natgillin/translations-raw huggingface dataset:
Levemir is a clear colourless solution for injection.
Zdravilo Levemir je bistra, brezbarvna raztopina za injiciranje.
It is available in a cartridge (PenFill) or in a prefilled pen (FlexPen and InnoLet).
Na voljo je v vložkih (PenFill) ali v predhodno napolnjenih injekcijskih peresnikih (FlexPen in InnoLet).
Levemir contains the active ingredient insulin detemir.
Zdravilo Levemir vsebuje zdravilno učinkovino insulin detemir.
Levemir is used to treat patients (adults and children over the age of 6) who have diabetes.
Levemir se uporablja za zdravljenje bolnikov s sladkorno boleznijo (odraslih in otrok, starejših od 6).
Levemir is administered subcutaneously (under the skin) by injection in the abdominal wall (tummy), the thigh, or the upper arm.
Zdravilo Levemir se daje subkutano (pod kožo) z injiciranjem v trebušno steno, stegno ali nadlaket.
Levemir is a long-acting insulin.
Levemir je insulin z dolgotrajnim delovanjem.
It can be used in the following ways: • once a day as an add-on to oral anti-diabetes medicines.
Lahko se uporablja na naslednje načine: • Enkrat dnevno kot dodatek k peroralnim antidiabetičnim zdravilom.
The dose should be adjusted according to the individual patients ’ blood glucose levels, • in combination with injections at mealtimes of a short- or rapid-acting insulin.
Odmerek je treba prilagoditi glede na posameznikovo raven glukoze v krvi. • V kombinaciji z injekcijami kratko - ali hitrodelujočega insulina ob obrokih.
It should be given once or twice a day depending on patients’ needs.
Daje se enkrat ali dvakrat dnevno, odvisno od bolnikovih potreb.
The patient ’ s blood glucose should be regularly tested to find the lowest effective dose.
Za določitev najmanjšega učinkovitega odmerka je treba raven glukoze v krvi bolnika redno preverjati.
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar.
Zdravilo Levemir je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna slinavka.
Levemir is a replacement insulin which is very similar to the insulin made by the pancreas. The active ingredient of Levemir, insulin detemir, is produced by a method known as ‘ recombinant DNA technology’.
Zdravilna učinkovina zdravila Levemir, humani insulin, je izdelana z metodo, znano pod imenom “ rekombinantna DNA tehnologija ”.
It is made by a yeast that has received a gene (DNA), which makes it able to produce insulin detemir.
Izdela ga kvasovka, ki je prejela gen (DNA), s pomočjo katerega lahko tvori insulin detemir.
Insulin detemir is very slightly different from human insulin, and the change means that it is absorbed more slowly by the body, and takes longer to reach its target in the body.
Insulin detemir se zelo malo razlikuje od človeškega insulina, ta razlika pa pomeni, da ga telo počasneje absorbira, in da traja dlje, da v telesu doseže svoj cilj.
This means that Levemir has a long duration of action.
To pomeni, da ima Levemir dolg čas učinkovanja.
By controlling the level of blood sugar, the symptoms and complications of diabetes are reduced.
Z uravnavanjem ravni sladkorja v krvi se simptomi in zapleti, povezani s sladkorno boleznijo, zmanjšajo.
Injections of fast-acting insulin were also used at mealtimes.
Zdravilo Levemir so preučili pri 1575 bolnikih s sladkorno boleznijo tipa I, pri kateri trebušna slinavka ne more tvoriti insulina, in pri več kot 2400 bolnikih s sladkorno boleznijo tipa II, pri kateri telo ne more učinkovito izrabiti insulina.
In four of the six studies in type 2 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V raziskavah so primerjali Levemir s humanim insulinom 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged diabetes, patients also received one or two oral anti-diabetes medicines.
V času obrokov so bile uporabljene tudi injekcije hitrodelujočega insulina.
All studies measured the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
V okviru vseh raziskav so merili raven glikoziliranega hemoglobina (HbA1c), ki kaže, kako dobro je glukoza v krvi nadzorovana.
What benefit has Levemir shown during the studies?
Kakšne koristi je zdravilo Levemir izkazalo med raziskavami?
The studies showed that Levemir controls HbA1c in a similar manner to insulin NPH, with less risk of low blood glucose level during the night and no associated weight gain.
Študije so pokazale, da zdravilo Levemir uravnava HbA1c na podoben način kot insulin NPH, vendar z manj tveganja za nočna znižanja ravni glukoze v krvi in brez hkratnega pridobivanja na telesni masi.
In combination with oral anti- diabetes medicines, Levemir also controlled HbA1c in a similar manner to insulin glargine.
V kombinaciji skupaj z peroralnimi antidiabetičnimi zdravili zdravilo Levemir uravnava HbA1c na podoben način kot insulin glargin.
The most common side effects when taking Levemir (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose) and injection site reactions (redness, swelling, itching).
Najpogostejši neželeni učinki povezani z jemanjem zdravila Levemir (opaženi med 1 in 10 bolniki od 100) so hipoglikemija (nizka raven glukoze v krvi) in reakcije na mestu injiciranja (pordelost, otekanje, srbenje).
In patients also taking oral anti-diabetes medicines, a common side effect is signs of allergy.
Pri bolnikih, ki jemljejo tudi peroralna antidiabetična zdravila so pogosti neželeni učinki tudi znaki alergije.
For the full list of all side effects reported with Levemir, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Levemir, glejte Navodilo za uporabo.
Levemir should not be used in people who may be hypersensitive to insulin detemir or any of the other ingredients.
Zdravila Levemir se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi na insulin detemir ali katero koli drugo sestavino.
Levemir doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).
Odmerke zdravila Levemir je morda potrebno prilagoditi, če se jemlje istočasno s katerim od drugih zdravil, ki lahko vplivajo na raven sladkorja v krvi (za celoten seznam glejte Navodilo za uporabo).
The Committee for Medicinal products for Human Use (CHMP) decided that Levemir’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Levemir pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
They recommended that Levemir be given marketing authorisation.
Zato je priporočil, da se za zdravilo Levemir podeli dovoljenje za promet.
Other information about Levemir:
Druge informacije o zdravilu Levemir:
The European Commission granted a marketing authorisation valid throughout the European Union for Levemir to Novo Nordisk A/ S on 1 June 2004.
Evropska komisija je dovoljenje za promet z zdravilom Levemir, veljavno po vsej Evropski uniji, odobrila družbi Novo Nordisk A/ S dne 1. junija 2004.
The full EPAR for Levemir is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Levemir je na voljo tukaj.
Route of administration
Raztopina za injiciranje
Packaging
5 vložkov
Package size
10 vložkov
Levemir Levemir Levemir Levemir Levemir Levemir Levemir Levemir Levemir
Vložek (steklo) v napolnjenem injekcijskem peresu (FlexPen)
Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection
Vložek (steklo) v napolnjenem injekcijskem peresu (FlexPen)
Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use
Vložek (steklo) v napolnjenem injekcijskem peresu (InnoLet)
Cartridge (glass) (Penfill) Cartridge (glass) (Penfill) Cartridge (glass) (Penfill) Cartridge (glass) in pre-filled pen (FlexPen) Cartridge (glass) in pre-filled pen (FlexPen) Cartridge (glass) in pre-filled pen (FlexPen) Cartridge (glass) in pre-filled pen (InnoLet) Cartridge (glass) in pre-filled pen (InnoLet) Cartridge (glass) in pre-filled pen (InnoLet)
Vložek (steklo) v napolnjenem injekcijskem peresu (InnoLet)
1 cartridge 5 cartridges 10 cartridges 1 pre-filled pen 5 pre-filled pens 10 pre-filled pens 1 pre-filled pen 5 pre-filled pens 10 pre-filled pens
10 napolnjenih injekcijskih peres
Levemir 100 U/ ml solution for injection in a cartridge.
Levemir 100 e. / ml raztopina za injiciranje v injekcijskem vložku
1 ml contains 100 U of insulin detemir (produced by recombinant DNA technology in Saccharomyces cerevisiae).
1 ml vsebuje 100 e. insulina detemir (pridobljenega s tehnologijo rekombinantne DNA iz Saccharomyces cerevisiae).
1 cartridge contains 3 ml equivalent to 300 U.
1 injekcijski vložek vsebuje 3 ml, kar ustreza 300 e.
One unit of insulin detemir contains 0.142 mg salt-free anhydrous insulin detemir.
Ena enota insulina detemir vsebuje 0, 142 mg brezvodnega insulina detemir brez soli.
One unit (U) of insulin detemir corresponds to one IU of human insulin.
Ena enota (e.) insulina detemir ustreza eni i. e. humanega insulina.
Penfill
Raztopina za injiciranje v injekcijskem vložku Penfill.
Levemir is a long-acting insulin analogue used as a basal insulin..
Levemir je dolgodelujoč analog insulina, ki se lahko uporablja kot bazalni insulin.
In combination with oral antidiabetic agents it is recommended to initiate Levemir treatment with once daily administration at a dose of 10 U or 0.1-0.2 U/ kg.
V kombinaciji s peroralnimi antidiabetiki je priporočljivo zdravljenje z insulinom Levemir začeti enkrat na dan z odmerkom 10 e. ali 0, 1– 0, 2 e. / kg.
The dose of Levemir should be titrated based on individual patients’ needs.
Odmerek zdravila Levemir je treba titrirati glede na potrebe posameznega bolnika.
Based on study results, the following titration guideline is recommended:
Glede na izsledke študije so priporočene naslednje smernice za titriranje:
Average pre-breakfast SMPG > 10.0 mmol/ L (180 mg/ dL) 9.1-10.0 mmol/ L (163-180 mg/ dL) 8.1-9.0 mmol/ L (145-162 mg/ dL) 7.1-8.0 mmol/ L (127-144 mg/ dL) 6.1-7.0 mmol/ L (109-126 mg/ dL) If one SMPG measurement
Povprečna SIGP pred zajtrkom > 10, 0 mmol/ l (180 mg/ dl) 9, 1– 10, 0 mmol/ l (163– 180 mg/ dl) 8, 1– 9, 0 mmol/ l (145– 162 mg/ dl) 7, 1– 8, 0 mmol/ l (127– 144 mg/ dl) 6, 1– 7, 0 mmol/ l (109– 126 mg/ dl) Če je ena meritev SIGP
Levemir dose adjustment +8 +6 +4 +2 +2
Prilagoditev odmerka zdravila Levemir +8 +6 +4 +2 +2
3.1-4.0 mmol/ L (56-72 mg/ dL) < 3.1 mmol/ L (< 56 mg/ dL)
3, 1– 4, 0 mmol/ l (56– 72 mg/ dl) < 3, 1 mmol/ l (< 56 mg/ dl)
-2 -4
– 2 – 4
When Levemir is used as part of a basal-bolus insulin regimen Levemir should be administered once or twice daily depending on patients’ needs.
Če je Levemir uporabljen kot del bazalno- bolusne sheme zdravljenja z insulinom, ga je treba aplicirati enkrat ali dvakrat na dan, odvisno od bolnikovih potreb.
Dosage of Levemir should be adjusted individually.
Odmerjanje insulina Levemir je treba prilagoditi posamezno.
2 For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered in the evening or at bedtime.
2 Bolnikom, ki zaradi boljšega uravnavanja glukoze v krvi potrebujejo odmerjanje dvakrat dnevno, je mogoče večerni odmerek aplicirati zvečer ali pred spanjem.
Transfer from other insulins:
Prehod z drugih vrst insulina:
Transfer to Levemir from intermediate or long-acting insulins may require adjustment of dose and timing of administration (see section 4.4).
Ob prehodu s srednje - ali dolgodelujočega insulina na Levemir je morda treba prilagoditi količino in čas apliciranja (glejte poglavje 4. 4).
As with all insulins, close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.
Kot velja za vse vrste insulina, je ob prehodu ter nekaj tednov po njem priporočljivo skrbno spremljanje glukoze v krvi.
Concomitant antidiabetic treatment may need to be adjusted (dose and/ or timing of oral antidiabetic agents or concurrent short/ rapid-acting insulins).
Spremljajoče zdravljenje diabetesa je morda treba prilagoditi (odmerek in/ ali čas uporabe peroralnih antidiabetikov ali dajanja sočasno uporabljenih kratko - / hitrodelujočih vrst insulina).
As with all insulins, in elderly patients and patients with renal or hepatic impairment, glucose monitoring should be intensified and insulin detemir dosage adjusted on an individual basis.
Kot velja za vse vrste insulina, je treba glukozo v krvi starejših bolnikov in tistih z ledvično ali jetrno okvaro spremljati pozorneje ter odmerjanje insulina detemir individualno prilagoditi.
The efficacy and safety of Levemir were demonstrated in children and adolescents aged 6 to 17 years in studies up to 6 months (see section 5.1).
Učinkovitost in varnost uporabe zdravila Levemir sta bili dokazani pri otrocih in mladostnikih, starih od 6 do 17 let v do 6 mesecev trajajočih raziskavah (glejte poglavje 5. 1).
The efficacy and safety of Levemir have not been studied in children below the age of 6 years.
Učinkovitosti in varnosti zdravila Levemir pri otrocih mlajših od 6 let niso preučevali.
Adjustment of dosage may also be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Odmerjanje je morda treba prilagoditi tudi ob povečani fizični aktivnosti, spremenjeni običajni prehrani ali spremljajoči bolezni.
Levemir is administered subcutaneously by injection in the thigh, abdominal wall, or the upper arm.
Levemir se aplicira subkutano z injekcijo v stegno, trebušno steno ali nadlaket.
As with human insulins, the rate and extent of absorption of insulin detemir may be higher when administered s. c. in the abdomen or deltoid than in the thigh.
Kot velja za humani insulin, sta lahko hitrost in obseg absorpcije insulina detemir višja, kadar ga subkutano apliciramo v trebušno ali deltoidno področje kot pa v stegno.
Injection sites should therefore be alternated within the same region.
Mesta injiciranja je treba na posameznem predelu menjavati.
Levemir Penfill is accompanied by a package leaflet with detailed instruction for use to be followed.
Zdravilu Levemir Penfill je priloženo navodilo za uporabo s podrobnimi napotki za uporabo, ki jih je treba upoštevati.
Levemir Penfill is designed to be used with Novo Nordisk delivery systems and NovoFine needles.
Levemir Penfill je namenjen za uporabo z aplikacijskimi sistemi Novo Nordisk in iglami NovoFine.
Hypersensitivity to insulin detemir or to any of the excipients.
Preobčutljivost za insulin detemir ali katero koli pomožno snov.
Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis.
Neustrezno odmerjanje ali prekinitev zdravljenja lahko, zlasti pri diabetesu tipa 1, povzroči hiperglikemijo in diabetično ketoacidozo.
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see section 4.8 and 4.9).
Hipoglikemija se lahko pojavi, če je odmerek insulina prevelik glede na potrebo po insulinu (glejte poglavji 4. 8 in 4. 9).
3 Patients, whose blood glucose control is greatly improved, e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
3 Bolnikom, ki se jim uravnanost glukoze v krvi zelo izboljša, npr. z intenziviranim insulinskim zdravljenjem, se običajni opozorilni simptomi hipoglikemije lahko spremenijo in jih je s to možnostjo treba seznaniti.
Changes in strength, brand (manufacturer), type, origin (animal, human, human insulin analogue) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dosage.
Spremembe jakosti, znamke (izdelovalca), vrste ali izvora (živalski, humani, analog humanega insulina) in/ ali načina izdelave (rekombinantna DNA ali živalski vir insulina) imajo lahko za posledico spremembo odmerjanja.
Patients taking Levemir may require a change in dosage from that used with their usual insulin.
Bolniki, ki uporabljajo Levemir, morajo morda spremeniti odmerjanje, ki so se ga držali pri običajnem insulinu.
On rare occasions, injection site reactions may require discontinuation of Levemir.
V redkih primerih lahko reakcije na mestu injiciranja zahtevajo prekinitev zdravljenja z insulinom Levemir.
Levemir should not be administered intravenously as it may result in severe hypoglycaemia.
Zdravila Levemir se ne sme aplicirati intravensko, ker lahko povzroči hudo hipoglikemijo.
If Levemir is mixed with other insulin preparations the profile of action of one or both individual components will change.
Če je Levemir zmešan z drugimi pripravki insulina, se delovanje ene ali obeh komponent spremeni.
Mixing Levemir with a rapid acting insulin analogue like insulin aspart, results in an action profile with a lower and delayed maximum effect compared to separate injections.
Mešanje zdravila Levemir s hitrodelujočim analogom insulina, kot je insulin aspart, povzroči zmanjšanje in zakasnitev največjega učinka v primerjavi z učinkom posameznih injekcij.
Therefore, mixing of rapid acting insulin with Levemir should be avoided.
Zatorej mešanje zdravila Levemir s hitrodelujočim insulinom ni primerno.
Levemir contains metacresol, which may cause allergic reactions.
Levemir vsebuje metakrezol, ki lahko povzroči alergijske reakcije.
The following substances may reduce the insulin requirements:
Potrebo po insulinu lahko zmanjšajo naslednje snovi:
Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates and alcohol.
Peroralni antidiabetiki, zaviralci monoaminooksidaze (MAOI), neselektivni zaviralci adrenergičnih receptorjev beta, zaviralci encima angiotenzinske konvertaze (ACE), salicilati in alkohol.
The following substances may increase the insulin requirements:
Potrebo po insulinu lahko zvečajo naslednje snovi:
Thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Tiazidi, glukokortikoidi, ščitnični hormoni, beta- simpatikomimetiki, rastni hormon in danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
Zaviralci beta lahko prikrijejo simptome hipoglikemije in upočasnijo okrevanje po njej.
Octreotide/ lanreotide may both increase and decrease insulin requirement.
Oktreotid/ lanreotid lahko potrebo po insulinu zveča ali zmanjša.
4 Pregnancy:
Nosečnost:
There is no clinical experience with insulin detemir during pregnancy.
Kliničnih izkušenj z insulinom detemir med nosečnostjo ni.
Animal reproduction studies have not revealed any differences between insulin detemir and human insulin regarding embryotoxicity and teratogenicity.
4 Reprodukcijske raziskave pri živalih niso pokazale razlik v embriotoksičnosti ali teratogenosti med insulinom detemir in humanim insulinom.
Caution should be exercised when prescribing to pregnant women.
Pri predpisovanju insulina detemir ženskam med nosečnostjo je zaželena previdnost.
There is no clinical experience with insulin detemir during lactation.
Kliničnih izkušenj z insulinom detemir med dojenjem ni.
Caution should be exercised when prescribing to lactating women.
Pri predpisovanju insulina detemir doječim materam je zaželena previdnost.
Lactating women may require adjustments in insulin dose and diet.
Doječim materam je morda treba prilagoditi odmerke in prehrano.
Adverse drug reactions observed in patients using Levemir are mainly dose-dependent and due to the pharmacologic effect of insulin.
Neželeni učinki, opaženi pri bolnikih, ki uporabljajo Levemir, so v glavnem odvisni od odmerka in so posledica farmakološkega učinka insulina.
Hypoglycaemia is a common undesirable effect.
Hipoglikemija je pogost neželen učinek.
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.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Huda hipoglikemija lahko povzroči nezavest, konvulzije ali oboje in ima za posledico lahko prehodno ali trajno okvaro delovanja možganov ali celo smrt.
Injection site reactions are seen more frequently during treatment with Levemir than with human insulin.
Reakcije na mestu injiciranja so med zdravljenjem z insulinom Levemir pogostejše kot med zdravljenju s humanim insulinom.
These reactions include redness, inflammation, bruising, swelling and itching at the injection site.
Med takšnimi reakcijami so pordelost, vnetje, potpludbe, oteklina, in srbenje na mestu injiciranja.
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.
The overall percentage of treated patients expected to experience adverse drug reactions is estimated to be 12%.
Celotni odstotek zdravljenih bolnikov, pri katerih lahko pričakujemo neželene učinke, ocenjujemo na 12%.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to Levemir are listed below.
Pogostosti posameznih neželenih učinkov iz kliničnih raziskav, ki jih pripisujemo zdravilu Levemir, so navedene spodaj.
Common (> 1/ 100, < 1/ 10)
Pogosto (> 1/ 100, < 1/ 10)
Symptoms of hypoglycaemia usually occur suddenly.
Simptomi hipoglikemije se ponavadi razvijejo nenadoma.
They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness,
Obsegajo lahko hladno znojenje, hladno bledo kožo, utrujenost, živčnost ali tremor, tesnobnost, nenavadno izčrpanost ali šibkost, zmedenost, težave s koncentracijo, zaspanost, čezmerno lakoto, motnje vida, glavobol, slabost in palpitacije.
confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
možganov ali celo smrt.
Injection site reactions:
Reakcije na mestu injiciranja:
Injection site reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Med zdravljenjem z insulinom se lahko pojavijo reakcije na mestu injiciranja (pordelost, oteklina in srbenje na mestu injiciranja).
These reactions are usually transitory and normally they disappear during continued treatment.
Te reakcije so ponavadi prehodne in med nadaljevanjem zdravljenja ponavadi izginejo.
Uncommon (> 1/ 1,000, < 1/ 100)
Občasno (> 1/ 1. 000, < 1/ 100)
Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Če bolnik mest injiciranj znotraj posameznega predela ne menjava krožno, se lahko na mestu injiciranja pojavi lipodistrofija.
Oedema:
Oteklina:
Oedema may occur upon initiation of insulin therapy.
Po začetku zdravljenja z insulinom se lahko pojavijo otekline.
These symptoms are usually of transitory nature.
Ti simptomi so ponavadi prehodni.
In three clinical studies with subjects treated in combination with oral antidiabetic agents a higher frequency (2.2%) of allergic reactions and potentially allergic reactions have been observed.
V treh kliničnih študijah so med uporabo v kombinaciji s peroralnimi antidiabetiki opažali večjo pogostnost (2, 2%) alergijskih reakcij in potencialnih alergijskih reakcij.
Uncommon (> 1/ 1,000, < 1/ 100) Eye disorders
Občasno (> 1/ 1. 000, < 1/ 100) Očesne bolezni