natgillin/translations-raw huggingface dataset:
Hexacima is available in pack containing 1 or 10 pre-filled syringes without attached needle.
Cepivo Hexacima je na voljo v pakiranju, ki vsebuje 1 ali 10 napolnjenih injekcijskih brizg brez pritrjene igle.
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§)
• suffers from an acute or chronic illness including chronic renal insufficiency or failure (inability of the kidneys to work properly).
• trpi za akutno ali kronično boleznijo vključno s kronično oslabljenim ledvičnim delovanjem
ELISA).
HHE).
General disorders and administration site conditions Oedematous reaction affecting one or both lower limbs may occur following vaccination with Haemophilus influenzae type b containing vaccines.
Splošne težave in spremembe na mestu injiciranja Po cepljenju s cepivi, ki vsebujejo komponento proti hemofilusu influence tipa b, lahko pride do edematoznih reakcij, ki prizadenejo eno ali obe spodnji okončini.
Data on concomitant administration of rotavirus vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
Podatki o sočasni uporabi rotavirusnih cepiv niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
- persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours of vaccination.
v 48 urah po cepljenju; - stalen, neutolažljiv jok, ki traja 3 ure ali več in se pojavi v 48 urah po cepljenju;
Abnormal crying (prolonged crying)
Bolezni živčevja zelo pogosti jok, zaspanost pogosti nenormalen jok (dolgotrajen jok)
40 D antigen units5
40 D-antigenskih enot5
Anti-diphtheria (≥ 0.1 IU/ml) Anti-tetanus (≥ 0.1 IU/ml) Anti-PT (Seroconversion‡‡) (Vaccine response§) Anti-FHA (Seroconversion‡‡) (Vaccine response§)
Protitelesa proti davici (≥ 0,1 i.e./ml) Protitelesa proti tetanusu (≥ 0,1 i.e./ml) Protitelesa proti PT (Serokonverzija ‡‡) (odziv na cepljenje§) Protitelesa proti FHA (Serokonverzija ‡‡) (odziv na cepljenje§)
c- Description of selected adverse reactions
† Poglejte poglavje c c- Opis označenega neželenega učinka
• Because symptoms of hepatitis B take a long time to develop, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
• Zaradi dolge dobe do pojava simptomov hepatitisa B je mogoče, da v času cepljenja že obstaja neprepoznana okužba s hepatitisom B. V takih primerih cepivo morda ne bo preprečilo okužbe s hepatitisom B.
• Common side effects (may affect up to 1 in 10 people) are: - abnormal crying (prolonged crying) - diarrhoea - injection site hardness (induration)
• Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 cepljenih) so: - nenormalen jok (dolgotrajen jok) - diareja - otrdelost na mestu injiciranja (induracija).
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 Hexacima 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
• 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 Hexacima 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 Hexacima ali na katero koli cepivo, ki vsebuje cepiva proti davici, tetanusu, oslovskem kašlju, otroški paralizi, hepatitisu B ali hemofilusu influence tipa b
Hexacima is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles.
Cepivo Hexacima je na voljo v pakiranju, ki vsebuje 1 ali 10 napolnjenih injekcijskih brizg z dvema ločenima iglama.
Otherwise, post-booster antibody concentration should be ≥ pre immunisation level (pre-dose 1)
Sicer pa naj bi bila koncentracija protiteles po obnovitvenem cepljenju ≥ kakor je bila pred cepljenjem (pred 1. odmerkom).
Extensive limb swelling: Large injection-site reactions (>50 mm), including extensive limb swelling from the injection site beyond one or both joints, have been reported in children.
- izpuščaj - večje reakcije na mestu injiciranja (večje od 5 cm), vključno z obširnim otekanjem udov od mesta injiciranja prek enega ali obeh sklepov.
Hexacima in vials 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).
After a 2-dose primary vaccination with Hexacima, a booster dose must be given.
Po osnovnem cepljenju z 2-odmerkoma cepiva Hexcima mora otrok prejeti obnovitveni odmerek.
If there is anything you do not understand, ask your doctor, pharmacist or nurse to explain.
Če česa ne razumete, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
History of an anaphylactic reaction after a previous administration of Hexacima.
Pojav anafilaktične reakcije po predhodnem cepljenju s cepivom Hexacima.
Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Zaradi dolge inkubacijske dobe hepatitisa B je mogoče, da v času cepljenja že obstaja neprepoznana okužba s hepatitisom B. V takih primerih cepivo morda ne bo preprečilo okužbe s hepatitisom B.
- fits (convulsions) with or without fever.
- krči (konvulzije) z zvišano telesno temperaturo ali brez nje.
Hexacima is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle.
Cepivo Hexacima je na voljo v pakiranju, ki vsebuje 1 ali 10 napolnjenih injekcijskih brizg z eno ločeno iglo.
10 vials (0.5 ml)
suspenzija za injiciranje 10 vial (0,5 ml)
Contents of the pack and other information
Shranjevanje cepiva Hexacima Vsebina pakiranja in dodatne informacije
- fits (convulsions) with or without fever, occurring within 3 days of vaccination.
- krče z zvišano telesno temperaturo ali brez nje, ki so se pojavili v treh dneh po cepljenju.
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA intramuskularna uporaba
• If your child gets any side effects, talk to your doctor, pharmacist or nurse.
• Če pri otroku opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
If co-administration with another vaccine is considered, immunisation should be carried out on separate injections sites.
V primeru sočasne aplikacije z drugimi cepivi je treba uporabiti ločena mesta injiciranja.
Convulsions with or without fever*
redki krči z zvišano telesno temperaturo ali brez nje*
After a 3-dose WHO EPI schedule with Hexacima (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 Hexacima 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.
Pyrexia (body temperature ≥39.6°C)
- zvišana telesna temperatura (39,6°C ali več).
After a 3-dose primary vaccination with Hexacima, a booster dose should be given.
Po osnovnem cepljenju s 3-odmerki cepiva Hexacima mora otrok prejeti obnovitveni odmerek.
Data on concomitant administration of Hexacima with a pneumococcal polysaccharide conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Podatki o sočasni uporabi cepiva Hexacima in polisaharidnega konjugiranega cepiva proti pnevmokokom niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
Haemophilus influenzae type b polysaccharide
10 mikrogramov polisaharid hemofilusa influence tipa b
- fits (convulsions) with or without fever
- krči (konvulzije) z zvišano telesno temperaturo ali brez nje
OTHER Sanofi Pasteur
DRUGI PODATKI Sanofi Pasteur
- collapse or shock-like state with hypotonic-hyporesponsive episode (drop in energy) within 48 hours of vaccination.
- kolaps ali šoku podobno stanje s hipotonično-hiporesponzivno epizodo (upad energije)
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 Hexacima se lahko uporabi za obnovitveno cepljenje.
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
- 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
The need for a toddler booster dose was seen in this study.
V tej študiji so opazili, da je pri malčkih potreben obnovitveni odmerek.
In addition, immunity against the hepatitis B component of the vaccine has been shown to persist up to 9 years of age after a primary series consisting of one dose of Hepatitis B vaccine given at birth followed by a 3-dose infant series at 2, 4, and 6 months of age without a toddler booster where 49.3%
Poleg tega je dokazano, da imunost proti komponenti hepatitisa B v cepivu traja do 9. leta starosti po primarnem cepljenju, ki obsega en odmerek cepiva proti hepatitisu B, uporabljen ob rojstvu, ter zaporedje 3 odmerkov pri dojenčku v starosti 2, 4 in 6 mesecev, brez obnovitvenega odmerka pri malih otrocih; pri tem je imelo 49,3 % cepljenih protitelesa ≥ 10 mi.e./ml, geometrična sredina koncentracije pa je bila 13,3 (95 % IZ: 8,82-20,0) mi.e./ml.
† See section c.
2 i.e. internacionalna enota.
0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), with 2 separate needles.
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (iz halobutila) in zaščiteni z zaporko (iz halobutila), z dvema ločenima iglama.
Disodium hydrogen phosphate, potassium dihydrogen phosphate, trometamol, saccharose, essential amino acids including L-phenylalanine, sodium hydroxide and/or acetic acid and/or hydrochloric acid (for pH adjustment), and water for injections.
Druge sestavine cepiva so: dinatrijev hidrogenfosfat, kalijev dihidrogenfosfat, trometamol, saharoza, esencialne aminokisline, vključno z L-fenilalaninom, natrijev hidroksid in/ali ocetna kislina in/ali klorovodikova kislina (za uravnavanje pH) in voda za injiciranje.
• Swelling of one or both feet and lower limbs which may occur along with bluish discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura) and severe crying following vaccination with Haemophilus influenzae type b containing vaccines.
To se lahko pojavi skupaj z modrikastim obarvanjem kože (cianoza), pordelostjo, majhnimi območji krvavitev pod kožo (prehodna purpura) in hudim jokom, ki lahko sledijo cepljenju s cepivom proti Haemophilusu Influenzae tipa b. Če se pojavi taka reakcija, se običajno pojavi po prvih cepljenjih in jo opažajo v prvih nekaj urah po cepljenju.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label - Vial
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
When a hepatitis B vaccine is given at birth, after a 3-dose primary vaccination, Hexacima 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 Hexacima ali s petvalentnim cepivom DTaP-IPV/Hib.
With hepatitis B at birth
S cepljenjem proti hepatitisu B ob rojstvu
Hexacima can be considered for the booster.
Cepivo Hexacima se lahko uporabi za obnovitveno cepljenje.
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.
Imunski odziv na (PRP) in antigene PT in FHA en mesec po prejemu 2 odmerka, ki sta bila dana pri 2 in 4 mesecu starosti je bil sličen, kot pri podskupini, ki je prejela 2 odmerka pri 3 in 5 mesecih starosti: 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.
Very common Vomiting Common
Bolezni prebavil zelo pogosti bruhanje pogosti driska
Pyrexia (body temperature ≥ 38.0°C)
- zvišana telesna temperatura (38°C ali več).
0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), with 1 separate needle.
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (iz halobutila) in zaščiteni z zaporko (iz halobutila), z eno ločeno iglo.
Prior to administration, the pre-filled syringe should be shaken in order to obtain a homogeneous, whitish, cloudy suspension.
Cepivo Hexacima v vialah Pred uporabo cepivo v viali pretresite, da dobite homogeno, belkasto, motno suspenzijo.
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.
Other side effects
Neželeni učinek
Injection-site induration
- vozlič na mestu injiciranja
5 Or equivalent antigenic quantity determined by a suitable immunochemical method 6 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
5 Ali enakovredna količina antigenov, določena z ustrezno imunokemijsko metodo.
IM
SERIJ
Data on concomitant administration of a booster dose of Hexacima 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 Hexacima in cepiva proti ošpicam, mumpsu in rdečkam niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
Package leaflet: Information for the user Hexacima 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)
Hexacima 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.
Talk to your doctor, pharmacist or nurse before vaccination if your child:
Pred cepljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če (je) vaš otrok: • ima zmerno do zelo povišano telesno temperaturo ali akutno bolezen (npr. vročino, vnetje grla,
Without hepatitis B at birth
Brez cepljenja proti hepatitisu B ob rojstvu
Anti-Polio type 1 (≥ 8 (1/dilution))
(≥ 8 (1/razredčenje))
Hexacima helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Hexacima is given to children from six weeks of age.
Cepivo Hexacima ščiti vašega otroka pred davico, tetanusom, oslovskim kašljem, hepatitisom B, otroško paralizo in hudimi boleznimi, ki jih povzroča Haemophilus influenzae tipa b. Cepivo
25 micrograms
25/25 µg
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed).
Mešano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in hemofilusu influence tipa b (konjugirano), adsorbirano.
1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
2 Kot spodnja meja zaupanja (p = 0,95).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, Francija
EXPIRY DATE EXP: MM/YYYY
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do: MM/LLLL
• Uncommon side effects (may affect up to 1 in 100 people) are: - allergic reaction - 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
With hepatitis B
s cepljenjem proti hepatitisu
Without hepatitis B vaccination at birth
s cepljenjem proti hepatitisu B ob rojstvu brez cepljenja proti hepatitisu B ob rojstvu
• has had any of the following events after receiving a pertussis vaccine, as the decision to give further doses of pertussis containing vaccine will need to be carefully considered: - fever of 40°C or above within 48 hours not due to another identifiable cause.
• imel po prejemu cepiva proti oslovskemu kašlju katerega koli izmed naslednjih neželenih učinkov, je treba temeljito pretehtati odločitev o dajanju nadaljnjih odmerkov cepiva:
Marketing Authorisation Holder: Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon , France
Imetnik dovoljenja za promet z zdravilom: Sanofi Pasteur, 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 Hexacima 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.
Additional injections (booster)
Dodatno cepljenje (obnovitveno cepljenje)
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.
MARKETING AUTHORISATION HOLDER Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, Francija
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hexacima suspension for injection
IME ZDRAVILA IN POT(I) UPORABE Hexacima suspenzija za injiciranje DTaP-IPV-HB-Hib i. m.
Disodium hydrogen phosphate
25 mikrogramov filamentozni hemaglutinin
Hexacima will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or by other liver pathogens.
A, hepatitis C in hepatitis E, ali drugi jetrni patogeni.
Some of these effects may be serious.
Nekateri od teh učinkov so lahko resni.
Day -- -
dan -- -
This will be done by a healthcare professional.
To bo naredil zdravstveni delavec.
Unopened vial 18 months.
Neodprta viala 18 mesecev.
Do not give by other routes.
Ne dajajte ga po drugi poti.
Therefore no dose recommendations can be made in this population.
Zato priporočil za odmerjanje pri tej populaciji ni mogoče dati.
Best response
Najboljši odziv
Dissolution of the lyophilised powder is completed in less than 2 minutes.
Raztapljanje liofiliziranega praška je končano v manj kot 2 minutah.
• Risk Management Plan (RMP)
- Načrt za obvladovanje tveganj (RMP)
Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Trenutno dostopni podatki so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni možno dati.
This is not considered clinically relevant.
Rezultat nima kliničnega pomena.
These patients should be monitored closely and appropriate precautions taken.
Te bolnike je treba skrbno spremljati in upoštevati ustrezne previdnostne ukrepe.
Information on autonomic neuropathy and its contribution to these undesirable effects is limited.
Podatki o avtonomni nevropatiji in tem, koliko ta prispeva k tem neželenim učinkom, so omejeni.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
To zdravilo bo injiciral vaš zdravnik ali medicinska sestra, zato ni verjetno, da bi ga lahko prejeli preveč.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 22 July 2016
Datum prve odobritve: 22. julij 2016 Datum zadnjega podaljšanja:
If, despite these measures, pregnancy occurs, tell your doctor immediately.
Če kljub tem ukrepom zanosite, takoj obvestite zdravnika.
Fertility studies were not performed but evaluation of reproductive tissues has been performed in the general toxicity studies.
Raziskave plodnosti niso opravili, opravili pa so ovrednotenje reproduktivnih tkiv v raziskavah splošne toksičnosti.
Treatment was administered for a maximum of 9 cycles (approximately 54 weeks) and was discontinued early for disease progression or unacceptable toxicity.
Zdravljenje je trajalo največ 9 krogov (približno 54 tednov) in je bilo v primeru napredovanja bolezni ali nesprejemljive toksičnosti prekinjeno prej.
This survival was greater than the six-to-nine month median survival anticipated by consultant clinical investigators for a similar patient population.
Ta stopnja preživetja je bila večja od 6 do 9-mesečne mediane preživetja, ki jo pričakujejo konziliarni klinični raziskovalci za podobno skupino bolnikov.
- swelling of body, to include around eyes and other parts of the body.
- otekanje telesa, vključno z otekanjem okoli oči in drugih delov telesa.
albumin, and region.
mikroglobulin, albumin in regija.
Decreased appetite
- izguba apetita
Most cases of PML were diagnosed within 12 months of their first dose of bortezomib.
Večina primerov PML je bila diagnosticirana v 12 mesecih po prvem odmerku bortezomiba.
• Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
One hundred and twenty seven matched pairs of patients were identified.
Definiranih je bilo stosedemindvajset izenačenih parov bolnikov.