natgillin/translations-raw huggingface dataset:
In a 1,277-patients randomised placebo-controlled study, ivabradine demonstrated a statistically significant additional efficacy on response to treatment (defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill ETT) on top of amlodipine 5 mg o.d. or nifedipine GITS 30 mg o.d. at the trough of drug activity (12 hours after oral ivabradine intake) over a 6-week treatment period (OR = 1.3, 95% CI [1.0-1.7]; p = 0.012).
V randomizirani, s placebom nadzorovani študiji pri 1.277 bolnikih je ivabradin kot dodatek amlodipinu 5 mg enkrat na dan ali nifedipinu GITS (gastrointestinalni terapevtski sistem) 30 mg enkrat na dan v času najmanjšega učinka (12 ur po peroralnem jemanju) med 6-tedenskim zdravljenjem (razmerje obetov = 1,3; 95% interval zaupanja [1,0-1,7]; p = 0,012) dokazal statistično značilno dodatno učinkovitost pri odzivu na zdravljenje (definiranem kot zmanjšanje za najmanj 3 napade angine pektoris na teden in/ali podaljšanje časa do 1-mm depresije segmenta ST za najmanj 60 s med obremenitvenim testiranjem (ETT) hoje po tekočem traku).
Headache, generally during the first month of treatment Dizziness, possibly related to bradycardia
Bolezni živčevja pogosti glavobol, večinoma v prvem mesecu zdravljenja omotica, možno zaradi bradikardije občasni*
How to take Ivabradine JensonR
Kako jemati zdravilo Ivabradin JensonR
Ivabradine JensonR is available in blister packs of 14, 14 x 1, 28, 56, 56 x 1, 98 and 112 film-coated tablets.
Tablete zdravila Ivabradin JensonR so na voljo v pretisnih omotih po 14, 14 x 1, 28, 56, 56 x 1, 98 in 112 filmsko obloženih tablet.
Cessation of treatment should be considered if any unexpected deterioration in visual function occurs.
Če se pojavi kakršnokoli nepričakovano poslabšanje funkcije vida, je potrebno razmisliti o prekinitvi zdravljenja.
The mean ivabradine doses allowing to achieve a 20% HRR were 0.13 ± 0.04 mg/kg bid, 0.10 ± 0.04 mg/kg bid and 4.1 ± 2.2 mg bid in the age subsets [1-3]years, [3-18]years and <40 kg and [3-18] years and ≥40 kg, respectively.
Povprečni odmerki ivabradina, s katerimi so dosegli 20% znižanje srčne frekvence, so bili pri podskupini bolnikov, starih [1-3] leta, 0,13 ± 0,04 mg/kg dvakrat na dan, pri bolnikih, starih [3-18] let, ki so tehtali manj kot 40 kg, 0,10 ± 0,04 mg/kg dvakrat na dan ter pri bolnikih, starih [3-18] let, ki so tehtali 40 kg ali več, 4,1 ± 2,2 mg dvakrat na dan.
Ivabradine JensonR contains lactose
Zdravilo Ivabradin JensonR vsebuje laktozo.
The pack sizes 14 x 1 and 56 x 1 film-coated tablets are presented in unit dose blisters.
Velikosti pakiranj po 14 x 1 in 56 x 1 filmsko obloženo tableto so na voljo v perforiranih enoodmernih pretisnih omotih.
- The other ingredients in the tablet core are: lactose anhydrous, magnesium stearate, maltodextrin, microcrystalline cellulose, colloidal anhydrous silica, hydroxypropyl cellulose, and in the tablet coating are : hypromellose, titanium dioxide, macrogol, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).
- Pomožne snovi so: brezvodna laktoza, maltodekstrin, mikrokristalna celuloza, brezvodni koloidni silicijev dioksid, hidroksipropilna celuloza, v oblogi tablet pa: hipromeloza, titanov dioksid, makrogol, polisorbat 80, rumeni železov oksid (E172), rdeči železov oksid (E172).
PVC/Aclar-Alu perforated unit dose pack in pack sizes of 14 x 1 and 56 x 1 film-coated tablets.
PVC/Aclaraluminijevi perforirani enoodmerni pretisni omoti po 14 x 1 in 56 x 1 filmsko obloženo tableto.
PVC/Aclar-Alu blisters in pack sizes of 14, 28, 56, 98 and 112 film-coated tablets.
PVC/Aclar-aluminijevi pretisni omoti po 14, 28, 56, 98 in 112 filmsko obloženih tablet.
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
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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:
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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.