natgillin/translations-raw huggingface dataset:
OPTISON improves the visualization of the inner cardiac walls in patients where the walls are difficult to see.
Zdravilo OPTISON izboljša predočitev notranjih sten srca pri bolnikih, pri katerih je te stene težje videti.
OPTISON contains microspheres (tiny gas bubbles) that after injection travel through the veins to the heart and fill the left heart chambers, allowing the doctor to visualise and asses the function of the heart.
Zdravilo OPTISON vsebuje mikrosfere (majhne plinske mehurčke), ki po vbrizganju potujejo po venah v srce in napolnijo levi srčni votlini, s čimer zdravniku omogočijo, da si predoči in oceni delovanje srca.
BEFORE YOU USE OPTISON
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO OPTISON
Do not use OPTISON
Ne uporabljajte zdravila OPTISON
- if you are allergic (hypersensitive) to perflutren or to any of the ingredients of OPTISON.
- če ste alergični na (preobčutljivi za) perflutren ali katerokoli sestavino zdravila OPTISON.
Take special care with OPTISON
Bodite posebno pozorni pri uporabi zdravila OPTISON
- if you have any known allergies.
- če imate kakšne znane alergije;
- if you have a severe heart, lung, kidney or liver disease.
- če imate hudo srčno, pljučno, ledvično ali jetrno bolezen.
The experience of OPTISON in severely ill
Izkušnje z zdravilom OPTISON pri hudo
patients is limited.
bolnih bolnikih so omejene;
- if you have an artificial valve in your heart.
- če imate umetno srčno zaklopko v srcu;
- if you have acute severe inflammation or sepsis.
- če imate hudo akutno vnetje ali sepso;
- if you have a known blood clotting problem
- če imate ugotovljene motnje strjevanja krvi.
Your heart activity and rhythm will be monitored when you get OPTISON.
Ko boste prejeli zdravilo OPTISON, vam bodo spremljali delovanje srca in srčni ritem.
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
17 Pregnancy and breast-feeding The safety of OPTISON for use during human pregnancy has not been fully established.
17 Varnost uporabe zdravila OPTISON v nosečnosti pri človeku ni povsem potrjena.
Therefore, the medicine should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the doctor.
Zato se zdravilo ne sme uporabljati v nosečnosti, razen če je korist večja od tveganja in je po presoji zdravnika uporaba nujna.
However, because OPTISON is based on human albumin (the main protein in our blood), it is highly unlikely that it will have any harmful effects in pregnancy.
Ker pa je osnova zdravila OPTISON humani albumin (glavna beljakovina v naši krvi), skoraj ni verjetno, da bi imel kakršnekoli škodljive učinke na nosečnost.
It is not known whether OPTISON passes into human milk.
Ni znano, ali zdravilo OPTISON prehaja v mleko pri človeku.
Therefore, caution should be exercised when OPTISON is administered to nursing women.
Zato se mora zdravilo OPTISON uporabljati previdno pri doječih materah.
Driving and using machines No effects are known.
Vpliv na sposobnost upravljanja vozil in strojev Ni znanih učinkov.
Important information about some of the ingredients of OPTISON This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium-free”.
Pomembne informacije o nekaterih sestavinah zdravila OPTISON To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘ brez natrija ’.
HOW TO USE OPTISON
KAKO UPORABLJATI ZDRAVILO OPTISON
OPTISON should only be administered by doctors experienced in the field of diagnostic ultrasound imaging.
Zdravilo OPTISON sme dajati samo zdravnik z izkušnjami na področju diagnostičnih ultrazvočnih preiskav.
OPTISON is administered via an intravenous injection to allow the microspheres to enter the heart chamber and fill the left heart chamber.
Zdravilo OPTISON se uporablja v obliki intravenske injekcije, ki omogoča, da mikrosfere vstopijo v srčno komoro in napolnijo levi srčni prekat.
OPTISON is injected during the ultrasound examination in order to allow the doctor to assess the function of your heart.
Zdravilo OPTISON se injicira med ultrazvočno preiskavo, da zdravniku omogoči oceniti delovanje vašega srca.
The recommended dose is 0.5 ml - 3.0 ml per patient.
Priporočeni odmerek je 0, 5 ml do 3, 0 ml na bolnika.
A dose of 3.0 ml is usually sufficient, but some patients may need higher doses.
Običajno zadošča odmerek 3, 0 ml, vendar lahko nekateri bolniki potrebujejo večje odmerke.
The duration of the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
Čas trajanja uporabnega slikanja je 2, 5 – 4, 5 minut za odmerek 0, 5 – 3, 0 ml.
Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ ml solution for injection or glucose 50 mg/ ml solution for injection should be injected at a rate of 1 ml/ s to optimise the effect of the contrast agent.
Takoj po injekciji zdravila OPTISON moramo injicirati 10 ml raztopine 9 mg/ ml natrijevega klorida za injiciranje ali raztopine 50 mg/ ml glukoze za injiciranje s hitrostjo 1 ml/ s, da čimbolj izboljšamo učinek kontrastnega sredstva.
If you are given more OPTISON than you should Effects suspected to be due to overdose have not been reported.
Če so vam dali večji odmerek zdravila OPTISON, kot bi smeli O učinkih, za katere bi sumili, da so posledica prevelikega odmerjanja, niso poročali.
Like all medicines, OPTISON can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo OPTISON neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Side effects to OPTISON are rare and usually not serious.
Neželeni učinki zdravila OPTISON so redki in običajno nenevarni.
In general the administration of human albumin has been associated with transient (non lasting)altered taste, nausea, flushing, rash, headache, vomiting, chills and fever.
Na splošno so uporabo humanih albuminov povezovali s prehodnimi (kratkotrajnimi) motnjami okušanja, slabostjo, rdečico, izpuščajem, glavobolom, bruhanjem, mrazenjem in povišano telesno temperaturo.
Rare severe allergic reactions (anaphylaxis) have been associated with the administration of human albumin products.
Redke težke alergijske reakcije (anafilaksija) so bile povezane z uporabo zdravil s humanimi albumini.
Reported side effects following the use of OPTISON:
Neželeni učinki po uporabi zdravila OPTISON, o katerih so poročali:
Common side effects (affects 1 to 10 users in 100): • Dysgeusia (altered taste) • Headache • Flushing (redness) • Warm sensation
Pogosti neželeni učinki (pojavijo se pri 1 do 10 uporabnikih od 100): • disgevzija (motnje okušanja), • glavobol, • napadi rdečice, • občutek toplote.
18 Uncommon side effects (affects 1 to 10 users in 1,000): • Eosinophilia (increased number of a type of white blood cells in the blood) • Dyspnoea (difficulty in breathing) • Chest pain
Občasni neželeni učinki (pojavijo se pri 1 do 10 uporabnikih od 1. 000): • eozinofilija (zvečano število ene od vrst belih krvničk v krvi), • dispnea (oteženo dihanje),
Rare side effects (affects 1 to 10 users in 10,000): • Tinnitus (noises in the ear) • Dizziness • Paraesthesia (tingling sensations)
Redki neželeni učinki (pojavijo se pri 1 do 10 uporabnikih od 10. 000): • tinitus (zvenenje v ušesih), • vrtoglavost, • parestezije (mravljinčenje).
Unknown frequency (side effects where frequency cannot be estimated from the available data): • Allergic type symptoms, for example, a severe allergic reaction or – shock (anaphylaxis), swelling of the face (face oedema), an itchy skin eruption (urticaria). • Visual disturbances
Neznana pogostnost (neželeni učinki, katerih pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): • simptomi alergijske vrste, na primer težka alergijska reakcija ali šok (anafilaksija), otekanje obraza (edem obraza), srbeč kožni izpuščaj (koprivnica), • motnje vida.
HOW TO STORE OPTISON
SHRANJEVANJE ZDRAVILA OPTISON
Do not use OPTISON after the expiry date which is stated on the label, after EXP.
Zdravila OPTISON ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na etiketi poleg oznake EXP.
Store upright in a refrigerator (2°C -8°C).
Shranjujte v hladilniku (2 °C - 8 °C) v pokončnem položaju.
The contents of the OPTISON vial should be used within 30 minutes after the rubber stopper has been penetrated.
Po predrtju gumijastega zamaška morate vsebino viale zdravila OPTISON uporabiti v 30 minutah.
What OPTISON contains
Kaj vsebuje zdravilo OPTISON
- The active substance is perflutren-containing microspheres of heat treated human albumin 5-
- Zdravilna učinkovina so mikrosfere s perflutrenom iz toplotno obdelanega humanega albumina
8 x 108/ ml, suspended in human albumin solution 1%.
v koncentraciji 5- 8 x 108/ ml, suspendirane v 1- odstotni raztopini humanega albumina.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg
V enem ml zdravila OPTISON je približno 0, 19 mg perflutren plina.
- The other ingredients are human albumin, sodium chloride, N-acetyltryptophan, caprylic acid,
- Pomožne snovi so humani albumin, natrijev klorid, N- acetiltriptofan, kaprilna kislina, natrijev
sodium hydroxide and water for injections.
hidroksid in voda za injekcije.
OPTISON is a dispersion for injection.
Izgled zdravila OPTISON in vsebina pakiranja Zdravilo OPTISON je disperzija za injiciranje.
The product is supplied as 1 vial of 3 ml and 5 vials of 3 ml.
1 viala po 3 ml in 5 vial po 3 ml.
19 Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom in izdelovalec
GE Healthcare AS Nycoveien 1-2, P. O. BOX 4220 Nydalen NO-0401 Oslo, Norway
GE Healthcare AS Nycoveien 1- 2, P. O. BOX 4220 Nydalen
ΗΡΑΚΛΕΙΟ ΑΘΗΝΑ Τηλ: +30 1 805 08 64
ΗΡΑΚΛΕΙΟ
The following information is intended for medical or healthcare professionals only:
Navodilo je bilo odobreno 21 Naslednje informacije so namenjene samo zdravstvenemu osebju:
OPTISON could be repeatedly administered, however, the clinical experience is limited.
Zdravilo OPTISON se lahko večkrat uporablja, vendar so klinične izkušnje omejene.
Attach a three-
Pritrdite
way stopcock to the cannula.
tripotni petelinček na kanilo.
- OPTISON should be withdrawn with care into the syringe within 1 minute after resuspension.
- Zdravilo OPTISON morate previdno odvzeti v brizgo v času do 1 minute po resuspendiranju.
- Inject the suspension through the plastic cannula, no smaller than 20 G at a maximum injection rate
- Injicirajte suspenzijo skozi plastično kanilo, ki ni manjša od 20 G, pri maksimalni hitrosti
ensure complete resuspension of the microspheres.
popolni resuspendiranosti mikrosfer.
Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution for injection should be injected at a rate of 1 ml/ s.
22 Takoj po injiciranju zdravila OPTISON morate injicirati 10 ml 0, 9% raztopine (9 mg/ ml) natrijevega klorida za injiciranje ali 5% raztopine (50 mg/ ml) glukoze za injiciranje s hitrostjo 1 ml/ s.
The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a ” to keep open” (TKO) rate.
Takrat morate pritrditi infuzijski set na tripotni petelinček in pričeti z intravenskim infundiranjem s hitrostjo, da je pretok ravno odprt (TKO - 'to keep open').
Immediately after OPTISON injection the intravenous infusion should be wide open until contrast begins to fade from the left ventricle.
Takoj po injiciranju zdravila OPTISON morate široko odpreti pretok intravenske infuzije, dokler ne začne kontrast v levem ventriklu izginjati.
What is Optisulin?
Kaj je zdravilo Optisulin?
Optisulin is a clear solution for injection containing the active substance insulin glargine.
Zdravilo Optisulin je bistra raztopina za injiciranje, ki vsebuje zdravilno učinkovino insulin glargin.
It is supplied in vials or as cartridges.
Na voljo je v vialah ali vložkih.
What is Optisulin used for?
Za kaj se zdravilo Optisulin uporablja?
Optisulin is used to treat adults, adolescents and children aged six years or older with diabetes mellitus, when they need insulin.
Zdravilo Optisulin se uporablja za zdravljenje odraslih, mladostnikov in otrok, starih šest let ali več, ki imajo sladkorno bolezen in potrebujejo insulin.
How is Optisulin used?
Kako se zdravilo Optisulin uporablja?
Optisulin is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (shoulder).
Zdravilo Optisulin se daje z injiciranjem pod kožo v trebušno steno (trebuh), stegno ali deltoidno mišico (ramo).
The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected.
Mesto injiciranja je treba pri vsaki injekciji menjati, da se preprečijo spremembe na koži (kot je odebelitev), zaradi česar bi lahko insulin deloval slabše od pričakovanega.
The patient ’ s blood glucose (sugar) should be regularly tested to find the lowest effective dose.
Raven glukoze (sladkorja) v krvi bolnika je treba redno preverjati, da določimo najmanjši učinkovit odmerek.
Optisulin is given once daily at any time during the day provided that it is the same time each day.
Zdravilo Optisulin se daje enkrat dnevno ob kateri koli uri, pod pogojem, da se daje vedno ob isti uri.
This should be in the evening when used in children.
Kadar se uporablja pri otrocih, se mora dajati zvečer.
Optisulin can also be given together with anti-diabetes medicines taken by mouth in patients who have non-insulin-dependent diabetes (type 2 diabetes).
Pri bolnikih, ki imajo od insulina neodvisno sladkorno bolezen (sladkorno bolezen tipa II), lahko zdravilo Optisulin dajemo skupaj s peroralnimi zdravili za sladkorno bolezen.
How does Optisulin work?
Kako zdravilo Optisulin deluje?
Optisulin is a replacement insulin that is very similar to the insulin made by the pancreas.
Zdravilo Optisulin je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna slinavka.
The active substance in Optisulin, insulin glargine, is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glargine.
Zdravilno učinkovino v zdravilu Optisulin, insulin glargin, proizvajajo z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri bakterija prejme gen (DNK), s katerim lahko tvori insulin glargin.
The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action.
Razlika se odraža v počasnejši in rednejši absorpciji v telo po injiciranju ter v daljšem trajanju delovanja.
How has Optisulin been studied?
Kako je bilo zdravilo Optisulin raziskano?
Optisulin was originally studied in 10 studies, in both type 1 and type 2 diabetes.
Zdravilo Optisulin so prvotno preučili v 10 študijah, pri sladkorni bolezni tipa 1 in tudi sladkorni bolezni tipa 2.
A total of 2,106 patients received Optisulin in all trials combined.
Zdravilo Optisulin je v vseh preskušanjih prejelo skupno 2106 bolnikov.
The main studies compared Optisulin given once a day at bedtime with human insulin NPH (an intermediate-acting insulin) given once or twice a day.
V glavnih študijah so primerjali prejemanje zdravila Optisulin enkrat dnevno pred spanjem in prejemanje humanega insulina NPH (insulina s srednjedolgim delovanjem) enkrat ali dvakrat dnevno.
Further studies were carried out to compare Optisulin and human insulin NPH in children and adolescents aged between five and 18 years, 200 of whom received Optisulin.
Izvedene so bile dodatne študije, v katerih so zdravilo Optisulin primerjali s humanim insulinom NPH pri otrocih in mladostnikih, starih med pet in 18 let, od katerih jih je 200 prejelo zdravilo Optisulin.
Studies were also carried out in nearly 1,400 adult patients with type 1 or type 2 diabetes to measure the effectiveness of Optisulin injected at any time during the day, compared with an evening injection.
Študije so bile izvedene tudi na skoraj 1400 odraslih bolnikih s sladkorno boleznijo tipa 1 ali 2, da bi izmerili učinkovitost zdravila Optisulin, injiciranega ob katerem koli času dneva, v primerjavi z injiciranjem pred spanjem.
All of the studies measured the level of ‘ fasting’ blood glucose (measured after not eating for at least eight hours) or of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
V vseh študijah so merili raven glukoze v krvi na tešče (izmerjeno vsaj osem ur po zadnjem obroku) ali snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako učinkovito je raven glukoze v krvi nadzorovana.
What benefit has Optisulin shown during the studies?
Kakšne koristi je zdravilo Optisulin izkazalo med študijami?
Optisulin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with human insulin.
Zdravilo Optisulin je povzročilo znižanje ravni HbA1c, kar kaže, da so bile ravni glukoze v krvi uravnane na podobno raven kot pri humanem insulinu.
Optisulin was effective for both type 1 and type 2 diabetes.
Zdravilo Optisulin je bilo učinkovito za sladkorno bolezen tipa I in tudi za sladkorno bolezen tipa II.
However, there were too few children aged below six years to determine the medicine ’ s effectiveness in this group.
Vendar pa je bilo premalo otrok, mlajših od šest let, da bi lahko določili učinkovitost zdravila v tej skupini.
The effectiveness of Optisulin was seen regardless of the time of the injection.
Opazili so, da je zdravilo Optisulin učinkovito ne glede na uro injiciranja.
What is the risk associated with Optisulin?
Kakšna tveganja so povezana z zdravilom Optisulin?
The most common side effect seen with Optisulin (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Najpogostejši neželeni učinek zdravila Optisulin (opažen pri več kot 1 bolniku izmed 10) je hipoglikemija (nizka raven glukoze v krvi).
Reactions at the site of the injection (redness, pain, itching and swelling) have been seen more often in children than in adults.
Reakcije na mestu injiciranja (rdečina, bolečine, srbečica in otekanje) so bile pogosteje opažene pri otrocih kot odraslih.
For the full list of all side effects reported with Optisulin, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Optisulin, glejte navodilo za uporabo.
Optisulin should not be used in people who may be hypersensitive (allergic) to insulin glargine or to any of the other ingredients.
Zdravila Optisulin ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) insulin glargin ali katero koli drugo sestavino zdravila.
Optisulin doses might also need to be adjusted when given with some other medicines that may have an effect on blood glucose levels.
Odmerke zdravila Optisulin bo morda treba prilagoditi, če se jemlje sočasno s katerim od drugih zdravil, ki vplivajo na raven sladkorja v krvi.
Why has Optisulin been approved?
Zakaj je bilo zdravilo Optisulin odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Optisulin’ s benefits are greater than its risks for the treatment of adults, adolescents and children of six years or above with diabetes mellitus, where treatment with insulin is required.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Optisulin za zdravljenje sladkorne bolezni pri odraslih, mladostnikih in otrocih, starejših od šest let, pri katerih je potrebno zdravljenje z insulinom, večje od z njim povezanih tveganj.
The Committee recommended that Optisulin be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Optisulin odobri dovoljenje za promet.
Other information about Optisulin:
Druge informacije o zdravilu Optisulin:
The European Commission granted a marketing authorisation valid throughout the European Union for Optisulin to Sanofi-Aventis Deutschland GmbH on 27 June 2000.
Evropska komisija je dovoljenje za promet z zdravilom Optisulin, veljavno po vsej Evropski uniji, odobrila družbi Sanofi- Aventis Deutschland GmbH dne 27. junija 2000.
The marketing authorisation was renewed on 27 June 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 27. junija 2005.
The full EPAR for Optisulin is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Optisulin je na voljo tukaj.
EU Number EU/ 1/ 00/ 133/ 001 EU/ 1/ 00/ 133/ 002 EU/ 1/ 00/ 133/ 003 EU/ 1/ 00/ 133/ 004 EU/ 1/ 00/ 133/ 005
številka EU EU/ 1/ 00/ 133/ 001 EU/ 1/ 00/ 133/ 002 EU/ 1/ 00/ 133/ 003 EU/ 1/ 00/ 133/ 004 EU/ 1/ 00/ 133/ 005 EU/ 1/ 00/ 133/ 006 EU/ 1/ 00/ 133/ 007 EU/ 1/ 00/ 133/ 008
Invented name Optisulin Optisulin Optisulin Optisulin Optisulin
izmišljeno ime Optisulin Optisulin Optisulin Optisulin Optisulin Optisulin Optisulin Optisulin
Strength 100 Units/ ml 100 Units/ ml 100 Units/ ml 100 Units/ ml 100 Units/ ml
jakost 100 enot/ ml 100 enot/ ml 100 enot/ ml 100 enot/ ml 100 enot/ ml 100 enot/ ml 100 enot/ ml 100 enot/ ml
Pharmaceutical Form Solution for injection in a vial Solution for injection in a vial Solution for injection in a vial Solution for injection in a vial Solution for injection in a cartridge
farmacevtska oblika raztopina za injiciranje v viali raztopina za injiciranje v viali raztopina za injiciranje v viali raztopina za injiciranje v viali raztopina za injiciranje v vložku raztopina za injiciranje v vložku raztopina za injiciranje v vložku raztopina za injiciranje v viali
Route of Administration Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use
pot uporabe subkutano subkutano subkutano subkutano subkutano subkutano subkutano subkutano
Packaging vial (glass) vial (glass) vial (glass) vial (glass) cartridge (glass)
ovojnina Viala (steklena) Viala (steklena) Viala (steklena) Viala (steklena) Vložek (steklen) Vložek (steklen) Vložek (steklen) Viala (steklena)
Content 5 ml 5 ml 5 ml 5 ml 3 ml
vsebina 5 ml 5 ml 5 ml 5 ml 3 ml 3 ml 3 ml 10 ml
Package size 1 vial 2 vials 5 vials 10 vials 4 cartridges
velikost pakiranja 1 viala 2 viali 5 vial 10 vial 4 vložki 5 vložkov 10 vložkov 1 viala
Optisulin 100 Units/ ml solution for injection in a vial
Optisulin 100 enot/ ml raztopina za injiciranje v viali
Each vial contains 5 ml of solution for injection, equivalent to 500 Units, or 10 ml of solution for injection, equivalent to 1000 Units.
Vsaka viala vsebuje 5 ml raztopine za injiciranje, kar ustreza 500 enotam, ali 10 ml raztopine za injiciranje, kar ustreza 1000 enotam.
The potency of this preparation is stated in units.
Jakost tega zdravila je navedena v enotah.
These units are exclusive to Optisulin and are not the same as IU or the units used to express the potency of other insulin analogues.
Te enote veljajo izključno za zdravilo Optisulin in niso enake mednarodnim enotam (i. e.) ali enotam, ki se uporabljajo za izražanje jakosti drugih insulinskih analogov.
Optisulin contains insulin glargine an insulin analogue with a prolonged duration of action.
Zdravilo Optisulin vsebuje insulin glargin, insulinski analog s podaljšanim delovanjem.
The dosage and timing of dose of Optisulin should be individually adjusted.
Odmerjanje in čas apliciranja zdravila Optisulin morata biti prilagojena individualno.
In patients with type 2 diabetes mellitus, Optisulin can also be given together with orally active antidiabetic medicinal products.
Pri bolnikih z diabetesom mellitusom tipa 2 je mogoče zdravilo Optisulin uporabljati tudi skupaj s peroralnimi antidiabetičnimi zdravili.
In children efficacy and safety of Optisulin have only been demonstrated when given in the evening.
Pri otrocih sta učinkovitost in varnost zdravila Optisulin dokazani samo pri uporabi zvečer.
Due to limited experience the efficacy and safety of Optisulin have not been demonstrated in children below the age of 6 years.
Zaradi omejenih izkušenj učinkovitost in varnost zdravila Optisulin nista dokazani pri otrocih do 6. leta starosti.
Transition from other insulins to Optisulin
Prehod z drugih insulinov na zdravilo Optisulin