natgillin/translations-raw huggingface dataset:
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Actavis have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Imatinib Actavis, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imatinib-actavis.
Nadaljnje informacije o zdravilu Imatinib Actavis so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/imatinib-actavis Informacije o referenčnem zdravilu so prav tako na voljo na spletni strani agencije.
What measures are being taken to ensure the safe and effective use of Imatinib Actavis?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imatinib Actavis?
Because Imatinib Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Imatinib Actavis generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Actavis.
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Glivec, zato jih ni treba ponoviti za zdravilo Imatinib Actavis.
The European Medicines Agency concluded that, in accordance with EU requirements, Imatinib Actavis has been shown to have comparable quality and to be bioequivalent to Glivec.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Imatinib Actavis primerljivo raven kakovosti in je bioekvivalentno z zdravilom Glivec.
The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem krvnega raka.
These enzymes can be found in some receptors on cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Ti encimi se nahajajo v določenih receptorjih v rakavih celicah, vključno z receptorji, ki spodbujajo celice, da se nenadzorovano delijo.
As for every medicine, the company provided studies on the quality of Imatinib Actavis.
Kot to velja za vsako zdravilo, je podjetje zagotovilo študije o kakovosti zdravila Imatinib Actavis.
An overview of Imatinib Actavis and why it is authorised in the EU
Pregled zdravila Imatinib Actavis in zakaj je odobreno v EU
Side effects reported with Imatinib Actavis are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Imatinib Actavis, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
As for all medicines, data on the use of Imatinib Actavis are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Imatinib Actavis stalno spremljajo.
What are the benefits and risks of Imatinib Actavis?
Kakšne so koristi in tveganja, povezani z zdravilom Imatinib Actavis?
This means that it blocks enzymes known as tyrosine kinases.
To pomeni, da zavira delovanje določenih encimov, imenovanih tirozin kinaze.
It is also used alone to treat adults with Ph+ ALL that has returned following previous treatment, or if other medicines are not working.
Uporablja se tudi samostojno pri odraslih za zdravljenje Ph+ ALL, ki se je po predhodnih zdravljenjih ponovno pojavila ali se ne odziva na druga zdravljenja;
Imatinib Actavis is used to treat adults with DFSP that cannot be removed with surgery, and in adults who cannot have surgery when the cancer has returned after treatment or has spread to other parts of the body.
Zdravilo Imatinib Actavis se uporablja za zdravljenje odraslih s to boleznijo, pri kateri sarkoma ni mogoče odstraniti s kirurškim posegom, ter odraslih, ki niso primerni za kirurški poseg po ponovnem pojavu raka po zaključenem zdravljenju ali pri razširitvi na druge dele telesa.
This means that Imatinib Actavis contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Glivec.
To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot referenčno zdravilo Glivec, ki je že odobreno v Evropski uniji (EU).
Why is Imatinib Actavis authorised in the EU?
Zakaj je bilo zdravilo Imatinib Actavis odobreno v EU?
Imatinib Actavis is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Zdravilo Imatinib Actavis se zaužije peroralno s hrano in velikim kozarcem vode, da se zmanjša tveganje za draženje želodca in črevesja.
What is Imatinib Actavis and what is it used for?
Kaj je zdravilo Imatinib Actavis in za kaj se uporablja?
Imatinib Actavis received a marketing authorisation valid throughout the EU for Imatinib Actavis on 17 April 2013.
Zdravilo Imatinib Actavis je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 17. aprila 2013.
The medicine is used in children who have been newly diagnosed with Ph+ CML and who cannot have a bone marrow transplant.
Zdravilo se uporablja pri otrocih, pri katerih je bila Ph+ KML na novo diagnosticirana in niso primerni za presaditev kostnega mozga.
Other information about Imatinib Actavis
Druge informacije o zdravilu Imatinib Actavis
Imatinib Actavis is a ‘generic medicine'.
Zdravilo Imatinib Actavis je „generično zdravilo“.
• myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
• mielodisplastičnih ali mieloproliferativnih bolezni (MDS/MPD), tj. skupine bolezni, pri katerih telo proizvaja velike količine nenormalnih krvnih celic.
• dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
• protuberantnega dermatofibrosarkoma (DFSP), tj. vrste raka (sarkoma), pri kateri se celice pod kožo nenadzorovano delijo.
Imatinib Actavis is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Zdravilo Imatinib Actavis se uporablja za zdravljenje odraslih z MDS/MPD v povezavi s preureditvijo genov za receptor za rastni faktor iz trombocitov (PDGFR);
• Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
• Ph+ akutne limfoblastne levkemije (ALL), tj. vrste raka, pri kateri se limfociti (druga vrsta belih krvnih celic) prehitro množijo.
Imatinib Actavis is used with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Zdravilo Imatinib Actavis se uporablja v kombinaciji z drugimi zdravili za zdravljenje raka pri odraslih in otrocih z na novo diagnosticirano Ph+ ALL.
The active substance in Imatinib Actavis, imatinib, is a protein-tyrosine-kinase inhibitor.
Učinkovina v zdravilu Imatinib Actavis, imatinib, je zaviralec beljakovine tirozin kinaze.
Imatinib Actavis is a cancer medicine that contains the active substance imatinib.
Imatinib Actavis je zdravilo za zdravljenje raka, ki vsebuje učinkovino imatinib.
The dose depends on the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Odmerek je odvisen od starosti bolnika, njegovega bolezenskega stanja in odziva na zdravljenje, vendar ne sme presegati 800 mg na dan. Za več informacij o uporabi zdravila Imatinib Actavis glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Imatinib Actavis is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Zdravilo Imatinib Actavis se uporablja za zdravljenje odraslih z napredovalim hipereozinofilnim sindromom ali kronično eozinofilno levkemijo, ki imajo posebno preureditev dveh genov, imenovanih FIP1L1 in PDGFRα;
• advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
• napredovalega hipereozinofilnega sindroma (HES) ali kronične eozinofilne levkemije (CEL), tj. bolezni, pri katerih eozinofilci (druga vrsta belih krvnih celic) začnejo nenadzorovano rasti.
Imatinib Actavis is also used in adults with Ph+ CML in blast crisis.
Zdravilo Imatinib Actavis se uporablja tudi pri odraslih s Ph+ KML v blastni krizi;
By blocking these receptors, Imatinib Actavis helps to control and slow down cell division.
Zdravilo Imatinib Actavis z zaviranjem teh receptorjev pomaga pri nadzoru deljenja celic.
Therefore, the Agency's view was that, as for Glivec, the benefit of Imatinib Actavis outweighs the identified risk and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Imatinib Actavis enako kot pri zdravilu Glivec odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
Imatinib Actavis is used when the patients are ‘Philadelphia-chromosome positive' (Ph+).
Zdravilo Imatinib Actavis se uporablja pri bolnikih s prisotnim kromosomom Philadelphia (Ph+).
• chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
• kronične mieloidne levkemije (KML), tj. raka belih krvnih celic, pri katerem začnejo granulociti (vrsta belih krvnih celic) nenormalno rasti.
How has Imatinib Actavis been studied?
Kako je bilo zdravilo Imatinib Actavis raziskano?
How is Imatinib Actavis used?
Kako se zdravilo Imatinib Actavis uporablja?
How does Imatinib Actavis work?
Kako zdravilo Imatinib Actavis deluje?
No data are available in older children (see sections 4.8 and 5.1)
Podatkov ni na voljo za starejše otroke (glejte poglavje 4.8 in 5.1)
However children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Hexyon but the protection may not be as good as in children whose immune system is healthy.
Vendar pa se otroke z dolgotrajnimi težavami s svojim imunskim sistemom kot so okužbo s HIV (AIDS) lahko cepi s Hexyon, vendar morda zaščita ne bo tako dobra, kot pri otrocih, katerih imunski sistem je zdrav.
If you forget one dose of Hexyon
Če pozabite en odmerek cepiva Hexyon
• As with any vaccine, Hexyon may not protect 100% of children who receive the vaccine.
• Kot velja za vsa cepiva, tudi cepivo Hexyon ne more 100% zaščititi otroka, ki je prejel to cepivo.
Pack of 1, 10 or 50.
Pakiranje po 1, 10 ali 50.
Other medicines or vaccines and Hexyon
Druga zdravila ali cepiva in cepivo Hexyon
Your doctor will advise you whether your child should have Hexyon.
Zdravnik vam bo svetoval, ali naj vaš otrok prejme cepivo Hexyon.
Vaccination with Hexyon may need to be delayed until your child is better.
Cepljenje s cepivom Hexyon bo morda treba preložiti, dokler se stanje vašega otroka ne izboljša.
Hexyon (DTaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases.
Hexyon (DTaP-IPV-HB-Hib) je cepivo, ki se uporabljajo za zaščito pred nalezljivimi boleznimi.
Other paediatric population:
Ostala pediatrična populacija
At the end of this period, Hexyon should be used or discarded.
Ob koncu tega obdobja morate cepivo Hexyon uporabiti ali zavreči.
What Hexyon is and what it is used for
Kaj je cepivo Hexyon in za kaj ga uporabljamo
† See section c c- Description of selected adverse reactions
† Poglejte poglavje c c- Opis označenega neželenega učinka
Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Zelo pogosti (≥1/10) Pogosti (≥1/100 do <1/10) Občasni (≥1/1.000 do <1/100) Redki (≥1/10.000 do <1/1.000) Zelo redki (<1/10.000)
• Hexyon will only help to prevent these diseases if they are caused by the bacteria or viruses targeted by the vaccine.
• Cepivo Hexyon ščiti pred temi boleznimi samo, če jih povzročajo bakterije ali virusi, proti katerim je cepivo usmerjeno.
What Hexyon is and what it is used for What you need to know before Hexyon is given to your child How to use Hexyon
Kaj je cepivo Hexyon in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok prejel cepivo Hexyon Kako uporabljati cepivo Hexyon
Possible side effects Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Možni neželeni učinki Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
d- Potential adverse events (i.e. adverse events which have been reported with other vaccines containing one or more of the components or constituents of Hexyon and not directly with Hexyon)
d- Možni neželeni učinki (Tj. neželeni učinki, o katerih poročajo pri drugih cepivih, ki vsebujejo eno ali več komponent ali sestavin cepiva Hexyon, in ne neposredno pri cepivu Hexyon.)
The safety of Hexyon in children over 24 months of age has not been studied in clinical trials.
Varnost cepiva Hexyon pri otrocih starejših od 24 mesecev ni bila raziskana v kliničnih preskušanjih.
The coughing often has a “whooping” sound.
Kašelj ima pogosto »oslovski«
• sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, accelerated heart rate associated with respiratory disorders
• nenadno in resno slabo počutje s padcem krvnega tlaka, ki povzroča omotico in izgubo zavesti, pospešen srčni utrip, povezan z boleznimi dihal.
In clinical studies in individuals who received Hexyon, the most frequently reported reactions include injection-site pain, irritability, crying, and injection-site erythema.
V kliničnih študijah pri posameznikih, ki so prejeli cepivo Hexyon, so bili najpogosteje poročani neželeni učinki: bolečina na mestu injiciranja, razdražljivost, jok in pordelost na mestu injiciranja.
These reactions start within 24-72 hours after vaccination, may be associated with redness, warmth, tenderness or pain at the injection site, and get better within 3-5 days without the need for treatment.
Te reakcije se pojavijo v 24-72 urah po cepljenju, lahko so povezane s pordelostjo, toploto, občutljivostjo ali bolečino na mestu injiciranja in se izboljšajo v 3-5 dneh brez potrebe po zdravljenju
The safety and efficacy of Hexyon in infants less than 6 weeks of age have not been established.
Varnost in učinkovitost cepiva Hexyon pri dojenčkih, mlajših od 6 tednov, nista bili dokazani.
Hexyon must not be mixed with any other vaccines or other parenterally administered medicinal products.
Cepiva Hexyon ne smemo mešati z drugimi cepivi ali drugimi parenteralno apliciranimi zdravili.
• Inflammation of several nerves causing sensory disorders or weakness of limbs
• vnetje več živcev, ki povzroči senzorične motnje ali mišično oslabelost okončin
Hexyon suspension for injection
Hexyon suspenzija za injiciranje
• has a moderate or high temperature or an acute illness (e.g. fever, sore throat, cough, cold or flu).
• ima zmerno do zelo povišano telesno temperaturo ali akutno bolezen (npr. vročino, vnetje grla, kašelj, prehlad ali gripo).
Pack of 10 for multipack (without blue box)
Pakiranje po 10 v združenem pakiranju (brez modrega okna)
Hexyon is given as an injection into a muscle (intramuscular route IM) in the upper part of your child's leg or upper arm.
Cepivo Hexyon se daje kot injekcija v mišico (intramuskularna pot uporabe - i. m.) v zgornji del otrokove noge ali nadlahti.
• Hexyon should not be mixed with other medicinal products.
• Cepiva Hexyon ne smete mešati z drugimi zdravili.
titers ≥ 0.15 µg/ml were observed in 73.0% of individuals, anti-PT vaccine response in 97.9% of individuals and anti-FHA vaccine response in 98.6% of individuals.
proti-PRP titer ≥ 0,15µg/ml je imelo 73,0% posameznikov, proti-PT odziv je imelo 97,9% posameznikov in proti-FHA odziv je imelo 98,6% posameznikov.
Component of a multipack, cannot be sold separately.
Komponente združenega pakiranja se ne izdajajo posebej.
Hexyon is available in pack containing 10 vials.
Cepivo Hexyon je na voljo v pakiranju, ki vsebuje 10 vial.
Immune memory against Hepatitis B had been demonstrated by the presence of an anamnestic response to a challenge Hepatitis B vaccination at the age of 9 years in 93% of vaccinees with development of geometric mean concentrations at 3692 (95% CI: 1886 - 7225) mIU/ml after vaccination.
Imunski spomin proti hepatitisu B je bil dokazan s prisotnostjo anamnestičnega odziva na provokacijsko cepljenje proti hepatitisu B v starosti 9 let pri 93 % cepljenih, s pojavom geometrične srednje koncentracije 3692 (95 % IZ: 1886-7225)
Hexyon can be given at the same time as other vaccines such as pneumococcal vaccines, measlesmumps-rubella vaccines, rotavirus vaccines or meningococcal vaccines.
Cepivo Hexyon se lahko daje istočasno kot druga cepiva, kot so polisaharidna konjugirana cepiva proti pnevmokokom, cepiva proti ošpicam, mumpsu in rdečkam, cepiva proti rotavirusom ali cepiva proti meningokokom.
• Hexyon will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E.
• Cepivo Hexyon ne ščiti pred okužbo s hepatitisom, ki ga povzročajo drugi agensi, kot so hepatitis A, hepatitis C in hepatitis E.
Do not use Hexyon if your child:
Cepivo Hexyon se ne sme uporabiti, če je vaš otrok
The long term capability of the acellular pertussis (aP) antigens contained in Hexyon to reduce pertussis incidence and control pertussis disease in the childhood has been demonstrated in a 10-year national pertussis surveillance on pertussis disease in Sweden with the pentavalent DTaP-IPV/Hib vaccine using a 3, 5, 12 months schedule.
Dolgoročno zmožnost brezceličnih antigenov oslovskega kašlja, ki jih vsebuje cepivo Hexyon, za zmanjšanje incidence oslovskega kašlja in nadzor bolezni v otroštvu so dokazali v desetletnem nacionalnem spremljanju oslovskega kašlja na Švedskem s petvalentnim cepivom DTaP-IPV/Hib z uporabo 3, 5, 12 mesečne sheme.
Multipack of 50 (5x10) (including blue box)
Združeno pakiranje po 50 (5x10) (vklučeno modro okno)
Hexyon suspension for injection in pre-filled syringe Hexyon suspension for injection
Hexyon suspenzija za injiciranje v napolnjeni injekcijski brizgi Hexyon suspenzija za injiciranje
Table 3: Seroprotection ratesa at the age of 4.5 years old after vaccination with Hexyon Antibody Thresholds
Preglednica 3: Deleži serološke zaščite a v starosti 4,5 leta po cepljenju s cepivom Hexyon
The vaccine effectiveness against Hib invasive disease of DTaP and Hib combination vaccines (pentavalent and hexavalent including vaccines containing the Hib antigen from Hexyon) has been demonstrated in Germany via an extensive (over five years follow-up period) post-marketing surveillance study.
Uspešnost zaščite pred invazivnimi boleznimi, ki povzroča Hib Učinkovitost kombiniranih cepiv proti DTaP in Hib (pentavalentna in heksavalentna cepiva, vključno s cepivi, ki vsebujejo enak antigen Hib kot cepivo Hexyon) proti invazivnim boleznim, ki jih povzroča Hib, so dokazali v Nemčiji z obširno (več kot petletno obdobje spremljanja) opazovalno študijo v obdobju trženja.
Vaccine efficacy of the acellular pertussis (aP) antigens contained in Hexyon against the most severe WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) is documented in a randomised double-blind study among infants with a 3 dose primary series using a DTaP vaccine in a highly endemic country (Senegal).
Učinkovitost cepiva z brezceličnimi antigeni oslovskega kašlja (aP), ki jih vsebuje cepivo Hexyon, proti tipičnemu oslovskemu kašlju v skladu z definicijo SZO (napadi kašlja, ki trajajo ≥ 21 dni), je dokumentirana v randomizirani dvojno slepi študiji pri dojenčkih z osnovno serijo treh odmerkov s cepivom DTaP v visoko endemični državi (Senegal).
Vaccination with Hexyon is contraindicated if the individual has experienced an encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine (whole cell or acellular pertussis vaccines).
Cepljenje s cepivom Hexyon je kontraindicirano, če je dojenček prebolel encefalopatijo neznanega izvora, ki se je pojavila v 7 dneh po predhodnem cepljenju s cepivom, ki je vsebovalo tudi cepivo proti oslovskemu kašlju (cepivo proti oslovskemu kašlju s celimi celicami ali acelularno).
OTHER Sanofi Pasteur Europe
DRUGI PODATKI Sanofi Pasteur Europe
Table 1: Seroprotection/Seroconversion rates* one month after a primary vaccination with 2 or 3 doses of Hexyon
Preglednica 1: Stopnja serozaščite/serokonverzije* en mesec po osnovnem cepljenju z 2 ali 3 odmerki cepiva Hexyon
• Very rare side effects (may affect up to 1 in 10,000 people) are: - episodes when your child goes into a shock-like state or is pale, floppy and unresponsive for a period of time (hypotonic reactions or hypotonic hyporesponsive episodes HHE).
• Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 cepljenih) so: - epizode, pri katerih je vaš otrok v šoku podobnem stanju oziroma je določen čas bled, mlahav in neodziven (hipotonične reakcije ali hipotonično-hiporesponzivne epizodeHHE).
Hexyon is provided as a suspension for injection in vial (0.5 ml).
Cepivo Hexyon je na voljo kot suspenzija za injiciranje v viali (0,5 ml).
What Hexyon looks like and contents of the pack
Izgled cepiva Hexyon in vsebina pakiranja
• Hexyon must be administered intramuscularly.
• Cepivo Hexyon se daje intramuskularno.
Booster vaccination at 11-12 months of age after a two doses primary course
Obnovitveno cepljenje pri starosti 1112 mesecih po osnovnem cepljenju z dvema odmerkoma
Hexyon does not protect against infectious diseases caused by other types of Haemophilus influenzae or against meningitis of other origins.
Cepivo Hexyon ne ščiti pred nalezljivimi boleznimi, ki jih povzročajo drugi tipi Haemophilusa influenzae, ali pred meningitisom drugačnega izvora.
The primary vaccination consists of two doses (with an interval of at least 8 weeks) or three doses (with an interval of at least 4 weeks) in accordance with the official recommendations.
Osnovno cepljenja je sestavljeno iz dveh odmerkov (v presledku najmanj 8 tednov) ali treh odmerkov
To make sure that Hexyon is suitable for your child, it is important to talk to your doctor or nurse if any of the points below apply to your child.
Kaj morate vedeti, preden bo vaš otrok prejel cepivo Hexyon Da bi se prepričali, da je cepivo Hexyon primerno za vašega otroka, je pomembno, da se pogovorite z zdravnikom ali medicinsko sestro, če kaj od spodaj navedenega velja za vašega otroka.
Data on concomitant administration of Hexyon with a meningococcal C conjugate vaccine or a meningococcal group A, C, W-135 and Y conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Podatki o sočasnem dajanju cepiva Hexyon z meningokoknim C konjugiranim cepivom ali z meningokoknim konjugiranim cepivom skupin A, C, W-135 in Y niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
When given at the same time with other vaccines, Hexyon will be given at different injection sites.
Če se cepljenje opravlja sočasno z drugim cepivom bo cepivo Hexyon injicirano na različno mesto.
QUALITATIVE AND QUANTITATIVE COMPOSITION One dose1 (0.5 ml) contains:
En odmerek1 (0,5 ml) vsebuje:
Pack size of 1 or 10 pre-filled syringes with or without needle.
Pakiranje po 1 ali 10 napolnjenih injekcijskih brizg z ali brez injekcijskih igel.
Otherwise, post-vaccination antibody concentration should be ≥ pre immunisation level.
Sicer pa naj bi bila koncentracija protiteles po cepljenju ≥ izmerjeni pred imunizacijo.
Where a dose of hepatitis B vaccine is given at birth, Hexyon can be used for supplementary doses of hepatitis B vaccine from the age of six weeks.
Če je bil otrok cepljen proti hepatitisu B ob rojstvu, se cepivo Hexyon lahko uporabi za dodatne odmerke cepiva proti hepatitisu B od starosti šestih tednov dalje.