ZENHALE Inhalation aerosol (2021)
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Περιεχόμενα
Name of the medicinal product
ZENHALE Inhalation aerosol. Corticosteroid and long-acting beta<sub>2</sub>-agonist combination for oral inhalation.
Summary product information
Route of Administration Dosage Form/Strength Nonmedicinal Ingredients Oral Inhalation aerosol 50, 100 or 200 mcg mometasone furoate & 5 mcg formoterol fumarate dihydrate per actuation Ethanol, HFA (propellant), ...
Indications and clinical use
ZENHALE (mometasone furoate/formoterol fumarate dihydrate inhalation aerosol), is a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA) indicated for the treatment ...
Contraindications
ZENHALE is contraindicated in: Patients who are hypersensitive to mometasone furoate, formoterol fumarate, or any ingredient in the formulation or component of the container. For a complete listing, see ...
Warnings and precautions
General Not for Acute Use ZENHALE should not be used to treat acute symptoms of asthma. Adequate education should be provided to the patient regarding the use of long-acting beta<sub>2</sub>-agonists and ...
Adverse reactions
Adverse Drug Reaction Overview ZENHALE contains both mometasone furoate and formoterol, therefore the type and severity of adverse reactions associated with each individual component of ZENHALE may be ...
Drug interactions
Drug-Drug Interactions In clinical studies, concurrent administration of ZENHALE and other drugs, such as short-acting beta<sub>2</sub>-agonist and intranasal corticosteroids have not resulted in an increased ...
Dosage and administration
Dosing Considerations ZENHALE should not be used in patients whose asthma can be managed by occasional use of short-acting, inhaled beta2-agonists or for patients whose asthma can be successfully managed ...
Overdosage
The risks associated with overdosage for the individual components apply to ZENHALE. Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function. ...
Action and clinical pharmacology
Mechanism of Action ZENHALE contains both mometasone furoate and formoterol fumarate; therefore, the mechanisms of actions described below for the individual components apply to ZENHALE. Mometasone furoate ...
Storage and stability
Store at controlled room temperature 15°-30°C. Do not freeze. For best results, the inhaler should be warmed to room temperature before use (e.g. by warming in the hands) if it is exposed to low temperatures. ...
Special handling instructions
No special requirements. Any unused product or waste should be disposed of in accordance with local requirements.
Dosage forms, composition and packaging
Dosage Forms ZENHALE is a pressurized metered dosed suspension for inhalation available in three strengths. ZENHALE 50/5 delivers 50 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate ...
Pharmaceutical information
Drug Substance Proper name: Mometasone furoate Chemical name: 9,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2)-furoate Molecular formula and molecular mass: C<sub>27</sub>H<sub> ...
Detailed pharmacology
Animal Non-clinical pharmacology studies were conducted for both individual active products. The results of the nonclinical studies did not identify any unique toxicities with the ZENHALE combination or ...
Clinical trials
Adult and Adolescent Patients aged 12 years and older The safety and efficacy of ZENHALE were demonstrated in three randomized, double-blind, parallel group, multicenter clinical studies (P04073, P04334, ...
Toxicology
The toxicity observed in animal studies with mometasone furoate and formoterol fumarate, given in combination as ZENHALE or separately, were effects associated with exaggerated pharmacological activity. ...
References
PRODUCT MONOGRAPH: FORADIL* (formoterol fumarate Dry Powder Capsules for Inhalation) PRODUCT MONOGRAPH: ASMANEX Twisthaler (Mometasone Furoate Dry Powder Inhaler). Meltzer E et al. Low-dose Mometasone ...
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