ProQuad · 4.1 Therapeutic indications · 1

HOS-094120 · has-adverse-reaction-information · PDF-Seite 7

a. Summary of the safety profile In 5 clinical trials, ProQuad was administered without concomitant vaccines to 6038 children 12 through 23 months of age. The children in these studies received either the current refrigerator-stable formulation or an earlier formulation of ProQuad. Children in these studies were monitored for six weeks post vaccination. The safety profiles were comparable for the two different formulations after a single dose. The only vaccine-related systemic adverse reactions reported at a significantly greater rate in individuals who received the earlier formulation of ProQuad compared to individuals who received the measles, mumps, and rubella vaccine manufactured by MSD and Varicella Vaccine live (Oka/Merck) were fever (≥39.4°C rectal equivalent or abnormal) and measles -like rash. Both fever and measles-like rash usually occurred within 5 to 12 days following the vaccination, were of short duration and resolved with no long-term sequelae. Pain/tenderness/soreness at the injection site was reported at a statistically lower rate in individuals who received ProQuad. 7 The only vaccine related injection site adverse reaction that was more frequent among recipients of ProQuad than among recipients of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by MSD was rash at the injection site. Following ProQuad given alone in 7 clinical trials, the observe d rates of fever (≥39.4°C rectal equivalent) ranged from 10.1% to 39.4%. In comparison, following ProQuad given concomitantly with Prevenar and/or hepatitis A vaccine in 3 clinical trials, the observed rates of reported fever (≥39.4°C rectal equivalent) ranged from 15.2% to 27.2%. In a clinical trial of ProQuad administered concomitantly with Infanrix Hexa, the rates of fever (≥38.0°C rectal equivalent) were 69.3% following concomitant administration, 61.1% following ProQuad alone, and 57.3% following Infanrix Hexa alone; the rates of fever (≥39.4°C rectal equivalent) were 22.6% following concomitant administration, 20.5% following ProQuad alone, and 15.9% following Infanrix Hexa alone. The overall safety profile of ProQuad was comparable whether it was administered concomitantly or alone. Children who received a second dose of ProQuad In eight clinical studies, the overall rates of adverse reactions after a second dose of ProQuad were generally similar to, or lower than, those seen with the

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094116 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to any varicella vaccine or measles, mumps, or rubella vaccine or to any of the excipients listed in section 6.1, including neomycin (see sections 2 and 4.4). Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system. Current immunosuppressive therapy (including high doses of corticosteroids) (see section 4.8). ProQuad is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g., for asthma prophylaxis or replacement therapy). Severe humoral or cellular (primary or acquired) immunodeficiency, e.g., severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific 3 CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%, children between 12-35 months: CD4+ <20%; children between 36-59 months: CD4+ <15% (see sections 4.4 and 4.8). In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported. Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated. Active untreated tuberculosis. Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunised with live measles virus vaccine. No studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis. Vaccination should be postponed during any illness with fever >38.5C. Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 4.6).

HOS-094115 · has-indication-information · PDF-Seite 2

ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age. ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles; see sections 4.2, 4.4, and 5.1). 2

HOS-094118 · has-interaction-information · PDF-Seite 6

At least 1 month should elapse between receipt of a live virus vaccine and ProQuad. Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad (see section 4.4). Do not give immunoglobulin (Ig) or Varicella-Zoster Immune Globulin (VZIG) concomitantly with ProQuad. Administration of immune globulins concomitantly with ProQuad may interfere with the expected immune response. Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of immune globulins (Ig). However, the appropriate suggested interval between transfusion or Ig administration and vaccination will vary with the type of transfusion or indication for, and dose of, Ig (e.g., 5 months for VZIG). Administration of varicella zoster virus antibody-containing blood products, including VZIG or other immune globulin preparations, within 1 month following a dose of ProQuad may reduce the immune response to the vaccine and hence reduce its protective efficacy. Therefore, administration of any of these products should be avoided within 1 month after a dose of ProQuad unless considered to be essential. It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks after immunisation with ProQuad. Concomitant use with other vaccines: Clinical studies have demonstrated that ProQuad can be given simultaneously (but at separate injection sites) with Prevenar and/or hepatitis A vaccine, or with monovalent or combination vaccines comprised of diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, or hepatitis B antigen. In these clinical studies, it was demonstrated that the immune 6 responses were unaffected. The safety profiles of the administered vaccines were comparable (see section 4.8). There are insufficient data to support the use of ProQuad with any other vaccines.

HOS-094119 · has-pregnancy-information · PDF-Seite 7

Pregnancy Pregnant women should not be vaccinated with ProQuad. Studies have not been conducted with ProQuad in pregnant women. In a review of more than 3 500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with a rubella-containing vaccine, no cases of congenital rubella syndrome were reported. Post-marketing surveillance has identified congenital rubella syndrome associated with a rubella vaccine strain following inadvertent vaccination of a pregnant woman with a measles, mumps, and rubella vaccine. Foetal damage has not been documented when measles, mumps or varicella vaccines have been given to pregnant women. Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay. Breast-feeding Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. In the infants with serological evidence of rubella infection, none had symptomatic disease. There is no evidence that varicella vaccine virus is excreted in breast milk. It is not known whether measles or mumps vaccine virus is secreted in human milk. Therefore, caution should be exercised when considering whether to administer ProQuad to a breast-feeding woman. Fertility Animal reproduction studies have not been conducted with ProQuad. ProQuad has not been evaluated for potential to impair fertility.

HOS-094117 · has-warning-information · PDF-Seite 4

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine. Additionally, live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions. The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases. Due caution should be employed in the administration of ProQuad to persons with individual or family history of convulsions, or a history of cerebral injury. The physician should be alert to the temperature elevation that may occur following vaccination (see section 4.8). Individuals less than 12 months of age who are vaccinated with a measles-containing vaccine during measles outbreaks or for other reasons may fail to respond to the vaccine due to the presence of circulating antibodies of maternal origin and/or immaturity of the immune system (see sections 4.2 and 5.1). Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad as Reye syndrome has been reported following the use of salicylates during wild-type varicella infection. Vaccination with ProQuad may not result in protection in all vaccine recipients. Transmission Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination. There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6). 4 There are no reports of transmission of the more attenuated Enders’ Edmonston strain of measles virus or the

Auszug; vollständigen Abschnitt im Original lesen.