natgillin/translations-raw huggingface dataset:
Accidental self-injection may produce similar effects in people to those seen in pigs.
Nenamerno samo-injiciranje lahko pri ljudeh povzroči enak učinek kot pri prašičih.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/05/ 2009
Datum pridobitve dovoljenja za promet: 11. maj 2009 Datum zadnjega podaljšanja dovoljenja za promet: 11/04/2014
Immunisation with Improvac induces an immune response against endogenous gonadotrophin releasing factor (GnRF), a factor that controls testicular function via the gonadotropic hormones LH and FSH.
Imunizacija z Improvac-om izzove imunski odgovor proti endogenemu gonadotropin sproščajočemu faktorju (GnRF), faktorju, ki kontrolira delovanje testisov preko gonadotropnih hormonov LH in FSH.
If self-injection with Improvac is suspected, reproductive physiology should be monitored by assay of testosterone or oestrogen levels (as appropriate).
Če sumite na samo-injiciranje z Improvac-om, je potrebno kontrolirati fiziologijo reprodukcije z določanjem nivoja testosterona ali estrogena (kot primerno).
Moreover, fully immunised boars develop metabolic characteristics typical of surgically castrated animals, including reduced concentrations of skatole, another key contributor to boar taint.
Poleg tega polno imunizirani merjasci razvijejo metabolične lastnosti, ki so tipične za kirurško kastrirane živali vključno z znižano koncentracijo skatola, drugim ključnim dejavnikom vonja po merjascu.
Accidental vaccination of male breeding stock may affect subsequent fertility.
Nenamerno cepljenje moške vzrejne črede lahko vpliva na poznejšo plodnost.
Clinically meaningful suppression of gonadal function should be managed with supportive endocrine replacement therapy until normal function returns.
Klinično pomembna supresija funkcij spolnih žlez naj se nadzira s podporno endokrino nadomestno terapijo dokler se ne povrne normalna funkcija.
Note that when using a safety vaccinator part of the needle will be covered by the needle guard and will not penetrate the pig.
Ko uporabljate varnostni aplikator, upoštevajte, da bo del igle prekrit s ščitnikom in ne bo penetriral v žival.
For use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty.
Za uporabo kot alternativa fizični kastraciji za zmanjšanje vonja po merjascu, ki ga povzroča ključna sestavina vonja po merjascu androstenon v celotnem prašiču samcu po nastopu pubertete.
This leads to reduced production and concentration of testosterone and other testicular steroids, including androstenone, one of the main substances responsible for boar taint.
To vodi do zmanjšanega nastajanja in koncentracije testosterona in drugih testikularnih steroidov, vključno z androstenonom, ene izmed glavnih spojin, odgovornih za vonj po merjascu.
Accidental self-injection could temporarily affect reproductive physiology of both men and women and may adversely affect pregnancy.
Nenamerno samo-injiciranje lahko začasno vpliva na fiziologijo reprodukcije pri moškem in ženski in lahko škodljivo učinkuje na nosečnost.
Another key contributor to boar taint, skatole, may also be reduced as an indirect effect.
Druga ključna sestavina vonja po merjascu, skatol, se lahko zaradi indirektnega učinka zniža.
In the event of accidental self-injection, wash the injury thoroughly with clean running water.
V primeru nenamernega samo-injiciranja natančno operite poškodbo s čisto, tekočo vodo.
Water for injections
Voda za injiciranje
Reduction of aggressive and sexual (mounting) behaviours can be expected from 1 to 2 weeks post second vaccination.
Zmanjšanje agresivnega in spolnega (zaskakovanje) vedenja lahko pričakujemo od 1 do 2 tedna po drugem cepljenju.
Advice to the physician:
Namenjeno zdravniku:
Boars given an initial dose of Improvac are immunologically primed but retain their full testicular function until they receive the second dose, which induces a strong immune response to GnRF and causes temporary immunological suppression of testicular function.
Merjasci, ki prejmejo začetni odmerek Improvac-a, so osnovno imunizirani toda ohranijo svojo polno funkcijo testisov, dokler ne prejmejo drugega odmerka, ki inducira močan imunski odgovor proti GnRF in povzroči začasno imunološko supresijo funkcije testisov.
Depending on the type of safety vaccinator, pressure may also be put on the skin and push the needle a few millimetres deeper into the tissue.
Glede na vrsto varnostnega aplikatorja, ki ga uporabljate, bo morda potrebno nekoliko povečati pritisk na kožo in na ta način potisniti iglo nekoliko globje v tkivo.
(a synthetic peptide analogue of GnRF conjugated to diphtheria toxoid) Adjuvant:
(sintetični peptidni analog GnRF konjugiran na toksoid davice) Dodatek:
The largest reactions were seen around 7 days post administration when the maximum size was 13 x 7 cm. By two weeks post administration the maximum size had decreased to 8 x 4 cm, showing a gradual resolution of the local reactions.
Največje reakcije so bile vidne 7 dni po dajanju, ko je bila največja velikost 13 x 7 cm. Do drugega tedna po dajanju se je največja velikost zmanjšala na 8 x 4 cm, kar kaže na postopno izginevanje lokalne reakcije.
In case of skin contact, wash immediately with soap and water.
V primeru stika s kožo, takoj sperite z milom in vodo.
The active ingredient in this immunological is a synthetically produced analogue of GnRF, which is conjugated with an immunogenic carrier protein.
Zdravilna učinkovina v tem imunološkem zdravilu je sintetično izdelan analog GnRF, ki je konjugiran z imunogenim nosilnim proteinom.
A transient increase in rectal temperature (post-vaccination hyperthermia) of around 0.5 °C is very commonly observed during the 24-hours period post vaccination.
Prehodno povišanje rektalne temperature (post vakcinalna hipertermija) okoli 0,5 °C se lahko opazi v obdobju 24 ur po cepljenju.
If slaughter is intended to be later than 10 weeks after the second dose a third dose should be given 4 to 6 weeks before the planned slaughter date.
Če je zakol načrtovan kasneje kot 10 tednov po drugem odmerku, je treba 4 do 6 tednov pred načrtovanim datumom zakola žival cepiti s tretjim odmerkom.
If pigs cannot be slaughtered within this recommended period the available trial data support that pigs may still be sent for slaughter up to 10 weeks after the final injection with minimal risk of boar taint.
Če prašiči ne morejo biti zaklani v priporočenem obdobju, se lahko prašiče pošlje v klanje do 10 tednov po zadnjem injiciranju z minimalnim tveganjem za vonj po merjascu, kar je podprto z dosegljivimi podatki poskusov.
In very rare cases anaphylactoid type reactions (dyspnoea, collapse, cyanosis and hypersalivation associated with or without muscle twitching or emesis) have been observed within a few minutes after the first vaccination with a duration of up to 30 minutes.
V zelo redkih primerih so v nekaj minutah po prvem cepljenju opazili anafilaktoiden tip reakcije (dispneja, kolaps, cianoza in povečano slinjenje, v povezavi ali pa tudi brez povezave s trzanjem mišic ali bruhanjem), ki traja do 30 minut.
The veterinary medicinal product must only be used with a safety vaccinator which has a dual safety system providing both a needle guard and a mechanism to prevent accidental operation of the trigger.
Zdravilo se mora uporabljati samo z varnostnim aplikatorjem, ki ima dvojni varnostni sistem, opremljen z varovalom za iglo in s sistemom, ki preprečuje naključno delovanje sprožilca.
The risk of a physiological effect is greater after a second or subsequent accidental injection than after a first injection.
Tveganje za fiziološki učinek je večje po drugem ali poznejšem nenamernem samo-injiciranju kot po prvi injekciji.
Do not administer the veterinary medicinal product in the future.
V prihodnosti zdravila ne uporabljajte.
Diethylaminoethyl (DEAE)-Dextran, an aqueous, non-mineral oil-based adjuvant
Dietilaminoetil (DEAE)-dekstran, vodni, ne mineralni, dodatek na oljni osnovi
A reduction of typical male behaviour such as mounting and aggressiveness when mixed with non-penmates can be expected after the second vaccination.
Zmanjšanje tipičnega moškega obnašanja, kot sta zaskakovanje in agresivnost se pričakuje po drugem cepljenju.
NAME OF THE VETERINARY MEDICINAL PRODUCT Improvac solution for injection for pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Improvac raztopina za injiciranje za prašiče
Do not use in male pigs intended for breeding.
Ne uporabite pri prašičih samcih, ki so namenjeni za vzrejo.
Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular function.
Indukcija protiteles proti GnRF za dosego začasne imunološke supresije funkcije testisov.
STATEMENT OF ACTIVE SUBSTANCES One dose (2 ml) contains:
En odmerek (2 ml) vsebuje:
Improvac has been shown to be safe in male pigs from 8 weeks of age onwards.
Improvac je pokazal varno uporabo pri živalih v starosti od 8 tednov naprej.
Administer by subcutaneous injection in the neck, immediately behind the ear, using a safety vaccinator.
Injicirajte subkutano v vrat neposredno za ušesom.
Entire male pigs from 8 weeks of age onwards should be vaccinated with 2 doses of 2 ml at least 4 weeks apart, with the second dose normally given 4 to 6 weeks prior to slaughter.
Vsi prašiči samci od 8 tedna starosti dalje naj bodo cepljeni z 2 odmerkoma s po 2 ml vsaj 4 tedne narazen, z drugim odmerkom običajno 4 do 6 tednov pred zakolom.
To avoid intramuscular deposition and lesions, it is recommended to use a shorter needle to give 5 mm to 9 mm penetration in undersized pigs and pigs younger than 16 weeks of age.
Da bi preprečili nenamerno intramuskularno injiciranje, pri manjših prašičih in pujskih, mlajših od 16 tednov, priporočamo uporabo krajše igle, ki omogoči 5 do 9 mm penetracije.
CONTRAINDICATIONS Do not use in female pigs.
KONTRAINDIKACIJE Ne uporabite pri svinjah.
The onset of immunity (induction of anti-GnRF antibodies) can be expected within 1 week post second vaccination.
Začetek imunosti (indukcija proti-GnRF protiteles) se lahko pričakuje v enem tednu po drugem cepljenju.
Do not use in female pigs.
Ne uporabite pri svinjah.
SC Read package leaflet before use.
s.c. Pred uporabo preberite navodilo za uporabo.
Administration of a double dose of Improvac (4 ml) to 8 week old piglets very commonly resulted in palpable injection site reactions.
Po dajanju dvojnega odmerka Improvac-a (4 ml) 8 tednov starim prašičkom so bile pogoste tipljive reakcije na mestu injiciranja.
In case of eye contact, rinse immediately with copious amounts of water.
V primeru stika z očmi, takoj izperite z veliko količino vode.
Once broached, the container should be returned to the refrigerator and then can be broached once more during the next 28 days, then discarded immediately after use.
Načet vsebnik morajo vrnete v hladilnik in ga nato v naslednjih 28 dneh še enkrat odprete, nato pa zavržete takoj po uporabi.
The active substance, being a principle of biological origin intended to produce active immunity, is not within the scope of Regulation (EC) No 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
Polyethylene bottle of 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber closure and secured with an aluminium cap.
Polietilenska plastenka s po 100 ml (50 odmerki) ali 250 ml (125 odmerki) zaprta z gumijastim zamaškom in zavarovana z aluminijasto zaporko.
Special care should be taken to avoid accidental self-injection and needle stick injury when administering the veterinary medicinal product.
Posebej je treba paziti, da se pri dajanju zdravila izognete nenamernemu samo-injiciranju in poškodbi s konico igle.
These circumstances should be taken into account when choosing an appropriate needle length.
Pri odločitvi za dolžino igle, ki jo boste uporabili, upoštevajte zgoraj navedeno.
When administered to older pigs (14-23 weeks of age) injection site swellings ranging from 2 cm to 5 cm in diameter are commonly observed, and injection site reactions at slaughter are commonly observed if the second vaccination is given only 4 weeks before slaughter.
Pri dajanju starejšim prašičem (14-23 tednov starosti) so na mestu injiciranja pogosto opazne otekline razpona od 2 do 5 cm v premeru, če pa je bilo drugo cepljenje izvedeno samo 4 tedne pred klanjem, so pri zakolu pogosto opazne tudi reakcije na mestu injiciranja.
Polyethylene (HDPE) bottle of, 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber closure and secured with an aluminium cap.
Polietilenska (HDPE) plastenka s po , 100 ml (50 odmerki) ali 250 ml (125 odmerki) zaprta z gumijastim zamaškom in zavarovana z aluminijasto zaporko.
TARGET SPECIES Male pigs (from 8 weeks of age).
CILJNE ŽIVALSKE VRSTE Prašiči, samci (od 8. tedna starosti).
PHARMACEUTICAL FORM Solution for injection
FARMACEVTSKA OBLIKA Raztopina za injiciranje
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 2 ml, by subcutaneous injection (injection given under the skin).
2 ml, subkutana injekcija (injekcija dana pod kožo).
DEAE-Dextran Chlorocresol Urea
DEAE-dekstran Klorokrezol
Outer packaging:
Zunanja ovojnina:
Do not use in female or male breeding pigs.
Ne uporabite pri ženskih ali moških vzrejnih živalih.
Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: Zoetis Belgium SA
− very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
− zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Male pigs (from 8 weeks of age).
Prašiči, samci (od 8 tedna starosti)
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous.
Nenamerno samo-injiciranje je nevarno.
GnRF analogue-protein conjugate: Zoetis Belgium SA Rue Laid Burniat 1
GnRF - DT - konjugat: Zoetis Belgium SA
PACKAGE SIZE 1 x 100 ml
VELIKOST PAKIRANJA 1 x 100 ml
Synthetic GnRF peptide analogue: Auspep Clinical Peptides PTY Ltd. 15, Mareno Road, Tullamarine, 3052 Victoria
Auspep Clinical Peptides PTY Ltd.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, 1 x 100 ml and 1 x 250 ml HDPE bottles
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla, , 1 x 100 ml in 1 x 250 ml HDPE steklenice
MARKETING AUTHORISATION NUMBER(S) EU/2/09/095/002 - 10 x 100 ml EU/2/09/095/003 - 4 x 250 ml
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/09/095/002 - 10 x 100 ml EU/2/09/095/003 - 4 x 250 ml
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
MARKETING AUTHORISATION NUMBER(S) EU/2/09/095/005 - 100 ml
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/09/095/005 - 100 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, 10 x 100 ml and 4 x 250 ml HDPE bottles
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla, , 10x100 ml in 4x250 ml HDPE steklenice
Pack sizes:
Velikost ovojnine:
Gonadotropin releasing factor (GnRF) analogue-protein conjugate min. 300 µg.
Analog gonadotropin sproščajočega faktorja (GnRF) - konjugiran protein min. 300 µg
The veterinary medicinal product should be stored safely out of the reach of children.
Zdravilo shranjujte nedosegljivo otrokom.
BELGIUM
Zoetis Belgium SA
Cardboard box with 10 bottles of 100 ml.
Kartonska škatla z 1 plastenko s po 100 ml. Kartonska škatla z 10 plastenkami s po 100 ml.
Pharmacotherapeutic group: Gonadotropin releasing factor analogue, conjugated.
Farmakoterapevtska skupina: Analog gonadotropin sproščujočega faktorja, konjugiran, oznaka ATC vet: QG03XA91.
STATEMENT OF ACTIVE SUBSTANCES GnRF analogue-protein conjugate min. 300 µg/2 ml
GnRF analog - konjugiran protein najmanj 300 µg/2ml
EXPIRY DATE EXP {month/year} Once broached, use within 28 days.
Načeto zdravilo uporabite v 28 dneh.
Cardboard box with 4 bottles of 250 ml.
Kartonska škatla s 1 plastenko s po 250 ml. Kartonska škatla s 4 plastenkami s po 250 ml.
Diphtheria toxoid:
Sintetični GnRF peptid:
− common (more than 1 but less than 10 animals in 100 animals treated)
− pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali)
QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml) contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
− rare (more than 1 but less than 10 animals in 10,000 animals treated)
− redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
6.1 List of excipient(s)
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
The patient should be advised not to administer Improvac and/or any other product with similar action in the future.
Improvac-a in/ali zdravil s podobnim delovanjem.
− uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
− občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali)
A gradual resolution of the local reactions occurs, but in 20-30% of the animals these may persist for more than 42 days.
Pri dajanju prašičem pri najnižji priporočeni starosti (8 tednov), so bile na mestu dajanja zelo pogosto opazne otekline do 4x8 cm. Lokalna reakcija postopno izgine, vendar pri 20-30 % živalih lahko ta ostane več kot 42 dni.
AUSTRALIA
Sečnina
Excipient: Chlorocresol
klorokrezol
After first broaching with a sterile needle, the container should be returned to the refrigerator.
Rok uporabnosti po prvem odpiranju vsebnika: po prvem odpiranju s sterilno iglo morajo vsebnik vrnete v hladilnik in ga nato v naslednjih 28 dneh še enkrat odprete, nato pa zavržete takoj po uporabi.
− very common (more than 1 in 10 animals treated displaying adverse reaction(s))
− zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
Zoetis LLC
Rp-Vet.
Immediate packaging:
Stična ovojnina:
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml and 250 ml HDPE bottles
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI 100 ml in 250 ml HDPE stekleničke
PACKAGE SIZE 10 x 100 ml 4 x 250 ml
VELIKOST PAKIRANJA 10 x 100 ml
Ref. EMEA/4193/2008
EMEA/90152/2008
This means that they were to be similar to biological medicines that are already authorised in the European Union (EU) and contain the same active substances (also known as the ‘reference medicines').
To pomeni, da bi naj bila podobna biološkim zdravilom, ki so že odobrena v Evropski uniji (EU) in vsebujejo isto zdravilno učinkovino (imenovanim tudi „referenčna zdravila“).
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Pismo podjetja, v katerem so EMEA obvestili o umiku vloge, je na voljo tukaj.
What were these medicines expected to be used for?
Za kaj naj bi se zdravila uporabljala?
The three ‘Marvel insulins' were to contain one or both types of insulin:
Trije „insulini Marvel“ naj bi vsebovali eno ali obe vrsti insulina:
These three medicines are all solutions for injection that contain 100 International Units of insulin per millilitre.
Ta tri zdravila so raztopine za injiciranje, ki vsebujejo 100 mednarodnih enot insulina na mililiter.
International non-proprietary name (INN): human insulin
Mednarodno nelastniško ime (INN): humani insulin
These medicines would have contained insulin in two different forms: a soluble form, which acts quickly (within 30 minutes of injection), and an ‘isophane' form, which is absorbed more slowly and gives a longer duration of action.
Zdravila bi vsebovala insulin v dveh različnih oblikah: v topni obliki, ki učinkuje hitro (v 30 minutah po injiciranju), ter v „izofani“ obliki, ki se absorbira počasneje ter posledično zagotavlja daljše trajanje učinkovanja.
The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to them.
CHMP je pripravil seznam vprašanj, na katera naj bi podjetje odgovorilo, vendar tega do sedaj še ni storilo.
The reference medicines for these insulins were to be Humulin S, Humulin I and Humulin M3.
Referenčna zdravila za te insuline bi naj bila Humulin S, Humulin I and Humulin M3.
They were to be available in vials or as cartridges to be used in injection pens.
Na voljo naj bi bila v vialah ali vložkih, namenjenih za uporabo kot injekcijski peresniki.
How are these medicines expected to work?
Kako naj bi zdravila delovala?
The CHMP was also concerned that the company had not supplied enough information on how the active substance or the finished products are made, and that the processes used to make them had not been validated.
CHMP je imel tudi zadržke v zvezi z dejstvom, da podjetje ni posredovalo dovolj informacij o tem, kako se zdravilna učinkovina ali končni izdelek proizvaja, ter da procesi, ki se uporabljajo za njuno proizvodnjo, niso validirani.
The active substance, insulin human, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin.
Zdravilna učinkovina, humani insulin, se proizvaja po metodi, imenovani „tehnologija rekombinantne DNA“: proizvaja ga bakterija, ki je prejela gen (DNA), s pomočjo katerega tvori insulin.
The main measure of effectiveness was the effect of the medicines on the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Glavno merilo učinkovitosti je bil vpliv zdravil na raven snovi, imenovane glikoziliran hemoglobin (HbA1c), v krvi, ki kaže, kako dobro je glukoza v krvi nadzorovana.
Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih izda dovoljenje.
The medicines were expected to be used to treat patients with diabetes who need insulin to maintain their blood levels within normal levels, and to control diabetes in newly diagnosed patients and pregnant women.
Zdravila naj bi se uporabljala za zdravljenje bolnikov s sladkorno boleznijo, ki potrebujejo insulin za vzdrževanje koncentracije sladkorja v krvi v normalnem območju, ter za nadzor sladkorne bolezni pri nanovo diagnosticiranih bolnikih in nosečnicah.
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar.
Sladkorna bolezen je bolezen, pri kateri telo ne proizvaja dovolj insulina za vzdrževanje primerne koncentracije sladkorja v krvi.
The company presented data from studies designed to show that the Marvel insulins were comparable with the reference medicines in experimental models and in humans.
Podjetje je predložilo podatke iz študij, zasnovanih z namenom, da bi dokazali, da so insulini Marvel primerljivi z referenčnimi zdravili, in sicer tako na eksperimentalnih modelih kot pri ljudeh.
It also presented the results of one main study in 526 patients with diabetes, who received either the Marvel insulins or the Humulin insulins for up to 12 months.
Podjetje je poleg tega predložilo rezultate ene glavne študije s 526 bolniki s sladkorno boleznijo, ki so do 12 mesecev prejemali ali insuline Marvel ali insuline Humulin.
The company informed the CHMP that there are no clinical trials or compassionate use programmes currently with the Marvel insulins.
Podjetje je CHMP obvestilo, da klinična preizkušanja ali programi sočutne uporabe insulinov Marvel trenutno ne potekajo.
The main concerns of the CHMP were that the comparability of the Marvel insulins and the Humulin insulins had not been shown.
Glavni zadržki CHMP so bili povezani dejstvom, da primerljivost insulinov Marvel in insulinov Humulin ni bila dokazana.
The studies in healthy volunteers did not show that the Marvel insulins had the same effect in lowering blood sugar levels as the Humulin insulins, and the main study showed a trend in favour of Humulin.
Raziskave z zdravimi prostovoljci niso dokazale, da bi imeli insulini Marvel enak vpliv na zniževanje ravni sladkorja v krvi kot insulini Humulin, glavna raziskava pa je izkazala trend v prid insulinov Humulin.