natgillin/translations-raw huggingface dataset:
If you have a weak immune system (such as due to HIV infection or medicines that affect the immune system) you may not get a full benefit from Nimenrix.
Če imate oslabel imunski sistem (npr. zaradi okužbe s HIV ali zaradi zdravil, ki vplivajo na imunski sistem), vam cepivo Nimenrix morda ne bo v celoti koristilo.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Med znaki alergijske reakcije so lahko srbeč izpuščaj na koži, težko dihanje in otekanje obraza ali jezika.
Immunisation should be carried out by intramuscular injection only.
Imunizacijo se sme opraviti le z intramuskularnim injiciranjem.
Nimenrix helps your body to produce its own protection (antibodies) against the bacteria.
Cepivo Nimenrix telesu pomaga, da ustvari svojo lastno zaščito (protitelesa) pred bakterijami.
Your doctor will tell you if and when you need an additional dose of Nimenrix, especially if you or your child:
Zdravnik vam bo povedal, če potrebujete dodaten odmerek cepiva Nimenrix, zlasti če ste vi ali vaš otrok:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh osebah.
Vaccination with Nimenrix should be postponed in subjects suffering from an acute severe febrile illness.
Cepljenje s cepivom Nimenrix je treba odložiti pri osebah z akutno, hudo febrilno boleznijo.
Protection against meningococcal disease
Zaščita pred meningokokno boleznijo
VR: vaccine response defined as the proportion of subjects with:
VR: odziv na cepivo (vaccine response), opredeljen kot delež preskušancev:
There was no impact of coadministration on immune responses to the other nine pneumococcal serotypes.
Sočasna uporaba ni vplivala na imunske odzive na drugih devet pnevmokoknih serotipov.
More than 98% of subjects had anti-PT, FHA or PRN concentrations above the assay cut-off thresholds.
Več kot 98 % preskušancev je imelo koncentracije protiteles proti PT, FHA ali PRN nad mejnimi vrednostmi preskusa.
No case of overdose has been reported.
Ni opisanih primerov prevelikega odmerjanja.
• A pooled analysis of data from 9,621 subjects administered a single dose of Nimenrix.
• Združena analiza podatkov 9.621 preskušancev, ki so prejeli en odmerek cepiva Nimenrix.
Table 1 Tabulated summary of adverse reactions by system organ class System Organ Class
Preglednica 1 Tabelarični povzetek neželenih učinkov po organskih sistemih Organski sistem
Nimenrix should not be mixed with other vaccines.
Cepiva Nimenrix se ne sme mešati z drugimi cepivi.
• The other ingredients are: - In the powder: sucrose and trometamol - In the solvent: sodium chloride and water for injections
• Pomožne snovi so: - V prašku: saharoza in trometamol - V vehiklu: natrijev klorid in voda za injekcije.
Nimenrix may not work as well if you are taking medicines that affect your immune system.
Cepivo Nimenrix lahko deluje slabše, če jemljete zdravila, ki vplivajo na imunski sistem.
Nimenrix may be given to adults, adolescents, children and infants over the age of 6 weeks.
Cepivo Nimenrix se lahko daje odraslim, mladostnikom, otrokom in dojenčkom, starejšim od 6 tednov.
No data are available beyond the age of 2 years.
Za otroke po 2. letu starosti ni podatkov.
In that case, the needle should be attached without screwing.
V tem primeru je treba iglo namestiti brez privijanja.
However, the syringe provided with Nimenrix might be slightly different (without screw thread) than the syringe described in the picture.
Brizga, priložena cepivu Nimenrix, je lahko nekoliko drugačna (brez navoja) kot brizga, prikazana na sliki.
Giving Nimenrix with or one month before a TT-containing vaccine in the second year of life does not impair the response to TT or significantly affect safety.
Dajanje cepiva Nimenrix skupaj s cepivom, ki vsebuje TT, ali en mesec pred takim cepivom v drugem letu življenja ne poslabša odziva na TT in ne vpliva pomembno na varnost.
• meningitis - an infection of the tissue that lines the brain and spinal cord.
• meningitis - okužbo ovojnic, ki prekrivajo možgane in hrbtenjačo,
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration.
Rekonstituirano cepivo je treba pred uporabo pregledati glede tujih delcev in/ali spremenjenega fizičnega videza.
After reconstitution, the vaccine should be used promptly.
Cepivo je treba uporabiti takoj po rekonstituciji.
If you are pregnant, think you may be pregnant, plan to become pregnant or are breast-feeding, you must tell your doctor before receiving Nimenrix.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite cepivo Nimenrix.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja.
Table 1 shows the adverse reactions reported from the studies in subjects aged from 6 weeks up to 55 years of age and post-marketing experience.
Preglednica 1 prikazuje neželene učinke, o katerih so poročali v študijah pri preskušancih, starih od 6 tednov do 55 let, ter v obdobju trženja cepiva.
To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock (See picture).
Za namestitev igle na brizgo, zasučite iglo v smeri urnega kazalca na brizgo, dokler ne začutite, da se je zaskočila (glejte sliko).
Nimenrix is available in packs of 1, 10 or 100.
Cepivo Nimenrix je na voljo v pakiranjih po 1, 10 ali 100.
Nimenrix will be given to you by a doctor or nurse.
Cepivo Nimenrix vam do dal zdravnik ali medicinska sestra.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited.
Pričakuje se lahko, da pri bolnikih, ki prejemajo imunosupresivno zdravljenje ali pri bolnikih z imunsko pomanjkljivostjo, ustrezen imunski odziv morda ne bo dosežen.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa (omedlevica), zlasti pri mladostnikih, kot psihološki odziv na injiciranje z iglo.
Similar responses in terms of % with hSBA titre ≥8 were observed with groups A and C (Table 7).
Podobne odzive (kar zadeva odstotke s titri hSBA ≥ 8) so opazili pri skupinah A in C (preglednica 7).
Pack sizes of 1 and 10 with or without needles.
Velikost pakiranj po 1 in 10 z iglami ali brez njih.
• you have a bleeding problem or you bruise easily.
• če imate težave s strjevanjem krvi ali se vam hitro pojavijo podplutbe.
Immunogenicity in infants
Imunogenost pri dojenčkih
An additional primary dose of Nimenrix may be considered appropriate for some individuals (see section 4.4).
Pri nekaterih posameznikih je lahko primeren dodaten osnovni odmerek cepiva Nimenrix (glejte poglavje 4.4).
However, talk to your doctor or nurse first.
Vendar se vseeno najprej posvetujte z zdravnikom ali medicinsko sestro;
A selection bias mainly due to revaccination of subjects with group C rSBA titres <8 and their exclusion from subsequent time-point(s) may have led to an overestimation of the titres.
Pristranskost izbire (predvsem zaradi ponovnega cepljenja preskušancev s titri rSBA proti skupini C < 8 in njihove izključitve na naslednji časovni točki/naslednjih časovnih točkah) je morda povzročila previsoko oceno titrov.
Nimenrix should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.
Cepivo Nimenrix se sme med nosečnostjo uporabiti le, če je jasno potrebno in če možne koristi odtehtajo možna tveganja za plod.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 1 VIAL AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 10 VIALS AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
PODATKI NA ZUNANJI OVOJNINI 1 VIALA IN 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ IGLE 1 VIALA IN 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 2 IGLAMA 10 VIAL IN 10 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 10 VIAL IN 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 20 IGLAMI
Immunogenicity in children aged 2-10 years
Imunogenost pri otrocih, starih od 2 do 10 let
Time point (year)
Časovna točka (leto)
The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Blažja okužba, npr. prehlad, pa ni razlog za odložitev cepljenja.
Pack sizes of 1, 10 and 100
Velikost pakiranj po 1, 10 ali 100.
Nimenrix was demonstrated to be immunologically non-inferior to the ACWY-PS vaccine in terms of vaccine response as defined above (Table 12).
Cepivo Nimenrix je bilo imunološko neinferiorno cepivu ACWY-PS kar zadeva odziv na cepivo, kot je definiran zgoraj (preglednica 12).
However, do not drive or use any machines if you are feeling unwell.
Toda če se ne počutite dobro, ne vozite in ne upravljajte strojev.
The powder or cake is white.
Prašek ali pogača je bele barve.
It is unknown whether Nimenrix is excreted in human milk.
Ni znano, ali se cepivo Nimenrix pri človeku izloča v materino mleko.
If Nimenrix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
Če je treba cepivo Nimenrix dati sočasno s kakšnim drugim cepivom za injiciranje, je treba cepivi vedno injicirati na različni mesti.
Nimenrix should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Cepivo Nimenrix se sme med obdobjem dojenja uporabiti le, če možne koristi odtehtajo možna tveganja.
The safety and antibody persistence data up to year 5 and the data on co-administration of MenACWY-TT with Prevenar 13 will be provided in sequential study reports at 1, 3 and 5 years after vaccination.
Podatki o varnosti cepiva in prisotnosti protiteles do 5 let ter podatki o sočasni uporabi cepiv MenACWY-TT in Prevenar 13 bodo podani v zaporednih poročilih študije ob 1, 3 in 5 letih po cepljenju.
Nimenrix is always injected into a muscle, usually in the upper arm or thigh.
Cepivo Nimenrix vam bodo vedno injicirali v mišico, običajno v nadlaket ali stegno.
However, if an individual is expected to be at particular risk of exposure to group A and received a dose of Nimenrix more than approximately one year previously, consideration may be given to administering a booster dose.
Toda če pri posamezniku obstaja posebej veliko tveganje za izpostavljenost skupini A in je odmerek cepiva Nimenrix prejel pred več kot približno enim letom, se lahko razmisli o uporabi obnovitvenega odmerka.
Study to evaluate immediate and longer term antibody titres elicited by one or two doses of Nimenrix administered in children aged 12-23 months.
Študija za oceno takojšnjih in dolgoročnih titrov protiteles, ki jih sprožita en ali dva odmerka cepiva Nimenrix, uporabljena pri otrocih, starih od 12 do 23 mesecev.
Study MenACWYTT-035 (18-55 years)
Študija MenACWTT-035 (18-55 let)
Meningococcal Group rSBA*
Meningoko kna skupina rSBA*
Robust anamnestic responses to the antigen(s) in the priming vaccine were observed.
Opazili so močne anamnestične odzive na antigen(e) v cepivu, ki so ga uporabili za osnovno cepljenje.
Pregnancy There is limited experience with use of Nimenrix in pregnant women.
Pri nosečnicah je malo izkušenj z uporabo cepiva Nimenrix.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Za navodila glede rekonstitucije cepiva pred dajanjem glejte poglavje 6.6.
In the 6-12 weeks and in the 12-14 months age groups who received 2 doses of Nimenrix given 2 months apart, the first and second doses were associated with similar local and systemic reactogenicity.
V starostnih skupinah od 6 do 12 tednov in od 12 do 14 mesecev, ki sta prejeli 2 odmerka cepiva Nimenrix v presledku 2 mesecev, sta bila prvi in drugi odmerek povezana s podobnimi lokalnimi in sistemskimi reakcijami.
• reactions where the injection is given such as itching, a feeling of warmth or numbness or a hard lump.
• reakcije na mestu injiciranja, npr. srbenje, občutek toplote ali omrtvičenosti, ali trda bula.
This total included 3,079 toddlers (12 months to 23 months), 909 children between 2 and 5 years of age, 990 children between 6 and 10 years of age, 2,317 adolescents (11 to 17 years) and 2,326 adults (18 to 55 years).
Med vsemi vključenimi je bilo 3.079 malčkov (od 12 do 23 mesecev), 909 otrok, starih med 2 in 5 let, 990 otrok, starih med 6 in 10 let, 2.317 mladostnikov (od 11 do 17 let) in 2.326 odraslih (od 18 do 55 let).
No studies on the effects of Nimenrix on the ability to drive and use machines have been performed.
Študij o vplivih cepiva Nimenrix na sposobnost vožnje in upravljanja strojev niso izvedli.
Anti-capsular meningococcal antibodies protect against meningococcal diseases via complement mediated bactericidal activity.
Antikapsularna protitelesa proti meningokokom ščitijo pred meningokoknimi boleznimi z baktericidnim delovanjem preko komplementa.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ
You will be informed when you or your child should come back for the next injection.
Ko boste morali vi ali vaš otrok priti po naslednjo injekcijo, vas bodo o tem obvestili.
Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y, even if they develop antibodies following vaccination with Nimenrix.
Pri osebah s familiarnimi pomanjkanji komplementa (na primer pomanjkanja C5 ali C3) in osebah, ki prejemajo zdravljenje, ki zavira aktivacijo terminalnega komplementa (na primer ekulizumab), obstaja povečano tveganje za invazivno bolezen, ki jo povzroča Neisseria meningitidis skupin A, C, W-135 in Y, tudi če po cepljenju s cepivom Nimenrix razvijejo protitelesa.
A decline in antibody titres over time has been observed for groups A, C, W-135 and Y. The clinical relevance of the waning antibody titres is unknown.
Upadanje titrov protiteles s časom so opazili pri skupinah A, C, W-135 in Y. Klinični pomen upadanja titrov protiteles ni znan.
Nimenrix may not fully protect everyone who is vaccinated.
Zgodi se lahko, da cepivo Nimenrix ne zaščiti popolnoma vseh cepljenih oseb.
The response against group C was non-inferior to the one elicited by licensed MenC-CRM and MenC-TT vaccines in terms of percentages with rSBA titres ≥8 at one month after the second dose.
Odziv proti skupini C je bil neinferioren tistemu, ki sta ga izzvali odobreni cepivi MenC-CRM in MenC-TT kar zadeva odstotke s titri rSBA ≥ 8 en mesec po drugem odmerku.
The reconstituted vaccine is a clear colourless solution.
Rekonstituirano cepivo je bistra, brezbarvna raztopina.
• swelling, pain and redness where the injection is given.
• oteklina, bolečine in pordelost na mestu injiciranja.
In individuals from 1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle (see sections 4.4 and 4.5).
Pri posameznikih, starejših od 1 leta, je priporočeno mesto injiciranja anterolateralni predel stegna ali deltoidna mišica (glejte poglavji 4.4 in 4.5).
Nimenrix MenC-CRM vaccine 116
Nimenrix cepivo MenC-CRM 116
Do not administer intravascularly, intradermally or subcutaneously.
Ne dajajte ga intravaskularno, intradermalno ali subkutano.
Study MenACWYTT-036 (11-17 years)
Študija MenACWTT-036 (11-17 let)
What Nimenrix is and what it is used for What Nimenrix is and what it is used for
Kaj je cepivo Nimenrix in za kaj ga uporabljamo
Nimenrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Previdnost pri dajanju cepiva Nimenrix je potrebna pri osebah s trombocitopenijo ali kakšno koagulacijsko motnjo, ker se jim lahko po intramuskularnem injiciranju pojavi krvavitev.
Nimenrix is available in packs of 1 or 10 with or without needles.
Cepivo Nimenrix je na voljo v pakiranjih po 1 ali 10, z iglami ali brez njih.
In Study Men ACWY-TT-104 the immune response following one or two doses of Nimenrix given 2 months apart was evaluated one month after the last vaccination.
V študiji Men ACWY-TT-104 so imunski odziv po enem ali dveh odmerkih cepiva Nimenrix, danih v presledku 2 mesecev, ocenili en mesec po zadnjem cepljenju.
Infants from 6 months of age, children, adolescents and adults One injection.
Dojenčki, stari 6 mesecev in več, otroci, mladostniki in odrasli: Ena injekcija.
The clinical relevance of the waning of hSBA antibody titres against group A is unknown.
Klinični pomen upadanja titrov protiteles hSBA proti skupini A ni znan.
Regarding waning of antibody against group A or group C after a first dose of Nimenrix in children aged 12-23 months, see under Persistence of serum bactericidal antibody titres.
Glede upadanja protiteles proti skupini A ali C po prvem odmerku cepiva Nimenrix pri otrocih, starih od 12 do 23 mesecev, glejte Vztrajanje titrov serumskih baktericidnih protiteles, spodaj.
What Nimenrix looks like and contents of the pack
Izgled cepiva Nimenrix in vsebina pakiranja
A new needle should be used to administer the vaccine.
Za injiciranje cepiva je treba uporabiti novo iglo.
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Vedno morata biti na voljo ustrezna medicinska oskrba in nadzor za primer, da se po dajanju cepiva pojavi anafilaktična reakcija, ki pa je redka.
After a booster dose, the hSBA titres to all four serogroups were comparable between the two dosing schedules.
Po obnovitvenem odmerku so bili titri hSBA proti vsem 4 seroskupinam primerljivi med obema shemama odmerjanja.
*tested at GSK laboratories
* testirano v laboratorijih družbe GSK
These must be mixed together before use.
Prašek in vehikel je treba pred uporabo zmešati skupaj.
• rash (infants).
• izpuščaj (pri dojenčkih).
In MenACWY-TT-081, Nimenrix was demonstrated to be non-inferior to another licensed MenCCRM vaccine in terms of vaccine response to group C [94.8% (95% CI: 91.4; 97.1) and 95.7% (95% CI: 89.2; 98.8) respectively], The GMT was lower for the Nimenrix group [2795 (95% CI: 2393; 3263)] versus the MenC-CRM vaccine [5292 (95% CI: 3815; 7340)].
V študiji MenACWY-TT-081 se je cepivo Nimenrix izkazalo za neinferiorno drugemu odobrenemu cepivu MenC-CRM, kar zadeva odziv na skupino C [94,8 % (95 % IZ: 91,4; 97,1) in 95,7 % (95 % IZ: 89,2; 98,8) v tem zaporedju]; GMT so bile v skupini s cepivom Nimenrix nižje [2.795 (95 % IZ: 2.393; 3.263)] kot s cepivom MenC-CRM [5.292 (95 % IZ: 3.815; 7.340)].
Non-clinical data reveal no special hazard for humans based on local tolerance, acute toxicity, repeated dose toxicity, developmental/reproductive toxicity and fertility studies.
Predklinični podatki na osnovi študij lokalnega prenašanja, akutne toksičnosti, toksičnosti pri ponavljajočih se odmerkih, razvojne/reproduktivne toksičnosti in plodnosti ne kažejo posebnega tveganja za človeka.
Intercurrent illness
Sočasna bolezen
Infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be administered.
Dojenčki, stari 6 mesecev in več, otroci, mladostniki in odrasli: uporabiti je treba en 0,5-ml odmerek.
A booster dose produced robust responses, comparable between the two dosing groups, against all four meningococcal groups.
Obnovitveni odmerek je izzval močne odzive proti vsem 4 meningokoknim skupinam, ki so bili primerljivi med obema skupinama odmerjanja.
Nimenrix should under no circumstances be administered intravascularly, intradermally or subcutaneously.
Cepiva Nimenrix se nikakor ne sme dajati intravaskularno, intradermalno ali subkutano.
In a separate study (MenACWY-TT-085) a single dose of Nimenrix was administered to 194 Lebanese adults 56 years of age and older (including 133 aged 56-65 years and 61 aged > 65 years).
V ločeni študiji (MenACWY-TT-085) je en odmerek cepiva Nimenrix prejelo 194 odraslih Libanoncev, starih 56 let ali več (od tega jih je bilo 133 starih od 56 do 65 let in 61 starih > 65 let).
*rSBA testing performed at Public Health England (PHE) laboratories in UK **hSBA tested at GSK laboratories (1) blood sampling performed 21 to 48 days post vaccination Data from MenACWY-TT-083 support the extrapolation of the immunogenicity data and posology to infants from 12 weeks to less than 6 months of age.
* testiranje rSBA so opravili v laboratorijih PHE (Public Health England) v Veliki Britaniji ** hSBA so testirali v laboratorijih družbe GSK odvzem krvi so opravili od 21 do 48 dni po cepljenju Podatki iz študije MenACWY-TT-083 podpirajo ekstrapolacijo podatkov o imunogenosti in odmerjanja na dojenčke, stare od 12 tednov do manj kot 6 mesecev.
*rSBA testing performed at PHE laboratories in UK.
*testiranje rSBA so opravili v laboratorijih PHE v Veliki Britaniji
In infants, the recommended injection site is the anterolateral aspect of the thigh.
Pri dojenčkih je priporočeno mesto injiciranja anterolateralni predel stegna.
After reconstitution, use promptly.
Uporabite takoj po rekonstituciji.
After the addition of the solvent to the powder, the mixture should be well shaken until the powder is completely dissolved in the solvent.
Po dodatku vehikla prašku je treba mešanico dobro pretresti, dokler se prašek povsem ne raztopi v vehiklu.
Although an increase of the anti-tetanus toxoid (TT) antibody concentrations was observed following vaccination with Nimenrix, Nimenrix does not substitute for tetanus immunisation.
Po cepljenju s cepivom Nimenrix so sicer opažali porast koncentracije protiteles proti tetanusnemu toksoidu (TT), vendar cepivo Nimenrix ne nadomešča imunizacije proti tetanusu.
Persistence of serum bactericidal antibody titres
Vztrajanje titrov serumskih baktericidnih protiteles
EU/1/12/767/001 - pack of 1 without needle EU/1/12/767/002 - pack of 10 without needle EU/1/12/767/003 - pack of 1 with 2 needles EU/1/12/767/004 - pack of 10 with 20 needles
EU/1/12/767/001 - pakiranje po 1 brez igle EU/1/12/767/002 - pakiranje po 10 brez igle EU/1/12/767/003 - pakiranje po 1 in 2 iglama EU/1/12/767/004 - pakiranje po 10 in 20 iglami
Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.
Cepivo Nimenrix je indicirano za aktivno imunizacijo posameznikov starejših od 6 tednov proti invazivnim meningokoknim boleznim, ki jih povzroča Neisseria meningitidis skupin A, C, W-135 in Y.
There was no impact of co-administration on immune responses to Nimenrix or the tetanus or diphtheria antigens included in Tdap.
Sočasna uporaba ni vplivala na imunske odzive na cepivo Nimenrix ali na antigene tetanusa ali davice, ki jih vsebuje cepivo Tdap.
In MenACWY-TT-038, Nimenrix was demonstrated to be non-inferior to the licensed ACWY-PS vaccine in terms of vaccine response to the four groups (A, C, W-135 and Y) (See Table 9).
V študiji MenACWY-TT-038 se je cepivo Nimenrix izkazalo za neinferiorno odobrenemu cepivu ACWY-PS, kar zadeva odziv na štiri skupine (A, C, W-135 in Y) po cepljenju (glejte preglednico 9).
Other medicines and Nimenrix
Druga zdravila in cepivo Nimenrix
Break the top of the ampoule, draw up the solvent with a syringe and add the solvent to the powder.
Odlomite vrh ampule, z brizgo izvlecite vehikel in dodajte vehikel k prašku.
DTaP-HBV-IPV/Hib and a 10-valent pneumococcal vaccine were co-administered.
Cepivo DTaP-HBV-IPV/Hib in 10-valentno pnevmokokno cepivo so dajali sočasno.
Two clinical studies have been conducted in infants, MenACWY-TT-083 and MenACWY-TT-087.
Pri dojenčkih so opravili 2 klinični študiji, in sicer študiji MenACWY-TT-083 in MenACWY-TT-087.