natgillin/translations-raw huggingface dataset:
Icandra is indicated in the treatment of type 2 diabetes mellitus: - Icandra is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. 
Icandra je indiciran u liječenju šećerne bolesti tipa 2: - Icandra je indiciran u liječenju odraslih bolesnika u kojih se ne može postići zadovoljavajuća kontrola glikemije primjenom oralnog metformina u maksimalno podnošljivoj dozi ili u bolesnika koji se već liječe kombinacijom odvojenih tableta vildagliptina i metformina.
Icandra combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class. 
Icandra sadrži kombinaciju dviju antihiperglikemijskih tvari s komplementarnim mehanizmima djelovanja za poboljšanje kontrole glikemije u bolesnika sa šećernom bolešću tipa 2: vildagliptin, pripadnik skupine stimulatora Langerhansovih otočića gušterače i metforminklorid, pripadnik skupine bigvanida.
Driving and using machines If you feel dizzy while taking Icandra, do not drive or use any tools or machines. 
Ako osjećate omaglicu dok uzimate Icandru, nemojte upravljati vozilima niti raditi s alatima ili strojevima.
- For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: 
- U bolesnika u kojih nije postignuta zadovoljavajuća kontrola dvojnom kombiniranom terapijom inzulinom i najvišom podnošljivom dozom metformina:
Icandra is used to treat adult patients with type 2 diabetes. 
Icandra se primjenjuje za liječenje bolesnika sa šećernom bolešću tipa
Bioequivalence has been demonstrated between Icandra at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses. 
Potvrđena je bioekvivalencija triju jačina doza Icandre (50 mg/500 mg, 50 mg/850 mg i 50 mg/1000 mg) u usporedbi sa slobodnom kombinacijom tableta vildagliptina i metforminklorida u odgovarajućim dozama.
If necessary, the dosage of Icandra may need to be adjusted during concomitant therapy and on its discontinuation. 
Ako je potrebno, dozu Icandre treba prilagoditi za vrijeme istodobne primjene te nakon njenog završetka.
Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and increased risk of lactic acidosis. 
Intravaskularna primjena jodiranih kontrastnih sredstava može dovesti do nefropatije izazvane kontrastom, što dovodi do nakupljanja metformina i povećanja rizika od laktacidoze.
Animal studies of up to 13-week duration have been conducted with the combined substances in Icandra. 
Ispitivanja kombinacije tvari iz Icandre provedena su na životinjama u trajanju do 13 tjedana.
No data are available with regard to overdose of Icandra. 
Nema dostupnih podataka o predoziranju Icandrom.
Therefore, you should not receive Icandra for the treatment of type 1 diabetes. 
Stoga ne smijete uzimati Icandru za liječenje šećerne bolesti tipa
It is especially important to mention the following: - glucocorticoids generally used to treat inflammation - beta-2 agonists generally used to treat respiratory disorders - other medicines used to treat diabetes - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) - certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II 
- glukokortikoide koji se obično koriste za liječenje upala - beta-2 agoniste koji se obično koriste za liječenje poremećaja disanja - druge lijekove koji se koriste za liječenje šećerne bolesti - lijekove koji povećavaju stvaranje mokraće (diuretici) - lijekove koji se primjenjuju za liječenje boli i upale (NSAIL i COX-2-inhibitori, kao što su ibuprofen i celekoksib) - određene lijekove za liječenje povišenog krvnog tlaka (ACE inhibitori i antagonisti receptora angiotenzina II)neke lijekove koji utječu na štitnjaču, ili - neke lijekove koji utječu na živčani sustav.
- Icandra is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea. 
- Icandra je indiciran u kombinaciji sa sulfonilurejom (tj. trojna kombinirana terapija) kao dodatak dijeti i tjelovježbi u odraslih bolesnika u kojih je kontrola nedostatna s metforminom i sulfonilurejom.
Symptoms of lactic acidosis include: vomiting stomach ache (abdominal pain) muscle cramps a general feeling of not being well with severe tiredness difficulty in breathing reduced body temperature and heartbeat 
Simptomi laktacidoze uključuju: - povraćanje - bol u trbuhu (bol u abdomenu) - grčevi u mišićima - opće loše osjećanje uz jaki umor - otežano disanje - smanjena tjelesna temperatura i usporen rad srca
In particular, if you are following a diabetic weight control diet, continue with this while you are taking Icandra. 
Ako se trebate pridržavati dijabetičke dijete za kontrolu tjelesne težine, onda svakako nastavite s njom i za vrijeme uzimanja Icandre.
A test to determine your liver function will be performed before the start of Icandra treatment, at three-month intervals for the first year and periodically thereafter. 
Testovi jetrene funkcije će se napraviti prije početka liječenja Icandrom, potom tijekom prve godine u razmacima od tri mjeseca te poslije toga periodički.
EU/1/08/484/019-024 EU/1/08/484/031-033 
EU/1/08/484/001-006 EU/1/08/484/013-015 EU/1/08/484/019-024 EU/1/08/484/031-033
Caution should be exercised in patients with a history of acute pancreatitis. 
Potreban je oprez u bolesnika s anamnezom akutnog pankreatitisa.
- Icandra is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control. 
- Icandra je indiciran u trojnoj kombiniranoj terapiji sa inzulinom kao dodatak dijeti i tjelovježbi za poboljšanje kontrole glikemije u odraslih bolesnika u kojih stabilna doza inzulina i metformina ne omogućuju odgovarajuću kontrolu glikemije.
LFTs should be performed prior to the initiation of treatment with Icandra in order to know the patient's baseline value. 
Testove jetrene funkcije treba napraviti prije početka liječenja Icandrom kako bi se utvrdile početne vrijednosti.
Icandra may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening. 
Liječenje Icandrom može se započeti s jačinom tablete ili od 50 mg/850 mg ili od 50 mg/1000 mg dvaput na dan, kao jedna tableta ujutro i druga navečer.
Skin reactions such as erythema, pruritus and urticaria *A decrease in vitamin B12 absorption with decrease in serum levels has been very rarely observed in patients treated long-term with metformin. 
*Smanjena apsorpcija vitamina B12 uz pad razine u serumu vrlo je rijetko zamijećena u bolesnika koji su dugotrajno liječeni metforminom.
The dose of Icandra should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. 
Doza lijeka Icandra mora biti 50 mg vildagliptina dvaput na dan (ukupna dnevna doza 100 mg) i doza metformina slična dosadašnjoj dozi.
Icandra is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets. 
Icandra je dostupan u pakiranjima od 10, 30, 60, 120, 180 ili 360 filmom obloženih tableta i u višestrukim pakiranjima od 120 (2x60), 180 (3x60) ili 360 (6x60) filmom obloženih tableta.
Other side effects Some patients have experienced the following side effects while taking Icandra: 
Neki su bolesnici imali sljedeće nuspojave kada su uzimali Icandru:
Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Icandra (see sections 4.2, 4.3 and 4.8). 
Icandra se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre, uključujući one u kojih su ALT ili AST prije početka liječenja bili >3x GGN (vidjeti dijelove 4.2, 4.3 i 4.8).
Icandra 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other. 
Icandra 50 mg/1000 mg filmom obložene tablete su tamnožute, ovalne tablete s oznakom „NVR” na jednoj strain i „FLO” na drugoj strani.
How to take Icandra 
Kako uzimati Icandru
Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Icandra in order to avoid low blood glucose (hypoglycaemia). 
Da bi izbjegao nisku koncentraciju glukoze u krvi (hipoglikemija), Vaš će liječnik možda htjeti smanjiti Vašu dozu sulfonilureje kad je uzimate zajedno s Icandrom.
What Icandra looks like and contents of the pack Icandra 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other. 
Icandra 50 mg/850 mg filmom obložene tablete su žute, ovalne tablete s oznakom „NVR” na jednoj strain i „SEH” na drugoj strani.
• Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain. 
Nakon što je lijek stavljen u promet, prijavljene su i sljedeće nuspojave: • učestalost nije poznata (učestalost se ne može procijeniti iz dostupnih podataka): osip koji svrbi, upala gušterače, lokalizirano ljuštenje kože ili mjehurići, bol u mišiću.
After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects. 
Apsolutna bioraspoloživost tablete od 500 mg metformina je približno 50-60% u zdravih ispitanika.
Icandra 50 mg/1000 mg film-coated tablets 
Icandra 50 mg/1000 mg filmom obložene tablete
- if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. 
Ako mislite da biste mogli biti alergični na bilo što od navedenog, razgovarajte sa svojim liječnikom prije uzimanja Icandre. - ako imate nekontroliranu šećernu bolest, uz, primjerice, tešku hiperglikemiju (visoka razina glukoze u krvi), mučninu, povraćanje, proljev, brz gubitak tjelesne težine, laktacidozu (vidjeti “Rizik od laktacidoze” niže) ili ketoacidozu.
Icandra 50 mg/850 mg film-coated tablets 
Icandra 50 mg/850 mg filmom obložene tablete
- Each Icandra 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin). 
- Jedna Icandra 50 mg/1000 mg filmom obložena tableta sadrži 50 mg vildagliptina i 1000 mg metforminklorida (što odgovara 780 mg metformina).
- Each Icandra 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin). 
- Jedna Icandra 50 mg/850 mg filmom obložena tableta sadrži 50 mg vildagliptina i 850 mg metforminklorida (što odgovara 660 mg metformina).
Talk to your doctor, pharmacist or nurse before taking Icandra if you have or have had a disease of the pancreas. 
Ako imate ili ste imali bolest gušterače, obratite se svom liječniku, ljekarniku ili medicinskoj sestri u dijabetološkoj ambulanti prije nego uzmete Icandru.
Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets 
Icandra 50 mg/850 mg filmom obložene tablete Icandra 50 mg/1000 mg filmom obložene tablete
Polychlorotrifluoroethylene (PCTFE)/PVC/Alu blister Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets. 
Dostupno u pakiranjima od 10, 30, 60, 120, 180 ili 360 filmom obloženih tableta i u višestrukim pakiranjima od 120 (2 pakiranja od 60), 180 (3 pakiranja od 60) ili 360 (6 pakiranja od 60) filmom obloženih tableta.
How to store Icandra 
Kako Čuvati Icandru
Aluminium/Aluminium (PA/Alu/PVC/Alu) blister Available in packs containing 10, 30, 60, 120,180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets. 
Dostupno u pakiranjima koja sadrže 10, 30, 60, 120,180 ili 360 filmom obloženih tableta i u višestrukim pakiranjima koja sadrže 120 (2 pakiranja od 60), 180 (3 pakiranja od 60) ili 360 (6 pakiranja od 60) filmom obloženih tableta.
Icandra 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride 
Icandra 50 mg/850 mg filmom obložene tablete vildagliptin/metforminklorid
Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride 
Icandra 50 mg/1000 mg filmom obložene tablete vildagliptin/metforminklorid
Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride 
Icandra 50 mg/850 mg filmom obložene tablete Icandra 50 mg/1000 mg filmom obložene tablete vildagliptin/metforminklorid
- If you get any side effects, talk to your doctor, pharmacist or nurse. 
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru..
EU/1/08/484/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/030 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/484/007 10 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/008 30 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/009 60 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/010 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/011 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/012 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/025 10 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/026 30 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/027 60 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/028 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/029 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/030 360 filmom obloženih tableta (PCTFE/PVC/Al)
EU/1/08/484/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/024 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/484/001 10 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/002 30 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/003 60 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/004 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/005 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/006 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/019 10 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/020 30 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/021 60 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/022 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/023 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/024 360 filmom obloženih tableta (PCTFE/PVC/Al)
- For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Icandra should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken. 
Uobičajena početna doza Icandre mora biti 50 mg vildagliptina dvaput na dan (ukupna dnevna doza 100 mg) plus dosadašnja doza metformina.
EU/1/08/484/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/036 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/484/016 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/017 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/018 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/034 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/035 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/036 360 filmom obloženih tablet (PCTFE/PVC/Al)
EU/1/08/484/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/033 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/484/013 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/014 180 filmom obloženih tableta (PA/Al/PVC/Alu) EU/1/08/484/015 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/031 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/032 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/033 360 filmom obloženih tableta (PCTFE/PVC/Al)
United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370 
Mylan Pharmaceuticals, S.L. Tel: +34 93 378 64 00
Intanza contains 15 micrograms of each of three different strains (varieties) of influenza virus (an H1N1 subtype, A/California/7/2009, NYMC X-179A; an H3N2 subtype, A/Hong Kong/4801/2014, NYMC X-263B; and a type B, B/Brisbane/60/2008, wild type). 
Intanza sadrži 15 mikrograma svakog od tri soja (vrste) virusa gripe (podvrsta H1N1, A/California/7/2009, NYMC X-179A, podvrsta H3N2, A/Hong Kong/4801/2014, NYMC X-263B i tip B, B/Brisbane/60/2008, divlji soj).
Influenza vaccine (split virion, inactivated) 
Cjepivo protiv influence (fragmentirani virion, inaktivirano)
What measures are being taken to ensure the safe and effective use of Intanza? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Intanza?
Two other studies looked at use of a lower strength in people under the age of 60. 
U drugim dvama ispitivanjima proučavane su primjene manjih doza u ljudi mlađih od 60 godina.
This is a summary of the European public assessment report (EPAR) for Intanza. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Intanza.
Fragments of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in Intanza before the 
Fragmenti sojeva virusa za koje se očekuje da će prouzročiti gripu u nadolazećoj sezoni, u skladu s preporukama SZO-a za sjevernu hemisferu kao i preporukama Europske unije (EU), moraju biti dodani cjepivu Intanza prije korištenja.
Intanza is a vaccine. 
Intanza je cjepivo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for 
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Intanza.
The most common side effects with Intanza (seen in more than 1 patient in 10) are headache, muscle pain and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching). 
Najčešće nuspojave cjepiva Intanza (zabilježene u više od 1 na 10 osoba) su glavobolja, bol u mišićima, i lokalne reakcije na mjestu cijepljenja (crvenilo, oteklina, otvrdnuće kože, bol i svrbež).
Intanza contains fragments from three different strains of flu virus. 
Intanza sadrži fragmente iz triju različitih sojeva virusa gripe.
Intanza is used to vaccinate adults aged 60 years and over against flu, especially those who are at an increased risk of developing complications from the disease. 
Intanza se koristi za cijepljenje osoba od 60 godina i starijih protiv gripe, posebice onih koji su izloženi većem riziku od razvijanja komplikacija bolesti.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intanza have been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Intanza nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
The ability of Intanza to trigger the production of antibodies (immunogenicity) was first assessed in five main studies involving almost 9,000 people. 
Sposobnost lijeka Intanza da potakne stvaranje protutijela (imunogenost) ocijenjena je u pet glavnih ispitivanja koja su obuhvatila gotovo 9 000 bolesnika.
Intanza must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients, or to any component that may be present in very small amounts such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol 9. 
Intanza se ne smije primjenjivati u osoba koje se preosjetljive (alergične) na djelatne tvari ili na bilo koji drugi sastojak, odnosno na bilo koju komponentu koja može biti prisutna u vrlo malim količinama poput jaja (ovalbumin, pileći protein), neomicina, formaldehida ili octoksinola 9. Osobe koje imaju vrućicu ili akutnu (kratkoročnu) upalu ne smiju primiti cjepivo sve dok se ne oporave.
Intanza is given as one ‘intradermal' injection into the upper layer of the skin, using a special micro-injection system. 
Intanza se primjenjuje „intradermalnom” injekcijom u gornji sloj kože uz pomoć posebnog sustava mikroinjekcije.
The studies compared the ability of the vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before injection and three weeks afterwards. 
Ispitivanjima je uspoređena sposobnost cjepiva da aktivira stvaranje protutijela (imunogenost), uspoređujući razine protutijela prije injekcije i tri tjedna nakon injekcije.
Intanza is a vaccine, which is available as a suspension for injection in a pre-filled syringe. 
Intanza je cjepivo koje je dostupno kao suspenzija za injekciju u prethodno napunjenoj štrcaljki.
Other information about Intanza 
Ostale informacije o lijeku Intanza
The CHMP decided that Intanza's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je odlučio da koristi od lijeka Intanza nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
In one study in people aged 60 years and over, Intanza was compared with a flu vaccine containing an adjuvant (a compound added to enhance the immune response). 
U jednom ispitivanju u osoba u dobi od 60 godina i starijih Intanza je uspoređena s cjepivom protiv gripe koje sadrži adjuvans (spoj koji se dodaje za pojačanje imunosnog odgovora).
Why has Intanza been approved? 
Zašto je lijek Intanza odobren?