Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

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.

Nimenrix 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 Nimenrix 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

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.

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

Nimenrix will only confer protection against Neisseria meningitidis groups 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 a serum bactericidal assay using rabbit complement (rSBA) than subjects who had not been vaccinated with any meningococcal vaccine in the preceding 10 years (see section 5.1). 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 (see section 4.5). 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 (see section 5.1). 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 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 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 (see section 5.1). The clinical relevance of this observation is unknown. If a toddler 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 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 (see section 5.1). 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’.

Effects on Driving

4.7    Effects on ability to drive and use machines

No studies on the effects of Nimenrix on the ability to drive and use machines have been performed.
However, some of the effects mentioned under section 4.8 “Undesirable effects” may affect the ability to drive or use machines.