natgillin/translations-raw huggingface dataset:
Insulin receptor binding: In vitro studies indicate that the affinity of insulin glargine and its metabolites M1 and M2 for the human insulin receptor is similar to the one of human insulin.
Vezava na insulinske receptorje: Študije in vitro kažejo, da je afiniteta insulina glargina in njegovih presnovkov M1 in M2 za človeške insulinske receptorje podobna afiniteti humanega insulina.
Do not use this SoloStar if the insulin is cloudy, coloured or has particles.
SoloStarja ne uporabite, če je insulin moten, obarvan ali so v njem delci.
To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with Lantus should reduce their dose by approximately 20%.
Da bi zmanjšali tveganje za hipoglikemijo, je treba bolnikom, ki spreminjajo odmerjanje bazalnega insulina z insulina glargina 300 enot/ml enkrat na dan na zdravilo Lantus enkrat na dan, odmerek zmanjšati za približno 20 %.
It is recommended that the date of the first use from the vial be noted on the label.
Priporočljivo je na nalepko vpisati datum prve uporabe viale.
If you stop using Lantus
Če ste prenehali uporabljati zdravilo Lantus
Switch from twice daily NPH insulin to Lantus
Prehod z insulina NPH dvakrat na dan na zdravilo Lantus
You should contact your doctor for advice on driving if: - you have frequent episodes of hypoglycaemia, - the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.
Z zdravnikom se pogovorite, ali je priporočljivo, da vozite, če: - imate pogoste hipoglikemije, - so prvi opozorilni znaki hipoglikemije šibki ali jih sploh nimate.
Do not stop Lantus without speaking to a doctor, who will tell you what needs to be done.
Ne prenehajte zdravljenja z zdravilom Lantus, ne da bi se pogovorili z zdravnikom.
Read carefully the "SoloStar Instructions for Use" included in this package leaflet.
Natančno preberite "Navodila za uporabo SoloStarja", ki jih vključuje to navodilo.
Only use needles that are compatible for use with SoloStar.
Uporabljajte le igle, primerne za uporabo s SoloStarjem.
The Lantus Solostar is grey with a purple injection button.
Lantus SoloStar je siv in ima škrlaten gumb za injiciranje.
The graph above shows the activity profiles over time of insulin glargine and NPH insulin.
Zgornji graf prikazuje časovni potek delovanja insulina glargin in insulina NPH.
Only use needles that are compatible for use with
Uporabljajte le igle, primerne za uporabo s
• At the request of the European Medicines Agency;
Posodobljen RMP je treba predložiti: • na zahtevo Evropske agencije za zdravila;
• If no insulin comes out after changing the needle, your SoloStar may be damaged.
• Če tudi po zamenjavi igle insulin ne pokaže, je SoloStar morda poškodovan.
SoloStar.
SoloStarjem.
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
Zaviralci adrenergičnih receptorjev beta, klonidin, litijeve soli ali alkohol lahko učinek znižanja glukoze v krvi pri insulinu bodisi stopnjujejo ali oslabijo.
Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.
Enkrat na dan injicirani insulin glargin doseže koncentracijo v stanju dinamičnega ravnovesja v 2 do 4 dneh po prvem odmerku.
A safety test must be performed before each injection.
Varnostni preizkus morate narediti pred vsakim injiciranjem.
When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Lantus, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products).
Pri prehodu s srednjedolgo- ali dolgodelujočega insulina na zdravljenje z zdravilom Lantus utegneta biti potrebna sprememba odmerka bazalnega insulina in prilagoditev sočasnega antidiabetičnega zdravljenja (odmerek in časovni razpored dodatnih običajnih insulinov ali hitrodelujočih insulinskih analogov oz. odmerek peroralnih antidiabetikov).
No metabolic effects of ingested insulin glargine on the breast-fed newborn/infant are anticipated since insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract.
Presnovnih učinkov zaužitega insulina glargin na dojenega novorojenčka/dojenčka ni pričakovati, ker se insulin glargin kot peptid v človeških prebavilih prebavi v aminokisline.
How to use Lantus
Kako uporabljati zdravilo Lantus
Animal data do not indicate reproductive toxicity.
Podatki, pridobljeni na živalih, ne kažejo vpliva na sposobnost razmnoževanja.
Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.
Natančno upoštevajte navodila za odmerjanje, nadziranje bolezni (testi krvi in urina), prehrano in telesno dejavnost (telesno delo in telovadbo) ter za postopek injiciranja, ki vam jih je dal zdravnik.
5 ml vial, cartridge, SoloStar pre-filled pen Zinc chloride
5 ml viala, vložek, SoloStar napolnjen injekcijski peresnik: Cinkov klorid
Empty pre-filled pens must never be reused and must be properly discarded.
Praznih injekcijskih peresnikov se nikoli ne sme ponovno uporabiti in jih je treba pravilno zavreči.
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
V študijah z evglikemično vklenjenostjo pri zdravih preiskovancih ali bolnikih z diabetesom tipa 1 je bil začetek delovanja subkutano apliciranega insulina glargin počasnejši kot humanega insulina NPH, potek njegovega delovanja je bil enakomeren in brez vrhov, trajanje delovanja pa podaljšano.
Severe allergic reactions (rare, may affect up to 1 in 1,000 people) - the signs may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Huda alergijska reakcija (redka, pojavi se lahko pri največ 1 od 1.000 bolnikov) - znaki so lahko obsežne kožne reakcije (izpuščaj in srbenje po celem telesu), hude otekline kože ali sluznic (angioedem), oteženo dihanje, znižanje krvnega tlaka s hitrim bitjem srca in znojenje.
For more information, see the box at the end of this leaflet.
Za več informacij poglejte okvir na koncu tega navodila za uporabo.
Lantus can be used in adolescents and children aged 2 years and above.
Zdravilo Lantus se lahko uporablja pri mladostnikih in otrocih, starih 2 leti in več.
Hydrochloric acid (for pH adjustment) Polysorbate 20
Klorovodikova kislina (za uravnavanje pH) Polisorbat 20
If you think you may have a problem with Lantus, have it checked by your doctor or pharmacist.
Če se vam zdi, da imate težave z zdravilom Lantus, naj ga pregleda vaš zdravnik ali farmacevt.
Very rare reported side-effects (may affect up to 1 in 10,000 people) In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
Zelo redko poročani neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) V zelo redkih primerih se lahko pojavita dizgevzija (motnje okušanja) in mialgija (bolečine v mišicah).
There is no experience in children under 2 years.
Pri otrocih, mlajših od 2 let, ni izkušenj.
Lantus is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above.
Zdravilo Lantus se uporablja za zdravljenje sladkorne bolezni pri odraslih, mladostnikih in otrocih, starih 2 leti in več.
- The active substance is insulin glargine.
- Zdravilna učinkovina je insulin glargin.
Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action.
Zdravilo Lantus vsebuje insulin glargin, insulinski analog s podaljšanim delovanjem.
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and glucose and ketone bodies in urine .
Žeja, pogostejše siljenje na vodo, utrujenost, suha koža, pordelost obraza, izguba teka, nizek krvni tlak, hitro bitje srca ter glukoza in ketoni v urinu.
It is completely soluble at the acidic pH of the Lantus injection solution (pH 4).
Pri kislem pH raztopine za injiciranje zdravilo Lantus (pH 4) pa je popolnoma topen.
Perform a Safety test
3. korak Opravite varnostni preizkus.
Each vial contains 5 ml of solution for injection (equivalent to 500 units) or 10 ml of solution for injection (equivalent to 1000 units).
Ena viala vsebuje 5 ml raztopine za injiciranje (ekvivalentno 500 enot) ali 10 ml raztopine za injiciranje (ekvivalentno 1000 enot).
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni »brez natrija«.
These include: - change in the injection area, - improved insulin sensitivity (e.g., by removal of stress factors), - unaccustomed, increased or prolonged physical activity, - intercurrent illness (e.g. vomiting, diarrhoea), - inadequate food intake, - missed meals, - alcohol consumption, - certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency), - concomitant treatment with certain other medicinal products (see section 4.5).
Med takšne spadajo: - sprememba predela injiciranja, - boljša občutljivost za insulin (npr. zaradi odprave dejavnikov stresa), - nevajena, večja ali dolgotrajnejša telesna dejavnost, - sočasna bolezen (npr. bruhanje, driska), - nezadostno uživanje hrane, - izpuščeni obroki, - pitje alkohola, - določene nekompenzirane endokrine motnje (npr. hipotiroidizem, insuficienca sprednjega režnja hipofize ali insuficienca nadledvične skorje), - sočasno zdravljenje z določenimi drugimi zdravili (glejte poglavje 4.5).
Keep the vial, cartridge or SoloStar pre-filled pen in the outer carton in order to protect from light.
Viale, vložek ali SoloStar napolnjen injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
INSTRUCTION FOR USE
NAVODILA ZA UPORABO
Via Valcanello, 4 03012 Anagni (FR) Italy
Sanofi S. p. A., Via Valcanello 4 03012 Anagni (FR) Italija
• Skin and allergic reactions at the injection site The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Kožne in alergijske reakcije na mestu injiciranja Znaki so lahko pordelost, nenavadno močna bolečina pri injiciranju, srbenje, koprivnica, otekanje ali vnetje.
Similar effects on glycohemoglobin and the incidence of symptomatic hypoglycemia were observed in both treatment groups, however fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group.
V obeh terapevtskih skupinah so ugotovili podobne učinke na glikirani hemoglobin in incidenco simptomatskih hipoglikemij, a glukoza v plazmi na tešče se je v primerjavi z izhodiščem v skupini z insulinom glargin zmanjšala bolj kot v skupini z insulinom NPH.
Lantus is a clear insulin.
Zdravilo Lantus je bister insulin.
Lantus 100 units/ml solution for injection in a vial It is important to ensure that syringes do not contain traces of any other material.
Lantus 100 enot/ml raztopina za injiciranje v viali Zagotoviti je treba, da injekcijske brizge ne vsebujejo sledov nobenih drugih snovi.
Packs of 1, 2, 5 and 10 vials
Pakiranja z 1, 2, 5 in 10 vialami.
Sodium hydroxide (for pH adjustment) Water for injections
Natrijev hidroksid (za uravnavanje pH) Voda za injekcije
Step 1.
1 enoto.
Refer to them before using your medicine.
Natančno jih preberite, preden začnete uporabljati zdravilo.
What Lantus contains
Kaj vsebuje zdravilo Lantus
To ensure you get the accurate dose, the Lantus cartridges are to be used only with the following pens: - JuniorSTAR which delivers doses in steps of 0.5 units - ClikSTAR, Tactipen, Autopen 24, AllStar or AllStar PRO which deliver doses in steps of 1 unit.
Da zagotovite, da prejmete pravilen odmerek, vložke zdravila Lantus uporabljajte samo z sledečimi injekcijskimi peresniki: - JuniorSTAR, s katerimi odmerjamo v korakih po 0,5 enot - ClikSTAR, Tactipen, Autopen 24, AllStar ali AllStar PRO, s katerimi odmerjamo v korakih po
There was less severe hypoglycaemia in the insulin glargine group as well.
V skupini, ki je uporabljala insulin glargin, je bilo tudi manj hudih hipoglikemij.
Needles are not included in the pack.
Igle niso priložene.
If administration by syringe is necessary, a vial should be used.
Če je potrebno dajanje z injekcijsko brizgo, je treba uporabiti vialo.
EU/1/00/134/001 1 vial of 5 ml EU/1/00/134/002 2 vials of 5 ml EU/1/00/134/003 5 vials of 5 ml EU/1/00/134/004 10 vials of 5 ml
EU/1/00/134/001 1 viala s 5 ml EU/1/00/134/002 2 viali s 5 ml EU/1/00/134/003 5 vial s 5 ml EU/1/00/134/004 10 vial s 5 ml
The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
Dosledno spoštujte izdelovalčeva navodila za uporabo injekcijskega peresnika glede nameščanja vložka in igle ter injiciranja insulina.
Subcutaneous use
Za subkutano uporabo
Before using SoloStar, the instructions for use included in the package leaflet must be read carefully (see section 6.6).
Pred uporabo SoloStarja natančno preberite navodila za ravnanje z injekcijskim peresnikom v navodilu za uporabo (glejte poglavje 6.6).
In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups.
V kliničnih študijah so protitelesa, ki navzkrižno reagirajo s človeškim insulinom in insulinom glargin, enako pogosto ugotavljali med prejemniki insulina NPH in insulina glargin.
Effects of insulin glargine (once daily) on diabetic retinopathy were evaluated in an open-label 5 year NPH-controlled study (NPH given bid) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography.
Učinke insulina glargin (enkrat na dan) na diabetično retinopatijo so raziskali v odprti, petletni, z NPH kontrolirani študiji (NPH apliciran dvakrat na dan) pri 1.024 bolnikih z diabetesom tipa 2.
D-65926 Frankfurt / Main Germany
D-65926 Frankfurt am Main Nemčija
If you think you may have a problem with SoloStar, consult your doctor, pharmacist or nurse.
Če menite, da gre za težavo s SoloStarjem, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
In clinical pharmacology studies, intravenous insulin glargine and human insulin have been shown to be equipotent when given at the same doses.
Kliničnofarmakološke študije so dokazale, da sta intravensko uporabljena insulin glargin in humani insulin v enakih odmerkih ekvipotentna.
Correspondingly, the incidences of nocturnal hypoglycaemia were 32% in the insulin glargine / lispro group versus 52% in the NPH / regular group.
Temu ustrezno je bila incidenca nočnih hipoglikemij v skupini z insulinom glargin in insulinom lispro 32% in v skupini z insulinom NPH in navadnim insulinom 52%.
- in whom an autonomic neuropathy is present, - with a long history of diabetes, - suffering from a psychiatric illness, - receiving concurrent treatment with certain other medicinal products (see section 4.5).
- ki se jim hipoglikemija razvije počasi, - ki so starejši, - po prehodu z živalskega na humani insulin, - ki imajo avtonomno nevropatijo, - z dolgo anamnezo diabetesa, - s psihiatrično boleznijo, - ki sočasno prejemajo določena druga zdravila (glejte poglavje 4.5).
It is recommended that the date of the first use be noted on the label.
Na nalepko je priporočljivo zapisati datum prve uporabe viale.
Use only clear and colourless solutions.
Uporabite le bistro in brezbarvno raztopino.
This can spread around the injection site.
Razširijo se tudi okoli mesta injiciranja.
Physiological concentrations of endogenous IGF-1 may activate the mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy, including in Lantus therapy, are considerably lower than the pharmacological concentrations required to activate the IGF-1 pathway.
Vendar so terapevtske koncentracije med insulinskim zdravljenjem, vključno z zdravljenjem z zdravilom Lantus, bistveno manjše kot farmakološke koncentracije, potrebne za aktivacijo poti IGF-1.
Do not freeze or place next to the freezer or a freezer pack.
Ne zamrzujte in ne shranjujte v bližini zamrzovalnika ali zamrzovalnega vložka.
The Lantus cartridges are to be used only in conjunction with the pens: ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO or JuniorSTAR (see section 4.2 and 4.4).
Vložki zdravila Lantus se uporabljajo samo skupaj z injekcijskimi peresniki ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO ali JuniorSTAR (glejte poglavji 4.2 in 4.4).
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija
Your blood sugar level may either rise or fall if you take: - beta-blockers (used to treat high blood pressure), - clonidine (used to treat high blood pressure), - lithium salts (used to treat psychiatric disorders).
Krvni sladkor se vam lahko zviša ali zniža, če jemljete: antagoniste adrenergičnih receptorjev beta (uporabljajo se za zdravljenje visokega krvnega tlaka), klonidin (uporablja se za zdravljenje visokega krvnega tlaka), litijeve soli (uporabljajo se za zdravljenje psihiatričnih motenj).
5 ml vial
5 ml viala
LABEL (cartridge)
NALEPKA (vložek)
Switch from insulin glargine 300 units/ml to Lantus Lantus and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable.
Zdravilo Lantus in zdravilo Toujeo (insulin glargin 300 enot/ml) nista bioekvivalentna in nista medsebojno zamenljiva.
If administration by syringe is necessary, a vial should be used (see section 4.2 and 4.4).
Če je potrebno odmerjanje z injekcijsko brizgo, je treba uporabiti vialo (glejte poglavji 4.2 in 4.4).
Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Lantus.
Bolnikom, ki zaradi protiteles proti humanemu insulinu potrebujejo velike odmerke insulina, se lahko po prehodu na zdravilo Lantus odziv na insulin izboljša.
Always perform the safety test before each injection.
Pred vsakim injiciranjem opravite varnostni preizkus.
- If you have missed a dose of Lantus or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia).
- Če ste izpustili odmerek zdravila Lantus ali če si niste injicirali dovolj insulina, se vam lahko koncentracija krvnega sladkorja preveč zviša (hiperglikemija).
Empty pens must not be re-filled and must be properly discarded.
Praznih injekcijskih peresnikov se ne sme ponovno polniti ter jih je treba pravilno zavreči.
SoloStar is a pre-filled pen for the injection of insulin.
SoloStar je napolnjen injekcijski peresnik za injiciranje insulina.
Select the dose
4. korak Izberite odmerek
The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if - you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of nervous disease (diabetic autonomic neuropathy), - you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly, - you have almost normal or, at least, greatly improved blood sugar levels, - you have recently changed from an animal insulin to a human insulin such as Lantus, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Prvi simptomi, ki opozarjajo na hipoglikemijo ("opozorilni simptomi"), se lahko spremenijo, oslabijo ali jih celo sploh ni več, če - ste starejši, - imate sladkorno bolezen že dolgo, - imate določeno vrsto okvare živčevja (diabetična avtonomna nevropatija), - ste nedavno (na primer prejšnji dan) doživeli hipoglikemijo ali če se hipoglikemija pojavi počasi, - imate skoraj normalno ali vsaj močno izboljšano koncentracijo krvnega sladkorja, - ste namesto živalskega insulina pred kratkim začeli uporabljati humani insulin, kakršen je zdravilo Lantus, - uporabljate ali ste uporabljali določena druga zdravila (glejte poglavje 2, "Druga zdravila in zdravilo Lantus").
Do not freeze or place next to the freezer compartment or a freezer pack.
Ne zamrzujte in ne shranjujte v bližini zamrzovalnega razdelka ali zamrzovalnega vložka.
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Med zdravili, ki lahko stopnjujejo učinek znižanja glukoze v krvi in povečajo nagnjenost k hipoglikemiji, so peroralni antidiabetiki, zaviralci angiotenzinske konvertaze (ACE), dizopiramid, fibrati, fluoksetin, zaviralci monoaminooksidaze (MAO), pentoksifilin, propoksifen, salicilati in sulfonamidni antibiotiki.
Lantus must not be mixed with any other insulin or diluted.
Zdravila Lantus se ne sme mešati z nobenim drugim insulinom ali ga redčiti.
2 vials of 5 ml.
2 viali s 5 ml.
INFORMATION IN BRAILLE
PODATKI V BRAILLOVI PISAVI Lantus
Problems with the insulin pen?
Težave z insulinskim injekcijskim peresnikom?
Rare reported side effect (may affect up to 1 in 1,000 people)
Redko poročani neželeni učinki (pojavijo se lahko pri največ 1od 1.000 bolnikov)
Lantus 100 units/ml solution for injection in a vial Each vial contains 5 ml of solution for injection, equivalent to 500 units, or 10 ml of solution for injection, equivalent to 1000 units.
Lantus 100 enot/ml raztopina za injiciranje v viali Ena viala vsebuje 5 ml raztopine za injiciranje, kar ustreza 500 enotam, ali 10 ml raztopine za injiciranje, kar ustreza 1.000 enotam.
SoloStar is a pre-filled disposable pen containing insulin glargine.
SoloStar je napolnjen injekcijski peresnik, ki vsebuje insulin glargin.
10 ml vial
10 ml viala
Do not use it after this time period.
Ko to časovno obdobje preteče, je ne uporabite več.
Solution for injection 1 vial of 5 ml.
raztopina za injiciranje 1 viala s 5 ml.
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Primeri simptomov, ki nakazujejo nizek krvni sladkor v možganih so: glavobol, huda lakota, slabost, bruhanje, utrujenost, zaspanost, motnje spanja, nemir, agresivno vedenje, motena koncentracija, poslabšane reakcije, depresija, zmedenost, motnje govora (včasih popolna izguba govora), motnje vida, tresenje, paraliza, mravljinčenje (parestezije), omrtvelost in mravljinčenje v predelu ust, omotica, izguba nadzora nad seboj, nezmožnost poskrbeti zase, krči, izguba zavesti.
Insulin administration may cause insulin antibodies to form.
Uporaba insulina lahko povzroči nastanek protiteles proti insulinu.
Lantus in pre-filled pen is only suitable for injecting just under the skin (see also section 3).
Zdravilo Lantus v napolnjenem injecijskem peresniku je primerno samo za injiciranje tik pod kožo (glejte tudi poglavje 3).
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM