natgillin/translations-raw huggingface dataset:
Most pharmacokinetics properties observed in patients with plaque psoriasis, psoriatic arthritis and ankylosing spondylitis were similar. 
Pri bolnikih s psoriazo s plaki, s psoriatičnim artritisom in pri tistih z ankilozirajočim spondilitisom so bile farmakokinetične lastnosti večinoma podobne.
In Ankylosing Spondylitis study 1 (AS study 1), Ankylosing Spondylitis study 2 (AS study 2), and Ankylosing Spondylitis study 3 (AS study 3), 27.0%, 38.8%, and 23.5% of patients, respectively, were previously treated with an anti-TNFα agent and discontinued the anti-TNFα agent for either lack of efficacy or intolerance (anti-TNFα-IR patients). 
V AS študiji 1, AS študiji 2 in AS študiji 3 je bilo 27,0 %, 38,8 % oziroma 23,5 % bolnikov predhodno zdravljenih z zaviralcem TNFα, zdravljenje z njim pa so prekinili bodisi zaradi neučinkovitosti ali neprenašanja zdravila (anti-TNFα neodzivni bolniki).
How to store Cosentyx 
Shranjevanje zdravila Cosentyx
The powder is a white solid lyophilisate. 
prašek za raztopino za injiciranje Prašek je bel liofilizat v trdni obliki.
Multipack: 6 (3 packs of 2) pre-filled syringes 
Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg
In the GESTURE study, secukinumab was superior to placebo at week 16 (33.3% for 300 mg, 22.1% for 150 mg, and 1.5% for placebo) as assessed by significant improvement of ppIGA 0 or 1 response (“clear” or “almost clear”) for patients with moderate to severe palmoplantar plaque psoriasis. 
V študiji GESTURE je bil pri bolnikih z zmerno do hudo palmoplantarno psoriazo s plaki sekukinumab boljši od placeba glede na oceno pomembnega izboljšanja od izhodišča do 16. tedna na osnovi ocene ppIGA (izraženost palmoplantarne psoriaze po oceni raziskovalca) oziroma doseganja odziva "0" oziroma "1" ("brez znakov" ali "skoraj brez znakov" prizadetosti) (33,3 % pri odmerku 300 mg, 22,1 % pri odmerku 150 mg in 1,5 % pri uporabi placeba).
Expel the air bubbles and advance the plunger to the 1.0 ml mark. 
Iztisnite zračne mehurčke in potiskajte bat še naprej do oznake 1,0 ml. Z alkoholnim zložencem očistite mesto za injiciranje na koži.
Statistically significant improvements in patient-reported signs and symptoms of itching, pain and scaling at week 16 and week 52 (CLEAR) were demonstrated in the Psoriasis Symptom Diary© 
Pri bolnikih, ki so prejemali sekukinumab, so v primerjavi s tistimi, ki so prejemali ustekinumab, s pomočjo dnevnika simptomov psoriaze (Psoriasis Symptom Diary©) dokazali statistično značilno izboljšanje znakov in simptomov srbenja, bolečin in luščenja kože po navedbah bolnikov v 16. in 52. tednu (študija CLEAR).
Each 300 mg dose is given as two subcutaneous injections of 150 mg. 
Bolnik prejme vsak 300-miligramski odmerek v obliki dveh subkutanih injekcij po 150 mg.
The renal elimination of intact secukinumab, an IgG monoclonal antibody, is expected to be low and of minor importance. 
Nespremenjen sekukinumab, torej monoklonsko protitelo IgG, naj bi se po pričakovanjih izločalo skozi ledvice v majhnem obsegu in tako ledvično izločanje nima velikega pomena.
Disposing of your Cosentyx SensoReady pen: 
Odstranjevanje injekcijskega peresnika SensoReady z zdravilom Cosentyx:
For other patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. 
Za druge bolnike je priporočeni odmerek 150 mg s subkutano injekcijo, in sicer z začetnim odmerjanjem enkrat na teden v tednih 0, 1, 2, 3 in 4.
Cosentyx contains the active substance secukinumab. 
Zdravilo Cosentyx vsebuje zdravilno učinkovino sekukinumab.
Serious infections have been observed in patients receiving secukinumab in the post-marketing setting. 
V okviru izkušenj po prihodu zdravila na trg so pri bolnikih, ki so prejemali sekukinumab, opažali resne okužbe.
The recommended dose is 300 mg of secukinumab by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. 
Priporočeni odmerek je 300 mg sekukinumaba s subkutano injekcijo in sicer z začetnim odmerjanjem enkrat na teden v tednih 0, 1, 2, 3 in 4.
Dispose of the used syringe in a sharps container (closable, puncture resistant container). 
Uporabljeno brizgo zavrzite v zbiralnik za ostre predmete (vsebnik, ki ga je mogoče zapreti, in je narejen iz materiala, ki ga ni mogoče prebosti).
Secukinumab-treated patients without concomitant MTX use had a higher ACR 20 response (53.6% and 53.6% for 150 mg and 300 mg, respectively, compared to placebo 10.4%) and ACR 50 response (37.5% and 32.1% for 150 mg and 300 mg, respectively, compared to placebo 6.3%). 
Tudi tisti bolniki, ki so prejemali sekukinumab brez sočasne uporabe metotreksata, so v večjem deležu dosegali odziv ACR 20 (53,6 % oziroma 53,6 % pri odmerkih 150 mg oziroma 300 mg v primerjavi z 10,4 % pri uporabi placeba).
A caregiver may also give you your Cosentyx injection after proper training. 
Zdravilo Cosentyx vam lahko po ustreznem usposabljanju injicira tudi vaš negovalec oziroma oseba, ki sicer skrbi za vas.
What Cosentyx looks like and contents of the pack Cosentyx solution for injection is a clear liquid. 
Raztopina za injiciranje Cosentyx je bistra tekočina.
Patients randomised to secukinumab received 75 mg or 150 mg subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month. 
Bolniki, ki so jih randomizirali na prejemanje sekukinumaba, so ga prejemali v odmerku 75 mg ali 150 mg subkutano enkrat na teden v tednih 0, 1, 2, 3 in 4, nato pa so enak odmerek prejemali vsak mesec.
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - pre-filled pen 
VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ PODATKOV V t.i. MODREM OKENCU) - napolnjen injekcijski peresnik
At week 16, patients who were randomised to placebo at baseline were re-randomised to receive secukinumab (either 150 mg or 300 mg subcutaneously) every month. 
Po 16 tednih so bolnike, ki so bili sprva randomizirani na prejemanje placeba, ponovno randomizirali, tako da so prejemali sekukinumab bodisi 150 mg ali 300 mg subkutano enkrat na mesec.
The recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. 
Priporočeni odmerek je 150 mg s subkutano injekcijo, in sicer z začetnim odmerjanjem enkrat na teden v tednih 0, 1, 2, 3 in 4.
Multipack containing 6 (3 x 2) pre-filled syringes 
Skupno pakiranje: 6 (3 x 2) napolnjenih injekcijskih brizg
Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown. 
Tekočine ne uporabljajte, če vsebuje jasno vidne delce, če je motna ali izrazito rjave barve.
Patients randomised to secukinumab received 75 mg, 150 mg or 300 mg subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month. 
Bolniki, ki so jih randomizirali na prejemanje sekukinumaba, so ga prejemali v odmerkih 75 mg, 150 mg ali 300 mg subkutano enkrat na teden v tednih 0, 1, 2, 3 in 4, nato pa so enak odmerek prejemali enkrat na mesec.
One pre-filled syringe contains 150 mg secukinumab in 1 ml of solution. 
Ena napolnjena injekcijska brizga vsebuje 150 mg sekukinumaba v 1 ml raztopine.
Patients randomised to secukinumab received 150 mg or 300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every month. 
Bolniki, ki so bili randomizirani na prejemanje sekukinumaba, so prejeli odmerke 150 mg oziroma 300 mg v tednih 0, 1, 2, 3 in 4, nato pa enak odmerek enkrat na mesec.
Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another medicine called methotrexate. 
Zdravilo lahko uporabljamo samostojno ali v kombinaciji z drugim zdravilom, ki se imenuje metotreksat.
In the TRANSFIGURE study, secukinumab was superior to placebo at week 16 (46.1% for 300 mg, 38.4% for 150 mg and 11.7% for placebo) as assessed by significant improvement from baseline in the Nail Psoriasis Severity Index (NAPSI %) for patients with moderate to severe plaque psoriasis with nail involvement. 
V študiji TRANSFIGURE je bil pri bolnikih z zmerno do hudo psoriazo s prizadetostjo nohtov sekukinumab boljši od placeba glede na oceno pomembnega izboljšanja od izhodišča do 16. tedna na osnovi indeksa izraženosti psoriaze s prizadetostjo nohtov (NAPSI - Nail Psoriasis Severity Index (46,1 % pri odmerku 300 mg, 38,4 % pri odmerku 150 mg in 11,7 % pri uporabi placeba).
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - pre-filled syringe 
ŠKATLA ZA SKUPNO PAKIRANJE (S PODATKI V t.i. MODREM OKENCU) - napolnjena injekcijska brizga
In PsA study 2, at week 24, secukinumabtreated patients with concomitant MTX use had a higher ACR 20 response (47.7% and 54.4% for 150 mg and 300 mg, respectively, compared to placebo 20.0%) and ACR 50 response (31.8% and 38.6% for 150 mg and 300 mg, respectively, compared to placebo 8.0%). 
V PsA študiji 2 je po 24 tednih zdravljenja odziv ACR 20 doseglo več tistih bolnikov, ki so sočasno s sekukinumabom prejemali še metotreksat (47,7 % oziroma 54,4 % pri odmerkih 150 mg oziroma 300 mg v primerjavi z 20,0 % pri uporabi placeba).
Number of patients PASI 75 response n (%) PASI 90 response n (%) PASI 100 response n (%) IGA mod 2011 “clear” or “almost clear” response n (%) 
PASI 100 n (%) odziv IGA mod 2011 "brez znakov" ali "skoraj brez znakov" n (%)
System Organ Class Frequency Adverse reaction Infections and infestations 
Organski sistem pogostnost neželeni učinek
However, if you stop, your psoriasis, psoriatic arthritis or ankylosing spondylitis symptoms may come back. 
Če ste prenehali uporabljati zdravilo Cosentyx Če prenehate uporabljati zdravilo Cosentyx, to ne predstavlja nobene nevarnosti, vendar se v tem primeru lahko ponovno pojavijo simptomi psoriaze, psoriatičnega artritisa ali ankilozirajočega spondilitisa.
Cosentyx 150 mg powder for solution for injection secukinumab 
Cosentyx 150 mg prašek za raztopino za injiciranje sekukinumab
Patients randomised to placebo who were non-responders at week 16 (early rescue) and all other placebo patients at week 24 were crossed over to receive secukinumab (either 75 mg or 150 mg subcutaneously), followed by the same dose every month. 
Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih ni prišlo do odziva do tedna 16, so takoj prešli na uporabo sekukinumaba (zgodnje reševanje), vsi drugi bolniki s placebom pa so prešli na uporabo sekukinumaba (bodisi 75 mg ali 150 mg subkutano) v tednu 24, nato pa so enak odmerek prejemali vsak mesec.
Patients randomised to receive placebo who were responders at week 16 were crossed over to receive secukinumab (either 150 mg or 300 mg subcutaneously) at week 24 followed by the same dose every month. 
Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih je prišlo do odziva do tedna 16, so prešli na uporabo sekukinumaba (bodisi 150 mg ali 300 mg subkutano) v tednu 24, nato pa so enak odmerek prejemali vsak mesec.
ASAS 40 response, % hsCRP, (post-BSL/BSL ratio) 
hsCRP (razmerje med kasnejšo in izhodiščno vrednostjo)
Patients randomised to placebo who were non-responders at week 16 (early rescue) and other placebo patients at week 24 were crossed over to receive secukinumab (either 75 mg or 150 mg subcutaneously) followed by the same dose every month. 
Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih ni prišlo do odziva do tedna 16, so takoj prešli na uporabo sekukinumaba (zgodnje reševanje), drugi bolniki s placebom pa so prešli na uporabo sekukinumaba (bodisi 75 mg ali 150 mg subkutano) v tednu 24, nato pa so enak odmerek prejemali vsak mesec.
During the blinded period, the ASAS 20 and ASAS 40 responses were 69.7% and 47.6% for 150 mg and 74.3% and 57.4% for 300 mg at week 52, respectively. 
V obdobju slepega zdravljenja je do 52. tedna v skupini z odmerkom 150 mg odziv ASAS 20 doseglo 69,7 % in odziv ASAS 40 47,6 % bolnikov, v skupini z odmerkom 300 mg pa je odziv ASAS 20 doseglo 74,3 % in odziv ASAS 40 57,4 % bolnikov.
CARTON OF UNIT PACK - pre-filled syringe 
ŠKATLA ZA POSAMIČNO PAKIRANJE - napolnjena injekcijska brizga
Each pre-filled syringe contains 150 mg secukinumab. 
Ena napolnjena injekcijska brizga vsebuje 150 mg sekukinumaba.
• Talk to your doctor if you are breast-feeding or are planning to breast-feed. 
• Če dojite ali nameravate začeti z dojenjem, se pogovorite s svojim zdravnikom.
One pre-filled pen contains 150 mg secukinumab in 1 ml of solution. 
En napolnjen injekcijski peresnik vsebuje 150 mg sekukinumaba v 1 ml raztopine.
All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 24 for PsA study 2, except for ACR70, Dactylitis and Enthesitis, which were exploratory endpoints and all endpoints at week 16. 
* p<0,05, ** p<0,01, *** p<0,001; v primerjavi s placebom V PsA študiji 2 so za teden 24 vse vrednosti p prilagojene na večkratnost testiranja po vnaprej opredeljenem hierarhičnem redu, razen vrednosti p za odziv ACR 70, daktilitis in entezitis, ki so bile raziskovalni cilji študije, in vsi cilji študije za teden 16.
Finger grips 
Gibljivost hrbtenice
Pack containing 2 pre-filled pens 
Pakiranje vsebuje 2 napolnjena injekcijska peresnika.
ASAS partial remission, % 
delna remisija po kriterijih ASAS, % 4,1
Each vial of powder contains 150 mg secukinumab. 
Ena viala s praškom vsebuje 150 mg sekukinumaba.
Based on your response, your doctor may increase your dose to 300 mg. 
Na osnovi vašega odziva vam bo zdravnik morda odmerek zvišal na 300 mg Ankilozirajoči spondilitis
Patients randomised to receive placebo who were non-responders at week 16 (early rescue) were then crossed over to receive secukinumab (either 150 mg or 300 mg subcutaneously) at week 16 followed by the same dose every month. 
Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih ni prišlo do odziva do tedna 16, so po 16 tednih (zgodnje reševanje) prešli na uporabo sekukinumaba (bodisi 150 mg ali 300 mg subkutano), nato pa so enak odmerek prejemali vsak mesec.
Your Cosentyx SensoReady pen: 
Injekcijski peresnik SensoReady z zdravilom Cosentyx:
Cosentyx 150 mg solution for injection in pre-filled syringe secukinumab 
Cosentyx 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku sekukinumab
Table 7 Clinical response in AS study 2 at week 16 
Preglednica 7 Klinični odziv v AS študiji 2 po 16 tednih izid (vrednost p za primerjavo z uporabo placeba)
CARTON OF UNIT PACK - pre-filled pen 
ŠKATLA ZA POSAMIČNO PAKIRANJE - napolnjen injekcijski peresnik
Cosentyx 150 mg solution for injection in pre-filled syringe 
Cosentyx 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Cosentyx is available in unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes. 
Zdravilo Cosentyx je na voljo v posamičnem pakiranjih, ki vsebujejo 1 ali 2 napolnjeni injekcijski brizgi in v skupnem pakiranju, ki vsebuje 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.
PASI 50 response n (%) 5 (8.2%) 48 
odziv ACR 50 n (%) teden 16
Keep the pre-filled syringes in the outer carton in order to protect from light. 
Napolnjeni injekcijski brizgi shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Store the syringes in the original package in order to protect from light. 
Injekcijske brizge shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
PASI 90 response n (%) 3 (1.2%) 95 
odziv PASI 90 n (%) teden 16
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - pre-filled pen 
ŠKATLA ZA SKUPNO PAKIRANJE (S PODATKI V t.i. MODREM OKENCU) - napolnjen injekcijski peresnik
Storage of the Cosentyx pre-filled syringe 
Napolnjena injekcijska brizga z zdravilom Cosentyx
BLISTER OF PRE-FILLED SYRINGE 
PRETISNI OMOT NAPOLNJENE INJEKCIJSKE BRIZGE
Cosentyx 150 mg solution for injection in pre-filled pen secukinumab 
Cosentyx 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku sekukinumab s.c.
Histidine 
Cosentyx;
Cosentyx 150 mg solution for injection in pre-filled pen 
Cosentyx 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
This medicine works by neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis and ankylosing spondylitis. 
To zdravilo deluje tako, da nevtralizira aktivnost beljakovine, ki jo imenujemo interlevkin-17A (IL-17A).
4.8 Undesirable effects a. Summary of the safety profile 
4.8 Neželeni učinki a. povzetek varnostnega profila
Data were as follows (values in brackets show the 95% confidence intervals): 
Pridobili so naslednje podatke (vrednosti v oklepajih kažejo 95 % intervale zaupanja):
Date of latest renewal: 24 February 2014 
Datum zadnjega podaljšanja: 24. februar 2014
- Headache and muscular pain. 
- Glavobol in bolečine v mišicah.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 February 2009 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 24. februar 2009
Pack size of 1 or 10 or 20. 
Velikost pakiranja je 1 ali 10 ali 20.
The use of IDflu should be based on official recommendations. 
Uporaba cepiva IDflu mora temeljiti na uradnih priporočilih.
• Any of the other ingredients of this vaccine (listed in section 6), 
• katerokoli sestavino tega cepiva (navedeno v poglavju 6)
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for 
Cepivo ustreza priporočilom Svetovne zdravstvene organizacije (severna polobla) in Odločbi EU za
The vein test is unnecessary. 
Venski test ni potreben.
Micro-Injection System 
Sistem za mikroinjiciranje
Genotoxicity and carcinogenic potential were not assessed because these studies are not appropriate for a vaccine. 
Potenciala genotoksičnosti in karcinogenosti niso ocenili, saj te študije za cepivo niso primerne.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you. 
Pred cepljenjem natančno in v celoti preberite to navodilo, ker vsebuje za vas pomembne podatke.
• Risk Management Plan (RMP) 
ZDRAVILA • Načrt zaobvladovanje tveganja (RMP)
You should see your doctor immediately if you experience symptoms of angioedema, such as: 
Nemudoma poiščite zdravniško pomoč, če občutite simptome angioedema kot npr.:
Non-clinical data revealed no special hazard for humans based on animal studies. 
Neklinični podatki niso pokazali posebnih nevarnosti za ljudi na podlagi študij na živalih.
* propagated in fertilised hens' eggs from healthy chicken flocks 
* razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat
Hold the system by placing the thumb and middle finger only on the finger pads; the index finger remains free. 
Sistem držite tako, da ga nastavite med palec in sredinec samo na blazinice za prste; kazalec ostane prost.
• Whenever the risk management system is modified, especially as the result of new information is received that may lead to a significant change to benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Please read the instructions before use 
Pred uporabo preberite navodila
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega
B A/New Caledonia/ 20/99 A/Wisconsin/ 67/2005 B/Malaysia/ 2506/2004 N = 2,586 
B A/New Caledonia/20/99 A/Wisconsin/67/2005 B/Malaysia/2506/2004
The transient false positive reactions could be due to the IgM response by the vaccine. 
Prehodno lažne pozitivne reakcije so lahko posledica proizvajanja IgM kot odziv na cepivo.
Nevertheless, single and repeated administrations led to transient local erythema and oedema. 
Vendar pa je enkratno in večkratno dajanje povzročilo prehodni lokali eritem in edem.
- Feeling generally unwell, fever (38.0°C or higher) and shivering. 
- Splošno počutje nelagodja, povišana telesna temperatura (38,0°C ali več) in tresenje.
Full effect of the vaccine is generally achieved 2-3 weeks after the 
Popolni učinek cepiva je običajno dosežen v 2 do 3 tednih po cepljenju.
The vaccine is a colourless and opalescent suspension. 
Cepivo je brezbarvna in motna suspenzija.
The vaccine was immunogenic in mice and rabbits. 
Cepivo je bilo imunogeno pri miših in kuncih.
Most of side effects listed above disappeared without treatment within 1 to 3 days after onset. 
Večina zgoraj naštetih neželenih učinkov izzveni brez zdravljenja v 1 do 3 dni.
Store in a refrigerator (2°C-8°C). 
Shranjujte v hladilniku (2ºC - 8ºC).
Most reactions resolved spontaneously within 1 to 3 days after onset. 
Večina reakcij je spontano izzvenela v 1 do 3 dneh po nastanku.
Children and adolescents IDflu is not recommended for use in children and adolescents below 18 years. 
Cepivo IDflu ni priporočeno za uporabo pri otrocih in mladostnikih pod 18 let.
- If, for any reason, you have a blood test within a few days following an influenza vaccination, please tell your doctor. 
- Če morate v dneh po cepljenju proti gripi opraviti krvni test o tem obvestite svojega zdravnika.
Immediately dispose of the system in the nearest sharps collector. 
Nemudoma odstranite sistem v najbližji koš za ostre predmete.
Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up for 2,974 subjects (population of two out of the three clinical trials). 
Ocena varnosti se je izvajala za vse osebe v prvih 3 tednih po cepljenju, resne neželene reakcije pa so se beležili v šestmesečnem obdobju spremljanja pri 2974 osebah (udeleženih v dveh od treh kliničnih preskušanj).
Finger pads 
Prstne blazinice
Do not place fingers on the windows. 
Pazite, da okenc ne zakrijete s prsti.
What you need to know before you use IDflu 
Kaj morate vedeti, preden boste uporabili cepivo IDflu
In the absence of compatibility studies, this medicinal product must not be mixed with other 
Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
Paresthesia, neuritis 
Parestezija, neuritis Pruritus,
After repetitive yearly injections the safety profile of IDflu is similar to the previous injections. 
Po ponovnem vsakoletnem cepljenju je bil profil varnosti cepiva IDflu podoben prejšnjim injekcijam.
Immunisation should be carried out on separate limbs. 
Imunizacijo je potrebno opraviti na ločenih okončinah.
- This vaccine should under no circumstances be administered into a vein (intravascularly). 
- To cepivo se pod nobenim pogojem ne sme dajati v žilo (intravaskularno).
Based on the experience with trivalent inactivated influenza vaccines administered by intramuscular or deep subcutaneous injection, the following events may be reported: 
Na podlagi izkušenj s trivalentnimi inaktiviranimi cepivi proti gripi, ki se dajejo v obliki intramuskularne ali globoke subkutane injekcije, bi lahko poročali o sledečih neželenih dogodkih:
4.7 Effects on ability to drive and use machines IDflu has no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo IDflu nima oziroma zanemarljivo vpliva na sposobnost vožnje in upravljanja s stroji.
Overdose is unlikely to have any untoward effect. 
Ni verjetno, da bi preveliko odmerjanje povzročilo kakršne koli neželene učinke.
In repeated-dose toxicity studies in rabbits there was no significant evidence of systemic toxicity. 
Študije toksičnosti pri ponavljajočih se odmerkih niso pokazale značilnih dokazov sistemske toksičnosti.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE