natgillin/translations-raw huggingface dataset:
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.
U četiri od tih ispitivanja Kinzalkomb je uspoređen s placebom (prividnim liječenjem) i s telmisartanom koji je samostalno uzimalo ukupno 2272 bolesnika.
The European Commission granted a marketing authorisation valid throughout the European Union for Kinzalkomb on 19 April 2002.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Kinzalkomb na snazi u Europskoj uniji od 19. travnja 2002.
For more information about treatment with Kinzalkomb, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Kinzalkomb pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
The most common side effect with Kinzalkomb (seen in between 1 and 10 patients in 100) is dizziness.
Najčešća nuspojava lijeka Kinzalkomb (uočena kod više od 10 na 100 bolesnika) je vrtoglavica.
Other information about Kinzalkomb
Ostale informacije o lijeku Kinzalkomb
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.
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.
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).
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).
A risk management plan has been developed to ensure that Kinzalkomb is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Kinzalkomb.
By lowering blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Snižavanjem krvnog tlaka smanjuju se rizici povezani s visokim krvnim tlakom, kao što je mogućnost moždanog udara.
Telmisartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Kinzalkomb je „antagonist receptora angiotenzina II”, što znači da blokira rad hormona angiotenzina II u tijelu.
Care must be taken when using Kinzalkomb with other medicines that have an effect on blood potassium levels.
Potreban je oprez prilikom uzimanja lijeka Kinzalkomb zajedno s drugim lijekovima koji utječu na razinu kalija u krvi.
What is the risk associated with Kinzalkomb?
Koji su rizici povezani s lijekom Kinzalkomb?
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.
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.
Kinzalkomb was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
Kinzalkomb je bio djelotvorniji u snižavanju dijastoličkog krvnog tlaka u odnosu na monoterapiju telmisartanom i placebo.
The Committee recommended that Kinzalkomb be given marketing authorisation.
Odbor je preporučio izdavanje odobrenja za stavljanje lijeka Kinzalkomb u promet.
It is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Dostupan je u obliku tableta (40 mg ili 80 mg irbesartana i 12,5 mg hidroklorotiazida; 80 mg irbesartana i 25 mg hidroklorotiazida).
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.
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.
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.
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.
What is Kinzalkomb?
Što je Kinzalkomb?
Kinzalkomb is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Kinzalkomb je lijek koji sadrži dvije djelatne tvari, telmisartan i hidroklorotiazid.
Why has Kinzalkomb been approved?
Zašto je Kinzalkomb odobren?
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.
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.
The full list of these medicines is given in the package leaflet.
Potpuni popis tih lijekova potražite u uputi o lijeku.
Kinzalkomb contains two active substances, telmisartan and hydrochlorothiazide.
Kinzalkomb sadrži dvije djelatne tvari, telmisartan i hidroklorotiazid.
Kinzalkomb is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
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.
What is Kinzalkomb used for?
Za što se Kinzalkomb koristi?
How is Kinzalkomb used?
Kako se Kinzalkomb koristi?
For the full list of all side effects reported with Kinzalkomb, see the Package Leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Kinzalkomb potražite u uputi o lijeku.
How does Kinzalkomb work?
Kako djeluje Kinzalkomb?
How has Kinzalkomb been studied?
Kako je Kinzalkomb ispitivan?
What benefit has Kinzalkomb shown during the studies?
Koje su koristi lijeka Kinzalkomb utvrđene u ispitivanjima?
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, and marketing authorisation holders in the Member States
Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene, i nositelja odobrenja za stavljanje lijeka u promet u državama članicama
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul.
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul. J. Lea 208
4822 NK BREDA The Netherlands
4822 NK BREDA
1,6 mg/g Syrup
1,6 mg/g sirup
28108 Alcobendas (Madrid) Spain
28108 Alcobendas (Madrid) Spain hidroksizindiklorid propifenazon kodeinfosfat
United Kingdom UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE
UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE United Kingdom
15 mg 100 mg 10 mg
15 mg 100 mg 10 mg tableta
Rua Victor Câmara, Edifício Q 60, D. Maria I, Piso 1 Fracção D, Quinta da Fonte 2770-229 Paço de Arcos Portugal
Maria I, Piso 1 Fracção D, Quinta da Fonte 2770-229 Paço de Arcos Portugal
Emilii Plater 53 00-113 Warszawa Poland
Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53 00-113 Warszawa Poland
Nat. Road Athens-Lamia 14564, K. Kifisia Greece
Road Athens-Lamia 14564, K.
ul.
Nat.
Atarax Syrup
oralna otopina
100 mg/2 ml Solution for injection
Atarax 100 mg/2 ml, solution injectable otopina za injekciju
Atarax 10mg film-coated tablets
Atarax 10mg film-coated tablets tableta
Hydroxyzine-2 HCl 25
The Netherlands hidroksizindiklorid Hydroxyzine-2 HCl 25
Hydroxyzine-2 HCl 10
The Netherlands hidroksizindiklorid Hydroxyzine-2 HCl 10
ATARAX 2mg/ml JARABE
Spain hidroksizindiklorid ATARAX 2mg/ml JARABE
HYDROXYZINE RENAUDIN 100 mg /2 ml, solution injectable
RENAUDIN 100 mg /2 ml, solution injectable otopina za injekciju
100 mg Coated tablet
100 mg obložena tableta Kroz usta
ATARAX 25 mg COMPRIMIDOS
Spain hidroksizindiklorid ATARAX 25 mg COMPRIMIDOS
Hydroxyzine dihydrochloride
Češka Republika hidroksizindiklorid Atarax
Hydroxyzinum Teva
HYDROXYZINE
Ucerax 25 mg film-coated tablets
Ucerax 25 mg film-coated tablets obložena tableta Kroz usta
100 mg Film-coated tablet Oral Use
100 mg filmom obložena tableta
84 (3 x 28 capsules) (multipack)
84 (3 x 28 kapsula) (višestruka pakovanja)
Immediate Packaging Pack size
Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja EU/1/11/677/001
1 month later
1 mjesec kasnije
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 off work for about a month.
Većina bolesnika se potpuno oporavi, no bolest je obično dosta teška da zadrži osobu bolesnu oko mjesec dana.
- This vaccine has been prescribed for you/ your child only.
Ovo cjepivo je propisano samo Vama/Vašem djetetu.
• 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 protiv ovih bolesti.
The safety profile presented below is based on data from approximately 800 subjects.
Sigurnosni profil, koji je naveden u nastavku, temelji se na podacima dobivenim na oko 800
Read all of this leaflet carefully before you start/ your child starts receiving this vaccine because it contains important information for you.
Pažljivo pročitajte cijelu uputu prije nego Vi/ Vaše dijete počnete primati ovo cjepivo jer sadrži Vama važne podatke.
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.
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.
Such patients may require additional doses of vaccine; nevertheless immunocompromised patients may fail to demonstrate an adequate response.
Takvim će bolesnicima možda biti potrebne dodatne doze cjepiva; unatoč tome u imunokompromitiranih bolesnika možda se neće postići adekvatan odgovor.
• you have a poor immune system due to illness or drug treatment.
• imate oslabljen imunološki sustav zbog bolesti ili drugih terapija.
Pack sizes of 1, 10 and 50 with or without needles.
Veličine pakiranja od 1,10 i 50 sa ili bez igli.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 February 1997
Datum prvog odobrenja: 10. veljače 1997.
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
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
Your doctor will advise on the possible need for extra doses, and future booster dosing.
Vaš liječnik će Vas savjetovati da li su potrebne dodatne doze ili buduće docjepljivanje.
• you have previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases.
• ste prethodno imali alergijsku reakciju na bilo koje cjepivo protiv hepatitisa A i hepatitisa B.
However, this route of administration may result in suboptimal immune response to the vaccine (see section 4.4).
Međutim, ovaj put primjene može rezultirati suboptimalnim imunološkim odgovorom na cjepivo (vidjeti dio 4.4.).
Twinrix Paediatric is available in packs of 1, 10 and 50 with or without needles.
Twinrix Paediatric je dostupan u pakiranjima od 1, 10 i 50 s ili bez igli.
• Fever equal to or greater than 37.5°C
• vrućica jednaka ili viša od 37,5°C • razdražljivost
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.
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.
AntiHBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected.
Geometrijske sredine koncentracije anti-HBs antitijela bile su niže kod istodobne primjene, ali nije poznata klinička važnost ovog opažanja s obzirom da su stope seroprotekcije ostale nepromijenjene.
The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh muscle of your child.
Liječnik će dati Twinrix Paediatric kao injekciju u mišić Vaše nadlaktice ili u bedreni mišić Vašeg djeteta.
0.2 milligrams Al3+
0,2 miligrama Al3+
0.025 milligrams Al3+
0,025 miligrama Al3+
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 kojeg uboda s iglom.
Specific humoral antibodies against hepatitis B were observed in approximately 67% of the subjects after the first dose and 100% after the third dose.
Specifična humoralna protutijela protiv hepatitisa B utvrđena su u oko 67% ispitanika nakon prve doze, te u 100% njih nakon treće doze.
The proportion of subjects reaching anti-HBs ≥ 10 mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone.
Udio ispitanika koji su postigli anti-HBs ≥10 mIU/ml bio je 98,3% kod istodobnog cijepljenja i 100% kod cijepljenja samo cjepivom Twinrix.
• you are allergic to: - the active substances, or any of the ingredients of this medicine (listed in section 6).
• ste alergični na: - djelatne tvari ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - neomicin
Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the adult formulation
Pretrage abnormalni nalazi jetrene funkcije *odnosi se na nuspojave zamijećene u kliničkim ispitivanjima provedenima s adultnim oblikom cjepiva
Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Paediatric on pregnancy or on the health of the fetus/newborn child.
Podaci o ishodu ograničenog broja trudnoća u cijepljenih žena ne ukazuju na bilo kakve neželjene učinke cjepiva Twinrix Paediatric na tijek trudnoće ili zdravlje fetusa/novorođenčeta.
The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age.
Doza od 0,5 ml (360 ELISA jedinica HA/10 µg HbsAg) preporučuje se za djecu i adolescente od 1.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Twinrix Paediatric should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Paediatric therapy to the woman.
Kod odluke da li nastaviti/prestati dojiti ili nastaviti/prestati s terapijom cjepivom Twinrix Paediatric treba uzeti u obzir dobrobit dojenja za dijete i dobrobit cijepljenja cjepivom Twinrix Paediatric za majku.
0.2 milligrams Al3+ - The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.
0,2 miligrama Al3+ - Drugi sastojci u cjepivu Twinrix Paediatric su: natrijev klorid, voda za injekcije.
• you have a bleeding problem or bruise/ bruises easily.
• imate problema s krvarenjem ili lako dobivate modrice.
Talk to you doctor or pharmacist before you receive Twinrix Paediatric if:
Obratite se svom liječniku ili ljekarniku prije nego primite Twinrix Paediatric ako
General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines, as follows.
Stoga se opće smjernice za docjepljivanje mogu izvesti iz iskustva s monovalentnim cjepivima kako slijedi.
The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established; however some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.
Nije ustanovljeno treba li docjepljivanje za cjepivo protiv hepatitisa B zdravim osobama koje su završile primarni ciklus cijepljenja; međutim, neki službeni programi cijepljenja trenutno uključuju preporuke za docjepljivanje cjepivom protiv hepatitisa B, te ih treba poštovati.
Twinrix Paediatric has no or negligible influence on the ability to drive and use machines.
Twinrix Paediatric ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
0,5 ml suspenzije u napunjenoj štrcaljki (staklo tip I) sa čepom klipa (butil guma).
For some categories of subjects or patients exposed to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level ≥ 10IU/l.
Za neke kategorije osoba ili bolesnika izloženih virusu HBV (npr. bolesnici na hemodijalizi ili imunokompromitirani), treba osigurati da im razina protutijela bude jednaka ili iznad zaštitne razine od 10 IU/l.
• Swelling of the face, mouth or throat (angioneurotic oedema)
• oticanje lica, usana, ždrijela (angioneurotski edem)
The standard primary course of vaccination with Twinrix Paediatric consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose.
- Shema primarnog cijepljenja Standardno primarno cijepljenje cjepivom Twinrix Paediatric sastoji se od tri doze, od kojih se prva primjenjuje odabranog datuma, druga mjesec dana kasnije, a treća šest mjeseci nakon prve doze.
Twinrix Paediatric is a white, slightly milky liquid presented in a glass pre-filled syringe (0.5 ml).
Twinrix Paediatric je bijela, lagano mliječna tekućina u napunjenoj staklenoj štrcaljki (0,5 ml).
However, exceptionally Twinrix Paediatric can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects (see section 4.2).
Ipak, iznimno se Twinrix Paediatric može primijeniti supkutano u osoba s trombocitopenijom ili poremećajima hemostaze jer nakon intramuskularne primjene u tih osoba može doći do krvarenja (vidjeti dio 4.2).
Twinrix Paediatric is not recommended for postexposure prophylaxis (e.g. needle stick injury).
Twinrix Paediatric se ne preporučuje za postekspozicijsku profilaksu (npr. nakon uboda iglom).
In haemodialysis patients, patients receiving immunosuppressive treatment or patients with an impaired immune system, the anticipated immune response may not be achieved after the primary immunisation course.
Može se dogoditi da se u bolesnika na hemodijalizi, kod bolesnika na imunosupresivnoj terapiji te bolesnika s oslabljenim imunološkim sustavom ne postigne predviđeni imunološki odgovor nakon primarne imunizacije.
• Diarrhoea, vomiting, stomach pain
• proljev, mučnina, bolovi u trbuhu
What Twinrix Paediatric is and what it is used for What you need to know before you receive Twinrix Paediatric How Twinrix Paediatric is given Possible side effects
Što je Twinrix Paediatric i za što se koristi Što morate znati prije nego primite cjepivo Twinrix Paediatric Kako se primjenjuje Twinrix Paediatric
EU/1/97/029/001 - pack of 1 without needle EU/1/97/029/002 - pack of 10 without needle EU/1/97/029/008 - pack of 50 without needle EU/1/97/029/006 - pack of 1 with 1 needle EU/1/97/029/007 - pack of 10 with 10 needles
EU/1/97/029/001 - pakiranje s 1 štrcaljkom bez igle EU/1/97/029/002 - pakiranje s 10 štrcaljki bez igle EU/1/97/029/008 - pakiranje s 50 štrcaljki bez igle EU/1/97/029/006 - pakiranje s 1 štrcaljkom s 1 iglom EU/1/97/029/007 - pakiranje s 10 štrcaljki s 10 igala EU/1/97/029/009 - pakiranje s 1 štrcaljkom s 2 igle EU/1/97/029/010 - pakiranje s 10 štrcaljki s 20 igala
• Second dose:
• Druga doza:
Twinrix Paediatric can be given concomitantly with Human Papillomavirus (HPV) vaccine.
Twinrix Paediatric može se istodobno dati s cjepivom protiv humanog papilomavirusa (HPV).
• Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness).
• teške alergijske reakcije (anafilaksija, anafilaktoidne reakcije i one koje oponašaju serumsku bolest).
What Twinrix Paediatric looks like and contents of the pack Suspension for injection in pre-filled syringe.
Kako Twinrix Paediatric izgleda i sadržaj pakiranja Suspenzija za injekciju u napunjenoj štrcaljki.
Twinrix Paediatric confers immunity against HAV and HBV infection by inducing specific anti-HA and anti-HBs antibodies.
Twinrix Paediatric pruža imunitet protiv zaraze HAV i HBV potičući stvaranje specifičnih anti-HA i anti-HBs protutijela.
The vaccine should be re-suspended following the steps below.
Cjepivo se treba resuspendirati slijedeći korake opisane ispod: 1.
Very common (these may occur with more than 1 in 10 doses of the vaccine) • Pain and redness at the injection site
Vrlo česte (mogu se javiti kod više od 1 na 10 doza cjepiva): • bol i crvenilo na mjestu uboda
It is possible that subjects may be in the incubation period of a HA or HB infection at the time of vaccination.
Moguće je da osobe u vrijeme cijepljenja budu u periodu inkubacije infekcije hepatitisa
• Hepatitis B: Hepatitis B is caused by the hepatitis B virus.
• Hepatitis B: Hepatitis B je bolest uzrokovana virusom hepatitisa B, koji uzrokuje oteknuće jetre (upalu).
Contents of the pack and other information What Twinrix Paediatric contains - The active substances are: Hepatitis A virus (inactivated)1,2
Sadržaj pakiranja i druge informacije Što Twinrix Paediatric sadrži: - Djelatne tvari su: inaktivirani virus hepatitisa A 1,2
Hepatitis B surface antigen3,4
360 ELISA jedinica površinski antigen virusa hepatitisa B 3,4
This disease is caused by the hepatitis A virus.
Ova je bolest izazvana virusom hepatitisa A. Virus Hepatitisa
• Upper respiratory tract infection
• infekcije gornjih dišnih puteva
Twinrix Paediatric should under no circumstances be administered intravascularly.
Twinrix Paediatric se ni u kom slučaju ne smije primijeniti intravaskularno.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Twinrix Paediatric, suspension for injection
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Twinrix Paediatric, suspenzija za injekciju
(meningitis)
(trombocitopenija)
The safety and immunogenicity of Twinrix Paediatric administered as a booster dose following a three dose primary course have not been evaluated.
Nije procijenjena sigurnost i imunogenost cjepiva Twinrix Paediatric primijenjenog docjepljivanjem nakon primarnog ciklusa cijepljenja trima dozama.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Iznimno se cjepivo može primijeniti supkutano u bolesnika s trombocitopenijom ili poremećajima hemostaze.
Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus.
tjedana nakon dolaska u kontakt s virusom.
Urticaria, pruritus*
• koprivnjača, svrbež