Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.3 · PDF-Seite 5

HOS-147497 · Präparat HOS-099678

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to diphtheria toxoid.

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

Wechselwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.5 · PDF-Seite 6

HOS-147498 · Präparat HOS-099678

Different injectable vaccines should always be administered at different vaccination sites.

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

Wechselwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.5 · PDF-Seite 6

HOS-147499 · Präparat HOS-099678

Do not mix Prevenar 20 with other vaccines or medicinal products in the same syringe.

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

Wechselwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.5 · PDF-Seite 6

HOS-147500 · Präparat HOS-099678

Paediatric population

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

Wechselwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.5 · PDF-Seite 6

HOS-147501 · Präparat HOS-099678

In infants and children, 6 weeks to less than 5 years of age, Prevenar 20 can be administered concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular pertussis, hepatitis B, Haemophilus influenzae type b, inactivated poliomyelitis, measles, mumps, rubella, and varicella vaccines. In clinical trials, rotavirus vaccines were permitted to be administered concomitantly with Prevenar 20 and no safety concerns were observed.

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): Haemophilus influenzae type b (HOS-111047)

Wechselwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.5 · PDF-Seite 6–7

HOS-147503 · Präparat HOS-099678

6 Individuals 18 years of age and older

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

Wechselwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.5 · PDF-Seite 7

HOS-147504 · Präparat HOS-099678

Prevenar 20 may be administered concomitantly with seasonal influenza vaccine (QIV; surface antigen, inactivated, adjuvanted). In subjects with underlying conditions associated with a high risk of developing life-threatening pneumococcal disease, consideration may be given to separating administrations of QIV and Prevenar 20 (e.g., by approximately 4 weeks). In a double-blind, randomised study (B7471004) in adults 65 years of age and older, the immune response was formally non-inferior, however numerically lower titres were observed for all pneumococcal serotypes included in Prevenar 20 when given concomitantly with seasonal influenza vaccine (QIV, surface antigen, inactivated, adjuvanted) compared to when Prevenar 20 was given alone. The clinical relevance of this finding is unknown.

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

Wechselwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.5 · PDF-Seite 7

HOS-147505 · Präparat HOS-099678

Prevenar 20 can be administered concomitantly with COVID-19 mRNA vaccine (nucleoside modified).

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

Wechselwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.5 · PDF-Seite 7

HOS-147506 · Präparat HOS-099678

There are no data on the concomitant administration of Prevenar 20 with other vaccines.

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 7

HOS-147507 · Präparat HOS-099678

Summary of the safety profile

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 7

HOS-147508 · Präparat HOS-099678

Paediatric population

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 7

HOS-147509 · Präparat HOS-099678

The safety of Prevenar 20 was evaluated in 5 987 participants, 6 weeks of age to less than 18 years of age, in 5 clinical trials (one Phase 2 and four Phase 3), 4 randomised, double-blind, active-controlled

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 7–8

HOS-147510 · Präparat HOS-099678

7 clinical trials and 1 single-arm clinical trial; 3 664 participants received at least 1 dose of Prevenar 20, and 2 323 participants received Prevenar 13 (control vaccine).

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 8

HOS-147511 · Präparat HOS-099678

Participants 6 weeks to less than 15 months of age

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 8

HOS-147512 · Präparat HOS-099678

Clinical trials were conducted in healthy infants 6 weeks to less than 15 months of age using a 3-dose schedule or a 4-dose schedule (see section 5.1). In these infant trials, 5 156 participants received at least 1 dose of vaccine: 2 833 received Prevenar 20, and 2 323 received Prevenar 13. Overall, approximately 90% of participants in each group received all doses through the study-specified toddler dose. In all studies, local reactions and systemic events were collected after each dose, and adverse events (AEs) were collected in all studies from the first dose through 1 month after the last infant vaccination and from the toddler dose through 1 month after the toddler dose. Serious adverse events were evaluated through 1 month after the last dose in the Phase 3 trial B7471012 (Study 1012) and through 6 months after the last dose in Phase 3 trials (Studies 1011, 1013) and Phase 2 trial (Study 1003).

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 8

HOS-147513 · Präparat HOS-099678

Prevenar 20 was well tolerated, when administered in a 3-dose and a 4-dose series, in the infant study populations with low rates of severe local reactions and systemic events, and most reactions resolving within 1 to 3 days. The percentages of participants with local reactions and systemic events after Prevenar 20 were generally similar to those after Prevenar 13. The most frequently reported local reactions and systemic events after any dose of Prevenar 20 were irritability, drowsiness, and pain at injection site. In these studies, Prevenar 20 was co-administered or permitted to be administered with certain routine paediatric vaccines (see section 4.5).

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 8

HOS-147514 · Präparat HOS-099678

Study 1012 was a pivotal, double-blind, randomised, active-controlled Phase 3 trial, in which 601 healthy infants received Prevenar 20 in a 3-dose series. The most frequently reported (> 10%) adverse reactions after any dose of Prevenar 20 were irritability (71.0% to 71.9%), drowsiness/increased sleep (50.9% to 61.2%), pain at injection site (22.8% to 42.4%), decreased appetite (24.7% to 39.3%), redness at the injection site (25.3% to 36.9%), swelling at the injection site (21.4% to 29.8%), and fever ≥ 38.0 ℃ (8.9% to 24.3%). Most adverse reactions occurred within 1 to 2 days following vaccination and were mild or moderate in severity and of short duration (1 to 2 days).

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 8

HOS-147515 · Präparat HOS-099678

Studies 1011, 1013 and 1003, were double-blind, randomised, active-controlled trials that included 2 232 healthy infants, vaccinated with Prevenar 20 in a 4-dose series. The most frequently reported (> 10%) adverse reactions observed after any dose of Prevenar 20 in infants were irritability (58.5% to 70.6%), drowsiness/increased sleep (37.7% to 66.2%), pain at injection site (32.8% to 45.5%), decreased appetite (23.0% to 26.4%), redness at the injection site (22.6% to 24.5%), and swelling at the injection site (15.1% to 17.6%). Most adverse reactions were mild or moderate following vaccination and most reactions resolving within 1 to 3 days. Severe reactions were reported infrequently.

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 8

HOS-147516 · Präparat HOS-099678

In Study 1013, the local reactions and systemic events in the preterm subgroup (111 infants born at 34 to less than 37 weeks of gestation) were similar to or lower than the term infants in the study. In the preterm subgroup, the frequency of any reported local reaction was 31.7% to 55.3% in the Prevenar 20 group, and any systemic event was 65.0% to 85.5% in the Prevenar 20 group.

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

Nebenwirkungen · Prevenar 20 (previously Apexxnar)

Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) · Abschnitt 4.8 · PDF-Seite 8

HOS-147517 · Präparat HOS-099678

Participants aged 15 months to less than 18 years of age

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