natgillin/translations-raw huggingface dataset:
Try standing in front of a mirror to locate the site or you may want to ask your caregiver to give you the injection. 
Postavite se pred ogledalo in poiščite predel, kamor si želite zdravilo injicirati, ali pa prosite osebo, ki vas neguje.
In HBV-DNA negative adults at least one week after liver transplantation subcutaneous injections of Zutectra per week or fortnightly according to serum anti-HBs trough levels. 
HBV-DNK-negativni odrasli morajo vsaj en teden po presaditvi jeter dobivati subkutane injekcije zdravila Zutectra na teden ali vsaka dva tedna, glede na najnižje serumske ravni protiteles anti-HBs.
Talk to your doctor about managing the dose. 
Vprašajte svojega zdravnika, kaj narediti z odmerkom.
Once the injection has been completed, dispose of all needles, syringes and empty glass containers without delay in a container intended for sharp objects you were provided with. 
Po končanem injiciranju takoj odvrzite vse igle, injekcijske brizge in prazne steklene vsebnike v zabojček, namenjen ostrim predmetom, ki ste ga prejeli.
Zutectra is for subcutaneous (under the skin) injection only. 
Zdravilo Zutectra je namenjeno samo za subkutano injiciranje (pod kožo).
You will be carefully observed during and shortly after the 1st injection with Zutectra to make sure that you do not suffer from a reaction. 
Med prvim injiciranjem zdravila Zutectra in takoj po njem vas bodo skrbno opazovali, da bi se prepričali, da pri vas ni prišlo do reakcije.
The objective of the open, prospective, single-arm clinical trial was the investigation of efficacy and safety of Zutectra for prevention of hepatitis B virus (HBV) re-infection ≥ one week after orthotopic liver transplantation in HBsAg and HBV-DNA negative patients. 
Cilj odprtega, prospektivnega kliničnega preskušanja z enim krakom je bil raziskati učinkovitost in varnost zdravila Zutectra pri preprečevanju ponovne okužbe z virusom hepatitisa B (HBV) en teden ali dlje po ortotopni presaditvi jeter pri HBsAg- in HBV-DNK-negativnih bolnikih.
NAME OF THE MARKETING AUTHORISATION HOLDER Biotest Pharma GmbH 
Imetnik dovoljenja za promet z zdravilom in izdelovalec Biotest Pharma GmbH
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus. 
Ukrepi, ki se izvajajo, se štejejo za učinkovite proti virusom z ovojnico, kot so humani virus imunske pomanjkljivosti (HIV), virus hepatitisa B in virus hepatitisa C ter proti virusu hepatitisa A, ki je brez ovojnice.
Clean the injection site by wiping it in a circular motion with the alcohol swab. 
Očistite mesto injiciranja tako, da ga s krožnimi gibi obrišete z alkoholno krpico.
Zutectra is used to prevent re-infection of hepatitis B in adults who have had a liver transplant at least 1 week ago because they had liver failure caused by hepatitis B. 
Zdravilo Zutectra se uporablja za preprečevanje ponovne okužbe s hepatitisom tipa B pri odraslih, ki so jim pred najmanj 1 tednom presadili jetra zaradi odpovedi jeter, ki jo je povzročil hepatitis tipa B.
4.7 Effects on ability to drive and use machines Hepatitis B immunoglobulin has no or negligible influence on the ability to drive and use machines. 
Immunoglobulin proti hepatitisu tipa B nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
It may be helpful to keep a record of where you had the last injection to avoid problems. 
Da se izognete težavam, je lahko v pomoč, če si beležite, na katero mesto ste si nazadnje dali injekcijo.
- Take the needle out of its sterile pack and fit the needle onto the syringe. 
- Vzemite iglo iz sterilnega ovoja in jo pritrdite na injekcijsko brizgo.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. 
Kljub temu pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni možno popolnoma izključiti možnosti prenosa povzročiteljev nalezljivih bolezni.
No clinical signs of a hepatitis B re-infection were observed and no patient was tested HBsAg positive or HBV-DNA positive during the study which confirms that effective protection against Hepatitis B virus re-infection was provided by subcutaneous administration of Zutectra as part of the combination treatment with HBV virostatic therapy 8 - 18 days after orthotopic liver transplantation. 
Med študijo niso opazili nobenih kliničnih znakov ponovne okužbe z virusom hepatitisa B in noben bolnik ni bil pozitiven za HBsAg ali HBV-DNK, kar potrjuje, da je bilo subkutano dajanje zdravila Zutectra kot del kombiniranega zdravljenja s HBV-virostatičnim zdravljenjem 8-18 dni po ortotopni presaditvi jeter učinkovita zaščita pred ponovno okužbo z virusom hepatitisa B. O povezavi z zdravilom Zutectra so poročali pri enem neželenem učinku (hematom na mestu injiciranja), ki ni bil resen.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Using the Clopper Pearson method, the failure rate after 18 weeks was 0 % for patients of the ITT set (95 % CI: [0, 14.8 %]). 
Ob uporabi Clopper Pearsonove metode je bila stopnja osipa po 18 tednih 0 % pri začetni (ITT,
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A virus (HAV). 
Ukrepi, ki se izvajajo, štejejo za učinkovite proti virusom z ovojnico, kot so virus humane imunske pomanjkljivosti (HIV), virus hepatitisa B (HBV) in virus hepatitisa C (HCV), ter proti virusu hepatitisa A, ki je brez ovojnice (HAV).
How to use Zutectra 
Kako uporabljati zdravilo Zutectra
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
It is strongly recommended that every time Zutectra is used (both at hospital or in a home treatment), the name and batch number of the medicine are recorded in order to maintain a record of the batches used. 
Zaradi ohranjanja sledljivosti uporabljenih serij je zelo priporočljivo, da se vsakič, ko je zdravilo Zutectra uporabljeno (v bolnišnici ali ob zdravljenju na domu), zabeležita ime in serijska številka zdravila.
If some areas are too difficult for you to reach, you may need a caregiver to help you with these injections. 
Če vam je kakšen od možnih predelov za injiciranje težko dosegljiv, boste morda pri injiciranju potrebovali pomoč osebe, ki vas neguje.
61A Drumul Plaiul Sarului Street, Room 5 013982 Bucharest, District 1 - RO Tel: + 40 743 207 205 
61A Drumul Plaiul Sarului Street, Room 5 013982 Bucharest, District 1 - RO
After administration of this medicinal product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines. 
Po dajanju tega zdravila morajo pred cepljenjem z živimi atenuiranimi virusnimi cepivi preteči vsaj
In isolated cases human normal immunoglobulins may cause an anaphylactic shock. 
V posameznih primerih lahko normalni humani imunoglobulini povzročijo anafilaktični šok.
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2°C-8°C). 
POSEBNA NAVODILA ZA SHRANJEVANJE Zdravilo shranjujte in prevažajte na hladnem (2°C-8°C).
IgG subclass distribution: 
Porazdelitev podrazredov IgG:
Hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs). 
Oznaka ATC: J06BB04 Imunoglobulin proti hepatitisu tipa B vsebuje pretežno imunoglobulin G (IgG) s specifično visoko vsebnostjo protiteles proti površinskemu antigenu virusa hepatitisa tipa B (HBs).
Official batch release 
Uradna sprostitev serije:
Human hepatitis B immunoglobulin should be administrated three to four weeks after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three months after the administration of human hepatitis B immunoglobulin. 
Humani imunoglobulin proti hepatitisu tipa B je treba aplicirati od tri do štiri tedne po cepljenju s takšnim živim atenuiranim cepivom; če je dajanje humanega imunoglobulina proti hepatitisu tipa B
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA
The open, prospective, single-arm clinical trial enrolled 23 liver transplant recipients, who had been receiving intravenous hepatitis B immunoglobulin prophylaxis and subsequently switched to subcutaneous Zutectra. 
Klinična učinkovitost in varnost Odprto, prospektivno klinično preskušanje z eno skupino je vključevalo 23 prejemnikov presajenih jeter, ki so predhodno prejemali intravensko imunoglobulinsko profilakso proti hepatitisu tipa B in so naknadno prešli na subkutano zdravilo Zutectra.
The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) subcutaneous injections on a weekly or fortnightly basis, according to the serum antiHBs concentrations and at the discretion of the physician in charge. 
Odmerek se lahko določi za vsakega bolnika posebej in prilagodi s 500 i.e. na največ 1.000 i.e. (v izjemnih primerih do 1.500 i.e.) subkutanih injekcij na teden ali vsaka dva tedna, glede na serumske koncentracije protiteles anti-HBs in po presoji lečečega zdravnika.
Human protein 150 mg/ml of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml. 
Humani protein 150 mg/ml, od katerega je najmanj 96 % IgG, z vsebnostjo protiteles proti površinskemu antigenu virusa hepatitisa tipa B (HBs) 500 i.e./ml.
Wipe the intended area with an alcohol swab. 
Obrišite izbrano mesto injiciranja z alkoholno krpico.
The solution must be brought to room temperature before use. 
Zdravilo naj pred uporabo doseže sobno temperaturo (pribl.
The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) weekly or fortnightly. 
Odmerek se lahko določi za vsakega bolnika posebej in prilagodi s 500 i.e. na največ 1.000 i.e. (v izjemnih primerih do 1.500 i.e.) na teden ali vsaka dva tedna.
If you get any side effects, talk to your doctor, healthcare professional or pharmacist. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, strokovnim zdravstvenim delavcem ali farmacevtom.
Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. 
Pri osebah s primanjkljajem IgA po dajanju sestavin krvi, ki vsebujejo IgA, lahko pride do razvoja protiteles proti IgA in do anafilaktične reakcije.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
In case of any adverse event after the injection speak to your doctor immediately. 
V primeru katerega koli neželenega učinka se takoj posvetujte z zdravnikom.
The following side effects have been reported with Zutectra: 
Z zdravilom Zutectra so poročali o naslednjih neželenih učinkih:
Once the injection has been completed, dispose of all needles and empty glass containers without delay in a container intended for sharp objects. 
Po končanem injiciranju takoj odvrzite vse igle, injekcijske brizge in prazne steklene vsebnike v zabojček, namenjen ostrim predmetom.
Human protein 150 mg of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU. 
Humani protein 150 mg, od katerega je najmanj 96 % IgG, z vsebnostjo protiteles proti površinskemu antigenu virusa hepatitisa tipa B (HBs) 500 i.e..
You should administer the injection immediately after opening the syringe. 
Injekcijo si dajte takoj po odprtju injekcijske brizge.
METHOD OF ADMINISTRATION Subcutaneous use 
subkutana uporaba
C/Frederic Mompou, 5 - 6° 3a A 
C/Frederic Mompou, 5 - 6° 3a A ES-08960 Sant Just Desvern
Tel.: +49 6103 801-0 Fax: +49 6103 801-150 Email: mail@biotest.com 
Faks: + 49 6103 801-150 E-pošta: mail@biotest.com
Prior to the initiation of subcutaneous treatment with Zutectra adequate anti-HBs serum levels should be stabilised with an intravenous hepatitis B immunoglobulin to levels at or above 300-500 IU/l in order to ensure adequate anti-HBs coverage during the transition from intravenous to subcutaneous dosing. 
Za zagotavljanje ustrezne ravni protiteles anti-HBs v obdobju prehoda z intravenskega na subkutano odmerjanje je treba pred uvedbo subkutanega zdravljenja z zdravilom Zutectra stabilizirati ustrezno serumsko raven protiteles anti-HBs z intravenskim imunoglobulinom proti hepatitisu tipa B do ravni, ki je enaka ali večja od 300-500 i.e./l.
Do not take a double dose to make up for a forgotten injection. 
Če ste pozabili uporabiti zdravilo Zutectra Ne vzemite dvojnega odmerka, če ste pozabili na prejšnjo injekcijo.
Common (may affect up to 1 in 10 people): - injection site reactions: pain, hives (urticaria) at injection site, haematoma (a collection of blood in tissue under the skin), reddening of the skin (erythema). 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - reakcije na mestu injiciranja: bolečina, izpuščaj (koprivnica) na mestu injiciranja, hematom
Store and transport refrigerated (2°C-8°C). 
Zdravilo shranjujte in prevažajte na hladnem (2°C-8°C).
Contents of the pack and other information How to inject Zutectra by yourself or by caregiver 
Vsebina pakiranja in dodatne informacije Samoinjiciranje zdravila Zutectra ali injiciranje s strani negovalnega osebja
Buttocks: Use any area where you can pinch up tissue. 
Zadnjica: Izberite kateri koli predel, kjer tkivo lahko stisnete in dvignete.
- Remove the protective cap from the syringe. 
- Z injekcijske brizge odstranite zaščitno zaporko.
Glycine 
Clondalkin
Pack size of five syringes in a blistered pack. 
Velikost pakiranja je pet injekcijskih brizg v pretisnem omotu.
No patient experienced HBV re-infection. 
Noben bolnik se ni ponovno okužil s HBV. Samoinjiciranje je bilo izvedljivo pri večini bolnikov.
BATCH NUMBER 
Številka serije
The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B reinfection prophylaxis. 
Kot standard preprečevanja ponovne okužbe s hepatitisom tipa B pride v poštev sočasna uporaba ustreznih virostatikov.
Zutectra is supplied in a pack size containing 5 pre-filled syringes each in a blister pack. 
Zdravilo Zutectra je na voljo v pakiranjih po 5 napolnjenih injekcijskih brizg v pretisnem omotu.
Allow yourself enough time to inject the whole of the solution until the syringe is empty. 
Vzemite si dovolj časa za injiciranje vse tekočine,
PHARMACEUTICAL PARTICULARS 
FARMACEVTSKA OBLIKA
It is hard to pinch up the tissue and inject Zutectra yourself using this site. 
Na tem mestu boste sami težko stisnili tkivo, dvignili in injicirali zdravilo Zutectra.
One pre-filled syringe of 1 ml contains Human hepatitis B immunoglobulin 500 IU. 
Ena 1-mililitrska napolnjena injekcijska brizga vsebuje humani imunoglobulin proti hepatitisu tipa B 500 i.e.
What Zutectra is and what it is used for 
Kaj je zdravilo Zutectra in za kaj ga uporabljamo Kaj je zdravilo Zutectra
Biotest Hungaria Kft. Torbágy u. 15/A H-2045 Törökbálint Tel.: + 36 23 511 311 
Torbágy u. 15/A H-2045 Törökbálint
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19 virus (causative agent of Ringel rubella). 
Ukrepi, ki se izvajajo, so morda manj učinkoviti proti virusom brez ovojnice, kot je parvovirus B19 (povzročitelj infekcijskega eritema).
Musculosceletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični spazmi redki*
The active substance is human hepatitis B immunoglobulin 500 IU/ml. 
Zdravilna učinkovina je humani imunoglobulin proti hepatitisu tipa B 500 i.e./ml.
49 patients received subcutaneous injections of Zutectra of 500 IU (1 mL) or 1,000 IU (2 mL) (dose adaptation in exceptional cases up to 1,500 IU) per week or fortnightly according to serum anti-HBs trough levels. 
Zutectra 500 i.e. (1 ml) ali 1.000 i.e. (2 ml) (prilagoditev odmerka v izjemnih primerih do 1.500 i.e.) na teden ali vsaka dva tedna, glede na najnižje ravni protiteles anti-HBs.
Make sure you use Zutectra as prescribed and as instructed by your doctor to avoid the risk of a hepatitis B re-infection. 
Da se izognete tveganju ponovne okužbe s hepatitisom tipa B, zagotovite, da boste uporabljali zdravilo Zutectra, kot vam je bilo predpisano in v skladu z navodili, ki ste jih prejeli od svojega zdravnika.
If you get any side effects, talk to your doctor or pharmacist. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
It is strongly recommended that every time that Zutectra is administered to a patient, the name and batch number of the medicinal product are recorded in order to maintain a link between the patient and the batch of the medicinal product. 
Za ohranitev sledljivosti med bolnikom in serijsko številko zdravila je zelo priporočljivo, da se ob vsakem dajanju zdravila Zutectra bolniku zabeležita ime in serijska številka zdravila.
Get rid of any air bubbles that may be in the syringe. 
Iz injekcijske brizge odstranite vse morebitne zračne mehurčke.
The colour of the solution can vary from clear to pale yellow up to light brown. 
Barva raztopine se lahko spreminja od bistre do bledorumene do svetlorjave.
Zutectra is intended for subcutaneous (under the skin) injection. 
Zdravilo Zutectra se uporablja kot subkutana (podkožna) injekcija.
Please tell your doctor or healthcare professional prior to treatment if you have been told that you have antibodies against immunoglobulins of the type IgA in your blood. 
če so vam povedali, da imate v krvi protitelesa proti imunoglobulinom tipa IgA.
Please tell your doctor about your treatment with Zutectra prior to any blood test. 
Pred vsako krvno preiskavo obvestite svojega zdravnika o zdravljenju z zdravilom Zutectra.
The objective of the study was to evaluate the level of compliance of patients using subcutaneous Zutectra as home selftreatment for preventing hepatitis B re-infection. 
Cilj študije je bil oceniti raven sodelovanja bolnikov, ki si zdravilo Zutectra samoinjicirajo doma za preprečitev ponovne okužbe s hepatitisom B. Bolnike naj bi z zdravilom Zutectra zdravili v skladu z informacijami in odmerki, navedenimi v povzetku glavnih značilnosti zdravila.
Zutectra must be brought to room temperature (approx. 23°C-27°C) before use. 
Zdravilo Zutectra naj pred uporabo doseže sobno temperaturo (pribl.
Antibody levels >100 IU/l should be maintained in HBsAg and HBV-DNA negative patients. 
Pri HBsAg negativnih in HBV-DNK negativnih bolnikih je treba ohranjati serumske ravni protiteles > 100 i.e./l.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 
Predpisovanje in izdaja zdravila je le na recept.
Ensure that Zutectra is not administered into a blood vessel, because of the risk of shock. 
Zaradi tveganja za pojav šoka zagotovite, da zdravilo Zutectra ne bo dano v krvno žilo.
Particularly if you do not have enough immunoglobulins of the type IgA in your blood, allergic reactions such as a sudden fall in blood pressure or shock may occur. 
Pojavijo se lahko alergijske reakcije, kot je nenaden padec krvnega tlaka ali šok.
The colour of the solution can vary from clear to pale yellow or light brown. 
Barva raztopine se lahko spreminja od bistre do bledorumene ali svetlorjave.
With normal immunoglobulins adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally. 
zvišana telesna temperatura, bruhanje, alergijske reakcije, slabost, bolečine v sklepih, nizek krvni tlak in zmerna bolečina v križu.
Zutectra is slowly absorbed into the recipient's circulation and reaches a maximum after a delay of 2-7 days. 
Zdravilo Zutectra se počasi absorbira v bolnikov krvni obtok in doseže najvišjo vrednost z zakasnitvijo
(≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). 
< 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000);
What Zutectra is used for 
Za kaj uporabljamo zdravilo Zutectra
No treatment failure defined as positive HBV-DNA and HBsAg findings occurred during the entire observation period. 
opredeljenega kot pozitivne vrednosti HBV-DNA in HBsAg.
Oropharyngeal pain 
PRETISNI OMOT
5 pre-filled syringes 
Raztopina za injiciranje 5 napolnjenih injekcijskih brizg
The solution is clear and pale yellow or light brown. 
Raztopina za injiciranje Raztopina je bistra in bledorumena ali svetlorjava.
Keep this leaflet. 
Glejte poglavje
The solution can vary from colourless to pale yellow up to light brown. 
Barva raztopine se lahko spreminja od brezbarvne do bledorumene in vse do svetlorjave.
two alcohol swabs, one syringe of Zutectra, one needle suitable for subcutaneous injection. 
eno iglo, primerno za podkožno injiciranje.
With other human immunoglobulin preparations the following additional symptoms have been reported: chills headache dizziness fever vomiting mild allergic reactions nausea (urge to vomit) joint pain low blood pressure moderate low back pain injection site reactions: swelling, soreness, redness, hardening of the skin, local heat, itching, bruising and rash. 
bolečine v sklepih nizek krvni tlak zmerne bolečine v križu reakcije na mestu injiciranja: oteklina, občutljivost, rdečina, zatrdlina na koži, lokalno povišana temperatura, srbenje, modrice in izpuščaj
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora orofaringealna bolečina redki*
In addition patient or caregiver must comply with the injection technique as well as with the dosing regimen to ensure anti-HBs trough serum levels > 100 IU/l after extended periods between level controls. 
Poleg tega se mora za zagotovitev najnižje serumske ravni anti-HBs > 100 i.e./l po podaljšanih razdobjih med posameznimi kontrolami bolnik oziroma negovalno osebje držati tehnike injiciranja in odmerne sheme.
Uncommon (may affect up to 1 in 100 people): - headache - upper abdominal pain (from your chest to the belly button) 
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - glavobol,
Furthermore the following reactions have been reported once only: tiredness (fatigue) high blood pressure (hypertension) inflammation of the nose and throat (nasopharyngitis) muscle spasm allergic reactions (hypersensitivity) abnormal heartbeat (palpitations), cardiac discomfort itching (pruritus), rash pain in the mouth and throat 
mišični spazem alergijske reakcije nenavaden srčni utrip (palpitacije), srčno nelagodje srbenje (pruritus), izpuščaj bolečina v ustih in žrelu
Biotest Pharma GmbH Landsteinerstrasse 5 D-63303 Dreieich Germany 
Landsteinerstrasse 5 D-63303 Dreieich
How to store Zutectra 
Shranjevanje zdravila Zutectra
Local reactions at injection sites Swelling, soreness, redness, induration, local heat, itching, bruising and rash. 
Oteklina, občutljivost, rdečina, zatrdlina, lokalna vročica, srbenje, modrice in izpuščaj.
Compliance according to anti-HBs serum levels could be shown for 57 (of 61) patients (93%), with no values below 100 IU/l and a mean anti-HBs serum level of 254.3 IU/l at the final visit. 
brez vrednosti pod 100 i.e./l in povprečnimi ravnmi anti-HBs v serumu 254,3 i.e/l ob končnem obisku.
NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU injection Human hepatitis B immunoglobulin Subcutaneous use 
Zutectra 500 i.e. injekcija humani imunoglobulin proti hepatitisu tipa B subkutana uporaba