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  • Nimenrix
    / Pfizer


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    (pwdr. and solvent for sol. for IM inj.): 1, 10, 100 × single dose (0.5ml)

    partial basket chart 50290 14558

    Related information


    Dosage

    Neisseria meningiditis vaccine should be used in accordance with available official recommendations.
    Primary: immunisation.
    Infants from 6 weeks to less than 6 months of age: two doses, each of 0.5 ml, should be administered with an interval of 2 months between doses.
    Infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be administered.
    An additional primary dose of Nimenrix may be considered appropriate for some individuals.
    Booster doses: After completion of the primary immunisation course in infants 6 weeks to less than 12 months of age, a booster dose should be given at 12 months of age with an interval of at least 2 months after the last Nimenrix vaccination.
    In previously vaccinated individuals 12 months of age and older, Nimenrix may be given as a booster dose if they have received primary vaccination with a conjugated or plain polysaccharide meningococcal vaccine.
    Method of administration: Immunisation should be carried out by intramuscular injection only. In infants, the recommended injection site is the anterolateral aspect of the thigh. In individuals from 1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle.


    Indications

    Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis group A, C, W-135 and Y.


    Contra-Indications

    Hypersensitivity to the active substances or to any of the excipients.


    Special Precautions

    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.
    Neisseria meningiditis vaccine should under no circumstances be administered intravascularly, intradermally or subcutaneously. It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable effects) and a clinical examination. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
    Intercurrent illness: Vaccination with Neisseria meningiditis vaccine should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
    Syncope: Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
    Thrombocytopenia and coagulation disorders: Neisseria meningiditis vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
    Immunodeficiency: It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited. 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.
    Protection against meningococcal disease: Neisseria meningiditis vaccine will only confer protection against Neisseria meningitidis group A, C, W-135 and Y. The vaccine will not protect against any other Neisseria meningitidis groups. A protective immune response may not be elicited in all vaccinees.
    Effect of prior vaccination with plain polysaccharide meningococcal vaccine:
    Subjects previously vaccinated with a plain polysaccharide meningococcal vaccine and vaccinated with Nimenrix 30 to 42 months later had lower Geometric Mean Titres (GMTs) measured with rabbit complement serum bactericidal assay (rSBA) than subjects who had not been vaccinated with any
    meningococcal vaccine in the preceding 10 years. The clinical relevance of this
    observation is unknown.
    Effect of pre-vaccination antibody to tetanus toxoid: The safety and immunogenicity of Nimenrix was evaluated when it was sequentially administered or co-administered with a vaccine containing, diphtheria and tetanus toxoids, acellular pertussis, inactivated polioviruses (1, 2 and 3), hepatitis B surface antigen and Haemophilus influenzae type b polyribosyl ribose phosphate conjugated to tetanus toxoid (DTaP-HBV-IPV/Hib ) in the second year of life. The administration of Nimenrix one month after the DTaP-HBV-IPV/Hib vaccine resulted in lower rSBA GMTs against groups A, C and W-135 compared with co-administration. The clinical relevance of this observation is unknown.
    Immune response in infants aged 6 months to less than 12 months: A single dose administered at 6 months was associated with lower human complement serum bactericidal assay (hSBA) titres to groups W-135 and Y compared with three doses administered at 2, 4, and 6 months. The clinical relevance of this observation is unknown. If an infant aged 6 months to less than 12 months is expected to be at particular risk of invasive meningococcal disease due to exposure to groups W-135 and/or Y, consideration may be given to administering a second primary dose of Nimenrix after an interval of 2 months.
    Immune responses in toddlers aged 12-14 months: Toddlers aged 12-14 months had similar rSBA titres responses to groups A, C, W-135 and Y at one month after one dose of Nimenrix or at one month after two doses of Nimenrix given two months apart.
    A single dose was associated with lower human complement serum bactericidal assay (hSBA) titres to groups W-135 and Y compared with two doses given two months apart. Similar responses to groups A and C were observed after one or two doses. The clinical relevance of the findings is unknown. If a toddler is expected to be at particular risk of invasive meningococcal disease due to exposure to groups W-135/or and Y, consideration may be given to administering a second dose of Nimenrix after an interval of 2 months. 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.
    Persistence of serum bactericidal antibody titres: Following administration of Nimenrix there is a waning of serum bactericidal antibody titres against group A when using hSBA.
    The clinical relevance of this observation is unknown. 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.
    A decline in antibody titres over time has been observed for groups A, C, W-135 and Y. The clinical relevance of this observation is unknown. A booster dose might be considered in individuals vaccinated at toddler age remaining at high risk of exposure to meningococcal disease caused by groups A, C, W-135 or Y (see section 5.1).
    Effect of Nimenrix on anti-tetanus antibody concentrations: Although an increase of the anti-tetanus toxoid (TT) antibody concentrations was observed following vaccination with Nimenrix, Nimenrix does not substitute for tetanus immunisation.
    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. No data are available beyond the age of 2 years.
    Sodium content
    This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’


    Side Effects

    Appetite lost, Irritability, Drowsiness, headache, Gastrointestinal symptoms (including diarrhoea, vomiting and nausea), Fever, swelling, pain and redness at injection site, fatigue, Injection site haematoma.
    See prescribing information for full details.


    Drug interactions

    From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines:
    hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles – mumps – rubella (MMR) vaccine, measles – mumps – rubella – varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine.
    In the second year of life, Nimenrix can also be given concomitantly with combined diphtheria – tetanus – acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b(HBV, IPV or Hib), such as DTaP-HBVIPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine.
    In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus bivalent [Type 16 and 18] vaccine, recombinant (HPV2).
    Whenever possible, Nimenrix and a TT containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, should be co-administered or Nimenrix should be administered at least one month before the TT containing vaccine.
    One month after co-administration with a 10-valent pneumococcal conjugate vaccine, lower Geometric Mean antibody Concentrations (GMCs) and opsonophagocytic assay (OPA) antibody GMTs were observed for one pneumococcal serotype (18C conjugated to tetanus toxoid carrier protein). The clinical relevance of this observation is unknown. There was no impact of coadministration on immune responses to the other nine pneumococcal serotypes.
    One month after co-administration with a combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap) in subjects aged 9 to 25 years, lower GMCs were observed to each pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]). More than 98% of subjects had anti-PT, FHA or PRN concentrations above the
    assay cut-off thresholds. The clinical relevance of these observations is unknown. There was no impact of co-administration on immune responses to Nimenrix or the tetanus or diphtheria antigens included in Tdap.
    If Nimenrix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
    It may be expected that in patients receiving immunosuppressive treatment an adequate response may not be elicited.


    Pregnancy and Lactation

    Pregnancy: There is limited experience with use of Nimenrix in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Nimenrix should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.
    Lactation: It is unknown whether Nimenrix is excreted in human milk. Nimenrix should only be used during breast-feeding when the possible advantages outweigh the potential risks.


    Overdose

    No case of overdose has been reported.


    Important notes

    Effects on ability to drive and use machines: No studies on the effects of Neisseria meningiditis vaccine on the ability to drive and use machines have been performed. However, some of the side effects may affect the ability to drive or use machines.
    Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light.
    Shelf life after reconstitution: After reconstitution, the vaccine should be used promptly. Although delay is not recommended, stability has been demonstrated for 8 hours at 30°C after reconstitution. If not used within 8 hours, do not administer the vaccine.


    Manufacturer
    PFIZER Manufacturing Belgium NV, Belgium
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