Wednesday, May 31, 2023

ACT-HIB 10 μg/0.5 ml pdre/solv p sol inj prefilled syringe



SYNTHESIS

pharmacotherapeutic classification:

Infectiology - Parasitology : Vaccines, immunotherapy - Inactivated vaccines, recombinants and toxoids : Infections with Haemophilus influenzae b ( Haemophilus influenzae b not associated).

Classification ATC :

GENERAL ANTIINFECTIVES FOR SYSTEMIC USE : VACCINES - BACTERIAL VACCINES : ANTIHAEMOPHILUS INFLUENZAE B VACCINES ( HAEMOPHILUS INFLUENZAE B, PURIFIED CONJUGATE ANTIGEN).

Substances:

  • haemophilus influenzae type b polyoside.
  • tetanus protein.

Excipients:

trometamol , sucrose , concentrated hydrochloric acid
solvent excipient:  sodium chloride , water for injection

Excipients with known effect:

EEN without threshold dose:  natural rubber

Presentation

  • ACT-HIB 10 µg/0.5 ml Pdre/solv p sol inj pre-filled syringe Fl+Ser prer/0.5ml
  • Cip : 3400933472016
  • Storage conditions: Before opening: 2° < t < 8° for 36 months (Store in the refrigerator, Do not freeze)
  • Approved for Communities
  • Refund: 65%
 

Source:

  • RCP of 07/21/2022
  • SHAPES AND PRESENTATIONS
  • Powder (white) and solvent (clear, colorless solution) for solution for injection.
  • Box containing: 1 vial of powder + 1 pre-filled syringe of 0.5 mL of solvent.

COMPOSITION:

  • A 0.5 mL dose of reconstituted vaccine contains:
  • Haemophilus influenzae type b polysaccharide: 10 micrograms
  • conjugated to tetanus protein: 18-30 micrograms
  • ACT-HIB may contain traces of formaldehyde used in manufacturing (see section Contraindications).

Excipients:

  • Powder: trometamol, sucrose, concentrated hydrochloric acid for pH adjustment.
  • Solvent: sodium chloride, water for injections.

DC:
INDICATIONS:

  • This vaccine is indicated for the prevention of invasive Haemophilus influenzae type b infections (meningitis, septicemia, cellulitis, arthritis, epiglottitis, etc.) in children from 2 months of age.
  • This vaccine does not protect against infections due to other types of Haemophilus influenzae , nor against meningitis of other origins.
  • Under no circumstances can the tetanus protein contained in this vaccine replace the usual tetanus vaccination.

DC:
WARNINGS AND PRECAUTIONS FOR USE:

Do not inject intravascularly ensuring that the needle does not enter a blood vessel.
Vaccination must be preceded by a search of the medical history (in particular for previous vaccinations and adverse events that may have occurred) and a clinical examination.
As with all injectable vaccines that may induce a possible immediate anaphylactic reaction, appropriate medical treatment is recommended.

Like any vaccine, this vaccine should be administered with caution in case of thrombocytopenia or coagulation disorders because intramuscular injection may cause bleeding in some subjects.

Vaccination can be performed in children with a congenital or acquired state of immunosuppression, knowing that depending on the state of the immune system, the vaccine response will be weaker. In children treated with immunosuppressants (corticosteroid therapy, anti-mitotic chemotherapy, etc.), it is recommended to wait until the end of the treatment before vaccinating.

The potential risk of apnea with the need for respiratory monitoring for 48-72 hours must be carefully taken into account when administering doses of primary vaccination in very premature infants (born at 28 weeks of pregnancy or less) and particularly in those with a history of respiratory immaturity. Due to the high benefit of vaccination in these infants, administration should not be suspended or postponed.

Syncope (fainting), as a psychogenic reaction to injection with a needle, may occur after or even before any vaccination. Measures should be put in place to prevent injury from fainting and manage syncopal reactions.

ACT-HIB contains sodium. ACT-HIB contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially 'sodium free'.

Traceability:

In order to improve the traceability of biological medicinal products, the name and the batch number of the product administered must be clearly recorded.
Interference with serological tests: see section Interactions .

PP:
PRECLINICAL SAFETY:

Non-clinical data from conventional studies of acute toxicology, repeated administration toxicology, local tolerance did not reveal any particular risk for humans.

DP:
INCOMPATIBILITIES:

This medicinal product must not be mixed with other medicinal products except those mentioned in the Elimination/Handling section .

DP:
THE DURATION OF THE CONVERSATION:

3 years
The vaccine should be administered immediately after reconstitution.

DP:
SPECIAL STORAGE CONDITIONS:

Store in the refrigerator (between 2°C and 8°C).
Do not freeze.
For storage conditions of the medicinal product after reconstitution, see section Shelf life .

DP:
SPECIAL PRECAUTIONS FOR DISPOSAL AND HANDLING:

Reconstitute the solution either by injecting the contents of the syringe of solvent into the vial of powder or by injecting the contents of a syringe of combined diphtheria-tetanus-pertussis or diphtheria-tetanus-pertussis-poliomyelitis vaccine. Shake until the powder is completely dissolved. The cloudy whitish appearance of the suspension after reconstitution with a syringe of diphtheria-tetanus-pertussis or diphtheria-tetanus-pertussis-poliomyelitis vaccine is normal.
Any unused medication or waste should be disposed of in accordance with applicable regulations.

PRESCRIPTION/ISSUE/CARE:

  • MA
  • CIP 3400933472016 (Fl+Ser prér/0.5ml).
  • Price :
  • 34.10 euros (Fl+Ser prér/0.5ml).
  • 65% Sec Remb.