natgillin/translations-raw huggingface dataset:
Less commonly reported (more than 1 in a 100 patients) side effects of Inovelon are:
Neželeni učinki Inovelona, o katerih poročajo manj pogosto (pri več kot 1 od 100 bolnikov), so:
Problems associated with the stomach including: stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss.
težave, povezane z živci, med drugim: težave s hojo, nenormalni gibi, konvulzije/ epileptični napadi, nenavadni očesni gibi, zamegljen vid, tresenje. težave, povezane z želodcem, med drugim: bolečine v želodcu, zaprtje, prebavne motnje, redko blato (driska), izguba ali sprememba teka, hujšanje. okužbe: okužbe ušes, gripa, nahod, okužbe pljuč.
In addition patients have experienced: anxiety, insomnia, nose bleeds, acne, rash, back pain, infrequent periods, bruising, head injury.
Poleg tega bolniki opažajo še: tesnobo, nespečnost,, krvavitve iz nosu, akne, izpuščaj, bolečine v križu, neredne menstruacije, modrice, poškodbe glave.
48 Uncommon (between 1 in a 100 and 1 in a 1000 patients) side effects of Inovelon are:
Občasni (pri 1 od 100 bolnikov do 1 od 1000 bolnikov) neželeni učinki Inovelona so:
Allergic reactions and an increase in markers of liver function (hepatic enzyme increase).
alergijske reakcije in zvišanje označevalcev jetrnih funkcij (zvišanje jetrnih encimov).
HOW TO STORE INOVELON
SHRANJEVANJE ZDRAVILA INOVELON
Keep Inovelon out of the reach and sight of children.
Zdravilo Inovelon shranjujte nedosegljivo otrokom
Do not use Inovelon after the expiry date which is stated on the blister and carton.
Zdravila Inovelon ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in kartonski škatli.
Do not store above 30°C.
48 Shranjujte pri temperaturi do 30 °C.
Do not use Inovelon if you notice a change in colour of the tablets.
Ne uporabljajte zdravila Inovelon, če opazite spremembo barve tablet.
Each Inovelon 100 mg film-coated tablet contains 100 mg of rufinamide.
- Ena 100- miligramska filmsko obložena tableta Inovelona vsebuje 100 mg rufinamida.
Each Inovelon 200 mg film-coated tablet contains 200 mg of rufinamide.
- Ena 200- miligramska filmsko obložena tableta Inovelona vsebuje 200 mg rufinamida.
Each Inovelon 400 mg film-coated tablet contains 400 mg of rufinamide.
- Ena 400- miligramska filmsko obložena tableta Inovelona vsebuje 400 mg rufinamida.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch,
- Pomožne snovi so laktoza monohidrat, mikrokristalna celuloza, koruzni škrob, premreženi
croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate and colloidal anhydrous silica.
natrijev karmezolat, hipromeloza, magnezijev stearat, natrijev lavrilsulfat in brezvodni koloidni silikagel.
The film-coating consists of Opadry 00F44042 [hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172)].
Filmsko oblogo sestavljajo Opadry 00F44042 [hipromeloza, makrogoli (8000), titanov dioksid (E171), smukec in rdeči železov oksid (E172)].
• Inovelon 100 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є 261’ on one side and blank on the other side.
• Inovelon 100 mg tablete so rožnate, ovalne, rahlo konveksne filmsko obložene tablete, z zarezo na obeh straneh, z vtisnjenim napisom ‘ Є261 ’ na eni strani in brez napisa na drugi strani.
They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.
Na voljo so v zloženkah, v katerih je po 10, 30, 50, 60 ali 100 filmsko obloženih tablet.
• Inovelon 200 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є 262’ on one side and blank on the other side.
• Inovelon 200 mg tablete so rožnate, ovalne, rahlo konveksne filmsko obložene tablete, z zarezo na obeh straneh, z vtisnjenim napisom ‘ Є262 ’ na eni strani in brez napisa na drugi strani.
• Inovelon 400 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є 263’ on one side and blank on the other side.
• Inovelon 400 mg tablete so rožnate, ovalne, rahlo konveksne filmsko obložene tablete, z zarezo na obeh straneh, z vtisnjenim napisom ‘ Є263 ’ na eni strani in brez napisa na drugi strani.
They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Na voljo so v zloženkah, v katerih je po 10, 30, 50, 60, 100 ali 200 filmsko obloženih tablet.
Eisai Ltd, Mosquito Way, Hatfield, Herts, AL10 9SN, UK.
Eisai Ltd, Mosquito Way, Hatfield, Herts, AL10 9SN, Velika Britanija.
49 Manufacturer:
Izdelovalec:
Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom
Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts, AL10 9SN, Velika Britanija
Detailed information on this product is available on the European Medicines Agency (EMEA) website http: / /www. emea. europa. eu
Podrobne informacije o izdelku so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.
Insulatard is a range of insulin suspensions for injection.
Zdravilo Insulatard obsega različne suspenzije insulina za injiciranje.
Insulatard is supplied in vials, cartridges (Penfill), or pre-filled pens (InnoLet, NovoLet and FlexPen).
Na voljo je v vialah, injekcijskih vložkih (Penfill) ali napolnjenih injekcijskih peresnikih (InnoLet, NovoLet in FlexPen).
Insulatard contains the active substance insulin human (rDNA).
Zdravilo Insulatard vsebuje zdravilno učinkovino humani insulin (rDNA).
Insulatard is used in patients with diabetes.
Zdravilo Insulatard se uporablja za zdravljenje sladkorne bolezni.
Insulatard is given subcutaneously (under the skin) by injection, usually in the thigh.
Zdravilo Insulatard se daje s subkutano (podkožno) injekcijo, ponavadi v stegno.
If convenient, it may also be given in the abdominal wall (tummy), the gluteal region (buttocks) or the deltoid region (shoulder).
Če je prikladno, se lahko daje tudi v trebušno steno (trebuh), glutealni predel (zadnjico) ali deltoidni predel (rame).
The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Za določitev najmanjšega učinkovitega odmerka je potrebno redno spremljati koncentracijo glukoze (sladkorja) v krvi bolnika.
Insulatard is a long-acting insulin.
Zdravilo Insulatard je insulin z dolgotrajnim delovanjem.
It can be given as a once- or twice-daily injection, with or without a fast-acting insulin (at meal times), according to the doctor’ s recommendation.
Lahko se daje enkrat dnevno ali dvakrat dnevno, z ali brez hitrodelujočega insulina (ob obrokih) v skladu s priporočili zdravnika.
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose.
Pri sladkorni bolezni telo ne tvori dovolj insulina za uravnavanje ravni glukoze v krvi.
Insulatard is a replacement insulin which identical to the insulin made by the pancreas.
Zdravilo Insulatard je nadomestni insulin, ki je enak insulinu iz trebušne slinavke.
The active substance in Insulatard, insulin human (rDNA), is produced by a method known as ‘ recombinant technology’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Zdravilna učinkovina zdravila Insulatard je humani insulin (rDNA), ki je izdelan z metodo, imenovano „ rekombinantna tehnologija “: pri tej metodi insulin izdela kvasovka, ki je prejela gen (DNA), s pomočjo katerega lahko tvori insulin.
This gives Insulatard a longer duration of action.
Zdravilo Insulatard vsebuje insulin v zmesi z drugo snovjo, protaminom, v obliki „ izofan “, ki se čez dan veliko počasneje absorbira, kar se odraža v daljšem trajanju delovanja.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Nadomestni insulin deluje enako kot insulin, ki se tvori naravno, ter omogoča prenos glukoze iz krvi v celice.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Z uravnavanjem ravni glukoze v krvi se simptomi in zapleti sladkorne bolezni zmanjšajo.
Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Zdravilo Insulatard so preučevali v štirih glavnih kliničnih preizkušanjih, v katere je bilo vključenih skupno 557 bolnikov s sladkorno boleznijo tipa I, pri kateri trebušna slinavka ne more tvoriti insulina (dve študiji, ki sta vključevali 81 bolnikov), in bolnikov s sladkorno boleznijo tipa II, pri kateri telo ne more učinkovito izrabiti insulina (dve študiji, ki sta vključevali 476 bolnikov).
The studies measured the levels of fasting blood glucose or a substance in the blood called 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V študijah so 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 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 glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 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 merili raven glukoze v krvi na tešče ali snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže učinkovitost uravnavanja ravni glukoze v krvi.
Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a pre-filled pen (InnoLet, NovoPen or FlexPen).
V dodatnih študijah zdravila Insulatard, izvedenih na 225 bolnikih, so delali primerjavo med injiciranjem zdravila Insulatard z brizgo in injiciranjem napolnjenega injekcijskega peresnika (InnoLet, NovoPen ali FlexPen).
What benefit has Insulatard shown during the studies?
Kakšne koristi je zdravilo Insulatard izkazalo med raziskavami?
Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins.
Zdravilo Insulatard je povzročilo znižanje ravni HbA1c, kar kaže, da so bile ravni glukoze v krvi uravnane na podobno raven kakor pri drugih humanih insulinih.
Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pens.
Zdravilo Insulatard je bilo učinkovito tako za sladkorno bolezen tipa I kot za sladkorno bolezen tipa II in pri uporabi standardne injekcije ali enega izmed injekcijskih peresnikov.
As with all insulins, Insulatard may cause hypoglycaemia (low blood glucose).
Tako kot vsi insulini, lahko tudi zdravilo Insulatard povzroči hipoglikemijo (nizko raven glukoze v krvi).
For the full list of all side effects reported with Insulatard, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Insulatard, glejte Navodilo za uporabo.
Insulatard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Zdravila Insulatard se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) humani insulin (rDNA) ali katerokoli drugo sestavino zdravila.
Insulatard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Odmerke zdravila Insulatard je morda treba prilagoditi, če se dajejo sočasno z drugimi zdravili, ki lahko vplivajo na raven glukoze v krvi.
The Committee for Medicinal products for Human Use (CHMP) decided that Insulatard’ s benefits are greater than its risks for the treatment of diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Insulatard pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
The Committee recommended that Insulatard be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Insulatard odobri dovoljenje za promet.
Other information about Insulatard:
Druge informacije o zdravilu Insulatard:
The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard to Novo Nordisk A/ S on 7 October 2002.
Evropska komisija je dovoljenje za promet z zdravilom Insulatard, veljavno po vsej Evropski uniji, odobrila družbi Novo Nordisk A/ S dne 7. oktobra 2002.
The marketing authorisation was renewed on 7 October 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 7. oktobra 2007.
The full EPAR for Insulatard is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Insulatard je na voljo tukaj.
EU number
EU Številka
Invented Name
Način uporabe
Pharmaceutical Form
za subkutano uporabo
Route of administration Packaging
suspenzija za injiciranje
Content (concentration) Package size
suspenzija za injiciranje
40 IU/ ml 40 IU/ ml 100 IU/ ml 100 IU/ ml 100 IU/ ml 100 IU/ ml 100 IU/ ml
3 ml (3, 5 mg/ ml)
Suspension for injection Suspension for injection Suspension for injection Suspension for injection Suspension for injection Suspension for injection Suspension for injection
100 i. e. / ml
Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use
suspenzija za injiciranje
Vial (glass) Vial (glass) Vial (glass) Vial (glass) Cartridge (glass) Cartridge (glass) Cartridge (glass)
za subkutano uporabo
10ml (1.4 mg/ ml) 10 ml (1.4 mg/ ml) 10 ml (3.5 mg/ ml) 10 ml (3.5 mg/ ml) 3 ml (3.5 mg/ ml) 3 ml (3.5 mg/ ml) 3 ml (3.5 mg/ ml)
3 ml (3, 5 mg/ ml)
1 vial 5 vials 1 vial 5 vials 1 cartridge 5 cartridges 10 cartridges
5 injekcijskih vložkov
100 IU/ ml
100 i. e. / ml
EU/ 1/ 02/ 233/ 014
1/ 2 EU/ 1/ 02/ 233/ 014
40 IU/ ml
40 i. e. / ml
5 x (1 x 10 ml) vials
5 x 1 viala
vial (glass) 10 ml (3.5 mg/ ml)
viala (steklena)
1/ 1
5 x 1 viala
Insulatard 40 IU/ ml suspension for injection in a vial.
Insulatard 40 i. e. / ml suspenzija za injiciranje v viali
Insulatard is a suspension of isophane (NPH) insulin.
Insulatard je suspenzija insulina izofan (NPH) za injiciranje.
CLINICAL PARTICULARS
KLINI NI PODATKI
4.2 Posology and method of administration
4. 2 Odmerjanje in na in uporabe
Insulatard is a long-acting insulin.
Insulatard je dolgodelujo i insulin.
Dosage Dosage is individual and determined in accordance with the needs of the patient.
Odmerjanje Odmerjanje je individualno in dolo eno skladno z bolnikovimi potrebami.
The daily insulin requirement may be higher in patients with insulin resistance (e. g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
Dnevna potreba po insulinu je lahko ve ja pri bolnikih z odpornostjo proti insulinu (npr. med puberteto pri mladih ali zaradi debelosti) in manjša pri bolnikih z rezidualnim endogenim nastajanjem insulina.
The physician determines whether one or several daily injections are necessary.
Zdravnik odlo i, ali je potrebna ena ali ve injekcij na dan.
Insulatard may be used alone or mixed with fast-acting insulin.
Insulatard se lahko uporablja sam ali mešan s hitrodelujo im insulinom.
In intensive insulin therapy the suspension may be used as basal insulin (evening and/ or morning injection) with fast-acting insulin given at meals.
Pri intenzivnem insulinskem zdravljenju se suspenzija lahko uporablja kot bazalni insulin (injiciranje zve er in/ ali zjutraj) skupaj s hitrodelujo im insulinom ob obrokih.
In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications.
im boljša glikemi na urejenost pri bolnikih z diabetesom mellitusom odloži nastanek poznih diabeti nih zapletov.
Close blood glucose monitoring is therefore recommended.
Zato je priporo ljivo natan no nadzorovanje glukoze v krvi.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Prilagoditev odmerjanja Spremljajo e bolezni, posebno okužbe in stanja z zvišano telesno temperaturo, ponavadi zve ajo bolnikovo potrebo po insulinu.
Renal or hepatic impairment may reduce insulin requirement.
Okvara ledvic ali jeter lahko potrebo po insulinu zmanjša.
2 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
2 Prilagoditev odmerjanja utegne biti potrebna tudi, e bolniki spremenijo svojo telesno dejavnost ali obi ajno prehrano.
Administration For subcutaneous use.
Na in uporabe Za subkutano uporabo.
If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used.
Insulatard se aplicira subkutano v stegno. e je prikladno, je mogo e uporabiti tudi trebušno steno, glutealni predel ali deltoidni predel.
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
V primerjavi z drugimi mesti injiciranj povzro i subkutano injiciranje v stegno po asnejšo in manj spremenljivo absorpcijo.
When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
V primeru mešanja dveh vrst insulinov je najprej treba izvle i odmerek hitrodelujo ega insulina in potem odmerek dolgodelujo ega.
Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed.
Insulinu Insulatard je priloženo navodilo za uporabo s podrobnimi napotki za uporabo, ki jih je treba upoštevati.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Preob utljivost za zdravilno u inkovino ali katero od pomožnih snovi (glejte poglavje 6. 1).
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9).
Hipoglikemija se lahko pojavi, e je odmerek insulina prevelik glede na potrebo po insulinu (glejte poglavji 4. 8 in 4. 9).
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.
Bolnikom, ki se jim uravnanost glukoze v krvi zelo izboljša, npr. z intenziviranim insulinskim zdravljenjem, se obi ajni opozorilni simptomi hipoglikemije lahko spremenijo in jih je s to možnostjo treba seznaniti.
If an adjustment is needed when switching the patients to Insulatard, it may occur with the first dose or during the first several weeks or months.
Spremembe jakosti, znamke (izdelovalec), vrste (hitro -, dvojno -, dolgodelujo i insulin itd.), izvora (živalski, humani ali analogni insulin) in/ ali na ina izdelave (rekombinantna DNA ali živalski vir insulina) imajo lahko za posledico spremembo odmerjanja. e je po prehodu bolnikov na Insulatard potrebna prilagoditev, je to lahko potrebno že pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
On rare occasions, injection site reactions may require discontinuation of Insulatard.
V redkih primerih utegne biti zaradi reakcij na mestu injiciranja potrebna prekinitev uporabe insulina Insulatard.
3 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Maloštevilni bolniki, ki so po prehodu z insulina živalskega izvora doživeli hipoglikemije, so navedli, da so bili zgodnji opozorilni simptomi hipoglikemije manj izraziti ali so se razlikovali od tistih, ki so jih doživeli s prejšnjim insulinom.
Insulin suspensions are not to be used in insulin infusion pumps.
Suspenzij insulina se ne sme uporabljati v infuzijskih rpalkah za insulin.
Insulatard contains metacresol, which may cause allergic reactions.
Insulatard vsebuje metakrezol, ki lahko povzro i alergijske reakcije.
The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
Zdravnik mora zato upoštevati možna medsebojna delovanja in mora bolnike vedno povprašati po vseh zdravilih, ki jih prejemajo.
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Potrebo po insulinu lahko zmanjšajo naslednje snovi: peroralni antidiabetiki, zaviralci monoaminoksidaze (MAOI), neselektivni zaviralci adrenergi nih receptorjev beta, zaviralci encima angiotenzinske konvertaze (ACE), salicilati, alkohol, anabolni steroidi in sulfonamidi.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Potrebo po insulinu lahko zve ajo naslednje snovi: peroralni kontraceptivi, tiazidi, glukokortikoidi, š itni ni hormoni, beta- simpatikomimetiki, rastni hormon in danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
Zaviralci receptorjev beta lahko prikrijejo simptome hipoglikemije in upo asnijo okrevanje po njej.
Octreotide/ lanreotide may both decrease and increase insulin requirement.
Oktreotid/ lanreotid lahko potrebo po insulinu zmanjša ali zve a.
4.6 Pregnancy and lactation
4. 6 Nose nost in dojenje
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
Zato je pri zdravljenju žensk s sladkorno boleznijo med nose nostjo in pred nameravano nose nostjo priporo ljivo intenzivnejše nadziranje.
However, the Insulatard dosage may need to be adjusted.
Potrebna pa utegne biti prilagoditev odmerjanja zdravila Insulatard.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
To je lahko nevarno v okoliš inah, v katerih sta ti zmožnosti posebej pomembni (npr. pri vožnji avta ali upravljanju s stroji).
4 hypoglycaemia or have frequent episodes of hypoglycaemia.
4 odsotnim zaznavanjem opozorilnih znakov hipoglikemije in pri tistih, ki imajo pogoste hipoglikemije.
The advisability of driving should be considered in these circumstances.
V takšnih okoliš inah je treba pretehtati, ali je priporo ljivo, da bolnik vozi.
4.8 Undesirable effects
4. 8 Neželeni u inki
Therefore, no specific frequency can be presented.
Natan ne pogostnosti zato ni mogo e navesti.
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 povzro i nezavest, konvulzije ali oboje in ima lahko za posledico prehodno ali trajno okvaro delovanja možganov ali celo smrt.
Frequencies of adverse drug reactions from clinical trials that are considered related to Insulatard are listed below.
Spodaj so navedene pogostnosti neželenih reakcij, ki so po splošni presoji povezane z zdravilom Insulatard.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
Pogostnosti so opredeljene kot: ob asni (1/ 1. 000 do < 1/ 100).
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
Posamezni spontani primeri so opisani kot zelo redki in opredeljeni kot < 1/ 10. 000, vklju no s posameznimi primeri.
Nervous system disorders Very rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed “ acute painful neuropathy”, which is usually reversible.
Bolezni živ evja Zelo redki – periferna nevropatija Hitro izboljšanje urejenosti glukoze v krvi lahko spremlja motnja, imenovana akutna bole a nevropatija, ki je ponavadi reverzibilna.
Eye disorders Very rare - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
O esne bolezni Zelo redki – refrakcijske motnje Po za etku zdravljenja z insulinom se lahko pojavijo refrakcijske anomalije.