natgillin/translations-raw huggingface dataset:
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Posamezni spontani primeri so opisani kot zelo redki in opredeljeni kot < 1/ 10. 000, vklju no s posameznimi primeri.
Therefore, no specific frequency can be presented.
V razvrstitvah pogostnosti so neželeni u inki navedeni po padajo i resnosti.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Bolezni živ evja Ob asni – periferna nevropatija Hitro izboljšanje urejenosti glukoze v krvi lahko spremlja motnja, imenovana ˝akutna bole a
The frequencies are defined as: uncommon (≥ 1/ 1,000 to
et nevropatija˝, ki je ponavadi reverzibilna.
ed < 1/ 100).
m O esne bolezni
or Nervous system disorders Uncommon - Peripheral neuropathy
o Ob asni – refrakcijske motnje
th Fast improvement in blood glucose control may be associated with a condition termed “ acute painful
pr Po za etku zdravljenja z insulinom se lahko pojavijo refrakcijske anomalije.
au neuropathy”, which is usually reversible.
Ponavadi so prehodne.
Eye disorders
Zelo redki – diabeti na retinopatija
er Uncommon - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
za Dolgoro no izboljšana urejenost glikemije zmanjša tveganje za napredovanje diabeti ne retinopatije.
These symptoms are usually of ng transitory nature. lo
Vendar lahko intenziviranje insulinskega zdravljenja s hitrim izboljšanjem urejenosti glikemije
Very rare - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. no
a spremlja prehodno poslabšanje diabeti ne retinopatije.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. ct
nj Bolezni kože in podkožja lje Ob asni – lipodistrofija e bolnik injekcijskih mest na posameznem predelu ne menja krožno, se lahko pojavi lipodistrofija. vo
Skin and subcutaneous tissue disorders du
Splošne težave in spremembe na mestu aplikacije do
Uncommon – Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites ro
Ve ina teh reakcij je prehodnih in med ā
within an area. lp
nadaljevanjem zdravljenja izginejo. ve
General disorders and administration site conditions Uncommon - Injection site reactions a
Ob asni – edemi a
Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may in
Ponavadi so prehodni. m
occur during treatment with insulin.
Bolezni imunskega sistema ni
Most reactions are transitory and disappear during continued treatment. ic ed
Ob asni – urtikarija, izpuš aj Zelo redki – anafilakti ne reakcije lo
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
tlaka in omedlevica/ izguba zavesti.
These symptoms are usually of transitory M
Generalizirane preob utljivostne reakcije so lahko smrtno ra
nature.
nevarne.
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.
Zato je priporo ljivo, da imajo diabeti ni bolniki pri sebi nekaj kock sladkorja, bonbone, piškote ali sadni sok, ki vsebuje sladkor. • Hude hipoglikemije, ko je bolnik nezavesten, je mogo e zdraviti z glukagonom (0, 5 do 1 mg), ki ga da ustrezno podu ena oseba intramuskularno ali subkutano ali z glukozo, ki jo da zdravstveni delavec intravensko.
Generalised hypersensitivity reactions are potentially life- threatening.
Glukozo, dano intravensko, je treba uporabiti tudi v primeru, e se bolnik v 10 do 15 minutah ne odzove na glukagon.
6 4.9 Overdose
6 Ko se bolnik zave, je priporo ljivo, da peroralno dobi ogljikove hidrate za prepre itev ponovitve.
th au 5.1 Pharmacodynamic properties
5. 1 Farmakodinami ne lastnosti
ATC
Oznaka ATC:
ng
Delovanje insulina na znižanje glukoze v krvi je posledica lažjega prehoda glukoze zaradi vezave
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose lo
et insulina na receptorje na miši nih in maš obnih celicah ter hkratne inhibicije sproš anja glukoze iz jeter.
output from the liver. no
m Klini no preskušanje zdravljenja hiperglikemije (glukoza v krvi nad 10 mmol/ l) v eni sami intenzivni
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 treatment with another fast ct
o enoti pri 204 diabeti nih in 1344 nediabeti nih bolnikih po ve ji operaciji je pokazala, da je
acting human insulin (Actrapid) reduced mortality by 42% (8% versus 4.6%). du
pr normoglikemija (glukoza v krvi 4, 4– 6, 1 mmol/ l), dosežena z intravenskim zdravljenjem z drugim hitrodelujo im humanim insulinom (Actrapid), zmanjšala umrljivost za 42% (8% v primerjavi s 4, 6%).
Velosulin is a fast-acting insulin. ro
za Velosulin je hitrodelujo i insulin.
When Velosulin is administered as a bolus injection 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. lp
a e je Velosulin uporabljen v bolusni injekciji, za ne delovati v ½ ure, doseže najve ji u inek v 1, 5 –
5.2 Pharmacokinetic properties a in
nj 3, 5 urah in ima celotni as delovanja približno 7– 8 ur. lje 5. 2 Farmakokineti ne lastnosti vo
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. ic ed
Zato asovni potek delovanja pripravka insulina dolo ajo samo njegove absorpcijske lastnosti. do
The pharmacokinetics of insulin products are therefore affected M
Na farmakokinetiko insulinskih zdravil torej vplivajo ā
by significant intra- and inter-individual variation.
pomembne intra - in interindividualne razlike. ve
Continuous subcutaneous infusion eliminates some of the variations/ fluctuations inherent to injection therapy.
Stalno subkutano infundiranje odpravi nekatere spremembe/ nihanja, povezane z injekcijskim a
Absorption The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
Razmeroma hitra absorpcija topnega insulina zagotavlja stalen dotok insulina v kri iz razmeroma m
7 Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
majhne koli ine pod kožo. ni
Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Najve ja koncentracija v plazmi je dosežena v 1, 5 do 2, 5 urah po subkutani uporabi. vi
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
Porazdelitev ra
Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Ugotovili niso nobene izrazite vezave na beljakovine v plazmi, razen na krože a protitelesa proti insulinu (e so prisotna).
The
Zd
ed terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of insulin from plasma (insulin in the blood stream has a t½ of a few minutes).
Presnova Opisano je, da se humani insulin razgradi z insulinsko proteazo ali encimi za razgradnjo insulina in morda s proteinsko disulfid- izomerazo.
Trials have indicated a t½
Predlagali so številna mesta razcepa (hidrolize) na molekuli humanega insulina; nobeden od presnovkov, nastalih po razcepu, ni aktiven.
is of about 2-5 hours.
Izlo anje Terminalni razpolovni as je dolo en s hitrostjo absorpcije iz podkožnega tkiva.
or Chrildren and adolescents The pharmacokinetic profile has been studied in a small number (n=18) of diabetic children (aged 6-
Terminalni razpolovni as (t1/ 2) je torej merilo absorpcije, ne izlo anja insulina iz plazme per se (insulin v krvnem obtoku ima t1/ 2 nekaj minut).
The
7 Otroci in mladostniki Farmakokineti ni profil zdravila Velosulin je bil raziskan pri majhnem številu (n = 18) diabeti nih otrok (starost 6– 12 let) in mladostnikov (starost 13– 17 let)., ki so uporabljali drug hitro delujo insulin (Actrapid).
au data are limited but suggest that the pharmacokinetic profile in children and adolescents may be similar to that in adults.
Podatkov je malo, vendar nakazujejo, da utegne biti farmakokineti ni profil pri otrocih in mladostnikih podoben kot pri odraslih.
5.3 Preclinical safety data er ng Non-clinical data reveal no special hazard for humans based on conventional studies of safety lo
5. 3 Predklini ni podatki o varnosti
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. no
Neklini ni podatki na podlagi obi ajnih študij farmakološke varnosti, toksi nosti pri ponavljajo ih odmerkih, genotoksi nosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne
PHARMACEUTICAL PARTICULARS ct
et kažejo posebnega tveganja za ljudi.
6.1 List of excipients du
FARMACEVTSKI PODATKI
Zinc chloride ro
pr 6. 1 Seznam pomožnih snovi
Glycerol Metacresol lp
za cinkov klorid glicerol
Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) a
a metakrezol
Hydrochloric acid (for pH adjustment) in
nj natrijev hidrogenfosfat dihidrat natrijev hidroksid (za uravnavo pH) lje klorovodikova kislina (za uravnavo pH) voda za injekcije vo
6.2 Incompatibilities ed
6. 2 Inkompatibilnosti do
M
Insulinska zdravila je dovoljeno dodajati le snovem, s katerimi so znano kompatibilna. Zdravila, dodana raztopini insulina, lahko povzro ijo razgradnjo insulina, npr. e zdravilo vsebuje tiole ali ā
Medicinal products added to the insulin solution may cause degradation of the insulin, e. g. if the medicinal products contain thiols or sulphites.
sulfite. ve
Concerning compatibility with insulin infusion pumps, reservoirs, catheters and needles, see section 6.6.
O združljivosti z insulinskimi infuzijskimi rpalkami, rezervoarji, katetri in iglami glejte poglavje 6. 6. a
6.3 Shelf life
6. 3 Rok uporabnosti m ni
30 months when stored between 2°C - 8°C.
30 mesecev pri temperaturi od 2 °C do 8 °C. lo
8 After first use as infusion, the insulin solution may be stored in the pump reservoir for six days at up to 37°C (close to the body).
temperaturi do 37 °C (blizu telesa). ra
6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje Zd
ed Keep the vial in the outer carton in order to protect from light.
Za zaš ito pred svetlobo hranite vialo v zunanji ovojnini. Zavarujte pred ezmerno vro ino in son no svetlobo.
or 6.5 Nature and contents of container
8 6. 5 Vrsta ovojnine in vsebina
th 10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective
10- ml steklena viala (steklo tipa 1), zaprta z brombutil/ poliizoprenskim gumijastim zamaškom in zaš itno varnostno zaporko.
au tamper-proof cap.
Velikost pakiranj:
6.6 Special precautions for disposal and other handling er ng Upon mixing Velosulin with infusion fluids an unpredictable amount of insulin will be absorbed to lo
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
the infusion material.
Po mešanju Velosulina s teko inami za infundiranje se nepredvidljiva koli ina insulina adsorbira na infuzijski material.
Monitoring of the patient's blood glucose during infusion is therefore recommended. no
Med infundiranjem je zato priporo ljivo nadziranje bolnikove glukoze v krvi.
When administered by CSII no other medicinal products or other insulin products should be mixed in the reservoir of the infusion pump with Velosulin. ct du
et Kadar se Velosulin uporablja v stalni subkutani infuziji, se z njim v rezervoarju infuzijske rpalke ne sme mešati nobenih drugih zdravil ali drugih insulinov.
Velosulin should not be mixed with insulin zinc suspensions ro
m o e je potrebna kombinacija z dolgodelujo imi insulini, je Velosulin mogo e mešati le z izofanim
since the phosphate buffer may interact with the zinc in the suspension and alter the timing of action of the insulin in an unpredictable way. lp
Zdravila Velosulin se ne sme mešati s suspenzijami insulina s cinkom, ker lahko fosfatni pufer reagira s cinkom v suspenziji, kar nepredvidljivo spremeni asovni potek delovanja insulina.
Insulin preparations which have been frozen must not be used. a
za 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. in
a Raztopin insulina se ne sme uporabiti, e niso bistre kot voda in brezbarvne.
Use only syringes made of polyethylene, polypropylene or glass. ed
nj Infundiranje insulina (stalna subkutana infuzija insulina): lje Uporabljajte samo brizge iz polietilena, polipropilena ali stekla.
M
Uporabljajte le katetre, v katerih je material, ki je v stiku z insulinom, iz polietilena ali polipropilena. vo
Use only teflon-coated or stainless steel needles.
Uporabljajte le s teflonom prekrite igle ali igle iz nerjave ega jekla. do
Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi. ā
MARKETING AUTHORISATION HOLDER
IMETNIK DOVOLJENJA ZA PROMET ve
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Nordisk A/ S a
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( E) DOVOLJENJA( DOVOLJENJ) ZA PROMET vi
EU/ 1/ 02/ 232/ 001-003
EU/ 1/ 02/ 232/ 001- 003 ra Zd
Date of first suthorisation:
Datum pridobitve dovoljenja za promet:
MANUFACTURER OF THE BIOLOGICAL ACTIVE lo
DATUM ZADNJE REVIZIJE BESEDILA
SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE no
9 et m o pr za a nj DODATEK II lje
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
IZDELOVALEC BIOLOŠKE ZDRAVILNE U INKOVINE IN vo
a
IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠ ANJE SERIJE do
lp
vi ra Zd
in ic ed M
B. lo
Novo Nordisk A/ S Novo Nordisk A/ S Novo Allé Hallas Allé DK-2880 Bagsværd Denmark Denmark
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd Danska
DK-4400 Kalundborg
Novo Nordisk A/ S Hallas Allé DK- 4400 Kalundborg Danska
ed Novo Nordisk A/ S
et Novo Nordisk A/ S Novo Allé
is Novo Allé DK-2880 Bagsværd
m DK- 2880 Bagsværd
th au B.
o Danska
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
pr V natisnjenem navodilu za uporabo mora biti navedeno ime in naslov izdelovalca, odgovornega za sproš anje zadevne serije.
er
za a B.
THE MARKETING AUTHORISATION HOLDER
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
ng
nj • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU lje DOVOLJENJA ZA PROMET Z ZDRAVILOM vo
Medicinal product subject to medical prescription lo
Izdaja zdravila je le na recept. do
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT no
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN U INKOVITO UPORABO ZDRAVILA ā
Not applicable. ct du ro ed M
Navedba smiselno ni potrebna. ve a m ni lo vi ra Zd
ic
11 et m o pr za a nj DODATEK III lje OZNA EVANJE IN NAVODILO ZA UPORABO vo do ā ve a m ni lo vi ra Zd
12 ed is or th au ANNEX III er ng LABELLING AND PACKAGE LEAFLET lo no ct du ro lp a in ic ed M
12 Zd ra vi lo ni m a ve ā
13 M ed ic in alp ro du ct
13 do vo A.
LABELLING lo ng er au th or is ed PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
OZNA EVANJE lje nj a za pr om et PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Velosulin 100 IU/ ml solution for injection or infusion in a vial Insulin human (rDNA)
Velosulin 100 i. e. / ml raztopina za injiciranje ali infundiranje v viali humani insulin (rDNA)
is 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
(3, 5 mg) humanega insulina (rDNA),
or th 3.
m o 3.
au zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections.
pr cinkov klorid, glicerol, metakrezol, natrijev hidrogenfosfat dihidrat, natrijev hidroksid, klorovodikova
er ng 4.
a nj 4.
Solution for injection or infusion no
FARMACEVTSKA OBLIKA IN VSEBINA lje Raztopina za injiciranje ali infundiranje 1 x 10 ml vo
1 x 10 ml 5 x 10 ml ct du
5 x 10 ml do
METHOD AND ROUTE(S) OF ADMINISTRATION ro
POSTOPEK IN POT( I) UPORABE ZDRAVILA ā
Subcutaneous or intravenous use Read the package leaflet before use
Za subkutano ali intravensko uporabo. ve
a
Pred uporabo natan no preberite priloženo navodilo! a m
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT in
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK ni
Keep out of the reach and sight of children ed M
Zdravilo shranjujte nedosegljivo otrokom! lo vi
OTHER SPECIAL WARNING(S), IF NECESSARY
DRUGA POSEBNA OPOZORILA, E SO POTREBNA ra Zd
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 May be kept in an infusion pump at up to 37°C for 6 days
V infuzijski rpalki lahko ostane pri temperaturi do 37 °C do 6 dni.
ed APPROPRIATE
et m 11.
th Novo Nordisk A/ S
o pr Novo Nordisk A/ S Novo Allé
au Novo Allé DK-2880 Bagsværd Denmark
za DK- 2880 Bagsværd Danska
er ng 12.
a nj 12.
MARKETING AUTHORISATION NUMBERS lo
ŠTEVILKA( E) DOVOLJENJA (DOVOLJENJ) ZA PROMET lje EU/ 1/ 02/ 232/ 001 1 x 10 ml vo
EU/ 1/ 02/ 232/ 001 1 x 10 ml EU/ 1/ 02/ 232/ 002 5 x 10 ml no
EU/ 1/ 02/ 232/ 002 5 x 10 ml do
BATCH NUMBER ct du
ŠTEVILKA SERIJE ā
Batch: ro
Serija: ve
GENERAL CLASSIFICATION FOR SUPPLY lp
NA IN IZDAJANJA ZDRAVILA a m
Medicinal product subject to medical prescription a in ic
Izdaja zdravila je le na recept. ni
INSTRUCTIONS ON USE ed
NAVODILA ZA UPORABO lo vi ra
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PODATKI V BRAILLOVI PISAVI Zd
Velosulin 100 IU/ ml solution for injection or infusion Insulin human (rDNA) SC, IV use
Velosulin 100 i. e. / ml raztopina za injiciranje ali infundiranje humani insulin (rDNA) Za subkutano ali intravensko uporabo.
is or 3.
mo 3.
th au EXP/
pr Upor. do /
er 4.
za a 4.
ng
nj Serija: lje vo
CONTENTS BY WEIGHT, BY VOLUME OR
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT do
10 ml ct du
10 ml ā ve
OTHER ro
DRUGI PODATKI
Novo Nordisk A/ S
Novo Nordisk A/ S a m ni lo vi ra Zd
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
16 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Velosulin 100 IU/ ml solution for injection or infusion in a vial Insulin human( rDNA)
Velosulin 100 i. e. / ml raztopina za injiciranje ali infundiranje v viali humani insulin (rDNA)
au zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections.
za cinkov klorid, glicerol, metakrezol, natrijev hidrogenfosfat dihidrat, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
PHARMACEUTICAL FORM AND CONTENTS lo
FARMACEVTSKA OBLIKA IN VSEBINA lje Raztopina za injiciranje ali infundiranje vo
Solusion for injection or infusion 1 x 10 ml no
1 x 10 ml To je del pakiranja z ve vialami in ni namenjen za prodajo posameznih vial. do
METHOD AND ROUTE(S) OF ADMINISTRATION du
POSTOPEK IN POT( I) UPORABE ZDRAVILA ā ve
Subcutaneous or intravenous use ro
Za subkutano ali intravensko uporabo.
Read the package leaflet before use lp
Pred uporabo natan no preberite priloženo navodilo! a m
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT a
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN ni
OF THE REACH AND SIGHT OF CHILDREN in ic
POGLEDA OTROK lo
Keep out of the reach and sight of children ed
Zdravilo shranjujte nedosegljivo otrokom! vi ra
OTHER SPECIAL WARNING(S), IF NECESSARY M
DRUGA POSEBNA OPOZORILA, E SO POTREBNA Zd
EU/ 1/ 02/ 232/ 003 no
ŠTEVILKA( E) DOVOLJENJA (DOVOLJENJ) ZA PROMET lje EU/ 1/ 02/ 232/ 003 vo do
BATCH NUMBER ct
ŠTEVILKA SERIJE ā
Batch: du ro
Serija: ve
Medicinal product subject to medical prescription a in
Izdaja zdravila je le na recept. ni
INSTRUCTIONS ON USE ic ed
NAVODILA ZA UPORABO lo vi ra
INFORMATION IN BRAILLE M
PODATKI V BRAILLOVI PISAVI Zd
19 PARTICULARS TO APPEAR ON THE PACKAGING
18 PODATKI NA OVOJNINI
Velosulin 100 IU/ ml Solution for injection or infusion in a vial Insulin human (rDNA)
Velosulin 100 i. e. / ml raztopina za injiciranje ali infundiranje v viali humani insulin (rDNA)
ed 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
(3, 5 mg) humanega insulina (rDNA),
is or 3.
o pr 3.
th zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric
za cinkov klorid, glicerol, metakrezol, natrijev hidrogenfosfat dihidrat, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
PHARMACEUTICAL FORM AND CONTENTS
FARMACEVTSKA OBLIKA IN VSEBINA lje Raztopina za injiciranje ali infundiranje vo
Solusion for injection or infusion 5 x (1 x 10 ml) lo
5 x (1 x 10 ml) To je pakiranje z ve vialami in ni namenjeno za prodajo posameznih vial. do
METHOD AND ROUTE(S) OF ADMINISTRATION ct
POSTOPEK IN POT( I) UPORABE ZDRAVILA ā ve
Subcutaneous or intravenous use du
Za subkutano ali intravensko uporabo.
Read the package leaflet before use ro
Pred uporabo natan no preberite priloženo navodilo! a m
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT lp
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN ni
OF THE REACH AND SIGHT OF CHILDREN a
POGLEDA OTROK lo
Keep out of the reach and sight of children in ic
Zdravilo shranjujte nedosegljivo otrokom! vi ra
OTHER SPECIAL WARNING(S), IF NECESSARY ed M
DRUGA POSEBNA OPOZORILA, E SO POTREBNA Zd
INFORMATION IN BRAILLE M
20 Zd ra vi lo ni m a ve ā
21 M ed ic in alp ro du ct
21 do vo lje B.
INFORMATION FOR THE USER
NAVODILO ZA UPORABO nj a za pr om et NAVODILO ZA UPORABO
Velosulin 100 IU/ ml solution for injection in a vial Insulin human (rDNA)
Velosulin 100 i. e. / ml raztopina za injiciranje v viali humani insulin (rDNA)
Read all of this leaflet carefully before you start using your insulin. – Keep this leaflet.
Preden za nete uporabljati vaš insulin, natan no preberite navodilo.! – Navodilo shranite.
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. – e imate dodatna vprašanja, se posvetujte z zdravnikom, diabetološko sestro ali farmacevtom. – Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Do not pass it on to others.
Njim bi lahko celo škodovalo, eprav imajo znake bolezni, podobne vašim. – e kateri koli neželeni u inek postane resen ali e opazite katerikoli neželeni u inek, ki ni
It may harm them, even if their symptoms are the same as yours. – 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 your pharmacist.
et omenjen v tem navodilu, obvestite svojega zdravnika, diabetološko sestro ali farmacevta.
ed is 1.
m o 1.
or Velosulin is human insulin to treat diabetes.
pr Velosulin je humani insulin za zdravljenje diabetesa.
th au 2.
za a 2.
BEFORE YOU USE VELOSULIN
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO VELOSULIN
If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
Znaki alergije so opisani v vo
Look out for the signs of allergy in 5 Possible side lo
poglavju 5.
effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom no
Možni neželeni u inki; e utite, da se pojavlja hipa (hipa je okrajšava za hipoglikemi no reakcijo in pomeni do
of low blood sugar).
simptome nizkega sladkorja v krvi).
Take special care with Velosulin ct du
Ukrepanje v nujnih primerih. ā ve