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Treść ulotki

1. INSTRUCTIONS for medical use of the medicinal product ADASUVE
   1. Composition
   2. Pharmaceutical form
   3. Main physical and chemical properties
   4. Pharmacotherapeutic group
   5. Pharmacological properties
   6. Clinical characteristics
   7. Interaction with other medicinal products and other types of interactions
   8. Special instructions
   9. Overdose
   10. Adverse reactions
   11. Shelf life
   12. Storage conditions
   13. Packaging
   14. Release category
   15. Manufacturer
   16. Manufacturer's location and address

INSTRUCTIONS for medical use of the medicinal product ADASUVE

ADASUVE (ADASUVE)

Composition

active substance: loxapine; 1 dose contains 10.0 mg of loxapine base, which corresponds to a delivered dose of 9.1 mg of loxapine.

Pharmaceutical form

Powder for inhalation, dosed.

Main physical and chemical properties

white plastic body and activation insert without visible defects.

Pharmacotherapeutic group

Agents acting on the nervous system. Psychotropic agents. Antipsychotic agents. Diazepines, oxazepines, thiazepines, and oxepines. ATC code N05A H01.

Pharmacological properties

Pharmacodynamics

The efficacy of loxapine is believed to be mediated by its high-affinity antagonism of dopamine D2 receptors and serotonin 5-HT2A receptors. Loxapine binds to noradrenergic, histaminergic, and cholinergic receptors, and this interaction may influence the spectrum of its pharmacological effects.

Pharmacokinetics

Absorption. After administration of the Adasuv preparation, rapid absorption of loxapine was noted; the median time to reach its maximum concentration in plasma (Tmax) is 2 minutes.

Clinical characteristics

Indications

For the rapid regulation of agitation from mild to moderate degree in adult patients with schizophrenia or bipolar disorders.

Contraindications

Increased sensitivity to the active substance or amoxapine. Presence of acute respiratory symptoms, such as stridor, or respiratory diseases, including bronchial asthma or chronic obstructive pulmonary disease (COPD).

Interaction with other medicinal products and other types of interactions

Concomitant use of benzodiazepines or other hypnotic-sedative agents, or respiratory depressants may be associated with increased sedation and respiratory depression or respiratory failure.

Special instructions

Proper use of the Adasuv inhaler

is important for the administration of the full dose of loxapine. Medical personnel should ensure that the patient uses the inhaler correctly.

Bronchospasm

During placebo-controlled clinical trials involving patients with bronchial asthma or COPD, bronchospasm was very frequently observed, which usually developed within 25 minutes after administration of the preparation.

Overdose

During clinical trials, no overdose with Adasuv was reported. In case of accidental overdose, symptoms will depend on the amount of the preparation taken and the individual patient's tolerance.

Adverse reactions

The assessment of adverse reactions is based on data from short-term (24-hour) placebo-controlled clinical trials (two phase 3 studies and one phase 2A study) involving 524 adult patients with agitation associated with schizophrenia (including 27 patients with schizoaffective disorders) or bipolar disorders, using the Adasuv preparation.

Shelf life

4 years.

Storage conditions

No special storage conditions are required. Store in the original packaging. Store in a place inaccessible to children.

Packaging

One foil pack with one Staccato inhaler in a cardboard pack.

Release category

Prescription only.

Manufacturer

Ferrer Internacional, S.A., Spain.

Manufacturer's location and address

Joan Buscalla, 1-9, Sant Cugat del Valles, Barcelona, 08173, Spain.