natgillin/translations-raw huggingface dataset:
Hepatobiliary disorders hepatic dysfunction including hepatic failure not known 
Poremećaji jetre i žuči disfunkcija jetre uključujući zatajenje jetre nepoznato
Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9) and is, therefore, not recommended for use in such patients (see sections 4.4 and 5.2). 
Alogliptin nije ispitan u bolesnika s teškim oštećenjem jetre (Child-Pugh indeks >9) te se stoga u takvih bolesnika njegova primjena ne preporučuje (vidjeti dijelove 4.4 i 5.2).
Table 4. 
PRILOG III.
Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9) and is, therefore, not recommended for use in such patients (see sections 4.2 and 5.2). 
Alogliptin nije ispitan u bolesnika s teškim oštećenjem jetre (Child-Pugh indeks >9) te se stoga u takvih bolesnika njegova primjena ne preporučuje (vidjeti dijelove 4.2 i 5.2).
Alogliptin 25 mg once daily with a thiazolidinedione ± metformin or a sulphonylurea (n=195) 
Alogliptin 25 mg jedanput na dan s tiazolidindionom + metformin ili sulfonilureja (n=195)
In patients with moderate or severe renal impairment, or end-stage renal disease on haemodialysis, an increase in systemic exposure to alogliptin of approximately 2- and 4-fold was observed, respectively. 
U bolesnika s umjerenim ili teškim oštećenjem bubrega, ili završnim stadijem bolesti bubrega na hemodijalizi, opaženo je povećanje sistemske izloženosti alogliptinu od približno 2 i 4 puta. (Bolesnici sa završnim stadijem bolesti bubrega su podvrgnuti hemodijalizi odmah nakon doziranja alogliptina.
Not known: - Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness, 
• problemi s jetrom poput mučnine ili povraćanja, boli u trbuhu, neobičnog ili neobjašnjivog umora, gubitka teka, tamne mokraće ili žutila kože ili bjeloočnica.
In these studies, 2,257 alogliptin-treated patients were ≥ 65 years old and 386 alogliptin-treated patients were ≥ 75 years old. 
≥ 65 godina starosti, a 386 bolesnika liječenih alogliptinom imalo je ≥ 75 godina starosti.
In addition, mean change from baseline in fasting plasma glucose at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001). 
Dodatno, srednja vrijednost promjene od početne vrijednosti glukoze u plazmi natašte bila je u 52. tjednu značajno veća za 25 mg alogliptina s 30 mg pioglitazona i metforminom nego za 45 mg pioglitazona s metforminom (p<0,001).
Vipidia 12.5 mg film-coated tablets 
Vipidia 12,5 mg filmom obložene tablete
Do not take Vipidia: - if you are allergic to alogliptin or any of the other ingredients of this medicine (listed in section 6) - if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar. 
• ako ste imali ozbiljnu alergijsku reakciju na neki drugi slični lijek koji uzimate radi kontrole šećera u krvi.
What Vipidia looks like and contents of the pack - Vipidia 25 mg film-coated tablets (tablets) are light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-25” printed in grey ink on one side. 
Kako Vipidia izgleda i sadržaj pakiranja - Vipidia 25 mg filmom obložene tablete (tablete) su svijetlocrvene, ovalne (otprilike 9,1 mm duge i 5,1 mm široke), bikonveksne filmom obložene tablete s oznakom „TAK“ i „ALG-25“ otisnutom sivom tintom na jednoj strani.
It is used to lower blood sugar levels in adults with type 2 diabetes. 
Koriste se za snižavanje razina šećera u krvi u odraslih sa šećernom bolešću tipa 2. Šećerna bolest tipa 2 također se zove i dijabetes melitus neovisan o inzulinu.
Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10 
Nositelj odobrenja Takeda Pharma A/S Dybendal Alle 10 2630 Taastrup Danska
Vipidia 12.5 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin. 
Vipidia 12,5 mg filmom obložene tablete Jedna tableta sadrži 12,5 mg alogliptina u obliku alogliptinbenzoata.
Alogliptin 25 mg once daily with a sulphonylurea (n=197) 
Alogliptin 25 mg jedanput na dan sa sulfonilurejom (n=197)
Mean change from baseline in HbA1c (%)† (SE) 
Srednja promjena od početne vrijednosti HbA1c (%)† (SE)
Vipidia 25 mg film-coated tablets 
Vipidia 25 mg filmom obložene tablete
MACE Reported in cardiovascular outcomes study Number of Patients (%) 
Tablica 4. MACE prijavljeni u ispitivanju kardiovaskularnih ishoda
Alogliptin as add-on therapy to insulin (with or without metformin) The addition of 25 mg alogliptin once daily to insulin therapy (mean dose = 56.5 IU, with or without metformin) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2). 
Alogliptin kao dodatna terapija inzulinu (s ili bez metformina) Dodavanje 25 mg alogliptina jedanput na dan liječenju inzulinom (srednja vrijednost doze = 56,5 i.j., s ili bez metformina) dovelo je u usporedbi s placebom do statistički značajnog poboljšanja vrijednosti HbA1c i glukoze i plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
Vipidia 6.25 mg film-coated tablets 
Vipidia 6,25 mg filmom obložene tablete
Vipidia 25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 25 mg alogliptin. 
Vipidia 25 mg filmom obložene tablete Jedna tableta sadrži 25 mg alogliptina u obliku alogliptinbenzoata.
More patients receiving 25 mg alogliptin and metformin (48.5%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving glipizide and metformin (42.8%) (p=0.004). 
Ciljne razine HbA1c od ≤ 7,0% postiglo je više bolesnika koji su primali 25 mg alogliptina s metforminom (48,5%) nego onih koji su primali glipizid s metforminom (42,8%) (p=0,004).
NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg film-coated tablets Vipidia 12.5 mg film-coated tablets Vipidia 25 mg film-coated tablets 
Vipidia 6,25 mg filmom obložene tablete Vipidia 12,5 mg filmom obložene tablete Vipidia 25 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Vipidia 12.5 mg tablets alogliptin 
NAZIV LIJEKA Vipidia 12,5 mg tablete alogliptin
Alogliptin 25 mg once daily with a thiazolidinedione + metformin vs a titrating thiazolidinedione + metformin 
Alogliptin 25 mg jedanput na dan s tiazolidindionom±metformin naspram titrirani tiazolidindion±metformin
NAME OF THE MEDICINAL PRODUCT Vipidia 25 mg tablets alogliptin 
NAZIV LIJEKA Vipidia 25 mg tablete alogliptin
- Vipidia 12.5 mg film-coated tablets (tablets) are yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-12.5” printed in grey ink on one side. 
- Vipidia 12,5 mg filmom obložene tablete (tablete) su žute, ovalne (otprilike 9,1 mm duge i 5,1 mm široke), bikonveksne filmom obložene tablete s oznakom „TAK“ i „ALG-12.5“ otisnutom sivom tintom na jednoj strani.
30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001). 
U 52. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su primali 25 mg alogliptina s 30 mg pioglitazona i metforminom (33,2%) nego oni koji su primali 45 mg pioglitazona s metforminom (21,3%) (p<0,001).
In a pooled analysis of the data from 13 studies, the overall rates of pancreatitis reports in patients treated with 25 mg alogliptin, 12.5 mg alogliptin, active control or placebo were 2, 1, 1 or 0 events per 1,000 patient years, respectively. 
25 mg alogliptina, 12,5 mg alogliptina, aktivnom kontrolom ili placebom bile su 2, 1, 1 odnosno 0 događaja na 1000 bolesnik godina.
NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg tablets alogliptin 
NAZIV LIJEKA Vipidia 6,25 mg tablete alogliptin
Your doctor may want to reduce your dose of sulphonylurea or insulin when you take any of them together with Vipidia in order to avoid too low blood sugar (hypoglycaemia) - if you have kidney disease, you can still take this medicine but your doctor may reduce the dose - if you have liver disease - if you suffer from heart failure - if you are taking insulin or an anti-diabetic medicine, your doctor may want to reduce your dose of the other anti-diabetic medicine or insulin when you take either of them together with Vipidia in order to avoid low blood sugar - if you have or have had a disease of the pancreas 
Liječnik će možda htjeti sniziti dozu sulfonilureje ili inzulina ako uz bilo koji od njih uzimate lijek Vipidia kako bi se izbjeglo pretjerano sniženje šećera u krvi (hipoglikemija)
- Vipidia 6.25 mg film-coated tablets (tablets) are light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-6.25” on printed in grey ink on one side. 
- Vipidia 6,25 mg filmom obložene tablete (tablete) su svijetloružičaste, ovalne (otprilike 9,1 mm duge i 5,1 mm široke), bikonveksne filmom obložene tablete s oznakom „TAK“ i „ALG-6.25“ otisnutom sivom tintom na jednoj strani.
Treatment with 25 mg alogliptin once daily resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose compared to placebo-control at Week 26 (Table 2). 
Liječenje s 25 mg alogliptina jedanput na dan dovelo je u usporedbi s kontrolnom skupinom do statistički značajnih poboljšanja vrijednosti HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
Patients with kidney disease 
Osobe s bolešću bubrega
Therefore, no dose adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9). 
Stoga u bolesnika s blagim do umjerenim oštećenjem jetre (Child-Pugh indeks 5 do 9) nije potrebna prilagodba doze.
The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,847 mg) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2). 
Dodavanje 25 mg alogliptina jedanput na dan terapiji metforminkloridom (srednja vrijednost doze = 1847 mg) dovelo je u usporedbi s placebom do statistički značajnih poboljšanja vrijednosti HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
The addition of 25 mg alogliptin once daily to glyburide therapy (mean dose = 12.2 mg) resulted in statistically significant improvements from baseline in HbA1c at Week 26 when compared to the addition of placebo (Table 2). 
Dodavanje 25 mg alogliptina jedanput na dan terapiji gliburidom (srednja vrijednost doze = 12,2 mg) dovelo je u usporedbi s placebom do statistički značajnog poboljšanja vrijednosti HbA1c u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate). 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 12,5 mg alogliptina (u obliku alogliptinbenzoata).
Warnings and precautions Talk to your doctor or pharmacist before taking Vipidia: - if you have type 1 diabetes (your body does not produce insulin) - if you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to breakdown glucose because there is not enough insulin). 
• ako imate dijabetičku ketoacidozu (komplikaciju šećerne bolesti koja se javlja kad se zbog nedostatka inzulina glukoza u tijelu ne može razgraditi).
Alogliptin as add-on therapy to a thiazolidinedione The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2). 
Dodavanje 25 mg alogliptina jedanput na dan terapiji pioglitazonom (srednja vrijednost doze = 35,0 mg, s ili bez metformina ili sulfonilureje) dovelo je u usporedbi s placebom do statistički značajnog poboljšanja vrijednosti HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
Yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-12.5” printed in grey ink on one side. 
Žute, ovalne (približno 9,1 mm duge i 5,1 mm široke), bikonveksne filmom obložene tablete s oznakom „TAK“ i „ALG-12.5“ otisnutom sivom tintom na jednoj strani.
Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg alogliptin, - The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172). 
- Drugi sastojci su: manitol, mikrokristalična celuloza, hidroksipropilceluloza, umrežena karmelozanatrij, magnezijev stearat, hipromeloza, titanijev dioksid (E171), crveni željezov oksid (E172), makrogol 8000, šelak i crni željezov oksid (E172).
More patients receiving 25 mg alogliptin (7.8%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (0.8%) at Week 26. 
U 26. tjednu je ciljne razine HbA1c od ≤7,0% postiglo više bolesnika koji su primali 25 mg alogliptina (7,8%) nego oni koji su primali placebo (0,8%) (p<0,001).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 6.25 mg alogliptin (as benzoate). 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 6,25 mg alogliptina (u obliku alogliptinbenzoata).
Treatment-corrected change from baseline in HbA1c (%)† 
Promjena od početne vrijednosti HbA1c korigirana za liječenje (%)† (1-strani CI)
Each 12.5 mg tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin - The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172). 
- Drugi sastojci su: manitol, mikrokristalična celuloza, hidroksipropilceluloza, umrežena karmelozanatrij, magnezijev stearat, hipromeloza, titanijev dioksid (E171), žuti željezov oksid (E172), makrogol 8000, šelak i crni željezov oksid (E172).
Vipidia 6.25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin. 
KVALITATIVNI I KVANTITATIVNI SASTAV Vipidia 6,25 mg filmom obložene tablete Jedna tableta sadrži 6,25 mg alogliptina u obliku alogliptinbenzoata.
Significantly more patients receiving 25 mg alogliptin (44.4%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (18.3%) at Week 26 (p<0.001). 
U 26. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su primali alogliptin (44,4%) nego oni koji su primali placebo (18,3%) (p<0,001).
Placebo-corrected change from baseline in HbA1c (%)† 
Promjena od početne vrijednosti korigirana za placebo HbA1c (%)† (2-strani 95% CI)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate). 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 25 mg alogliptina (u obliku alogliptinbenzoata)
Light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-25” printed in grey ink on one side. 
Svijetlocrvene, ovalne (približno 9,1 mm duge i 5,1 mm široke), bikonveksne filmom obložene tablete s oznakom „TAK“ i „ALG-25“ otisnutom sivom tintom na jednoj strani.
Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-6.25” printed in grey ink on one side. 
Svijetloružičaste, ovalne (približno 9,1 mm duge i 5,1 mm široke), bikonveksne filmom obložene tablete s oznakom „TAK“ i „ALG-6.25“ otisnutom sivom tintom na jednoj strani.
Significantly more patients receiving 25 mg alogliptin (34.8%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (18.2%) at Week 26 (p=0.002). 
U 26. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su primali alogliptin (34,8%) nego oni koji su primali placebo (18,2%) (p<0,002).
Takeda Pharma AS Tel: +372 617 7669 
Takeda Pharma AS Tel: +372 617 7669 info@nycomed.ee
Your blood sugar levels may increase when you stop taking Vipidia. 
Nakon prekida uzimanja lijeka Vipidia mogu porasti razine šećera u krvi.
Tel: +420 234 722 722 
Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 722
Clinically meaningful reductions in HbA1c compared to control were also observed with 25 mg alogliptin regardless of baseline background treatment. 
U skupini liječenoj s 25 mg alogliptina klinički značajna smanjenja HbA1c opažena su bez obzira na osnovno liječenje.
Alogliptin has not been studied in combination with sodium glucose co-transporter 2 (SGLT-2) inhibitors or glucagon like peptide 1 (GLP-1) analogues nor formally as triple therapy with metformin and a sulphonylurea. 
SGLT-2) ili analozima glukagonu sličnog peptida 1 (engl.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription. 
PRILOG II. A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D.
Magyarország Takeda Pharma Kft. Tel: +361 2707030 
Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 600
An approximate 1.7-fold increase in AUC for alogliptin was observed in patients with mild renal impairment. 
U bolesnika s blagim oštećenjem bubrega opaženo je povećanje AUC od približno 1,7 puta.
at an elected date 
na odabrani datum
- This vaccine has been prescribed for you only. 
Ovo cjepivo je propisano samo Vama.
Date of latest renewal: 28 August 2006 
Datum posljednje obnove: 28. kolovoza 2006.
Most people recover completely but the illness is usually severe enough to keep people ill for about a month. 
Većina bolesnika se potpuno oporavi, no bolest je obično dosta teška da zadrži osobu bolesnu oko mjesec dana.
A minor infection such as a cold should not be a problem, but talk to your doctor first. 
Manje infekcije kao što je prehlada ne bi trebale biti problem, ali savjetujte se najprije sa svojim liječnikom.
The severity and type of symptoms can vary. 
Težina i tip simptoma mogu varirati.
Such reactions may occur before leaving the doctor's surgery. 
Ovakve reakcije mogu nastupiti prije napuštanja liječničke ordinacije.
Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you. 
Pažljivo pročitajte cijelu uputu prije nego počnete primati ovo cjepivo jer sadrži Vama važne podatke.
You will receive a total of three injections over 6 months. 
Dobiti ćete ukupno tri injekcije unutar 6 mjeseci.
None of the components in the vaccine are infectious. 
Niti jedna komponenta u cjepivu nije infektivna.
Freezing destroys the vaccine. 
Zamrzavanje uništava cjepivo.
• you have a severe infection with a high temperature (over 38°C). 
• Imate tešku infekciju sa povišenom tjelesnom temperaturom (iznad 38°C).
Vaccination is the best way to protect against these diseases. 
Cijepljenje je najbolji način zaštite od ovih bolesti.
Each injection is given on a separate visit. 
Svaka injekcija će biti dana tijekom odvojene posjete.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. 
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
Therefore tell the doctor or nurse if you fainted with a previous injection. 
Zbog toga recite liječniku ili medicinskoj sestri ako ste se onesvijestili kod prijašnje injekcije.
• you have a poor immune system due to illness or drug treatment. 
• imate oslabljen imunološki sustav zbog bolesti ili zbog liječenja.
Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. 
A počinju 3 do 6 tjedana nakon dolaska u kontakt s virusom.
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primite ovo cjepivo.
After a few days the whites of eyes and skin may become yellowish (jaundice). 
Nakon par dana, bjeloočnice i koža mogu požutjeti (žutica).
Guidelines for boosting are based on the assumption that antibodies are required for protection; anti-HAV antibodies have been predicted to persist for at least 10 years. 
Smjernice za docjepljivanje temelje se na pretpostavci da su za zaštitu potrebna protutijela; predviđeno trajanje anti-HAV protutijela je najmanje 10 godina.
This schedule may be given to adults only needing a rapid protection (e.g. overseas travellers). 
Ta shema se može dati u iznimnim okolnostima u odraslih, samo kada je potrebna brza zaštita (npr. prekomorsko putovanje).
If not, your doctor will advise you on the possible need to have extra doses. 
Ako niste, Vaš liječnik će Vas savjetovati o mogućoj potrebi primjene dodatnih doza.
Your doctor may advise you to have a blood test after you have completed the course of vaccinations to check if you have made a satisfactory response. 
Možda će Vaš liječnik zatražiti pretrage krvi nakon završenog ciklusa cijepljenja kako bi provjerio jeste li razvili zadovoljavajući odgovor.
A dose of 1.0 ml is recommended for adults and adolescents 16 years of age and above. 
Doza od 1,0 ml preporučuje se za odrasle i adolescente od navršene 16. godine života.
Hold the syringe upright in a closed hand. 
Držite štrcaljku u uspravnom položaju u zatvorenoj šaci.
The vaccine may contain traces of neomycin which is used during the manufacturing process (see section 4.3). 
Cjepivo može sadržavati tragove neomicina, koji se koristi tijekom proizvodnog postupka (vidjeti dio 4.3).
• you have experienced any health problems after previous administration of a vaccine. 
• ste imali bilo kakve zdravstvene probleme nakon prethodne primjene cjepiva.
This study did not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/fetal development, parturition or post-natal development. 
To ispitivanje nije pokazalo direktan ili indirektan štetni utjecaj na plodnost, trudnoću, embrionalni/fetalni razvoj, porod ili postnatalni razvoj.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or neomycin. 
Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na neomicin.
6 months after the first dose 
6 mjeseci nakon prve doze
While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection. 
Iako se ne očekuje da bi rekombinantni površinski antigen virusa hepatitisa B imao negativnog utjecaja na trudnoću ili fetus, preporučuje se odgoditi cijepljenje do nakon poroda, osim ako ne postoji hitna potreba za zaštitom majke od hepatitis B infekcije.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. 
Nesvjestica se može pojaviti (većinom u adolescenata) nakon ili čak prije bilo koje injekcije s iglom.
Pharmaco-therapeutic group: Hepatitis vaccines, ATC code: J07BC20. 
Farmakoterapijska skupina: Cjepiva protiv hepatitisa, ATK oznaka: J07BC20.
The vaccine has not been tested in patients with impaired immunity. 
Cjepivo nije ispitivano u bolesnika s oslabljenim imunitetom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 1996 
Datum prvog odobrenja: 20. rujna 1996.
Talk to your doctor or pharmacist before receiving Twinrix Adult if 
Obratite se svom liječniku ili ljekarniku prije nego primite Twinrix Adult ako:
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people. 
Virus je nađen u tjelesnim tekućinama kao što su krv, sjemena tekućina, vaginalni sekret ili slina (ispljuvak) zaraženih osoba.
Turbid white suspension. 
Mutno bijela suspenzija.