FrancophonIA/ELRC3.0 huggingface dataset:
English: These safety concerns also included a risk of other severe side effects including certain cancers, gastro-intestinal perforations (holes in the wall of the gut), liver damage and problems with increased lipid (fat) levels in the blood.
Slovenian: Zadržki glede varnosti so se nanašali tudi na tveganje za druge hude neželene učinke, vključno z nekaterimi vrstami raka, perforacijami v črevesju (luknjami v steni črevesja), okvaro jeter in težavami z zvišanimi ravnmi lipidov (maščob) v krvi.
English: However, the studies were not sufficient to show a consistent reduction in disease activity and structural damage to joints, particularly at the lower 5-mg dose of Xeljanz and in the target population of patients in whom treatment with at least two other DMARDs has been unsuccessful.
Slovenian: Vendar pa študije niso bile zadostne za to, da bi pokazale dosledno zmanjšanje dejavnosti bolezni in strukturnih okvar sklepov, še zlasti pri manjšem, 5-mg odmerku zdravila Xeljanz in pri ciljni populaciji bolnikov, pri katerih zdravljenje z najmanj dvema drugima DMARD ni bilo uspešno.
English: However, the lack of robust evidence on prevention of structural damage with Xeljanz in the proposed dose and population still contributed to the Committee's view that the benefits of treatment did not outweigh significant and unresolved concerns about safety.
Slovenian: Kljub temu pa je pomanjkanje trdnih dokazov o tem, da zdravilo Xeljanz v predlaganem odmerku preprečuje strukturne okvare pri predlagani populaciji, še vedno prispevalo k tem, da je Odbor menil, da koristi zdravljenja ne odtehtajo pomembnih in nerešenih zadržkov glede varnosti.
English: It was to be used in patients in whom treatment with at least one other medicine known as a biological disease-modifying antirheumatic drug (biological DMARD1), had been unsuccessful either because patients were unable to tolerate treatment due to side effects, or because they did not respond adequately.
Slovenian: Uporabljalo naj bi se pri bolnikih, pri katerih zdravljenje z najmanj enim drugim zdravilom, ki se imenuje biološko imunomodulirajoče antirevmatično zdravilo (biološko DMARD1), ni bilo uspešno, ker bolniki zaradi neželenih učinkov niso mogli prenašati zdravljenja ali ker se nanj niso ustrezno odzvali.
English: There were significant and unresolved concerns about the risk and type of serious infections seen with tofacitinib, which are related to the immunosuppressant action of the medicine.
Slovenian: Izpostavljeni so bili pomembni in nerešeni zadržki v zvezi s tveganjem za resne okužbe in vrsto teh okužb, ki so jih opazili pri uporabi tofacitiniba in so povezane z imunosupresivnim delovanjem zdravila.
English: The company that applied for authorisation is Pfizer Limited.
Slovenian: Vlogo za pridobitev dovoljenja za promet je predložila družba Pfizer Limited.
English: What were the CHMP's main concerns that led to the refusal?
Slovenian: Kateri so bili glavni zadržki, zaradi katerih je CHMP predlagal zavrnitev dovoljenja za promet?
English: In April 2013, the Committee considered that, taken together, the data from the five main studies showed that treatment with Xeljanz resulted in an improvement in the signs and symptoms of rheumatoid arthritis and the physical function of patients.
Slovenian: Aprila 2013 je Odbor menil, da so na splošno podatki iz petih glavnih študij pokazali, da je zdravljenje z zdravilom Xeljanz izboljšalo znake in simptome revmatoidnega artritisa ter fizično zmogljivost bolnikov.
English: On 25 April 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Xeljanz, intended for the treatment of rheumatoid arthritis.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je 25. aprila 2013 sprejel negativno mnenje, s katerim je priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Xeljanz, namenjenim zdravljenju revmatoidnega artritisa.
English: The CHMP refusal was confirmed after re-examination.
Slovenian: Zavrnitev, ki jo je predlagal Odbor, je bila po ponovnem pregledu potrjena.
English: Refusal of the marketing authorisation for Xeljanz (tofacitinib)
Slovenian: Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Xeljanz (tofacitinib)
English: Xeljanz is a medicine that contains the active substance tofacitinib.
Slovenian: Xeljanz je zdravilo, ki vsebuje zdravilno učinkovino tofacitinib.
English: The active substance in Xeljanz, tofacitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system) that works by blocking the action of enzymes known as Janus kinases.
Slovenian: Zdravilna učinkovina v zdravilu Xeljanz, tofacitinib, je imunosupresiv (zdravilo, ki zmanjša delovanje imunskega sistema), ki učinkuje tako, da preprečuje delovanje encimov, imenovanih Janus kinaze.
English: What is Xeljanz?
Slovenian: Kaj je zdravilo Xeljanz?
English: These enzymes play an important role in the process of inflammation and damage of the joints that occurs in rheumatoid arthritis.
Slovenian: Ti encimi imajo pomembno vlogo pri vnetju in okvari sklepov, ki se pojavi pri revmatoidnem artritisu.
English: By blocking the enzymes, tofacitinib is expected to reduce the inflammation and other symptoms of the disease.
Slovenian: Tofacitinib naj bi z zaviranjem teh encimov zmanjšal vnetje in druge simptome bolezni.
English: Xeljanz was expected to be used in the treatment of moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
Slovenian: Zdravilo Xeljanz naj bi se uporabljalo za zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa (bolezni imunskega sistema, ki povzroča okvaro in vnetje sklepov).
English: Therefore, in April 2013 the CHMP was of the opinion that the benefits of Xeljanz did not outweigh its risks and recommended that it be refused marketing authorisation.
Slovenian: Posledično je CHMP aprila 2013 sprejel mnenje, da koristi zdravila Xeljanz niso večje od z njim povezanih tveganj, in priporočil zavrnitev vloge za pridobitev dovoljenja za promet z njim.
English: These studies compared Xeljanz (in a dose of 5 or 10 mg twice daily) with placebo (a dummy treatment), either alone or as an addition to other background medicines (DMARDs).
Slovenian: V študijah so primerjali zdravilo Xeljanz (v odmerku 5 ali 10 mg dvakrat na dan) in placebo (zdravilo brez zdravilne učinkovine), ki so ju dajali samostojno ali kot dodatek k drugim zdravilom za osnovno bolezen (imunomodulirajočim antirevmatičnim zdravilom).
English: What was Xeljanz expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Xeljanz uporabljalo?
English: Biological DMARDs are medicines that target specific proteins in the immune system.
Slovenian: Biološka imunomodulirajoča antirevmatična zdravila (DMARD) so zdravila, ki učinkujejo na določene beljakovine imunskega sistema.
English: How is Xeljanz expected to work?
Slovenian: Kako naj bi zdravilo Xeljanz delovalo?
English: After first use: 1 month.
Slovenian: Po prvi uporabi: 1 mesec.
English: Date of first authorisation: 30 June 2009 Date of last renewal: 11 April 2014
Slovenian: Datum prve odobritve: 30. junij 2009 Datum zadnjega podaljšanja: 11. april 2014
English: This reduction was observed within the first two weeks of treatment.
Slovenian: Do tega znižanja je prišlo v prvih dveh tednih zdravljenja.
English: The relevance for humans is likely to be low but cannot be completely excluded.
Slovenian: Pomen tega za človeka je verjetno majhen, vendar ga ni mogoče povsem izključiti.
English: Then take your next dose as usual the following day.
Slovenian: Uporabite naslednji odmerek kot ponavadi naslednji dan.
English: You may need medical treatment.
Slovenian: Morda boste potrebovali zdravniško pomoč.
English: All patients recovered without complications.
Slovenian: Vsi bolniki so si opomogli brez zapletov.
English: Time from randomisation (months)
Slovenian: Čas od randomizacije (meseci)
English: Before opening:
Slovenian: Pred odprtjem:
English: Detailed instructions for use are provided on the other side of this leaflet.
Slovenian: Podrobna navodila za uporabo so opisana na drugi strani teh navodil.
English: Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Slovenian: Zdravnik vam bo povedal, kako zdraviti nizek krvni sladkor in kaj storiti, če opazite te opozorilne znake.
English: These reactions have usually been mild.
Slovenian: Te reakcije so bile po navadi blage.
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Slovenian: Odbor CHMP se strinja z znanstvenimi zaključki odbora PRAC.
English: The mean duration of diabetes was 12.8 years.
Slovenian: Povprečno trajanje sladkorne bolezni je bilo 12,8 let.
English: It also slows food passage through your stomach and can help prevent heart disease.
Slovenian: Prav tako upočasni prehajanje hrane skozi želodec in lahko pomaga preprečiti bolezni srca.
English: 30 months.
Slovenian: 20 mesecev.
English: No interaction study has been performed.
Slovenian: Študija medsebojnega delovanja ni bila izvedena.
English: Patients at risk
Slovenian: Bolniki s tveganjem
English: Ethnic origin
Slovenian: Etnično poreklo
English: Using the wrong medicine could cause severe harm.
Slovenian: Uporaba napačnega zdravila lahko zelo škoduje.
English: In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Slovenian: V primeru prevelikega odmerjanja je treba začeti ustrezno podporno zdravljenje glede na bolnikove klinične znake in simptome.
English: Liraglutide should therefore be used with caution in these patients.
Slovenian: Liraglutid je treba pri teh bolnikih uporabljati previdno.
English: Very rare
Slovenian: Zelo redki
English: Important information
Slovenian: Pomembne informacije
English: • in addition to other medicinal products for the treatment of diabetes.
Slovenian: • kot dodatek k drugim zdravilom za zdravljenje sladkorne bolezni.
English: • Risk Management Plan
Slovenian: • Načrt za obvladovanje tveganj (RMP)
English: You can give yourself the injection at any time of the day, regardless of meals.
Slovenian: Zdravilo si lahko injicirate ob kateri koli uri, ne glede na obroke.
English: It is not known whether liraglutide is excreted in human milk.
Slovenian: Ni znano, ali se liraglutid izloča v človeško mleko.
English: Do not change your dose unless your doctor has told you to.
Slovenian: Ne spreminjajte odmerka, če vam tega ne naroči zdravnik.
English: • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
Slovenian: • kot monoterapija, kadar metformin ni primeren zaradi intolerance ali kontraindikacij;
English: If you split the dose wrong, you may inject too much or too little liraglutide.
Slovenian: Če odmerek razdelite napačno, lahko injicirate preveč ali premalo liraglutida.
English: It also ensures that the dosing is accurate.
Slovenian: Zagotavlja tudi točnost odmerjanja.
English: If you experience these symptoms you should seek immediate medical help and inform your doctor as soon as possible.
Slovenian: Če opazite te simptome, morate nemudoma poiskati medicinsko pomoč in o tem čim prej obvestiti zdravnika.
English: • The starting dose is 0.6 mg once a day, for at least one week.
Slovenian: • Začetni odmerek je 0,6 mg enkrat na dan vsaj en teden.
English: • Decreased appetite
Slovenian: • zmanjšan apetit
English: 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 safety of this medicine.
Slovenian: 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 zdravila.
English: Primary endpoint - MACE Components of MACE:
Slovenian: Primarni opazovani dogodek - MACE Komponente MACE:
English: Patients should be informed of the characteristic symptoms of acute pancreatitis.
Slovenian: Bolnike je treba seznaniti z značilnimi simptomi akutnega pankreatitisa.
English: Frequencies for all events have been calculated based on their incidence in phase 3a clinical trials.
Slovenian: Za vse dogodke so pogostnosti izračunane glede na njihovo pojavnost v kliničnih preskušanjih faze 3a.
English: Do not take an extra dose or increase the dose on the following day to make up for the missed dose.
Slovenian: Ne uporabite dodatnega odmerka oziroma ne povečajte odmerka naslednji dan, da bi nadoknadili zamujen odmerek.
English: • Do not try to wash, soak or lubricate it - this can harm the pen.
Slovenian: • Ne poskušajte ga oprati, namočiti ali namazati - to je za injekcijski peresnik lahko škodljivo.
English: Patients with an event (%)
Slovenian: Bolniki, pri katerih je prišlo do dogodka (%)
English: The estimated hazard ratio was consistently below 1 for all 3 MACE components.
Slovenian: Ocenjeno razmerje ogroženosti je bilo dosledno manjše od 1 za vse 3
English: • Dehydration, sometimes with a decrease in kidney function
Slovenian: • dehidracija, včasih vključno z zmanjšanjem funkcije ledvic
English: The duration of observation was a minimum of 3.5 years and up to a maximum of 5 years.
Slovenian: 3,5 leta in do največ 5 let.
English: These reactions usually diminish within a few days or weeks on continued treatment.
Slovenian: Ponavadi se med nadaljevanjem zdravljenja po nekaj dneh ali tednih zmanjšajo.
English: ATC code: A10BJ02
Slovenian: Oznaka ATC: A10BJ02.
English: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists.
Slovenian: Akutni pankreatitis je bil opažen pri uporabi agonistov receptorjev GLP-1.
English: There are no adequate data from the use of liraglutide in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi liraglutida pri nosečnicah.
English: Frequencies are defined as: 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).
Slovenian: Pogostnosti so opredeljene kot: 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); ni znano (ni mogoče oceniti iz razpoložljivih podatkov).
English: Avoid driving or using machines if you experience signs of hypoglycaemia.
Slovenian: Izogibajte se upravljanju vozil ali uporabi strojev, če občutite znake hipoglikemije.
English: Before you use the pen for the first time, your doctor or nurse will show you how to use it.
Slovenian: Preden prvič uporabite injekcijski peresnik, vam bo zdravnik ali medicinska sestra pokazal/-a, kako ga uporabljate.
English: 2 IU a According to the individualised recommendation by the investigator at the previous visit, for example depending on whether the patient has experienced hypoglycaemia.
Slovenian: aGlede na individualizirana raziskovalčeva priporočila na prejšnjem pregledu, npr. odvisno od tega, ali je bolnik imel hipoglikemijo.
English: This leaflet was last revised in Other sources of information
Slovenian: Navodilo je bilo nazadnje posodobljeno: Drugi viri informacij
English: The injection site and timing can be changed without dose adjustment.
Slovenian: Mesto in čas injiciranja je mogoče spreminjati brez prilagoditve odmerka.
English: No data are available in children below 10 years of age.
Slovenian: Za otroke, mlajše od 10 let, podatki niso na voljo.
English: Victoza should not be used during pregnancy because it is not known if it may harm your unborn child.
Slovenian: Zdravila Victoza se ne sme uporabljati med nosečnostjo, saj ni znano, če lahko škoduje nerojenemu otroku.
English: Warfarin and other coumarin derivatives
Slovenian: Varfarin in drugi kumarinski derivati
English: This is normal and does not affect your dose.
Slovenian: To je normalno in ne vpliva na injicirani odmerek.
English: Interaction studies have only been performed in adults.
Slovenian: Študije medsebojnega delovanja so izvedli le pri odraslih bolnikih.
English: Use a calculator to plan the doses.
Slovenian: Za načrtovanje odmerkov uporabite kalkulator.
English: Do not inject it into a vein or muscle.
Slovenian: Zdravila ne injicirajte v veno ali mišico.
English: Do not use the cartridge scale to measure how much liraglutide to inject - it is not accurate enough.
Slovenian: Ne uporabljajte merila na vložku za merjenje količine liraglutida za injiciranje - to ni dovolj natančno.
English: This will make any air bubbles collect at the top of the cartridge.
Slovenian: Tako se bodo zračni mehurčki zbrali na vrhu vložka.
English: Needles are not included.
Slovenian: Igle niso priložene.
English: Interaction studies did not show any clinically relevant delay of absorption and therefore no dose adjustment is required.
Slovenian: Študije medsebojnega delovanja niso pokazale klinično pomembne upočasnitve absorpcije, torej prilagoditev odmerka ni potrebna.
English: This indicates the pen is defective and you must use a new one.
Slovenian: To namreč pomeni, da je injekcijski peresnik pokvarjen in morate uporabiti novega.
English: Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
English: If you stop using it, your blood sugar levels may increase.
Slovenian: Če prenehate uporabljati zdravilo, se lahko koncentracija krvnega sladkorja poveča.
English: • Your doctor will tell you when to increase it to 1.2 mg once a day.
Slovenian: • Zdravnik vam bo povedal, kdaj morate odmerek povečati na 1,2 mg enkrat na dan.
English: Animal studies did not indicate direct harmful effects with respect to fertility but slightly increased early embryonic deaths at the highest dose.
Slovenian: Študije na živalih niso pokazale neposrednih škodljivih vplivov na plodnost, so pa pokazale nekaj več zgodnjih embrionalnih smrti pri največjem odmerku.
English: • Do not try to repair your pen or pull it apart.
Slovenian: • Ne poskušajte ga popraviti ali razstaviti.
English: For further instructions on administration, see section 6.6.
Slovenian: Za dodatna navodila glede apliciranja zdravila glejte poglavje 6.6.
English: The mean age was 64 years and the mean BMI was 32.5 kg/m².
Slovenian: Povprečna starost je bila 64 let in povprečni ITM je bil 32,5 kg/m2.
English: If no drop appears, repeat steps E to G up to four times.
Slovenian: Če se kapljica ne pojavi, ponavljajte korake od E do G največ štirikrat.
English: Victoza has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Victoza nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: However, if it is more than 12 hours since you should have used Victoza, skip the missed dose.
Slovenian: Če pa je minilo že več kot 12 ur, odkar bi morali uporabiti zdravilo Victoza, preskočite ta odmerek.
English: Combination therapy with sulfonylurea is only valid for adult patients.
Slovenian: Kombinirano zdravljenje s sulfonilsečnino velja le za odrasle bolnike.
English: If there is still no drop of liraglutide, change the needle and repeat steps E to G once more.
Slovenian: Če še ne vidite kapljice liraglutida, zamenjajte iglo in ponovite korake E do G še enkrat.
English: During use:
Slovenian: Med uporabo:
English: GLP-1 receptors are also expressed in specific locations in the heart, vasculature, immune system, and kidneys.
Slovenian: Receptorji GLP-1 so izraženi tudi na določenih mestih v srcu, ožilju, imunskem sistemu in ledvicah.
English: Never try to put the inner needle cap back on the needle.
Slovenian: Nikoli ne poskušajte znova namestiti notranjega pokrovčka na iglo.
English: Other clinical data
Slovenian: Drugi klinični podatki
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: This prevents contamination, infection and leakage.
Slovenian: To prepreči kontaminacijo, okužbo in puščanje.
English: Because of lack of experience, Victoza should not be used during breast-feeding.
Slovenian: Zaradi pomanjkanja izkušenj se zdravila Victoza ne sme uporabljati med dojenjem.
English: On average, 8.6% of patients developed antibodies.
Slovenian: V povprečju so se protitelesa razvila pri 8,6 % bolnikov.
English: The safety profile of liraglutide was generally similar to that observed in other studies with liraglutide.
Slovenian: Varnostni profil liraglutida je bil na splošno podoben kot pri drugih študijah z liraglutidom.
English: It is not an insulin and should therefore not be used as a substitute for insulin.
Slovenian: To zdravilo ni insulin in se ga zato ne sme uporabljati kot zamenjavo za insulin.
English: Liraglutide is not a substitute for insulin.
Slovenian: Liraglutid ni nadomestilo za insulin.
English: It is unknown whether the reduced pup growth is caused by reduced pup milk intake due to a direct GLP-1 effect or reduced maternal milk production due to decreased caloric intake.
Slovenian: Ni znano, ali je upočasnjena rast mladičev posledica zmanjšanja hranjenja mladičev z materinim mlekom zaradi neposrednega vpliva GLP-1 ali posledica manjšega nastajanja mleka pri materi zaradi manjšega kaloričnega vnosa.
English: If your pen is already in use, go to ‘Select your dose', step H.
Slovenian: Če je injekcijski peresnik že bil uporabljen, glejte poglavje ‘Izbira odmerka', korak H.
English: What Victoza is and what it is used for What you need to know before you use Victoza How to use Victoza
Slovenian: Kaj je zdravilo Victoza in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Victoza Kako uporabljati zdravilo Victoza
English: Victoza should not be used if it has been frozen.
Slovenian: Zdravila Victoza ne smete uporabiti, če je bilo zamrznjeno.
English: For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Slovenian: Za rezultate študij v zvezi s kombinacijami, učinki na urejenost glikemije in srčno-žilne dogodke, ter skupinami bolnikov, ki so jih preučili, glejte poglavja 4.4., 4.5 in 5.1.
English: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark
Slovenian: Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd Danska
English: Absolute bioavailability of liraglutide following subcutaneous administration is approximately 55%.
Slovenian: Absolutna biološka uporabnost liraglutida po subkutani aplikaciji je približno 55 %.
English: Patients (%) achieving
Slovenian: Bolniki (%), ki so dosegli vrednost
English: It is not known if Victoza passes into breast milk, therefore do not use this medicine if you are breastfeeding.
Slovenian: Ni znano, ali zdravilo Victoza prehaja v materino mleko in zato ne jemljite tega zdravila, če dojite.
English: • Your doctor may tell you to further increase the dose to 1.8 mg once a day, if your blood glucose is not adequately controlled with a dose of 1.2 mg.
Slovenian: • Zdravnik vam bo morda naročil, da še povečate odmerek na 1,8 mg enkrat na dan, če glukoze v krvi ni mogoče ustrezno nadzorovati z odmerkom 1,2 mg.
English: In addition, liraglutide had a beneficial effect on plasma lipids.
Slovenian: Poleg tega je imel liraglutid tudi ugoden vpliv na lipide v plazmi.
English: Liraglutide should not be used during pregnancy, and the use of insulin is recommended instead.
Slovenian: Liraglutida se ne sme uporabljati med nosečnostjo; namesto tega se uporablja insulin.
English: Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility.
Slovenian: Razen rahlega zmanjšanja števila živih ugnezdenj študije na živalih niso pokazale škodljivih učinkov na plodnost.
English: Pull out the needle.
Slovenian: Izvlecite iglo.
English: Be careful not to bend or damage the needle.
Slovenian: Pazite, da igle ne zvijete ali poškodujete.