FrancophonIA/ELRC3.0 huggingface dataset:
English: Povidone (E1201), Microcrystalline Cellulose (E460i), Colloidal Anhydrous Silica, Sodium Benzoate (E211).
Croatian: Povidon (E1201), mikrokristalna celuloza (E460), koloidna bezvodna silika, natrij benzoat (E211).
English: • 30 ml glass mixing tube with cap.
Croatian: • staklenu bočicu od 30 ml za miješanje s poklopcem.
English: One tablet contains: 100 mg
Croatian: Jedna tableta sadrži: 100 mg 13C-uree
English: All foods contain a substance called carbon 13 (
Croatian: Sva hrana, u različitim količinama, sadrži tvar koja se naziva ugljik13 (13C).
English: i. Remove the cap from the tube ii.
Croatian: Uklonite poklopac s epruvete ii.
English: Analysis Request Form
Croatian: Obrazac zahtjeva za analizu
English: What the Pylobactell tablet contains
Croatian: Što sadrži tableta Pylobactell
English: • Analysis Request Form.
Croatian: • Obrazac zahtjeva za analizu.
English: ADDITIONAL KIT ITEM: MIXING AND ADMINISTRATION VIAL
Croatian: DODATNI ARTIKL U KOMPLETU: BOČICA ZA MIJEŠANJE I PRIMJENU
English: Medicinal product subject to medical prescription.
Croatian: NAČIN IZDAVANJA LIJEKA Lijek se izdaje na recept.
English: Pylobactell 100mg soluble tablet C-Urea
Croatian: Pylobactell 100mg topljiva tableta 13C-urea
English: If fasting is a problem e.g. for diabetic patients, please tell your doctor, pharmacist or nurse.
Croatian: Ako Vam post predstavlja problem, primjerice bolesnicima s dijabetesom, obavijestite svog liječnika.
English: Pharmacotherapeutic group: Other diagnostic agents
Croatian: FARMAKOLOŠKA SVOJSTVA 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: ostali dijagnostički lijekovi
English: C-urea - The other ingredients are povidone (E1201), microcrystalline cellulose (E460i), colloidal anhydrous silica and sodium benzoate (E211).
Croatian: Drugi sastojci su povidon (E1201), mikrokristalna celuloza (E460), koloidna bezvodna silika i natrij benzoat (E211).
English: Pylobactell, 100 mg, Soluble Tablet
Croatian: Pylobactell, 100 mg, topljiva tableta
English: 07 May 2008
Croatian: Datum prvog odobrenja: 07 svibanj 1998.
English: C-urea or to any of the other ingredients of this medicine (listed in Section 6).
Croatian: Nemojte primjenjivati Pylobactell: - ako ste alergični na 13C-urea ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Torbet Laboratories Ireland Ltd, 20 Holles Street, Dublin 2, Ireland.
Croatian: Torbet Laboratories Ireland Ltd, 20 Holles Street, Dublin 2, Irska.
English: C-UBT) for Helicobacter pylori
Croatian: Pylobactell [13ugljik] -UREA IZDISAJNI TEST (13C-UBT) za Helicobacter pylori
English: Number: EU/1/98/064/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/064/001
English: If you have eaten a heavy meal it will be necessary to fast for six hours before the test. You can drink water during the fasting period.
Croatian: Ako ste objedovali kalorično jelo, bit će nužno postiti šest sati prije testa.
English: Povidone (E1201) Microcrystalline Cellulose (E460i) Colloidal Anhydrous Silica Sodium Benzoate (E211)
Croatian: Mikrokristalna celuloza (E460i) Koloidna bezvodna silika Natrij benzoat (E211)
English: Analysis Request Form.
Croatian: Obrazac zahtjeva za analizu.
English: Samples logged on by :
Croatian: Uzorke evidentirao/la :
English: Add water to the mark on the vial and replace the cap. Gently shake the vial to dissolve the tablet.
Croatian: Dodajte vodu do oznake na bočici i zamijenite poklopac.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Pylobactell if:
Croatian: Upozorenja i mjere opreza Važno je da obavijestite svog liječanika ako:
English: Patient Name:
Croatian: Ime i prezime bolesnika: Datum rođenja:
English: Safely discard the 30 ml mixing vial.
Croatian: Sigurno zbrinite bočicu za miješanje od 30 ml.
English: (iii) eradication therapy in the last 28 days?
Croatian: (iii) eradikacijsku terapiju u posljednjih
English: These breath samples are used to measure the natural level of
Croatian: Ovi izdisajni uzorci koriste se za mjerenje prirodne razine 13C u ugljičnom dioskidu daha.
English: These samples will be analysed to measure the normal amount of
Croatian: Ovi uzorci analizirat će se kako bi se izmjerila normalna količina 13C u ugljičnom dioksidu Vašeg izdisaja.
English: Carbon-urea solution
Croatian: Priprema 13ugljik-urea otopine
English: This will help keep the test
Croatian: To će pomoći zadržavanju testne otopine 13C
English: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Ireland.
Croatian: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Irska
English: Gradually remove the straw from the tube as you breathe out.
Croatian: Postupno uklanjajte slamčicu iz epruvete kako izdišete. iv. Odmah stavite poklopac.
English: Diagnostic test kit FOR ORAL ADMINISTRATION Read the package leaflet before use.
Croatian: NAČINI I PUT(EVI) PRIMJENE LIJEKA Komplet za dijagnostički test ZA JEDNOKRATNU UPORABU Prije uporabe pročitajte uputu o lijeku.
English: iv.
Croatian: v.
English: How to store Pylobactell
Croatian: KAKO PRIMJENJIVATI PYLOBACTELL
English: Time
Croatian: Serija
English: M.A.
Croatian: A.
English: Marketing Authorisation Holder: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Ireland
Croatian: BROJODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Irska.
English: MEDICATION RECORD
Croatian: BILJEŠKE O LIJEKOVIMA
English: Referring Doctor:
Croatian: Liječnik:
English: AFFIX BAR-CODE LABEL HERE PLEASE PLACE BAR-CODE LABEL ON PATIENT RECORDS, IF APPLICABLE
Croatian: S BAR-KÔDOM NA BILJEŠKE O BOLESNIKU
English: Date of Test:
Croatian: Referentni broj bolesnika: Datum testiranja:
English: 30 ml mixing and administration glass vial with cap. Two straws.
Croatian: Staklenu bočicu od 30 ml za miješanje i primjenu s poklopcem.
English: C, which will be present if the patient is H.pylori positive.
Croatian: Treba uzeti tri epruvete izdahnutog zraka, koje se koriste za mjerenje prisutnosti razina viškova 13C, koji će biti prisutni ako je bolesnik H.pylori pozitivan.
English: Date of latest renewal:
Croatian: Datum posljednje obnove odobrenja: 07 svibanj 2008.
English: - The active substance is
Croatian: NAVOĐENJE DJELATNE/IH
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Croatian: PRILOG III OZNAČAVANJE I UPUTA O LIJEKU
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnutvarili neku od pomoćnih tvari.
English: Pylobactell, 100 mg, soluble tablet C-urea
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Pylobactell, 100 mg, topljiva tableta 13C-urea
English: Explanation of results:
Croatian: Objašnjenje rezultata:d 13C:
English: In such cases, the western blot method is negative.
Croatian: U takvim je slučajevima metoda Western blot negativna.
English: A-2304 Orth/Donau Austria
Croatian: A-2304 Orth/Donau
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što primite ovo cjepivo jer sadrži Vama važne podatke.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Croatian: U tom slučaju, cijepljenje će obično biti odgođeno dok se ne budete osjećali bolje.
English: What you need to know before you receive VEPACEL
Croatian: Što morate znati prije nego primite VEPACEL
English: The use of this vaccine should be in accordance with official recommendations.
Croatian: Uporaba ovog cjepiva treba biti u skladu sa službenim preporukama.
English: If vaccination is considered necessary, facilities for resuscitation should be immediately available in case of need (see section 4.4).
Croatian: Ako se cijepljenje smatra nužnim, oprema za reanimaciju treba biti odmah dostupna u slučaju potrebe (vidjeti dio 4.4).
English: Date of latest renewal: 04/01/2017
Croatian: Datum posljednje obnove: 04. 01. 2017.
English: No data is available on the safety and efficacy of VEPACEL in children younger than 6 months of age.
Croatian: Nema dostupnih podataka o sigurnosti i djelotvornosti VEPACELA u djece mlađe od 6 mjeseci.
English: None of the ingredients in the vaccine can cause flu.
Croatian: Nijedan sastojak u cjepivu ne može uzrokovati gripu.
English: 7.5 micrograms
Croatian: 7,5 mikrograma
English: • pain in arms and/or legs (in the majority of cases reported as pain in the vaccination arm)
Croatian: • bol u rukama i/ili nogama (u većini slučajeva prijavljeno kao bol u ruci u kojoj je izvršeno cijepljenje)
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Croatian: Ako niste sigurni, obratite se svom liječniku ili medicinskoj sestri prije primanja ovog cjepiva.
English: You should tell your doctor before vaccination: - if you have a severe infection with a high temperature (over 38°C).
Croatian: Prije cijepljenja obavijestite svog liječnika: - ako imate tešku infekciju s visokom temperaturom (iznad 38°C).
English: 4.8 Undesirable effects a) Summary of safety profile
Croatian: 4.8 Nuspojave a) Sažetak sigurnosnog profila
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Croatian: Kad osoba primi cjepivo, imunološki sustav (prirodni obrambeni sustav tijela) će stvoriti vlastitu zaštitu (protutijela) protiv bolesti.
English: Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world.
Croatian: Pandemijska je gripa vrsta influence koja se javlja svakih nekoliko desetljeća i brzo se širi diljem svijeta.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Croatian: Vaš liječnik ili medicinska sestra primijenit će cjepivo u skladu sa službenim preporukama.
English: If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice if you should receive VEPACEL.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet ako trebate primiti VEPACEL.
English: Tell the doctor requesting the test that you have recently received VEPACEL.
Croatian: Obavijestite liječnika koji traži tu pretragu da ste nedavno primili VEPACEL.
English: Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Croatian: Promptna analiza skupnih informacija o sigurnosti, s obzirom na razmjer izloženosti, bit će ključna za regulatorne odluke i zaštitu populacije koja će se cijepiti.
English: What VEPACEL is and what it is used for
Croatian: Što je VEPACEL i za što se koristi
English: The use of VEPACEL during pregnancy and lactation may be considered in a pre-pandemic situation, taking into account official recommendations.
Croatian: Uporaba VEPACELA tijekom trudnoće i dojenja može se razmatrati u prepandemijskoj situaciji, uzimajući u obzir službene preporuke.
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Croatian: U bilo kojem od ovih slučajeva, OBAVIJESTITE SVOG LIJEČNIKA ILI MEDICINSKU SESTRU, jer cijepljenje možda neće biti preporučeno ili će ga možda trebati odgoditi.
English: Dizziness Headache Crying
Croatian: Glavobolja Plač
English: • severe stabbing or throbbing pain along one or more nerves
Croatian: • jaka probadajuća ili pulsirajuća bol duž jednog ili više živaca
English: Therefore, hypersensitivity reactions may occur.
Croatian: Zbog toga može doći do reakcija preosjetljivosti.
English: Prior to administration, visually inspect the suspension for any foreign particulate matter and/or abnormal physical appearance.
Croatian: Prije primjene vizualno pregledajte suspenziju kako biste provjerili sadrži li bilo kakve strane čestice i/ili je neuobičajenog fizičkog izgleda.
English: However, in a pandemic situation, it may be appropriate for you to have the vaccine, provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Croatian: Međutim, u pandemijskoj će situaciji možda biti potrebno da primite cjepivo, pod uvjetom da je odgovarajuća medicinska skrb odmah dostupna u slučaju alergijske reakcije.
English: The symptoms of pandemic flu are similar to those of an ordinary flu but are usually more severe.
Croatian: Simptomi pandemijske gripe slični su onima obične gripe, no uglavnom su teži.
English: other paediatric Population
Croatian: Ostala pedijatrijska populacija
English: 21 Days after 2nd Dose
Croatian: 21 dan nakon 2.doze
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Croatian: Tijekom pandemijske situacije, učestalost podnošenja periodičkih izvješća o neškodljivosti lijeka navedena u članku 24 Uredbe (EK) br. 726/2004 neće biti primjerena za praćenje sigurnosti pandemijskog cjepiva za koje se očekuju visoke razine izlaganja u kratkom vremenskom roku.
English: It is intended to be given before the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
Croatian: Namijenjen je za primjenu prije sljedeće pandemije influence (gripe) kako bi se spriječila gripa uzrokovana virusom tipa H5N1.
English: Immunisation shall be postponed in patients with severe febrile illness or acute infection.
Croatian: Imunizacija će se odgoditi u bolesnika s teškom febrilnom bolesti ili s akutnom infekcijom.
English: Immunoglobulin is not to be given with VEPACEL unless it is necessary during a medical emergency to provide immediate protection.
Croatian: Imunoglobulin se ne smije primijeniti zajedno s VEPACELOM osim ako je potrebno pružiti trenutnu zaštitu u hitnom medicinskom slučaju.
English: Very Common (≥1/10) Common (≥1/100 - <1/10) Uncommon (≥1/1,000 - <1/100) Rare (≥1/10,000 - <1/1,000)
Croatian: Manje često (≥1/1000 - <1/100) Rijetko (≥1/10 000 - <1/1000) Vrlo rijetko (<1/10 000)
English: Information from non-clinical studies
Croatian: Informacije iz nekliničkih ispitivanja
English: As with all vaccines, VEPACEL may not fully protect all persons who are vaccinated.
Croatian: Kao kod svih cjepiva, VEPACEL možda neće potpuno zaštititi sve osobe koje su cijepljene.
English: Pandemic and Pre-pandemic vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Croatian: Pandemijska i prepandemijska cjepiva sadrže antigene gripe koji su različiti od onih u trenutačno cirkulirajućim virusima influence.
English: If necessary, VEPACEL may be given at the same time as normal or specific immunoglobulin into separate limbs.
Croatian: Ako je potrebno, VEPACEL se može primijeniti u isto vrijeme s normalnim ili specifičnim imunoglobulinom u suprotne udove.
English: Animal reproductive and developmental toxicology studies do not indicate harmful effects in regard to female fertility, embryo-foetal and pre- and post-natal toxicity.
Croatian: Ispitivanja reproduktivne i razvojne toksičnosti na životinjama ne upućuju na štetne učinke na plodnost ženki, embrio-fetalnu, prenatalnu i postnatalnu toksičnost.
English: Irritability Malaise Feeling Cold
Croatian: Iritabilnost Malaksalost Osjećaj hladnoće
English: Please tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, or if you have recently received any other vaccine.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate, ako ste nedavno uzimali ili ćete možda uzeti bilo koji drugi lijek, uključujući lijekove dobivene bez recepta, ili ako ste nedavno primili bilo koje drugo cjepivo.
English: Adults, older people, and special risk groups
Croatian: Odrasli, starije osobe i posebne rizične skupine
English: Adults and children from 6 months onwards:
Croatian: Odrasli i djeca od 6 mjeseci nadalje:
English: If you take any medicines that reduce immunity to infections or have any other type of treatment that affects the immune system (such as radiotherapy), VEPACEL can still be given but your response to the vaccine may be poor.
Croatian: Ako uzimate bilo kakve lijekove koji smanjuju imunost na infekcije ili primate bilo koju drugu vrstu liječenja koja utječe na imunološki sustav (kao što je zračenje), VEPACEL se može primijeniti, no odgovor na cjepivo mogao bi biti slab.
English: What VEPACEL contains
Croatian: Što VEPACEL sadrži
English: The most frequently occurring side effect was injection- site pain, which was usually mild.
Croatian: Najčešća nuspojava bila je bol na mjestu injekcije, koja je obično bila blaga.
English: Children and adolescents aged 3 to 17 years:
Croatian: Djeca i adolescenti od 3 do 17 godina:
English: Healthcare providers should carefully consider the potential risks and benefits for each specific patient before prescribing VEPACEL.
Croatian: Zdravstveni djelatnici trebaju pažljivo razmotriti moguće rizike i koristi za svakog pojedinog bolesnika prije propisivanja VEPACELA.
English: The suspension is clear to opalescent.
Croatian: Suspenzija je bistra do opalescentna.
English: In consequence, as soon as the pandemic is declared and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update.
Croatian: Zbog toga će, čim se proglasi pandemija i upotrijebi prepandemijsko cjepivo, nositelj odobrenja podnositi češća pojednostavljena periodička izvješća o neškodljivosti lijeka u formatu i s učestalosti koji su definirani u "Preporukama CHMP-a za Glavni plan upravljanja rizicima za cjepiva protiv influence pripremljena od virusa koji mogu uzrokovati pandemiju, a namijenjena su za uporabu izvan konteksta glavnog dosjea" (EMEA/49993/2008) te sve daljnje dopune plana.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Croatian: Znakovi alergijske reakcije mogu uključivati osip na koži praćen svrbežom, nedostatak daha i oteknuće lica ili jezika.
English: These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Croatian: Ti se antigeni mogu smatrati "novim" antigenima i simuliraju situaciju u kojoj je ciljna populacija za cijepljenje imunološki naivna (neprokužena).
English: Such reactions have occurred both in patients with a history of multiple allergies and in patients with no known allergy.
Croatian: Takve su se reakcije pojavile u bolesnika s više alergija, kao i u bolesnika bez poznatih alergija.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove (EMA): http://www.ema.europa.eu/
English: This vaccine may contain traces of formaldehyde, benzonase, sucrose, trypsin and Vero host cell protein, which are used during the manufacturing process.
Croatian: Ovo cjepivo može sadržavati tragove formaldehida, benzonaze, saharoze, tripsina i proteina Vero stanice domaćina, koji se koriste tijekom proizvodnog postupka.
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleeding.
Croatian: Zato zdravstveni djelatnici trebaju ocijeniti koristi i moguće rizike primjene cjepiva u pojedinaca s trombocitopenijom ili drugim poremećajima krvarenja koji su kontraindikacija za intramuskularnu injekciju, osim ako je moguća korist značajnija od rizika od krvarenja.
English: Allergic reactions, in rare cases leading to shock, have been reported.
Croatian: Prijavljene su alergijske reakcije koje u rijetkim slučajevima mogu dovesti do šoka.
English: 60 years and above
Croatian: 60 i više godina
English: What VEPACEL is and what it is used for What you need to know before you receive VEPACEL How VEPACEL is given
Croatian: Što je VEPACEL i za što se koristi Što morate znati prije nego primite VEPACEL
English: In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Croatian: U slučaju da sadrži bilo kakve čestice i/ili je neuobičajenog izgleda, cjepivo treba baciti.
English: The vaccine contains 10 doses of 0.5 ml.
Croatian: Cjepivo sadrži 10 doza od 0,5 ml.
English: See section 6.6 for administration instructions.
Croatian: Vidjeti dio 6.6 za upute za uporabu.
English: The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older people.
Croatian: Sigurnosni profil imunokompromitiranih ispitanika i bolesnika s kroničnim bolestima sličan je sigurnosnom profilu zdravih odraslih i starijih osoba.
English: OTHER Ology Bioservices Ireland Ltd Logo
Croatian: Ology Bioservices Ireland LTD
English: • reduced blood pressure, feeling faint (syncope)
Croatian: • smanjen krvni tlak, gubitak svijesti (sinkopa)
English: • Adults, older people, and special risk groups
Croatian: • Odrasli, starije osobe i posebne rizične skupine
English: • feeling cold c) The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years.
Croatian: • osjećaj hladnoće c) Sljedeće su nuspojave zabilježene u kliničkim ispitivanjima u adolescenata u dobi od 9 do 17 godina.
English: Sensory disturbance (paresthesia, dysesthesia, oral dysesthesia, hypoesthesia, dysgeusia, and burning sensation)
Croatian: Senzorni poremećaji (parestezija, dizestezija, oralna dizestezija, hipoestezija, dizgeuzija i osjećaj žarenja)
English: • swelling of tissue just below the skin
Croatian: • oteknuće tkiva ispod kože
English: Data obtained with the H5N1 vaccines will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with H5N1 vaccines are relevant for the pandemic and pre-pandemic vaccines.
Croatian: Podaci dobiveni na cjepivima protiv virusa H5N1 omogućuju stvaranje strategije cijepljenja koja će se vjerojatno koristiti za pandemijsko cjepivo: klinički podaci koji se odnose na imunogenost, sigurnost i reaktogenost dobiveni cjepivima protiv virusa H5N1 relevantni su za pandemijska i prepandemijska cjepiva.
English: In the clinical studies conducted in adults and older people most side effects were mild in nature and short term.
Croatian: U kliničkim ispitivanjima provedenim na odraslim osobama i starijim osobama,većina nuspojava bila je blage naravi i kratkotrajna.
English: Uncommon (affects 1 to 10 users in 1,000): • generalised skin reactions including urticaria (hives)
Croatian: Manje često (javlja se kod 1 do 10 na 1000 korisnika): • generalizirane kožne reakcije uključujući urtikariju (koprivnjaču)
English: How to store VEPACEL
Croatian: Kako čuvati VEPACEL
English: This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1).
Croatian: Ova indikacija temelji se na podacima o imunogenosti u ispitanika u dobi od 6 mjeseci nadalje nakon primjene dviju doza cjepiva pripremljenog sa sojevima podtipa H5N1 (vidjeti dio 5.1).
English: However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Croatian: Međutim, ako je indicirana istovremena primjena s drugim cjepivom, imunizacija se treba provesti na suprotnim udovima.
English: Other medicines and VEPACEL
Croatian: Drugi lijekovi i VEPACEL