natgillin/translations-raw huggingface dataset:
In particular, patients naive to human normal immunoglobulin, patients switched from an alternative product or when there has been a long interval since the previous injection should be monitored during the first injection and for the first hour after the first injection, in order to detect potential adverse signs.
Zlasti bolnike, ki še niso prejemali normalnega humanega imunoglobulina, bolnike, ki so prešli z alternativnega zdravila ali če je od prejšnjega injiciranja preteklo dalj časa, je treba spremljati med prvim injiciranjem in v prvi uri po prvem injiciranju, da se odkrijejo morebitni neželeni znaki.
The best places for injections are where the skin is loose and soft for example in the abdomen, arm, thigh or buttocks, and away from joints, nerves, bones.
Najboljša mesta za injiciranje so tam, kjer je koža ohlapna in mehka, na primer na trebuhu, rokah, stegnu ali zadnjici in stran od sklepov, živcev in kosti.
If you have any further questions, ask your doctor or pharmacist.
Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
The non-interventional post authorization safety study (PASS 978) enrolled 61 adult patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure.
V neinterventno študijo o varnosti zdravila po pridobitvi dovoljenja za promet (PASS 978) je bilo vključenih 61 odraslih bolnikov ≥ 6 mesecev po presaditvi jeter zaradi s hepatitisom tipa B izzvane odpovedi jeter.
Biotest Medical, S.L.U.
España Biotest Medical, S.L.U.
Do not use Zutectra - if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
Kaj morate vedeti, preden boste uporabili zdravilo Zutectra Ne uporabljajte zdravila Zutectra: če ste alergični na humani imunoglobulin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Precautions to be taken before handling or administering the medicinal product Injection of the medicinal product by the patient or by caregiver in a home treatment requires training by a physician experienced in the guidance of patients for home treatment.
Injiciranje zdravila s strani bolnika ali negovalnega osebja ob zdravljenju na domu zahteva usposabljanje, ki naj ga vodi zdravnik z izkušnjami pri vodenju bolnikov, ki se zdravijo doma.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Pri zdravilih, ki se izdelajo iz človeške krvi ali plazme, se izvajajo določeni ukrepi za preprečevanje prenosa okužb na bolnike.
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca biološke zdravilne učinkovine
No fatal case was observed during the study.
V času študije ni bilo smrtnih primerov.
Most side effects observed with Zutectra were mild to moderate in nature.
Večina neželenih učinkov, ki so jih opazili z zdravilom Zutectra, je bilo blage do zmerne narave.
- Hold the syringe with the needle pointing upwards, and tap the syringe gently with your fingers until the air has collected at the tip.
- Injekcijsko brizgo držite z iglo obrnjeno navzgor in s prsti nežno trkajte po brizgi, dokler se ves zrak ne zbere tik pod vrhom.
Immunoglobulins like Zutectra have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
Imunoglobulini, kot je zdravilo Zutectra, niso bili povezani z okužbami s hepatitisom A ali parvovirusom B19 verjetno zato, ker so protitelesa proti tem okužbam, ki so vsebovana v zdravilu, zaščitna.
Immunoglobulins are normal constituents of the human body, therefore toxicity testing in heterologous species is of no relevance.
5.3 Predklinični podatki o varnosti Imunoglobulini so normalna sestavina človeškega telesa, zato testiranje njihove toksičnosti na heterolognih vrstah nima pomena.
Then pull the needle out immediately and let go of the pinched skin.
Nato takoj izvlecite iglo in sprostite stisk na koži.
Aquilant Pharmaceuticals 21 Fonthill Business Park Fonthill Road Clondalkin
21 Fonthill Business Park Fonthill Road
Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell antibodies, for example the direct antiglobulin test (DAT, direct Coombs' test).
A, B, D, lahko ovira nekatere serološke teste na protitelesa proti rdečim krvnim celicam, na primer antiglobulinski test (Coombsov test).
Inject the liquid by pressing gently on the plunger.
Tekočino injicirajte z nežnim pritiskom na bat.
Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps, measles and varicella for a period of 3 months.
Dajanje imunoglobulinov lahko vpliva na razvoj imunskega odgovora na živa atenuirana virusna cepiva, kot so cepivo proti rdečkam, mumpsu, ošpicam in noricam (varicella), v obdobju 3 mesecev.
Zutectra contains 150 mg/ml of human plasma protein of which at least 96 % is immunoglobulin G (IgG).
Zdravilo Zutectra vsebuje 150 mg/ml humanega plazemskega proteina, od katerega je najmanj 96 % imunoglobulina G (IgG).
A sufficient surveillance period with stable anti-HBs trough serum levels of > 100 IU/l as well as a fixed dosage regimen is required: the monitoring schedule of patients anti-HBs antibody levels (see above) needs to be closely followed.
Potrebno je ustrezno obdobje nadzora s stabilnimi najnižjimi serumskimi ravnmi anti-HBs > 100 i.e./l in fiksna odmerna shema: natančno je treba upoštevati načrt spremljanja ravni protiteles anti-HBs pri bolnikih (glejte zgoraj).
Potential complications can often be avoided by ensuring that patients: are not sensitive to human normal immunoglobulin, by initially injecting the product slowly; are carefully monitored for any symptoms throughout the injection.
Morebitnim zapletom se je pogosto mogoče izogniti z zagotavljanjem, da: da bolniki niso preobčutljivi na normalni humani imunoglobulin; na začetku naj se zdravilo injicira počasi;
If you are administering Zutectra yourself, please read instructions in the section “How to inject Zutectra by yourself or by caregiver” carefully.
Če si boste zdravilo Zutectra dajali sami, natančno preberite navodila v poglavju »Samoinjiciranje zdravila Zutectra ali injiciranje s strani negovalnega osebja«.
Zutectra contains antibodies against the hepatitis B virus which are the body's own defensive substances to protect you from hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus.
Zdravilo Zutectra vsebuje protitelesa proti virusu hepatitisa tipa B, ki so telesu lastne obrambne snovi za zaščito pred hepatitisom tipa B. Hepatitis tipa B je vnetje jeter, ki ga povzroča virus hepatitisa tipa B.
The maximum IgA content is 6,000 micrograms/ml.
Največja vsebnost IgA je 6.000 mikrogramov/ml.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.
Ob sumu na reakcije alergijskega ali anafilaktičnega tipa je treba injiciranje takoj prekiniti.
The weekly subcutaneous dose was 500 IU for patients with bodyweight < 75 kg (a dose increase to 1000 IU was allowed, if medically required to maintain a safety level of > 100 IU) and 1000 IU for patients with bodyweight ≥ 75 kg. 2 patients received a higher and 2 patients received a lower dose than recommended by the weight based dosing regimen.
Tedenski subkutani odmerek je bil 500 i.e. pri bolnikih s telesno maso < 75 kg (dovoljeno je bilo zvišanje odmerka do 1.000 i.e., če je obstajala medicinsko utemeljena potreba za zagotovitev varnostne ravni > 100 i.e.) in 1.000 i.e. pri bolnikih s telesno maso ≥ 75 kg. 2 bolnika sta prejela večji, 2 pa manjši odmerek od priporočenega režima odmerjanja glede na telesno maso.
Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Redko humani normalni imunoglobulini lahko izzovejo nenaden padec krvnega tlaka in v izoliranih primerih anafilaktični šok, in to celo v primerih, ko pri predhodnem dajanju zdravila bolnik ni pokazal preobčutljivosti.
Driving and using machines Zutectra has no or negligible effects on your ability to drive or use machines.
Zdravilo Zutectra nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
You can inject Zutectra yourself without the help of your doctor, if they have trained you to do this.
Samoinjiciranje zdravila ali injiciranje s strani negovalnega osebja Zdravilo Zutectra si lahko injicirate sami, brez pomoči vašega zdravnika, če ste bili o tem ustrezno poučeni.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Cepiva, pripravljena iz živih oslabljenih virusov
In total, 53/66 patients (80.3 %) used antiviral medication and 13 patients received monotherapy with Zutectra during this study.
Skupaj je v tej študiji 53/66 bolnikov (80,3 %) uporabljalo protivirusna zdravila in 13 bolnikov je prejelo monoterapijo z zdravilom Zutectra.
However, if you have used more than the prescribed dose of Zutectra, contact your doctor, healthcare professional or pharmacist straight away for advice.
Vseeno se v primeru, da ste uporabili večji odmerek zdravila Zutectra, kot vam je bilo predpisano, po nasvet takoj obrnite na svojega zdravnika, strokovnega zdravstvenega delavca ali farmacevta.
The maximum immunoglobulin A (IgA) content is 6,000 micrograms/ml.
Največja vsebnost imunoglobulina A (IgA) je 6.000 mikrogramov/ml.
Zutectra must not be administered intravascularly.
Zdravila Zutectra se ne sme dajati intravaskularno.
Frequency per injection has been evaluated using the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Pogostnost v povezavi s posameznim injiciranjem je bila ovrednotena po naslednjih kriterijih: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do
It's harder to give yourself an injection here.
Tukaj si le težko sami injicirate.
Serum anti-HBs antibody levels should be measured at least every 2-4 weeks and at the discretion of the physician in charge for at least half a year.
Serumske ravni protiteles anti-HBs je treba vsaj pol leta meriti najmanj vsake 2 do 4 tedne po presoji lečečega zdravnika.
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women.
Varnosti uporabe zdravila v nosečnosti v nadzorovanih kliničnih preskušanjih na ljudeh niso raziskali, zato ga je treba pri nosečnicah uporabljati previdno.
An allergic reaction may include sudden wheeziness, difficulty in breathing, fast pulse, swelling of the eyelids, face, lips, throat or tongue, rash or itching.
Alergijska reakcija lahko vključuje nenadno sopenje, težave pri dihanju, hiter srčni utrip, zatekanje vek, obraza, ustnic, žrela ali jezika, izpuščaj ali srbenje.
One ml solution in a pre-filled syringe (Type I glass) with a stopper (bromobutyl) and a tip cap (bromobutyl rubber).
En ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom (bromobutil) in snemljivo zaporko (bromobutilna guma).
Serum antiHBs trough levels of 100 IU/l and higher (primary efficacy endpoint) were maintained for all patients during the 18 to 24 week trial period.
Najnižje serumske anti-HBs ravni 100 i.e./l in več (primarno merilo učinkovitosti) so se v 18-24 tednih trajanja preskušanja ohranile pri vseh bolnikih.
No treatment failures occurred during the 6month study period.
V 6-mesečnem obdobju študije ni bilo nobenega primera neuspešnega zdravljenja.
Do not use this medicine after the expiry date which is stated on the outer carton and the syringe label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na injekcijski brizgi poleg oznake Uporabno do:.
The > 100 IU/l safety margin is the generally accepted level of effective prevention against HBV re-infection in liver transplant patients at risk.
Varnostna mejna vrednost > 100 i.e./l je splošno sprejeta raven učinkovitega preprečevanja ponovne okužbe z virusom hepatitisa tipa B (HBV) pri bolnikih s presajenimi jetri, ki so izpostavljeni tveganju.
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Ukrepi, ki se izvajajo, so morda manj učinkoviti proti virusom brez ovojnice, kot je parvovirus B19.
In total, 42/61 patients (68.9 %) used antiviral medication and 19 patients received monotherapy with Zutectra during this study.
Skupaj je v tej študiji 42/61 bolnikov (68,9 %) uporabljalo protivirusna zdravila in 19 bolnikov je prejelo monoterapijo z zdravilom Zutectra.
LIST OF EXCIPIENTS Excipients: Glycine, water for injections.
SEZNAM POMOŽNIH SNOVI Pomožne snovi: glicin, voda za injekcije.
Prepare the Zutectra syringe:
Pripravite injekcijsko brizgo zdravila Zutectra:
Serum HBs antibody concentrations above the minimum safety trough level of >100 IU/L were measured in all patients at all timepoints independent of the type of administration (investigator, caregiver or self-injection), the dose regimen (500 IU, 1000 IU, 1500 IU) or the treatment intervals.
Pri vseh bolnikih so na vseh časovnih točkah izmerili serumske koncentracije protiteles HBs nad najnižjo varnostno ravnjo > 100 i.e./l, neodvisno od vrste aplikacije (raziskovalec, negovalec ali samoinjiciranje), režim odmerjanja (500 i.e., 1.000 i.e., 1.500
Zutectra is presented as a solution for injection provided in pre-filled syringes (500 IU/ml - pack size of 5 in a blister).
Zdravilo Zutectra je na voljo v obliki raztopine za injiciranje v napolnjenih injekcijskih brizgah (500 i.e./ml - pakiranje po 5 v pretisnem omotu).
Do not use Zutectra if you notice that the solution is cloudy or has particles.
Ne uporabljajte zdravila Zutectra, če opazite, da je raztopina motna ali da so v njej prisotni delci.
What Zutectra looks like and the contents of the pack
Izgled zdravila Zutectra in vsebina pakiranja
Keep the syringes and syringe disposal unit out of the reach of children; lock the supplies if possible.
Injekcijske brizge in zabojček, kamor odvržete uporabljene brizge, hranite zunaj dosega otrok; po možnosti jih zaklenite.
HBV-DNA negative status should be confirmed within the last 3 months prior to OLT.
Negativni status HBV-DNK je treba potrditi v 3 mesecih pred ortotopno presaditvijo jeter.
Avoid using the belt line area, as rubbing may irritate the injection site.
Izogibajte se predelu pasu, ker drgnjenje lahko draži mesto injiciranja.
Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
V redkih primerih lahko humani imunoglobulin proti hepatitisu tipa B povzroči padec krvnega tlaka z anafilaktično reakcijo, in sicer celo pri bolnikih, ki so predhodno zdravljenje s humanimi imunoglobulini dobro prenašali.
Pharmacotherapeutic group: Immune sera and immunoglobulins, Specific immunoglobulins, Hepatitis B immunoglobulin
Farmakoterapevtska skupina: imunski serumi in imunoglobulini, specifični imunoglobulini, imunoglobulin hepatitisa B
One pre-filled syringe of 1 ml Zutectra contains 500 IU.
Ena 1-mililitrska napolnjena injekcijska brizga zdravila Zutectra vsebuje 500 i.e.
Arms: The back of the upper arm should be used.
Roke: Uporabite zadnjo stran nadlakti.
It is much easier for someone else to use this site if you do need help.
Če potrebujete pomoč, je veliko preprosteje, če to mesto za injiciranje uporabi kdo drug.
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