natgillin/translations-raw huggingface dataset:
Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5). 
Uporabi ivabradina se je potrebno izogibati pri bolnikih, ki imajo prirojeni sindrom podaljšanega intervala QT ali jemljejo zdravila, ki ga podaljšujejo (glejte poglavje 4.5).
Constipation Diarrhoea Abdominal pain* 
Bolezni prebavil slabost zaprtje diareja bolečina v trebuhu*
In the subgroup of patients with HR ≥75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI [0.74; 1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31;1.53]). 
V podskupini bolnikov s srčno frekvenco ≥ 75 utripov na minuto zdravljenih s priporočenim ciljnim odmerkom antagonista adrenergičnih receptorjev beta, ni bilo opažene statistično značilne koristi glede primarnega sestavljenega končnega izida (razmerje tveganja: 0,97, 95% interval zaupanja [0,74; 1,28]) in drugih sekundarnih končnih izidov, vključno s hospitalizacijo zaradi poslabšanja srčnega popuščanja (razmerje tveganja: 0,79, 95% interval zaupanja [0,56; 1,10]) ali umrljivosti zaradi srčnega popuščanja (razmerje tveganja: 0,69, 95% [0,31; 1,53]).
Do not take Ivabradine JensonR if you are breast-feeding (see “Do not take Ivabradine JensonR”). 
Ne jemljite zdravila Ivabradin JensonR, če dojite (glejte “Ne jemljite zdravila Ivabradin JensonR”).
Pink colour, oval shape, biconvex film-coated scored tablets, approximately 7.9 mm by 4.15 mm debossed with “Ι 5” on one side and “M” on other side of the tablet. 
Ovalne, bikonveksne filmsko obložene tablete rožnate barve z razdelilno zarezo, velikosti približno 7,9 mm krat 4,15 mm in z vtisnjeno oznako „Ι 5“ na eni strani in „M“ na drugi strani tablete.
Talk to your doctor if you are breast-feeding or intending to breast-feed as breast-feeding should be discontinued if you take Ivabradine JensonR. 
Če dojite ali nameravate dojiti se posvetujte z zdravnikom, ker morate z dojenjem prekiniti, če jemljete zdravilo Ivabradin JensonR.
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use. 
Pred uporabo preberite priloženo navodilo!
Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated (see section 5.1). 
do IV. razreda po funkcijski razvrstitvi Newyorškega društva za srce (NYHA) s sistolično disfunkcijo pri bolnikih v sinusnem ritmu, pri katerih je srčna frekvenca ≥ 75 utripov na minuto, v kombinaciji s standardno terapijo, vključno z zdravljenjem z antagonistom adrenergičnih receptorjev beta oziroma tudi ko je zdravljenje z antagonistom adrenergičnih receptorjev beta kontraindicirano ali ga bolnik ne prenaša dobro (glejte poglavje 5.1).
If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily (one half 5 mg tablet twice daily). 
Če se med zdravljenjem srčna frekvenca znižuje pod 50 utripov na minuto v mirovanju ali če bolniki doživljajo simptome, povezane z bradikardijo, kot so omotica, utrujenost ali hipotenzija, morate odmerek titrirati navzdol, vključno do najmanjšega odmerka 2,5 mg dvakrat na dan (eno polovico 5mg tablete dvakrat na dan).
Cold form blisters (OPA/Alu/PVC) in pack sizes of 14, 28, 56, 98 and 112 film-coated tablets. 
Hladno oblikovani OPA/Alu/PVC pretisni omoti po 14, 28, 56, 98 in 112 filmsko obloženih tablet.
Cold form perforated unit dose blisters (OPA/Alu/PVC) in pack sizes of 14 x 1 and 56 x 1 film-coated tablets. 
Hladno oblikovani OPA/Alu/PVC perforirani enoodmerni pretisni omoti po 14 x 1 in 56 x 1 filmsko obloženo tableto.
Each film-coated tablet contains 5 mg ivabradine (as hydrochloride). 
Ena filmsko obložena tableta vsebuje 5 mg ivabradina (v obliki klorida).
If, during treatment, resting heart rate decreases persistently below 50 bpm or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.2). 
Če se med zdravljenjem srčna frekvenca vztrajno znižuje pod 50 utripov na minuto v mirovanju ali če imajo bolniki simptome, povezane z bradikardijo, kot so omotica, utrujenost ali hipotenzija, je potrebno odmerek titrirati navzdol ali zdravljenje prekiniti, če se srčna frekvenca zniža pod 50 utripov na minuto ali simptomi bradikardije vztrajajo (glejte poglavje 4.2).
If during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia, the dose must be titrated downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily. 
Če se med zdravljenjem srčna frekvenca vztrajno znižuje pod 50 utripov na minuto v mirovanju ali če bolniki doživljajo simptome, povezane z bradikardijo, je potrebno odmerek titrirati navzdol do naslednjega manjšega odmerka pri bolnikih, ki jemljejo 7,5 mg dvakrat dnevno ali 5 mg dvakrat dnevno.
As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product. 
Če ste prenehali jemati zdravilo Ivabradin JensonR Ker je zdravljenje angine pektoris ali kroničnega srčnega popuščanja običajno doživljenjsko, se pred prenehanjem jemanja tega zdravila posvetujte z zdravnikom.
Caution should be exercised when using ivabradine in patients with moderate hepatic impairment. 
Pri predpisovanju ivabradina bolnikom z zmerno jetrno okvaro je potrebna previdnost.
What Ivabradine JensonR looks like and contents of the pack Ivabradine JensonR 5 mg tablets are pink-coloured, oval shaped film-coated tablets scored on both sides, marked with “ I 5” on one side and “M” on the other side of the tablet. 
Izgled zdravila Ivabradin JensonR in vsebina pakiranja Tablete zdravila Ivabradin JensonR 5 mg so rožnate barve, ovalne in filmsko obložene, z razdelilno zarezo na obeh straneh in vrezano oznako „I 5“ na eni strani in „M“ na drugi strani tablete.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
How does Ivabradine JensonR work 
Kako deluje zdravilo Ivabradin JensonR?
HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2) - Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see section 4.5) - Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6) 
- kombinacija z verapamilom ali diltiazemom, zmernima zaviralcema citokroma P450 3A4, ki imata lastnosti zniževanja srčne frekvence (glejte poglavje 4.5) - nosečnost, dojenje in ženske v rodnem obdobju, ki za zaščito ne uporbaljajo zanesljivih kontracepcijskih metod (glejte poglavje 4.6).
What Ivabradine JensonR looks like and contents of the pack Ivabradine JensonR 7.5 mg tablets are pink-coloured, round film-coated tablets marked with “I 7” on one side and “M” on the other side of the tablet. 
Izgled zdravila Ivabradin JensonR in vsebina pakiranja Tablete zdravila Ivabradin JensonR 7,5 mg so rožnate barve, okrogle in filmsko obložene, z vrezano oznako „I 7“ na eni strani in „M“ na drugi strani tablete.
Ivabradine JensonR is also available in bottles with a screw cap and a desiccant of 56, 98 and 100 film-coated tablets. 
Zdravilo Ivabradin JensonR je na voljo tudi v plastenkah z navojno zaporko in sušilnim sredstvom s po 56, 98 in 100 filmsko obloženih tablet.
Ivabradine JensonR 5 mg film-coated tablets Each film-coated tablet contains 5 mg ivabradine (as hydrochloride). 
Ivabradin JensonR 5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 5 mg ivabradina (v obliki klorida).
QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, 
Zdravila, ki podaljšujejo interval QT: - srčno-žilna zdravila, ki podaljšujejo interval QT (na primer kinidin, dizopiramid, bepridil,
Ivabradine JensonR 7.5 mg film-coated tablets Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride). 
Ivabradin JensonR 7,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (v obliki klorida).
EU/1/16/1145/001 EU/1/16/1145/002 EU/1/16/1145/003 EU/1/16/1145/004 EU/1/16/1145/005 EU/1/16/1145/006 EU/1/16/1145/007 EU/1/16/1145/008 EU/1/16/1145/009 EU/1/16/1145/010 EU/1/16/1145/011 EU/1/16/1145/012 EU/1/16/1145/013 EU/1/16/1145/014 EU/1/16/1145/015 EU/1/16/1145/016 EU/1/16/1145/017 
EU/1/16/1145/001 EU/1/16/1145/002 EU/1/16/1145/003 EU/1/16/1145/004 EU/1/16/1145/005 EU/1/16/1145/006 EU/1/16/1145/007 EU/1/16/1145/008 EU/1/16/1145/009 EU/1/16/1145/010 EU/1/16/1145/011 EU/1/16/1145/012 EU/1/16/1145/013 EU/1/16/1145/014 EU/1/16/1145/015 EU/1/16/1145/016 EU/1/16/1145/017 EU/1/16/1145/018 EU/1/16/1145/019 EU/1/16/1145/020 EU/1/16/1145/021
Marketing Authorisation Holder Jenson R+ Limited Fishleigh Court, 
JensonR+ Limited Fishleigh Court, Fishleigh Road, Barnstaple,
Ivabradine is approximately 70% plasma protein bound and the volume of distribution at steady-state is close to 100 l in patients. 
Ivabradin se veže na beljakovine v plazmi v približno 70% in volumen porazdelitve v stanju dinamičnega ravnovesja pri bolnikih znaša blizu 100 l. Največja koncentracija v plazmi po kroničnem jemanju priporočenega odmerka 5 mg dvakrat na dan je 22 ng/ml (koeficient variacije = 29%).
- Non cardiovascular QT prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, 
sotalol, ibutilid, amiodaron) - nesrčno-žilna zdravila, ki podaljšujejo interval QT (na primer pimozid, ziprazidon, sertindol,
The starting dose was 0.02 mg/kg bid in age-subset [6-12]months, 0.05 mg/kg bid in [1-3]years and [3-18]years <40 kg, and 2.5 mg bid in [3-18]years and ≥40 kg. 
Začetni odmerek ivabradina pri podskupini bolnikov, starih [6-12] mesecev, je bil 0,02 mg/kg dvakrat na dan, pri podskupini bolnikov, starih [1-3] leta, in bolnikih, starih [3-18] let, ki so tehtali manj kot 40 kg, je bil odmerek 0,05 mg/kg dvakrat na dan, pri bolnikih, starih [3-18] let, ki so tehtali 40 kg ali več, pa je bil odmerek 2,5 mg dvakrat na dan. Odmerek je bil prilagojen glede na terapevtski odziv, pri čemer so bili najvišji odmerki 0,2 mg/kg dvakrat na dan oz. 0,3 mg/kg dvakrat na dan oz. 15 mg dvakrat na dan.
Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Ivabradine JensonR or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions: - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure). 
Vedno povejte zdravniku, če jemljete katero od naslednjih zdravil, saj je lahko potrebno prilagajanje odmerka zdravila Ivabradin JensonR ali spremljanje: - flukonazol (zdravilo proti glivicam) - rifampicin (antibiotik) - barbiturate (za zdravljenje nespečnosti ali epilepsije) - fenitoin (za zdravljenje epilepsije) - šentjanževko (Hypericum perforatum) (zdravilna rastlina za zdravljenje depresije) - zdravila proti motnjam srčnega ritma ali drugim stanjem, ki podaljšujejo interval QT:
EU/1/16/1145/001 EU/1/16/1145/002 EU/1/16/1145/003 EU/1/16/1145/004 EU/1/16/1145/005 EU/1/16/1145/006 EU/1/16/1145/007 EU/1/16/1145/008 EU/1/16/1145/009 EU/1/16/1145/010 EU/1/16/1145/011 EU/1/16/1145/012 EU/1/16/1145/013 EU/1/16/1145/014 EU/1/16/1145/015 
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Cardiac disorders 
Srčne aritmije
Ivabradine should therefore be used with precaution in this population. 
Pri predpisovanju ivabradina tem bolnikom je potrebna previdnost.
Treatment effect on the primary composite endpoint, its components and secondary endpoints 
Učinek zdravljenja na primarni sestavljeni končni izid, njegove komponente in sekundarne končne izide placebo (N=3264) n (%)
Talk to your doctor or pharmacist before taking Ivabradine JensonR - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems 
- če imate simptome atrijske fibrilacije (nenavadno visok srčni utrip v mirovanju (nad 110 utripov na minuto) ali brez posebnega vzroka nereden srčni utrip, ki ga je težko izmeriti); - če ste nedavno imeli možgansko kap (možganski napad); - če imate blago do zmerno znižan krvni tlak; - če imate nenadzorovan krvni tlak, še posebno po zamenjavi zdravljenja zvišanega krvnega tlaka; - če imate hudo srčno popuščanje ali srčno popuščanje z nepravilnostjo EKG, ki se imenuje
Ivabradine is indicated: - in adults unable to tolerate or with a contraindication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. 
Ivabradin je indiciran: - pri odraslih, pri katerih so antagonisti adrenergičnih receptorjev beta kontraindicirani ali jih ne
Blister 
Plastenka
Ivabradine JensonR 5 mg film-coated tablets 
Ivabradin JensonR 5 mg filmsko obložene tablete
INFORMATION IN BRAILLE Ivabradine JensonR 5 mg film-coated tablets 
PODATKI V BRAILLOVI PISAVI Ivabradin JensonR 5 mg filmsko obložene tablete
INFORMATION IN BRAILLE Ivabradine JensonR 7.5 mg film-coated tablets 
PODATKI V BRAILLOVI PISAVI Ivabradin JensonR 7,5 mg filmsko obložene tablete
Ivabradine JensonR 7.5 mg film-coated tablets ivabradine 
Ivabradin JensonR 7,5 mg filmsko obložene tablete ivabradin
Common (may affect more than 1 in 10 people): 
Pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride) 
Ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (v obliki klorida).
Ivabradine JensonR 5 mg film-coated tablets ivabradine 
Ivabradin JensonR 5 mg filmsko obložene tablete ivabradin
NAME OF THE MEDICINAL PRODUCT Ivabradine JensonR 5 mg film-coated tablets Ivabradine JensonR 7.5 mg film-coated tablets 
Ivabradin JensonR 5 mg filmsko obložene tablete Ivabradin JensonR 7,5 mg filmsko obložene tablete
itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris); - if you are a woman able to have children and not using reliable contraception; - if you are pregnant or trying to become pregnant; - if you are breast-feeding. 
- če imate srčno popuščanje, ki se je pred kratkim poslabšalo; - če vam srčni utrip narekuje izključno vaš srčni spodbujevalnik; - če imate hude težave z jetri; - če že jemljete zdravila proti glivičnim okužbam (na primer ketokonazol, itrakonazol), makrolidne antibiotike (na primer josamicin, klaritromicin, telitromicin ali eritromicin peroralno), zdravila proti okužbam z virusom HIV (na primer nelfinavir, ritonavir) ali nefazodon (zdravilo proti depresiji) ali diltiazem, verapamil (uporabljata se za zniževanje krvnega tlaka oz.
Pink colour, round, beveled edge, biconvex film-coated tablets, approximately 6.65 mm in diameter debossed with “Ι 7” on one side and “M” on other side of the tablet. 
Ivabradin JensonR 7,5 mg filmsko obložene tablete Okrogle, bikonveksne filmsko obložene tablete rožnate barve z zaobljenim robom, s premerom približno 6,65 mm in z vtisnjeno oznako „Ι 7“ na eni strani in „M“ na drugi strani tablete.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING 
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA/NALEPKA ZA PLASTENKO
ibutilide, amiodarone). 
- kinidin, dizopiramid, ibutilid, sotalol, amiodaron (za zdravljenje motenj srčnega ritma)
Ivabradine influences on retinal function (see section 5.1). 
Ni dokazov, da bi imelo dolgotrajno zdravljenje z ivabradinom toksičen učinek na mrežnico (glejte poglavje 5.1).
Suspension (inactivated) 
Suspenzija (inaktivirana)
*** International units. 
***mednarodne enote.
* Tissue culture infectious dose 50%. 
*50% infektivnega odmerka za tkivno kulturo.
** Antibody micro agglutination-lytic reaction. 
**reakcija mikroaglutinacije-lize protiteles.
--1 Lyophilisate (live attenuated) Canine distemper virus, strain CDV Bio 11/A 
--1 Liofilizat (živi atenuirani) Virus pasje kuge, sev CDV Bio 11/A
Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 
Virus pasjega parvovirusa tipa 2b, sev CPV-2b Bio 12/B
Canine adenovirus Type 2, strain CAV-2 Bio 13 
Virus pasjega adenovirusa tipa 2, sev CAV-2 Bio 13
Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 
Leptospira interrogans serološka skupina Australis serovar Bratislava, sev MSLB 1088
Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB 
Leptospira interrogans serološka skupina Canicola serovar Canicola, sev MSLB 1090
This summary was last updated in 11-2010. 
Povzetek je bil nazadnje posodobljen 11-2010.
These levels were maintained in over 93% of the children after two years. 
Te ravni so se po dveh letih ohranile pri 93 % otrok.
After five years, the marketing authorisation was renewed for a further five years. 
Po petih letih je bilo dovoljenje za promet z zdravilom podaljšano še za pet let.
The antibodies will help to protect against the diseases caused by these viruses. 
Protitelesa mu bodo pomagala pri zaščiti pred boleznimi, ki jih povzročajo ti virusi.
The vaccine should never be injected into a vein. 
Cepivo se ne sme nikoli injicirati v veno.
Vaccination with Ambirix should be postponed in patients with a severe sudden fever. 
Cepljenje z zdravilom Ambirix je treba odložiti pri bolnikih s hudo nenadno vročino.
The full EPAR for Ambirix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ambirix je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
For more information about treatment with Ambirix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ambirix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Ambirix is a vaccine. 
Zdravilo Ambirix je cepivo.
The European Commission granted a marketing authorisation valid throughout the EU for Ambirix to GlaxoSmithKline Biologicals s.a. on 30 August 2002. 
Evropska komisija je dovoljenje za promet z zdravilom Ambirix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 30. avgusta 2002.
The CHMP decided that Ambirix's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Ambirix večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This is a summary of the European public assessment report (EPAR) for Ambirix. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ambirix.
Three main studies of Ambirix were carried out in a total of 615 children from one year of age. 
Tri glavne študije cepiva Ambirix so izvedli pri 615 otrocih, starih več kot eno leto.
An additional study in 208 children compared the vaccine's effectiveness when a six-month or a 12-month interval was used between the two injections. 
V dodatni študiji so pri 208 otrocih primerjali učinkovitost cepiva pri šestmesečnem ali dvanajstmesečnem intervalu med dvema cepljenjema.
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 Ambirix. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Ambirix, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The most common side effects with Ambirix (seen in more than one in 10 doses of the vaccine) are loss of appetite, irritability, headache, fatigue (tiredness) and pain and redness at the site of injection. 
Najpogostejši neželeni učinki cepiva Ambirix (opaženi pri več kot enem odmerku cepiva od 10) so pomanjkanje teka, razdražljivost, glavobol, utrujenost ter bolečina in rdečina na mestu injiciranja.
Other information about Ambirix 
Druge informacije o zdravilu Ambirix:
All of the children received two doses of Ambirix six months apart. 
Vsi otroci so prejeli dva odmerka zdravila Ambirix v razmaku šestih mesecev.
What benefit has Ambirix shown during the studies? 
Kakšne koristi je zdravilo Ambirix izkazalo med študijami?
The three vaccines are used to protect against the same diseases, but Twinrix Adult and Twinrix Paediatric are given as a three-dose schedule. 
Vsa tri cepiva se uporabljajo za zaščito proti istim boleznim, pri čemer pa se cepivi Twinrix Adult in Twinrix Paediatric dajeta v treh odmerkih.
Ambirix should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic). 
Zdravila Ambirix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) katero koli od zdravilnih učinkovin, katero koli od drugih sestavin zdravila ali neomicin (antibiotik).