natgillin/translations-raw huggingface dataset:
Figure 2: Forest plot of analyses of individual cardiovascular event types - FAS population
Slika 2: Drevesni diagram (»forest plot«) analize posameznih vrst srčno-žilnih dogodkovanaliza podatkov celotne populacije (FAS population)
If you have symptoms of acute pancreatitis, such as persistent, severe stomach ache, you should consult your doctor immediately (see section 4).
Če imate znake akutnega vnetja trebušne slinavke, na primer neprestane, hude bolečine v trebuhu, se takoj posvetujte z zdravnikom (glejte poglavje 4).
In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following active substances:
Še posebej pomembno pa je, da takoj obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete zdravila, ki vsebujejo katero koli od spodaj navedenih učinkovin:
Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na injekcijskem peresniku in na škatli poleg oznake »Uporabno do« ali »EXP«.
Exposure was significantly lower (44%) in patients with severe hepatic impairment (Child Pugh score >9).
Izpostavljenost je bila bistveno nižja (44 %) pri bolnikih s hudo okvaro jeter (več kot 9 točk po Child
You may only split your dose between your current pen and a new pen if trained or advised by your healthcare professional.
Odmerek lahko razdelite med uporabljani peresnik in novi peresnik le, če ste za to usposobljeni oz. vam to svetuje vaš zdravnik.
Tell your doctor if you are, you think you might be, or are planning to become pregnant.
Nosečnost in dojenje Obvestite zdravnika, če ste noseči, mislite, da ste noseči, ali nameravate zanositi.
Antibody formation has not been associated with reduced efficacy of liraglutide.
Nastajanje protiteles ni bilo povezano z zmanjšanjem učinkovitosti liraglutida.
The efficacy and safety profile of Victoza was comparable to that observed in the adult population treated with Victoza.
Učinkovitost in varnostne značilnosti zdravila Victoza so bile primerljive tistim, ki so jih ugotovili v populaciji odraslih, zdravljenih z zdravilom Victoza.
* human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.
* analog humanega glukagonu podobnega peptida-1 (GLP-1 - glucagon-like peptide-1), pridobljen s tehnologijo rekombinantne DNA iz Saccharomyces cerevisiae.
There was a comparable risk of hypoglycaemic episodes between the two treatment groups.
Tveganje za hipoglikemije je bilo med obema skupinama bolnikov primerljivo.
Victoza is available in packs containing 1, 2, 3, 5 or 10 pens.
Zdravilo Victoza je na voljo v pakiranjih z 1, 2, 3, 5 ali 10 injekcijskimi peresniki.
Always use a new needle for each injection.
Za vsako injiciranje vedno uporabite novo iglo.
In five large long-term clinical phase 3a trials over 2,500 adult patients have received treatment with Victoza alone or in combination with metformin, a sulfonylurea (with or without metformin) or metformin plus rosiglitazone.
V petih obsežnih in dolgotrajnih kliničnih preskušanjih faze 3a so več kot 2.500 odraslih bolnikov zdravili samo z zdravilom Victoza ali skupaj z metforminom, sulfonilsečnino (z ali brez metformina) ali metforminom in rosiglitazonom.
Unlike native GLP-1, liraglutide has a pharmacokinetic and pharmacodynamic profile in humans suitable for once daily administration.
Za razliko od naravnega GLP-1 ima liraglutid v človeškem telesu farmakokinetične in farmakodinamične lastnosti, ki omogočajo njegovo uporabo enkrat na dan.
Oral contraceptives
Peroralni kontraceptivi
The urine and faeces radioactivity was mainly excreted during the first 68 days, and corresponded to three minor metabolites, respectively.
Radioaktivnost v urinu in blatu se je v glavnem pojavila v prvih 6-8 dneh in je šla na račun treh manj pomembnih presnovkov.
If you forget a dose, use Victoza as soon as you remember.
Če ste pozabili uporabiti en odmerek, ga uporabite takoj, ko se spomnite.
In the LEADER trial, no long-term clinical impact of increased heart rate on the risk of cardiovascular events was observed.
LEADER niso opazili nobenega dolgotrajnega kliničnega vpliva povečanega srčnega utripa na tveganje za pojav srčno-žilnih dogodkov.
There was no clinically relevant effect on the overall exposure of either ethinyloestradiol or levonorgestrel.
Klinično pomembnega vpliva na celotno izpostavljenost etinilestradiolu ali levonorgestrelu ni bilo.
This medicine should not be used if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar and increase in effort to breathe).
Tega zdravila ne smete uporabljati, če imate sladkorno bolezen tipa 1 (vaše telo ne proizvaja insulina) ali diabetično ketoacidozo (zaplet sladkorne bolezni, kjer se pojavijo zelo visok krvni sladkor in težave pri dihanju).
Please see section 4 for the warning signs of low blood sugar.
Za opozorilne znake nizkega krvnega sladkorja glejte poglavje 4.
Consistent with the potentially immunogenic properties of medicinal products containing proteins or peptides, patients may develop anti-liraglutide antibodies following treatment with liraglutide.
Glede na morebitne imunogenske lastnosti zdravil, v katerih so beljakovine ali peptidi, se lahko po zdravljenju z liraglutidom pri bolnikih razvijejo protitelesa proti liraglutidu.
Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported in patients treated with liraglutide.
Znaki in simptomi dehidracije, vključno z okvaro ledvic in akutno odpovedjo ledvic, so bili opisani pri bolnikih, ki se zdravijo z liraglutidom.
Caregivers must be very careful when handling used needles - to prevent needle injury and cross-infection.
Osebe, ki skrbijo za bolnika, morajo biti pri ravnanju z uporabljenimi iglami zelo pazljive, da preprečijo poškodbe z iglami in navzkrižno okužbo.
At the beginning of the therapy, these gastrointestinal adverse reactions may occur more frequently.
Na začetku zdravljenja so lahko ti neželeni učinki na prebavilih pogostejši.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Table 2 Liraglutide clinical phase 3 trials in monotherapy (52 weeks) and in combination with oral antidiabetics (26 weeks)
Preglednica 2 Monoterapija z liraglutidom v kliničnih preskušanjih 3. faze (52 tednov) in kombinirano zdravljenje s peroralnimi antidiabetiki (26 tednov)
Population pharmacokinetic analysis suggests that body mass index (BMI) has no significant effect on the pharmacokinetics of liraglutide.
Populacijska farmakokinetična analiza kaže, da indeks telesne mase (ITM) ne vpliva bistveno na farmakokinetiko liraglutida.
Overall, frequency, type and severity of adverse reactions in adolescents and children aged 10 years and above were comparable to that observed in the adult population.
Na splošno so bile pogostnost, vrsta in izrazitost neželenih učinkov pri mladostnikih in otrocih, starih 10 let ali več, podobne kot v odrasli populaciji.
Contents of the pack and other information What Victoza contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Victoza
There is no therapeutic experience in patients with end-stage renal disease, and Victoza is therefore not recommended for use in these patients (see sections 5.1 and 5.2).
Terapevtskih izkušenj pri bolnikih z odpovedjo ledvic ni, zato uporaba zdravila Victoza pri teh bolnikih ni priporočljiva (glejte poglavji 5.1 in 5.2).
A clinically relevant interaction with active substances with poor solubility or with narrow therapeutic index such as warfarin cannot be excluded.
Klinično pomembnega medsebojnega delovanja liraglutida in učinkovin s slabo topnostjo in ozkim terapevtskim indeksom, kot je na primer varfarin, ni mogoče izključiti.
Tap the cartridge gently with your finger a few times.
S prstom nekajkrat rahlo potrkajte po vložku.
The risk of hypoglycaemia can be lowered by a reduction in the dose of sulfonylurea or insulin.
Tveganje za hipoglikemijo je mogoče zmanjšati z zmanjšanjem odmerka sulfonilsečnine ali insulina.
Combination with insulin
Kombinacija z insulinom
Do not stop using Victoza without talking to your doctor.
Ne prenehajte uporabljati zdravila Victoza, ne da bi se prej posvetovali z zdravnikom.
Victoza is supplied as a clear, and colourless or almost colourless, solution for injection in a pre-filled pen.
Zdravilo Victoza je na voljo kot bistra in brezbarvna ali skoraj brezbarvna raztopina za injiciranje v napolnjenem injekcijskem peresniku.
The absorption of liraglutide following subcutaneous administration is slow, reaching maximum concentration 8-12 hours post dosing.
Absorpcija liraglutida po subkutanem odmerku je počasna; največjo koncentracijo doseže v 8-12 urah po odmerku.
Five double-blind, randomised, controlled clinical phase 3a adult trials were conducted to evaluate the effects of liraglutide on glycaemic control (Table 2).
Opravljenih je bilo pet dvojno slepih, randomiziranih in kontroliranih kliničnih preskušanj faze 3a pri odraslih, v katerih so ocenjevali vpliv liraglutida na uravnavanje glikemije (preglednica 2).
• Wind (flatulence)
• vetrovi (napenjanje)
26-week open label trial and were randomised to add liraglutide or a single dose of insulin aspart (with the largest meal).
Preostali bolniki so ostali v 26-tedenskem odprtem preskušanju in so bili randomizirani na dodatek liraglutida ali dodatek enega odmerka insulina aspart (ob največjem obroku).
The treatment difference in HbA1c was 1.3% after additional 26 weeks of open label extension, confirming the sustained glycaemic control with Victoza.
Razlika v vrednosti HbA1c med zdravljenjema je bila po dodatnih 26 tednih odprtega podaljšanja 1,3 %; to potrjuje trajno urejenost glikemije z zdravilom Victoza.
Liraglutide reduced postprandial glucose across all three daily meals by 31-49 mg/dl (1.682.71 mmol/l).
Liraglutid je zmanjšal postprandialno koncentracijo glukoze po vseh treh dnevnih obrokih za 31-49 mg/dl (1,68-2,71 mmol/l).
You can keep the pen for 1 month when stored at a temperature below 30˚C or in a refrigerator (2˚C8˚C), away from the freezer compartment.
Injekcijski peresnik lahko shranjujete 1 mesec pri temperaturi do 30 °C ali v hladilniku (2 °C - 8 °C) ter proč od zamrzovalnega razdelka.
You may stick yourself with the needle.
Z iglo se lahko zbodete.
Victoza is used on its own if your blood sugar is not properly controlled by diet and exercise alone, and you cannot use metformin (another diabetes medicine).
Zdravilo Victoza se uporablja sámo, če krvni sladkor z dieto in s telesno vadbo ni zadostno urejen in ne morete jemati metformina (drugega zdravila za zdravljenje sladkorne bolezni).
Liraglutide also significantly reduced the risk of expanded MACE (primary MACE, unstable angina pectoris leading to hospitalisation, coronary revascularisation, or hospitalisation due to heart failure) and other secondary endpoints (Figure 2).
Liraglutid je pomembno zmanjšal tudi tveganje za razširjene pomembne srčno-žilne neželene dogodke (primarni pomembni srčno-žilni neželeni dogodki, nestabilna angina pektoris, zaradi katere je potrebna hospitalizacija, koronarna revaskularizacija ali hospitalizacija zaradi srčnega popuščanja) ter druge sekundarne opazovane dogodke (slika 2).
Pull off the paper tab from a new disposable needle.
Odstranite papirno nalepko z nove igle za enkratno uporabo.
This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.
Tako zmanjšate tveganje za kontaminacijo, okužbo, puščanje liraglutida, zamašitev igel in netočno odmerjanje.
The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, nervous, anxious, confused, difficulty concentrating, shaking (tremor).
• hipoglikemija (nizek krvni sladkor); opozorilni znaki nizkega krvnega sladkorja se lahko pojavijo nenadoma in lahko obsegajo: hladno znojenje, hladno in bledo kožo, glavobol, hitro bitje srca, občutek slabosti v želodcu, hudo lakoto, spremembe vida, zaspanost, šibkost,
Liraglutide exposure increased proportionally with dose.
Izpostavljenost liraglutidu se je povečevala sorazmerno z odmerkom.
Data from clinical trials showed that liraglutide is associated with delayed gastric emptying.
Podatki iz kliničnih preskušanj so pokazali, da je uporaba liraglutida povezana z zakasnelim praznjenjem želodca.
Liraglutide action is mediated via a specific interaction with GLP-1 receptors, leading to an increase in cyclic adenosine monophosphate (cAMP).
Liraglutid deluje s specifičnim učinkom na receptorje GLP-1 in tako povzroči porast cikličnega adenozin monofosfata (cAMP).
Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when Victoza therapy is started and insulin is reduced.
Samokontrola glukoze v krvi pa je potrebna za prilagajanje odmerka sulfonilsečnine in insulina, zlasti ob začetku zdravljenja z zdravilom Victoza in zmanjšanju odmerka insulina.
Over the duration of the phase 3a trials, liraglutide decreased the systolic blood pressure on average of 2.3 to 6.7 mmHg from baseline and compared to active comparator the decrease was 1.9 to 4.5 mmHg.
V času trajanja preskušanj faze 3a je liraglutid znižal sistolični krvni tlak v povprečju za 2,3 do 6,7 mm Hg v primerjavi z izhodiščem in za 1,9 do 4,5 mm Hg v primerjavi z aktivno primerjalno učinkovino.
Treatment with liraglutide alone and in combination with one or two oral antidiabetic drugs resulted in a reduction in fasting plasma glucose of 13-43.5 mg/dl (0.72-2.42 mmol/l).
Zdravljenje z liraglutidom samim in skupaj z enim ali dvema peroralnima antidiabetikoma je zmanjšalo koncentracijo glukoze v plazmi na tešče za 13-43,5 mg/dl (0,72-2,42 mmol/l).
No dose adjustment of lisinopril is required based on these results.
Prilagoditev odmerka lizinoprila na podlagi teh rezultatov ni potrebna.
These tumours were not seen in monkeys treated for 20 months.
Teh tumorjev niso opazili pri opicah, ki so jih zdravili
Other medicines and Victoza
Druga zdravila in zdravilo Victoza
Victoza can be administered with needles up to a length of 8 mm and as thin as 32G.
Zdravilo Victoza je mogoče injicirati z iglo dolžine do 8 mm in ne tanjšimi kot 32G.
Pull off the outer needle cap and keep it for later.
Snemite zunanji pokrovček igle in ga shranite za pozneje.
Turn the dose selector until the flow check symbol lines up with the pointer.
Vrtite izbirnik odmerka, dokler ni simbol za preverjanje pretoka poravnan s kazalnikom.
If you are also taking a sulfonylurea (such as glimepiride or glibenclamide) or insulin, your doctor may tell you to test your blood sugar levels.
Če hkrati jemljete tudi sulfonilsečnino (na primer glimepirid ali glibenklamid) ali insulin, vam bo zdravnik morda naročil, da si merite koncentracijo krvnega sladkorja.
The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells.
Receptor za GLP-1 je tarča naravnega GLP-1: to je endogen inkretinski hormon, ki od glukoze odvisno poveča izločanje insulina iz celic beta trebušne slinavke.
Dosing with Victoza during mid-gestation caused a reduction in maternal weight and foetal growth with equivocal effects on ribs in rats and skeletal variation in the rabbit.
Uporaba zdravila Victoza v srednjem obdobju gestacije je povzročila zmanjšanje materine telesne mase in zastoj rasti ploda, nejasen vpliv pa se je pokazal tudi na rebra podgan ter na spreminjanje skeleta pri kuncih.
Pancreatitis can be a serious, potentially life-threatening medical condition.
• vnetje trebušne slinavke (pankreatitis); pankreatitis je lahko resna in potencialno življenjsko ogrožajoča bolezen.
Patients treated with liraglutide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion.
Bolnike, ki se zdravijo z liraglutidom, je treba seznaniti z možnimi tveganji dehidracije, povezane z neželenimi učinki na prebavilih, in s previdnostnimi ukrepi za preprečitev pomanjkanja tekočine.
• Keep your pen out of the reach of others, especially children.
• Injekcijski peresnik hranite nedosegljivo drugim osebam, še posebej otrokom.
The exposure of liraglutide decreases with increasing body weight.
Izpostavljenost liraglutidu se s povečevanjem telesne mase zmanjšuje.
The primary endpoint was the time from randomisation to first occurrence of any major adverse cardiovascular events (MACE): CV death, non-fatal myocardial infarction or non-fatal stroke.
Primarni opazovani dogodek je bil čas od randomizacije do prvega pojava katerega od pomembnih srčno-žilnih neželenih dogodkov (Major Adverse Cardiovascular Events (MACE)): smrt zaradi srčnožilnih zapletov, miokardni infarkt brez smrtnega izida ali možganska kap brez smrtnega izida.
In mouse models of atherosclerosis, liraglutide prevented aortic plaque progression and reduced inflammation in the plaque.
V modelih ateroskleroze pri miših je liraglutid preprečil napredovanje plaka v aorti in zmanjšal vnetje v plaku.
Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.
Tako izboljšanje uravnavanja glikemije kot zmanjšanje obolevnosti in umrljivosti zaradi srčno-žilnih dogodkov sta bistvena dela zdravljenja sladkorne bolezni tipa 2.
This will help your doctor to decide if the dose of the sulfonylurea or insulin needs to be changed.
Tako se bo vaš zdravnik lažje odločil, če morate spremeniti odmerek sulfonilsečnine ali insulina.
• Allergic reactions like pruritus (itching) and urticaria (a type of skin rash)
• alergijske reakcije, kot sta pruritus (srbečica) in koprivnica (vrsta kožnega izpuščaja)
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or inflammatory bowel disease.
Uporaba tega zdravila ni priporočljiva, če imate hude težave z želodcem ali črevesjem in se vam zato želodec počasneje prazni (gastropareza) ali če imate kronično vnetno črevesno bolezen.
Prepare your pen Check the name and coloured label of your pen to make sure that it contains liraglutide.
Preverite ime in barvo nalepke injekcijskega peresnika in se tako prepričajte, da vsebuje liraglutid.
The mean HbA1c at baseline was 8.7% for liraglutide and placebo.
V izhodišču je bila povprečna vrednost HbA1c 8,7 % pri liraglutidu in placebu.
When you first start using these medicines together, your doctor may tell you to lower the dose of the sulfonylurea or insulin.
Ko začnete hkrati jemati ti dve zdravili, vam bo morda zdravnik naročil, da zmanjšate odmerek zdravila, ki vsebuje sulfonilsečnino ali insulin.
• Postprandial glucose
• Postprandialna koncentracija glukoze
• Increase of pancreatic enzymes (such as lipase and amylase).
• zvišanje koncentracije encimov trebušne slinavke (npr. lipaze in amilaze)
The mechanism of blood glucose lowering also involves a minor delay in gastric emptying.
Mehanizem zniževanja glukoze v krvi vključuje tudi manjšo upočasnitev praznjenja želodca.
When the pen is empty, carefully dispose of it without a needle attached.
Ko je injekcijski peresnik prazen, ga pazljivo zavrzite brez nameščene igle.
If the dose selector stops before 0.6 mg lines up with the pointer, prepare a new pen and inject the full dose with the new pen.
Če se izbirnik odmerka ustavi, preden se s kazalnikom poravna odmerek 0,6 mg, pripravite nov injekcijski peresnik in z njim injicirajte celotni odmerek.
≤5.5 mmol/l (≤100 mg/dl) Target
≤ 5,5 mmol/l (≤ 100 mg/dl) cilj brez prilagoditve
If a patient wishes to become pregnant, or pregnancy occurs, treatment with Victoza should be discontinued.
Če želi bolnica zanositi ali če zanosi, prekinite zdravljenje z zdravilom Victoza.
On the basis of the scientific conclusions for liraglutide the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing liraglutide is unchanged subject to the proposed changes to the product information
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za liraglutid odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) liraglutid, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
The most frequent adverse reactions leading to withdrawal for liraglutide-treated patients were nausea (2.8% of patients) and vomiting (1.5%).
Najpogostejša neželena učinka, zaradi katerih je bilo zdravljenje z liraglutidom prekinjeno, sta bila navzea (2,8 % bolnikov) in bruhanje (1,5 %).
• Do not share your pen or needles with anyone else.
• Injekcijskega peresnika ali igel ne delite z drugimi.
The patient should be advised to discard the injection needle in accordance with local requirements after each injection and store the pen without an injection needle attached.
Bolnika opozorite, naj po vsakem injiciranju zdravila injekcijsko iglo zavrže v skladu z lokalnimi predpisi in shrani injekcijski peresnik brez nameščene igle.
Gastrointestinal adverse events were more frequently reported with liraglutide treatment (43.6% vs 37.1%).
Neželeni učinki na prebavilih so bili pogosteje poročani pri zdravljenju z liraglutidom (43,6 % v primerjavi s 37,1 %).
Low blood sugar (hypoglycaemia) may reduce your ability to concentrate.
Vpliv na sposobnost upravljanja vozil in strojev Nizek krvni sladkor (hipoglikemija) lahko zmanjša vašo zmožnost koncentracije.
No other treatment-related tumours have been found.
Drugih tumorjev, povezanih z zdravljenjem s tem zdravilom, niso ugotovili.
There was a small increase in the rate of minor hypoglycaemic episodes (0.23 versus 0.03 events per patient years).
Ugotovili so manjše povečanje deleža blagih hipoglikemičnih epizod (0,23 v primerjavi z 0,03 dogodka na bolnik-let).
Use of liraglutide is not recommended in these patients since it is associated with transient gastrointestinal adverse reactions, including nausea, vomiting and diarrhoea.
Uporaba liraglutida pri teh bolnikih ni priporočljiva, saj je povezana s prehodnimi neželenimi učinki na prebavilih, vključno z navzeo, bruhanjem in drisko.
Victoza is administered once daily at any time, independent of meals, and can be injected subcutaneously in the abdomen, in the thigh or in the upper arm.
Zdravilo Victoza je treba aplicirati enkrat na dan ob kateri koli uri, ne glede na obroke, injicira pa se lahko subkutano v predel trebuha, stegno ali nadlaket.
The mean clearance following subcutaneous administration of a single dose liraglutide is approximately 1.2 l/h with an elimination half-life of approximately 13 hours.
Povprečen očistek po subkutani aplikaciji enkratnega odmerka liraglutida je približno 1,2 l/h, eliminacijski razpolovni čas pa je približno 13 ur.
In the LEADER study, delayed gastric emptying was reported three times more frequently in the liraglutide group compared to the placebo group.
V študiji LEADER so pri skupini preiskovancev, ki je prejemala liraglutid, trikrat pogosteje poročali o zakasnelem praznjenju želodca kot pri skupini, ki je prejemala placebo.
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity or genotoxicity.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
• Injection site reactions (such as bruising, pain, irritation, itching and rash)
• reakcije na mestu injiciranja (npr. podplutbe, bolečina, draženje, srbenje in izpuščaj)