Medicinal Products

APOKINON 30 mg / 3 ml (1%)

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

Injectable solution
in pre-filled pen box of 10 pre-filled pens of 3 ml
All forms

Indication

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

Dosage APOKINON 30 mg / 3 ml (1%) solution for injection in pre-filled pen box of 10 pre-filled pens of 3 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 ).

Intermittent apomorphine therapy is not indicated for patients with levodopa on-reaction with severe dyskinesia or dystonia.

Adverse effects Apokinon 30 Mg / 3 Ml

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 bisulfite, there is a 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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