Procomvax - summary of medicine characteristics

2. QUALITATIVE AND QUANTITATIVE COMPOSITIONPolyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC7.5For excipent, see section 6.1.Suspension for injection in vial.4.2 Posology and method3. PHARMACEUTICAL FORM4. CLINICAL PARTICULARS4.1 Therapeutic indications.0 ^gby all known subtypes of hepatitis B virus in infants 6

2. QUALITATIVE AND QUANTITATIVE COMPOSITIONPo­lyribosylribi­tol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC7.5For excipent, see section 6.1.Suspension for injection in vial.4.2 Posology and method3. PHARMACEUTICAL FORM4. CLINICAL PARTICULARS4.1 The­rapeutic indications.0 ^gby all known subtypes of hepatitis B virus in infants 6

Neisseria meningitidis OMPC (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B)

Adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae)

PROCOMVAX is indicated for vaccinati influenzae type b and against infectio weeks to 15 months of age.

Posology

Infants born of HBsAg negative mothers should be vaccinated with three 0.5ml doses of PROCOMVAX, ideally at 2, 4, and 12–15 months of age. If the recommended schedule cannot be followed exactly, the interval between the first two doses should be approximately two months and the interval between the second and third dose should be as close as possible to eight to eleven months. All three must be administered to complete the vaccination regimen.

o receive one dose of hepatitis B vaccine at or shortly after birth may be administered VAX on the schedule of 2, 4, and 12 –15 months of age.

hildren not vaccinated according to recommended schedule

accination schedules for children not vaccinated according to the recommended schedule should be onsidered on an individual basis.

Method of administration

FOR INTRAMUSCULAR ADMINISTRATION

Do not inject intravenously, intradermally, or subcutaneously

4.3 Contraindications

4.4 Special warnings and special precautions for use

4.4 Special warnings and special precautions for use

ot induce protective antibody levels immediately following vaccination and tective antibody response in all individuals given the vaccine.

ith Haemophilus b Polysaccharide Vaccine and another Haemophilus b Conjugate

s of Haemophilus b disease may occur in the week after vaccination, prior to the onset of ective effects of the vaccines.

e potential risk of apnoea and the need for respiratory monitoring for 48–72h should be considered when administering the primary immunisation series to very premature infants (born < 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

4.5 Interaction with other medicinal products and other forms of interaction

4.5 Interaction with other medicinal products and other forms of interaction

Immunogenicity results from open-labeled studies indicate that PROCOMVAX can be administered concomitantly with DTP (Diphtheria, Tetanus and whole cell Pertussis vaccine), OPV (Oral Poliomyelitis vaccine), IPV ( inactivated poliomyelitis vaccine) and Merck MMR (Measles, Mumps, and Rubella Virus Vaccine Live) using separate sites and syringes for injectable vaccines. Additionally, limited immunogenicity results from an open-labeled, controlled study indicate that PROCOMVAX may be administered concomitantly with DTaP (Diphtheria, Tetanus, and acellular Pertussis vaccine), using separate sites and syringes for injectable vaccines.

Efficacy of whole cell or acellular pertussis vaccines when given concomitantly with PROCOMVAX has not been established in field trials.

4.6 Pregnancy and lactation

4.6 Pregnancy and lactation

Not applicable. For paediatric use only.

4.7 Effects on ability to drive and use machines

Not applicable. For paediatric use only.

4.8 Undesirable effects

In clinical trials involving the administration of 7,350 doses of PROCOMVAX

infants 6 weeks to 15 months of age, PROCOMVAX was generally well t 1,177 were involved in clinical trials in which most received PROCOMVA licensed paediatric vaccines. Of these, 1,110 were monitored for both serio experiences. The remaining 1,816 infants were involved in trials where PROCOMVAX was administered concomitantly with either an investigational pneumococcal polysaccharide protein conjugate vaccine or an investigational preparation of diphtheria, tetanus, pertussis, and inactivated

poliovirus vaccine and were under surveillance for serio

Among the 2,993 children given PROCOMVAX, 33 had serious adverse experiences within 14 days of vaccination. None of the serious adverse expe was judged by the study investigator to be related to this vaccine.

In one of these trials, a randomized, multicenter study, 882 infants were assigned in a 3:1 ratio to receive either PROCOMVAX or Merck Haemophilus b Conjugate Vaccine (Meningococcal Protein

Conjugate) (Merck PRP-OMPC Vaccine) plus Merck Hepatitis B (Recombinant) Vaccine at 2, 4, and 12–15 months of age, with the children monitored daily for five days after each injection for local reactions and systemic co nts. Most children received DTP and OPV concomitantly with the first two doses of PROCOMV Merck PRP-OMPC Vaccine or Merck Hepatitis B (Recombinant) Vaccine. Across all three      of PROCOMVAX, there were no significant differences in the

experiences between PROCOMVAX and the monovalent vaccines Merck PRP-rck Hepatitis B (Recombinant) Vaccine. However, the frequency of irritability r after all three injections of PROCOMVAX combined and after the first MVAX compared to the monovalent vaccines.

cal reactions and systemic complaints were reported in >1.0 % of children within five

days after any injection of PROCOMVAX: pain/soreness, erythema, swelling/induration at the injection site; fever (>38.3 °C, rectal equivalent); anorexia, vomiting, diarrhoea; irritability, somnolence, crying including unusual high-pitched crying, prolonged crying (>4hrs), and crying not herwise specified; otitis media. No increase in the frequency or severity of adverse events was seen ith subsequent doses.

PROCOMVAX

Hypersensitivity

Rarely : anaphylaxis, angioedema, urticaria, erythema multiforme.

Nervous System

Seizure, febrile seizure

Respiratory, thoracic and mediastinal disorders

Apnoea in very premature infants (< 28 weeks of gestation) (see section 4.4)

Skin

Injection site nodule

Potential Adverse Effects

In addition, a variety of adverse effects have been reported with marketed use of either Merck PRP-OMPC Vaccine or Merck Hepatitis B (Recombinant) Vaccine in infants and children through 71 months of age. These adverse effects are listed below.

Liquid Merck PRP-OMPC Vaccine

Haematologic/Lym­phatic Lymphadenopathy

Skin

Pain at the injection site

Merck Hepatitis B (Recombinant) Vaccine Common reactions

Local reactions at injection site: transient soreness,

elevation of liver enzymes, fatigue, fever, symptoms, serum sickness, thromboc

dizziness, headache, paresthesia nausea, vomiting, diarrhea, a arthralgia, myalgia rash, pruritus,

uropathy, neuritis (including Guillain Barre Syndrome, myelitis tis), encephalitis, optical neuritis.

4.9 Overdose

Pharmacodynamic properties

harmacotherapeutic group : anti infectious, ATC code : J07CA

PROCOMVAX is a sterile bivalent vaccine made of the antigenic components used in producing Merck PRP-OMPC Vaccine and Merck Hepatitis B (Recombinant) Vaccine. These components are the Haemophilus influenzae type b capsular polysaccharide (PRP) that is covalently bound to an outer membrane protein complex (OMPC) of Neisseria meningitidis and hepatitis B surface antigen (HBsAg) from recombinant yeast cultures.

The protective efficacy of the components of PROCOMVAX has been established in field trials performed with the monovalent vaccines.

Anti-HBs Responses to PROCOMVAX in Infants Not Previously Vaccinated with Hepatitis B Vaccine

In 4 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 1809 infants, approximately 2 months of age, who had not previously received any hepatitis B vaccine. These infants nominally received PROCOMVAX at 2, 4, and 12–15 months of age.

In these studies, 1503 infants had anti-HBs results available following the first 2 doses of PROCOMVAX and 1309 had anti-HBs results available following the third dose of PROCOMVAX. Post-dose 2, 77% to 96% of infants developed a protective level of anti-HBs (> 10 mIU/ml) and the GMTs ranged from 30 mIU/ml to 190 mIU/ml. Post-dose 3, 96 % to 100 % of infants developed protective level of anti-HBs and the GMTs ranged from 897 mIU/ml to 4467 mIU/ml.

Anti-HBs Responses to PROCOMVAX in Infants Previously Vaccinated with Hepatitis

In 4 clinical trials conducted between 1992 and 2000, PROCOMVAX was administer infants, approximately 2 months of age, who had previously received a single vaccine at birth. These infants nominally received PROCOMVAX at 2–3, 4–5, age

In these studies, 618 infants had anti-HBs results available following the first 2 doses of PROCOMVAX and 461 had anti-HBs results available following the third dose of PROCOMVAX. Post-dose 2, 93 % to 100 % of infants developed a protective level of anti-HBs (> 10 mIU/ml) and the GMTs ranged from 125 mIU/ml to 417 mIU/ml. Post-dose 3, 98 % to 100 % of infants developed a protective level of anti-HBs and the GMTs ranged from 150 /ml to 3913 mIU/ml.