natgillin/translations-raw huggingface dataset:
INFORMATION FOR THE USER Angiox 250 mg powder for concentrate for solution for injection and infusion bivalirudin
26 NAVODILO ZA UPORABO Angiox 250 mg prašek za koncentrat za raztopino za injiciranje ali infundiranje bivalirudin
- If you have further questions, ask your doctor.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
please tell your doctor.
v tem navodilu, obvestite svojega zdravnika.
What Angiox is and what it is used for 2.
Kaj je zdravilo Angiox in za kaj ga uporabljamo 2.
Before you are given Angiox 3.
Kaj morate vedeti, preden boste uporabili zdravilo Angiox 3.
How Angiox is used 4.
Kako uporabljati zdravilo Angiox 4.
How to store Angiox 6.
Možni neželeni učinki 5 Shranjevanje zdravila Angiox 6.
WHAT ANGIOX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ANGIOX IN ZA KAJ GA UPORABLJAMO
Angiox is an antithrombotic medicine.
Zdravilo Angiox je antitrombotsko zdravilo.
• with chest pain due to heart disease (acute coronary syndromes - ACS) • who are having surgery to treat blockages in their blood vessels (angioplasty and/or percutaneous coronary intervention - PCI).
z bolečinami v prsih zaradi srčne bolezni (akutni koronarni sindrom – AKS) o ki imajo kirurški poseg za zdravljenje blokad v žilah (angioplastija ali perkutana koronarna o intervencija – PCI ali oboje).
BEFORE YOU ARE GIVEN ANGIOX
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO ANGIOX
Do not use Angiox:
Ne uporabljajte zdravila ANGIOX
(See
- če ste alergični na (preobčutljivi za) bivalirudin ali katerokoli sestavino zdravila Angiox (Za
section 6 for a list of these).
njihov seznam glejte poglavje 6),
- if you have, or have recently had, any bleeding from your stomach, intestines, bladder or other
- če krvavite ali ste nedolgo tega krvaveli iz želodca, črevesja, sečnega mehurja ali drugih organov,
organs, for example, if you have noticed abnormal blood in your stools or urine, (except from menstrual bleeding).
kot na primer, če ste opazili nenormalno kri v blatu ali urinu (izjema so menstruacijske krvavitve),
- if you have, or have had, difficulty with your blood clotting (a low platelet count).
- če imate ali ste imeli težave s strjevanjem krvi (majhno število trombocitov),
- if you have, or have had, severe high blood pressure.
- če imate ali ste imeli zelo visok krvni tlak,
- if you have, or have had, an infection of the heart tissue.
- če imate ali ste imeli okužbo srčnega tkiva,
- if you have severe kidney problems or if you need kidney dialysis.
- če imate hude težave z ledvicami ali če potrebujete ledvično dializo.
Check with the doctor if you are unsure.
Če ste negotovi se posvetujte s svojim zdravnikom.
Please tell your doctor
Uporaba drugih zdravil
• if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. • If you are taking blood thinners (anticoagulants e.g. warfarin) or medicines to prevent blood clots (antithrombotics) • if you have been treated before with medicines similar to Angiox (e.g. lepirudin)
Obvestite svojega zdravnika: • če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, • če jemljete zdravila za redčenje krvi (antikoagulanti, npr. varfarin) ali zdravila za preprečevanje krvnih strdkov (antitrombotiki), • če ste se že zdravili z zdravili, ki so podobna zdravilu Angiox (npr. lepirudin)
Because these medicines may increase the risk of side effects such as bleeding when given at the same time as Angiox.
Ta zdravila lahko povečajo tveganje za pojav neželenih učinkov kot je krvavitev, če se jih daje skupaj z zdravilom Angiox.
Pregnancy and breast-feeding
- ste noseči ali mislite, da ste noseči.
You must tell the doctor if:
- načrtujete zanositev.
• you are pregnant or think you may be pregnant • you are planning to become pregnant • you are breast-feeding.
- dojite.
If you are breast-feeding, the doctor will decide whether Angiox should be used.
Če dojite, bo zdravnik odločil, ali naj uporabljate zdravilo Angiox.
No studies of the effects on the ability to drive and use machines have been performed, but the effects of this medicine are known to be short-term.
Študij o vplivu na sposobnost upravljanja vozil in strojev niso izvedli, vendar je znano, da so učinki tega zdravila kratki.
Angiox is only given when a patient is in hospital.
Zdravilo Angiox se daje le, kadar je bolnik v bolnici.
HOW ANGIOX IS USED
KAKO UPORABLJATI ZDRAVILO ANGIOX
The doctor will decide how much Angiox you receive, and will prepare the medicine.
Zdravnik bo odločil, koliko zdravila Angiox boste dobili in bo zdravilo tudi pripravil.
This is administered and supervised by a doctor experienced in caring for patients with heart disease.
Zdravilo Angiox je namenjeno injiciranju, ki mu sledi infundiranje (kapljično) v veno (nikoli v mišico).
• Throughout your treatment, the doctor will check you for any signs of bleeding.
Zdravilo vam bo dal in zdravljenje nadzoroval zdravnik z izkušnjami z zdravljenem srčnih bolnikov. • Zdravnik bo med zdravljenjem preverjal, ali so se pojavili znaki krvavitev.
If bleeding occurs, treatment with Angiox will be stopped. • Before the start of the injection or infusion, the doctor will tell you about the signs of allergic reaction.
Če bi prišlo do krvavitve, bo zdravljenje z zdravilom Angiox prekinjeno. • Pred začetkom injiciranja ali infundiranja vam bo zdravnik povedal o znakih alergičnih reakcij.
Such a reaction is rare (occurring in fewer than 1 in every 1,000 patients treated). • Extra care will be taken if you are having radiation treatment in the vessels that supply blood to the heart (treatment called beta or gamma brachytherapy). • The dose given depends on your weight and on the kind of treatment you are being given.
Take reakcije so redke (pojavljajo se pri manj kot 1 od 1. 000 zdravljenih bolnikov). • Posebna pazljivost bo potrebna, če prestajate radiacijsko zdravljenje žil, ki srcu dostavljajo kri (zdravljenje, ki se imenuje beta ali gama brahiterapija). • Odmerek, ki ga boste prejeli, je odvisen od vaše telesne mase in vrste zdravljenja, ki ste ga deležni.
29 Dosage
Odmerjanje
For patients with acute coronary syndromes (ACS) the recommended starting dose is:
Za bolnike z akutnim koronarnim sindromom (AKS) je priporočen začetni odmerek:
(0.1 mg/kg body weight means one tenth of a milligram of the medicine for each kilogram you weigh; 0.25 mg/kg body weight per hour means a quarter of a milligram for each kilogram you weigh, per hour).
0, 1 mg/ kg telesne mase v obliki injekcije, ki ji sledi infundiranje (kapljično) 0, 25 mg/ kg telesne mase na uro (0, 1 mg/ kg telesne mase pomeni, da za vsak kilogram vaše telesne mase vsako uro prejmete desetinko miligrama zdravila; 0, 25 mg/ kg telesne mase pomeni, da za vsak kilogram vaše telesne mase vsako uro prejmete četrtinko miligrama).
• 0.5mg/kg body weight for the injection, followed by an infusion of 1.75mg/kg body weight, per hour.
0, 5 mg/ kg telesne mase za injekcijo, ki ji sledi infundiranje 1, 75 mg/ kg telesne mase na uro za infuzijo.
• When this treatment is finished, the infusion may go back to 0.25 mg/kg body weight, per hour.
Ko bo to zdravljenje končano, se bo odmerek za infundiranje zmanjšal nazaj na 0, 25 mg/ kg telesne mase na uro.
• 0.75mg/kg body weight as an injection, followed immediately by an infusion of 1.75mg/kg body weight, per hour.
0, 75 mg/ kg telesne mase v obliki injekcije, ki ji sledi infundiranje (kapljično) 1, 75 mg/ kg telesne mase na uro.
(The infusion may continue for up to 4 hours).
(Infundiranje se lahko izvaja največ 4 ure).
If you have mild kidney problems, the dose of Angiox may need to be reduced.
Če imate blage težave z ledvicami, bo morda treba odmerek zdravila Angiox zmanjšati.
If you have more of this medicine than you should
Če ste uporabili večji odmerek zdravila Angiox, kot bi smeli
These doses are carefully checked by the doctor, so an overdose is very unlikely.
Ker odmerke skrbno preverja vaš zdravnik, je verjetnost, da boste prejeli prekomeren odmerek, zelo majhna.
If you forget to have Angiox
Če ste pozabili uporabiti zdravilo Angiox
Because treatment with Angiox is administered and supervised by a doctor, this is very unlikely.
Ker vam zdravilo Angiox daje zdravnik, ki tudi nadzoruje vaše zdravljenje, je verjetnost, da bi prišlo do izpuščenega odmerka zelo majhna.
If you have any further questions on the use of this product, ask the doctor.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom.
If side effects occur, they may need medical attention.
Kot vsa zdravila ima lahko tudi zdravilo Angiox neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most common, important side effect of treatment with anticoagulants, including Angiox, is bleeding.
Najpogostejši pomembni neželeni učinek zdravljenja z antikoagulanti, vključno z zdravilom Angiox, je krvavitev.
This can become serious, and may, very rarely, be fatal, (fewer than 1 in every 10,000 patients treated).
Krvavitev lahko postane resna in v zelo redkih primerih smrtna (manj kot 1 od 10. 000 zdravljenih bolnikov).
Bleeding is more likely to occur when Angiox is used in combination with other anticoagulant or antithrombotic medicines (see section 2 ‘Taking other medicines’).
Pojav krvavitve je bolj verjeten, kadar zdravilo Angiox uporabljate v kombinaciji z drugimi antikoagulacijskimi ali antitrombotičnimi zdravili (glejte poglavje 2 "Uporaba drugih zdravil").
If y ou get any of the following, potentially serious, side effects:
Če opazite kateregakoli izmed naslednjih, morebitno resnih, neželenih učinkov:
o while you are in hospital: tell the doctor or nurse immediately – o after you’ve left hospital: go immediately to the Emergency Department of your nearest hospital -
ko ste v bolnišnici: takoj obvestite zdravnika ali sestro o ko zapustite bolnišnico: takoj obiščite urgentni oddelek najbližje bolnišnice – o
• Bleeding – a common side effect (fewer than 1 in every 10 patients treated).
krvavitve – pogosti neželeni učinek (manj kot 1 od 10 zdravljenih bolnikov).
This could result in complications such as anaemia (a low blood cell count) or haematoma (bruising).
Krvavitve lahko pripeljejo do zapletov, kakršen je anemija (majhno število krvnih telesc) ali hematomov (podplutb).
30 • Allergic reactions, such as hives (nettle rash), itching all over your body, tightness of the chest.
Alergične reakcije, kakršne so izpuščaji (koprivnica), srbenje po celem telesu, stiskanje v prsih.
These are uncommon reactions (fewer than 1 in every 100 patients treated). • Thrombosis (blood clots) which may result in serious complications such as heart attack.
Ti neželeni učinki so občasni (manj kot 1 od 100 zdravljenih bolnikov).
This is an uncommon side effect (fewer than 1 patient in every 100 patients treated). • Pain, bleeding and bruising at the puncture site (after PCI treatment).
Ta neželeni učinek je občasen (manj kot 1 bolnik od 100 zdravljenih bolnikov).
These side effects are rare (fewer than 1 in every 1,000 patients treated).
Ti neželeni učinki so redki (manj kot 1 bolnik od 100 zdravljenih bolnikov).
If y ou get any of the following, (potentially less serious), side effects:
Če pride do naslednjih (potencialno manj resnih) neželenih učinkov:
o while you are in hospital: tell the doctor or nurse - o after you’ve left hospital: go immediately to the Emergency Department of your nearest hospital -
ko ste v bolnišnici: takoj obvestite zdravnika ali sestro o ko zapustite bolnišnico: takoj obiščite urgentni oddelek najbližje bolnišnice – o
- severe bruising (which may be due to a reduction in the number of platelets in your blood.
- hude podplutbe (ki se pojavijo zaradi zmanjšanja števila trombocitov v vaši krvi.
This
To prepreči
may prevent your blood from clotting as well as it should)
strjevanje krvi, kar je tudi namen zdravljenja)
- changes in blood pressure
- spremembe krvnega tlaka
- changes in the rate of your heart beat
- spremembe frekvence bitja srca
- nausea (feeling sick) and/or vomiting (being sick)
- navzea (slabost) in/ ali bruhanje
- back pain
- bolečine v hrbtu
- chest pain
- bolečine v prsih
- shortness of breath
- zadihanost
- rash
- izpuščaji
These side effects are uncommon (fewer than 1 in every 100 patients treated).
Ti neželeni učinki so občasni (manj kot 1 od 100 zdravljenih bolnikov).
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
HOW TO STORE ANGIOX
SHRANJEVANJE ZDRAVILA ANGIOX
Angiox is not to be used after the expiry date which is stated on the label and carton after ‘EXP’.
Zdravila Angiox ne uporabljajte po izteku roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake" EXP ".
Lyophilised (freeze-dried) powder:
Liofiliziran (sušen z zamrzovanjem) prašek:
Store in a refrigerator (2 – 8oC)..
Shranjujte v hladilniku (2 oC – 8 oC).
What Angiox contains The active substance is bivalirudin.
Kaj vsebuje zdravilo Angiox Zdravilna učinkovina je bivalirudin.
After reconstitution, 1ml contains 50 mg bivalirudin.
Po rekonstituciji 1 ml vsebuje 50 mg bivalirudina.
After further dilution, 1ml contains 5 mg bivalirudin.
Po nadalnjem redčenju 1 ml vsebuje 5 mg bivalirudina.
The other ingredients are mannitol and sodium hydroxide.
Pomožne snovi sta manitol in natrijev hidroksid.
31 What Angiox looks like and contents of the pack
Izgled zdravila Angiox in vsebina pakiranja
Angiox is available in cartons containing 2 and 10 vials.
Zdravilo Angiox je na razpolago v škatlah, ki vsebujejo 2 in 10 vial.
Marketing Authorisation Holder:
Imetnik dovoljenja za promet z zdravilom
The Medicines Company UK Limited 115L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM
The Medicines Company UK Limited 115L Milton Park Abingdon Oxfordshire OX14 4SA VELIKA BRITANIJA
Hälsa Pharma GmbH Immermannstraße 9 33619 Bielefeld GERMANY
Izdelovalec Hälsa Pharma GmbH Immermannstraße 9 33619 Bielefeld Nemčija
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
30 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
France The Medicines Company UK Ltd Tél: + 800 843 633 26 ou +41 61 564 1320 Email:
31 România France The Medicines Company UK Ltd The Medicines Company UK Ltd Tel: + 800 843 633 26 Tél: + 800 843 633 26 sau +41 61 564 1320 ou +41 61 564 1320 E- mail:
Italia The Medicines Company UK Ltd Tel: + 800 843 633 26 o +41 61 564 1320 Email:
Suomi/ Finland Italia The Medicines Company UK Ltd The Medicines Company UK Ltd Puh. / tel. + 800 8436 3326 Tel: + 800 843 633 26 tai +41 61 564 1320 o +41 61 564 1320 S- posti:
This leaflet was last approved in {MM/YYYY}.
Navodilo je bilo odobreno {datum}
Apidra is a solution for injection.
Zdravilo Apidra je raztopina za injiciranje.
It is available in a vial, in cartridges (standard or OptiClick) or in a pre-filled pen (OptiSet or SoloStar).
Na voljo je v vialah, vložkih (standardni vložek ali OptiClick) ali predhodno napolnjenih injekcijskih peresnikih (OptiSet ali SoloStar).
Apidra contains the active substance insulin glulisine.
Zdravilo Apidra vsebuje zdravilno učinkovino insulin glulisin.
Apidra is used to treat adults, adolescents and children aged six years or over who have diabetes and need insulin treatment.
Zdravilo Apidra se uporablja za zdravljenje odraslih, mladostnikov in otrok, starejših od šest let, ki imajo sladkorno bolezen in potrebujejo zdravljenje z insulinom.
Apidra is given subcutaneously (under the skin) by injection in the abdominal wall (tummy), the thigh, or the upper arm, or by continuous infusion using an insulin pump.
Zdravilo Apidra se daje subkutano (pod kožo) z injekcijo v trebušno steno, stegno ali nadlaht ali s kontinuirano infuzijo z insulinsko črpalko.
The patient ’ s blood glucose (sugar) levels should be regularly tested to find the lowest effective dose.
Raven glukoze (sladkorja) v krvi bolnika je treba redno preverjati, da določimo najmanjši učinkovit odmerek.
Apidra should be given up to 15 minutes before or just after a meal.
Zdravilo Apidra je treba uporabiti do 15 minut pred obrokom ali takoj po njem.
Apidra is a short-acting insulin that is used in combination with intermediate- or long-acting insulins or insulin analogues (modified forms of insulin).
Zdravilo Apidra je insulin s kratkotrajnim delovanjem, ki se ga uporablja v kombinaciji z insulini s srednjedolgim ali dolgotrajnim delovanjem ali analogi insulina (spremenjenimi oblikami insulina).
It may also be used in combination with antidiabetic medicines that are taken by mouth.
Lahko se uporablja tudi v kombinaciji z antidiabetičnimi zdravili, ki se zaužijejo peroralno.
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen je bolezen, pri kateri v telesu ne nastaja dovolj insulina za uravnavanje ravni glukoze v krvi ali pri kateri telo ne more učinkovito izrabiti insulina.
The active substance in Apidra, insulin glulisine, is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glulisine.
Zdravilna učinkovina zdravila Apidra, insulin glulisin, proizvajajo z metodo, imenovano „ tehnologija rekombinantne DNK “: izdela ga bakterija, ki prejme gen (DNK), s katerim lahko tvori insulin glulisin.
The difference means that insulin glulisine acts more rapidly, and has a shorter duration of action than a short-acting human insulin.
Ta razlika pa pomeni, da insulin glulisin deluje hitreje in ima krajši čas učinkovanja kot humani insulin s kratkotrajnim delovanjem.
The replacement insulin acts in same way as naturally produced insulin and helps glucose to enter cells from the blood.
Nadomestni insulin deluje enako kot naravno proizveden insulin in omogoča, da lahko glukoza vstopi iz krvi v celico.
This helps to control the level of blood glucose, reducing the symptoms and complications of diabetes.
To pomaga uravnavati ravni glukoze v krvi in zmanjšati simptome in zaplete, povezane s sladkorno boleznijo.
Apidra, used in combination with a long-acting insulin, has been studied in patients with type 1 diabetes (when the body cannot produce insulin) in two studies involving a total of 1,549 adults and in one study involving 572 children aged between four and 17 years.
Zdravilo Apidra, uporabljeno v kombinaciji z insulinom z dolgotrajnim delovanjem, so preučevali pri bolnikih s sladkorno boleznijo tipa 1 (telo ne more tvoriti insulina) v dveh študijah, ki sta vključevali skupaj 1549 bolnikov, in v eni študiji, v katero je bilo vključenih 572 otrok, starih med štiri in 17 let.
In this study, Apidra was used in combination with an intermediate-acting insulin and antidiabetic medicines taken by mouth.
Pri bolnikih s sladkorno boleznijo tipa 2 (kadar telo ne more učinkovito izrabiti insulina) so zdravilo Apidra uporabili v kombinaciji z insulinom s srednjedolgim delovanjem in zdravili proti sladkorni bolezni, ki se jemljejo peroralno.
In all four studies, Apidra was compared with other insulins or insulin analogues (regular human insulin or insulin lispro).
V vseh štirih študijah so zdravilo Apidra primerjali z drugimi insulini ali analogi insulina (običajni humani insulin ali insulin lispro).
The main measure of effectiveness was the change in the blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Glavno merilo učinkovitosti je bila sprememba ravni snovi, imenovane glikozilirani hemoglobin (HbA1c), v krvi, kar kaže, kako dobro je glukoza v krvi nadzorovana.
Blood glucose control with Apidra was at least as effective as that with the comparator insulins.
Nadzor glukoze v krvi z zdravilom Apidra je bilo vsaj tako učinkovito kot s primerjalnimi insulini.
In all studies, the change in the level of HbA1c observed with Apidra was similar to that seen with the comparator insulins.
V vseh študijah je bila sprememba ravni HbA1c, ki so jo opazili ob uporabi zdravila Apidra, podobna z ravnmi, opaženimi pri primerjalnih insulinih.
In the first study of adults with type 1 diabetes, there was a decrease of 0.14% (from 7.60% to 7.46%) after six months, compared with a decrease of 0.14% for insulin lispro.
V prvi študiji, ki je vključevala odrasle s sladkorno boleznijo tipa 1, se je raven po šestih mesecih znižala za 0, 14% (s 7, 60% na 7, 46%) v primerjavi z znižanjem za 0, 14%, doseženim z insulinom lispro.
Similar reductions were seen in the second study in adults, which compared Apidra with regular human insulin.
Podobna znižanja so bila opažena v drugi študiji z odraslimi, v kateri so zdravilo Apidra primerjali z običajnim humanim insulinom.
In the study in children, Apidra and insulin lispro produced similar changes in HbA1c after six months.
V študiji z otroki sta zdravilo Apidra in insulin lispro po šestih mesecih povzročila podobne spremembe v ravneh HbA1c.
However, there was not enough information to show whether Apidra was effective in children aged below six years.
Vendar pa ni bilo zadostnih informacij, ki bi potrdili, ali je zdravilo Apidra učinkovito pri otrocih, mlajših od šest let.
In adults with type 2 diabetes, there was a decrease in HbA1c of 0.46% after six months of Apidra, compared with 0.30% for regular human insulin.
Pri odraslih bolnikih s sladkorno boleznijo tipa 2 je znižanje ravni HbA1c po šestih mesecih jemanja zdravila Apidra znašalo 0, 46% v primerjavi z znižanjem za 0, 30%, doseženim z običajnim humanim insulinom.
The most common side effect with Apidra (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Najpogostejši neželeni učinek zdravila Apidra (opažen pri več kot 1 bolniku od 10) je hipoglikemija (nizke ravni glukoze v krvi).
Apidra should not be used in people who may be hypersensitive (allergic) to insulin glulisine or any of the other ingredients, or in patients who already have hypoglycaemia.
Zdravila Apidra ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) insulin glulisin ali katero koli drugo sestavino zdravila, ali bolniki, ki že imajo hipoglikemijo.
Apidra doses might need to be adjusted when given with some other medicines that may have an effect on blood glucose levels.
Odmerke zdravila Apidra bo morda treba prilagoditi, če se zdravilo jemlje sočasno z nekaterimi drugimi zdravili, ki lahko vplivajo na ravni glukoze v krvi.
The Committee for Medicinal Products for Human Use (CHMP) decided that Apidra’ s benefits are greater than its risks for the treatment of adults, adolescents and children six years or older with diabetes mellitus, where treatment with insulin is required.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Apidra pri zdravljenju odraslih, mladostnikov in otrok, starih šest let ali več, s sladkorno boleznijo, pri katerih je potrebno zdravljenje z insulinom, večje od z njim povezanih tveganj.
The Committee recommended that Apidra be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Apidra odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Apidra to Sanofi-Aventis Deutschland GmbH on 27 September 2004.
Evropska Komisija je dovoljenje za promet z zdravilom Apidra, veljavno po vsej Evropski uniji, odobrila družbi Sanofi- Aventis Deutschland GmbH dne 27. septembra 2004.
This summary was last updated in 06-2008.
Povzetek je bil nazadnje posodobljen 06- 2008.
100 Units/ ml
100 enot/ ml
vial (glass)
viala (steklena)
Solution for injection
raztopina za
pre-filled pen (glass) (OptiSet)
vložek (steklen) v napolnjenem
4 pre-filled pens
4 napolnjeni injekcijski
6 pre-filled pens
6 napolnjenih
8 pre-filled pens
8 napolnjenih
9 pre-filled pens
9 napolnjenih
Apidra 100 Units/ ml, solution for injection in a vial
Apidra 100 enot/ ml raztopina za injiciranje v viali
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
En mililiter vsebuje 100 enot insulina glulisin (kar ustreza 3, 49 mg).