natgillin/translations-raw huggingface dataset:
If an adjustment is needed when switching the patients to Actrapid, it may occur with the first dose or during the first several weeks or months.
Če je po prehodu bolnikov na Actrapid potrebna prilagoditev, utegne biti potrebna že pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
3 Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times.
V redkih primerih utegne biti zaradi reakcij na mestu injiciranja potrebna prekinitev uporabe zdravila Actrapid.
Due to the risk of precipitation in pump catheters, Actrapid should not be used in insulin pumps for continuous subcutaneous insulin infusion.
Zdravila Actrapid se zaradi nevarnosti precipitacije v katetrih črpalk ne sme uporabljati v insulinskih črpalkah za stalno subkutano infundiranje insulina.
Actrapid contains metacresol, which may cause allergic reactions.
Actrapid vsebuje metakrezol, ki lahko povzroči alergijske reakcije.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Potrebo po insulinu lahko zvečajo naslednje snovi: peroralni kontraceptivi, tiazidi, glukokortikoidi, ščitnični hormoni, beta- simpatikomimetiki, rastni hormon in danazol.
However, the Actrapid dosage may need to be adjusted.
Lahko pa je potrebna prilagoditev odmerjanja zdravila Actrapid.
Frequencies of adverse drug reactions from clinical trials that are considered related to Actrapid, are listed below.
Spodaj so navedene pogostnosti neželenih reakcij, ki so po splošni presoji povezane z zdravilomActrapid.
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, vključno s posameznimi primeri.
Nervous system disorders Uncommon - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed “ acute painful neuropathy”, which is usually reversible.
Bolezni živčevja Občasni – periferna nevropatija Hitro izboljšanje urejenosti glukoze v krvi lahko spremlja motnja, imenovana ˝akutna boleča nevropatija˝, ki je ponavadi reverzibilna.
Eye disorders Uncommon - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
Očesne bolezni Občasni – refrakcijske motnje Po začetku zdravljenja z insulinom se lahko pojavijo refrakcijske anomalije.
Very rare - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Zelo redki – diabetična retinopatija Dolgoročno izboljšana urejenost glikemije zmanjša tveganje za napredovanje diabetične retinopatije.
It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Zato je priporočljivo, da imajo diabetični bolniki pri sebi nekaj kock sladkorja, bonbone, piškote ali sadni sok, ki vsebuje sladkor. • Hude hipoglikemije, ko je bolnik nezavesten, je mogoče zdraviti z glukagonom (0, 5 do 1 mg), ki ga da intramuskularno ali subkutano ustrezno podučena oseba, ali z glukozo, ki jo da
5 • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
5 intravensko zdravstveni delavec.
A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/ l) in 204 diabetic and 1344 non-diabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 – 6.1 mmol/ l) induced by intravenous Actrapid reduced mortality by 42% (8% versus 4.6%).
Klinično preskušanje zdravljenja hiperglikemije (glukoza v krvi nad 10 mmol/ l) v eni sami intenzivni enoti pri 204 diabetičnih in 1344 nediabetičnih bolnikih po večji operaciji je pokazala, da je normoglikemija (glukoza v krvi 4, 4– 6, 1 mmol/ l), dosežena z intravenskim insulinom Actrapid, zmanjšala umrljivost za 42% (8% v primerjavi s 4, 6%).
Actrapid is a fast-acting insulin.
Actrapid je hitrodelujoč insulin.
Onset of action is within ½ hour, reaches a maximum effect within 1.5-3.5 hours and the entire duration of action is approximately 7-8 hours.
Delovati začne v 1/ 2 ure, največji učinek doseže v 1, 5– 3, 5 urah, celotni čas delovanja pa je približno 7– 8 ur.
Absorption The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
Absorpcija Največja koncentracija v plazmi je dosežena v 1, 5 do 2, 5 urah po subkutani uporabi.
Trials have indicated a t½ of about 2-5 hours.
Preskušanja so pokazala t1/ 2 približno 2– 5 ur.
6 Children and adolescents The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
Otroci in mladostniki Farmakokinetični profil zdravila Actrapid je bil raziskan pri majhnem številu (n = 18) diabetičnih otrok (starost 6– 12 let) in mladostnikov (starost 13– 17 let).
5.3 Preclinical safety data
6 5. 3 Predklinični podatki o varnosti
Zinc chloride Glycerol Metacresol Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
cinkov klorid glicerol metakrezol natrijev hidroksid (za uravnavo pH) klorovodikova kislina (za uravnavo pH) voda za injekcije
Medicinal products added to the insulin solution may cause degradation of the insulin, e. g. if the medicinal products contain thiols or sulphites.
Zdravila, dodana raztopini insulina, lahko povzročijo razgradnjo insulina, npr. če zdravilo vsebuje tiole ali sulfite.
4 weeks when used or stored at room temperature (below 25°C).
4 tedne, če bolnik uporablja zdravilo ali ga hrani pri sobni temperaturi (do 25 °C).
Keep the vial in the outer carton in order to protect from light.
Viale shranjujte v zunanji ovojnini za zagotovitev zaščite insulina pred svetlobo.
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof plastic cap.
10 ml steklena viala (tipa 1), zaprta z zamaškom iz brombutil/ poliizoprenske gume in zaščitno varnostno plastično zaporko.
7 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
For intravenous use, infusion systems with Actrapid at concentrations 0.05 IU/ ml - 1.0 IU/ ml insulin human in the following infusion fluids; 0.9% sodium chloride, 5% dextrose and 10% dextrose inclusive 40 mmol/ l potassium chloride, using polypropylene infusion bags, are stable at room temperature for 24 hours.
Za intravensko uporabo so infuzijski sistemi z insulinom Actrapid v koncentracijah od 0, 05 i. e. / ml do 1, 0 i. e. / ml humanega insulina v tekočinah za infundiranje (0, 9% raztopina natrijevega klorida, 5% raztopina glukoze ali 10% raztopina glukoze s 40 mmol/ l raztopine kalijevega klorida) ob uporabi polipropilenskih vrečk za infundiranje pri sobni temperaturi stabilni 24 ur.
Although stable over time, a certain amount of insulin will initially be absorbed to the material of the infusion bag.
Kljub stabilnosti skozi čas se določena količina insulina uvodoma adsorbira na material vrečke za infundiranje.
Monitoring of blood glucose is necessary during the infusion.
Med infundiranjem je treba nadzorovati glukozo v krvi.
Insulin preparations which have been frozen must not be used.
7 Pripravkov insulina, ki so bili zamrznjeni, se ne sme uporabiti.
Insulin solutions should not be used if they do not appear water clear and colourless.
Raztopin insulina se ne sme uporabiti, če niso bistre kot voda in brezbarvne.
Actrapid should not be used in insulin pumps for continuous subcutaneous insulin infusion.
Zdravila Actrapid se ne sme uporabljati v insulinskih črpalkah za stalno subkutano infundiranje insulina.
Actrapid 100 IU/ ml solution for injection in a vial
Actrapid 100 i. e. / ml raztopina za injiciranje v viali
1 vial contains 10 ml equivalent to 1000 IU.
1 viala vsebuje 10 ml, kar ustreza 1000 i. e.
Actrapid is a fast-acting insulin and may be used in combination with long-acting insulin products.
Actrapid je hitrodelujoč insulin in se lahko uporablja v kombinaciji z dolgodelujočimi insuliniskimi zdravili.
9 Administration For subcutaneous or intravenous use.
9 Način uporabe Za subkutano ali intravensko uporabo.
On rare occasions, injection site reactions may require discontinuation of Actrapid
V redkih primerih utegne biti zaradi reakcij na mestu injiciranja potrebna prekinitev uporabe zdravila Actrapid.
10 Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times.
10 Bolniku je treba svetovati, naj se pred potovanjem med različnimi časovnimi pasovi posvetuje z zdravnikom, saj takšno potovanje lahko pomeni, da bo moral bolnik uporabiti insulin in uživati obroke ob drugačnem času.
11 4.8 Undesirable effects
11 4. 8 Neželeni učinki
Frequencies of adverse drug reactions from clinical trials that are considered related to Actrapid, are listed below.
Spodaj so navedene pogostnosti neželenih reakcij, ki so po splošni presoji povezane z zdravilom Actrapid.
General disorders and administration site conditions Uncommon - Injection site reactions Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin.
Splošne težave in spremembe na mestu aplikacije Občasni – reakcije na mestu injiciranja Med zdravljenjem z insulinom se lahko pojavijo reakcije na mestu injiciranja (pordelost, oteklina, srbenje, bolečine in hematomi na injekcijskem mestu).
12 • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
12 intravensko zdravstveni delavec.
13 Children and adolscents The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
Otroci in mladostniki Farmakokinetični profil zdravila Actrapid je bil raziskan pri majhnem številu (n = 18) diabetičnih otrok (starost 6– 12 let) in mladostnikov (starost 13– 17 let).
5.3 Preclinical safety data
13 5. 3 Predklinični podatki o varnosti
6 weeks when used or stored at room temperature (below 25°C)
6 tednov, če bolnik uporablja zdravilo ali ga hrani pri sobni temperaturi (do 25 °C).
Do not store them in or too near the freezer section or cooling element.
Ne v zamrzovalniku in ne preblizu zamrzovalnika ali hladilnega elementa.
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof plastic cap.
10 ml steklena viala (tipa 1), zaprta z zamaškom iz brombutil/ poliizoprenskim gume in zaščitno varnostno plastično zaporko.
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
1 in 5 vial x 10 ml in skupno pakiranje 5 x (1 x 10ml) vial.
14 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Insulin preparations which have been frozen must not be used.
14 Pripravkov insulina, ki so bili zamrznjeni, se ne sme uporabiti.
Actrapid Penfill 100 IU/ ml solution for injection in a cartridge
Actrapid Penfill 100 i. e. / mlraztopina za injiciranje v injekcijskem vložku
Solution for injection in a cartridge.
Raztopina za injiciranje v injekcijskem vložku.
16 Administration For subcutaneous use.
16 Način uporabe Za subkutano uporabo.
The intravenous use of Actrapid from any pen or cartridge should be an exception only in situations where vials are not available.
Izjemoma lahko intravensko apliciramo Actrapid iz katerega koli injekcijskega peresnika ali injekcijskega vložka, vendar le, ko nimamo na razpolago vial.
In this case Actrapid should be drawn into an insulin syringe, provided air is avoided, or infused with an infusion system.
V tem primeru moramo Actrapid povleči v insulinsko injekcijsko brizgo, brez zraka, ali pa uporabiti infuzijski sistem.
This procedure should only be carried out by health care professionals.
Ta postopek lahko izvede le zdravstveno osebje.
Actrapid is accompanied by a package leaflet with detailed instruction for use to be followed.
Insulinu Actrapid je priloženo navodilo za uporabo s podrobnimi navodili za pripravo, ki jih je treba upoštevati.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Preobčutljivost za zdravilno učinkovinoali katero od pomožnih snovi (glejte poglavje 6. 1).
17 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.
17 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.
4.8 Undesirable effects
18 4. 8 Neželeni učinki
19 4.9 Overdose
19 intravensko zdravstveni delavec.
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
Predlagali so številna mesta razcepa (hidrolize) na molekuli humanega insulina.; nobeden od presnovkov, nastalih po razcepu, ni aktiven.
Children and adolescents The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
Otroci in mladostniki Farmakokinetični profil zdravila Actrapid je bil raziskan pri majhnem številu (n = 18) diabetičnih otrok (starost 6– 12 let) in mladostnikov (starost 13– 17 let).
5.3 Preclinical safety data
20 5. 3 Predklinični podatki o varnosti
6 weeks when used or carried as a spare (below 30°C).
6 tednov pri sobni temperaturi (do 30 °C), če bolnik uporablja zdravilo ali ga ima pri sebi kot rezervo.
Do not freeze.
Ne shranjujte v zamrzovalniku in ne preblizu zamrzovalnika ali hladilnega elementa. Ne zamrzujte!
Keep the cartridge in the outer carton in order to protect from light.
Viale shranjujte v zunanji ovojnini za zagotovitev zaščite insulina pred svetlobo.
21 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
3 ml glass cartridge (type 1) with a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
3 ml steklen vložek (tipa 1) z batom iz brombutilne gume in brombutil/ poliizoprenskim gumijastim zamaškom.
Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively.
21 Vložke se sme uporabljati samo z izdelki, s katerimi so kompatibilni in ki omogočajo varno in učinkovito delovanje vložkov.
Actrapid Penfill is for single person use only.
Actrapid Penfill je namenjen uporabi ene same osebe.
Actrapid NovoLet 100 IU/ ml solution for injection in a pre-filled pen
Actrapid NovoLet 100 i. e. / ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
23 Administration For subcutaneous use.
23 Način uporabe Za subkutano uporabo.
The intravenous use of Actrapid from any pen or cartridge should be an exception only in situations where vials are not available.
Intravensko apliciranje insulina Actrapid iz katerega koli peresnika ali vložka mora biti izjema, le v okoliščinah, ko vial ni na voljo.
In this case Actrapid should be drawn into an insulin syringe, provided air is avoided, or infused with an infusion system.
V takšnem primeru je treba Actrapid potegniti v insulinsko brizgo (pod pogojem, da se vanjo ne potegne zraka) ali infundirati v infuzijski sistem.
This procedure should only be carried out by health care professionals
Ta postopek sme opraviti le zdravstveno osebje.
Actrapid NovoLet is designed to be used with NovoFine needles.
Actrapid NovoLet je namenjen za uporabo z iglami NovoFine.
The dose is set by turning the selector, which returns to zero during the injection..
Odmerek se nastavi z vrtenjem številčnice, ki se med injiciranjem vrne na ničlo.
24 reduce or prevent these reactions.
24 dneh do nekaj tednih.
25 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
25 odsotnim zaznavanjem opozorilnih znakov hipoglikemije in pri tistih, ki imajo pogoste hipoglikemije.
26 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Bolezni imunskega sistema Občasni – urtikarija, izpuščaj Zelo redki – anafilaktične reakcije Med simptomi generalizirane preobčutljivosti so lahko generaliziran izpuščaj na koži, srbenje, znojenje, gastrointestinalne motnje, angionevrotični edem, težko dihanje, palpitacije, znižanje krvnega tlaka in omedlevica/ izguba zavesti.
4.9 Overdose
26 4. 9 Preveliko odmerjanje
27 Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Porazdelitev Ugotovili niso nobene izrazite vezave na beljakovine v plazmi, razen na krožeča protitelesa proti insulinu (če so prisotna).
Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
27 Izločanje Končni razpolovni čas je določen s hitrostjo absorpcije iz podkožnega tkiva.
Chrildren and adolescents The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
Otroci in mladostniki Farmakokinetični profil zdravila Actrapid je bil raziskan pri majhnem številu (n = 18) diabetičnih otrok (starost 6– 12 let) in mladostnikov (starost 13– 17 let).
Zinc chloride Glycerol Metacresol Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
6. 1 Seznam pomožnih snovi cinkov klorid glicerol metakrezol natrijev hidroksid (za uravnavo pH) klorovodikova kislina (za uravnavo pH) voda za injekcije
28 During use: do not refrigerate.
Med uporabo: ne shranjujte v hladilniku!
Keep the pen cap on in order to protect from light.
Za zaščito pred svetlobo naj bo injekcijski peresnik vedno pokrit s pokrovčkom.
6.6 Special precautions for disposal and other handling
28 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Pens should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
Injekcijske peresnike se sme uporabljati samo z izdelki, s katerimi so kompatibilni in ki omogočajo varno in učinkovito delovanje teh peresnikov.
Actrapid NovoLet is for single person use only.
Actrapid NovoLet je namenjen uporabi ene same osebe.
Actrapid InnoLet 100 IU/ ml solution for injection in a pre-filled pen
Actrapid InnoLet 100 i. e. / ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4 Special warnings and precautions for use).
Pri prehodu bolnikov z enega insulinskega pripravka na drugega utegne biti potrebna prilagoditev odmerka (glejte poglavje 4. 4).
30 Administration For subcutaneous use.
30 Način uporabe Za subkutano uporabo.
This procedure should only be carried out by health care professionals.
Ta postopek sme opraviti le zdravstveno osebje.
Actrapid InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Actrapid InnoLet je namenjen za uporabo z iglami NovoFine s kratkim pokrovčkom, dolgimi 8 mm ali manj.
On rare occasions, injection site reactions may require discontinuation of Actrapid
V redkih primerih utegne biti zaradi reakcij na mestu injiciranja potrebna prekinitev uporabe zdravila Actrapid
32 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
33 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Bolezni imunskega sistema Občasni – urtikarija, izpuščaj Zelo redki – anafilaktične reakcije Med simptomi generalizirane preobčutljivosti so lahko generaliziran izpuščaj na koži, srbenje, znojenje, gastrointestinalne motnje, angionevrotični edem, težko dihanje, palpitacije, znižanje krvnega tlaka in omedlevica/ izguba zavesti.
34 Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Porazdelitev Ugotovili niso nobene izrazite vezave na beljakovine v plazmi, razen na krožeča protitelesa proti insulinu (če so prisotna).
Chrildren and adolescents The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
34 Otroci in mladostniki Farmakokinetični profil zdravila Actrapid je bil raziskan pri majhnem številu (n = 18) diabetičnih otrok (starost 6– 12 let) in mladostnikov (starost 13– 17 let).
35 During use: do not refrigerate.
Med uporabo: ne shranjujte v hladilniku!
6.6 Special precautions for disposal and other handling
35 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
For intravenous use, infusion systems with Actrapid at concentrations 0.05 IU/ ml - 1.0 IU/ ml insulin human in the following infusion fluids; 0.9% sodium chloride, 5% dextrose and 10% dextrose inclusive 40 mmol/ l potassium chloride, using polypropylene infusion bags, are stable at room temperature for 24 hours.
Za intravensko uporabo so infuzijski sistemi z insulinom Actrapid v koncentracijah od 0, 05i. e. / ml do 1, 0 i. e. / ml humanega insulina v tekočinah za infundiranje (0, 9% raztopina natrijevega klorida, 5% raztopina glukoze ali 10% raztopina glukoze s 40 mmol/ l raztopine kalijevega klorida) ob uporabi polipropilenskih vrečk za infundiranje pri sobni temperaturi stabilni 24 ur.
Actrapid InnoLet is for single person use only.
Actrapid InnoLet je namenjen uporabi ene same osebe.
Actrapid FlexPen 100 IU/ ml solution for injection in a pre-filled pen
Actrapid FlexPen 100 i. e. / ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
37 Administration For subcutaneous use.
37 Način uporabe Za subkutano uporabo.
This procedure should only be carried out by health care professionals.
Ta postopek sme opraviti le zdravstveno osebje
Actrapid FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Actrapid FlexPen je namenjen za uporabo z iglami NovoFine s kratkim pokrovčkom, dolgimi 8 mm ali manj.
Actrapid is accompanied by a package leaflet with detailed instruction for use to be followed.
Actrapid je priloženo navodilo za uporabo s podrobnimi navodili za pripravo, ki jih je treba upoštevati.
38 reduce or prevent these reactions.
38 dneh do nekaj tednih.
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 zgornji opozorilni simptomi hipoglikemije manj izraziti ali so se razlikovali od tistih, ki so jih doživeli s prejšnjim insulinom.
39 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji