natgillin/translations-raw huggingface dataset:
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
39 odsotnim zaznavanjem opozorilnih znakov hipoglikemije in pri tistih, ki imajo pogoste hipoglikemije.
40 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.
It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. • 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.
40 • 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 intravensko zdravstveni delavec.
41 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).
41 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).
30 months when stored between 2°C - 8°C..
30 mesecev pri temperaturi od 2 °C do 8 °C.
42 During use: do not refrigerate.
Med uporabo: ne shranjujte v hladilniku!
6.6 Special precautions for disposal and other handling
42 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.
Med infundiranjem je treba nadzorovati glukozo v krvi. Injekcijske peresnike se sme uporabljati samo z izdelki, s katerimi so kompatibilni in ki omogočajo varno in učinkovito delovanje teh peresnikov.
Actrapid FlexPen is for single person use only.
Actrapid FlexPen je namenjen uporabi ene same osebe.
October 2002
7. oktober 2002
43 ANNEX II
43 DODATEK II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
ZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
Novo Nordisk A/ S Hallas Allé DK-4400 Kalundborg Denmark
Novo Nordisk A/ S Hallas Allé DK- 4400 Kalundborg Danska
Actrapid Penfill and FlexPen:
Actrapid Penfill in FlexPen:
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVIL
45 ANNEX III
45 DODATEK III
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
47 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Actrapid 40 IU/ ml solution for injection in a vial Insulin human (rDNA)
Actrapid 40 i. e. / ml raztopina za injiciranje v viali humani insulin (rDNA)
1 ml solution contains 40 IU (1.4 mg) of insulin human (rDNA).
(1, 4 mg) humanega insulina (rDNA)
zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.
cinkov klorid, glicerol, metakrezol, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
Solution for injection 1 x 10 ml 5 x 10 ml
Raztopina za injiciranje 1 x 10 ml 5 x 10 ml
Subcutaneous or intravenous use Read the package leaflet before use
Pred uporabo natančno preberite priloženo navodilo!
EXP/ During use: use within 4 weeks
Upor. do / Med uporabo: porabite v 4 tednih.
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Med uporabo: ne shranjujte v hladilniku; shranjujte pri temperaturi do 25 °C!
EU/ 1/ 02/ 230/ 001 1 x 10 ml EU/ 1/ 02/ 230/ 002 5 x 10 ml
EU/ 1/ 02/ 230/ 001 EU/ 1/ 02/ 230/ 002
Actrapid vial 40 IU/ ml
Actrapid viala 40 i. e. / ml
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
49 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
IME ZDRAVILA IN POT( I) UPORABE
Actrapid 40 IU/ mlsolution for injection Insulin human (rDNA) SC, IV use
Actrapid 40 i. e. / ml raztopina za injiciranje humani insulin (rDNA) Za s. c., i. v. uporabo.
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
50 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Actrapid 100 IU/ ml solution for injection in a vial Insulin human (rDNA)
Actrapid 100 i. e. / ml raztopina za injiciranje v viali humani insulin (rDNA)
1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
(3, 5 mg) humanega insulina (rDNA)
EU/ 1/ 02/ 230/ 003 1 x 10 ml EU/ 1/ 02/ 230/ 004 5 x 10 ml
EU/ 1/ 02/ 230/ 003 EU/ 1/ 02/ 230/ 004
1 vial of 10 ml contains 1000 IU
Ena 10- ml viala vsebuje 1000 i. e.
Actrapid vial 100 IU/ ml
Actrapid viala 100 i. e. / ml
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
52 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Actrapid 100 IU/ ml solution for injection Insulin human (rDNA) SC, IV use
Actrapid 100 i. e. / ml raztopina za injiciranje humani insulin( rDNA) Za s. c., i. v. uporabo.
10 ml 1 vial of 10 ml contains 1000 IU
10 ml Ena 10- ml viala vsebuje 1000 i. e.
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
53 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Actrapid 40 IU/ ml solution for injection in a vial Insulin human (rDNA)
Actrapid 40 i. e. / ml raztopina za injiciranje v viali humani insulin( rDNA)
Solution for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
Raztopina za injiciranje 1 x 10 ml To je del pakiranja z več vialami in ni namenjen za izdajanje posameznih vial.
Subcutaneous or intravenous use Read the package leaflet before use
Pred uporabo natančno preberite priloženo navodilo.
55 PARTICULARS TO APPEAR ON THE PACKAGING
55 PODATKI NA NALEPKI ZUNANJEGA OVOJA VEČJIH PAKIRANJ, OVITIH V PROSOJNO FOLIJO
OUTER WRAPPER LABEL ON MULTIPACKS
NALEPKA ZA VIALO
Solution for injection 5 x (1 x 10 ml) This is a multipack and not for sale of individual vials
Raztopina za injiciranje 5 x (1 x 10 ml) To pakiranje z več vialami ni namenjeno za izdajanje posameznih vial.
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Actrapid 100 IU/ ml solution for injection in a vial Insulin human (rDNA)
Actrapid 100 i. e. / ml raztopina za injiciranje v viali humani insulin( rDNA)
EXP/ During use: use within 6 weeks
Upor. o do / Med uporabo: porabite v 6 tednih.
59 PARTICULARS TO APPEAR ON THE PACKAGING OUTHER WRAPPER LABEL ON MULTIPACKS
59 PODATKI NA NALEPKI ZUNANJEGA OVOJA VEČJIH PAKIRANJ, OVITIH V PROSOJNO FOLIJO
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
61 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Actrapid Penfill 100 IU/ ml solution for injection in a cartridge Insulin human (rDNA)
Actrapid Penfill 100 i. e. / ml raztopina za injiciranje v injekcijskem vložku humani insulin (rDNA)
Solution for injection 1 x 3 ml 5 x 3 ml 10 x 3 ml
Raztopina za injiciranje 1 x 3 ml 5 x 3 ml 10 x 3 ml
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Read the package leaflet before use Actrapid Penfill is for use by one person only
Actrapid Penfill je namenjen uporabi ene same osebe.
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the cartridge in the outer carton in order to protect from light During use: do not refrigerate or store above 30°C
Med uporabo: ne shranjujte v hladilniku; shranjujte pri temperaturi do 30 °C!
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
63 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Actrapid Penfill 100 IU/ ml solution for injection Insulin human (rDNA) SC use
Actrapid Penfill 100 i. e. / ml raztopina za injiciranje humani insulin (rDNA) Za subkutano uporabo.
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
64 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Actrapid NovoLet 100 IU/ ml solution for injection in a pre-filled pen Insulin human (rDNA)
Actrapid NovoLet 100 i. e. / ml raztopina za injiciranje v napolnjenem injekcijskem peresniku humani insulin (rDNA)
Solution for injection 5 x 3 ml 10 x 3 ml
Raztopina za injiciranje 5 x 3 ml 10 x 3 ml
Subcutaneous use Actrapid NovoLet is designed to be used with NovoFine needles Read the package leaflet before use Actrapid NovoLet is for use by one person only
Actrapid NovoLet je namenjen uporabi ene same osebe.
Store in a refrigerator (2°C - 8°C) Do not freeze Protect from light During use: do not refrigerate or store above 30°C
Med uporabo: ne shranjujte v hladilniku; shranjujte pri temperaturi do 30 °C!
66 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
66 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Actrapid NovoLet 100 IU/ ml solution for injection Insulin human (rDNA) SC use
Actrapid NovoLet 100 i. e. / ml raztopina za injiciranje humani insulin (rDNA) Za subkutano uporabo.
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
67 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Actrapid InnoLet 100 IU/ ml solution for injection in a pre-filled pen Insulin human (rDNA)
Actrapid InnoLet 100 i. e. / ml raztopina za injiciranje v napolnjenem injekcijskem peresniku humani insulin (rDNA)
Subcutaneous use Actrapid InnoLet is designed to be used with NovoFine S needles Read the package leaflet before use Actrapid InnoLet is for use by one person only
Actrapid InnoLet je namenjen uporabi ene same osebe.
BATCH NUMBER
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA
69 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
69 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Actrapid InnoLet 100 IU/ ml solution for injection Insulin human (rDNA) SC use
Actrapid InnoLet 100 i. e. / ml raztopina za injiciranje humani insulin (rDNA) Za subkutano uporabo.
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
70 PODATKI NA ZUNANJI OVOJNINI PRIMARNI OVOJNINI
Actrapid FlexPen 100 IU/ ml solution for injection in a pre-filled pen Insulin human (rDNA)
Actrapid FlexPen 100 i. e. / ml raztopina za injiciranje v napolnjenem injekcijskem peresniku humani insulin (rDNA)
Subcutaneous use Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm.
Igle niso priložene.
Needles are not includedRead the package leaflet before use Actrapid FlexPen is for use by one person only
Actrapid FlexPen je namenjen uporabi ene same osebe.
72 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
72 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Actrapid FlexPen 100 IU/ ml solution for injection Insulin human (rDNA) SC use
Actrapid FlexPen 100 i. e. / ml raztopina za injiciranje humani insulin (rDNA) Za subkutano uporabo.
74 PACKAGE LEAFLET:
74 NAVODILO ZA UPORABO
Actrapid 40 IU/ ml solution for injection in a vial Insulin human (rDNA)
Actrapid viala 40 i. e. / ml raztopina za injiciranje v viali humani insulin (rDNA)
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
Morda ga boste želeli ponovno prebrati. – Če imate dodatna vprašanja, se posvetujte z zdravnikom, diabetološko sestro ali s farmacevtom. – Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
WHAT ACTRAPID IS AND WHAT IT IS USED FOR
KAJ JE ACTRAPID IN ZA KAJ GA UPORABLJAMO
Actrapid is human insulin to treat diabetes.
Actrapid je humani insulin za zdravljenje diabetesa.
This means that it will start to lower your blood sugar about half an hour after you take it, and the effect will last for approximately 8 hours.
To pomeni, da začne sladkor v krvi zniževati približno pol ure po uporabi, njegov učinek pa traja približno 8 ur.
Actrapid is often given in combination with longer-acting insulin products.
Actrapid se pogosto uporablja v kombinaciji z dalj časa delujočimi insulinskimi zdravili.
BEFORE YOU USE ACTRAPID
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ACTRAPID
► If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
Ne uporabljajte zdravila Actrapid če ste alergični na (preobčutljivi za) ta insulin, na metakrezol ali kakršno koli drugo sestavino ► tega zdravila (glejte poglavje 7.
Look out for the signs of allergy in 5 Possible side effects ► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
Možni neželeni učinki. če čutite, da se pojavlja hipa (hipa je okrajšava za hipoglikemično reakcijo in pomeni ► simptome nizkega sladkorja v krvi).
Take special care with Actrapid
Ukrepanje v nujnih primerih.
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands ► If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach ► If you are exercising more than usual or if you want to change your usual diet ► If you are ill: carry on taking your insulin ► If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Pri uporabi zdravila Actrapid bodite posebno pozorni: če imate težave z ledvicami, jetri, nadledvično žlezo, hipofizo ali ščitnico. ► če pijete alkohol: pazite na znake hipe in alkohola nikdar ne pijte na prazen želodec. ► če ste telesno bolj dejavni kot ponavadi ali želite spremeniti svojo običajno prehrano. ► če ste bolni: insulin uporabljajte še naprej. ► če potujete v tujino: potovanje med različnimi časovnimi pasovi lahko vpliva na potrebe po ► insulinu in časovni razpored injekcij.
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Vaša potreba po insulinu se lahko spremeni, če uporabljate tudi: peroralna antidiabetična zdravila, zaviralce monoaminooksidaze (MAOI), zaviralce receptorjev beta, zaviralce ACE, acetilsalicilno kislino, anabolne steroide, sulfonamide, peroralne kontraceptive, tiazide, glukokortikoide, zdravljenje s ščitničnimi hormoni, beta- simpatikomimetike, rastni hormon, danazol, oktreotid in lanreotid.
75 Driving and using machines
75 hipa.
HOW TO USE ACTRAPID
KAKO UPORABLJATI ACTRAPID
► Check the label to make sure it is the right type of insulin ► Disinfect the rubber membrane with a medicinal swab.
Preden uporabite Actrapid preverite nalepko, da se boste prepričali, ali imate pravo vrsto insulina. ► dezinficirajte gumijasto membrano z medicinskim zložencem. ►
► In insulin infusion pumps ► If the protective cap is loose or missing.
Zdravila Actrapid ne uporabljajte v insulinskih infuzijskih črpalkah ► če zaščitna zaporka ne sedi trdno ali je sploh ni.
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Actrapid) ► If it does not appear water clear and colourless.
Če ta tedaj, ko dobite vialo, ni v povsem brezhibnem stanju, vialo vrnite dobavitelju. če ni bil shranjen pravilno ali je zamrznil (glejte poglavje 6, Shranjevanje zdravila Actrapid). ► če ni bister kot voda in brezbarven. ►
Actrapid is for injection under the skin (subcutaneously).
Uporaba tega insulina Actrapid je namenjen injiciranju pod kožo (subkutani uporabi).
Actrapid may also be administered intravenously in special situations by medical professionals.
Actrapid je mogoče aplicirati tudi intravensko, vendar le pod strogim nadzorom zdravnika.
1.
Za injiciranje zdravila Actrapid samega 1.
Inject the air into the vial: push the needle through the rubber stopper and press the plunger 3.
3.
1.
Za mešanje zdravila Actrapid z dolgodelujočim insulinom 1.
Roll the vial of long-acting insulin between your hands.
Počnite to, dokler tekočina ni enakomerno bela in motna.
Draw as much air into the syringe as the dose of long-acting insulin you need.
V brizgo potegnite tolikšno količino zraka, kot je odmerek dolgodelujočega insulina, ki ga potrebujete.
Inject the air into the long-acting insulin vial, then pull out the needle
Injicirajte zrak v vialo z dolgodelujočim insulinom in nato potegnite iglo iz nje.
Draw as much air into the syringe as the dose of Actrapid you need.
Injicirajte zrak v vialo z insulinom Actrapid.
Inject the air into the Actrapid vial.
Obrnite vialo in brizgo tako, da bo brizga spodaj.
Draw the right dose of Actrapid into the syringe.
V brizgo potegnite pravi odmerek zdravila Actrapid.
Make sure there is no air left in the syringe: point the needle upwards and push the air out.
Prepričajte se, da v brizgi ni ostalo nič zraka: obrnite iglo navzgor in iztisnite zrak.
Draw the right dose of long-acting insulin into the syringe 8.
Potegnite v brizgo pravi odmerek dolgodelujočega insulina.
Inject the mixture straight away.
Mešanico si takoj injicirajte.
Always mix fast-acting and long-acting insulin in this order.
Hitrodelujoči in dolgodelujoči insulin vedno zmešajte v tem zaporedju.
Inject the insulin
Injicirajte insulin Insulin injicirajte pod kožo.
► Inject the insulin under the skin.
Za injiciranje uporabite postopek, ki vam ga je svetoval zdravnik ► ali diabetološka sestra.
Use the injection technique advised by your doctor or diabetes nurse ► Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
Igla mora ostati pod kožo vsaj 6 sekund, da je zanesljivo injiciran celotni odmerek. ►
If you get a hypo
Če doživite hipo
If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Če se pojavi kateri od teh znakov, zaužijte tablete glukoze ali prigrizek, ki vsebuje veliko sladkorja (bonbone, piškote, sadni sok) in nato počivajte.
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
Iz nezavesti se boste morda zbudili prej, če dobite injekcijo hormona glukagona; dati jo mora oseba, ki ga zna uporabljati.
You get a hypo if your blood sugar gets too low.
Hipa se pojavi, če se sladkor v krvi preveč zniža.
77 If your blood sugar gets too high
Če se vam sladkor v krvi preveč zviša
Your blood sugar may get too high (this is called hyperglycaemia).
Sladkor v krvi se vam lahko preveč zviša (to imenujemo hiperglikemija).
If you get any of these signs, test your blood sugar level and test your urine for ketones if you can.
Če se pojavi kateri od teh znakov, si izmerite sladkor v krvi in določite ketone v urinu, če imate to možnost; potem pa takoj poiščite zdravniški nasvet.
These may be signs of a very serious condition called diabetic ketoacidosis.
77 To so lahko znaki zelo resnega stanja, ki ga imenujemo diabetična ketoacidoza.
Like all medicines, Actrapid can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Actrapid neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Actrapid may cause hypoglycaemia (low blood sugar).
Actrapid lahko povzroči hipoglikemijo (nizek krvni sladkor).
See the advice in 4 What to do in an emergency.
Glejte nasvet v poglavju 4, Ukrepanje v nujnih primerih.
Side effects reported uncommonly (in less than 1 patient in 100)
(manj kot 1 bolnik na 100)
Changing the site with each injection may help to prevent such skin changes.
Če na mestu injiciranja opazite ugreznjenost ali izbočenost kože, morate to povedati zdravniku ali diabetološki medicinski sestri.
You may have a very rare serious allergic reaction to Actrapid or one of its ingredients (called a systemic allergic reaction).
Morda imate zelo redko, resno alergijsko reakcijo na Actrapid ali eno njegovih sestavin (to imenujemo sistemska alergijska reakcija).
See also warning in 2 Before you use Actrapid.
Glejte tudi opozorilo v poglavju 2.
78 Side effects reported very rarely (in less than 1 patient in 10,000)
(manj kot 1 bolnik na 10. 000)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.
78 Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, diabetološko sestro ali farmacevta.
HOW TO STORE ACTRAPID
SHRANJEVANJE ZDRAVILA ACTRAPID
Do not use Actrapid after the expiry date which is stated on the label and the carton.
Zdravila Actrapid ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatlici.
The vials that are not being used are to be stored in a refrigerator (2°C - 8°C).
Viale, ki jih ne uporabljate, shranjujte v hladilniku (med 2 °C in 8 °C).
Keep the vials in the original package.
Viale hranitev originalni ovojnini!
The vials that are being used or about to be used are not to be kept in a refrigerator.
Vial, ki jih uporabljate ali jih boste pravkar uporabili, ne shranjujte v hladilniku!
You can carry them with you and keep them at room temperature (not above 25ºC) for up to 4 weeks.
S seboj jih lahko nosite in shranjujete na sobni temperaturi (do 25 °C) do 4 tedne.
Always keep the vial in the outer carton when you’ re not using it in order to protect it from light.
Kadar viale ne uporabljate, jo vedno shranjujte v zunanji ovojnini, da bo zaščitena pred svetlobo.
Actrapid must be protected from excessive heat and sunlight.
Actrapid je treba zaščititi pred čezmerno toploto in sončno svetlobo.
Actrapid should not be disposed of via wastewater or household waste.
Zdravila Actrapid ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What Actrapid contains
Kaj vsebuje zdravilo Actrapid
– The active substance is insulin human made by recombinant biotechnology.
– Zdravilna učinkovina je humani insulin, pridobljen z rekombinantno biotehnologijo.
– The other ingredients are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.
– Pomožne snovi so cinkov klorid, glicerol, metakrezol, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
Not all packs may be marketed.
Izgled zdravila Actrapid in vsebina pakiranja Raztopina za injiciranje je bistra, brezbarvna vodna raztopina, opremljena v pakiranjih z 1 ali 5 10- ml vialami ali v pakiranjih z več vialami, v katerih je 5 x (1 x 10 ml) vial (na trgu lahko ni vseh navedenih pakiranj).
79 PACKAGE LEAFLET:
79 NAVODILO ZA UPORABO
Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Posvetujte se z zdravnikom ali s farmacevtom, če jemljete ali ste jemali katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
80 Driving and using machines
80 Vpliv na sposobnost upravljanja vozil in strojev Če vozite ali uporabljate orodja ali stroje: pazite na znake hipe.
► In insulin infusion pumps ► If the protective cap is loose or missing.
Ne uporabljajte zdravila Actrapid v insulinskih infuzijskih črpalkah ► če zaščitna zaporka ne sedi trdno ali je sploh ni.