Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

NATIONAL VACCINATION PROGRAMME pneumococci
Intramuscular 6 weeks up to 9 weeks [6] First vaccination 0.5 ml/dose, once only. 4 months [6] Second vaccination 0.5 ml/dose, once only. 11 months [6] Third vaccination 0.5 ml/dose, once only. Start vaccination programm at age < 6 months [6] <according to national vaccination schedule>

Immunization against pneumococci: Non-standard schedules (not the National Vaccination Programme)

Intramuscular 0 years up to 18 years [2] [4] [5] [8] Synflorix: Premature infants born between 27-36 weeks duration of pregnancy: 4 doses, of which the first is at the age of 2 months. The first 3 doses are given with 1 month between each dose and the fourth is given at least 6 months after the third dose. 6 weeks-6 months: Regimen of 4 doses, of which the first three are given with 1 month between each dose and the fourth is given at least 6 months after the third , preferably at an age of 12-15 months. Regimen of 3 doses, of which the first 2 are given with 2 months between each dose; the third is given at least 6 months after the second dose. Previously unvaccinated infants and older children: 7 months to 11 months: 3 doses, of which the first 2 are given with at least 1 month between each dose and the third is given in the second year of life, at least 2 months after the second dose. 12 months-5 years: 2 doses with at least 2 months in between doses. Prevenar 13: Premature infants (< 37 weeks): 4 doses, of which the first is given at the age of 6-8 weeks, the next 2 are given with 1 month between each dose and the fourth is given at least 6 months after the third dose, preferably at an age of 11-15 months. 6 weeks to 6 months: Regimen of 4 doses: of which the first three are given with 1 month between each dose and the fourth is given at least 6 months after the third , preferably at an age of 11-15 months. Regimen of 3 doses: of which the first 2 doses are given with 2 months between each dose; the third dose is recommended at 11-15 months. Previously unvaccinated infants and older children: 7 months to 11 months: 3 doses, of which the first 2 are given with at least 1 month between each dose and the third is given in the second year of life. 12-23 months: 2 doses with at least 2 months in between doses. 2-17 years: 1 dose. Vaxneuvance Standard vaccination schedule Premature infants (< 37 weeks at birth): primary series of three doses followed by a booster dose. First dose at 6 weeks of age, with 4-8 weeks interval between primary doses. 4th dose (booster dose) at left age 11-16 months and at least 2 months after the 3rd dose. 6 weeks to 2 years: 4-dose schedule: primary series of three doses followed by a booster dose. First dose at 6 weeks of age, with 4-8 weeks interval between primary doses. 4th dose (booster dose) at 11-16 months of age and at least 2 months after the 3rd dose. 3 dose schedule: primary series of 2 doses followed by a booster dose. First dose at 6 weeks of age and 2nd dose 8 weeks later. 3rd dose (booster dose) at 11-16 months of age. Schedule for previously unvaccinated children: 7 months-12 months: 2 doses at 4-week intervals. A third booster dose after 12 months of age and at least 2 months after the last dose 12 months-2 years: 2 doses at 2-month intervals 2 - 18 years: (unvaccinated or incompletely vaccinated children) 1 dose (at least 2 months after a previous dose of pneumococcal conjugate vaccine Infants and children who have begun immunization with another pneumococcal conjugate vaccine may switch to Vaxneuvance at any time within the schedule Pneumovax 23: (at-risk groups) > 2 years: 1 dose. Revaccination should be considered if the last vaccination took place more than 5 years ago and in children aged < 10 years with nephrotic syndrome, asplenia or sickle cell anaemia who were vaccinated 3-5 years ago.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Synflorix

Very common (> 10%): pain, redness and swelling at the injection site, fever ≥ 38 ° C (age <2 years), irritability, somnolence, decreased appetite.

Common (1-10%): Injection site reactions such as induration, fever> 39 ° C with age <2 years. After booster vaccination also: fever ≥ 38 ° C at age 2–5 years.

Uncommon (0.1-1%): Injection site reactions such as itching, hematoma, haemorrhage and nodule, abnormal crying, apnea in very premature infants (≤28 weeks gestation), diarrhea, vomiting, rash. After the booster vaccination also: diffuse swelling of the vaccinated limb, itching, headache, nausea (age 2–5 years), fever> 40ºC in the case of age <2 years or> 39ºC in the age of 2–5 years.

Rare (0.01-0.1%): allergic reactions such as dermatitis, atopic dermatitis, eczema, (febrile) convulsions, urticaria, hypotonic-hyporesponsive episode.

Very rare (<0.01%): anaphylaxis, angioedema, Kawasaki disease.

Prevenar 13

Children ≤ 5 years:
Very common (> 10%): decreased appetite, fever, irritability, drowsiness, poor sleep, injection site reactions (such as swelling, induration, erythema, pain, tenderness).

Common (1-10%): vomiting, diarrhea, rash, fever> 39 ° C, vaccination site movement restriction.

Uncommon (0.1-1%): (febrile) seizures, urticaria, (abnormal) crying,

Rare (0.01-0.1%): hypersensitivity reactions (such as facial edema, dyspnoea, bronchospasm), hypotonic-hyporesponsive episode.

Further reported: anaphylaxis, angioedema, lymphadenopathy, apnea in very preterm infants (≤28 weeks gestation), erythema multiforme, itching and injection site rash, flushing.

Children 6–17 years:
Very common (> 10%): decreased appetite, irritability, injection site reactions (such as swelling, induration, erythema, pain, tenderness, limited movement), somnolence, poor sleep.

Common (1-10%): headache, vomiting, diarrhea, rash, urticaria, fever.

Children with sickle cell disease, HIV, or a haematopoietic stem cell transplant have similar side effects, except headache, vomiting, diarrhea, fever, fatigue, arthralgia and myalgia are very common.

Pneumovax 23

Very common (> 10%): local reactions such as erythema, edema, induration, tenderness, swelling. heat and pain. Fever (≤ 38.8 ° C).

Rare (<0.01%): Injection site cellulitis.

Further reported: haemolytic anemia, leukocytosis, lymphadenitis, lymphadenopathy, thrombocytopenia. Anaphylactoid reactions, angioneurotic edema, serum sickness. Febrile seizures, Guillain-Barré syndrome, headache, paraesthesia, radiculo-neuropathy. Nausea, vomiting. skin rash, urticaria. Arthralgia, Arthritis, Myalgia. Asthenia, chills, fever, malaise, reduced mobility or peripheral edema in injected limb,

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Acute severe disease with fever. Hypersensitivity to any one of the carrier proteins.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Synflorix, Prevenar 13:
Protection against otitis media is substantially lower than against invasive diseases.

Safety and immunogenicity data are available for HIV infected infants (asymptomatic or with mild symptoms according to the WHO classification), HIV negative infants born to HIV positive mothers, children with sickle cell disease and children with spleen dysfunction. These are not available for other specific immunocompromised groups. Risks and benefits of vaccination should be assessed on a case-by-case basis for children of these groups. .

The vaccine does not replace the 23-valent pneumococcal polysaccharide vaccine in children over two years of age with conditions that are more prone to invasive diseases by Streptococcus pneumoniae such as sickle cell anemia, asplenia, HIV infection, chronic diseases, or other immune-compromising conditions; if applicable, maintain an interval of at least eight weeks between the administration of Synflorix (10-valent vaccine) and the 23-valent vaccine.

It is recommended that prophylactic antipyretic medications be administered when co-administered with whole pertussis cell vaccines and in a history of epileptic or febrile seizures; however, there is some evidence that prophylactic administration of paracetamol could reduce the immune response to Synflorix; the clinical relevance is unknown.

When administering the primary immunization series to very preterm infants (born ≤ 28 weeks of gestation), consider respiratory monitoring for 48–72 hours due to the potential risk of apnea, especially in children with a history of insufficient lung maturation; however, since the benefit of vaccination is great in this group of children, do not withhold or delay vaccination.

Pneumovax 23
Delay vaccination for illness with significant fever, other infections, or when a systemic reaction could pose a significant risk, except when delay would be an even greater risk.

Vaccinate as soon as possible after diagnosis of (a) symptomatic HIV infection.

The antibody response after vaccination may be reduced in patients with a suppressed immune system (eg genetic defect, HIV infection, immunosuppressive treatment (drugs, radiotherapy, splenectomy) after the first or second dose. Some patients showed a significant improvement in the antibody response during the period of 2 years following the end of chemotherapy or immunosuppressive therapy, especially with a longer interval between the end of treatment and the start of vaccination.

Vaccine may not be effective in preventing infection due to a skull base fracture or external contact with cerebrospinal fluid.

Do not interrupt necessary prophylactic treatment against pneumococcal infection with antibiotics after vaccination.

 

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• ANTIINFECTIVES FOR SYSTEMIC USE
• VACCINES

BACTERIAL VACCINES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Cholera vaccines
	Cholera vaccin Related Medicines Menu">	J07AE01

Haemophilus influenzae B vaccines
	Haemophilus influenzae B vaccine (HiB) Related Medicines Menu">	J07AG01

Meningococcal vaccines
	Meningococcen B vaccin Related Medicines Menu">	J07AH09
	Meningococcen C vaccin Related Medicines Menu">	J07AH07
	Meningococcus A, C, W135, Y vaccin Related Medicines Menu">	J07AH08

Pertussis vaccines
	Difterie-Tetanus-Kinkhoest (DTP) vaccin Related Medicines Menu">	J07AJ52

Tuberculosis vaccines
	BCG vaccine Related Medicines Menu">	J07AN01

Typhoid vaccines
	Typhoid vaccine Related Medicines Menu">	J07AP03
	Typhoid vaccine (oral) Related Medicines Menu">	J07AP01

References

1. Nederlands Vaccin Instituut, Vaccinatieschema (geraadpleegd 28 okt 2009)., www.nvi-vaccins.nl, http://www.nvi-vaccin.nl/?id=564
2. GlaxoSmithKline Biologicals S.A., SmPC Synflorix (EU/1/09/508//001-010)Rev 31, 30-11-2018, www.geneesmiddeleninformatiebank.nl
3. RIVM, Rijksvaccinatieprogramma 2011-Richtlijn 2011, www.rivm.nl
4. Pfizer Limited, SPC Prevenar 13 (EU/1/09/590/001-006) Rev 40, 08-01-2021, www.ema.europa.eu
5. Merck Sharp & Dohme B.V. , SPC Pneumovax 23 (RVG 25853) 09-07-2019, www.geneesmiddeleninformatiebank.nl
6. RIVM , Rijksvaccinatieprogramma pneumokokken, www.rivm.nl, 27 november 2013, http://www.rivm.nl/Documenten_en_publicaties/Algemeen_Actueel/Nieuwsberichten/2013/Baby’s_krijgen_één_prik_minder_tegen_pneumokokken
7. RIVM, Richtlijn voor preventie van infecties bij mensen met (functionele) hypo-en asplenie., Feb 2012
8. Merck Sharp & Dohme B.V. , SmPC Vaxneuvance (EU/1/21/1591) Rev 5, 22-09-2023, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring

Overdose