natgillin/translations-raw huggingface dataset:
By acting as a functional antagonist on S1P1 receptors on lymphocytes, siponimod prevents egress from lymph nodes. 
Siponimod na receptorjih S1P1 na limfocitih deluje kot funkcionalni antagonist in tako preprečuje izstop limfocitov iz bezgavk, kar zmanjša obseg ponovnega vstopa limfocitov T v centralni živčni sistem (CŽS), to pa zmanjša obseg vnetja v centralnem živčevju.
• Arrange an ophthalmological evaluation prior to initiating therapy and follow-up evaluations while receiving therapy in patients with a history of diabetes mellitus, uveitis or underlying/co-existing retinal disease. 
• Pri bolnikih z anamnezo sladkorne bolezni, uveitisa ali obstoječe oziroma sočasno prisotne bolezni mrežnice je treba opraviti oftalmološki pregled pred začetkom zdravljenja in izvajati kontrolne preglede v času prejemanja siponimoda.
Bradyarrhythmic effects are more pronounced when siponimod is added to beta-blocker therapy. 
Kadar bolnik poleg zdravljenja z zaviralci adrenergičnih receptorjev beta začne prejemati siponimod, so bradiaritmični učinki močneje izraženi.
Discontinue treatment if significant liver injury is confirmed. 
Če izvidi potrdijo pomembno okvaro jeter, prekinite zdravljenje.
Because of the potential additive effect on heart rate, treatment with siponimod should generally not be initiated in patients who are concurrently treated with these substances (see section 4.4). 
Bolnikom, ki se že zdravijo z navedenimi učinkovinami, se zaradi možnosti aditivnega učinka na srčno frekvenco zdravljenja s siponimodom načeloma ne sme uvesti (glejte poglavje 4.4).
It is recommended that siponimod be discontinued if a patient develops macular oedema. 
Če pri bolniku pride do makularnega edema, se priporoča prekinitev zdravljenja s siponimodom.
• Counsel the patient in case of inadvertent pregnancy. 
• Če pride do nenačrtovane nosečnosti, je treba poskrbeti za ustrezno strokovno svetovanje bolnici.
Time to 3-month CDP versus placebo 
Čas do 3-mesečnega potrjenega napredovanja invalidnosti v primerjavi z uporabo placeba
Tablet coating 
Kožni tumorji
Pale red, round, biconvex, bevelled-edged film-coated tablet of approximately 6.1 mm diameter with company logo on one side and “T” on the other side. 
6,1 mm, z logotipom družbe na eni strani in oznako “T” na drugi.
These may be symptoms of a condition called posterior reversible encephalopathy syndrome (PRES). 
• če imate simptome, kot so nenaden pojav hudega glavobola, zmedenost, napad s krči in motnje vida: lahko gre za simptome bolezni, ki jo imenujemo sindrom posteriorne reverzibilne encefalopatije (posterior reversible encephalopathy syndrome, PRES).
It must not be used by patients who: 
Ne smejo ga uporabljati bolniki, ki imajo:
• have certain heart problems; 
• določena obolenja srca;
• have or have had asthma; 
• astmo ali so imeli astmo v preteklosti;
Brinzolamide has been authorised in the European Union (EU) as Azopt since 2000. 
Brinzolamid je v Evropski uniji (EU) odobren od leta 2000 kot zdravilo Azopt.
The European Commission granted a marketing authorisation valid throughout the EU for Azarga on 25 November 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Azarga, veljavno po vsej Evropski uniji, odobrila 25. novembra 2008.
• have severely reduced kidney function. 
• močno zmanjšano delovanje ledvic.
It is available as eye drops. 
Na voljo je v obliki kapljic za oči.
Azarga brinzolamide / timolol 
Azarga brinzolamid/timolol
The full EPAR for Azarga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Azarga je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Azarga? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Azarga?
Other information about Azarga 
Druge informacije o zdravilu Azarga
This is a summary of the European public assessment report (EPAR) for Azarga. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Azarga.
Azarga must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients, other beta blockers (such as some heart medicines) or sulphonamides (an antibiotic). 
Zdravila Azarga se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) zdravilni učinkovini zdravila, katero koli od sestavin zdravila, druge zaviralce receptorjev beta (kot so npr. nekatera zdravila za srce) ali sulfonamide (antibiotik).
What benefit has Azarga shown during the studies? 
Kakšne koristi je zdravilo Azarga izkazalo med študijami?
A risk management plan has been developed to ensure that Azarga is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Azarga je bil pripravljen načrt obvladovanja tveganj.
If it is used with another eye medicine, the different medicines should be used at least 5 minutes apart. 
Če se uporablja sočasno z drugim zdravilom za oči, mora med dajanjem obeh zdravil preteči najmanj 5 minut.
In both studies, the main measure of effectiveness was the change in IOP over the first six months of treatment. 
V obeh študijah je bilo glavno merilo učinkovitosti sprememba očesnega tlaka v prvih šestih mesecih zdravljenja.
• have hyperchloraemic acidosis (excess acid in the blood caused by too much chloride); 
• hiperkloremično acidozo (prekomerno količino kisline v krvi, ki jo povzroča prevelika koncentracija klorida);
For more information about treatment with Azarga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Azarga preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is used in adults with open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal). 
Uporablja se pri odraslih, ki imajo glavkom z odprtim zakotjem (bolezen, pri kateri se očesni tlak zvišuje, ker tekočina ne more iztekati iz očesa) ali okularno hipertenzijo (očesni tlak je višji od običajnega).
The most common side effects with Azarga (seen in between 1 and 10 patients in 100) are blurred vision, eye pain and eye irritation. 
Najpogostejši neželeni učinki zdravila Azarga (opaženi pri 1 do 10 bolnikih od 100) so zamegljenost vida, bolečine v očesu in draženje v očesu.
The Committee decided that Azarga's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zaključil je, da so koristi zdravila Azarga večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
By lowering the pressure, Azarga reduces the risk of damage. 
Zdravilo Azarga z zniževanjem tlaka zmanjša nevarnost poškodb.
Brinzolamide is a carbonic anhydrase inhibitor that works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body. 
Brinzolamid je zaviralec karboanhidraze in deluje tako, da zavira encim, imenovan karboanhidraza, ki v telesu tvori bikarbonatne ione.
The Committee for Medicinal Products for Human Use (CHMP) noted that combining the two active substances in Azarga simplifies therapy and helps patients to stick to their treatment. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da kombinacija obeh zdravilnih učinkovin v zdravilu Azarga poenostavi zdravljenje in bolnikom pomaga vzdrževati redno uporabo zdravila.
Raised IOP causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. 
Povišani intraokularni tlak povzroča poškodbe očesne mrežnice (na svetlobo občutljivega sloja, ki se nahaja v ozadju očesa) in optičnega živca, ki pošilja signale od oči do možganov.
Azarga has been studied in two main studies involving a total of 960 adults with open-angle glaucoma or ocular hypertension. 
Zdravilo Azarga so raziskali v dveh glavnih študijah, ki sta vključevali skupno 960 odraslih z glavkomom odprtega zakotja ali očesno hipertenzijo.
Azarga was more effective than either of the active substances used alone and was as effective as the combination of timolol and dorzolamide. 
Zdravilo Azarga je bilo učinkovitejše od katere koli od obeh učinkovin, uporabljenih posamično, in enako učinkovito kot kombinacija timolola in dorzolamida.
If the other eye medicine is an eye ointment it should be used last. 
Če gre pri tem drugem zdravilu za mazilo za oči, le-tega nanesemo nazadnje.
Azarga is used to reduce intra-ocular pressure (IOP, pressure inside the eye). 
Zdravilo Azarga se uporablja za zmanjševanje intraokularnega tlaka (tlaka znotraj očesa).
IOP was measured in ‘millimetres of mercury' (mmHg). 
Očesni tlak se meri v „milimetrih živega srebra“ (mmHg).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Azarga, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Azarga in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Azarga contains benzalkonium chloride, which is known to discolour soft contact lenses. 
Zdravilo Azarga vsebuje benzalkonijev klorid, za katerega je znano, da razbarva mehke kontaktne leče.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Azarga. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The two substances work by reducing the production of the aqueous humour (the watery fluid in the eye) in different ways. 
Obe učinkovini delujeta tako, da na različen način zmanjšujeta tvorbo prekatne vodke (vodene tekočine v očesu).
• have a severe allergic rhinitis (allergy affecting the nose and airways); 
• hudi alergijski rinitis (alergijo, ki prizadene nosno votlino in dihalne poti);
What is the risk associated with Azarga? 
Kakšna tveganja so povezana z zdravilom Azarga?
Timolol is a beta blocker that has been commonly used to treat glaucoma since the 1970s. 
Timolol je zaviralec receptorjev beta, ki se od sedemdesetih let prejšnjega stoletja uporablja za zdravljenje glavkoma.
The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone. 
Učinka obeh zdravilnih učinkovin v kombinaciji se seštevata, saj njuna kombinacija zmanjšuje tlak v očesu bolj kot katera koli od obeh učinkovin posamično.
Azarga is used when treatment with a medicine containing only one active substance has been tried but has not reduced the IOP sufficiently. 
Zdravilo Azarga se uporablja, kadar je bilo pri bolniku preizkušeno zdravljenje z zdravilom, ki vsebuje le eno zdravilno učinkovino, vendar to ni zadostno zmanjšalo intraokularnega tlaka.
• have severe chronic obstructive pulmonary disease (COPD, a disease causing narrowing of the airways); 
• hudo kronično obstruktivno pljučno bolezen (KOPB, tj. obolenje, ki povzroča zožitev dihalnih poti);
This compared with 5.1 to 5.6 mmHg in those using brinzolamide and 5.7 to 6.9 mmHg in those using timolol. 
V primerjavi s tem se je očesni tlak pri bolnikih, ki so uporabljali brinzolamid, zmanjšal za 5,1 do 5,6 mmHg, medtem ko se je pri bolnikih, ki so uporabljali timolol, zmanjšal za 5,7 do 6,9 mmHg.
Why has Azarga been approved? 
Zakaj je bilo zdravilo Azarga odobreno?
The second was a 12-month study comparing Azarga with the combination of timolol and dorzolamide (another carbonic anhydrase inhibitor) in 437 patients. 
V drugi študiji, ki je trajala 12 mesecev, so zdravilo Azarga pri 437 bolnikih primerjali s kombinacijo timolola in dorzolamida (drugega zaviralca karboanhidraze).
For the full list of all side effects reported with Azarga, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Azarga, glejte navodilo za uporabo.
Azarga is a medicine that contains two active substances, brinzolamide and timolol. 
Azarga je zdravilo, ki vsebuje dve zdravilni učinkovini, brinzolamid in timolol.
Bicarbonate is required for the production of the aqueous humour. 
Bikarbonat je potreben pri tvorbi prekatne vodke.
In the second study, IOP had fallen from around 26 mmHg by around 8.3 mmHg after six months in both groups of patients. 
V drugi študiji se je očesni tlak po šestih mesecih zdravljenja pri obeh skupinah bolnikov z izhodiščnih 26 mmHg zmanjšal za okoli 8,3 mmHg.
The first was a six-month study comparing Azarga with brinzolamide and with timolol used on their own in 523 patients. 
V prvi študiji, ki je trajala šest mesecev, so zdravilo Azarga pri 523 bolnikih primerjali z brinzolamidom in timololom, ki so ju uporabili kot samostojni zdravili.
In the first study, IOP fell from around 21 mmHg by 8.0 to 8.7 mmHg in the patients using Azarga. 
V prvi študiji se je očesni tlak pri bolnikih, ki so uporabljali zdravilo Azarga, z izhodiščnih 21 mmHg znižal za 8,0 do 8,7 mmHg.
Azarga is given as one drop into the affected eye(s) twice a day. 
Odmerek zdravila Azarga je ena kapljica v prizadeto oko (očesi) dvakrat na dan. Suspenzijo je treba pred uporabo dobro pretresti.
Azarga contains two active substances, brinzolamide and timolol. 
Zdravilo Azarga vsebuje dve zdravilni učinkovini, brinzolamid in timolol.
What is Azarga used for? 
Za kaj se zdravilo Azarga uporablja?
How has Azarga been studied? 
Kako je bilo zdravilo Azarga raziskano?
How does Azarga work? 
Kako zdravilo Azarga deluje?
What is Azarga? 
Kaj je zdravilo Azarga?
How is Azarga used? 
Kako se zdravilo Azarga uporablja?
This summary was last updated in 12-2008. 
Povzetek je bil nazadnje posodobljen 12-2008.
This medicine is the same as Insuman, which is already authorised in the European Union (EU). 
To zdravilo je enako zdravilu Insuman, ki je že odobreno v Evropski uniji (EU).
The patient's blood glucose should be tested regularly to find the lowest effective dose. 
Koncentracijo glukoze v krvi bolnika je treba redno testirati, da se tako določi najmanjši učinkoviti odmerek.
The European Commission granted a marketing authorisation valid throughout the EU for Insulin Human Winthrop to Sanofi-Aventis Deutschland GmbH on 17 January 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Insulin Human Winthrop, veljavno po vsej Evropski uniji, odobrila družbi Sanofi-Aventis Deutschland GmbH dne 17. januarja 2007.
Insulin Human Winthrop has been studied in two trials in 611 patients with either type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively). 
Zdravilo Insulin Human Winthrop so proučevali v okviru dveh študij s 611 bolniki s sladkorno boleznijo tipa 1 (kadar telo ne more tvoriti insulina) ali sladkorno boleznijo tipa 2 (kadar telo ne more učinkovito uporabljati insulina).
Insulin Human Winthrop Rapid may also be given into a vein, but only in hospital where the patient can be closely monitored. 
Zdravilo Insulin Human Winthrop Rapid se lahko daje tudi v veno, vendar le v bolnišnici, kjer je mogoče bolnika natančno nadzorovati.
It is supplied in vials, cartridges, or pre-filled disposable pens (OptiSet and SoloStar). 
Na voljo je v vialah, injekcijskih vložkih ali predhodno napolnjenih injekcijskih peresnikih za enkratno uporabo (OptiSet in SoloStar).
• Insulin Human Winthrop Comb 50: 50% soluble insulin and 50% crystalline protamine insulin. 
• Insulin Human Winthrop Comb 50: 50 % topnega insulina in 50 % kristalnega protamin-insulina.
The studies measured the ‘fasting' blood glucose levels (measured when the patient had not eaten for at least eight hours), or the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. 
V okviru študij so merili raven glukoze na tešče (izmerjeno, ko bolnik najmanj osem ur ni zaužil hrane) ali koncentracijo snovi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi uravnana.
The studies also looked at the number of patients who developed hypoglycaemia (low blood glucose levels). 
V študijah so merili tudi število bolnikov, pri katerih se je pojavila hipoglikemija (nizka koncentracija glukoze v krvi).
The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood. 
Nadomestni insulin učinkuje na enak način kot naravno tvorjeni insulin ter omogoča vstop glukoze iz krvi v celice.
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. 
Sladkorna bolezen je bolezen, pri kateri telo ne proizvaja dovolj insulina za vzdrževanje primerne koncentracije glukoze v krvi.
Insulin Human Winthrop should not be used in people who may be hypersensitive (allergic) to insulin human or any of the other ingredients. 
Zdravila Insulin Human Winthrop ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) humani insulin ali katero koli drugo sestavino.
The active substance in Insulin Human Winthrop, 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. 
Zdravilno učinkovino v zdravilu Insulin Human Winthrop, humani insulin, proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri bakterija prejme gen (DNK), s katerim lahko tvori insulin.
Insulin Human Winthrop contains insulin in various forms: the soluble form, which acts quickly (within 30 minutes of injection), and the isophane and crystallineprotamine forms, which are absorbed much more slowly during the day, giving them a longer duration of action. 
Zdravilo Insulin Human Winthrop vsebuje insulin v različnih oblikah: v topni obliki, ki učinkuje hitro (v 30 minutah po injiciranju), ter v izofan in kristalni obliki s protaminom, ki se absorbira veliko počasneje čez dan ter posledično zagotavlja daljše trajanje učinkovanja.
The Committee for Medicinal Products for Human Use (CHMP) decided that Insulin Human Winthrop's benefits are greater than its risks for the treatment of diabetes mellitus. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Insulin Human Winthrop pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
Insulin Human Winthrop should be given before meals. 
Zdravilo Insulin Human Winthrop je treba dajati pred obrokom.
The company that makes Insuman has agreed that its scientific data can be used for Insulin Human Winthrop. 
Družba, ki izdeluje zdravilo Insuman, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Insulin Human Winthrop.
Insulin Human Winthrop doses might need to be adjusted when it is given with other medicines that may have an effect on blood glucose levels. 
Odmerke zdravila Insulin Human Winthrop bo morda treba prilagoditi, če se zdravilo daje z drugimi zdravili, ki lahko vplivajo na koncentracije glukoze v krvi.
Insulin Human Winthrop Rapid can also be used for the treatment of hyperglycaemic coma (coma caused by too much blood glucose [sugar]) and ketoacidosis (high levels of ketones [acids] in the blood), and to control blood glucose before, during or after an operation. 
Zdravilo Insulin Human Winthrop Rapid je primerno tudi za zdravljenje hiperglikemične kome (kome, ki jo povzroči previsoka koncentracija glukoze [sladkorja] v krvi) in ketoacidoze (visoke ravni ketonov [kislin] v krvi) ter za uravnavanje glukoze v krvi pred operacijo, med njo in po njej.
Insulin Human Winthrop is used in patients with diabetes who need treatment with insulin. 
Zdravilo Insulin Human Winthrop se uporablja pri bolnikih s sladkorno boleznijo, ki potrebujejo zdravljenje z insulinom.
Insulin Human Winthrop Infusat is specially prepared ready to be used in infusion pumps. 
Zdravilo Insulin Human Winthrop Infusat je posebej pripravljeno za uporabo v infuzijskih črpalkah.
Insulin Human Winthrop was effective for both type 1 and type 2 diabetes. 
Zdravilo Insulin Human Winthrop je bilo učinkovito pri sladkorni bolezni tipa 1 in tipa 2.
The Insulin Human Winthrop range is comprised of fast-acting insulin solutions (Insulin Human Winthrop Rapid and Insulin Human Winthrop Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insulin Human Winthrop Basal) that contains isophane insulin, and combinations of fast- and intermediateacting in various proportions (Insulin Human Winthrop Comb): 
Paleta izdelkov Insulin Human Winthrop vključuje raztopine insulinov s hitrim delovanjem (Insulin Human Winthrop Rapid in Insulin Human Winthrop Infusat), ki vsebujejo topni insulin, suspenzije insulinov s srednje dolgim delovanjem (Insulin Human Winthrop Basal), ki vsebujejo insulin izofan, ter kombinacije insulina s hitrim in srednje dolgim delovanjem v različnih razmerjih (Insulin Human Winthrop Comb):
The desired blood glucose levels, the type of Insulin Human Winthrop to be used, and the dose and timing of injections are determined by the doctor for each patient individually, and are adjusted to suit the patient's diet, physical activity and lifestyle. 
Zdravnik za vsakega posameznika posebej določi zaželene koncentracije glukoze v krvi, vrsti zdravila Insulin Human Winthrop , ki ga je treba uporabiti, in čas uporabe injekcij ter jih prilagodi, da kar najbolje ustrezajo prehrani, telesni aktivnosti in življenjskemu slogu bolnika.
Other information about Insulin Human Winthrop: 
Druge informacije o zdravilu Insulin Human Winthrop:
For the full list of all side effects reported with Insulin Human Winthrop, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Insulin Human Winthrop, glejte navodilo za uporabo.
In one of the studies, Insulin Human Winthrop was used in an insulin pump. 
V eni od teh študij je bilo zdravilo Insulin Human Winthrop uporabljeno v insulinski črpalki.
Insulin Human Winthrop is given by injection under the skin, generally in the abdominal wall (tummy) or the thigh, according to the doctor's recommendations. 
Zdravilo Insulin Human Winthrop se daje z injekcijo pod kožo, običajno v trebušno steno ali stegno v skladu s priporočilom zdravnika.
Insulin Human Winthrop led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with semi-synthetic human insulin. 
Zdravilo Insulin Human Winthrop je povzročilo znižanje koncentracije HbA1c, kar kaže, da so bile koncentracije glukoze v krvi vzdrževane na podobni ravni kot pri polsinteznem humanem insulinu.
Insulin Human Winthrop can cause hypoglycaemia. 
Zdravilo Insulin Human Winthrop lahko povzroči hipoglikemijo.
In the other study, Insulin Human Winthrop Comb 25 was compared with semi-synthetic human insulin. 
V drugi študiji pa so zdravilo Insulin Human Winthrop Comb 25 primerjali s polsinteznim humanim insulinom.
Insulin Human Winthrop is a replacement insulin that is identical to the insulin made by the body. 
Zdravilo Insulin Human Winthrop je nadomestni insulin, ki je identičen insulinu, ki ga tvori telo.
The Committee recommended that Insulin Human Winthrop be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Insulin Human Winthrop odobri dovoljenje za promet.
What benefit has Insulin Human Winthrop shown during the studies? 
Kakšne koristi je zdravilo Insulin Human Winthrop izkazalo med študijami?
The full EPAR for Insulin Human Winthrop is available here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Insulin Human Winthrop je na voljo tukaj.
Insulin Human Winthrop contains the active substance insulin human. 
Zdravilo Insulin Human Winthrop vsebuje zdravilno učinkovino humani insulin.