Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.3 · PDF-Seite 3

HOS-144187 · Präparat HOS-099130

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or after previous administration of the vaccine or a vaccine containing the same components.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 5

HOS-144188 · Präparat HOS-099130

Use with other vaccines

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 5

HOS-144189 · Präparat HOS-099130

Injection sites on separate limbs and separate syringes must be used in the case of concomitant administration.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 5

HOS-144190 · Präparat HOS-099130

In infants, MenQuadfi can be co-administered with combined diphtheria - tetanus - acellular pertussis (DTaP) – inactivated poliovirus (IPV) – hepatitis B (HepB) – Haemophilus influenzae type b (Hib, in which the Hib component is conjugated to tetanus protein) vaccine (DTaP-IPV-HepB-Hib), rotavirus vaccine (live attenuated) and with 10-valent pneumococcal conjugate vaccine (PCV10).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): poliovirus (HOS-091116) Haemophilus influenzae type b (HOS-111047)

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 5

HOS-144193 · Präparat HOS-099130

In toddlers aged 12-23 months, MenQuadfi can be co-administered with the measles-mumps-rubella vaccine (MMR) and varicella vaccine (V), DTaP vaccines, including combination DTaP vaccines with IPV, HepB, and Hib such as DTaP-IPV-HepB-Hib (Hib conjugated to tetanus toxoid) vaccine, PCV10, and 13-valent pneumococcal polysaccharide conjugated vaccine (PCV13). When MenQuadfi was administered concomitantly with PCV13 in toddlers aged 12-23 months, lower hSBA GMTs on day 30 post-dose for serogroup A were observed. The clinical relevance of this observation is unknown. As a precaution in toddlers initiating MenQuadfi vaccination at 12-23 months of age and who are at high risk for serogroup A disease, consideration might be given for administration of MenQuadfi and PCV13 vaccines separately.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 5–6

HOS-144194 · Präparat HOS-099130

5 There was no impact on the immune response to MenQuadfi when a meningococcal serogroup B vaccine was co-administered at 12 months of age and older.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 6

HOS-144195 · Präparat HOS-099130

For ages 10-17 years, MenQuadfi can be co-administered with diphtheria, tetanus, pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) (Tdap), or Tdap and IPV (Tdap-IPV), and 4- valent human papillomavirus vaccine (recombinant, adsorbed) (4vHPV) or 9valent HPV vaccine (9vHPV). However, the antibody responses to some of the antigens might be affected by the co- administration.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): human papillomavirus (HOS-086547)

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 6

HOS-144197 · Präparat HOS-099130

Meningococcal vaccine-naïve children and adolescents aged 10-17 years had non inferior response for PT and lower antibody responses to FHA, PRN and FIM when Tdap vaccine was administered concomitantly with MenQuadfi and 4vHPV compared to co-administration with 4vHPV vaccine alone (immune response assessed after the full series of HPV was completed). The clinical implications of the observed pertussis antigen responses also observed with other quadrivalent meningococcal conjugate vaccines are unknown.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 6

HOS-144198 · Präparat HOS-099130

The co-administration of MenQuadfi with Tdap-IPV and 9vHPV in children and adolescents aged 10-17 years resulted in lower GMTs and seroresponse rates for serogroup A, lower GMTs for serogroup W, lower responses to inactivated polio types 1 and 3, diphtheria, and anti-HPV types 6 and 58 (immune response assessed after the first dose of 9vHPV) compared to when MenQuadfi was given sequentially with Tdap-IPV and 9vHPV. The clinical implication of the observed reduced titre responses is unclear. Consideration might be given for sequential administration of MenQuadfi with Tdap-IPV and 9vHPV (e.g. for children and adolescents at higher risk).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 6

HOS-144199 · Präparat HOS-099130

Concomitant vaccines should always be administered at separate injection sites and preferably contralateral.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 6

HOS-144200 · Präparat HOS-099130

Concomitant administration of MenQuadfi and other vaccines than those listed above has not been studied.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 6

HOS-144201 · Präparat HOS-099130

Use with systemic immunosuppressive medicinal products

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.5 · PDF-Seite 6

HOS-144202 · Präparat HOS-099130

It may be expected that in patients receiving immunosuppressive treatment an adequate immune response may not be elicited (see also section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.8 · PDF-Seite 7

HOS-144203 · Präparat HOS-099130

Summary of the safety profile

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.8 · PDF-Seite 7

HOS-144204 · Präparat HOS-099130

The safety of MenQuadfi presented in the tables below is based on three clinical datasets: • For children, adolescents, adults, and older adults, a pooled analysis of data from 4 919 participants who received a single dose of MenQuadfi either as a primary dose (N = 4 517) or a booster dose (N = 402). This included 498 children aged 2 through 9 years; 2 289 adolescents aged 10 through 17 years; 1 684 adults aged 18 through 55 years; 199 older adults aged 56 through 64 years; and 249 elderly aged ≥ 65 years. Of these, 392 adolescents received MenQuadfi co-administered with Tdap and 4vHPV. • A pooled analysis of 1 389 toddlers aged 12 through 23 months of age who received a single dose of MenQuadfi. Of these, 589 toddlers received MenQuadfi co-administered with MMR+V (N = 189), DTaP-IPV-HepB-Hib (N = 200) or PCV13 (N = 200). • A pooled analysis of data from 6 060 infants initiating vaccination from 6 weeks through 11 months of age who received at least one dose of a primary series consisting of one, two or three primary doses of MenQuadfi of which 5 373 toddlers received a booster dose from 12 through 18 months of age. MenQuadfi was co-administered with routine paediatric vaccines.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.8 · PDF-Seite 7

HOS-144205 · Präparat HOS-099130

Rates of adverse reactions after a booster dose of MenQuadfi in participants from 12 months of age and older were comparable to those seen in participants who received a primary dose of MenQuadfi.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.8 · PDF-Seite 7

HOS-144206 · Präparat HOS-099130

When MenQuadfi was co-administered with routine paediatric and adolescent vaccines, the safety profiles of the vaccines were comparable to those observed when they were given alone or with a different meningococcal serogroup A, C, W, Y vaccine, except:

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.8 · PDF-Seite 7

HOS-144207 · Präparat HOS-099130

• Overall, rates of adverse reactions were higher in toddlers aged 12-23 months of age who received PCV13 given concomitantly with MenQuadfi (36.5%) than in toddlers who received PCV13 alone (17.2%). • Rates of injection site pain at the 9vHPV injection site were higher when children and adolescents aged 10-17 years of age were given MenQuadfi concomitantly with the first dose of Tdap-IPV (83.6%) compared to when Tdap-IPV and 9vHPV were given without MenQuadfi (67.3%). • Higher rates and intensity of solicited adverse reactions were observed in participants aged 12 to 13 months and 13 to 26 years of age. Higher rates of unsolicited adverse reactions were observed in participants aged 12 to 13 months, who received MenQuadfi concomitantly with a meningococcal serogroup B vaccine (MenB), compared to when MenQuadfi was administered alone.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.8 · PDF-Seite 7

HOS-144208 · Präparat HOS-099130

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · MenQuadfi

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY · Abschnitt 4.8 · PDF-Seite 7–8

HOS-144209 · Präparat HOS-099130

7 The following adverse reactions, as listed below, have been identified from (1) clinical trials conducted with MenQuadfi when the vaccine was given alone to participants 2 years of age and older and (2) post- marketing surveillance. The safety profile observed in infants and toddlers aged 6 weeks through 23 months is presented in the paediatric population section. The adverse reactions are listed by MedDRA system organ class and by frequency according to the following frequency categories: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1 000 to < 1/100); Rare (≥ 1/10 000 to <1/1 000); Very rare (< 1/10 000); Not known (cannot be estimated from the available data).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.