natgillin/translations-raw huggingface dataset:
1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle 50 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with 1 needle 10 pre-filled syringes (0.5 ml) with 10 needles 1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 20 needles
suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga (0,5 ml) brez injekcijske igle 10 napolnjenih injekcijskih brizg (0,5 ml) brez injekcijske igel 50 napolnjenih injekcijskih brizg (0,5 ml) brez injekcijske igel 1 napolnjena injekcijska brizga (0,5 ml) z 1 injekcijsko iglo 10 napolnjenih injekcijskih brizg (0,5 ml) z 10 injekcijskimi iglami
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
POGOJI IN OMEJITVE GLEDE VARNOSTI IN UČINKOVITOSTI ZDRAVILA
A dose of 0.5 ml is withdrawn using a syringe for injection.
Odmerek 0,5 ml iz viale odvzamite s pomočjo injekcijske brizge.
Hexyon may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or a pentavalent DTaP-IPV/Hib vaccine associated with a monovalent hepatitis B vaccine.
Cepivo Hexyon se lahko uporabi za obnovitveno cepljenje posameznikov, ki so bili pred tem cepljeni z drugim šestvalentnim cepivom ali petvalentnim cepivom DTaP-IPV/Hib povezanim z monovalentnim cepivom proti hepatitisu B.
When a dose of hepatitis B vaccine is given at birth, the sequential infant primary vaccination hexavalent/pentavalent/hexavalent schedule with Hexyon and a pentavalent DTaP-IPV/Hib vaccine can be used in accordance with official recommendations.
Če je bil ob rojstvu uporabljen odmerek cepiva proti hepatitisu B, je mogoče za zaporedno primarno cepljenje dojenčka uporabiti razpored heksavalentno/pentavalentno/heksavalentno s cepivom Hexyon in pentavalentnim cepivom DTaP-IPV/Hib v skladu z uradnimi priporočili.
N=322†† N=934 to
N=249** N =123 do 220† N=322†† N=934 do
1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+)
1 Adsorbiran na hidratirani aluminijev hidroksid (0,6 mg Al3+).
Hexyon in vials
Cepivo Hexyon v vialah
The immune responses to Hib (PRP) and pertussis antigens (PT and FHA) were evaluated after 2 doses in a subset of subjects receiving Hexyon (N=148) at 2, 4, 6 months of age.
Imunski odzivi na antigena Hib in oslovskega kašlja po 2 odmerkih v starosti 2 in 4 mesece Imunski odziv na Hib (PRP) in antigene oslovskega kašlja (PT in FHA) je bil ovrednoten po prejemu dveh odmerkov v podskupini, ki je prejemala Hexyon (N=148) pri starosti 2, 4 in 6 mesecev.
• has had respiratory disorder or swelling of the face (anaphylactic reaction) after administration of Hexyon.
• imel motnje dihanja ali otekanje obraza (anafilaktično reakcijo) po cepljenju s cepivom Hexyon.
Pack size of 50 pre-filled syringes without needle.
Pakiranje po 50 napolnjenih injekcijskih brizg brez injekcijskih igel.
There may be a clinically relevant interference in the antibody response of Hexyon and a varicella vaccine and these vaccines should not be administered at the same time.
Klinično pomembne spremembe odziva protiteles se lahko pojavijo pri sočasni uporabi cepiv Hexyon in cepiva proti noricam, zato ju ne smemo uporabljati istočasno.
Table 2: Seroprotection/Seroconversion rates* one month after booster vaccination with Hexyon Antibody Thresholds
Preglednica 2: Stopnja serozaščite/serokonverzije* en mesec po obnovitvenem cepljenju s cepivom Hexyon
Multipack of 50 (5 packs of 10) pre-filled syringes without needle.
Združeno pakiranje po 50 (5 pakiranj po 10) napolnjenih injekcijskih brizg brez injekcijskih igel.
Hexyon will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virus hepatitisa B, poliovirus ali Haemophilus influenzae tipa b. Vendar je mogoče pričakovati, da bo cepljenje preprečilo hepatitis D, saj se hepatitis D (ki ga povzroča agens delta) ne pojavi v odsotnosti okužbe s hepatitisom B.
Hexyon is provided as a suspension for injection in pre-filled syringe (0.5 ml).
Cepivo Hexyon je na voljo kot suspenzija za injiciranje v napolnjeni injekcijski brizgi (0,5 ml).
Hexyon in pre-filled syringes EU/1/13/829/002
Cepivo Hexyon v napolnjenih injekcijskih brizgah EU/1/13/829/002
Diphtheria Toxoid not less than 20 IU2
davični toksoid ne manj kot 20 i.e.2
Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.
Oslovski kašelj lahko povzroči vnetje ušes, okužbo pljuč (bronhitis), ki lahko traja zelo dolgo, pljučno okužbo (pljučnico), krče,
Pharmaco-therapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC code: J07CA09 The immunogenicity of Hexyon in children over 24 months of age has not been studied in clinical trials.
Farmakoterapevtska skupina: Cepiva, kombinacije bakterijskih in virusnih cepiv, oznaka ATC: J07CA09
MARKETING AUTHORISATION NUMBER(S) EU/1/13/829/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/829/001
The administration of Hexyon must be carefully considered in individuals who have a history of serious or severe reactions within 48 hours following administration of a vaccine containing similar components.
Pri posameznikih z anamnezo resnih oziroma hudih reakcij v 48 urah po predhodni injekciji cepiva, ki je vsebovalo podobne komponente, je treba skrbno premisliti o cepljenju s cepivom Hexyon.
Hexyon in vials EU/1/13/829/001
Cepivo Hexyon v vialah EU/1/13/829/001
Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
Cepivo Hexyon (DTaP-IPV-HB-Hib) je indicirano za osnovno in obnovitveno cepljenje dojenčkov in malčkov, starejših od šest tednov, proti davici, tetanusu, oslovskemu kašlju, hepatitisu B,
Other side effects not listed above have been reported occasionally with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines and not directly with Hexyon:
Možni neželeni učinki O drugih neželenih učinkih, ki niso navedeni zgoraj, poročajo občasno pri drugih cepivih, ki vsebujejo cepiva proti davici, tetanusu, oslovskemu kašlju, otroški paralizi, hepatitisu B ali hemofilusu influence tipa b vendar ne neposredno pri uporabi cepiva Hexyon:
Hexyon will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Kako uporabljati cepivo Hexyon Cepivo Hexyon bo vašemu otroku injiciral zdravnik ali medicinska sestra, saj sta usposobljen za uporabo cepiv in za obravnavo vseh občasnih hudih alergijskih reakcij na injekcijo.
A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Hexyon.
Anamneza vročinskih krčev in družinska anamneza krčev ali sindroma nenadne smrti dojenčka (SIDS
Anti-diphtheria (≥ 0.01 IU/ml) Anti-tetanus (≥ 0.01 IU/ml) Anti PT (Seroconversion‡‡) (Vaccine response§) Anti FHA (Seroconversion‡‡) (Vaccine response§)
Protitelesa proti davici (≥ 0,01 i.e./ml) Protitelesa proti tetanusu (≥ 0,01 i.e./ml) Protitelesa proti PT (Serokonverzija ‡‡) (odziv na cepljenje§) Protitelesa proti FHA (Serokonverzija ‡‡) (odziv na cepljenje§)
Hexyon - Carton for pre-filled syringe with two separate needles.
Hexyon - škatla z napolnjeno injekcijsko brizgo, z dvema ločenima iglama.
Months N=249** N=204† N=178†† N=177 to
Obnovitveno cepljenje v drugem letu starosti po treh odmerkih osnovnega cepljenja mesecev tednov mesecev mesecev N = 249** N = 204† N = 178†† N = 177 do 396‡
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Hexyon - Carton for vial.
PODATKI NA ZUNANJI OVOJNINI Hexyon - škatla z vialami.
0.5 ml suspension in vial (type I glass) with a stopper (halobutyl).
0,5 ml suspenzije v viali (steklo tipa I) z zamaškom (halobutil).
Hexyon is available in multipack comprising 5 cartons, each containing 10 pre-filled syringes without attached needle.
Cepivo Hexyon je na voljo v združenem pakiranju 5 škatel, vsaka vsebuje 10 napolnjenih injekcijskih brizg brez injekcijskih igel.
Hexyon helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Hexyon is given to children from six weeks of age.
Cepivo Hexyon ščiti vašega otroka pred davico, tetanusom, oslovskim kašljem, hepatitisom B, otroško paralizo in hudimi boleznimi, ki jih povzroča Haemophilus influenzae tipa b. Cepivo Hexyon se daje otrokom starejšim od šestih tednov.
Contents of the pack and other information What Hexyon contains The active substances are per dose (0.5 ml)1: Diphtheria Toxoid not less than 20 IU2
Zdravilne učinkovine na odmerek (0,5 ml)1 so: davični toksoid ne manj kot 20 i.e.2
Anti-Polio type 2 (≥ 8 (1/dilution))
Protitelesa proti poliovirusu tipa 2 (≥ 8 (1/redčitev))
• has had an allergic reaction - to the active substances, - to any of the excipients listed in section 6, - to glutaraldehyde, formaldehyde, neomycin, streptomycin or polymyxin B, as these substances are used during the manufacturing process - after previous administration of Hexyon or any other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines.
- na katero koli pomožno snov, navedeno v poglavju 6; - na gluteraldehid, formaldehid, neomicin, streptomicin ali polimiksin B, saj se te snovi uporabljajo pri procesu izdelave cepiva; - po predhodni aplikaciji cepiva Hexyon ali na katero koli cepivo, ki vsebuje cepiva proti davici, tetanusu, oslovskem kašlju, otroški paralizi, hepatitisu B ali hemofilusu influence tipa b
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any pertussis vaccine, or after previous administration of Hexyon or a vaccine containing the same components or constituents.
Preobčutljivost na zdravilne učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1, na sledove zaostankov (gluteraldehida, formaldehida, neomicina, streptomicina in polimiksina B), na katero koli cepivo proti oslovskemu kašlju ali preobčutljivost po predhodnem cepljenju s cepivom
Hexyon - Carton for pre-filled syringe with one separate needle.
Hexyon - škatla z napolnjeno injekcijsko brizgo brez igle, z eno ločeno iglo.
After a 2-dose primary vaccination with Hexyon, a booster dose must be given.
Po osnovnem cepljenju z 2-odmerkoma cepiva Hexyon mora otrok prejeti obnovitveni odmerek.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/829/009
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/829/009
History of an anaphylactic reaction after a previous administration of Hexyon.
Pojav anafilaktične reakcije po predhodnem cepljenju s cepivom Hexyon.
Hexyon is available in pack containing 1,10 or 50 pre-filled syringes without attached needle.
Cepivo Hexyon je na voljo v pakiranju, ki vsebuje 1, 10 ali 50 napolnjenih injekcijskih brizg brez pritrjene igle.
Hexyon is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles.
Cepivo Hexyon je na voljo v pakiranju, ki vsebuje 1 ali 10 napolnjenih injekcijskih brizg z dvema ločenima iglama.
After a 3-dose WHO EPI schedule with Hexyon (6, 10, 14 weeks) and in the absence of hepatitis B vaccination at birth, a hepatitis B vaccine booster must be given.
Po 3-odmerkih cepiva Hexyon po EPI shemi SZO (6, 10 in 14 tednov) in če cepljeni ni prejel cepiva proti hepatitisu B ob rojstvu, ga je treba cepiti z obnovitvenim odmerkom cepiva proti hepatitisu B. Potrebno je dati najmanj obnovitveni odmerek cepiva proti otroški paralizi.
Hexyon is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle.
Cepivo Hexyon je na voljo v pakiranju, ki vsebuje 1 ali 10 napolnjenih injekcijskih brizg z eno ločeno iglo.
After a 3-dose primary vaccination with Hexyon, a booster dose should be given.
Po osnovnem cepljenju s 3-odmerki cepiva Hexyon mora otrok prejeti obnovitveni odmerek.
Pack of 1 or 10.
Pakiranje po 1 ali
Contents of the pack and other information
Shranjevanje cepiva Hexyon Vsebina pakiranja in dodatne informacije
Immune responses to Hib and pertussis antigens after 2 doses at 2 and 4 months of age
Imunski odziv na (PRP) in antigene PT in FHA en mesec po prejemu 2 odmerka, ki sta bila dana pri 2 in 4
With hepatitis B vaccination at birth
S cepljenjem proti hepatitisu B ob rojstvu
No significant clinical interaction with other treatments or biological products has been reported except in the case of immunosuppressive therapy (see section 4.4).
razen v primeru imunosupresivnega zdravljenja (glejte poglavje 4.4).
How to store Hexyon
Shranjevanje cepiva Hexyon
With hepatitis B vaccination at birth Without hepatitis B vaccination at birth 97.2
s cepljenjem proti hepatitisu B ob rojstvu brez cepljenja proti hepatitisu B ob rojstvu
AUTHORISATION
Pojavnost
Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, France
Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, Francija
Without hepatitis B vaccination at birth
Brez cepljenja proti hepatitisu B ob rojstvu
• Inflammation of several nerves causing sensory disorders or weakness of limbs (polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision
(poliradikulonevritis), ohromelost obraza, motnje vida, nenadna zatemnitev ali izguba vida
In the absence of hepatitis B vaccination at birth, it is necessary to give a hepatitis B vaccine booster dose.
Če cepljeni ni bil cepljen proti hepatitisu B ob rojstvu, je nujno obnovitveno cepljenje s cepivom proti hepatitisu B. Cepivo Hexyon se lahko uporabi za obnovitveno cepljenje.
When a hepatitis B vaccine is given at birth, after a 3-dose primary vaccination, Hexyon or a pentavalent DTaP-IPV/Hib vaccine can be administered for the booster.
Če je cepljeni prejel cepivo proti hepatitisu B ob rojstvu in nato 3-odmerke osnovnega cepljenja, je priporočljivo obnovitveno cepljenje s cepivom Hexyon ali s petvalentnim cepivom DTaP-IPV/Hib.
(optic neuritis), inflammatory disease of brain and spinal cord (central nervous system demyelination, multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine.
(optični nevritis) ter vnetna bolezen možganov in hrbtenjače (demielinizacija centralnega živčevja, multipla skleroza) o takšnih neželenih učinkih so poročali po aplikaciji cepiva, ki vsebuje antigen hepatitisa B. • otekanje ali obolenje možganov (encefalopatija/encefalitis)
Data on concomitant administration of a booster dose of Hexyon with measles-mumps-rubella vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
Podatki o sočasni uporabi obnovitvenega odmerka cepiva Hexyon in cepiva proti ošpicam, mumpsu in rdečkam niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
(polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision (optic neuritis), inflammatory disease of brain and spinal cord (central nervous system demyelination, multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine.
- periferna nevropatija (poliradikulonevritis, obrazna paraliza), optični nevritis in demielinizacija centralnega živčevja (multipla skleroza) je bila poročana po aplikaciji cepiva, ki vsebuje antigen hepatitisa B - encefalopatija/encefalitis
Essential amino acids including L-phenylalanine Sodium hydroxide, acetic acid or hydrochloric acid (for pH adjustment) Water for injections.
dinatrijev hidrogenfosfat kalijev dihidrogenfosfat trometamol saharoza esencialne aminokisline, vključno z L-fenilalaninom natrijev hidroksid, ocetna kislina ali klorovodikova kislina (za uravnavanje pH) voda za injiciranje
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, France
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, Francija
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE
20.0) mIU/ml.
(≥ 10 m i.e./ml)
Hexyon can be considered for the booster.
Cepivo Hexyon se lahko uporabi za obnovitveno cepljenje.
Multipack: 50 (5 packs of 10) pre-filled syringes (0.5ml) without needle.
FARMACEVTSKA OBLIKA IN VSEBINA suspenzija za injiciranje v napolnjeni injekcijski brizgi Združeno pakiranje: 50 (5 pakiranj po 10) napolnjenih injekcijskih brizg (0,5 ml) brez injekcijskih igel.
The immune responses to PRP, PT and FHA antigens one month after 2 doses given at 2 and 4 months of age were similar to those observed one month after a 2-dose priming given at 3 and 5 months of age: anti-PRP
mesecu starosti je bil sličen, kot pri podskupini, ki je prejela 2 odmerka pri 3 in 5 mesecih starosti:
Prior to administration, the pre-filled syringe should be shaken in order to obtain a homogeneous, whitish, cloudy suspension.
Cepivo Hexyon v vialah Pred uporabo cepivo v viali pretresite, da dobite homogeno, belkasto, motno suspenzijo.
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in pre-filled syringe.
FARMACEVTSKA OBLIKA IN VSEBINA suspenzija za injiciranje v napolnjeni injekcijski brizgi 10 napolnjenih injekcijskih brizg (0,5 ml) brez injekcijskih igel.
Marketing Authorisation Holder: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, France
Imetnik dovoljenja za promet z zdravilom: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, Francija
0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), without needle.
Cepivo Hexyon v napolnjenih injekcijskih brizgah 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (iz halobutila) in zaščiteni z zaporko (iz halobutila), brez igle.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hexyon suspension for injection
IME ZDRAVILA IN POT(I) UPORABE Hexyon suspenzija za injiciranje DTaP-IPV-HB-Hib i. m.
Data on concomitant administration of Hexyon with a pneumococcal polysaccharide conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Podatki o sočasni uporabi cepiva Hexyon in polisaharidnega konjugiranega cepiva proti pnevmokokom niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
Hexyon is a whitish, cloudy suspension.
FARMACEVTSKA OBLIKA suspenzija za injiciranje Cepivo Hexyon je belkasta, motna suspenzija.
Hexyon suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) DTaP-IPV-HB-Hib
Hexyon suspenzija za injiciranje v napolnjeni injekcijski brizgi Mešano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in hemofilusu influence tipa b (konjugirano), adsorbirano.
Package leaflet: Information for the user Hexyon suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Navodilo za uporabo Hexyon suspenzija za injiciranje v napolnjeni injekcijski brizgi Mešano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in hemofilusu influence tipa b (konjugirano), adsorbirano.
Anti-PRP (≥ 1.0 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth (Mexico) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration (pre-dose 1) <8 EU/ml, then the post-booster antibody concentration should be ≥8 EU/ml.
‡‡ Serokonverzija: najmanj 4-kratno povišanje v primerjavi s stopnjo pred cepljenjem (pred odmerkom 1) § Odziv na cepljenje: Če je koncentracija protiteles pred cepljenjem < 8 EU/ml je koncentracija protiteles po cepljenju lahko ≥ 8 EU/ml.
Package leaflet: Information for the user Hexyon suspension for injection Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Navodilo za uporabo Hexyon suspenzija za injiciranje Mešano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in hemofilusu influence tipa b (konjugirano), adsorbirano.
• Uncommon side effects (may affect up to 1 in 100 people) are: - allergic reaction - a lump (nodule) at the injection site - high fever (temperature 39.6°C or higher)
• Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 cepljenih) so: - alergijska reakcija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Hexyon - Carton for pre-filled syringe without needle.
Hexyon - škatla z napolnjeno injekcijsko brizgo brez igle.
Nervous system disorders - Brachial neuritis and Guillain-Barré Syndrome have been reported after administration of a tetanus toxoid containing vaccine - Peripheral neuropathy (polyradiculoneuritis, facial paralysis), optic neuritis, central nervous system demyelination (multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine - Encephalopathy/encephalitis
Bolezni živčevja - o brahialnem nevritisu in Guillain-Barréjevem sindromu so poročali po aplikaciji cepiva, ki vsebuje tetanusni toksoid
Metabolism and nutrition disorders
Presnovne in prehranske motnje zelo pogosti
Hexyon will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or by other liver pathogens.
hepatitis C in hepatitis E, ali drugi jetrni patogeni.
Revasc can cause serious harm to your baby.
Revasc lahko vašemu otroku povzroči resne poškodbe.
It is therefore important to tell your doctor if you are pregnant or planning to become pregnant.
Zato je pomembno, da zdravniku poveste, če ste noseči ali nameravate zanositi.
It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines.
Morda bo treba spremeniti odmerek, upoštevati druge previdnostne ukrepe ali, v nekaterih primerih, opustiti jemanje enega od zdravil.
Injections should be rotated between at least four different sites.
Injekcijsko mesto je treba krožno menjati med najmanj štirimi različnimi mesti.
Patients should be informed that they have received Revasc.
Bolnike je treba seznaniti s tem, da so dobivali Revasc.
Pack size of 1, 2 or 10.
Velikost pakiranja: 1, 2 in 10.
In such cases desirudin should be discontinued.
V takšnih primerih je treba desirudin prekiniti.
You will be given the first injection within 5 to 15 minutes before the operation.
Prvo injekcijo boste dobili od 5 do 15 minut pred operacijo.