FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking Glubrava with or just after food may reduce any stomach problems caused by metformin.
Croatian: Uzimanje lijeka Glubrava s hranom ili smjesta nakon obroka može smanjiti eventualne želučane probleme koje uzrokuje metformin.
English: The company that markets Glubrava will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Croatian: Tvrtka koja lijek Glubrava stavlja u promet osigurat će edukativne materijale za liječnike koji propisuju taj lijek, a koji će obuhvaćati informacije o mogućem riziku od srčanog zastoja i raka mjehura u primjeni terapija koje sadrže pioglitazon, kriterijima za odabir pacijenata te potrebi za redovitim procjenjivanjem učinaka terapije i prekidu liječenja u slučaju kada bolesnici više nemaju koristi od nje.
English: In all studies, adding pioglitazone 30 mg to metformin led to an improvement in the control of blood glucose, with levels of HbA1c which further decreasing by 0.64 to 0.89% compared with the levels on metformin alone.
Croatian: Kombiniranje pioglitazona u dozi od 30 mg s metforminom u svim je ispitivanjima dovelo do poboljšanja kontrole glukoze u krvi, pri čemu su se razine tvari HbA1c dodatno smanjile za od 0,64 % do 0,89 % u odnosu na razine u slučaju kada se metformin koristi kao monoterapija.
English: At subsequent reviews, prescribers should confirm that benefits to patients are maintained.
Croatian: U naknadnim ponovnim procjenama, liječnici koji propisuju terapiju moraju potvrditi da su se održale koristi u bolesnika.
English: Other side effects such as bone fracture, increased weight and oedema (swelling) may occur in less than 1 in 10 patients.
Croatian: Ostale nuspojave, kao što su prijelom kostiju, povećanje tjelesne težine i edem (oticanje), mogu se javiti u manje od 1 na 10 bolesnika.
English: Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Croatian: Metformin djeluje uglavnom tako da onemogućuje proizvodnju glukoze i smanjuje njezinu apsorpciju u crijevima.
English: Patients changing from metformin only to Glubrava may need to introduce pioglitazone slowly until a dose of 30 mg per day is reached.
Croatian: Bolesnici koji prelaze s metformina samo na lijek Glubrava možda će se morati postupno privikavati na pioglitazon sve do dosezanja doze od 30 mg na dan.
English: Glubrava must not be used in patients who have a disease that causes lack of oxygen to the tissues such as a recent heart attack or shock.
Croatian: Lijek Glubrava ne smije se primjenjivati u bolesnika koji imaju bolest koja uzrokuje manjak kisika u tkivu kao što su nedavni srčani udar ili šok.
English: The CHMP concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Glubrava simplifies treatment and improves compliance when a combination of the active substances is required.
Croatian: CHMP je zaključio da je utvrđena djelotvornost pioglitazona i metformina u liječenju dijabetesa tipa 2 te da lijek Glubrava pojednostavljuje liječenje i poboljšava usklađenost kada je potrebna kombinacija tih dviju djelatnih tvari.
English: Glubrava must not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may affect the kidneys, and during breast-feeding.
Croatian: Lijek Glubrava ne smije se primjenjivati u slučaju intoksikacije alkoholom i dijabetičke ketoacidoze (visokih razina ketona), stanja koja mogu utjecati na bubrege te tijekom dojenja.
English: Pioglitazone on its own has been approved in the EU under the name Actos and can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Croatian: Pioglitazon kao monoterapija odobren je u EU-u pod nazivom Actos i može se koristiti s metforminom u bolesnika s dijabetesom tipa 2 koji ne mogu postići zadovoljavajuću kontrolu samo metforminom.
English: Treatment with Glubrava should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Croatian: Nakon tri do šest mjeseci liječenja potrebno je procijeniti učinke terapije lijekom Glubrava i prekinuti liječenje u bolesnika kod kojih nisu vidljive dostatne koristi.
English: They measured the level in the blood of a substance (HbA1c), which gives an indication of how well the blood glucose is controlled.
Croatian: U ispitivanjima se mjerila razina tvari HbA1c u krvi, koja pokazuje koliko se uspješno kontrolira glukoza u krvi.
English: What is Glubrava used for?
Croatian: Za što se Glubrava koristi?
English: Other information about Glubrava
Croatian: Ostale informacije o lijeku Glubrava:
English: It is possible to change to Glubrava directly from metformin if appropriate.
Croatian: Ako je potrebno, na lijek Glubrava može se izravno prijeći s metformina.
English: The Committee decided that Glubrava's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi lijeka Glubrava nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Glubrava must not be used in patients who have heart failure, or problems with their liver or their kidneys.
Croatian: Lijek Glubrava ne smije se primjenjivati u bolesnika sa srčanim zastojem ili u bolesnika koji imaju probleme s jetrom ili bubrezima.
English: What benefit has Glubrava shown during the studies?
Croatian: Koje su koristi lijeka Glubrava utvrđene u ispitivanjima?
English: How is Glubrava used?
Croatian: Kako se Glubrava koristi?
English: Three studies of Actos used with metformin as separate tablets were used to support the use of Glubrava in the same indication.
Croatian: Kako bi se dokazala korist od primjene lijeka Glubrava u istoj indikaciji, upotrijebljena su tri ispitivanja lijeka Actos u kombinaciji s metforminom kao zasebnim tabletama.
English: For the full list of all side effects reported with Glubrava, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Glubrava potražite u uputi o lijeku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Glubrava have also been included in the summary of product characteristics and the package leaflet.
Croatian: U sažetku opisa svojstava lijeka i uputi o lijeku također se nalaze preporuke i mjere opreza za sigurnu i učinkovitu primjenu lijeka Glubrava kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: How does Glubrava work?
Croatian: Kako djeluje Glubrava?
English: Glubrava is used in adults (particularly those who are overweight) who have type 2 diabetes.
Croatian: Lijek Glubrava primjenjuje se u odraslih osoba (osobito onih s prekomjernom tjelesnom težinom) koje imaju dijabetes tipa 2. Lijek Glubrava primjenjuje se u bolesnika koji ne mogu postići zadovoljavajuću kontrolu samo metforminom (lijekom za liječenje dijabetesa) u najvišim podnošljivim dozama.
English: The full EPAR for Kinzalkomb can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Kinzalkomb nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Kinzalkomb is taken by mouth once a day with liquid, with or without food.
Croatian: Kinzalkomb se uzima kroz usta jednom na dan s tekućinom, uz ili bez obroka.
English: Kinzalkomb must not be used in women who are more than three months pregnant.
Croatian: Kinzalkomb ne smiju uzimati žene koje su trudne dulje od tri mjeseca.
English: What measures are being taken to ensure the safe and effective use of Kinzalkomb?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kinzalkomb?
English: Kinzalkomb telmisartan / hydrochlorothiazide
Croatian: Kinzalkomb telmisartan/hidroklorotiazid
English: This is a summary of the European public assessment report (EPAR) for Kinzalkomb.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Kinzalkomb.
English: 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 Kinzalkomb.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Kinzalkomb.
English: Kinzalkomb has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Croatian: Kinzalkomb je ispitivan u pet glavnih ispitivanja kojima je obuhvaćeno ukupno 2985 bolesnika s umjerenom hipertenzijom.
English: It works by increasing urine output, reducing the amount of fluid in the blood and reducing blood pressure.
Croatian: Djeluje povećavajući količinu izbačenog urina, smanjujući količinu tekućine u krvi i snižavajući krvni tlak.
English: In four of these studies, Kinzalkomb was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
Croatian: U četiri od tih ispitivanja Kinzalkomb je uspoređen s placebom (prividnim liječenjem) i s telmisartanom koji je samostalno uzimalo ukupno 2272 bolesnika.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kinzalkomb on 19 April 2002.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Kinzalkomb na snazi u Europskoj uniji od 19. travnja 2002.
English: For more information about treatment with Kinzalkomb, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Kinzalkomb pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: The most common side effect with Kinzalkomb (seen in between 1 and 10 patients in 100) is dizziness.
Croatian: Najčešća nuspojava lijeka Kinzalkomb (uočena kod više od 10 na 100 bolesnika) je vrtoglavica.
English: Other information about Kinzalkomb
Croatian: Ostale informacije o lijeku Kinzalkomb
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kinzalkomb, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Kinzalkomb nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Kinzalkomb must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Croatian: U bolesnika s tipom 2 dijabetesa ili u bolesnika s umjerenim ili ozbiljnim oštećenjem funkcije bubrega, Kinzalkomb se ne smije koristiti u kombinaciji s lijekovima koji sadrže aliskiren (koji se također koristi za liječenje esencijalne hipertenzije).
English: A risk management plan has been developed to ensure that Kinzalkomb is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Kinzalkomb.
English: By lowering blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Croatian: Snižavanjem krvnog tlaka smanjuju se rizici povezani s visokim krvnim tlakom, kao što je mogućnost moždanog udara.
English: Telmisartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Kinzalkomb je „antagonist receptora angiotenzina II”, što znači da blokira rad hormona angiotenzina II u tijelu.
English: Care must be taken when using Kinzalkomb with other medicines that have an effect on blood potassium levels.
Croatian: Potreban je oprez prilikom uzimanja lijeka Kinzalkomb zajedno s drugim lijekovima koji utječu na razinu kalija u krvi.
English: What is the risk associated with Kinzalkomb?
Croatian: Koji su rizici povezani s lijekom Kinzalkomb?
English: The dose of Kinzalkomb to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Croatian: Doza lijeka Kinzalkomb koja će se primjenjivati ovisi o dozi telmisartana koju je bolesnik prethodno uzimao: bolesnici koji su primali 40 mg telmisartana trebaju uzimati tablete od 40/12,5 mg, a bolesnici koji su primali 80 mg telmisartana trebaju uzimati tablete od 80/12,5 mg.
English: Kinzalkomb was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
Croatian: Kinzalkomb je bio djelotvorniji u snižavanju dijastoličkog krvnog tlaka u odnosu na monoterapiju telmisartanom i placebo.
English: The Committee recommended that Kinzalkomb be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje lijeka Kinzalkomb u promet.
English: It is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Croatian: Dostupan je u obliku tableta (40 mg ili 80 mg irbesartana i 12,5 mg hidroklorotiazida; 80 mg irbesartana i 25 mg hidroklorotiazida).
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to Kinzalkomb.
Croatian: Tablete od 80/25 mg se koriste u bolesnika čiji se krvni tlak ne može kontrolirati primjenom tableta jačine 80/12,5 mg ili koji su stabilizirani primjenom dvije djelatne tvari koje se uzimaju zasebno prije prelaska na Kinzalkomb.
English: The CHMP decided that Kinzalkomb's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Croatian: CHMP je odlučio da koristi od lijeka Kinzalkomb nadmašuju s njim povezane rizike za liječenje esencijalne hipertenzije u bolesnika čiji se krvni tlak ne kontrolira primjereno monoterapijom telmisartana.
English: What is Kinzalkomb?
Croatian: Što je Kinzalkomb?
English: Kinzalkomb is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Croatian: Kinzalkomb je lijek koji sadrži dvije djelatne tvari, telmisartan i hidroklorotiazid.
English: Why has Kinzalkomb been approved?
Croatian: Zašto je Kinzalkomb odobren?
English: Kinzalkomb must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Croatian: Kinzalkomb se ne smije koristiti ni kod bolesnika s teškim jetrenim, bubrežnim ili žučnim problemima, s preniskom razinom kalija u krvi niti s previsokom razinom kalcija u krvi.
English: The full list of these medicines is given in the package leaflet.
Croatian: Potpuni popis tih lijekova potražite u uputi o lijeku.
English: Kinzalkomb contains two active substances, telmisartan and hydrochlorothiazide.
Croatian: Kinzalkomb sadrži dvije djelatne tvari, telmisartan i hidroklorotiazid.
English: Kinzalkomb is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
Croatian: Kinzalkomb se koristi kod odraslih bolesnika s esencijalnom hipertenzijom (visokim krvnim tlakom) koja se ne može na odgovarajući način kontrolirati samo telmisartanom. „Esencijalno” znači da ne postoji očiti uzrok hipertenzije.
English: What is Kinzalkomb used for?
Croatian: Za što se Kinzalkomb koristi?
English: How is Kinzalkomb used?
Croatian: Kako se Kinzalkomb koristi?
English: For the full list of all side effects reported with Kinzalkomb, see the Package Leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Kinzalkomb potražite u uputi o lijeku.
English: How does Kinzalkomb work?
Croatian: Kako djeluje Kinzalkomb?
English: How has Kinzalkomb been studied?
Croatian: Kako je Kinzalkomb ispitivan?
English: What benefit has Kinzalkomb shown during the studies?
Croatian: Koje su koristi lijeka Kinzalkomb utvrđene u ispitivanjima?
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, and marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene, i nositelja odobrenja za stavljanje lijeka u promet u državama članicama
English: Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul.
Croatian: Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul. J. Lea 208
English: 4822 NK BREDA The Netherlands
Croatian: 4822 NK BREDA
English: 1,6 mg/g Syrup
Croatian: 1,6 mg/g sirup
English: 180 00 Praha 8
Croatian: 180 00 Praha 8 Czech Republic
English: 28108 Alcobendas (Madrid) Spain
Croatian: 28108 Alcobendas (Madrid) Spain hidroksizindiklorid propifenazon kodeinfosfat
English: United Kingdom UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE
Croatian: UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE United Kingdom
English: 15 mg 100 mg 10 mg
Croatian: 15 mg 100 mg 10 mg tableta
English: Rua Victor Câmara, Edifício Q 60, D. Maria I, Piso 1 Fracção D, Quinta da Fonte 2770-229 Paço de Arcos Portugal
Croatian: Maria I, Piso 1 Fracção D, Quinta da Fonte 2770-229 Paço de Arcos Portugal
English: Luxembourg UCB Pharma S.A. Allée de la Recherche, 60 1070 Bruxelles
Croatian: Luksemburg UCB Pharma S.A. Allée de la Recherche, 60 1070 Bruxelles
English: Emilii Plater 53 00-113 Warszawa Poland
Croatian: Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53 00-113 Warszawa Poland
English: Nat. Road Athens-Lamia 14564, K. Kifisia Greece
Croatian: Road Athens-Lamia 14564, K.
English: ul.
Croatian: Nat.
English: Atarax Syrup
Croatian: oralna otopina
English: 100 mg/2 ml Solution for injection
Croatian: Atarax 100 mg/2 ml, solution injectable otopina za injekciju
English: Atarax 10mg film-coated tablets
Croatian: Atarax 10mg film-coated tablets tableta
English: Hydroxyzine-2 HCl 25
Croatian: The Netherlands hidroksizindiklorid Hydroxyzine-2 HCl 25
English: Hydroxyzine-2 HCl 10
Croatian: The Netherlands hidroksizindiklorid Hydroxyzine-2 HCl 10
English: Hydroxyzinum VP 10 mg
Croatian: Hydroxyzinum VP
English: ATARAX 2mg/ml JARABE
Croatian: Spain hidroksizindiklorid ATARAX 2mg/ml JARABE
English: UCB Pharma B.V. Lage Mosten 33
Croatian: Lage Mosten 33
English: HYDROXYZINE RENAUDIN 100 mg /2 ml, solution injectable
Croatian: RENAUDIN 100 mg /2 ml, solution injectable otopina za injekciju
English: 100 mg Coated tablet
Croatian: 100 mg obložena tableta Kroz usta
English: ATARAX 25 mg COMPRIMIDOS
Croatian: Spain hidroksizindiklorid ATARAX 25 mg COMPRIMIDOS
English: Hydroxyzine dihydrochloride
Croatian: Češka Republika hidroksizindiklorid Atarax
English: Hydroxyzinum Teva
Croatian: HYDROXYZINE
English: Ucerax 25 mg film-coated tablets
Croatian: Ucerax 25 mg film-coated tablets obložena tableta Kroz usta
English: 100 mg Film-coated tablet Oral Use
Croatian: 100 mg filmom obložena tableta
English: 84 (3 x 28 capsules) (multipack)
Croatian: 84 (3 x 28 kapsula) (višestruka pakovanja)
English: Immediate Packaging Pack size
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja EU/1/11/677/001
English: 1 month later
Croatian: 1 mjesec kasnije
English: Date of latest renewal: 28 August 2006
Croatian: Datum posljednje obnove: 28. kolovoza 2006
English: Most people recover completely but the illness is usually severe enough to keep people off work for about a month.
Croatian: Većina bolesnika se potpuno oporavi, no bolest je obično dosta teška da zadrži osobu bolesnu oko mjesec dana.
English: - This vaccine has been prescribed for you/ your child only.
Croatian: Ovo cjepivo je propisano samo Vama/Vašem djetetu.
English: • you have a severe infection with a high temperature (over 38°C).
Croatian: • imate tešku infekciju sa povišenom tjelesnom temperaturom (iznad 38°C).
English: Vaccination is the best way to protect against these diseases.
Croatian: Cijepljenje je najbolji način zaštite protiv ovih bolesti.
English: The safety profile presented below is based on data from approximately 800 subjects.
Croatian: Sigurnosni profil, koji je naveden u nastavku, temelji se na podacima dobivenim na oko 800
English: Read all of this leaflet carefully before you start/ your child starts receiving this vaccine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego Vi/ Vaše dijete počnete primati ovo cjepivo jer sadrži Vama važne podatke.
English: This leaflet has been written assuming the person receiving the vaccine is reading it, but it can be given to adolescents and children so you may be reading it for your child.
Croatian: Ova uputa je pisana s pretpostavkom da će ju čitati osoba koja prima cjepivo, no cjepivo može biti dano adolescentu ili djetetu tako da ga Vi možete čitati za svoje djete.
English: Such patients may require additional doses of vaccine; nevertheless immunocompromised patients may fail to demonstrate an adequate response.
Croatian: Takvim će bolesnicima možda biti potrebne dodatne doze cjepiva; unatoč tome u imunokompromitiranih bolesnika možda se neće postići adekvatan odgovor.
English: • you have a poor immune system due to illness or drug treatment.
Croatian: • imate oslabljen imunološki sustav zbog bolesti ili drugih terapija.
English: Pack sizes of 1, 10 and 50 with or without needles.
Croatian: Veličine pakiranja od 1,10 i 50 sa ili bez igli.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 February 1997
Croatian: Datum prvog odobrenja: 10. veljače 1997.
English: 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 50 PRE-FILLED SYRINGES WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
Croatian: 1 NAPUNJENA ŠTRCALJKA BEZ IGLE 10 NAPUNJENIH ŠTRCALJKI BEZ IGLE 50 NAPUNJENIH ŠTRCALJKI BEZ IGLE 1 NAPUNJENA ŠTRCALJKA S 1 IGLOM 10 NAPUNJENIH ŠTRCALJKI S 10 IGALA 1 NAPUNJENA ŠTRCALJKA S 2 IGLE 10 NAPUNJENIH ŠTRCALJKI S 20 IGALA
English: Your doctor will advise on the possible need for extra doses, and future booster dosing.
Croatian: Vaš liječnik će Vas savjetovati da li su potrebne dodatne doze ili buduće docjepljivanje.
English: • you have previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases.
Croatian: • ste prethodno imali alergijsku reakciju na bilo koje cjepivo protiv hepatitisa A i hepatitisa B.
English: However, this route of administration may result in suboptimal immune response to the vaccine (see section 4.4).
Croatian: Međutim, ovaj put primjene može rezultirati suboptimalnim imunološkim odgovorom na cjepivo (vidjeti dio 4.4.).
English: Twinrix Paediatric is available in packs of 1, 10 and 50 with or without needles.
Croatian: Twinrix Paediatric je dostupan u pakiranjima od 1, 10 i 50 s ili bez igli.
English: • Fever equal to or greater than 37.5°C
Croatian: • vrućica jednaka ili viša od 37,5°C • razdražljivost
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Croatian: Kao i kod svih cjepiva za injiciranje, uvijek mora biti odmah dostupno odgovarajuće medicinsko liječenje i liječnički nadzor, u slučaju rijetke anafilaktičke reakcije nakon primjene cjepiva.