Aggripal NH

AGRIPPAL™ S1
Suspension for injection in pre-filled syringe
Influenza Vaccine, Surface Antigen, Inactivated
2011-2012 NH Season

Presentation:

Clear, colourless, sterile liquid for injection.

Composition

Each dosage (0.5 ml) contains: Influenza virus surface antigen (haemagglutinin and neuraminidase),
propagated in eggs, and inactivated with formaldehyde of strains:

• A/California/07/2009 (H1N1)-like strain (A/California/07/2009, NYMC X-181) ≥15 micrograms HA*
• A/Perth/16/2009 (H3N2)-like strain (A/Victoria/210/2009, NYMC X-187) ≥15 micrograms HA*
• B/Brisbane/60/2008 – like strain (B/Brisbane/60/2008, NYMC BX-35) ≥15 micrograms HA*

*An overage of up to 15% of the HA concentration is included for each virus strain
Excipients: Sodium chloride; potassium chloride; potassium dihydrogen phosphate; disodium phosphate
dihydrate; magnesium chloride; calcium chloride; water for injection.
This vaccine complies with the WHO recommendations (northern hemisphere) and EU decision for the
2011/2012 season.

Mode of action:

Pharmacodynamic properties
Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to
homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.
ATC Code JO7BB02.

Indications

Influenza prophylaxis, especially in those subjects who run an increased risk of influenza-associated
complications.

Posology and method of administration

• Adult ≥ 18 years of age: one dose of 0.5 ml
• The vaccine should be administered by intramuscular or deep subcutaneous injection
• AGRIPPAL S1 should be allowed to reach room temperature before use
• Shake before use.
  

Warnings and Precautions

Warnings

Antibody response in patients with endogenous (due to illness) or iatrogenic (due to medicine)
immunosuppression may be insufficient.

Precautions for use
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily
available in case of a rare anaphylactic event following the administration of the vaccine.
AGRIPPAL S1 under no circumstances must be administered intravascularly

Important information about some of the ingredients of AGRIPPAL S1.

AGRIPPAL S1 does not contain more than 0.4 µg of ovalbumin per ml.

Pregnancy and lactation

No relevant to animals data are available. In humans, up to now, the data available are inadequate to
assess teratogenic or foetotoxic risk during pregnancy. In pregnant high risk patients, the possible risks of
infection should be weighed against the possible risks of vaccination.
AGRIPPAL S1 may be used during lactation.

Effects on ability to drive and operate machinery

AGRIPPAL S1 is unlikely to produce any effect on the ability to drive and use machines.

Overdose

Overdosage is unlikely to have untoward effect.

Adverse effects:

The following reactions are most common:

• Local reactions: redness, swelling, pain, ecchymosis (bruises), induration
• Systemic reactions: fever, malaise, shivering, fatigue, headache, sweating, myalgia (muscular pain),
  arthralgia (articular pain)
• These undesired reactions usually disappear within 1-2 days without treatment
• The following effects were rarely observed: neuralgia (pain in the nerve area of a sensitive nerve),
  paeresthesia (abnormal feeling like burning, numbness, stinging, etc.), convulsions, transient
  thrombocytopenia (reduction of blood platelets)
• Allergic reactions, in rare cases leading to shock, have been reported
• Vasculitis with transient renal involvement has been reported in very rare cases
• Rarely, neurological disorders such as encephalomyelitis, neuritis and Guillain Barré syndrome [acute
  inflammation of the peripheral nervous system (polyneuropathy) mainly resulting in motor impairment
  (paralysis)] have been reported
• These side-effects are generally transient. When they appear it is advisable to consult a physician.
  It is important to inform the doctor if any side-effects which are not described on the leaflet appear.
  

Contraindications

Hypersensitivity to the active substances, to any of the excipients and to eggs, chicken proteins,
kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and
polysorbate 80. Immunisation shall be postponed in patients with febrile illness or acute infection.

Drug Interactions

• AGRIPPAL S1 may be given at the same time as other vaccines. Immunisation should be carried out on
  separate limbs. It should be noted that the adverse reactions may be intensified
• The immunological response may be diminished if the patient is undergoing immunodepressants
  treatment
• Following influenza vaccination, false positive results in serology tests using the ELISA method to detect
  antibodies against HIV1, Hepatitis C and especially HTLV1, have been observed. The Western Blot
  technique disproves the results. The transient false positive reactions could be due to the IgM response to
  the vaccine.
  

Packing:

Box, 1 prefilled syringe @ 0.5 ml (single dose)
Reg. No.: DKI1127900443A1

Storage and expiration date

Do not use the product after the expiry date indicated on the box. Information regarding the medicinal
product should always be kept at hand, therefore keep both the box and the package leaflet. AGRIPPAL
S1 must be stored at a temperature between +2°C /+ 8°C in the refrigerator. Do not freeze.
Protect from light. Keep medicines out of the reach of children.
Shelf life: 1 year

ON MEDICAL PRESCRIPTION ONLY

HARUS DENGAN RESEP DOKTER

Manufactured by:

Novartis Vaccines and Diagnostics S.r.l.
Loc. Bellaria 53018, Rosia, Siena – Italy.

Imported by:

PT. NOVARTIS INDONESIA, Jakarta, Indonesia