natgillin/translations-raw huggingface dataset:
The active substances in Ristfor, sitagliptin and metformin hydrochloride, each have a different mode of action. 
Zdravilni učinkovini v zdravilu Ristfor, sitagliptin in metforminijev klorid, imata različna načina delovanja.
In the second, HbA1c levels were reduced by 1.03% after 18 weeks in patients adding sitagliptin to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo. 
V drugi študiji so bile ravni HbA1c znižane za 1,03 % po 18 tednih pri bolnikih, ki so sitagliptin dodajali metforminu in rosiglitazonu, v primerjavi s padcem za 0,31 % pri tistih, ki so kot dodatek prejemali placebo.
What is Ristfor used for? 
Za kaj se zdravilo Ristfor uporablja?
Adding 100 mg sitagliptin to metformin reduced HbA1c levels by 0.67% (from around 8.0%) after 24 weeks, compared with a fall of 0.02% in the patients adding placebo. 
Z dodajanjem 100 mg sitagliptina k metforminu so se ravni HbA1c po 24 tednih znižale za 0,67 % (z okoli 8,0 %) v primerjavi z znižanjem za 0,02 % pri bolnikih, ki so kot dodatek prejemali placebo.
In the study in which sitagliptin was added to glimepiride and metformin, the levels of HbA1c were reduced by 0.59% after 24 weeks, compared with an increase of 0.30% in the patients adding placebo. 
V študiji, pri kateri se je sitagliptin dodajal glimepiridu in metforminu, so se ravni HbA1c po 24 tednih znižale za 0,59 % v primerjavi s povečanjem za 0,30 % pri bolnikih, ki so kot dodatek prejemali placebo.
How has Ristfor been studied? 
Kako je bilo zdravilo Ristfor raziskano?
For the full list of all side effects reported with Ristfor, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ristfor, glejte navodilo za uporabo.
• in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own; 
• pri bolnikih, pri katerih sladkorna bolezen ni zadostno nadzorovana samo z metforminom
How is Ristfor used? 
Kako se zdravilo Ristfor uporablja?
Finally, they were reduced by 0.59% after 24 weeks in patients adding sitagliptin to insulin, compared with a fall of 0.03% in those adding placebo. 
V zadnji študiji pa so bile po 24 tednih znižane za 0,59 % pri bolnikih, ki so insulinu dodajali sitagliptin, v primerjavi z znižanjem za 0,03 % pri bolnikih, ki so kot dodatek prejemali placebo.
How does Ristfor work? 
Kako zdravilo Ristfor deluje?
The second injection is given three to four weeks later. 
Druga injekcija se da tri do štiri tedne pozneje.
There can be a slight rise in body temperature, usually no more than 1 °C, in the 24 hours following vaccination. 
Pojavi se lahko tudi rahlo povišanje telesne temperature, navadno za največ 1°C, v 24 urah po cepljenju.
Vaccination may be followed by a small local swelling at the injection site, which normally resolves within five weeks. 
Po cepljenju se lahko pojavi majhna oteklina na mestu injiciranja, ki navadno izgine v petih tednih.
Two studies were conducted in sheep and cattle to establish the period of protection provided by the vaccine. 
Dve študiji sta bili izvedeni pri ovcah in govedu za določitev obdobja zaščite, ki ga zagotavlja cepivo.
The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease. 
Cepivo se uporablja za preprečitev viremije (prisotnosti virusov v krvi) in zmanjšanje znakov bolezni.
The duration of protection of the vaccine in both sheep and cattle was found to be 12 months. 
Zaščita po cepljenju pri ovcah in govedu znaša 12 mesecev.
The studies also showed that the vaccine can be used in pregnant sheep and cattle as well as lactating cattle. 
Študije so pokazale tudi, da se cepivo lahko uporabi pri brejih ovcah in kravah ter pri molznih kravah.
The European Commission granted a marketing authorisation valid throughout the European Union, for BTVPUR AlSap 1 on 17 December 2010. 
Evropska komisija je dovoljenje za promet s cepivom BTVPUR AlSap 1, veljavno po vsej Evropski uniji, odobrila dne 17. decembra 2010.
In 2013 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR AlSap 1 to convert to a normal status. 
Leta 2013 je CVMP menil, da predloženi podatki zadostujejo, da dovoljenje za promet s cepivom BTVPUR AlSap 1 dobi običajen status.
The withdrawal period for BTVPUR AlSap 1 for meat and milk for cattle and sheep is zero days. 
Obdobje karence za cepivo BTVPUR AlSap 1 za meso in mleko pri govedu in ovcah je nič dni.
In the future, if the animals are exposed to the bluetongue virus, their immune system will be able to produce antibodies more quickly. 
Ob ponovni izpostavitvi virusu bolezni modrikastega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
The first injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal's mother is already immune to the disease. 
Živalim, ki še nikoli niso bile izpostavljene bolezni, se da prva injekcija od enega meseca starosti, mladičem mater, ki so že imune na bolezen, pa od 2,5 meseca starosti.
The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotype 1. 
Študije so pokazale, da je cepivo varno za uporabo pri ovcah in govedu ter da zmanjšuje simptome bolezni in preprečuje viremijo pri živalih, starejših od enega meseca, ki so okužene s serotipom 1 virusa bolezni modrikastega jezika.
The safety of the vaccine was studied in two main overdose laboratory safety studies carried out in sheep and cattle. 
Varnost cepiva so proučevali v dveh glavnih laboratorijskih študijah varnosti glede prevelikega odmerjanja, ki so ju opravili pri ovcah in govedu.
When it is given to sheep and cattle, the animals' immune systems recognise the viruses as ‘foreign' and make antibodies against them. 
Ko ovce in govedo prejmejo cepivo, njihov imunski sistem viruse prepozna kot „tujke“ in proti njim razvije protitelesa.
The company also presented results from a series of trials conducted with vaccines of similar composition but including different serotypes from the one in BTVPUR AlSap 1 in order to extrapolate further conclusions on the effectiveness of the vaccine. 
Družba je predstavila tudi rezultate niza preskušanj, izvedenih s cepivi s podobno sestavo, ki pa so vključevali serotipe, drugačne od serotipa v cepivu BTVPUR AlSap 1, da bi pridobili nadaljnje zaključke o učinkovitosti cepiva.
Results also from a series of laboratory safety trials performed with vaccines of similar composition but including different bluetongue serotypes (including studies in pregnant ewes and cows) were presented in order to extrapolate safety conclusions. 
Predloženi so bili tudi rezultati niza laboratorijskih preskušanj varnosti s cepivi s podobno sestavo, vendar drugačnimi serotipi virusa modrikastega jezika (vključno s študijami pri brejih ovcah in kravah), da bi pridobili zaključke o varnosti.
The effectiveness of the vaccine was studied in three main laboratory trials using a vaccine with bluetongue serotype 1 in sheep and cattle of young age. 
Učinkovitost cepiva so proučevali v treh glavnih laboratorijskih preskušanjih z uporabo cepiva, ki vsebujejo virus modrikastega jezika, serotip 1, pri mladih ovcah in govedu.
BTVPUR AlSap 1 was initially authorised under ‘exceptional circumstances'. 
Cepivo BTVPUR AlSap 1 je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
The benefitrisk balance may be found in the scientific discussion module of this EPAR. 
Za razmerje med koristmi in tveganji glejte modul o znanstveni razpravi tega evropskega javnega poročila o oceni zdravila (EPAR).
BTVPUR AlSap 1 is a vaccinethat is available as a suspension for injection. 
Zdravilo BTVPUR AlSap 1 je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
BTVPUR AlSap 1 contains bluetongue virus of one types (‘serotype 1'). 
Cepivo BTVPUR AlSap 1 vsebuje en tip virusa modrikastega jezika („serotip 1“).
Inactivated adjuvanted vaccine against bluetongue disease virus serotype 1 
inaktivirano cepivo z adjuvansom proti virusu modrikastega jezika, serotip 1
BTVPUR AlSap 1 is a vaccine. 
Zdravilo BTVPUR AlSap 1 je cepivo.
The CVMP concluded that the benefits of BTVPUR AlSap 1 exceed the risks for active immunisation of sheep and cattle to prevent infection, viraemia and clinical signs caused by the bluetongue virus serotype 1, and recommended that BTVPUR AlSap 1 be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva BTVPUR AlSap 1 za aktivno imunizacijo ovac in goveda za preprečitev okužbe, viremije in kliničnih znakov, ki jih povzroča serotip 1 virusa bolezni modrikastega jezika, večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has BTVPUR AlSap 1 shown during the studies? 
Kakšne koristi je zdravilo BTVPUR AlSap 1 izkazalo med študijami?
BTVPUR AlSap 1 is used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.. 
Cepivo BTVPUR AlSap 1 se uporablja pri ovcah in govedu za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo prenašajo trzače, povzroča pa jo virus modrikastega jezika.
Other information about BTVPUR AlSap 1: 
Druge informacije o zdravilu BTVPUR AlSap 1:
It contains inactivated (killed) bluetongue serotype 1 virus. 
Vsebuje inaktivirane (uničene) viruse modrikastega jezika, serotip 1.
BTVPUR AlSap 1 contains a bluetongue virus that has been inactivated so that it cannot cause the disease. 
Cepivo BTVPUR AlSap 1 vsebuje inaktivirani virus bolezni modrikastega jezika, ki ne povzroča bolezni.
What is the risk associated with BTVPUR AlSap 1? 
Kakšna tveganja so povezana z zdravilom BTVPUR AlSap 1?
Why has BTVPUR AlSap 1 been approved? 
Zakaj je bilo zdravilo BTVPUR AlSap 1 odobreno?
What is BTVPUR AlSap 1 used for? 
Za kaj se zdravilo BTVPUR AlSap 1 uporablja?
This means that it was not possible to obtain complete information about BTVPUR AlSap 1 at the time of the initial authorisation. 
To pomeni, da ob prvotni odobritvi ni bilo mogoče pridobiti vseh podatkov o njem.
What is BTVPUR AlSap 1? 
Kaj je zdravilo BTVPUR AlSap 1?
How has BTVPUR AlSap 1 been studied? 
Kako je bilo zdravilo BTVPUR AlSap 1 raziskano?
How does BTVPUR AlSap 1 work? 
Kako zdravilo BTVPUR AlSap 1 deluje?
The effectiveness of ProteqFlu-Te was first assessed in several laboratory and field studies. 
Učinkovitost cepiva ProteqFlu-Te so najprej ocenili v več laboratorijskih in terenskih študijah.
Other information about ProteqFlu-Te: 
Druge informacije o zdravilu ProteqFlu-Te:
The European Commission granted a marketing authorisation valid throughout the European Union, for ProteqFlu-Te on 6 March 2003. 
Evropska komisija je dovoljenje za promet z zdravilom ProteqFlu-Te, veljavno po vsej Evropski uniji, izdala 6. marca 2003.
In case of increased risk of infection or insufficient intake of colostrum (first milk), an additional initial injection can be given at the age of 4 months, followed by the full vaccination programme (primary vaccination and following revaccinations). 
V primeru povečanega tveganja okužbe ali nezadostnega zaužitja kolostruma (prvega mleka), se lahko pri starosti štirih mesecev injicira dodatni začetni odmerek, čemur sledi popoln program cepljenja (prvotno cepljenje, ki mu sledijo ponovitve).
The muscle stiffness usually starts from the jaw and neck, then affects the whole body. 
Okorelost mišic se navadno začne v čeljusti in vratu, nato se razširi po celem telesu.
The vaccine is given as an intramuscular injection (injection into a muscle). 
Cepivo se daje z intramuskularno injekcijo (vbrizganjem v mišico).
This means that a gene from two different equine influenza strains (A/eq/Ohio/03 and A/eq/Richmond/1/07) was inserted in to the canarypox vector viruses, which do not produce disease in horses, allowing the vector to produce specific proteins from these influenza strains. 
To pomeni, da je bil gen iz dveh različnih sevov virusa konjske influence (A/eq/Ohio/03 in A/eq/Richmond/1/07) vstavljen v viruse vektorja canarypox, ki pri konjih ne povzroči bolezni, a omogoči vektorju, da proizvede določene beljakovine iz teh sevov influence.
ProteqFlu-Te is a vaccine for use in horses. 
ProteqFlu-Te je cepivo, ki se uporablja pri konjih.
The vaccine also stimulates protection against tetanus to prevent mortality. 
Cepivo spodbuja tudi zaščito pred tetanusom za preprečevanje pogina.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu-Te exceed the risks for the approved indication and recommended that ProteqFlu-Te be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva ProteqFlu-Te večje od z njim povezanih tveganj, kadar se uporablja za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
The vaccine also contains a tetanus toxoid which is a tetanus toxin processed in order to decrease its toxic effect, but retain its antigenic power. 
Cepivo vsebuje tudi tetanusni toksoid, ki je toksin tetanusa, obdelan tako, da je njegov strupeni učinek manjši, a obdrži lastnosti antigena.
What benefit has ProteqFlu-Te shown during the studies? 
Kakšne koristi je zdravilo ProteqFlu-Te izkazalo med študijami?
ProteqFlu-Te is a vaccine which was produced with the use of recombinant DNA technology. 
Zdravilo ProteqFlu-Te je cepivo, izdelano s tehnologijo rekombinantne DNK.
A short lived swelling at the injection site may occur (max. diameter 5 cm) which decreases within 4 days. 
Na mestu injiciranja se lahko pojavi kratkotrajna oteklina (največjega premera 5 cm), ki izgine v štirih dneh.
Horses should receive a primary vaccination, consisting of two injections at 5-6 months of age, given 4-6 weeks apart. 
Konji prejmejo prvotno cepljenje, ki vključuje dve injiciranji pri starosti petih do šestih mesecev in se ju izvede v štiri- do šesttedenskem razmiku.
Tetanus is an acute, often fatal disease caused by the neurotoxin of the bacterium Clostridium tetani. 
Tetanus je akutna bolezen, ki ima pogosto smrten izid, povzroča pa jo nevrotoksin bakterije Clostridium tetani.
ProteqFlu-Te contains an adjuvant (carbomer) to enhance the immune response. 
Zdravilo ProteqFlu-Te vsebuje adjuvans (karbomer) za povečanje imunskega odziva.
This should be followed by revaccination 5 months later, and afterwards by booster vaccinations every two years for protection against tetanus or for protection against influenza vaccination every year alternating with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum two years for tetanus. 
Temu mora slediti ponovno cepljenje po petih mesecih in nato poživitvena cepljenja vsaki dve leti za zaščito pred tetanusom, za zaščito pred influenco pa morajo prejeti cepljenje vsako leto izmenjaje s cepivom ProteqFlu ali ProteqFlu-Te in ob tem upoštevati največ dveletni razmik, če gre za tetanus.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for consumption or milk used for consumption. 
Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso ali mleko uporabi za prehrano.
It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively, and a tetanus toxoid (chemically weakened toxins from the tetanus bacterium). 
Vsebuje dele dveh sevov virusa konjske influence (gripe), vstavljenih v dva virusa vektorja (prenašalca) canarypox, in tetanusni toksoid (kemično oslabljen toksin iz bakterije tetanusa).
The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles. 
Za bolezen, ki se navadno začne v okuženih ranah, so značilni rigidnost (otrdelost) celotnega telesa in sunkoviti krči mišic.
What is the risk associated with ProteqFlu-Te? 
Kakšna tveganja so povezana z zdravilom ProteqFlu-Te?
ProteqFlu-Te is available as a suspension for injection. 
Zdravilo ProteqFlu-Te je na voljo v obliki suspenzije za injiciranje.
Horses are among the most susceptible species to tetanus. 
Konji spadajo med živali, ki ji tetanus najpogosteje prizadene.
The studies showed that ProteqFlu-Te was effective in reducing clinical signs and virus excretion after infection with equine influenza, and against tetanus to prevent mortality from 14 days after primary vaccination. 
Študije so pokazale, da je bilo cepivo ProteqFlu-Te pri zmanjševanju kliničnih znakov in izločanju virusa po okužbi s konjsko influenco ter pri preprečevanju pogina zaradi tetanusa učinkovito 14 dni po prvotnem cepljenju.
The current formulation of ProteqFlu-Te produced similar antibody responses against the two flu strains and tetanus toxoid included in the vaccine to those seen in the main studies. 
Trenutna formulacija cepiva ProteqFlu-Te je sprožila podobne odzive protiteles proti obema sevoma influence in tetanusnega toksoida, vključenim v cepivo, kot so bili tisti v glavnih študijah.
The measure of effectiveness in all studies was antibody levels of against the two influenza vaccine strains and against tetanus toxoid. 
Merilo učinkovitosti v vseh študijah je bila raven protiteles proti obema sevoma virusa konjske influence in tetanusnega toksoida.
Why has ProteqFlu-Te been approved? 
Zakaj je bilo zdravilo ProteqFlu-Fe odobreno?
When ProteqFlu-Te is given to horses, the animals' immune system recognises the specific proteins from the equine influenza strains and the tetanus toxoid as ‘foreign' and makes antibodies against them. 
Ko konji prejmejo cepivo ProteqFlu, imunski sistem živali prepozna določene beljakovine iz sevov virusa konjske influence in toksoid tetanusa kot tujke in začne proti njim tvoriti protitelesa.
In laboratory studies, horses were challenged (infected) with equine influenza virus and the clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non-vaccinated animals or those vaccinated with a competitive product). 
Klinične znake in izločanje virusa influence po okužbi so primerjali med cepljenimi in kontrolnimi živalmi (živalmi, ki niso bile cepljene ali so bile cepljene s konkurenčnim cepivom).
ProteqFlu-Te is used to vaccinate horses from 4 months of age against equine influenza and tetanus. 
Zdravilo ProteqFlu-Te se uporablja za cepljenje konjev, starejših od štirih mesecev, proti konjski influenci in tetanusu.
The withdrawal period for ProtequFlu-Te for meat and milk is zero days. 
Karenca za cepivo ProteqFlu-Fe za meso in mleko je nič dni.
The duration of protection was 5 months after primary vaccination and one year for the equine influenza and two years for the tetanus after the third vaccination. 
Trajanje zaščite je bilo pet mesecev po prvotnem cepljenju, po tretjem cepljenju pa eno leto proti konjski influenci in dve leti proti tetanusu .
How has ProteqFlu-Te been studied? 
Kako je bilo zdravilo ProteqFlu-Te raziskano?
What is ProteqFlu-Te used for? 
Za kaj se zdravilo ProteqFlu-Te uporablja?
This will help to protect against equine influenza and tetanus. 
To pomaga zaščititi živali pred konjsko influenco in tetanusom.
The immune system will then be able to make those protective antibodies more quickly when the animal is naturally exposed to the equine flu viruses and the tetanus bacterium. 
Imunski sistem je nato pri naravni izpostavitvi virusom konjske gripe in bakteriji, ki povzroča tetanus, sposoben hitreje ustvarjati ta zaščitna protitelesa.
How does ProteqFlu-Te work? 
Kako zdravilo ProteqFlu-Te deluje?
Equine influenza and tetanus vaccine 
ProteqFlu-Te cepivo proti influenci konj in tetanusu
It may request a reexamination of the opinion within 15 days of receipt of notification of this negative opinion. 
Družba lahko zahteva ponovno preučitev mnenja v 15 dneh po prejemu uradnega obvestila o negativnem mnenju.
The company presented the results of 4 main studies involving a total of 588 patients. 
Družba je predložila rezultate štirih glavnih študij, v katere je bilo skupno vključenih 588 bolnikov.
Overweight men with hypogonadotropic hypogonadism produce too much of the hormone oestrogen. 
Moški s čezmerno telesno maso s hipogonadotropnim hipogonadizmom proizvajajo preveč hormona estrogena.
Refusal of the marketing authorisation for EnCyzix (enclomifene) EMA/CHMP/54473/2018 
Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom EnCyzix (enklomifen) EMA/CHMP/54473/2018
On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product EnCyzix, intended for the treatment of hypogonadotropic hypogonadism in men. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 25. januarja 2018 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom EnCyzix, namenjenim zdravljenju hipogonadotropnega hipogonadizma pri moških.
This stops the release of other hormones called gonadotrophins, which are needed for the testes to produce testosterone and to work normally. 
S tem se ustavi sproščanje drugih hormonov, imenovanih gonadotropini, ki jih moda potrebujejo za proizvodnjo testosterona in normalno delovanje.
EnCyzix was to be used in overweight men with a body mass index (BMI) of at least 25 kg/m2. 
Zdravilo EnCyzix naj bi se uporabljalo pri moških s čezmerno telesno maso z indeksom telesne mase (ITM) vsaj 25 kg/m2.
Refusal of the marketing authorisation for EnCyzix (enclomifene) 
Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom EnCyzix (enklomifen)
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with EnCyzix. 
Družba je odbor CHMP obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe zdravila EnCyzix.
EnCyzix was expected to be used to treat hypogonadotropic hypogonadism in men. 
Zdravilo EnCyzix naj bi se uporabljalo za zdravljenje hipogonadotropnega hipogonadizma pri moških.
In this condition, the sex organs (the testes in men) do not work properly resulting in symptoms such as infertility, low libido, impotence, weakened bones and weight gain. 
Pri tej bolezni spolni organi (tj. moda pri moških) ne delujejo pravilno, kar se kaže s simptomi, kot so neplodnost, nizek libido, impotenca, šibke kosti in pridobivanje telesne mase.
The CHMP noted that although the studies showed an increase in testosterone levels with EnCyzix, they did not look at whether EnCyzix would improve symptoms such as bone strength, weight gain, impotence and libido. 
Odbor CHMP je poudaril, da so študije z zdravilom EnCyzix sicer pokazale zvišanje ravni testosterona, vendar v njih niso preučevali, ali zdravilo izboljša simptome, kot so kostna trdnost, pridobivanje telesne mase, impotenca in libido.
In addition, there is a risk of venous thromboembolism (problems due to the formation of blood clots in the veins) with the medicine. 
Poleg tega zaradi zdravila obstaja tveganje za vensko trombembolijo (težave zaradi nastajanja krvnih strdkov v venah).
Therefore, the CHMP was of the opinion that the benefits of EnCyzix did not outweigh its risks and recommended that it be refused marketing authorisation. 
Posledično je odbor CHMP tedaj menil, da koristi zdravila EnCyzix ne odtehtajo z njim povezanih tveganj, in priporočil, da se dovoljenje za promet z njim zavrne.
EnCyzix is a medicine that contains the active substance enclomifene. 
EnCyzix je zdravilo, ki vsebuje zdravilno učinkovino enklomifen.
How does EnCyzix work? 
Kako zdravilo EnCyzix deluje?
EnCyzix blocks the excess oestrogen enabling release of gonadotrophins and normal testicular function. 
Zdravilo EnCyzix zavira odvečni estrogen, kar omogoča sproščanje gonadotropinov in normalno delovanje mod.
The company that applied for authorisation is Renable Pharma Limited. 
Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba Renable Pharma Limited.
What is EnCyzix? 
Kaj je zdravilo EnCyzix?