijedite upute navedene u vodiču za korisnika da biste uklonili prazan uložak NovoRapid
NovoRapid InnoLet is only suitable for injecting under the skin. 
NovoRapid InnoLet je prikladan samo za ubrizgavanje pod kožu.
Insulins and analogues for injection, fast-acting. 
Farmakoterapijska skupina: lijekovi za liječenje šećerne bolesti, inzulini i analozi za injiciranje brzog djelovanja.
You must use the pen as described in the instructions on how to use NovoRapid FlexTouch. 
Brizgalicom morate rukovati na način opisan u uputama za uporabu brizgalice NovoRapid FlexTouch.
Tubings in which the inner surface materials are made of polyethylene or polyolefin have been evaluated and found compatible with pump use. 
NovoRapid se može primijeniti uz pomoć infuzijske pumpe (KSII), kako je opisano u dijelu 4.2. Ispitani su kateteri čija je unutarnja stijenka načinjena od polietilena ili poliolefina te je utvrđeno da su kompatibilni s pumpama.
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm 
Za uporabu s jednokratnim iglama NovoFine ili NovoTwist duljine do 8 mm.
NovoRapid Penfill is only suitable for subcutaneous injections from a reusable pen. 
NovoRapid Penfill je prikladan samo za supkutane injekcije pomoću brizgalice za višekratnu uporabu.
NovoRapid FlexTouch is only suitable for subcutaneous injections. 
NovoRapid FlexTouch brizgalica je prikladna samo za supkutane injekcije.
Insulin window 
Prozorčić inzulina
► Needles and NovoRapid InnoLet must not be shared. 
► Igle i NovoRapid InnoLet ne smiju se dijeliti s drugim osobama.
To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen. 
Kako bi se osiguralo ispravno doziranje, NovoRapid PumpCart nikada se ne smije primjenjivati u inzulinskoj brizgalici.
► NovoRapid InnoLet is only suitable for injecting under the skin. 
► NovoRapid InnoLet je prikladan samo za ubrizgavanje pod kožu.
Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark Now turn over for information on how to use your FlexTouch. 
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Danska Okrenite stranicu radi informacija o uporabi brizgalice FlexTouch.
MARKETING AUTHORISATION NUMBER EU/1/99/119/015 5 packs of 1 x 10 ml vial 
12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/119/015 5 pakiranja s 1 bočicom od 10 ml
Each cartridge contains 300 units of insulin aspart in 3 ml solution for injection. 
300 jedinica aspart inzulina u 3 ml otopine za injekciju.
Glycerol 
Glicerol Fenol
L Lead the needle tip into the outer needle cap on a flat surface. 
Na ravnoj površini uvedite vrh igle u vanjski zatvarač igle.
NovoRapid FlexPen is only suitable for subcutaneous injections. 
NovoRapid FlexPen brizgalica je prikladna samo za supkutane injekcije.
OTHER SPECIAL WARNINGS, IF NECESSARY Use solution only if clear and colourless 
DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO
► Needles and NovoRapid FlexTouch must not be shared. 
► Igle i NovoRapid FlexTouch ne smiju se dijeliti s drugim osobama.
Pack sizes of 5 and 10 cartridges. 
Veličine pakiranja: 5 i 10 uložaka.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL (PRE-FILLED PEN. 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BRIZGALICI (NAPUNJENA BRIZGALICA.
SPECIAL STORAGE CONDITIONS Before opening: Store in a refrigerator (2°C to 8°C) 
Prije otvaranja: čuvati u hladnjaku (2°C do 8°C).
Always remove and discard the needle after each injection and store your InnoLet without the needle attached. 
Nakon svakog injiciranja iglu skinite i bacite je u otpad, a potom spremite InnoLet bez nataknute igle.
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. 
Prije otvaranja: NovoRapid PumpCart koji ne koristite čuvati u hladnjaku na temperaturi od 2°C do 8°C, dalje od rashladnih dijelova.
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens of 3 ml. 
Veličine pakiranja: 1 (sa ili bez igala), 5 (bez igala) i 10 (bez igala) napunjenih brizgalica od 3 ml.
1 cartridge contains 3 ml equivalent to 300 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). 
1 ml otopine sadrži 100 jedinica aspart inzulina* (što odgovara 3,5 mg).
Other medicines and NovoRapid PumpCart 
Prije primjene lijeka NovoRapid PumpCart
NovoRapid is presented as a solution for injection. 
NovoRapid je otopina za injekciju.
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. 
Prije otvaranja: NovoRapid Penfill koji ne koristite čuvati u hladnjaku na temperaturi od 2°C do 8°C, dalje od rashladnih dijelova.
OTHER SPECIAL WARNING, IF NECESSARY Use solution only if clear and colourless 
DRUGO POSEBNO UPOZORENJE, AKO JE POTREBNO
Your FlexPen is a pre-filled dial-a-dose insulin pen. 
Vaš FlexPen je napunjena inzulinska brizgalica s mogućnošću odabira doze inzulina.
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, as described in section 4.2. 
NovoRapid PumpCart namijenjen je za primjenu samo uz pomoć inzulinske infuzijske pumpe namijenjene za uporabu s ovim uloškom, kao što su inzulinske pumpe Accu-Chek Insight i YpsoPump, kako je opisano u dijelu 4.2. Ispitani su kateteri čija je unutarnja stijenka načinjena od polietilena ili poliolefina te je utvrđeno da su kompatibilni s pumpama.
* see section 4.8, Description of selected adverse reactions. 
Manje često - reakcije na mjestu injiciranja Manje često - edem * vidjeti dio 4.8, Opis odabranih nuspojava
EU/1/99/119/022 
EU/1/99/119/024 EU/1/99/119/025
MARKETING AUTHORISATION HOLDER Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Danska
5 x 1.6 ml cartridges 
5 uložaka od 1,6 ml
G Hold the pen with the needle pointing up. 
G Brizgalicu držite iglom okrenutom prema gore.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK (PRE-FILLED PEN. 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA (NAPUNJENA BRIZGALICA.
► NovoRapid FlexPen is only suitable for injecting under the skin. 
► NovoRapid FlexPen je prikladan samo za ubrizgavanje pod kožu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK (VIAL - with blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA (BOČICA-s plavim okvirom)
Keep the vial/cartridge in the outer carton in order to protect from light. 
Bočicu/uložak čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
NovoRapid should never be mixed with any other insulin when used in a pump. 
NovoRapid koji se koristi u pumpi ne smije se nikada miješati s drugim inzulinima.
1 pre-filled pen contains 3 ml equivalent to 300 units. 
NAVOĐENJE DJELATNE TVARI 1 napunjena brizgalica sadrži 3 ml, što odgovara 300 jedinica.
► NovoRapid FlexTouch is only suitable for injecting under the skin. 
► NovoRapid FlexTouch je prikladan samo za ubrizgavanje pod kožu.
Always keep the pen cap on your FlexPen when you are not using it in order to protect it from light. 
Uvijek držite zatvarač na brizgalici FlexPen kad je ne koristite, radi zaštite od svjetlosti.
How to use NovoRapid 
Kako primijeniti NovoRapid
NovoRapid FlexPen is only suitable for injecting under the skin. 
NovoRapid FlexPen je prikladan samo za ubrizgavanje pod kožu.
Name and address of the manufacturers responsible for batch release 
PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
NovoRapid 100 units/ml solution for injection in vial Insulin aspart 
NovoRapid 100 jedinica/ml otopina za injekciju aspart inzulin
NovoRapid PumpCart 100 units/ml solution for injection in cartridge Insulin aspart 
NovoRapid PumpCart 100 jedinica/ml otopina za injekciju u ulošku aspart inzulin
Always keep the pen cap on your InnoLet when you are not using it in order to protect it from light. 
Uvijek držite zatvarač na brizgalici InnoLet kad je ne koristite, radi zaštite od svjetlosti.
Read carefully the instructions on how to use NovoRapid InnoLet included in this package leaflet. 
Pažljivo pročitajte upute za uporabu brizgalice NovoRapid InnoLet sadržane u ovoj uputi o lijeku.
METHOD OF ADMINISTRATION InnoLet 
Provjera protoka inzulina
Thereafter it can be used for up to 7 days below 37°C in an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. 
Nakon toga može se primjenjivati u inzulinskim infuzijskim pumpama namijenjenima za uporabu s ovim uloškom, kao što su inzulinske pumpe Accu-Chek Insight i YpsoPump, do 7 dana na temperaturi ispod 37°C.
NovoRapid vial can also be used if intravenous administration of insulin aspart, by physicians or other healthcare staff, is applicable. 
Ako je potrebna intravenska primjena aspart inzulina od strane liječnika ili drugog zdravstvenog radnika također se može koristiti NovoRapid bočica.
How to take NovoRapid 
Kako primjenjivati NovoRapid
NovoRapid FlexTouch is only suitable for injecting under the skin. 
NovoRapid FlexTouch je prikladan samo za ubrizgavanje pod kožu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR MULTIPACK (PRE-FILLED PEN. 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (NAPUNJENA BRIZGALICA.
You should always have an alternative delivery method for your insulin available for injection under the skin in case of pump system failure. 
U slučaju neispravnosti pumpe uvijek morate na raspolaganju imati neko drugo pomagalo za injiciranje inzulina pod kožu.
• Follow the instructions in the pump user manual that comes with your pump to insert a new NovoRapid PumpCart cartridge in your pump. 
• Kako biste stavili novi uložak NovoRapid PumpCart u pumpu, slijedite upute navedene u vodiču za korisnika kojeg ste dobili s pumpom.
• Bring NovoRapid PumpCart to room temperature. 
Prije umetanja uloška NovoRapid PumpCart u pumpu • NovoRapid PumpCart treba postići sobnu temperaturu.
B Remove the paper tab from a new disposable needle. 
Otrgnite papirnatu naljepnicu s nove igle za jednokratnu uporabu.
Store below 37°C Do not freeze 
Čuvati na temperaturi ispod 37°C.
NovoRapid FlexPen Pen cap 
NovoRapid FlexPen Zatvarač brizgalice
Thereafter it can be used for up to 7 days below 37°C in a pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. 
Nakon toga može se primijeniti u pumpi namijenjenoj za uporabu s ovim uloškom, kao što su inzulinske pumpe Accu-Chek Insight i YpsoPump, do 7 dana na temperaturi ispod 37°C.
Your NovoRapid FlexTouch pen is a pre-filled insulin pen. 
NovoRapid FlexTouch je napunjena inzulinska brizgalica.
Always keep the cartridge in the outer carton when you are not using it in order to protect it from light. 
Uvijek čuvajte uložak u vanjskoj kutiji kad ga ne koristite, radi zaštite od svjetlosti.
Other medicines and NovoRapid 
Prije primjene lijeka NovoRapid
NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen Insulin aspart 
NovoRapid InnoLet 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici aspart inzulin
NovoRapid FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit. 
Primjena FlexPen brizgalicom NovoRapid FlexPen je napunjena brizgalica (označena bojom) namijenjena uporabi s jednokratnim iglama NovoFine ili NovoTwist duljine do 8 mm.
Read carefully the instructions on how to use NovoRapid FlexTouch included in this package leaflet. 
Pažljivo pročitajte upute za uporabu brizgalice NovoRapid FlexPen sadržane u ovoj uputi o lijeku.
5 vials of 10 ml 
1 bočica od 10 ml 5 bočica od 10 ml
Misuse of NovoRapid PumpCart 
Pogrešna uporaba uloška NovoRapid PumpCart
3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene). 
3 ml otopine u ulošku (staklo tipa 1) s klipom (brombutil) i gumenim zatvaračem
NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen Insulin aspart 
NovoRapid FlexPen 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici aspart inzulin
H Press the dose button with your thumb until the dose counter returns to 0. 
Palcem pritisnite gumb za doziranje dok se brojčanik doze ne vrati na 0.
• Follow the instructions in the pump user manual to continue using your pump. 
• Za nastavak primjene pumpe slijedite upute navedene u vodiču za korisnika.
Do not use this medicine after the expiry date which is stated on the FlexTouch label and carton, after ‘EXP'. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici FlexPen brizgalice i kutiji iza oznake ‘Rok valjanosti'.
MARKETING AUTHORISATION NUMBERS EU/1/99/119/001 1 vial of 10 ml EU/1/99/119/008 5 vials of 10 ml 
12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/119/001 1 bočica od 10 ml
NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen Insulin aspart 
NovoRapid FlexTouch 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici aspart inzulin
NovoRapid Penfill 100 units/ml solution for injection in cartridge Insulin aspart 
NovoRapid Penfill 100 jedinica/ml otopina za injekciju u ulošku aspart inzulin
MARKETING AUTHORISATION NUMBER EU/1/99/119/021 2 x 5 pens of 3 ml 
EU/1/99/119/021 2 x 5 brizgalica od 3 ml
Preparing your NovoRapid FlexPen 
Priprema NovoRapid FlexPen brizgalice
► Remove and discard the needle after each injection. 
► Nakon svakog injiciranja iglu skinite i bacite u otpad.
1.6 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene). 
1,6 ml otopine u ulošku (staklo tipa 1) s klipom (brombutil) i gumenim zatvaračem
Phenol 
Penfill
Do not use this medicine after the expiry date which is stated on the InnoLet label and carton, after ‘EXP'. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici InnoLet brizgalice i kutiji iza oznake ‘Rok valjanosti'.
• Thyroid hormones (used to treat thyroid gland disorders) 
• hormone štitnjače (koriste se za liječenje poremećaja štitnjače)
Pen label Dose counter 
Naljepnica brizgalice
► Discard the needle after each injection. 
► Nakon svakog injiciranja iglu bacite u otpad.
Always keep the pen cap on your FlexTouch when you are not using it in order to protect it from light. 
Uvijek držite zatvarač na brizgalici FlexTouch kad je ne koristite, radi zaštite od svjetlosti.
Hold the dose button down until the dose counter returns to 0 after the injection. 
Nakon injekcije, držite gumb za doziranje pritisnutim dok se brojčanik doze ne vrati na 0.
How to store NovoRapid 
Kako čuvati NovoRapid
OTHER SPECIAL WARNINGS, IF NECESSARY Use solution only if clear and colourless For use by one person only 
Upotrijebiti otopinu samo ako je bistra i bezbojna.
NovoRapid vial 
NovoRapid bočica
MARKETING AUTHORISATION NUMBERS EU/1/99/119/003 5 cartridges of 3 ml EU/1/99/119/006 10 cartridges of 3 ml 
12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/119/003 5 uložaka od 3 ml
Always protect the cartridge from light during use. 
Tijekom primjene uvijek zaštitite uložak od svjetlosti.
EU/1/99/119/019 1 pen of 3 ml EU/1/99/119/020 5 pens of 3 ml EU/1/99/119/022 1 pen of 3 ml and 7 NovoFine needles EU/1/99/119/023 1 pen of 3 ml and 7 NovoTwist needles 
EU/1/99/119/022 1 brizgalica od 3 ml i 7 NovoFine igala
What NovoRapid PumpCart is and what it is used for What you need to know before you use NovoRapid PumpCart How to use NovoRapid PumpCart Possible side effects 
Što morate znati prije nego počnete primjenjivati NovoRapid PumpCart Nemojte primjenjivati NovoRapid PumpCart
Pointer 
NovoRapid
Do not use this medicine after the expiry date which is stated on the vial label and carton, after ‘EXP'. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici uloška i kutiji iza oznake ‘Rok valjanosti'.
Lipodystrophy: 
Lipodistrofija:
• Never share your pen or your needles with other people. 
• Nikada nemojte dijeliti svoju brizgalicu ili igle s drugim osobama jer može doći do prijenosa infekcije.
• Discard the needle after each injection. 
• Nakon svakog injiciranja iglu bacite u otpad.
NovoRapid Vial, InnoLet, FlexTouch and PumpCart: 
Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet NovoRapid bočica, InnoLet, FlexTouch i PumpCart: Novo Nordisk A/S
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 mjerilo učinkovitosti bilo je smanjenje hromosti za jedan ili više stupnjeva na temelju sustava bodovanja od 1 do 5.
The company that applied for authorisation is Centauri Biotech SL. 
Zahtjev za izdavanje odobrenja podnijela je tvrtka Centauri Biotech SL.
Finally, the Committee had concerns about the way the medicine was manufactured and its quality ensured. 
Naposljetku, Odbor je izrazio zabrinutost u pogledu načina proizvodnje lijeka i jamčenja njegove kvalitete.
What were the CVMP's main concerns that led to the refusal? 
Koji su bili glavni razlozi za zabrinutost CVMP-a koji su doveli do odbijanja zahtjeva?
It was to be available as a suspension for injection into a joint. 
Trebao je biti dostupan kao suspenzija za primjenu injekcijom u zglob.
What is Horse Allo 20? 
Što je Horse Allo 20?
Following a request from the European Commission, the CVMP revised part of its opinion concerning compliance with Good Manufacturing Practice (GMP). 
Na zahtjev Europske komisije CVMP je revidirao dio svojeg mišljenja koji se odnosi na usklađenost s dobrom proizvođačkom praksom (GMP).
Osteoarthritis is a condition that causes swelling and pain in the joints and which is often associated with lameness. 
Osteoartritis je bolest koja uzrokuje oticanje i bol u zglobovima i koja je često povezana s hromošću.
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 djelovanja mezenhimalnih matičnih stanica nije jasno utvrđen, ali objavljena ispitivanja upućuju na to da one imaju protuupalno djelovanje i da mogu utjecati na regeneraciju 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. 
CVMP je uočio probleme u pogledu oblikovanja i provedbe glavnog ispitivanja te je zaključio da učinkovitost VMP-a nije dostatno dokazana.
The CVMP was also concerned about the high number of side effects reported in the field study. 
CVMP je ujedno izrazio zabrinutost zbog velikog broja nuspojava zabilježenih u terenskom ispitivanju.
The Committee removed its previous objection that the company did not comply with GMP but all other concerns remained. 
Odbor je povukao svoj prethodni prigovor o neusklađenosti tvrtke s dobrom proizvođačkom praksom, ali su ostali prisutni svi ostali razlozi za zabrinutost.
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. 
Horse Allo 20 razvijen je kao novi lijek za terapiju koji sadržava stanice koje su izmijenjene kako bi se mogle primijeniti za popravak, regeneraciju ili zamjenu tkiva.
This was expected to help control the inflammation and joint damage associated with osteoarthritis in horses, and so reduce lameness. 
Očekivalo se da će to pomoći u kontroli upale i oštećenja zglobova povezanih s osteoartritisom u konja te da će se time smanjiti hromost.
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. 
Podnositelj zahtjeva dostavio je podatke iz terenskog ispitivanja koje je obuhvatilo konje u dobi od dvije i više godina s osteoartritisom, pri čemu je 37 konja liječeno VMP-om Horse Allo 20, dok su 33 konja primila slijepo liječenje.
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. 
Stoga je CVMP smatrao da koristi VMP-a Horse Allo 20 ne nadmašuju s njim povezane rizike te je preporučio odbijanje odobrenja za stavljanje VMP-a u promet.
Horse Allo 20 was expected to be used to treat lameness in adult horses with osteoarthritis. 
Horse Allo 20 trebao se koristiti za liječenje hromosti odraslih konja s osteoartritisom.
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 veterinarsko-medicinske proizvode (Committee for Medicinal Products for Veterinary Use - CVMP) donio je negativno mišljenje i preporučio odbijanje izdavanja odobrenja za stavljanje u promet VMP-a Horse Allo 20, koji je namijenjen liječenju hromosti odraslih konja s osteoartritisom.