natgillin/translations-raw huggingface dataset:
3 Renal impairment in elderly patients is frequent and asymptomatic.
Pri starejših bolnikih je okvara ledvic pogosta in asimptomatska.
Hepatic impairment 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).
Okvara jeter Zdravilo Icandra se ne sme uporabljati pri bolnikih z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti ALT ali AST nad 3- kratno zgornjo mejo normalnih vrednosti (glejte poglavja 4. 2, 4. 3 in 4. 8).
Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Icandra therapy is recommended.
Če zvišanje AST ali ALT na ali nad 3- kratno zgornjo mejo normalnih vrednosti (ULN - upper limit of normal) vztraja, je priporočena prekinitev zdravljenja z zdravilom Icandra.
Metformin is contraindicated in patients with heart failure, therefore Icandra is contraindicated in this patient population (see section 4.3).
Metformin je kontraindiciran pri bolnikih s srčnim popuščanjem, zato je tudi zdravilo Icandra kontraindicirano za to skupino bolnikov (glejte poglavje 4. 3).
Surgery As Icandra contains metformin, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
Operacijski poseg Zdravilo Icandra vsebuje metformin, zato je treba zdravljenje z njim prekiniti 48 ur pred načrtovanim operacijskim posegom s splošno anestezijo, ponovno pa se ga sme uvesti šele 48 ur po posegu.
Therefore, due to the metformin active substance, Icandra should be discontinued prior to, or at the time of, the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Ker zdravilo Icandra vsebuje zdravilno učinkovino metformin, ga je treba ukiniti pred preiskavo ali v času preiskave, ponovno pa se ga sme uvesti šele 48 ur po preiskavi in sicer samo v primeru, da ponovno vrednotenje pokaže normalno delovanje ledvic (glejte poglavje 4. 5).
Metformin Combinations not recommended There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Icandra (see section 4.4).
Metformin Kombinacije, ki niso priporočene Zaradi metformina, zdravilne učinkovine v zdravilu Icandra, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience), povečano tveganje za laktacidozo (glejte poglavje 4. 4).
5 4.6 Pregnancy and lactation
5 Zaviralci angiotenzinske konvertaze (zaviralci ACE) lahko znižujejo koncentracije glukoze v krvi.
Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Icandra should not be used during lactation (see section 4.3).
Tako zaradi potencialnega tveganja, da bi pri novorojenčku zaradi metformina prišlo do hipoglikemije, kot tudi zaradi pomanjkanja podatkov o vildagliptinu pri ljudeh, se zdravila Icandra ne sme uporabljati v obdobju dojenja (glejte poglavje 4. 3).
There have been no therapeutic clinical trials conducted with Icandra.
Terapevtskih kliničnih študij z zdravilom Icandra niso izvajali.
However, bioequivalence of Icandra with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Dokazali pa so bioekvivalenco zdravila Icandra s sočasno uporabljanima vildagliptinom in metforminom (glejte poglavje 5. 2).
9 Metformin may exert its glucose -lowering effect via three mechanisms:
Metformin lahko deluje na zniževanje glukoze v krvi na tri načine:
Icandra Absorption 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.
Zdravilo Icandra Absorpcija Za zdravilo Icandra so dokazali bioekvivalenco treh jakosti (50 mg/ 500 mg, 50 mg/ 850 mg in 50 mg/ 1000 mg) s kombinacijo ločenih tablet vildagliptina in metforminijevega klorida v skladnih odmerkih.
The rate and extent of absorption of metformin from Icandra 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h).
Hitrost in obseg absorpcije metformina iz zdravila Icandra 50 mg/ 1000 mg pa sta bili pri jemanju s hrano zmanjšani, kar se je odražalo na znižanju Cmax za 26%, zmanjšanju AUC za 7% in na podaljšanem Tmax (2, 0 do 4, 0 ure).
10 Distribution The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Porazdelitev Vildagliptin se v majhni meri veže na proteine v plazmi (9, 3%) in se enakomerno porazdeli med plazmo in eritrocite.
Ethnic group:
Etnična pripadnost:
Metformin Absorption After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h..
11 Metformin Absorpcija Po peroralni aplikaciji metformin doseže najvišjo koncentracijo v plazmi po približno 2, 5 ure (Cmax).
11 schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml.
Pri običajnih odmerkih in shemah odmerjanja se plazemske koncentracije v stanju dinamičnega ravnovesja dosežejo v 24- 48 urah, večinoma pa so nižje od 1 µg/ ml.
An increased incidence of wavy ribs was observed in rats in association with reduced maternal body weight parameters, with a no-effect dose of 75 mg/kg (10-fold human exposure).
Pri podganah so opažali zvišano incidenco valovite deformacije reber v povezavi s parametri zmanjšane telesne mase mater, pri tem je bil odmerek brez učinka 75 mg/ kg (kar pomeni izpostavljenost, ki je 10- krat večja od izpostavljenosti pri človeku).
In rabbits, decreased foetal weight and skeletal variations indicative of developmental delays were noted only in the presence of severe maternal toxicity, with a no-effect dose of 50 mg/kg (9-fold human exposure).
12 zmanjšano telesno maso zarodkov in skeletne različice, ki nakazujejo zaostanke v razvoju, pri tem je bil odmerek brez učinka 50 mg/ kg (kar pomeni izpostavljenost, ki je 9- krat večja od izpostavljenosti pri človeku).
An increased incidence of mammary adenocarcinomas and haemangiosarcomas was observed with a no-effect dose of 500 mg/kg (59-fold human exposure) and
Opažali so višjo incidenco adenokarcinomov dojke, pri čemer je bil odmerek brez učinka 500 mg/ kg (izpostavljenost, ki je 59- krat večja od izpostavljenosti pri človeku), in hemangiosarkomov, pri čemer je bil odmerek brez učinka 100 mg/ kg (izpostavljenost, ki je 16- krat večja od izpostavljenosti pri človeku).
In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day.
V 13- tedenski toksikološki študiji na opicah (vrste javanski makak) so zabeležili kožne spremembe pri odmerkih ≥ 5 mg/ kg/ dan.
6.4 Special precautions for storage
13 6. 4 Posebna navodila za shranjevanje
13 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje
Icandra 50 mg/1000 mg film-coated tablets
Icandra 50 mg/ 1000 mg filmsko obložene tablete
Adults Based on the patient’s current dose of metformin, 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.
Odrasli Glede na odmerek metformina, ki ga je bolnik uporabljal do tedaj, je mogoče začeti z uporabo zdravila Icandra bodisi jakosti 50 mg/ 850 mg ali 50 mg/ 1000 mg dvakrat dnevno in sicer eno tableto zjutraj, drugo pa zvečer.
Additional information on special populations Renal impairment Icandra should not be used in patients with creatinine clearance < 60 ml/min (see sections 4.3, 4.4 and 5.2).
Dodatni podatki o posebnih skupinah bolnikov Okvara ledvic Bolniki z očistkom kreatinina < 60 ml/ min ne smejo uporabljati zdravila Icandra (glejte poglavja 4. 3, 4. 4 in 5. 2).
Hepatic impairment Icandra should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
15 Okvara jeter Zdravila Icandra ne smejo uporabljati bolniki z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti alanin- aminotransferaze (ALT) ali aspartat- aminotransferaze (AST) nad 3- kratno zgornjo mejo normalnih vrednosti (upper limit of normal - ULN) (glejte poglavja 4. 3, 4. 4 in 4. 8).
15 Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Icandra should have their renal function monitored regularly (see section 4.4).
Starejši (≥ 65 let) Metformin se izloča preko ledvic, pri starejših bolnikih pa je delovanje ledvic pogosto zmanjšano, zato je treba starješim bolnikom, ki jemljejo zdravilo Icandra, redno pregledovati delovanje ledvic (glejte poglavje 4. 4).
−
- - -
Renal impairment As metformin is excreted by the kidney, serum creatinine concentrations should be monitored regularly:
16 Okvara ledvic Metformin se izloča preko ledvic, zato je treba koncentracije kreatinina v serumu redno spremljati:
16 Renal impairment in elderly patients is frequent and asymptomatic.
Pri starejših bolnikih je okvara ledvic pogosta in asimptomatska.
Cardiac failure Experience with vildagliptin therapy in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II is limited and therefore vildagliptin should be used cautiously in these patients.
Srčno popuščanje Pri bolnikih s kongestivnim srčnim popuščanjem funkcijskih razredov I- II po klasifikaciji Združenja za srce iz New Yorka (New York Heart Association - NYHA) je malo so izkušenj z uporabo vildagliptina, zato je potrebna previdnost pri uporabi vildagliptina pri teh bolnikih.
18 4.6 Pregnancy and lactation
18 Zaviralci angiotenzinske konvertaze (zaviralci ACE) lahko znižujejo koncentracije glukoze v krvi.
22 Metformin may exert its glucose-lowering effect via three mechanisms:
Metformin lahko deluje na zniževanje glukoze v krvi na tri načine:
23 Distribution The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Porazdelitev Vildagliptin se v majhni meri veže na proteine v plazmi (9, 3%) in se enakomerno porazdeli med plazmo in eritrocite.
Metformin Absorption After an oral dose of metformin, the maximum plasma concentration (Tmax) is achieved after about 2.5 h..
24 Metformin Absorpcija Po peroralni aplikaciji metformin doseže najvišjo koncentracijo v plazmi po približno 2, 5 ure (Cmax).
24 schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml.
Pri običajnih odmerkih in shemah odmerjanja se plazemske koncentracije v stanju dinamičnega ravnovesja dosežejo v 24- 48 urah, večinoma pa so nižje od 1 µg/ ml.
In rabbits, decreased foetal weight and skeletal variations indicative of developmental delays were noted only in the presence of severe maternal toxicity, with a no-effect dose of 50 mg/kg (9-fold human exposure).
25 zmanjšano telesno maso zarodkov in skeletne različice, ki nakazujejo zaostanke v razvoju, pri tem je bil odmerek brez učinka 50 mg/ kg (kar pomeni izpostavljenost, ki je 9- krat večja od izpostavljenosti pri človeku).
6.4 Special precautions for storage
26 6. 4 Posebna navodila za shranjevanje
26 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3. 0, predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
PSURs The PSUR cycle of Icandra will correspond to the one attributed to the cross-referred product, Eucreas, until otherwise specified.
Periodična poročila o varnosti zdravila (PSUR) Periode za predložitev periodičnih poročil o varnosti zdravila Icandra se bodo ujemale s periodami, ki so določene za referenčno zdravilo Eucreas, dokler ni zahtevano drugače.
Icandra 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Icandra 50 mg/ 850 mg filmsko obložene tablete vildagliptin/ metforminijev klorid
Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Icandra 50 mg/ 1000 mg filmsko obložene tablete vildagliptin/ metforminijev klorid
Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets
Icandra 50 mg/ 850 mg filmsko obložene tablete Icandra 50 mg/ 1000 mg filmsko obložene tablete
What Icandra is and what it is used for 2.
Kaj je zdravilo Icandra in za kaj ga uporabljamo 2.
Before you take Icandra 3.
Kaj morate vedeti, preden boste vzeli zdravilo Icandra 3.
How to take Icandra 4.
Kako jemati zdravilo Icandra 4.
How to store Icandra 6.
Shranjevanje zdravila Icandra 6.
WHAT ICANDRA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ICANDRA IN ZA KAJ GA UPORABLJAMO
The active substances of Icandra belong to a group of medicines called “oral antidiabetics”.
Zdravilni učinkovini v zdravilu Icandra sodita v skupino zdravil, ki se imenujejo “ peroralni antidiabetiki ”.
This type of diabetes is also known as non- insulin-dependent diabetes mellitus.
Zdravilo Icandra se uporablja za zdravljenje bolnikov z diabetesom tipa 2, ki se imenuje tudi od insulina neodvisna sladkorna bolezen.
Icandra contains two active substances called vildagliptin and metformin.
Zdravilo Icandra vsebuje dve zdravilni učinkovini, ki se imenujeta vildagliptin in metformin.
BEFORE YOU TAKE ICANDRA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ICANDRA
Do not take Icandra
Ne jemljite zdravila Icandra
Icandra (listed in section 6).
Icandra (s seznama v poglavju 6).
Please also see information about this in section “Take special care with Icandra”.
kateri v žilo vbrizgajo barvilo), informacije o tem dobite tudi pod naslovom “ Bodite posebno pozorni pri uporabi zdravila Icandra ”;
Take special care with Icandra Stop taking this medicine and talk to your doctor if you experience one or more of the following symptoms which may be related to a condition called “lactic acidosis”:
Bodite posebno pozorni pri uporabi zdravila Icandra Če pride do enega ali več spodaj navedenih simptomov, ki so lahko povezani z zapletom, imenovanim “ laktacidoza ”, prenehajte jemati zdravilo in se posvetujte s svojim zdravnikom:
If you have previously taken Galvus (vildagliptin) or Icandra but had to stop taking it because of side effects (liver disease), you should not take Icandra again.
Če ste zdravilo Galvus (vildagliptin) ali Icandra že jemali, pa ste ga prenehali zaradi stranskih neželenih učinkov (bolezni jeter), ga ne smete ponovno jemati.
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.
Pred začetkom zdravljenja z zdravilom Icandra boste opravili preiskavo delovanja jeter, med zdravljenjem pa boste v prvem letu opravljali kontrolne preiskave na tri mesece in kasneje le še občasno.
Elderly patients (65-74 years) taking Icandra should have their kidney function monitored regularly.
Pri starejših bolnikih (65- 74 let), ki jemljejo zdravilo Icandra, je treba redno spremljati delovanje ledvic.
Icandra is not recommended for patients aged 75 years or older.
Uporaba zdravila Icandra ni priporočena za bolnike, ki so stari 75 let ali več.
48 Pregnancy and breast-feeding
48 Jemanje zdravila Icandra skupaj s hrano in pijačo Tablete zaužijte s hrano ali takoj po njej.
- Do not use Icandra if you are breast-feeding.
- Če dojite, ne smete uporabljati zdravila Icandra.
HOW TO TAKE ICANDRA
KAKO JEMATI ZDRAVILO ICANDRA
Always take Icandra exactly as your doctor has told you.
Pri jemanju zdravila Icandra natančno upoštevajte zdravnikova navodila.
How much to take The amount of Icandra that people have to take varies depending on their condition.
Koliko zdravila vzeti Koliko zdravila Icandra morajo ljudje jemati, je odvisno od njihove bolezni.
Your doctor will tell you exactly the dose of Icandra to take.
Zdravnik vam bo natančno povedal, kakšen odmerek zdravila Icandra morate jemati.
If you take more Icandra than you should If you take too many Icandra tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila Icandra, kot bi smeli Če ste vzeli preveč tablet zdravila Icandra ali če kdo drug vzame vaše tablete, se takoj obrnite na zdravnika ali farmacevta.
If you forget to take Icandra If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway.
Če ste pozabili vzeti zdravilo Icandra Če ste pozabili vzeti tableto, jo vzemite z naslednjim obrokom, razen če je že čas, da vzamete naslednjo tableto.
If you stop taking Icandra Do not stop taking Icandra unless your doctor tells you to.
Če ste prenehali jemati zdravilo Icandra Ne prenehajte jemati zdravila Icandra, če vam tega ne naroči zdravnik.
Like all medicines, Icandra can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Icandra neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
These side effects may occur with certain frequencies, which are defined as follows: • very common: affects more than 1 patient in 10 • common: affects 1 to 10 patients in 100 • uncommon: affects 1 to 10 patients in 1,000 49 • rare: affects 1 to 10 patients in 10,000 • very rare: affects less than 1 patient in 10,000 • not known: frequency cannot be estimated from the available data.
Ti neželeni učinki se lahko pojavljajo z določenimi pogostnostmi, ki so opredeljene takole: • zelo pogosti: prizadenejo več kot 1 bolnika od 10, • pogosti: prizadenejo 1 do 10 bolnikov od 100, • občasni: prizadenejo 1 do 10 bolnikov od 1. 000, • redki: prizadenejo 1 do 10 bolnikov od 10. 000, • zelo redki: prizadenejo manj kot 1 bolnika od 10. 000, • neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Some symptoms need immediate medical attention You should stop taking Icandra and see your doctor immediately if you experience the following side effects:
Pri nekaterih simptomih je potrebna takojšnja zdravniška pomoč V primeru, da pride do naslednjih neželenih učinkov, morate prenehati jemati zdravilo Icandra in takoj obiskati zdravnika:
HOW TO STORE ICANDRA
SHRANJEVANJE ZDRAVILA ICANDRA
The expiry
- Zdravila Icandra ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na
date refers to the last day of that month.
pretisnem omotu in škatli.
What Icandra contains
Kaj vsebuje zdravilo Icandra
- Each Icandra 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg
- Vsaka filmsko obložena tableta Icandra 50 mg/ 850 mg vsebuje 50 mg vildagliptina in 850 mg
- Each Icandra 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg
- Vsaka filmsko obložena tableta Icandra 50 mg/ 1000 mg vsebuje 50 mg vildagliptina in 1000 mg
metformin hydrochloride (corresponding to 780 mg of metformin).
metforminijevega klorida (kar ustreza 780 mg metformina).
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.
Izgled zdravila Icandra in vsebina pakiranja Icandra 50 mg/ 850 mg filmsko obložene tablete so rumene, ovalne tablete z oznako “ NVR ” na eni strani in “ SEH ” na drugi.
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 filmsko obložene tablete so temno rumene, ovalne tablete z oznako “ NVR ” na eni strani in “ FLO ” na drugi.
What is IDflu?
Kaj je zdravilo IDflu?
The vaccine contains fragments of influenza (flu) viruses that have been inactivated (killed).
Vsebuje delce virusov gripe, ki so bili inaktivirani (uničeni).
IDflu contains three different strains (types) of influenza virus (A/ New Caledonia/ 20/ 99, A/ Wisconsin/ 67/ 2005 and B/ Malaysia/ 2506/ 2004).
Zdravilo IDflu vsebuje tri različne seve (tipe) virusa gripe (A/ New Caledonia/ 20/ 99, A/ Wisconsin/ 67/ 2005 in B/ Malaysia/ 2506/ 2004).
What is IDflu used for?
Za kaj se zdravilo IDflu uporablja?
IDflu is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications of the disease.
Zdravilo IDflu se uporablja za cepljenje odraslih proti gripi, zlasti tistih, pri katerih obstaja povečano tveganje za nastanek zapletov pri bolezni.
The use of the vaccine should be based on official recommendations.
Uporaba cepiva mora temeljiti na uradnih priporočilih.
Adults up to the age of 59 years receive the lower strength (containing 9 micrograms of each virus strain).
Odrasli, stari do 59 let, prejmejo odmerek manjše jakosti (ki vsebuje 9 mikrogramov vsakega seva virusa).
People aged 60 years and over receive the higher strength (15 micrograms of each virus strain).
Osebe, starejše od 60 let, prejmejo odmerek večje jakosti (15 mikrogramov vsakega seva virusa).
How is IDflu used?
Kako se zdravilo IDflu uporablja?
IDflu is given as one ‘ intradermal’ injection into the upper layer of the skin, using a special micro-injection system.
Zdravilo IDflu se daje kot intradermalna injekcija v zgornjo plast kožo ob uporabi posebnega mikroinjekcijskega sistema.
The shoulder is the recommended site of injection.
Priporočeno mesto za cepljenje je hrbet.
When a person is given the vaccine, the immune system recognises the virus fragments as ‘ foreign’ and makes antibodies against them.
Ko oseba prejme cepivo, imunski sistem prepozna delce virusa kot tujke in proti njim razvije protitelesa.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains.
Ko bo imunski sistem naslednjič izpostavljen kateremu od teh virusnih sevov, bo lahko hitreje izdelal protitelesa.
These virus strains need to be included in IDflu before the vaccine can be used.
Te seve virusov je treba vključiti v zdravilo IDflu, preden se cepivo uporabi.
IDflu currently contains fragments of the virus strains that were expected to cause flu in the 2006/ 2007 season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU).
Zdravilo IDflu trenutno vsebuje delce virusnih sevov, za katere se je glede na priporočila SZO za severno poloblo in priporočila Evropske unije (EU) predvidevalo, da bodo povzročali gripo v sezoni 2006/ 2007.
The virus strains in IDflu will need to be replaced again before the vaccine can be used in subsequent seasons.
Virusne seve v zdravilu IDflu bo treba ponovno zamenjati, preden bo cepivo mogoče uporabljati v naslednjih sezonah.
How has IDflu been studied?
Kako je bilo zdravilo IDflu raziskano?
The effects of IDflu were first tested in experimental models before being studied in humans.
Učinki zdravila IDflu so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Four studies involving over 8,000 people were carried out to study the effectiveness of IDflu in protecting against flu.
Izvedene so bile štiri študije, v katere je bilo vključenih več kot 8 000 oseb, da bi raziskali učinkovitost zdravila IDflu pri zaščiti proti gripi.
Two of the studies looked at people under the age of 60 years, who were vaccinated with the 9-microgram strength.
V dveh študijah so proučevali osebe, mlajše od 60 let, ki so bile cepljene z 9- miligramskim odmerkom.
The other two studies looked at people aged 60 years and over, who were vaccinated with the 15-microgram strength.
V drugih dveh študijah so proučevali osebe, stare 60 let ali več, ki so bile cepljene s 15- miligramskim odmerkom.