natgillin/translations-raw huggingface dataset:
Following reconstitution with water for injections, the medicinal product must be used immediately and cannot be stored for future use. 
Po redčenju z vodo za injiciranje je treba zdravilo uporabiti takoj in se ga ne sme shraniti za poznejšo uporabo.
Of the 31 partial LD subgroup patients evaluated, 27 (87%) had familial partial LD and 4 (13%) had acquired partial LD. 
Med 31 analiziranimi bolniki iz podskupine s parcialno LD jih je 27 (87 %) imelo familiarno parcialno LD in 4 (13 %) pridobljeno parcialno LD.
• high blood sugar levels 
• povišane ravni krvnega sladkorja
Myalepta reconstituted with water for injection is for single use only and should be administered immediately. 
Zdravilo Myalepta, razredčeno z vodo za injiciranje, je predvideno samo za enkratno uporabo in ga je treba vzeti takoj.
o Ways to prevent the occurrence of medication errors - Myalepta is administered by SC injection and proper technique should be used to avoid intramuscular injection in patients with minimal SC tissue. 
o Načini preprečevanja napak pri uporabi zdravila - Zdravilo Myalepta se daje s subkutano injekcijo, zato je treba uporabiti primerno tehniko, da se pri bolnikih z minimalnim subkutanim tkivom prepreči intramuskularno injiciranje.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 
Morebitno neporabljeno zdravilo ali odpadni material je treba zavreči v skladu z lokalnimi predpisi.
If you need to stop using Myalepta, your doctor will gradually reduce the dose over two weeks. 
Če morate prenehati z jemanjem zdravila Myalepta, vam bo zdravnik postopoma zmanjševal odmerek v obdobju dveh tednov.
Overall, 51 (77%) patients were female, 31 (47%) were Caucasian, 11 (17%) Hispanic, and 16 (24%) Black. 
Skupno je bilo 51 (77 %) bolnikov žensk, 31 (47 %) jih je bilo belcev, 11 (17 %) Hispancev in 16 (24 %) črncev.
• If you are female and weigh more than 40 kg: 
• Če ste ženska in tehtate več kot 40 kg:
Blood glucose abnormal, Blood triglycerides increased, Drug specific antibody present, Glycosylated haemoglobin increased, Weight increased 
Nenormalna raven glukoze v krvi, povečani trigliceridi v krvi, prisotnost za zdravilo specifičnih protiteles, povečan glikoziliran hemoglobin, povečanje telesne teže
If you need to stop using Myalepta, your doctor will gradually reduce the dose over two weeks before stopping it altogether. 
Če morate prenehati z uporabo zdravila Myalepta, vam bo zdravnik postopoma zmanjševal odmerek v obdobju dveh tednov, preden boste zdravilo povsem prenehali uporabljati.
If any of the above apply to you (or you are not sure), talk to your doctor before using Myalepta. 
Če jemljete katero od zgornjih zdravil (ali ste negotovi), se pred uporabo zdravila Myalepta posvetujte z zdravnikom.
In the generalised LD group, mean decreases from baseline in HbA1c were noted in all age groups ≥ 6 years; the mean decreases to Month 12/last observation carried forward LOCF were similar in the two older age groups (-1.1% and -2.6%). 
V skupini z generalizirano LD je bilo pri vseh starostnih skupinah ≤ 6 let zabeleženo povprečno zmanjšanje od izhodiščne ravni HbA1c; povprečna zmanjšanja po 12 mesecih/zadnjem izvedenem spremljanju (LOCF - last observation carried forward) so bila podobna pri obeh starejših starostnih skupinah (-1,1 % in -2,6 %).
Talk to a doctor straight away if you notice any signs of an inflamed pancreas, including: 
Takoj se posvetujte z zdravnikom, če opazite katere koli znake vnete trebušne slinavke, vključno z naslednjimi:
The AUC exposure of pregnant mice was approximately 2 to 3 times greater than observed in non-pregnant mice after 10 mg/kg subcutaneous administration of metreleptin. 
Izpostavljenost na podlagi AUC pri brejih miših je bila približno 2- do 3-krat večja kot pri nebrejih miših po 10 mg/kg subkutanega prejemanja metreleptina.
Specific clinical studies have not been conducted to assess the effect of age, gender, race, or body mass index on the pharmacokinetics of metreleptin in patients with lipodystrophy. 
Starost, spol, rasa, indeks telesne mase Specifičnih kliničnih študij za oceno učinka starosti, spola, rase ali indeksa telesne mase na farmakokinetiko metreleptina pri bolnikih z lipodistrofijo niso izvedli.
• having a high temperature 
• povišana telesna temperatura
If a patient misses a dose, the dose should be administered as soon as the omission is noticed and the normal dosing schedule resumed the next day. 
Če bolnik izpusti odmerek, ga mora vzeti takoj, ko to opazi, ter naslednji dan nadaljevati z normalnim odmerjanjem.
• Remove the syringe from the plastic ampoule. 
• Odstranite brizgo iz plastične ampule.
o See the “Instructions for Use” to find out which syringe to use. 
o V "priročniku za uporabo" je navedeno, katero brizgo uporabiti.
Your doctor, nurse or pharmacist will show you how to prepare and inject this medicine. 
Zdravnik, medicinska sestra ali farmacevt vam bo pokazal, kako zdravilo pripraviti in ga injicirati.
Tell your doctor straight-away if you have any symptoms of an allergic reaction. 
Svojega zdravnika takoj obvestite o morebitnih simptomih alergijske reakcije.
• increased blood sugar (glucose) 
• povišan krvni sladkor (glukoza)
All reports of hypoglycaemia in patients with generalised LD and in the subgroup of partial LD patients, have been mild in nature with no pattern of onset or clinical sequelae. 
Vsi pojavi hipoglikemije pri bolnikih z generalizirano LD in v podskupini bolnikov s parcialno LD so bili blage narave in brez vzorca nastanka ali kliničnih posledic.
A dose increment of 1.25 mg increases the daily dose to 3.75 mg. 
povečanjem v koraku po 1,25 mg se dnevni odmerek poveča na 3,75 mg.
However, in published studies, leptin treatment of euleptinaemic prepubertal female mice has led to an earlier onset of puberty. 
Vendar pa je pri objavljenih študijah dajanje metreleptina predpubertetnim mišjim samicam vodilo do zgodnejšega začetka pubertete.
● Fasting insulin concentration > 30 μU/mL, or 
● koncentracija insulina na tešče > 30 μ e./ml ali
- Guidance in the educational materials on: The size of syringes and needles to prescribe Prescribing the dose in both mg and ml and, where a 0.3 mL U100 insulin syringe is used, informing patients on the dose in "units" on the syringe to inject The prescribing of ampoule/vial sizes volumes of water for injection in appropriate volumes to reduce the risk of re-use Pharmacists will be guided in the educational materials on the ancillary items that need to be dispensed to patients including appropriate sized reconstitution and administration syringes and needles, appropriate sized vials/ampoules of water for injection, alcohol swabs and a sharps bin plus how to access Aegerion reconstitution and administration kits containing all of the above items except the water for injection and sharps bin. 
Predpisovanju odmerka v mg in ml ter, v primeru uporabe 0,3 ml-insulinske brizge U100, o obveščanju bolnikov o odmerku v »enotah« na brizgi za injiciranje Predpisovanju ampul/vial z vodo za injekcije z ustreznim volumnom, da se zmanjša tveganje ponovne uporabe zdravila V izobraževalnem gradivu dobijo farmacevti napotke o pomožnem materialu, ki ga je treba izdati bolnikom, vključno z ustrezno velikostjo brizg in iglel za rekonstitucijo in dajanje zdravila, ustrezno velikostjo viala/ampula vodo za injekcije z ustreznim volumnom, alkoholnimi blazinicami in vsebnikom za ostre predmete, ter napotke o zagotovitvi kompletov za rekonstitucijo in dajanje podjetja Aegerion, ki vsebujejo ves omenjeni material, razen vode za injekcije in vsebnika za ostre predmete.
In studies of healthy adult subjects, following intravenous administration of metreleptin, leptin volume of distribution (endogenous leptin and metreleptin) was approximately 4 to 5 times plasma volume; volumes (mean ± SD) were 370 ± 184 mL/kg, 398 ± 92 mL/kg, and 463 ± 116 mL/kg for 0.3, 1.0, and 3.0 mg/kg/day doses, respectively. 
Pri študijah z zdravimi odraslimi osebami je bil po intravenskem odmerjanju metreleptina porazdelitveni volumen leptina (endogeni leptin in metreleptin) približno 4- do 5-krat večji od volumna plazme; volumni (povprečni ± SD) so bili 370 ± 184 ml/kg, 398 ± 92 ml/kg in 463 ± 116 ml/kg za 0,3, 1,0 oz. 3,0 mg/kg/dnevni odmerek.
The maximum daily dose in males and females is 10 mg or 2 mL injection volume 
Največji dnevni odmerek pri moških in ženskah je 10 mg ali 2 ml injiciranega volumna.
• If you are male and weigh more than 40 kg: 
• Če ste moški in tehtate več kot 40 kg:
• The needle should be facing down. 
• Igla mora biti usmerjena navzdol.
• All of the water for injection should be injected into the vial. 
• V vialo je treba injicirati vso vodo za injekcije.
Insert the needle into the vial containing the lyophilized powder, through the centre of the stopper and direct the stream of solvent to the wall of the vial to avoid excessive foaming. 
Iglo vstavite v vialo z liofiliziranim praškom skozi sredino zamaška in usmerite curek topila ob steno viale, da preprečite prekomerno penjenje.
o Myalepta may increase fertility, due to effects on LH and thus the chances of unplanned pregnancy. 
o Zdravilo Myalepta lahko poveča plodnost zaradi učinka na LH, zaradi česar obstaja možnost nenačrtovane nosečnosti.
Metreleptin has not been studied in patients with impaired renal or hepatic function. 
Metreleptin ni bil preučen pri bolnikih z okvarami ledvic ali jeter.
● Percent change from baseline in fasting serum TGs at Month 12 
● odstotna sprememba v ravneh TG v serumu na tešče v 12. mesecu glede na izhodišče.
• fluid in your lungs - difficulty breathing or cough 
• tekočina v pljučih - oteženo dihanje ali kašelj
• Do not move the plunger. 
• Ne premikajte bata.
Adverse reactions are classified by MedDRA System Organ Class and absolute frequency in Table 7. 
Neželeni učinki so razvrščeni v Preglednica 7 glede na organske sisteme MedDRA in absolutno pogostost.
• muscle pain (‘myalgia') 
• bolečine v mišicah ("mialgija")
The median age at baseline was 38 years (range: 15-64 years), with 5 (16%) patients being less than 18 years of age. 
Povprečna starost je bila 38 let (razpon: 15-64 let), od tega je bilo 5 (16 %) bolnikov mlajših od 18 let.
The cake of lyophilised powder should be intact and white in colour. 
Pogača iz liofiliziranega praška mora biti intaktna in bele barve.
o The 0.3 mL syringe will show the injection amount in ‘Unit' instead of ‘mL'. 
o Na 0,3-mililitrski brizgi bo količina za injiciranje prikazana v "enoti" namesto v "ml".
The importance of tapering the dose of Myalepta over two weeks if it is to be discontinued. 
Pomembnost postopnega zmanjšanja odmerka zdravila Myalepta v obdobju dveh tednov v primeru prenehanja jemanja zdravila.
The benefits and risks of treatment should be carefully considered in patients with acquired generalised LD and/or in patients with significant haematological abnormalities (including leukopenia, neutropenia, bone marrow abnormalities, lymphoma, and/or lymphadenopathy). 
Koristi in tveganja zdravljenja je treba skrbno pretehtati pri bolnikih z generalizirano LD in/ali bolnikih s hudimi hematološkimi motnjami (vključno z levkopenijo, nevtropenijo, boleznimi kostnega mozga, limfomom in/ali limfadenopatijo).
Of the 66 generalised LD patients enrolled, 45 (68%) had congenital generalised LD and 21 (32%) had acquired generalised LD. 
Med 66 vključenimi bolniki z generalizirano LD jih je 45 (68 %) imelo prirojeno generalizirano LD, 21 (32 %) pa jih je imelo pridobljeno generalizirano LD.
27) Gently use your thumb to push the plunger all the way down. 
27) Nežno s palcem potisnite bat do konca navzdol.
2) Before preparing Myalepta solution, allow the powder vial to reach room temperature for about 10 minutes. 
2) Pred pripravo raztopine zdravila Myalepta počakajte približno 10 minut, da se viala s praškom segreje na sobno temperaturo.
Very limited data are available for children, especially less than 6 years, with generalised LD. 
Za otroke z generalizirano LD, še posebej za mlajše od 6 let, je podatkov zelo malo.
Study NIH 991265/20010769 was conducted over 14 years, with the primary efficacy assessments being made in both generalised LD and partial LD patients after 12 months of treatment. 
Študija NIH 991265/20010769 je potekala 14 let, pri čemer so se primarne ocene učinkovitosti izvajale po 12 mesecih zdravljenja tako pri bolnikih z generalizirano LD kot tudi s parcialno LD.
The median age at baseline was 15 years (range: 1-68 years), with 45 (68%) patients being less than 18 years of age. 
Povprečna starost je bila 15 let (razpon: 1-68 let), od tega je bilo 45 (68 %) bolnikov mlajših od 18 let.
• 1 U is the same as 0.01 mL. 
• 1 U je enako 0,01 ml.
• Until the powder dissolves and the liquid is clear. 
• To počnite, dokler se prašek ne raztopi in nastane prozorna tekočina.
• Tap the side of the syringe to move the air pocket/air bubbles to the top of the syringe. 
• Potrkajte po strani brizge, da prestavite morebitni zračni žep/zračne mehurčke do vrha brizge.
Neutralising antibodies 
Nevtralizirajoča protitelesa
• Hold the bottom of the ampoule in one hand and the top of the ampoule in your other hand. 
• Spodnji del ampule primite z eno roko, vrh pa z drugo.
What Myalepta looks like and contents of the pack 
Izgled zdravila Myalepta in vsebina pakiranja
The median fasting leptin concentration at baseline was 1.0 ng/mL in males (range: 0.3-3.3 ng/mL) and 1.1 ng/mL in females (range: 0.2-5.3 ng/mL) using the LINCO RIA test method. 
Povprečna koncentracija leptina na tešče je bila ob izhodišču 1,0 ng/ml pri moških (razpon: 0,3-3,3 ng/ml) in 1,1 ng/ml pri ženskah (razpon: 0,2-5,3 ng/ml), določeno z uporabo testne metode LINCO RIA.
Myalepta might increase fertility in women with lipodystrophy. 
Zdravilo Myalepta lahko poveča plodnost pri ženskah z lipodistrofijo.
Dose adjustments (injection volume) 
Prilagoditve odmerka (volumen injekcije)
Other medicines and Myalepta 
Druga zdravila in zdravilo Myalepta
The plastic ampoule is a sealed container with a twist-off top. 
Plastična ampula je zatesnjen vsebnik z navojnim pokrovčkom.
A review of the patient's self-administration technique is recommended every 6 months whilst using Myalepta. 
Pri uporabi zdravila Myalepta se vsakih 6 mesecev priporoča preverjanje bolnikove tehnike samoinjiciranja zdravila.
There are limited data on the pharmacokinetics of metreleptin in patients with lipodystrophy and therefore no formal exposure-response analysis has been performed. 
O farmakokinetiki metreleptina pri bolnikih z lipodistrofijo so na voljo samo omejeni podatki, zaradi česar ni bila izvedena formalna analiza razmerja med izpostavljenostjo in odzivom.
For all patients weighing more than 40 kg an incremental adjustment increase in daily dose would be 1.25 mg or 0.25 mL injection volume. 
Pri vseh bolnikih, ki tehtajo več kot 40 kg, se dnevni odmerek povečuje v korakih po 1,25 mg ali 0,25 ml injiciranega volumna.
T-cell lymphoma 
T-celični limfom
Example: A male patient is initiated at 2.5 mg of Myalepta daily. 
Primer: Moški bolnik na začetku prejme 2,5 mg zdravila Myalepta dnevno.
14) Take the needle out of the vial and throw away the syringe into a sharps disposal container. 
14) Odstranite iglo iz viale in zavrzite brizgo v vsebnik za ostre predmete.
Patients/carers educational material should contain: 
Izobraževalno gradivo za bolnike/skrbnike mora vsebovati:
Patients and/or carers should prepare and administer the first dose of the medicinal product under the supervision of a qualified healthcare professional. 
Bolniki in/ali negovalci morajo pripraviti in injicirati prvi odmerek zdravila pod nadzorom kvalificiranega medicinskega strokovnjaka.
• increase in fatty tissue 
• povečanje maščobnih tkiv
They will provide a ‘sharps disposal container' for you to put your used vials, syringes and needles in. 
Prav tako boste prejeli vsebnik za odstranjevanje ostrih predmetov, v katerega boste odstranjevali rabljene viale, brizge in igle.
In the generalised LD group, the number of patients according to age group was as follows: 5 patients < 6 years (including a single patient < 2 years), 12 patients ≥ 6 to < 12 years and 28 patients aged ≥ 12 to < 18 years; in the partial LD subgroup, there were no patients < 12 years of age and 4 patients ≥ 12 to < 18 years. 
V skupini z generalizirano LD je bilo število bolnikov glede na starostno skupino sledeče: 5 bolnikov < 6 let (vključno z enim bolnikom < 2 leti), 12 bolnikov ≤ 6 do < 12 let in 28 bolnikov, starih ≤ 12 do
• a higher than normal desire for food or excessive eating 
• večja želja po hrani kot običajno ali prekomerno prehranjevanje • hitrejši srčni utrip od običajnega
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Myalepta should be permanently discontinued immediately and appropriate therapy initiated. 
Če pride do anafilaktične reakcije ali druge resne alergijske reakcije, je treba z dajanjem zdravila Myalepta takoj trajno prenehati in uvesti ustrezno zdravljenje.
• The 0.3 mL syringe shows the injection amount in ‘U' instead of ‘mL'. 
• Na 0,3-mililitrski brizgi je količina za injiciranje prikazana v "U" namesto v "ml".
The European Medicines Agency has deferred the obligation to submit the results of studies with Myalepta in one or more subsets of the paediatric population in the treatment of lipodystrophy (see section 4.2 for information on paediatric use). 
Myalepta za eno ali več podskupin pediatrične populacije pri zdravljenju lipodistrofije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The needle will now be facing up. 
Igla bo sedaj usmerjena navzgor.
If you notice any of the symptoms above, or you are not sure, talk to your doctor straight away. 
Če opazite katere od zgornjih simptomov oz. niste prepričani, se takoj posvetujte z zdravnikom.
If an anaphylactic reaction or other serious allergic reaction occurs, administration should be permanently discontinued immediately and appropriate therapy initiated. 
Če pride do anafilaktične reakcije ali druge resne alergijske reakcije, je treba takoj prenehati z dajanjem zdravila in uvesti ustrezno terapijo.
0.3 mL U100 Insulin Syringe 
0,3 ml insulinska brizga U100
• Without the needle attached, insert the 1 mL syringe tip into the top of the plastic ampoule as far as possible. 
• Brez pritrjene igle vstavite konico 1-mililitrske brizge čim dlje v vrh plastične ampule.
Attach the needle to the syringe. 
Pritrdite iglo na brizgo.
Myalepta is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Zdravila Myalepta ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Symptoms of high blood sugar levels include: 
Simptomi visokih ravni krvnega sladkorja vključujejo:
TGs for the generalised LD group were noted in all age groups with larger mean changes observed in the older age group (-42.9%) compared to the younger age groups (-10.5% and -14.1%). 
Povprečna zmanjšanja od izhodišča do 12 mesecev/LOCF v ravni TG v skupini z generalizirano LD so bila zabeležena pri vseh starostnih skupinah, večje povprečne spremembe pa so bile opazne pri starejši starostni skupini (-42,9 %) v primerjavi z mlajšima starostnima skupinama (-10,5 % in -14,1 %).
- Patients and/or caregivers should prepare and administer the first dose under the supervision of a qualified HCP. 
- Bolniki in/ali skrbniki morajo pripraviti in dati prvi odmerek pod nadzorom usposobljenega zdravstvenega delavca.
Read the “Instructions for Use” (see section 7) for how to make the solution before injecting. 
V " priročniku za uporabo" (glejte 7. poglavje) je opisano, kako pripraviti raztopino pred injiciranjem.
How to store Myalepta 6. 
Shranjevanje zdravila Myalepta 6.
Patients were eligible for inclusion if they were > 6 months old, with a leptin level of < 12 ng/mL, and had at least 1 of the following 3 metabolic abnormalities: 
> 6 mesecev, so imeli raven leptina < 12 ng/ml in so imeli vsaj 1 od naslednjih 3 presnovnih nepravilnosti:
• medicines for epilepsy or fits (such as phenytoin) 
• zdravila za zdravljenje epilepsije ali napadov krčev (kot je fenitoin);
− A starting dose is 0.06 mg (0.012 mL of solution) for each kilogram of body weight. 
− začetni odmerek je 0,06 mg (0,012 ml raztopine) za vsak kilogram telesne mase,
Action 
Dejanje
Safety and efficacy data were analysed in a subgroup of partial LD patients with the following characteristics: 12 years of age and above with leptin levels < 12 ng/mL, TG ≥ 5.65 mmol/l and/or 
Podatki o varnosti in učinkovitosti so bili analizirani v podskupini bolnikov s parcialno LD z naslednjimi značilnostmi: starostjo 12 let ali več in ravnmi leptina < 12 ng/ml, TG ≥ 5,65 mmol/l in/ali HbA1c ≥ 8 %.
• If your dose is 1.50 mg (0.30 mL of solution) or less, you will need to use a 0.3 mL syringe. 
• Če je vaš odmerek 1,50 mg (0,30 ml raztopine) ali manj, morate uporabiti 0,3-mililitrsko brizgo.
• Hold the ampoule so that the top is facing up. 
• Ampulo držite tako, da bo vrh usmerjen navzgor.
You may have higher amounts of sugar (‘hyper-glycaemia') or fat (‘hyper-triglyceridaemia') in your blood while on Myalepta, which may be a sign that this medicine is not working as well as it should. 
ali maščob ("hipertrigliceridemija") v krvi, kar je lahko znak, da zdravilo ne deluje tako dobro, kot bi moralo.
Once insulin requirements have stabilised, dose adjustments of other anti-diabetics may also be needed in some patients. 
Ko se potreba po insulinu stabilizira, bo pri nekaterih bolnikih morda treba prilagoditi tudi druge antidiabetike.
Do not reconstitute with other diluents. 
Ne redčite z drugimi topili.
Actual body weight at initiation of treatment should always be used when calculating the dose. 
Pri izračunu odmerka je treba vedno uporabiti bolnikovo telesno maso na začetku zdravljenja.
Non-compliance with, or abrupt discontinuation of, Myalepta may result in worsening hypertriglyceridaemia and associated pancreatitis, particularly in patients with risk factors for pancreatitis (e.g. history of pancreatitis, severe hypertriglyceridaemia) (see section 4.8). 
Nepravilno zdravljenje ali nenadna prekinitev jemanja zdravila Myalepta lahko povzroči poslabšanje hipertrigliceridemije in povezanega pankreatitisa, predvsem pri bolnikih z dejavniki tveganja za pankreatitis (npr. anamneza pankreatitisa, huda hipertrigliceridemija) (glejte poglavje 4.8).
• The other ingredients are: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment). 
• Druge sestavine zdravila so: glicin, saharoza, polisorbat 20, glutaminska kislina, natrijev hidroksid (za uravnavanje pH).
7) Remove any air pocket or air bubbles. 
7) Odstranite morebitne zračne žepe in zračne mehurčke.
The water for injection will come in either: 
Voda za injekcije je lahko v:
Fatigue, Injection site bruising, Injection site erythema, Injection site reaction 
Utrujenost, podplutba na mestu injiciranja, eritem na mestu injiciranja, reakcija na mestu injiciranja
• Remove the syringe from the ampoule and hold it so that the needle faces up. 
• Odstranite brizgo iz ampule in jo primite tako, da bo igla usmerjena navzgor.
• Do not insert the needle into a muscle. 
• Ne vstavite igle v mišico.
Maximum daily dose (injection volume) 
Največji dnevni odmerek (volumen injekcije)
• feeling sleepy or confused 
• občutek zaspanosti ali zmedenosti
Fat tissue increased, Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site swelling, Malaise, Peripheral swelling 
Povečanje maščobnega tkiva, krvavitev na mestu injiciranja, bolečina na mestu injiciranja, srbenje na mestu injiciranja, oteklina na mestu injiciranja, splošno slabo počutje, periferno otekanje
For the 32 patients with generalised LD who were receiving oral anti-diabetic medicinal products at baseline, 7 (22%) were able to discontinue their use. 
Med 32 bolniki z generalizirano LD, ki so ob izhodišču prejemali peroralne antidiabetike, jih je lahko 7 (22 %) prenehalo z jemanjem le-teh.
• With the syringe still inserted into the glass vial or plastic ampoule, tap the side of the syringe to move the air pocket/air bubbles to the top of the syringe. 
• Z brizgo še vedno v stekleni viali ali plastični ampuli potrkajte po strani brizge, da prestavite morebitni zračni žep in/ali zračne mehurčke do vrha brizge.