natgillin/translations-raw huggingface dataset:
Patients with anaemia, thrombocytopenia, leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Pri bolnikih z anemijo, trombocitopenijo in levkopenijo (samo ali v kateri koli kombinaciji) bo morda potrebno bolj pogosto spremljanje celotne krvne slike, diferencialne krvne slike in števila trombocitov.
Betaferon is injected under the skin so any food or drink you consume is not thought to have any effect on Betaferon.
Zdravilo Betaferon se injicira pod kožo, zato vpliva hrane ali pijače ni mogoče pričakovati.
− Keep your syringes and syringe disposal unit out of the sight and reach of children; lock the supplies away if possible.
- Brizge in posode za odstranjevanje brizg shranjujte nedosegljivo otrokom; če je mogoče, hranite pribor zaklenjen.
6 - Hold the blister pack on the outside and place it on top of the vial.
6 - Pretisni omot držite na zunanji strani in ga namestite na vrh viale.
C) Reconstituting the solution, step by step 1 - Wash your hands thoroughly with soap and water before beginning this process.
1 - Pred začetkom postopka si temeljito umijte roke z milom in vodo.
The binding of interferon beta-1b to these receptors induces the expression of a number of gene products that are believed to be the mediators of the biological actions of interferon beta-1b.
Vezava interferona beta-1b na te receptorje inducira ekspresijo številnih genskih produktov, ki veljajo za mediatorje biološkega delovanja interferona beta-1b.
15 - Remove any air bubbles by gently tapping the syringe and pushing the plunger to the 1-ml mark, or to the volume prescribed by your doctor.
15 - Zračne mehurčke odstranite tako, da nežno potrkate po brizgi, bat pa potisnete do oznake za 1 ml, oziroma do prostornine, ki vam jo je predpisal zdravnik.
Interferon beta-1b also enhances the suppressor activity of peripheral blood mononuclear cells.
Poleg tega interferon beta-1b okrepi zaviralno (supresorsko) delovanje mononuklearnih celic v periferni krvi.
8 - Pick up the syringe.
8 - Vzemite brizgo.
− Patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients listed in section 6.1.
− bolniki z znano preobčutljivostjo na naravni ali rekombinantni interferon beta, humani albumin ali katero koli pomožno snov, navedeno v poglavju 6.1
Remove them by gently tapping the syringe and pushing the plunger to the respective marking on the syringe.
Odstranite jih z rahlim potrkavanjem na brizgo in potisnite bat do ustrezne oznake na brizgi.
Interferon beta-1b has been shown to change the response of the immune system and to help to reduce disease activity.
Interferon beta-1b lahko spremeni odziv imunskega sistema in tako pomaga pri zmanjševanju učinka bolezni.
In multifocal patients, the risk for CDMS was independent from MRI findings at baseline, indicating a high risk for CDMS because of the dissemination of the disease based on clinical findings.
Pri multifokalnih bolnikih je bilo tveganje za CDMS neodvisno od izvidov magnetnoresonančnega slikanja na začetku preskušanja, kar kaže na veliko tveganje za nastanek CDMS zaradi diseminacije bolezni, in temelji na izsledkih iz kliničnih preskušanj.
1 frequencies based on pooled clinical trials (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to < 1/100, rare ≥1/10,000 to <1/1,000, very rare < 1/10,000).
1 pogostnost glede na združene podatke iz kliničnih preskušanj (zelo pogosti ≥1/10, pogosti ≥1/100 do <1/10, občasni ≥1/1.000 do <1/100, redki ≥1/10.000 do <1/1.000, zelo redki <1/10.000).
F) Quick review of the process
F) Kratek pregled postopka
Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Betaferon should be considered.
V primeru nefrotskega sindroma je potrebno takojšnje zdravljenje; razmisliti pa je treba tudi o prenehanju zdravljenja z zdravilom Betaferon.
Your doctor will regularly check the way you inject yourself, particularly if you have experienced injection site reactions.
Zdravnik bo redno preverjal vaš postopek samoinjiciranja, še zlasti, če se pojavijo reakcije na mestu injiciranja.
Your doctor may perform tests to check your kidney function.
Zdravnik lahko opravi preiskave za oceno delovanja ledvic.
− Betaferon contains human albumin and therefore carries a potential risk for transmission of viral diseases.
- Zdravilo Betaferon vsebuje humani albumin, zato obstaja morebitno tveganje za prenos virusnih bolezni.
In retrospective meta-analyses including the data of both studies, an overall treatment effect was found which was statistically significant (p=0.0076; 8.0 million IU Betaferon versus all placebo patients).
V retrospektivni metaanalizi podatkov iz obeh preskušanj so ugotovili statistično pomemben skupni učinek zdravljenja (p = 0,0076; 8,0 milijonov i.e. zdravila Betaferon v primerjavi z vsemi bolniki, ki so prejemali placebo).
Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidney.
Zdravnik bo morda želel spremljati vaš krvni tlak, krvno sliko (število krvnih ploščic) in delovanje vaših ledvic.
► who suffer from relapsing-remitting multiple sclerosis, with at least two relapses within the last two years.
► z recidivno-remitentno multiplo sklerozo z vsaj dvema relapsoma v zadnjih dveh letih.
Generally, dose titration is recommended at the start of treatment.
Na splošno se na začetku zdravljenja priporoča titriranje odmerka.
After preparing the solution you should use it immediately.
Po pripravi je treba raztopino nemudoma uporabiti.
It can be extensive and may involve muscle fascia as well as fat and therefore can result in scar formation.
Lahko je obsežna in lahko zajame mišično fascijo in maščobno tkivo, kar lahko povzroči nastanek brazgotin.
With the titration pack, withdraw solution only up to the mark on the syringe:
Pri pakiranju za titriranje, potegnite vehikel samo do oznake na brizgi:
However, the in-use stability has been demonstrated for 3 hours at 2-8 °C.
Stabilnost med uporabo je dokazana za 3 ure pri temperaturi od 2 do 8 °C.
This may suggest a disease of the heart muscle (cardiomyopathy) which has been reported rarely in patients using Betaferon.
Morda je to znak bolezni srčne mišice (kardiomiopatija), o kateri v redkih primerih poročajo pri bolnikih, ki jemljejo zdravilo Betaferon.
Patients exhibiting depression should be monitored closely during therapy with Betaferon and treated appropriately.
Depresivne bolnike je treba med zdravljenjem z zdravilom Betaferon pozorno spremljati in ustrezno zdraviti.
The majority of patients in both treatment groups had no disability progression over the 5-year period.
V petih letih pri večini bolnikov v obeh skupinah, ki sta bili zdravljeni, niso opazili napredovanja invalidnosti.
Caution should be exercised when Betaferon is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. anti-epileptics.
Previdnost je potrebna pri sočasni uporabi zdravila Betaferon in zdravil, ki imajo ozek terapevtski indeks in katerih očistek je v največji meri odvisen od jetrnega sistema citokrom P450 npr. antiepileptiki.
11 - With the syringe assembly still attached, swirl the vial around gently to completely dissolve the dry Betaferon powder.
11 - Medtem ko je sklop brizge še vedno pritrjen, vialo nežno zavrtite, da se suh prašek zdravila Betaferon povsem raztopi.
There have been no formal clinical trials undertaken in children or adolescents.
Otroci in mladostniki Formalnih kliničnih preskušanj pri otrocih ali mladostnikih niso izvedli.
The risk for progression to CDMS within 2 years was higher in monofocal patients with at least 9 T2-lesions or Gd-enhancement on brain MRI at baseline.
Tveganje za napredovanje do CDMS v 2 letih je bilo večje pri monofokalnih bolnikih z vsaj 9 lezijami T2 ali ojačanjem z Gd na magnetnoresonančnem slikanju možganov na začetku preskušanja.
While Betaferon does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
Čeprav zdravilo Betaferon nima znane neposredne toksičnosti za srce, so lahko gripi podobni simptomi, povezani z uporabo interferonov, stresni za bolnike s pomembno srčno boleznijo.
Patients receiving Betaferon showed a reduction in frequency (30%) and severity of clinical relapses, as well as the number of hospitalisations due to disease.
Bolniki, ki so prejemali zdravilo Betaferon, so imeli manj pogoste (30 %) in manj hude klinične recidive in so bili redkeje hospitalizirani zaradi bolezni.
If reactions are severe, Betaferon should be discontinued and appropriate medical intervention instituted.
Če so reakcije hude, je treba prenehati zdravljenje z zdravilom Betaferon in ustrezno ukrepati.
Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
Zdravljenje je treba začeti z odmerkom 62,5 mikrogramov (0,25 ml) subkutano vsak drugi dan, nato pa ga počasi povečevati do odmerka 250 mikrogramov (1 ml) vsak drugi dan (glejte preglednico A).
10 - Hold the syringe assembly at the bottom of the vial.
10 - Sklop brizge držite na dnu viale.
Betaferon should also be used with caution in patients who suffer from pre-existing cardiac disorders.
Zdravilo Betaferon je treba previdno uporabljati pri bolnikih, ki že imajo srčno bolezen.
Removing the vial and adapter from the syringe ensures that the solution will flow out from the needle when injected.
Če vialo in adapter odstranite z brizge, boste zagotovili, da bo raztopina pri injiciranju tekla iz igle.
In both trials secondary progressive multiple sclerosis patients receiving Betaferon showed a reduction in frequency (30%) of clinical relapses.
V obeh preskušanjih se je pri bolnikih s sekundarno progresivno multiplo sklerozo, ki so prejemali zdravilo Betaferon, pogostnost kliničnih recidivov zmanjšala (30 %).
Retrospective analyses in subgroups showed that a treatment effect on disability progression is most likely in patients with active disease before treatment commences (Hazard Ratio 0.72, 95% confidence interval (0.59, 0.88), p=0.0011, corresponding to a 28 % risk reduction due to Betaferon in patients with relapses or pronounced EDSS progression, 8.0 million IU Betaferon versus all placebo patients).
Retrospektivne analize podskupin so pokazale, da je učinek zdravljenja na napredovanje invalidnosti najverjetnejši pri bolnikih, ki imajo aktivno bolezen, preden se začne zdravljenje (razmerje ogroženosti = 0,72, 95-% interval zaupanja (0,59, 0,88), p = 0,0011, kar ustreza 28 % zmanjšanju tveganja zaradi zdravila Betaferon pri bolnikih s poslabšanjem bolezenskih znakov ali izrazitim napredovanjem glede na EDSS, ki so dobivali 8,0 milijonov i.e. zdravila Betaferon v primerjavi z vsemi bolniki, ki so prejemali placebo).
The treatment with Betaferon should be initiated under the supervision of a physician experienced in the treatment of the disease.
Zdravljenje z zdravilom Betaferon je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem te bolezni.
‘How to use Betaferon').
Kako uporabljati zdravilo Betaferon).
• Sodium - this medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free'.
• natrij - to zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 1 ml, kar v bistvu pomeni ‘brez natrija'.
During the post-marketing period very rare reports have been received of worsening of cardiac status in patients with pre-existing significant cardiac disease temporarily associated with the initiation of Betaferon therapy.
V obdobju trženja so zelo redko poročali o prehodnem poslabšanju srčne bolezni pri bolnikih s pomembno srčno boleznijo v anamnezi, ki je bilo povezano z uvedbo zdravljenja z zdravilom Betaferon.
Metabolism and nutrition disorders Blood glucose decreased (<55 mg/dl) ×
Presnovne in prehranske motnje zmanjšana vrednost glukoze (< 55 mg/dl) ×
When you use the solution, warm it up in your hands before injecting to avoid pain.
Injekcijo pred injiciranjem segrejte med dlanmi, da preprečite bolečino.
Important: Do not use any area where you can feel lumps, bumps, firm knots, pain or an area that is discoloured, indented, scabbed, or where the skin is broken.
Pomembno: Ne uporabljajte predelov, na katerih čutite zatrdline, bulice, čvrste vozliče, predelov, ki so boleči, ali predelov, na katerih je koža spremenjena, vdrta, pokrita s krastami ali ranjena.
Flu-like symptoms may also be reduced by administration of non-steroidal anti-inflammatory drugs.
Gripi podobni simptomi se lahko zmanjšajo z uporabo nesteroidnih protivnetnih zdravil.
The recommended dose of Betaferon is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.
Priporočeni odmerek zdravila Betaferon je 250 mikrogramov (8,0 milijonov i.e.), kolikor ga vsebuje 1 ml rekonstituirane raztopine (glejte poglavje 6.6), ki ga je treba injicirati subkutano vsak drugi dan.
If foam is present -- which can happen if the vial is shaken or swirled too much - let the vial sit undisturbed until the foam settles.
Če je v viali pena, kar se lahko zgodi, če jo premočno pretresete ali zavrtite, pustite vialo mirovati, da pena izgine.
NOTE: The injection should be administered immediately after mixing (if the injection is delayed, refrigerate the solution and inject it within 3 hours).
OPOMBA: Raztopino si injicirajte nemudoma po pripravi (če to ni možno, raztopino shranite v hladilnik in si jo injicirajte v 3 urah).
Patients who develop neutropenia should be monitored closely for the development of fever or infection.
Bolnike, pri katerih se pojavi nevtropenija, je treba pozorno spremljati glede morebitnega zvišanja telesne temperature ali pojava okužb.
If you forget to use Betaferon
Če ste pozabili uporabiti zdravilo Betaferon
The incidence of injection site reactions may be reduced by the use of an autoinjector.
Pogostnost reakcij na mestu injiciranja se lahko zmanjša z uporabo avtoinjektorja.
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 1 ml, kar v bistvu pomeni »brez natrija«.
No individual sale of single packs.
Posamezna pakiranja niso za prodajo.
Risk reduction Hazard ratio with 95% confidence interval log-rank test
Razmerje tveganja s 95-% intervalom zaupanja
Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activities.
Dokazano je, da interferon beta-1b deluje protivirusno in imunoregulacijsko.
The following adverse event listing is based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from the post-marketing surveillance (Table 2, frequencies - where known- based on pooled clinical trials (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to < 1/100, rare ≥1/10,000 to <1/1,000, very rare < 1/10,000)) of Betaferon use.
Spodnja seznama neželenih učinkov temeljita na poročilih iz kliničnih preskušanj (preglednica 1, neželeni učinki in nenormalni izvidi laboratorijskih preiskav) in spremljanj iz obdobja trženja zdravila Betaferon (preglednica 2, pogostnosti - kjer so znane - glede na združene podatke iz kliničnih preskušanj (zelo pogosti ≥ 1/10, pogosti ≥ 1/100 do <1/10, občasni ≥ 1/1.000 do < 1/100, redki ≥ 1/10.000 do < 1/1.000, zelo redki < 1/10.000)).
Other medicines and Betaferon
Druga zdravila in zdravilo Betaferon
During Betaferon treatment you are likely to experience injection site reactions.
Med zdravljenjem z zdravilom Betaferon se bodo verjetno pojavile reakcije na mestu injiciranja.
No separate investigations were performed regarding the influence of Betaferon on the cardiovascular system, respiratory system and the function of endocrine organs.
Posebnih študij o vplivu zdravila Betaferon na srce in ožilje, dihala in delovanje endokrinih organov niso izvedli.
Betaferon should be used with caution with: - medicines which need a certain liver enzyme system (known as cytochrome P450 system) for their removal from the body, for example medicines used to treat epilepsy (like phenytoin).
- zdravili, ki potrebujejo določen jetrni encimski sistem (t.i. sistem citokrom P450) za odstranitev iz telesa, na primer z zdravili, ki se uporabljajo za zdravljenje epilepsije (kot je fenitoin),
187.5 microgram
187,5 mikrogramov
Be sure that the orange tip cap is firmly attached to the solvent syringe!
Prepričajte se, da je oranžni pokrov trdno pritrjen na brizgo z vehiklom.
There are follow-up data under controlled clinical conditions for patients with relapsing-remitting MS for up to 5 years and for patients with secondary progressive MS for up to 3 years.
Za bolnike z recidivno-remitentno multiplo sklerozo obstajajo podatki o spremljanju v nadzorovanih kliničnih pogojih za obdobje do 5 let, za bolnike s sekundarno progresivno multiplo sklerozo za obdobje do 3 let.
Separate Annex: INTRODUCTORY LEAFLET FOR TITRATION PACK
Posebna priloga: NAVODILO ZA UPORABO SETA ZA TITRIRANJE
RR-MS, SP-MS and single clinical event suggestive of MS Betaferon was effective in all multiple sclerosis studies to reduce disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
RR-MS, SP-MS in enkratni demielinizacijski dogodek, ki nakazuje multiplo sklerozo Zdravilo Betaferon je v vseh študijah multiple skleroze učinkovito zmanjšalo aktivnost bolezni (akutno vnetje v osrednjem živčevju in trajne spremembe tkiva), merjeno z magnetnoresonančnim slikanjem (MRS).
Work through each rotation cycle in turn.
Zaporedoma upoštevajte vse rotacijske cikle.
Interferon alpha, interferon beta, and interferon gamma have overlapping yet distinct biologic activities.
Interferoni alfa, beta in gama imajo prekrivajoče se, vendar med seboj različno biološko delovanje.
Two controlled clinical trials with Betaferon involving a total of 1,657 patients with secondary progressive multiple sclerosis (baseline EDSS 3 to 6.5, i.e. patients were able to walk) were performed.
1657 bolnikov s sekundarno progresivno multiplo sklerozo (izhodiščni EDSS 3 do 6,5, tj. bolniki so lahko hodili).
Push it down firmly until you feel it snap into place on the vial.
Potisnite ga navzdol, dokler ne začutite, da je skočil v pravi položaj.
This might happen several weeks to several years after starting Betaferon.
To se lahko pojavi nekaj tednov do nekaj let po začetku zdravljenja z zdravilom Betaferon.
It is best to use your thumb rather than your nail as it could break.
Ne odpirajte je z nohtom, ker se lahko zlomi.
The most serious events often occurred in patients exposed to other drugs or substances known to be associated with hepatotoxicity or in the presence of comorbid medical conditions (e.g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Najbolj resni neželeni učinki so se pogosto pojavili pri bolnikih, ki so prejemali še druga zdravila ali snovi z znanimi hepatotoksičnimi učinki in pri bolnikih s sočasnimi boleznimi (npr. metastatsko maligno boleznijo, hudo okužbo in sepso, zlorabo alkohola).
Triple pack 4
Tridelno pakiranje 4
16 - Next, hold the blue vial adapter with the attached vial and remove it from the syringe by twisting it and then pulling it down, away from the syringe.
16 - Nato primite modri adapter za vialo na katerem je pritrjena viala in ga odstranite z brizge tako, da ga zavrtite in nato povlečete stran od brizge.
In MS, inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly.
Pri MS vnetje uniči zaščitno ovojnico (imenovano mielinska ovojnica), ki obdaja živce v osrednjem živčevju in prepreči njihovo pravilno delovanje.
5 - Holding the syringe like a pencil or a dart, push the needle straight into the skin at a 90˚ angle with a quick, firm motion.
5 - Brizgo primite kot svinčnik ali puščico za pikado in iglo s hitrim, odločnim gibom zapičite naravnost v kožo pod kotom 90˚.
The effect of alternate-day administration of 250 microgram (8.0 million IU) of Betaferon on drug metabolism in multiple sclerosis patients is unknown.
Učinek uporabe 250 mikrogramov (8,0 milijonov i.e.) zdravila Betaferon vsak drugi dan na presnovo zdravil pri bolnikih z multiplo sklerozo ni znan.
Injection site reactions may occur less frequently, if you use an auto-injector device.
Reakcije na mestu injiciranja so lahko redkejše, če uporabljate avtoinjektor.
If your depression and/or suicidal thoughts are severe, you will not be prescribed Betaferon (see also ‘Do not use Betaferon').
Če so vaša depresija in/ali samomorilne misli resne, vam ne bodo predpisali zdravila Betaferon (glejte tudi poglavje Ne uporabljajte zdravila Betaferon).
The two studies showed inconsistent results for the primary endpoint time to confirmed progression, representing delay of disability progression:
Izsledki obeh preskušanj niso usklajeni glede primarnega končnega izida, tj. čas do potrjene progresije bolezni, kar pomeni odložitev napredovanja invalidnosti.
In patients with a single clinical event suggestive of multiple sclerosis, the progression to clinically definite multiple sclerosis was significantly delayed over a period of five years.
Pri bolnikih z enim samim kliničnim dogodkom, ki nakazuje multiplo sklerozo, je bilo v obdobju petih let napredovanje do klinično potrjene multiple skleroze pomembno upočasnjeno.
Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with Betaferon.
Pljučna arterijska hipertenzija se lahko pojavi ob različnih časovnih točkah zdravljenja, lahko tudi nekaj let po začetku zdravljenja z zdravilom Betaferon.
10 - 15 cm from groin
10-15 cm od komolca
List 2: Side effects reported on the marketed product (from spontaneous reporting, frequencieswhere known - based on clinical trials)
Seznam 2: Neželeni učinki iz obdobja trženja zdravila (iz spontanih poročil, pogostnosti - kjer so znane - glede na podatke iz kliničnih preskušanj)
HR = 0.76 [0.52, 1.11]
RT = 0,76 [0,52; 1,11]
17 - Dispose of the vial and any unused portion of the solution in the disposal unit
17 - Vialo in neporabljen del raztopine zavrzite v posodo za odpadke.
These blood clots could affect your kidneys.
Ti krvni strdki lahko vplivajo na delovanje ledvic.
− if you notice pain in your belly which is radiating to your back, and/or you feel sick or have a fever.
- če imate bolečine v trebuhu, ki se širijo v hrbet, in/ali vam je slabo ali imate zvišano telesno temperaturo.
One of the two studies demonstrated a statistically significant delay in the time to disability progression (Hazard Ratio = 0.69, 95% confidence interval (0.55, 0.86), p=0.0010, corresponding to a 31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (Hazard Ratio = 0.61, 95% confidence interval (0.44, 0.85), p=0.0036, corresponding to a 39% risk reduction due to Betaferon) in patients who received Betaferon.
Prva od njiju je pri bolnikih, ki so prejemali zdravilo Betaferon, ugotovila statistično značilno odložitev do napredovanja invalidnosti (razmerje ogroženosti = 0,69, 95-% interval zaupanja (0,55, 0,86), p = 0,0010, kar ustreza 31 % zmanjšanju tveganja zaradi zdravila Betaferon) in priklenjenosti na invalidski voziček (razmerje ogroženosti = 0,61, 95-% interval zaupanja (0,44, 0,85), p = 0,0036, kar ustreza 39 % zmanjšanju tveganja zaradi zdravila Betaferon).
Table 1: Adverse events and laboratory abnormalities with incidence rates ≥ 10% and the respective percentages under placebo; significantly associated side effects < 10% based on reports from clinical trials
Preglednica 1: Neželeni učinki in nenormalni izvidi laboratorijskih preiskav s pogostnostjo ≥ 10 % in ustrezni odstotki pri placebu; glede na poročila iz kliničnih preskušanj jih je z zdravilom pomembno povezanih <10 %
► Choosing an injection site
► Izbira mesta injiciranja
No primary endpoint
Ni primarnega končnega izida