natgillin/translations-raw huggingface dataset:
Other common side effects of Herceptin, occurring in less than 10 out of 100 patients, are: allergic reactions, abnormal blood counts (anaemia, low platelet count and low white blood count), constipation, heartburn (dyspepsia), infections, including bladder and skin infections, shingles, inflammation of the breast, inflammation of the pancreas or liver, kidney disorders, increased muscle tone / tension (hypertonia), tremor, numbness or tingling of the fingers and toes, nail disorders, hair loss, inability to sleep (insomnia), sleepiness (somnolence), nose bleeds, acne, itchiness, dry mouth
Drugi pogosti neželeni učinki zdravila Herceptin, ki se pojavijo pri manj kot 10 od 100 bolnikov, so: preobčutljivostne reakcije, nepravilnosti krvne slike (anemija, znižana koncentracija trombocitov v krvi in znižanje koncentracije levkocitov v krvi), zaprtje, zgaga (dispepsija), okužbe, vključno z
34 and skin, dry or watery eyes, sweating, feeling weak and unwell, anxiety, depression, abnormal thinking, dizziness, loss of appetite, weight loss, altered taste, asthma, lung disorders, back pain, neck pain, bone pain, leg cramps, haemorrhoids (piles), bruises and arthritis.
34 okužbami mehurja in kože, pasasti izpuščaj, vnetje dojk, vnetje trebušne slinavke ali jeter, bolezni ledvic, povečan mišični tonus/ napetost (hipertonija), tremor, otrplost ali zbadanje v prstih rok in nog, spremembe na nohtu, izguba las, nespečnost (insomnija), zaspanost (somnolenca), krvavitve iz nosu, akne, srbež, suha usta in koža, suhe ali solzne oči, znojenje, občutek šibkosti in slabo počutje, utesnjenost, depresija, motnje razmišljanja, omotica, izguba apetita, izguba telesne mase, sprememba okusa, astma, motnje delovanja pljuč, bolečina v hrbtenici, vratu, v kosteh, krči v nogah, hemoroidi (zlata žila), modrice in vnetje sklepov.
If you receive Herceptin in combination with chemotherapy, some of them may also be due to the chemotherapy.
Če prejemate skupaj z zdravilom Herceptin tudi kemoterapijo, so lahko nekateri neželeni učinki tudi nastali zaradi kemoterapije.
If you experience any of the side effects mentioned in this leaflet or notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Če se pri vas pojavi katerikoli neželen učinek omenjen v tem navodilu ali če opazite druge neželene učinke, ki niso omenjeni v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE HERCEPTIN
SHRANJEVANJE ZDRAVILA HERCEPTIN
Do not use this medicine after the expiry date stated on the outer carton and on the vial label (EXP).
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in na nalepki na viali (Uporabno do:).
- The active substance is trastuzumab.
- Zdravilna učinkovina je trastuzumab.
Each vial contains 150 mg trastuzumab.
Vsaka viala vsebuje 150 mg trastuzumaba.
- The other ingredient(s) are L-histidine hydrochloride, L-histidine, α ,α -trehalose dihydrate,
- Pomožne snovi so L- histidinijev klorid, L- histidin, α, α- trehaloza dihidrat in polisorbat 20.
Herceptin 150 mg Powder for concentrate for solution for infusion trastuzumab
Herceptin 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Roche Pharma AG Emil- Barell- Strasse- 1 D- 79639 Grenzach- Wyhlen Nemčija
35 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Always keep this medicine in the closed original pack at a temperature of 2 - 8°C in a refrigerator.
Zdravilo shranjujte v dobro zaprti originalni ovojnini pri temperaturi 2- 8 °C, v hladilniku.
A vial of Herceptin reconstituted with sterile water for injections (not supplied) is stable for 48 hours at 2
Po rekonstituciji vsebine viale zdravila Herceptin s sterilno vodo za injekcije (ni dodana) je pripravljena raztopina stabilna 48 ur pri temperaturi od 2- 8 °C.
- 8°C after reconstitution and must not be frozen.
Pripravljene raztopine ne smemo zamrzniti.
Each vial of Herceptin is reconstituted with 7.2 ml of sterile water for injections (not supplied).
Vsebino viale zdravila Herceptin raztopimo v 7, 2 ml sterilne vode za injekcije (ni dodana).
This yields a 7.4 ml solution for single-dose use, containing approximately 21 mg/ ml trastuzumab.
Rekonstitucija da 7, 4 ml raztopine za enkratno uporabo in vsebuje približno 21 mg/ ml trastuzumaba.
A volume overage of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
4% presežek volumna omogoča, da na nalepki naveden odmerek 150 mg res odvzamemo iz viale.
Volume (ml) = Body weight (kg) x dose (4 mg/ kg for loading or 2 mg/ kg for maintenance) 21 (mg/ ml, concentration of reconstituted solution)
volumen (ml) = telesna masa (kg) x odmerek (4 mg/ kg za uvajanje ali 2 mg/ kg za vzdrževanje) 21 (mg/ ml, koncentracija pripravljene raztopine)
based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:
za uvajalni odmerek 8 mg trastuzumaba/ kg telesne mase ali za nadaljnje tritedenske odmerke 6 mg trastuzumaba/ kg telesne mase s pomočjo formule:
Volume (ml) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/ml, concentration of reconstituted solution)
volumen (ml) = telesna masa (kg) x odmerek (8 mg/ kg za uvajanje ali 6 mg/ kg za vzdrževanje) 21 (mg/ ml, koncentracija pripravljene raztopine)
The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 ml of 0.9% sodium chloride solution.
Primerno količino raztopine je potrebno odvzeti iz viale in dodati polivinilkloridni, polietilenski ali polipropilenski infuzijski vrečki, ki vsebuje 250 ml 0, 9% raztopine natrijevega klorida.
Once the infusion is prepared it should be
Ko je infuzija pripravljena, jo je potrebno takoj infundirati.
HEXAVAC International Nonproprietary Name (INN):
HEXAVAC Mednarodno nelastniško ime (INN):
Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted
Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno), otroški ohromelosti (inaktivirano), hepatitisu B (rekombinantno) in proti Hemofilius influenzae tipa b (konjugirano cepivo), z adjuvansom
Purified adsorbed diptheria toxoid (PDT)
Prečiščen adsorbiran davični toksoid (PDT) Zdravilna učinkovina:
Purified tetanus toxoid (PTT) Purified pertussis toxoid (PTxT) Purified pertussis filamentous haemagglutinin (FHA) Hepatitis B S surface antigen recombinant (HBsAG) Inactivated poliovirus (IPV): type 1 (Mahoney) type 2 (MEF 1) type 3 (Saukett) Haemophilus influenzae type b polysaccharide, conjugated to tetanus protein (PRP-T)
Prečiščen tetanusni toksoid (PTT) Prečiščen toksoid pertusisa (PTxT) Prečiščen filamentozni hemaglutinin pertusisa (FHA) Rekombinantni površinski antigen virusa hepatitisa B S (HBsAG) Inaktivirani poliovirus (IPV): tipa 1 (Mahoney) tipa 2 (MEF 1) tipa 3 (Saukett) Polisaharid bakterije Hemofilius influenzae tipa b, konjugiran na tetanusni protein (PRP- T)
Pharmaco-therapeutic group (ATC Code):
Kombinacije bakterijskih in virusnih cepiv Farmakoterapevtska skupina (JO7CA) (ATC oznaka):
This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.
Kombinirano cepivo je indicirano za osnovno in Trenutno odobrena( e) terapevtska( e) obnovitveno cepljenje otrok proti davici, tetanusu, indikacija( e): pertusisu, hepatitisu B, ki ga povzročajo vsi znani podtipi virusov, otroški ohromelosti in invazivnim okužbam, ki jih povzroča Haemophilus influenzae tipa b.
See the Module “ All authorised presentations”
Glejte modul ” All authorised presentations ” Odobrene farmacevtske oblike:
Marketing Authorisation Holder:
AVENTIS PASTEUR MSD, SNC Imetnik dovoljenja za promet z zdravilom:
AVENTIS PASTEUR MSD, SNC 8, rue Jonas Salk F-69007 Lyon France
8 rue Jonas Salk F- 69007 Lyon Francija
23 October 2000
23. oktober 2000 Datum izdaje dovoljenja za promet z zdravilom, veljavnega po vsej Evropski uniji:
Orphan medicinal product designation date:
Navedba smiselno ni potrebna Datum določitve zdravila kot zdravila sirote:
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2005 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hexavac is a hexavalent vaccine which contains combined antigens derived from Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, polio virus and Haemophilus influenzae type b.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2005 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hexavac je heksavalentno cepivo, ki vsebuje kombinirane antigene, ki izhajajo iz Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virusa hepatitisa B, virusa polia ter Haemophilusu influenzae typa b.
The following adverse effects were reported very rarely: allergic reaction, chills, fatigue, hypotonic- hyporesponsive episode, malaise, oedema, pallor, swelling or oedema of the entire limb(s), transient local lymph node swelling, convulsions (febrile and non febrile), encephalitis, encephalopathy with acute brain oedema, eyes rolling, Guillain Barré Syndrome, hypotonia, neuritis, abdominal pain, meteorism, nausea, petechiae, purpura, purpura thrombocytopenic, thrombocytopenia, agitation, sleep disorder, dyspnoea or Stridor inspiratory, angioedema, erythema, pruritus, rash, urticaria and flushing.
Zelo redko pa poročajo o naslednjih neželenih učnikih: alergične reakcije, mrzlica, utrujenost, hipotonična- hipoodzivna epizoda, splošna slabost, edem bledica, otekanje ali edem celotnega uda( ov), prehodno otekanje lokalnih limfnih vozljev, krči (vročinski in nevročinski), encefalitis, encefalopatija za akutnim edemom v možganih, vrtenje oči, sindrom Guillain Barré hipotonija, nevritis, bolečine v trebuhu meteorizem, slabost, petehije, purpura, trombocitopenična purpura, trombocitopenija, razburjenje, motnje spanja, oteženo dihanje ali škripavo vdihovanje, angioedem, rdeč kožni madeži, srbečica, izpuščaj, urtikarija in rdenje.
The CHMP, on the basis of quality, efficacy and safety data submitted, consideres that the overall benefit / risk ratio for Hexavac remains favourable in the approved indication.
Na podlagi predloženih podatkov o kakovosti, učinkovitosti in varnosti CHMP meni, da vsesplošno razmerje med koristmi in tveganji za zdravilo Hexavac ostaja ugodno za odobreno indikacijo.
Invented name
Zaščiteno ime Jakost Farmacevtska oblika
Pharmaceutical form Route of administration
Ovojnina
Content
Velikost pakiranja
Package size
- 1 -
Hexavac
Hexavac Suspenzija za injiciranje - 1 -
Suspension for Intramuscular use injection
Intramuskularna uporaba
10 syringes with attached needle
10 injekcijskih brizg s priloženimi iglami
25 syringes with attached needle
25 injekcijskih brizg s priloženimi iglami
50 syringes with attached needle
50 injekcijskih brizg s priloženimi iglami
10 syringes without attached needle
10 injekcijskih brizg brez priloženih igel
25 syringes without attached needle
25 injekcijskih brizg brez priloženih igel
EU/ 1/ 00/ 147/ 008
EU/ 1/ 100/ 147/ 008 Hexavac
Hexavac
- 1 -
-1-
Suspenzija za injiciranje
50 syringes without attached needle
50 injekcijskih brizg brez priloženih igel
EU/ 1/ 00/ 147/ 009
EU/ 1/ 00/ 147/ 009 Hexavac
EU/ 1/ 00/ 147/ 010
EU/ 1/ 00/ 147/ 010 Hexavac
EU/ 1/ 00/ 147/ 011
EU/ 1/ 00/ 147/ 011 Hexavac
EU/ 1/ 00/ 147/ 012
EU/ 1/ 00/ 147/ 012 Hexavac 1 Posamezni odmerek 0, 5 ml vsebuje:
Hexavac
Suspenzija za injiciranje
Suspension for Intramuscular use injection
Intramuskularna uporaba ≥ 20 i. e.
≥ 40 IU
Prečiščen davični toksoid, adsorbiran (PDT) ≥ 40 i. e.
1/ 2 Purified pertussis toxoid, adsorbed (PTxd) Purified filamentous haemagglutinin adsorbed (FHA) Recombinant hepatitis B surface antigen, S (HBsAg) Inactivated poliomyelitis virus (IPV):
1/ 2 Prečiščen filamentozni hemaglutinin bordetele pertusis, adsorbiran (FHA)
25 µg 25 µg 5.0 µg
25 µg
type 1 type 2 type 3 Haemophilus influenzae polysaccharide type b conjugated to tetanus protein (PRP-T)
tipa 1 tipa 2 tipa 3 Polisaharid Haemophilus influenzae tipa B konjugiran na tetanusni toksoid (PRP- T)
40 D units 8 D units 32 D units 12 µg 24 µg
40 D enot 8 D enot 32 D enot 12 µg 24 µg
Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted.
Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno), otroški ohromelosti (inaktivirano), hepatitisu B (rekombinantno) in proti hemofilusu tipa b (konjugirano).
Each 0.5 ml adjuvanted dose contains:
En 0, 5 mililitrski odmerek adsorbiranega cepiva vsebuje:
Purified diphtheria toxoid....................................................... equal to or greater than 20 IU* (30 Lf) Purified tetanus toxoid............................................................ equal to or greater than 40 IU* (10 Lf) Purified pertussis toxoid.........................................................
Prečiščen davični toksoid....................................................... ne manj kot 20 i. e. * (30 Lf) Prečiščen tetanusni toksoid..................................................... ne manj kot 40 i. e. * (10 Lf) Prečiščen toksoid bordetele pertusis.......................................
25 micrograms Purified pertussis filamentous haemagglutinin......................
25 mikrogramov Prečiščen filamentozni hemaglutinin bordetele pertusis........
25 micrograms Hepatitis B surface antigen **................................................
25 mikrogramov Površinski antigen virusa hepatitisa B **...............................
D antigen^:
5, 0 mikrogramov Inaktiviran poliovirus tipa 1 (Mahoney)................................. antigen D^:
D antigen^:
40 enot † Inaktiviran poliovirus tipa 2 (MEF 1).................................... antigen D^:
D antigen^:
8 enot † Inaktiviran poliovirus tipa 3 (Saukett).................................... antigen D^:
32 units † Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 12 micrograms conjugated to tetanus toxoid (24 micrograms)
32 enot † Polisaharid Haemophilus influenzae tipa b (poliribozilribitol fosfat) 12 mikrogramov, konjugiran na tetanusni toksoid (24 mikrogramov)
Adjuvanted on aluminium hydroxide (0.3 mg)
Adsorbirano na: aluminijev hidroksid (0, 3 mg)
* As lower confidence limit (p = 0.95). ** Surface antigen of hepatitis B virus produced from recombinant strain 2150-2-3 of the yeast Saccharomyces cerevisiae. ^ Quantity of antigen in the final bulk product, according to W. H. O.
* Spodnja meja intervala zaupanja (p=0, 95). ** Površinski antigen virusa hepatitisa B proizvaja rekombinantni sev 2150- 2- 3 kvasovke Saccharomyces cerevisiae. ^ Količina antigena v končnem proizvodu po W. H. O.
(TRS 673, 1992) † Or equivalent antigenic quantity determined by a suitable immunochemical method
(TRS 673, 1992) † Ali enakovredna količina antigena določena s primerno imunokemijsko metodo
For excipients, see 6.1
Za pomožne snovi glejte 6. 1.
The primary vaccination schedule consists of two or three doses of 0.5 ml administered within the first year of life according to official recommendations.
Med odmerki naj bo najmanj enomesečni presledek: npr.
There should be an interval of at least 1 month between doses: such as 2, 3, 4 months; 2, 4, 6 months; 3, 5 months.
2., 3., 4. mesec; 2., 4., 6. mesec; 3., 5. mesec.
2 Booster:
Obnovitveno cepljenje:
After a primary vaccination with 2 doses of HEXAVAC (i. e.
2 Po uradnih priporočilih se mora pri primarnem cepljenju z 2 odmerkoma HEXAVAC- a (npr.
3, 5 months), a booster dose must be given between 11 and 13 months of age; after a primary vaccination with 3 doses of Hexavac (e. g.
3. in 5. mesec) obnovitveno cepljenje izvesti med 11. in 13. mesecem življenja; po primarnem cepljenju s 3 odmerki HEXAVAC- a (npr.
Method of administration HEXAVAC should be administered intramuscularly into the quadriceps or deltoid preferably at alternating sites for subsequent injections.
Zaželeno je izmenjevanje mest vnosa pri naslednjih injekcijah.
Infants born of hepatitis B virus surface antigen (HBsAg)-positive mothers should receive Hepatitis B Immune Globulin (HBIG) and Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
Novorojenčki mater pozitivnih za površinski antigen virusa hepatitisa B (HBsAg) naj ob rojstvu prejmejo imunoglobulin proti virusu hepatitisa B (HBIG) in rekombinantno cepivo proti hepatitisu B, nato pa dokončajo zaporedje cepljenj proti hepatitisu B.
The subsequent administration of HEXAVAC for completion of the hepatitis B vaccination series in infants who were born of HBsAg-positive mothers and received HBIG or infants born of mothers of unknown status has not been studied.
Dajanje HEXAVAC- a za dokončanje zaporedja cepljenj proti hepatitisu B pri novorojenčkih mater pozitivnih za HBsAg, ki so prejeli HBIG, in pri novorojenčkih mater neznanega statusa ni preučeno.
HEXAVAC should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Pri dajanju HEXAVAC- a osebam s trombocitopenijo ali motnjo krvavitve je potrebna previdnost, saj se lahko pri teh osebah razvije krvavitev kot posledica intramuskularnega odmerjanja.
If any of the following events are known to have occurred in temporal relation to receipt of the vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:
Temperatura ≥ 40, 0 °C v 48 urah brez drugega vzroka.
Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause.
Kolaps ali šokovno stanje (hipotoničnost- hipoodzivnost) v 48 urah po cepljenju.
3 As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of vaccine.
Kot pri vseh cepivih, ki se injicirajo, mora biti na voljo primerno zdravljenje in zdravniški nadzor za takojšnje ukrepanje za primer razvoja redke anafilaktične reakcije po cepljenju.
Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of immunisation.
3 Zaradi dolge inkubacijske dobe hepatitisa B, je možno, da je v času cepljenja prisotna nezaznavna okužba z virusom hepatitisa B.
The vaccine may not prevent hepatitis B infection in such cases.
V takšnih primerih cepivo ne more preprečiti okužbe z virusom hepatitisa B.
The immunogenicity of HEXAVAC could be reduced by immunosuppressive treatment or immunodeficiency.
Imunosupresivno zdravljenje ali imunska pomanjkljivost lahko zmanjšata imunogenost HEXAVAC- a.
There are currently no sufficient data available regarding immunogenicity of the concomitant administration of HEXAVAC with PREVENAR (pneumococcal polysaccharide conjugated vaccine, adsorbed).
Trenutno ni na voljo dovolj podatkov glede imunogenosti sočasnega cepljenja s HEXAVAC- om in PREVENAR- jem (pnevmokokno polisaharidno konjugirano cepivo z adjuvansom).
However when HEXAVAC was co-administered with PREVENAR (pneumococcal polysaccharide conjugated vaccine, adsorbed) in clinical studies, the rate of febrile reactions was higher compared to that occurring following the administration of hexavalent vaccines alone.
Vendar je bila v kliničnih poskusih sočasnega dajanja HEXAVAC- a in PREVENAR- ja (pnevmokoknega polisaharidnega konjugiranega cepiva z adjuvansom) stopnja febrilnih reakcij višja kot pri cepljenju samo s heksavalentnimi cepivi.
HEXAVAC must not be mixed in the same syringe with other vaccines or other parenterally administered drugs.
HEXAVAC- a se v isti injekcijski brizgi ne sme mešati z drugimi cepivi ali drugimi zdravili za parenteralno uporabo.
Except in the case of immunosuppressive therapy (see 4.4 Special warnings and special precautions for use), no significant clinical interaction with other treatments or biological products has been documented.
Razen v primerih imunosupresivnega zdravljenja (glejte poglavje 4. 4 Posebna opozorila in previdnostni ukrepi) niso znane pomenljive klinične interakcije z drugimi zdravljenji ali biološkimi proizvodi.
There are no data in regards to the efficacy and safety of concomitant administration of HEXAVAC with Measles, Mumps and Rubella Virus Vaccine, live.
Trenutno ni podatkov o učinkovitosti in varnosti sočasnega cepljenja s HEXAVAC- om in živimi cepivi proti ošpicami, mumpsu in rdečkami.
In clinical trials, more than 3,900 infants and 4,400 toddlers (from 12 to 20 months of age) have received HEXAVAC.
V kliničnih poskusih je prejelo HEXAVAC več kot 3. 900 dojenčkov in 4. 400 malčkov (med 12. in 20. mesecem starosti).
Commonly reported reactions included redness and/ or induration/ swelling/ pain at the injection site, fever equal to or greater than 38 °C, irritability, drowsiness, loss of appetite, insomnia, diarrhoea and vomiting.
Pogosto poročane reakcije so bile rdečina in/ ali otrdlina/ oteklina/ bolečina na mestu vbrizganja, vročina ≥ 38 °C, razdražljivost, zaspanost, izguba teka, nespečnost, driska in bruhanje.
Less commonly, fever equal to or greater than 40 °C, tenderness at the injection site, prolonged inconsolable crying and redness and/ or induration > 7 cm at the injection site or swelling of the entire limb have been reported.
Manj pogosto 4 poročane reakcije so bile vročina ≥ 40 °C, občutljivost na mestu vbrizganja, trajajoč neutolažljiv jok in rdečina in/ ali otrdlina > 7 cm na mestu vbrizganja ali otekanje celotnega uda.
The rate of fever equal to or greater than 40 °C increased after booster immunisation but remained < 1%.
Stopnja pojavnosti vročine ≥ 40 °C je povečana pri poživitvenem cepljenju, vendar ostaja pod 1%.
Redness and/ or induration > 7 cm at the injection site increased after booster immunisation but remained < 1%.
Stopnja pojavnosti rdečine in/ ali otekline > 7 cm na mestu vbrizganja je povečana pri poživitvenem cepljenju, vendar ostaja pod 1%.
Oedema / Pruritus / Urticaria.
• Postmarketinške izkušnje O spodaj navedenih neželenih učinkih so poročali po začetku splošne uporabe HEXAVAC- a, Pogosti (> 1/ 100 in < 1/ 10) Motnje na mestu uporabe (reakcije na mestu vbrizganja): edem / srbečica / urtikarija.
Prolonged or abnormal crying.
Redki (> 1/ 10. 000 in < 1/ 1. 000) Telo kot celota - splošne težave: trajajoč in nenormalen jok.
Allergic reaction / Chills / Fatigue / Hypotonic-hyporesponsive episode / Malaise / Oedema / Pallor / Swelling or oedema of the entire limb(s) / Transient local lymph node swelling.
Zelo redki (< 1/ 10. 000) Telo kot celota - splošne težave: alergijska reakcija / mrazenje / utrujenost / hipotonična- hipoodzivna epizoda / splošna slabost / edem / bledica / otekanje ali edem celotnega uda( ov) / prehodno otekanje lokalnih limfnih vozljev.
Convulsions (febrile and non febrile) / Encephalitis / Encephalopathy with acute brain oedema / Eyes rolling / Guillain Barré Syndrome / Hypotonia / Neuritis.
Bolezni centralnega in perifernega živčevja: krči (vročinski in nevročinski) / encefalitis / encefalopatija z akutnim edemom v možganih / vrtenje oči / sindrom Guillain Barré / hipotonija / Nevritis.
Abdominal pain / Meteorism / Nausea.
Bolezni prebavil: bolečine v trebuhu / meteorizem / slabost.
Petechiae / Purpura / Purpura thrombocytopenic / Thrombocytopenia.
Motnje trombocitov, krvavitev in strjevanja: petehije / purpura / trombocitopenična purpura / trombocitopenija.
Psychiatric disorders:
Psihiatrične motnje: razburjenje / motnje spanja.
Agitation / Sleep disorder.
Bolezni dihal: oteženo dihanje ali škripavo vdihovanje.