Medicinal Products

AGRIPPAL Injectable booster of 1 pre-filled syringe with needle of ¢ mL

Generic drug of the therapeutic class: Infectiology - Parasitology
Active Ingredients: [Seasonal Influenza Vaccine, 4577]
laboratory: Novartis Pharma SA

Injectable suspension
All forms

Indication

Preventing influenza, especially in those who are at risk for associated complications.

Agrippal is indicated in adults and children from 6 months.

The use of Agrippal must be based on official recommendations.

AGRIPPAL Dosage Injectable booster of 1 pre-filled syringe with needle of ¢ mL

Preventing influenza, especially in those who are at risk for associated complications.

Agrippal is indicated in adults and children from 6 months.

The use of Agrippal must be based on official recommendations.

Against indications

Hypersensitivity to the active substances, to any of the excipients listed under Composition, residues (eg eggs or chicken proteins such as ovalbumin).

Known hypersensitivity to the following substances which may contain residues: kanamycin sulfate or neomycin sulfate, formaldehyde, cetyltrimethylammonium bromide (CTAB), barium sulfate and polysorbate 80.

Anaphylactoid reaction that occurred during a previous influenza vaccination.

Vaccination should be differentiated in case of febrile illness or acute infection.

Agrippal side effects

Adverse Events Observed During Clinical Trials

Tolerance of inactivated trivalent influenza vaccines is assessed in open, unrestricted clinical trials conducted annually in accordance with regulatory requirements, including at least 50 adults aged 18 to 60 years and at least 50 people over 61 years old.

Tolerance assessment is carried out during the first 3 days following vaccination.

The following undesirable effects have been observed in clinical trials at the following frequencies:

Very often (≥ 1/10); frequent (≥ 1/100, <1/10); not very frequent (≥ 1/1 000, <1/100)

Table of undesirable events:

Class of organ

Very good

FrÚquents

Not very frequent

( ? 1/10)

(≥ 1/100; <1/10)

(≥ 1/1000; <1/100)

Nervous System Affections

CÚphalÚes *.

Skin and subcutaneous tissue disorders

* Sweats.

Musculoskeletal and systemic disorders

Myalgia, arthralgia *.

General disorders and administration site abnormalities

Fever, discomfort, chills, fatigue.

Local reactions: redness, swelling, pain, bruising, induration *.

* These reactions usually disappear after 1 or 2 days, without treatment.

Undesirable events reported during postmarketing surveillance

The undesirable events reported during postmarketing surveillance, in addition to those already observed during clinical trials, are as follows:

Hematological and lymphatic system disorders:

Thrombocytopenia (very rare cases were severe cases with platelet count at "5000 per mm 3 ), transient lymphadenopathy.

Immune system disorders:

Allergic reactions, leading to "shock in rare cases, angioedÃŽme.

Nervous system disorders:

Neuralgia, paresthesia, febrile convulsions, neurological disorders, such as encesphalomyelitis, nevritis and Guillain-BarrÃs syndrome.

Vascular disorders:

Vasculitis with transient renal involvement in very rare cases.

Skin and subcutaneous tissue disorders:

Generalized cutaneous reactions including pruritus, urticaria, nonspecific rash.

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