natgillin/translations-raw huggingface dataset:
Orencia must not be used in patients with severe and uncontrolled infections, such as sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) or ‘opportunistic' infections (infections seen in patients with a weakened immune system).
Zdravilo Orencia se ne sme uporabljati pri bolnikih s hudimi nenadzorovanimi okužbami, kot so npr. sepsa (pri kateri bakterije in njihovi toksini krožijo v krvi in povzročajo poškodbe organov) ali oportunistične okužbe (opažene pri bolnikih z oslabljenim imunskim sistemom).
Orencia contains the active substance abatacept.
Zdravilo Orencia vsebuje učinkovino abatacept.
The Agency also concluded that Orencia could be a valuable option in the treatment of polyarticular juvenile idiopathic arthritis.
Zaključila je tudi, da bi lahko bilo zdravilo Orencia pomembna možnost zdravljenja poliartikularnega juvenilnega idiopatskega artritisa.
The European Medicines Agency concluded that Orencia had a modest anti-inflammatory effect in rheumatoid arthritis and, in combination with methotrexate, it reduced the worsening of joint damage and improved physical function.
Evropska agencija za zdravila je zaključila, da ima zdravilo Orencia zmeren protivnetni učinek pri revmatoidnem artritisu in da v kombinaciji z metotreksatom zmanjša poslabšanje poškodb sklepov in izboljša funkcijsko zmogljivost.
In the fourth study, Orencia in combination with methotrexate was compared with Orencia alone and methotrexate alone in 351 adults who had not been treated with methotrexate (or with any biologic agents such as TNF alpha blockers), but may have been on other medicines for management of rheumatoid arthritis.
V četrti študiji so zdravilo Orencia v kombinaciji z metotreksatom primerjali z zdravilom Orencia, ki se daje samostojno, pri 351 odraslih, ki predhodno niso bili zdravljeni z metotreksatom (ali s katerimi drugimi biološkimi učinkovinami, kot so zaviralci TNF-alfa), so pa morda jemali druga zdravila za obvladovanje revmatoidnega artritisa.
In rheumatoid arthritis, if the patient is receiving Orencia for the first time, the first dose can be given by infusion.
Če bolnik pri revmatoidnem artritisu prejme zdravilo Orencia prvič, se prvi odmerek lahko da z infundiranjem.
Orencia can only be obtained with a prescription, and treatment with it should be started and supervised by a specialised doctor with experience in the diagnosis and treatment of rheumatoid arthritis or polyarticular juvenile idiopathic arthritis.
Predpisovanje in izdaja zdravila Orencia je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa ali juvenilnega idiopatskega artritisa.
After being trained and with the agreement of their doctor, patients or carers may inject the medicine themselves.
Bolniki ali njihovi negovalci lahko po opravljenem usposabljanju in s soglasjem zdravnika zdravilo injicirajo sami.
The study also led to similar improvements in symptoms to those seen with Orencia given into a vein in adults and children.
V študiji so bile ugotovljene tudi podobne izboljšave na področju simptomov kot pri zdravilu Orencia, kadar se daje v veno pri odraslih in otrocih.
Four main studies involving a total of 1,733 adults found Orencia effective in rheumatoid arthritis.
V štirih glavnih študijah, ki so vključevale skupaj 1 733 odraslih, so ugotovili, da je zdravilo Orencia učinkovito pri revmatoidnem artritisu.
The third study included 391 patients in whom TNF blockers had not worked well enough.
Tretja študija je vključevala 391 bolnikov, pri katerih zaviralci TNF niso bili dovolj učinkoviti.
• moderate to severe active polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints), in adolescents and children from 2 years of age in whom other medicines have not worked well enough.
• zmernega do hudega aktivnega poliartikularnega juvenilnega idiopatskega artritisa (redke otroške bolezni, ki povzroča vnetje številnih sklepov) pri mladostnikih in otrocih od drugega leta dalje, pri katerih druga zdravila niso bila dovolj učinkovita.
Orencia is available as a powder that is made up into a solution for infusion (drip) into a vein and as a solution for injection under the skin in pre-filled syringes and pre-filled pens.
Zdravilo Orencia je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno in kot raztopina za injiciranje v podkožje v napolnjenih injekcijskih brizgah in napolnjenih peresnikih.
How does Orencia work?
Kako zdravilo Orencia deluje?
A further study in 219 children with polyarticular juvenile idiopathic arthritis aged 2 to 17 years showed that Orencia given by injection under the skin produced expected levels of active substance in the blood based on data with Orencia given into a vein for other conditions.
V dodatni študiji pri 219 otrocih s poliartikularnim juvenilnim idiopatskim artritisom, starih od 2 do 17 let, je bilo dokazano, da so z injiciranjem zdravila Orencia pod kožo v krvi nastale pričakovane ravni učinkovine na podlagi podatkov o zdravilu Orencia, ki se je infundiralo v veno pri drugih obolenjih.
• psoriatic arthritis (arthritis combined with psoriasis, a condition causing red, scaly patches on the skin) in adults in whom treatment with other medicines, including methotrexate, has not worked well enough.
• psoriaznega artritisa (artritisa v kombinaciji s psoriazo, tj. obolenjem, ki povzroča rdeče, luskaste zaplate na koži) pri odraslih, pri katerih zdravljenje z drugimi zdravili, vključno z metotreksatom, ni bilo dovolj učinkovito.
In addition, a study involving around 1,370 patients with rheumatoid arthritis found similar benefit for both Orencia given by injection under the skin and Orencia given by infusion.
Poleg tega so v študiji, ki je vključevala okrog 1 370 bolnikov z revmatoidnim artritisom, ugotovili podobne koristi pri zdravilu Orencia, ki se daje s podkožno injekcijo, in zdravilu Orencia, ki se daje z infundiranjem.
• moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints) in adults using it in combination with methotrexate when other medicines including methotrexate or a ‘tumour necrosis factor (TNF) blocker' have not worked well enough;
• zmernega do hudega aktivnega revmatoidnega artritisa (bolezni imunskega sistema, ki povzroča poškodbe in vnetje sklepov) pri odraslih, ki ga uporabljajo v kombinaciji z metotreksatom, kadar druga zdravila, vključno z metotreksatom ali „zaviralcem tumorje nekrotizirajočega faktorja (TNF)“, niso bila dovolj učinkovita;
When injected under the skin, Orencia is given once a week.
Kadar se zdravilo Orencia injicira v podkožje, se daje enkrat na teden.
How is Orencia used?
Kako se zdravilo Orencia uporablja?
In another study involving 170 patients with psoriatic arthritis, Orencia given by infusion at the recommended dose reduced symptoms by at least 20% after 24 weeks in over 47% of the patients (19 out of 40) compared with 19% of the patients (8 out of 42) who received placebo.
V drugi študiji, ki je vključevala 170 bolnikov s psoriatičnim artritisom, je zdravilo Orencia, ki so ga dajali z infundiranjem v priporočenem odmerku, po 24 tednih zmanjšalo simptome za vsaj 20 % pri več kot 47 % (19 od 40) bolnikov v primerjavi z 19 % (8 od 42) bolnikov, ki so prejemali placebo.
In polyarticular juvenile idiopathic arthritis, Orencia infusion was found effective in one main study involving patients aged between 6 and 17 years whose previous treatment had not worked.
Pri poliartikularnem juvenilnem idiopatskem artritisu so v eni glavni študiji, ki je vključevala bolnike, stare od 6 do 17 let, pri katerih predhodno zdravljenje ni bilo uspešno, ugotovili, da je infuzija zdravila Orencia učinkovita.
Orencia given by injection under the skin reduced symptoms in 39% of the patients (84 out of 213) compared with 22% of the patients (47 out of 211) who received placebo.
Zdravilo Orencia, ki so ga dajali s podkožno injekcijo, je zmanjšalo simptome pri 39 % (84 od 213) bolnikov v primerjavi z 22 % (47 od 211) bolnikov, ki so prejemali placebo.
In the first study, symptoms of the disease were reduced in 61% (70 out of 115) of the patients adding the recommended dose of Orencia to methotrexate for 6 months, compared with 35% (42 out of 119) of the patients adding placebo (a dummy treatment).
V prvi študiji so se simptomi bolezni zmanjšali pri 61 % (70 od 115) bolnikov, ki so šest mesecev metotreksatu dodajali priporočeni odmerek zdravila Orencia, v primerjavi s 35 % (42 od 119) bolnikov, ki so dodajali placebo (zdravilo brez učinkovine).
Adding Orencia and methotrexate to existing treatment for 12 months reduced symptoms in 61% of the patients (70 out of 115), compared with 42% of the patients on Orencia alone (48 out of 113) and 45% of the patients on methotrexate alone (52 out of 115).
Dodajanje zdravila Orencia in metotreksata obstoječemu zdravljenju je v 12 mesecih privedlo do zmanjšanja simptomov pri 61 % (70 od 115) bolnikov v primerjavi z 42 % (48 od 113) bolnikov, ki so zdravilo Orencia jemali kot samostojno zdravilo, in 45 % (52 od 115) tistih, ki so jemali samo metotreksat.
The second study found a similar effect of Orencia on symptoms of rheumatoid arthritis, as well as improved physical function and a reduced rate of joint damage after a year of treatment.
V drugi študiji je bil po enem letu zdravljenja ugotovljen podoben učinek zdravila Orencia na simptome revmatoidnega artritisa, poleg tega pa sta bili ugotovljeni boljša funkcijska zmogljivost in manj poškodb sklepov.
Adding Orencia to existing treatment led to a reduction in symptoms in 50% of the patients (129 out of 256) after 6 months, compared with 20% of the patients adding placebo (26 out of 133).
Dodajanje zdravila Orencia obstoječemu zdravljenju je v šestih mesecih privedlo do zmanjšanja simptomov pri 50 % (129 od 256) bolnikov v primerjavi z 20 % (26 od 133) bolnikov, pri katerih so dodajali placebo.
Over 6 months, 20% of the patients receiving Orencia had a flare-up (12 out of 60), compared with 53% of those receiving placebo (33 out of 62).
V šestih mesecih je bolezen ponovno izbruhnila pri 20 % (12 od 60) bolnikov, ki so prejemali zdravilo Orencia, in pri 53 % (33 od 62) tistih, ki so prejemali placebo.
T cells are immune system cells that are involved in causing the inflammation in rheumatoid, psoriatic and polyarticular juvenile idiopathic arthritis.
Učinkovina v zdravilu Orencia, abatacept, je beljakovina, ki zavira aktivacijo celic T. Celice T so imunske celice, ki sodelujejo pri povzročanju vnetja pri revmatoidnem, psoriatičnem in poliartikularnem juvenilnem idiopatskem artritisu.
Orencia was found effective in one main study involving 424 adult patients with psoriatic arthritis.
V eni glavni študiji, ki je vključevala 424 odraslih bolnikov s psoriatičnim artritisom, so ugotovili, da je zdravilo Orencia učinkovito.
It is used alone or in combination with methotrexate for patients who do not need other medicines by mouth or by injection to control their psoriasis.
Pri bolnikih, ki za obvladovanje psoriaze ne potrebujejo drugih zdravil, ki se dajejo peroralno ali z injiciranjem, se uporablja kot samostojno zdravilo ali v kombinaciji z metotreksatom.
See also Serious allergic reaction above.
Glejte tudi podpoglavje Resna alergijska reakcija zgoraj.
41% 32% Odds Ratio:
41 % 32 % Razmerje obetov:
If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Če je prilagoditev potrebna, utegne biti potrebna že pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
The injection can be given at any time during the day, but at the same time each day.
Odmerek se lahko injicira kadar koli v dnevu, vendar vsak dan ob istem času.
Baseline values for these parameters were similar in the two groups.
Izhodiščne vrednosti teh parametrov so bile med skupinama podobne.
Select the dose you need.
Izberite si odmerek, ki ga potrebujete.
Ask your doctor about this.
O tem povprašajte svojega zdravnika.
How often to inject
Kako pogosto injicirati
Date of last renewal: 16 April 2009
Datum zadnjega podaljšanja dovoljenja za promet: 16. april 2009
The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 June 2004
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 01. junij 2004
The overall percentage of treated patients expected to experience adverse reactions is estimated to be 12%.
Celotni odstotek zdravljenih bolnikov, pri katerih lahko pričakujemo neželene učinke, se ocenjuje na 12 %.
Careful monitoring is recommended in these patients.
Pri teh bolnikih je priporočljivo skrbno nadziranje.
Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Glukozo je treba dati intravensko v primeru, da se bolnik v 10 do 15 minutah ne odzove na glukagon.
Intramuscular administration should also be avoided.
Intramuskularnemu apliciranju se je treba izogibati.
Most of the injection site reactions are minor and of a transitory nature, i.e. they normally disappear during continued treatment in a few days to a few weeks.
Večina reakcij na mestu injiciranja je blagih in prehodnih, tj. med nadaljevanjem zdravljenja običajno izginejo v nekaj dneh do nekaj tednih.
Your dose may have to be adjusted by your doctor if:
Zdravnik bo odmerek morda moral prilagoditi, če:
No change in dose (target)
brez spremembe odmerka (ciljna vrednost je dosežena)
Levemir which has been frozen must not be used.
Zdravila Levemir, ki je bil zamrznjen, ne smete uporabiti.
Maximum serum concentration is reached between 6 and 8 hours after administration.
Največja koncentracija v serumu je dosežena v 6 do 8 urah po aplikaciji.
The trial including children above 2 years was extended for an additional 12 months (total of 24 months treatment data) to assess antibody formation after long-term treatment with Levemir.
Preskušanje, ki je vključevalo otroke, starejše od 2 let, so podaljšali za dodatnih 12 mesecev (skupaj 24 mesecev podatkov o zdravljenju) za oceno nastajanja protiteles po dolgotrajnem zdravljenju z zdravilom Levemir.
However, when used in combination with oral antidiabetic medicinal products, three clinical studies have shown a frequency of common (2.2% of allergic reactions and potentially allergic reactions have been observed).
Toda med uporabo v kombinaciji s peroralnimi antidiabetiki so v treh kliničnih študijah ugotovili, da je to pogost neželeni učinek (opažali so 2,2 % alergijskih reakcij in potencialnih alergijskih reakcij).
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
The duration of action is up to 24 hours depending on dose providing an opportunity for once or twice daily administration.
Trajanje delovanja je odvisno od odmerka in lahko znaša do 24 ur, kar omogoča enkrat ali dvakrat dnevno apliciranje.
Levemir must be protected from excessive heat and light.
Zdravilo Levemir je treba zaščititi pred čezmerno toploto in svetlobo.
Treatment with Levemir can be considered during pregnancy, but any potential benefit must be weighed against a possibly increased risk of an adverse pregnancy outcome.
Zdravilo Levemir se lahko uporabi med nosečnostjo, vendar je treba morebitno korist pretehtati v primerjavi z možnim povečanjem tveganja za neželeni izid nosečnosti.
Overall number of major hypoglycaemia episodes during pregnancy (per patient year)
Celotno število hujših hipoglikemij med nosečnostjo (na bolnica-leto)
*Self-Monitored Plasma Glucose
* samoizmerjena glukoza v plazmi
An apparent volume of distribution for Levemir (approximately 0.1 l/kg) indicates that a high fraction of insulin detemir is circulating in the blood.
Navidezen volumen porazdelitve zdravila Levemir (približno 0,1 l/kg) kaže na to, da se velik delež insulina detemir nahaja v krvnem obtoku.
From clinical investigations, it is known that major hypoglycaemia, defined as requirement for third party intervention, occurs in approximately 6% of the patients treated with Levemir.
Iz kliničnih raziskav je znano, da se hude hipoglikemije - opredeljene kot takšne, pri katerih je nujno posredovanje nekoga drugega - pojavijo pri približno 6 % bolnikov, zdravljenih z zdravilom Levemir.
Proportions of patients achieving HbA1c <7% targets
Deleži bolnikov, ki so dosegli ciljno vrednost HbA1c < 7 %
Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester.
Potreba po insulinu se v prvem trimesečju ponavadi zmanjša, potem pa se v drugem in tretjem trimesečju zveča.
However, this does not appear to have any impact on glycaemic control.
Vendar ne kaže, da bi to vplivalo na urejenost glikemije.
Observed rates of minor hypoglycaemic episodes were similar and no severe hypoglycaemic episodes were observed in either group.
Opaženi delež blagih hipoglikemičnih epizod je bil med skupinama podoben, v nobeni skupini pa niso opazili hudih hipoglikemičnih epizod.
It can also be used in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists.
Uporabljati ga je mogoče tudi v kombinaciji s peroralnimi antidiabetiki in/ali agonisti receptorjev GLP-1.
Time Since Insulin Injection (hours) Levemir ….. 0.2 U/kg 0.3 U/kg .
Čas od injiciranja insulina (v urah) Levemir ….. 0,2 e./kg 0,3 e./kg .
Primary objective of this study was to assess the effect of Levemir on blood glucose regulation in pregnant women with diabetes (see section 5.1).
Primarni cilj študije je bil oceniti učinek zdravila Levemir na uravnavanje glukoze v krvi pri nosečnicah s sladkorno boleznijo (glejte poglavje 5.1).
The most frequently reported adverse reaction during treatment is hypoglycaemia, please see section 4.8, Description of selected adverse reactions.
Najpogosteje opisani neželeni učinek med zdravljenjem je hipoglikemija; glejte poglavje 4.8, podpoglavje Opis izbranih neželenih učinkov.
Levemir can be used in elderly patients.
Zdravilo Levemir lahko uporabite pri starejših bolnikih.
Adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class.
Spodaj navedeni neželeni učinki temeljijo na podatkih iz kliničnih preskušanj in so razvrščeni po MedDRA pogostnosti in organskih sistemih.
Duration of action (hr) GIRmax (mg/kg/min) †estimated values
Trajanje delovanja (h) GIRmax (mg/kg/min) †ocenjene vrednosti
NPH insulin CV (%)
Insulin NPH CV (%)
This should be kept in mind if treatment with the combination of pioglitazone and Levemir is considered.
To je treba upoštevati pri načrtovanju zdravljenja s kombinacijo pioglitazona in zdravila Levemir.
Discuss this with your doctor.
O tem se posvetujte z zdravnikom.
*Insulin detemir is produced in Saccharomyces cerevisiae by recombinant DNA technology.
* Insulin detemir je pridobljen iz Saccharomyces cerevisiae s tehnologijo rekombinantne DNA.
Animal data do not indicate reproductive toxicity (see section 5.3).
Študije na živalih ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Your InnoLet is designed to work accurately and safely.
Vaš injekcijski peresnik InnoLet je izdelano za natančno in varno delovanje.
You must never inject Levemir directly into a vein (intravenously) or muscle (intramuscularly).
Zdravila Levemir si nikoli ne smete injicirati neposredno v veno (intravensko) ali mišico (intramuskularno).
Receptor affinity data and in vitro mitogenicity tests revealed no evidence of an increased mitogenic potential compared to human insulin.
Podatki o receptorski afiniteti in in-vitro poskusi mitogenosti niso pokazali povečanega mitogenega potenciala v primerjavi s humanim insulinom.
Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Prilagoditev odmerka je lahko potrebna tudi v primeru večje telesne aktivnosti, spremenjene običajne prehrane ali med spremljajočimi boleznimi.
Glucose infusion rate (mg/kg/min)
Hitrost infuzije glukoze (mg/kg/min)
The terminal half-life after subcutaneous administration is determined by the rate of absorption from the subcutaneous tissue.
Terminalni razpolovni čas po subkutani aplikaciji je določen s hitrostjo absorpcije iz podkožnega tkiva.
B. Check that the insulin in your pen is clear and colourless.
B. Preverite, da je insulin v injekcijskem peresniku bister in brezbarven.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov (glejte poglavje 6.1).
During use: Use within 6 weeks
Med uporabo: porabite v 6 tednih.
Change in body weight after insulin treatment Study duration Levemir once daily
Sprememba telesne mase po zdravljenju z insulinom Trajanje študije Zdravilo Levemir enkrat na dan
Frequency categories are defined according to the following convention: 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); not known (cannot be estimated from the available data).
Skupine pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki
It is unknown whether insulin detemir is excreted in human milk.
Ni znano, ali se insulin detemir izloča v materino mleko.
During use or when carried as a spare: The product can be stored for a maximum of 6 weeks.
Med uporabo in ko se zdravilo uporablja kot rezerva: zdravilo je lahko shranjeno največ 6 tednov.
The potency of insulin analogues, including insulin detemir, is expressed in units, whereas the potency of human insulin is expressed in international units.
Moč insulinskih analogov, tudi insulina detemir, izražamo v enotah, moč humanega insulina pa v mednarodnih enotah.
The pharmacokinetic properties of Levemir were investigated in young children (1-5 years), children (6-12 years) and adolescents (13-17 years) and compared to adults with type 1 diabetes.
Farmakokinetične lastnosti zdravila Levemir so raziskali pri mlajših otrocih (od 1. do 5. leta), otrocih (od 6. do 12. leta) in mladostnikih (od 13. do 17. leta) in jih primerjali s tistimi pri odraslih s sladkorno boleznijo tipa 1.
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
Če imate zmanjšano funkcijo ledvic ali jeter, ali če ste starejši od 65 let, morate krvni sladkor kontrolirati bolj redno, o spremembah odmerka insulina pa se morate posvetovati z zdravnikom.
The 39% of patients not achieving target were randomised to have Levemir once-daily added or continue on liraglutide+metformin for 52 weeks.
39 % bolnikov, ki niso dosegli cilja, pa so randomizirali bodisi na dodatek zdravila Levemir enkrat na dan bodisi na nadaljevanje kombinacij liraglutid + metformin za 52 tednov.
Levemir was the basal insulin product for 33% (n=147) of the patients (97.3% using metformin).
Zdravilo Levemir je bil bazalni insulin pri 33 % (N = 147) vseh bolnikov (97,3 % bolnikov je uporabljalo tudi metformin).
Pharmacodynamic Parameters for Levemir and NPH
Farmakodinamični parametri za Levemir in NPH
• Screw the needle straight and tightly onto your InnoLet (picture A).
• Iglo naravnost in trdno privijte na vaš injekcijski peresnik InnoLet (slika A).