Medicinal Products

APOKINON 5 mg / ml solution for injection box of 10 ampoules of 10 ml

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Apomorphine
laboratory: Aguettant

SC Injection Solution
All forms

Indication

Treatment of motor fluctuations (on-off phenomenon) in patients with Parkinson's disease insufficiently controlled by antiparkinsonian oral therapy.

Dosage APOKINON 5 mg / ml solution for injection box of 10 ampoules of 10 ml

Treatment of motor fluctuations (on-off phenomenon) in patients with Parkinson's disease insufficiently controlled by antiparkinsonian oral therapy.

Against indications

This medicine is contraindicated in case of:

Hypersensitivity to the apomorphine or excipients of the product,

· Children and adolescents under 18,

· Hepatic insufficiency,

· Respiratory depression,

· Dementia,

· mental confusion,

· Psychotic manifestations,

· Combination with anti-emetic neuroleptics (see section Interactions with other medicinal products and other forms of interaction ).

Apokinon side effects

The main adverse effects are related to stimulation of dopamine receptors.

Hematological and lymphatic system disorders:

· Eosinophilia

Immune system disorders:

· Due to the presence of sodium metabisulfite, risk of allergic reactions, including anaphylactic reactions and bronchospasm (see Warnings and Precautions section ).

Psychiatric disorders:

· Impulse control disorders: pathological gambling, increased libido, hypersexuality, compulsive spending or shopping, excessive food consumption and compulsive eating may occur in patients treated with dopamine agonists, including APOKINON ( see section Warnings and precautions for use ).

· Psychological disturbances (including confusional state and hallucinations) to reduce the dosage or interrupt treatment.

Neurological disorders:

· Drowsiness and sleep disturbances have been reported during apomorphine therapy,

Vascular disorders:

· Orthostatic hypotension, pallor

Gastrointestinal disorders:

· Constipation, nausea, vomiting, hypersalivation.

General disorders and administration site defects:

· Asthenia, hyperhidrosis,

· Injection site reactions: pruritus, erythema, nodules, cutaneous necrosis.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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