natgillin/translations-raw huggingface dataset:
However children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Hexacima 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 Hexacima, vendar morda zaščita ne bo tako dobra, kot pri otrocih, katerih imunski sistem je zdrav.
In these cases the immune response to the vaccine may be decreased.
V teh primerih je imunski odziv na cepivo lahko zmanjšan.
Very common Anorexia (decreased appetite)
Anoreksija (zmanjšan apetit)
Other paediatric population
Ostala pediatrična populacija
If you forget one dose of Hexacima
Če pozabite en odmerek cepiva Hexacima
No significant clinical interaction with other treatments or biological products has been reported except in the case of immunosuppressive therapy (see section 4.4).
Poročana ni bila nobena pomembna klinična interakcija z drugimi zdravljenji ali z biološkimi zdravili, razen v primeru imunosupresivnega zdravljenja (glejte poglavje 4.4).
Vaccination with Hexacima may need to be delayed until your child is better.
Cepljenje s cepivom Hexacima bo morda treba preložiti, dokler se stanje vašega otroka ne izboljša.
In some people, the virus can stay in the body for a long time, and can eventually lead to serious liver problems, including liver cancer.
Pri nekaterih ljudeh lahko virus ostane v telesu zelo dolgo časa in lahko privede do resnih težav z jetri vključno do raka na jetrih.
Before the injection of any biological, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions.
Pred injiciranjem bioloških sestavin mora odgovorna oseba upoštevati vse znane varnostne ukrepe za preprečevanje alergijskih ali drugih reakcij.
* Adverse reactions from spontaneous reporting.
* Neželeni učinki iz spontanega poročanja
When these signs or symptoms (signs or symptoms of anaphylactic reaction) occur they usually develop quickly after the injection is given and while the child is still in the clinic or doctor's surgery.
Če se pojavijo ti znaki ali simptomi (znaki ali simptomi anafilaktične reakcije), se običajno razvijejo hitro po prejeti injekciji, ko je otrok še vedno v bolnišnici ali v zdravnikovi ambulanti.
• Diphtheria is an infectious disease that usually first affects the throat.
• Davica je nalezljiva bolezen, ki običajno najprej prizadene grlo.
However, a lower immune response may be observed and the level of clinical protection is unknown.
Opazili so, da je imunski odziv lahko slabši, raven klinične zaščite pa je neznana.
In this case, the decision to give any further vaccine containing tetanus toxoid should be evaluated by your doctor.
V tem primeru mora odločitev o nadaljnjem dajanju cepiva, ki vsebuje tetanusni toksoid, pretehtati zdravnik.
Date of latest renewal: 08 January 2018
Datum prve odobritve: 17. april 2013 Datum zadnjega podaljšanja: 8. januar 2018
Your doctor will advise you whether your child should have Hexacima.
Zdravnik vam bo svetoval, ali naj vaš otrok prejme cepivo Hexacima.
Very rare (<1/10,000) Not known (cannot be estimated from available data)
Neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Vaccination is usually justified for individuals whose primary vaccination is incomplete (i.e. fewer than three doses have been received).
Cepljenje je običajno utemeljeno pri posameznikih, pri katerih osnovna shema cepljenja še ni zaključena (tj. prejeli so manj kot tri odmerke).
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
V skladu s členom 114 Direktive 2001/83/EC z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
QUALITATIVE AND QUANTITATIVE COMPOSITION One dose
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Immune responses to the vaccine have not been studied in the context of genetic polymorphism.
Imunskih odzivov na cepivo v okviru genetskih polimorfizmov niso preučevali.
Other medicines or vaccines and Hexacima
Druga zdravila ali cepiva in cepivo Hexacima
The intradermal or intravenous routes must not be used.
Intradermalna ali intravenska pot uporabe se ne smeta uporabljati.
At the end of this period, Hexacima should be used or discarded.
Ob koncu tega obdobja morate cepivo Hexacima uporabiti ali zavreči.
Efficacy and effectiveness in protecting against pertussis
Učinkovitost in uspešnost zaščite proti oslovskemu kašlju
Hexacima (DTaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases.
Hexacima (DTaP-IPV-HB-Hib) je cepivo, ki se uporabljajo za zaščito pred nalezljivimi boleznimi.
The vaccine effectiveness was of 96.7% for the full primary series, and 98.5% for booster dose (irrespective of priming).
Učinkovitost cepiva je bila 96,7 % pri popolni osnovni seriji in 98,5 % pri obnovitvenem odmerku (ne glede na osnovno shemo).
The vaccine will never be given into a blood vessel or into or under the skin.
Cepivo ne bo nikoli dano v žilo ali pod kožo.
• Temperature of ≥ 40°C within 48 hours not due to another identifiable cause;
• temperatura ≥ 40°C v 48 urah, ki ji ni možno pripisati drugega ugotovljenega vzroka;
What Hexacima is and what it is used for
Kaj je cepivo Hexacima in za kaj ga uporabljamo
At the injection sites, chronic histological inflammatory changes were observed, that are expected to have a slow recovery.
Na mestih injiciranja so opazili kronične histološke vnetne spremembe, pri katerih je pričakovano daljše okrevanje.
The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4th and 5th doses.
Kaže, da je tveganje odvisno od števila predhodnih odmerkov cepiva, ki vsebuje acelularno komponento proti oslovskemu kašlju, pri čemer je tveganje večje po 4. in 5. odmerku.
• Poliovirus (Inactivated) Types 1/2/3
• poliovirus (inaktiviran) tip 1/2/3
Do not administer by intravascular, intradermal or subcutaneous injection.
Ne aplicirajte z intravaskularnim, intradermalnim ali subkutanim injiciranjem.
The suspension should be visually inspected prior to administration.
Pred uporabo je treba vizualno pregledati suspenzijo.
Results of long term follow-up demonstrated a dramatic reduction of the pertussis incidence following the second dose regardless of the vaccine used.
Rezultat po dolgotrajnem spremljanju kažejo znatno zmanjšanje pojavnosti oslovskega kašlja po drugem odmerku ne glede na uporabljeno cepivo.
The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause these different infections:
Cepivo deluje tako, da v telesu spodbudi nastajanje lastne zaščite (protiteles) proti bakterijam in virusom, ki povzročajo naslednje okužbe:
LLOQ value for anti-PT and anti-FHA is 2 EU/ml
Vrednost LLOQ za anti-PT in anti-FHA je 2 E.e./ml.
• is having a treatment that suppresses her/his immune system (the body's natural defenses) or has any disease that causes the weakness of the immune system.
• bil zdravljen z zdravilom, ki zavira njegov/njen imunski sistem (naravni obrambni mehanizem telesa), ali ima otrok katerokoli bolezen, ki povzroča šibkost imunskega sistema.
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 (v presledku najmanj 4 tednov) skladno z uradnimi priporočili.
12 µg conjugated to Tetanus protein
12 µg konjugiran na tetanusno beljakovino
Primary 6-10-14 weeks and booster at 15-18 months
Primarno pri 6-10-14 tednih in obnovitveni odmerek po 15 do 18 mesecih
Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed within 1 to 2 weeks following vaccination.
Ker se kapsularni polisaharidni antigen Hib izloča v urin, se lahko v 1 do 2 tednih po cepljenju pojavi pozitiven izvid urinskega testa.
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 Hexacima and not directly with Hexacima)
d- Možni neželeni učinki (Tj. neželeni učinki, o katerih poročajo pri drugih cepivih, ki vsebujejo eno ali več komponent ali sestavin cepiva Hexacima, in ne neposredno pri cepivu Hexacima.)
• As with any vaccine, Hexacima may not protect 100% of children who receive the vaccine.
• Kot velja za vsa cepiva, tudi cepivo Hexacima ne more 100% zaščititi otroka, ki je prejel to cepivo.
Paralysis of the muscles that control breathing and swallowing can be fatal.
Paraliza mišic, ki nadzorujejo dihanje in požiranje, je lahko usodna.
Associated symptoms may include cyanosis, redness, transient purpura and severe crying.
Povezani simptomi lahko vključujejo cianozo, rdečico, prehodno purpuro in hud jok.
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Apneja pri zelo prezgodaj rojenih nedonošenčkih (v 28. tednu gestacije ali prej) (glejte poglavje 4.4)
Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse reactions).
Pred cepljenjem je treba preučiti anamnezo (predvsem predhodnih cepljenj in morebitnih neželenih učinkov).
• Hexacima will only help to prevent these diseases if they are caused by the bacteria or viruses targeted by the vaccine.
• Cepivo Hexacima ščiti pred temi boleznimi samo, če jih povzročajo bakterije ali virusi, proti katerim je cepivo usmerjeno.
Tell your doctor or nurse if your child is taking, has recently taken or might take any other medicines or vaccines.
Obvestite svojega zdravnika ali farmacevta ali medicinsko sestro, če vaš otrok jemlje ali pa bo morda začel jemati katero koli drugo zdravilo ali cepivo.
• Shake the vial so that the contents become homogeneous.
• Vialo pretresite, da se vsebina homogenizira.
Serious allergic reactions (anaphylactic reaction)
Hude alergijske reakcije (anafilaktična reakcija)
After the first course of injections, your child will receive a booster dose, in accordance with local recommendations, at least 6 months after the last dose of the first course.
Po prvem cepljenju v skladu z lokalno shemo cepljenja bo vaš otrok skladno z lokalnimi priporočili vsaj 6 mesecev po zadnjem odmerku prvega cepljenja prejeti obnovitveni odmerek.
• has any problems with the blood that cause easy bruising or bleeding for a long time after minor cuts.
• ima težave s krvjo, ki povzročajo nagnjenost k podplutbam ali krvavitvam, ki trajajo dlje časa po manjših urezninah.
What Hexacima is and what it is used for What you need to know before Hexacima is given to your child How to use Hexacima
Kaj je cepivo Hexacima in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok prejel cepivo Hexacima Kako uporabljati cepivo Hexacima
The safety of Hexacima in children over 24 months of age has not been studied in clinical trials.
Varnost cepiva Hexacima pri otrocih starejših od 24 mesecev ni bila raziskana v kliničnih preskušanjih.
Read all of this leaflet carefully before your child is vaccinated because it contains important information for him/her.
Preden vaš otrok dobi to cepivo, natančno preberite navodilo, ker vsebuje zanj/zanjo pomembne podatke!
1541 avenue Marcel Mérieux 69280 Marcy L'Etoile France
1541 avenue Marcel Mérieux 69280 Marcy l'Etoile Francija
As with all injectable vaccines, the vaccine must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.
Kot pri vseh cepivih, ki se injicirajo, je treba cepivo dajati previdno pri posameznikih s trombocitopenijo ali motnjami krvavitve, saj lahko po intramuskularni aplikaciji pride do krvavitve.
• 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.
Serious allergic reactions are a rare possibility (may affect up to 1 in 1,000 people) after receiving this vaccine.
Hude alergijske reakcije se pojavijo redko (pri največ 1 od 1.000 cepljenih) po prejemu tega cepiva.
Pertussis vaccine should not be administered to individuals with uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilised and the benefit clearly outweighs the risk.
Posamezniki z nenadzorovano nevrološko boleznijo ali nenadzorovano epilepsijo ne smejo prejeti cepiva proti oslovskemu kašlju, dokler se ne uvede tak režim zdravljenja, da se stanje stabilizira ter dokler koristi jasno ne odtehtajo tveganja.
In clinical studies in individuals who received Hexacima, the most frequently reported reactions include injection-site pain, irritability, crying, and injection-site erythema.
V kliničnih študijah pri posameznikih, ki so prejeli cepivo Hexacima, so bili najpogosteje poročani neželeni učinki: bolečina na mestu injiciranja, razdražljivost, jok in pordelost na mestu injiciranja.
Individuals with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.
Cepljene posameznikov z anamnezo vročinskih krčev je treba natančno spremljati, saj se taki neželeni učinki lahko pojavijo v dveh do treh dneh po cepljenju.
If any of these symptoms occur after leaving the place where your child received his/her injection, you must consult a doctor IMMEDIATELY:
Če se kateri od teh simptomov pojavi, ko zapustite kraj, kjer je vaš otrok prejel injekcijo, se morate
Hypotonic reactions or hypotonic-hyporesponsive episodes (HHE)
zelo redki hipotonične reakcije ali hipotonično hiporesponzivna epizoda (HHE)
Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
000 do <1/100) Redki (≥1/10.000 do <1/1.000) Zelo redki (<1/10.000)
• suffers from any undiagnosed illness of the brain or epilepsy which is not controlled.
• trpi za nediagnosticirano boleznijo možganov ali nenadzorovano epilepsijo.
• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination;
• kolaps ali šoku podobno stanje (hipotonično-hiporesponzivna epizoda) v 48 urah po cepljenju;
Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.
Ne aplicirajte z intravaskularnim injiciranjem: pazite, da igla ne prodre v žilo.
Immunisation must be carried out by intramuscular (IM) injection.
Cepljenje je treba opraviti z intramuskularno injekcijo (i.m.).
It is normally recommended to wait until the end of the treatment or disease before vaccinating.
Priporoča se, da se pred cepljenjem počaka do konca zdravljenja ali bolezni.
• In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2 - 3 days after vaccination.
• pri zelo prezgodaj rojenih nedonošenčkih (v 28. tednu nosečnosti ali prej) so lahko 2 do 3 dni po cepljenju razmiki med vdihi daljši kot normalno.
If this reaction occurs, it is mainly after primary injections and within the first few hours following vaccination.
Če se pojavi taka reakcija, se običajno pojavi pri osnovnem cepljenju in jo opažajo v prvih nekaj urah po cepljenju.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following administration of the vaccine.
Kot pri vseh cepivih, ki se injicirajo, je treba vedno zagotoviti ustrezno zdravljenje in nadzor, ki morata biti nemudoma na voljo v primeru anafilaktične reakcije po cepljenju.
The safety and efficacy of Hexacima in infants less than 6 weeks of age have not been established.
Varnost in učinkovitost cepiva Hexacim pri dojenčkih, mlajših od 6 tednov, nista bili dokazani.
Persistence of immune response
Trajanje imunskega odziva
All events should resolve spontaneously without sequel within 24 hours.
Vse reakcije minejo spontano in brez posledic v 24 urah.
For instructions on handling see section 6.6.
Za navodila zdravila pred dajanjem glejte poglavje 6.6.
• Hexacima should not be mixed with other medicinal products.
• Cepiva Hexacima ne smete mešati z drugimi zdravili.
In the throat, the infection causes pain and swelling which can lead to suffocation.
V grlu okužba povzroči bolečino in otekanje, ki lahko privede do zadušitve.
• Haemophilus influenzae type b infections (often just called Hib) are serious bacterial infections and can cause meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness.
• Okužbe s Haemophilusom influenzae tipa b (pogosto imenovan Hib) so hude bakterijske okužbe in lahko povzročajo meningitis (vnetje zunanje možganske ovojnice), kar lahko privede do poškodb možganov, gluhosti, epilepsije ali delne slepote.
If Guillain-Barré syndrome or brachial neuritis has occurred following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks, such as whether or not the primary vaccination has been completed.
Če se po prejemu predhodnega cepiva, ki vsebuje tetanusni toksoid, razvije Guillain-Barréjev sindrom ali brahialni nevritis, je treba odločitev o nadaljevanju cepljenja s cepivi, ki vsebujejo tetanusni toksoid, skrbno pretehtati glede na morebitne koristi in tveganja, kot na primer, ali je bila osnovna shema cepljenja zaključena.
• Tetanus (often called lock jaw) is usually caused by the tetanus bacteria entering a deep wound.
• Tetanus (pogosto imenovan mrtvični krč) običajno povzročajo bakterije tetanusa, ki vstopajo skozi globoko rano.
Primary 2-4-6 months and booster at 12-24 months
Primarno pri 2-4-6 mesecih in obnovitveni odmerek po 12 do 24 mesecih
Hexacima must not be mixed with any other vaccines or other parenterally administered medicinal products.
Cepiva Hexaxim ne smemo mešati z drugimi cepivi ali drugimi parenteralno apliciranimi zdravili.
If your child misses a scheduled injection, it is important that you discuss with your doctor or nurse who will decide when to give the missed dose.
Če vaš otrok zamudi predvideni odmerek je pomembno, da se pogovorite s svojim zdravnikom ali medicinsko sestro, ki bosta določila, kdaj naj otrok prejme izpuščeni odmerek.
3 Or equivalent activity determined by an immunogenicity evaluation 4 Produced on Vero cells
3 Ali enakovredna aktivnost, določena z oceno imunogenosti.
Months N=249** N=204† N=178†† N=177 to
3-5 mesecev 6-10-14 tednov mesecev mesecev N = 249** N = 204† N = 178†† N = 177 do
Immunisation should be postponed in individuals suffering from moderate to severe acute febrile illness or infection.
Cepljenje je treba prestaviti, kadar ima posameznik zmerno ali hudo vročinsko akutno bolezen ali okužbo.
PHARMACEUTICAL FORM Suspension for injection.
FARMACEVTSKA OBLIKA suspenzija za injiciranje.
Hexacima is given as an injection into a muscle (intramuscular route IM) in the upper part of your child's leg or upper arm.
Cepivo Hexacima se daje kot injekcija v mišico (intramuskularna pot uporabe - i. m.) v zgornji del otrokove noge ali nadlahti.
For syringes without an attached needle, the needle must be fitted firmly to the syringe, rotating it by a one-quarter turn.
Pri injekcijskih brizgah brez pritrjene igle morate iglo trdno pritrditi na injekcijsko brizgo tako, da jo zavrtite za četrt obrata.
Tetanus Toxoid not less than 40 IU2,3
tetanusni toksoid ne manj kot 40 i.e.2,3
• Tetanus Toxoid
• tetanusni toksoid
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.
It is important to follow the instructions from the doctor or nurse so that your child completes the course of injections.
Pomembno je, da sledite navodilom zdravnika ali medicinske sestre tako, da bo vaš otrok zaključil celotno shemo cepljenja.
Table 1: Adverse Reactions from clinical trials and reported during commercial use System Organ Class
Tabela 1: Neželeni učinki iz kliničnih študij in poročanja po prihodu zdravila na trg
Booster doses should be given at least 6 months after the last priming dose and in accordance with the official recommendations.
Obnovitvene odmerke je treba dati najmanj v 6 mesecih po osnovnem cepljenju skladno z uradnimi priporočili.
The recommended injection site is preferably the antero-lateral area of the upper thigh and the deltoid muscle in older children (possibly from 15 months of age).
Priporočena mesta za injiciranje so zgornji anterolateralni predel stegna in deltoidna mišica pri starejših otrocih (po možnosti od 15 meseca starosti dalje).
The immune responses to Hib (PRP) and pertussis antigens (PT and FHA) were evaluated after 2 doses in a subset of subjects receiving Hexacima (N=148) at 2, 4, 6 months of age.
Imunski odziv na Hib (PRP) in antigene oslovskega kašlja (PT in FHA) je bil ovrednoten po prejemu dveh odmerkov v podskupini, ki je prejemala Hexacima (N=148) pri starosti 2, 4 in 6 mesecev.
Hexacima can be given at the same time as other vaccines such as pneumococcal vaccines, measlesmumps-rubella vaccines, rotavirus vaccines or meningococcal vaccines.
Cepivo Hexacima 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.
• Hexacima will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E.
• Cepivo Hexacima ne ščiti pred okužbo s hepatitisom, ki ga povzročajo drugi agensi, kot so hepatitis A, hepatitis C in hepatitis E.
Hexacima is available in pack containing 10 vials.
Cepivo Hexacima je na voljo v pakiranju, ki vsebuje 10 vial.
• suffered from a severe reaction affecting the brain (encephalopathy) within 7 days of a prior dose of a pertussis vaccine (acellular or whole cell pertussis).
• trpel zaradi hude reakcije na možganih (encefalopatija) v 7 dneh po predhodnem odmerku cepiva proti oslovskemu kašlju (brezceličnega ali s celimi celicami).
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.
Cepivo lahko vsebuje sledove gluteraldehida, formaldehida, neomicina, streptomicina ali polimiksina B.
First course of vaccination (primary vaccination) Your child will receive either two injections given at an interval of two months or three injections given at an interval of one to two months (at least four weeks apart).
Vaš otrok bo prejel ali dve injekciji v razmiku dveh mesecev ali tri injekcije v razmiku enega do dveh mesecev (vsaj štiri tedne narazen).
The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination.
Blaga okužba in/ali nekoliko zvišana telesna temperatura ne smeta biti vzrok za odložitev cepljenja.
Pack of 10.
Pakiranje po 10.
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, poškodbe možganov in celo smrt.
• Hepatitis B is caused by the hepatitis B virus.
• Hepatitis B povzroča virus hepatitisa B. Povzroča oteklino (vnetje) jeter.