FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipient: Sulpfobutylether beta cyclodextrin sodium (SBECD).
Croatian: Pomoćna tvar: natrijev sulfobutileter beta ciklodekstrin (SBECD).
English: [CYP3A4 substrate; CYP2C19 inhibitor]
Croatian: Oralni kontraceptivi* [supstrati CYP3A4; inhibitori CYP2C19]
English: Phenytoin may be co-administered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg IV BID or from 200 mg to 400 mg oral BID, (100 mg to 200 mg oral BID in patients less than 40 kg) (see section 4.2).
Croatian: Fenitoin se može primjenjivati istodobno s vorikonazolom ako se doza održavanja vorikonazola povisi na 5 mg/kg BID intravenski, ili s 200 mg na 400 mg BID peroralno (sa 100 mg na 200 mg BID peroralno
English: Although not studied, voriconazole is likely to increase the plasma concentrations of sulfonylureas and cause hypoglycaemia.
Croatian: Iako nije ispitivano, primjena vorikonazola vjerojatno će povećati koncentracije sulfonilureje u plazmi i izazvati hipoglikemiju.
English: Everolimus (CYP3A4 substrate, P-gp substrate)
Croatian: Everolimus (supstrat CYP3A4, supstrat P-glikoproteina):
English: Tacrolimus Cmax ↑ 117% Tacrolimus AUCt ↑ 221%
Croatian: Takrolimus AUCt ↑221%
English: Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID)*
Croatian: Efavirenz 300 mg QD, primijenjeno istodobno s vorikonazolom u dozi od 400 mg BID*
English: Voriconazole Hikma is a single dose unpreserved sterile lyophile.
Croatian: Hikma je sterilni liofilizat bez konzervansa za jednokratnu primjenu.
English: Voriconazole Hikma 200 mg powder for solution for infusion Voriconazole
Croatian: Vorikonazol Hikma 200 mg prašak za otopinu za infuziju vorikonazol
English: Although not studied, voriconazole is likely to increase the plasma concentrations of vinca alkaloids and lead to neurotoxicity.
Croatian: Iako nije ispitivano, primjena vorikonazola vjerojatno će povećati koncentracije vinka alkaloida u plazmi i dovesti do neurotoksičnosti.
English: Voriconazole Cmax ↑ 23% Voriconazole AUCτ ↓ 7%
Croatian: Vorikonazol Cmax ↑23% Vorikonazol AUCτ ↓7%
English: • Sirolimus (used in transplant patients)
Croatian: • sirolimus (koristi se u bolesnika s presatkom organa)
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for infusion
Croatian: Prašak za otopinu za infuziju
English: Success at day 180*
Croatian: Pojava invazivne gljivične infekcije - 180. dan Uspjeh na 180. dan*
English: Although not studied, carbamazepine and long-acting barbiturates are likely to significantly decrease plasma voriconazole concentrations.
Croatian: Iako nije ispitivano, karbamazepin i barbiturati dugog djelovanja vjerojatno će značajno sniziti
English: Voriconazole has been associated with cases of serious hepatic toxicity in patients with other serious underlying conditions.
Croatian: U bolesnika s ozbiljnom osnovnom bolešću liječenje vorikonazolom se povezivalo sa slučajevima ozbiljne hepatotoksičnosti.
English: When voriconazole is coadministered with efavirenz the dose of voriconazole should be increased to 400 mg every 12 hours and that of efavirenz should be decreased to 300 mg every 24 hours (see sections 4.2, 4.3 and
Croatian: Efavirenz (induktor CYP450; inhibitor i supstrat CYP3A4) Kada se vorikonazol primjenjuje istodobno s efavirenzom, dozu vorikonazola treba povećati na 400 mg svakih 12 sati, a dozu efavirenza smanjiti na 300 mg svaka 24 sata (vidjeti dijelove 4.2, 4.3 i 4.5).
English: Efavirenz (CYP450 inducer; CYP3A4 inhibitor and substrate)
Croatian: Efavirenz (nenukleozidni inhibitor reverzne transkriptaze) [induktor CYP450; inhibitor i supstrat CYP3A4]
English: Your doctor should also monitor your liver function while you are being treated with Voriconazole Hikma by doing blood tests.
Croatian: Za vrijeme liječenja lijekom Vorikonazol Hikma liječnik također mora nadzirati funkciju Vaše jetre putem krvnih pretraga.
English: Although not studied, voriconazole is likely to increase the plasma concentrations of ergot alkaloids and lead to ergotism.
Croatian: Iako nije ispitivano, primjena vorikonazola vjerojatno će povisiti koncentracije ergot alkaloida u plazmi i dovesti do ergotizma.
English: Voriconazole Cmax ↓ 49% Voriconazole AUCτ ↓ 69%
Croatian: Vorikonazol Cmax ↓49% Vorikonazol AUCτ ↓69%
English: Intravenous loading doses of 6 mg/kg IV twice daily on day 1 followed by 4 mg/kg intravenous dose twice daily and 300 mg oral tablets twice daily were evaluated in one adolescent pharmacokinetic study.
Croatian: U jednom farmakokinetičkom ispitivanju u adolescenata ocijenjena je primjena intravenske udarne doze od 6 mg/kg dvaput na dan prvog dana, nakon čega je slijedila intravenska doza od 4 mg/kg dvaput na dan i peroralna primjena tableta od 300 mg dvaput na dan.
English: Other Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.g., delavirdine, nevirapine)*
Croatian: Ostali nenukleozidni inhibitori reverzne transkriptaze (NNRTI) (npr., delavirdin, nevirapin)* [supstrati CYP3A4, inhibitori ili induktori CYP450]
English: Voriconazole Cmax ↓ 69% Voriconazole AUCτ ↓ 78%
Croatian: Vorikonazol Cmax ↓69% Vorikonazol AUCτ ↓ 78%
English: 300 mg QD (co-administered with voriconazole 400 mg BID)*
Croatian: 300 mg QD (primijenjeno istodobno s vorikonazolom u dozi od 400 mg BID)*
English: Reconstitution and dilution information
Croatian: Informacije o pripremi razrjeđivanju
English: Mode of action
Croatian: Način primjene
English: Required Volumes of 10 mg/ml Voriconazole Hikma Concentrate
Croatian: Potreban volumen koncentrata lijeka Vorikonazol Hikma od 10 mg/ml
English: Do not take Voriconazole Hikma: - If you are allergic to the active ingredient voriconazole or to sulfobutylether beta cyclodextrin sodium
Croatian: - Ako ste alergični na djelatnu tvar vorikonazol ili na natrijev sulfobutileter beta ciklodekstrin (naveden u dijelu 6.).
English: There was evidence of attenuation with repeated doses of voriconazole.
Croatian: Postoje dokazi o smanjenju intenziteta oštećenja vida kod primjene višekratnih doza vorikonazola.
English: Hepatic impairment
Croatian: Bubrežne nuspojave
English: hepatic failure, hepatomegaly, cholecystitis, cholelithiasis
Croatian: zatajenje jetre, hepatomegalija, kolecistitis,
English: Fluconazole (CYP2C9, CYP2C19 and CYP3A4 inhibitor) Coadministration of oral voriconazole and oral fluconazole resulted in a significant increase in Cmax and AUCτ of voriconazole in healthy subjects.
Croatian: Istodobna primjena peroralnog vorikonazola i peroralnog flukonazola dovela je do značajnog povećanja vrijednosti Cmax i AUCτ vorikonazola u zdravih ispitanika.
English: EOT
Croatian: Lot
English: How to store Voriconazole Hikma
Croatian: Kako čuvati Vorikonazol Hikma
English: In the case of treatment-related adverse events, discontinuation of voriconazole and use of alternative antifungal agents must be considered (see section 4.4 and 4.8)
Croatian: Pri upotrebi u profilaksi, prilagodba doze se ne preporučuje u slučaju izostanka djelotvornosti ili štetnih događaja povezanih s liječenjem.U slučaju štetnih događaja povezanih s liječenjem, treba razmisliti o prekidu uzimanja vorikonazola i primjeni zamjenskih antimikotika (vidjeti dijelove 4.4 i 4.8).
English: parapsilosis and C. tropicalis.
Croatian: niži u odnosu na one infekcije čiji su uzročnici bili C. albicans, C. parapsilosis i C. tropicalis.
English: Short acting opiates (CYP3A4 substrate)
Croatian: Opijati kratkog djelovanja (supstrati CYP3A4)
English: • Carbamazepine (used to treat seizures)
Croatian: • karbamazepin (koristi se za liječenje epileptičkih napadaja)
English: Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.2).
Croatian: hipomagnezemije i hipokalcemije treba nadzirati i po potrebi korigirati prije početka i tijekom liječenja vorikonazolom (vidjeti dio 4.2).
English: This should be taken into consideration for patients on a controlled sodium diet.
Croatian: O tome treba voditi računa u bolesnika s ograničenjem unosa natrija.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported with the use of voriconazole.
Croatian: Drug reaction with eosinophilia and systemic symptoms, DRESS), koje mogu biti opasne po život ili smrtonosne.
English: Voriconazole Cmax and AUCτ ↔ No dose adjustment
Croatian: Vorikonazol Cmax and AUCτ ↔ Vorikonazol Cmax and AUCτ
English: 2 In clinical studies, response to voriconazole in patients with C glabrata infections was 21% lower compared to C. albicans, C. parapsilosis and C. tropicalis.
Croatian: 2 U kliničkim ispitivanjima je odgovor na vorikonazol u bolesnika s infekcijama uzročnika C. glabrata bio 21%
English: Voriconazole is metabolised by, and inhibits the activity of, cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4.
Croatian: Vorikonazol se metabolizira putem izoenzima citokroma P450: CYP2C19, CYP2C9 i CYP3A4 i inhibira njihovu aktivnost.
English: • Tacrolimus (used in transplant patients)
Croatian: • takrolimus (koristi se u bolesnika s presatkom organa)
English: Protein binding of voriconazole was not affected by impaired hepatic function.
Croatian: Oštećenje funkcije jetre nije utjecalo na vezivanje vorikonazola za proteine.
English: Candidaemia in non-neutropenic patients
Croatian: Kandidemija u bolesnika bez neutropenije
English: How to take Voriconazole Hikma
Croatian: Kako primati Vorikonazol Hikma
English: In vitro activity against the following pathogens has been shown, but the clinical significance is unknown: Curvularia spp.
Croatian: Dokazana je i aktivnost in vitro protiv vrsta iz rodova Curvularia i Sporothrix, no klinički značaj tog nalaza nije poznat.
English: Warfarin (30 mg single dose, coadministered with 300 mg BID voriconazole) [CYP2C9 substrate] Other oral coumarins (e.g., phenprocoumon, acenocoumarol) [CYP2C9 and CYP3A4 substrates]
Croatian: Varfarin (jedna doza od 30 mg, primijenjena istodobno s vorikonazolom u dozi od 300 mg BID) [supstrat CYP2C9]
English: 8 mg/kg dose (number of vials)
Croatian: dozu od 8 mg/kg (broj bočica)
English: • Itchiness
Croatian: Vorikonazol
English: Dosage
Croatian: Stevens
English: Long acting opiates (CYP3A4 substrate)
Croatian: Opijati dugog djelovanja (supstrati CYP3A4)
English: After reconstitution:
Croatian: Nakon pripreme
English: Voriconazole Hikma contains the active substance voriconazole.
Croatian: Hikma sadrži djelatnu tvar vorikonazol.
English: Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended when co-administered with voriconazole since methadone levels increased following coadministration of voriconazole.
Croatian: Budući da je nakon istodobne primjene s vorikonazolom došlo do povećanja razine metadona, kod istodobne primjene metadona i vorikonazola preporučuju se česte kontrole zbog mogućih nuspojava i toksičnih učinaka metadona, uključujući produljenje QTc-intervala.
English: Intravenous
Croatian: Intravenski
English: 9 mg/kg dose (number of vials)
Croatian: dozu od 9 mg/kg (broj bočica)
English: Compared to efavirenz 600 mg QD,
Croatian: Rifampicin (600 mg QD)
English: Scedosporium spp.
Croatian: Hikma Italia S.p.A.
English: Completed at least 100 days of study drug prophylaxis
Croatian: Uspjeh na 180. dan* Uspjeh na 100. dan Dovršeno najmanje 100 dana profilakse ispitivanim lijekom Preživljenje do 180. dana
English: PHARMACEUTICAL FORM Powder for solution for infusion (powder for infusion) White to off-white lyophilised cake.
Croatian: OBLIK Prašak za otopinu za infuziju (prašak za infuziju) Bijeli ili gotovo bijeli liofilizirani kolačić. pH pripremljene otopine je 4,0 do 7,0.
English: Undesirable effects reported in subjects receiving voriconazole:
Croatian: Nuspojave prijavljene u ispitanika koji su primali vorikonazol: Klasa organskih sustava
English: 4 mg/kg dose (number of vials)
Croatian: dozu od 4 mg/kg (broj bočica)
English: Tel.: +351 219 608 410
Croatian: Hikma Farmacêutica (Portugal), S.A. Tel.: +351 219 608 410
English: • Jaundice; changes in blood tests of liver function
Croatian: - osip - žutica; promjene u krvnim pretragama jetrene funkcije - pankreatitis (upala gušterače) što se može očitovati kao jaka bol u trbuhu.
English: Dose reduction of alfentanil, fentanyl and other short acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered.
Croatian: Fentanil AUC0-∞↑1,34 puta strukturno sličnih alfentanilu koji se metaboliziraju pomoću CYP3A4 (npr. sufentanil).
English: What Voriconazole Hikma looks like and contents of the pack Voriconazole Hikma is a white to off-white lyophilised cake.
Croatian: Kako Vorikonazol Hikma izgleda i sadržaj pakiranja Vorikonazol
English: Voriconazole Cmax ↑ 104%
Croatian: Vorikonazol Cmax ↓93%
English: Intravenous use only
Croatian: Samo za intravensku primjenu.
English: Prevention of fungal infections in high risk bone marrow transplant recipients This medicinal product should only be used under the supervision of a doctor.
Croatian: Ovaj se lijek smije uzimati samo pod nadzorom liječnika.
English: 6 mg/kg dose (number of vials)
Croatian: dozu od 6 mg/kg (broj bočica)
English: • Omeprazole (used for treating ulcers)
Croatian: • omeprazol (koristi se za liječenje vrijeda)
English: • Double vision, serious conditions of the eye including: pain and inflammation of the eyes and eyelids, , abnormal eye movement, damage to the optic nerve resulting in vision impairment, optic disc swelling
Croatian: - pretjerana aktivnost štitnjače - propadanje moždane funkcije kao ozbiljna komplikacija jetrene bolesti - gubitak većine vlakana vidnog živca, zamagljenje rožnice, neželjeni pokreti oka - povećana osjetljivost na svjetlost popraćena mjehurićima - poremećaj u kojem obrambeni sustav tijela napada dio perifernog živčanog sustava - problemi s ritmom ili provođenjem srca (ponekad opasni po život)
English: 3 mg/kg dose (number of vials)
Croatian: dozu od 3 mg/kg (broj bočica)
English: Dose for the first 24 hours (Loading Dose)
Croatian: Doza tijekom prva 24 sata (udarna doza)
English: Interaction Geometric mean changes (%)
Croatian: Promjene geometrijske sredine
English: Oral Contraceptives*
Croatian: karcinom skvamoznih stanica*
English: • Red, scaly patches or ring-shaped skin lesions that may be a symptom of an autoimmune disease called cutaneous lupus erythematosus
Croatian: Druge značajne nuspojave čija učestalost nije poznata, ali mora biti odmah prijavljena Vašem liječniku: - rak kože - upala tkiva oko kosti - crvene, ljuskaste mrlje ili prstenasta oštećenja na koži koji mogu biti simptomi autoimune bolesti zvane kožni eritemski lupus
English: Loading Dose Regimen (first 24 hours)
Croatian: Udarna doza (prva 24 sata)
English: Breakthrough IFI - Day 180 1 (1.0%)
Croatian: 16,0 ml (1) 18,0 ml (1)
English: Cardiovascular
Croatian: Dojenje
English: NAME OF THE MEDICINAL PRODUCT Voriconazole Hikma 200 mg powder for solution for infusion
Croatian: Vorikonazol Hikma 200 mg prašak za otopinu za infuziju
English: Study Endpoints
Croatian: Ishodi ispitivanja
English: Omeprazole Cmax ↑ 116% Omeprazole AUCτ ↑ 280% Voriconazole Cmax ↑ 15% Voriconazole AUCτ ↑ 41% Other proton pump inhibitors that are CYP2C19 substrates may also be inhibited by voriconazole and may result in increased plasma concentrations of these medicinal products.
Croatian: Vorikonazol može inhibirati metabolizam i drugih inhibitora protonske pumpe koji su supstrati CYP2C19, što može dovesti do povećanja koncentracije tih lijekova u plazmi.
English: • Acute breathing difficulty, chest pain, swelling of the face (mouth, lips and around eyes), fluid accumulation in the lungs
Croatian: - vrućica - osip - mučnina, povraćanje, proljev - glavobolja - oticanje udova - bolovi u trbuhu - otežano disanje
English: Voriconazole Cmax ↓ 93% Voriconazole AUCτ ↓ 96%
Croatian: Vorikonazol AUCτ ↓ 96%
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 200 mg of voriconazole.
Croatian: TVARI Jedna bočica sadrži 200 mg vorikonazola.
English: • Anxiety, depression, confusion, agitation, inability to sleep, hallucinations
Croatian: nesanica, agitacija, smetenost
English: Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
Croatian: U bolesnika u kojih nisu uočeni dodatni faktori rizika zabilježene su uglavnom prolazne jetrene reakcije, uključujući hepatitis i žuticu.
English: Voriconazole Hikma contains sodium
Croatian: Hikma sadrži natrij
English: Infusion-related reactions, predominantly flushing and nausea, have been observed during administration of the intravenous formulation of voriconazole.
Croatian: Tijekom primjene intravenskog oblika vorikonazola zabilježene su reakcije povezane s infuzijom, pretežno crvenilo praćeno osjećajem užarenosti i mučnina.
English: Diclofenac Cmax ↑ 114% Diclofenac AUC0-∞ ↑ 78%
Croatian: Vorikonazol Cmax ↑104% Vorikonazol AUCτ ↑ 87%
English: Reconstitute and dilute before use.
Croatian: Prije primjene lijek se mora pripremiti i razrijediti.
English: 6 mg/kg every 12 hours 400 mg every 12 hours 200 mg every 12 hours
Croatian: 400 mg svakih 12 sati
English: [CYP3A4 substrates, inhibitors or CYP450 inducers]
Croatian: [snažni induktori CYP450]
English: 9 Includes dyspnoea and dyspnoea exertional.
Croatian: 9 Uključuje teško disanje i teško disanje uslijed napora.
English: subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life-threatening skin condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below
Croatian: - simptomi nalik gripi, nadraženost i upala probavnog trakta, upala probavnog trakta koja uzrokuje proljev povezan uz antibiotike, upala limfnih žila - upala tankog tkiva kojim je obložena unutarnja stijenka trbuha i koja prekriva trbušne organe - povećani limfni čvorovi (ponekad bolni), zatajenje koštane srži, povećani broj eozinofila - smanjena funkcija nadbubrežne žlijezde, smanjena aktivnost štitnjače - poremećaj moždane funkcije, simptomi slični Parkinsonovoj bolesti, ozljeda živca s posljedičnom utrnulošću, boli, trncima ili žarenjem u šakama ili stopalima - smetnje ravnoteže ili koordinacije - oticanje mozga - dvoslike, ozbiljna stanja oka uključujući: bol i upalu očiju i vjeđa, neuobičajeni očni pokreti, oštećenje očnog živca s posljedičnim oštećenjem vida, oticanje optičkog diska - smanjen osjet dodira - poremećen osjet okusa - poteškoće sa sluhom, zvonjenje u ušima, vrtoglavica - upala određenih unutarnjih organa - gušterače i dvanaesnika, oticanje i upala jezika - povećanje jetre, zatajenje jetre, bolest žučnog mjehura, žučni kamenci - upala zglobova, upala vena ispod kože (što može biti povezano sa stvaranjem krvnog ugruška) - upala bubrega, bjelančevine u mokraći, oštećenja bubrega - vrlo brz puls ili preskočeni otkucaji srca, katkad s nasumičnim električnim impulsima - poremećaj elektrokardiograma (EKG-a) - povišen kolesterol u krvi, povišena ureja u krvi - alergijske kožne reakcije (ponekad teške), uključujući kožna stanja opasna po život koja uzrokuju bolne mjehure i rane na koži i sluzokoži, posebice u ustima, upalu kože, koprivnjaču, opekotine od sunca ili tešku kožnu reakciju uslijed izlaganja svjetlosti ili suncu, crvenilo i nadraženost kože, crvenu ili ljubičastu promjenu boje kože koja može biti prouzročena niskim brojem trombocita, ekcem - reakcija na mjestu infuzije - alergijska reakcija ili pretjerani imunološki odgovor
English: Results are presented in Table 9.
Croatian: Rezultati su prikazani u Tablici 9.
English: Date of latest renewal: 04 December 2014
Croatian: Datum posljednje obnove odobrenja: 04. prosinca 2014.
English: What Menveo is and what it is used for
Croatian: Što je Menveo i za što se koristi
English: - This vaccine has been prescribed for you or your child only.
Croatian: Ovo je cjepivo propisano samo Vama ili Vašem djetetu.
English: The components of the vaccine should be visually inspected before and after reconstitution.
Croatian: Komponente cjepiva treba vizualno pregledati prije i nakon rekonstitucije.
English: The use of this vaccine should be in accordance with official recommendations.
Croatian: Cjepivo se mora primjenjivati u skladu sa službenim preporukama.
English: 53100 Siena, Italy
Croatian: 53100 Siena, Italija
English: The clinical relevance of this observation is unknown.
Croatian: Klinički značaj ovog zapažanja nije poznat.
English: Paediatric population (under 2 years of age)
Croatian: Pedijatrijska populacija (mlađi od 2 godine)
English: Other medicines and Menveo
Croatian: Drugi lijekovi i Menveo
English: However, chemical and physical stability after reconstitution was demonstrated for 8 hours below 25°C.
Croatian: Međutim, lijek pokazuje kemijsku i fizičku stabilnost 8 sati nakon rekonstitucije na temperaturi ispod 25°C.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is given.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovaj lijek.
English: Non-clinical data reveal no special hazard for humans based on conventional repeated-dose and reproductive and developmental toxicity studies.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnog ispitivanja ponovljenih doza i reproduktivne i razvojne toksičnosti.
English: Menveo cannot cause bacterial meningitis.
Croatian: Menveo ne može prouzročiti bakterijski meningitis.
English: Since there was no direct impact on the seroprotection rate, the clinical consequences are presently unknown.
Croatian: S obzirom da nije bilo izravnog utjecaja na stopu seroprotekcije, kliničke posljedice u ovom trenutku nisu poznate.
English: Intramuscular injection.
Croatian: Intramuskularna injekcija.
English: Shake well before use.
Croatian: Prije uporabe dobro protresite.
English: The presence of a minor infection is not a contraindication.
Croatian: Manja infekcija nije kontraindikacija.
English: The powder is a white to off- white cake.
Croatian: Prašak je kolačić bijele do bjelkaste boje.
English: If a severe allergic reaction occurs tell your doctor straight away or go immediately/ take your child to the nearest Accident and Emergency department because urgent medical help may be needed.
Croatian: Ako dođe do teške alergijske reakcije, odmah obavijestite liječnika ili odvedite dijete u najbližu ustanovu za hitnu liječničku pomoć, jer mu je potrebna hitna medicinska pomoć.
English: After reconstitution 0.5 ml dose contains:
Croatian: Nakon rekonstitucije doza od 0,5 ml sadrži:
English: The incidence and severity of any, local, systemic, and other reactions were generally similar in the Menveo groups across all studies and within the adolescent and adult age groups.
Croatian: Incidencija i težina bilo koje lokalne, sistemske i drugih reakcija općenito su bile slične u skupinama koje su primale Menveo u svim ispitivanjima te unutar skupina adolescenata i odraslih.
English: The most common local and systemic adverse reactions observed in clinical trials were pain at the injection site and headache.
Croatian: Najčešće zapažene lokalne i sistemske nuspojave u kliničkim ispitivanjima bile su bol na mjestu injiciranja i glavobolja.
English: For information on the reconstitution of the vaccine see the section for medical or healthcare professionals at the end of this leaflet.
Croatian: Informacije o rekonstituciji cjepiva potražite u dijelu namijenjenom medicinskim ili zdravstvenim djelatnicima na kraju ove upute.
English: The vaccine works by causing your body to make its own protection (antibodies) against these bacteria.
Croatian: Cjepivo djeluje tako da potiče tijelo na stvaranje vlastite zaštite (protutijela) protiv ovih bakterija.
English: After vaccination, over 97% of subjects had detectable pertussis titers to all three pertussis antigens.
Croatian: Nakon cijepljenja, više od 97% ispitanika imalo je detektabilne titre na sva tri antigena pertusisa.