ATIMOS MODULITE Pressurised inhalation solution (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Atimos Modulite 12 micrograms/actuation pressurised inhalation solution.
Qualitative and quantitative composition
Each metered dose contains 12 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose of 10.1 micrograms. For a full list of excipients, see section 6.1. <u>Excipient with known ...
Pharmaceutical form
Pressurised inhalation solution.
Therapeutic indications
For the long-term symptomatic treatment of persistent, moderate to severe asthma in patients requiring regular bronchodilator therapy in combination with long-term anti-inflammatory therapy (inhaled and/or ...
Posology and method of administration
Posology The dosage depends on the type and severity of disease. The following dosages are recommended for adults, including elderly patients, and adolescents aged 12 years and above. Asthma Adults and ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Atimos Modulite should not be used (and is not sufficient) as the first treatment for asthma. Asthmatic patients who require therapy with long-acting β<sub>2</sub>-agonists, should also receive optimal ...
Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been carried out with formoterol. There is a theoretical risk that concomitant treatment with other drugs known to prolong the QTc-interval may give rise to a pharmacodynamic ...
Pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of formoterol in pregnant women. In animal studies formoterol has caused implantation losses as well as decreased early postnatal survival ...
Effects on ability to drive and use machines
Atimos Modulite has no influence on the ability to drive and use machines.
Undesirable effects
The most commonly reported adverse events of β<sub>2</sub>-agonist therapy, such as tremor and palpitations, tend to be mild and disappear within a few days of treatment. Adverse reactions, which have ...
Overdose
There is limited clinical experience on the management of overdose. An overdosage of Atimos Modulite would be likely to lead to effects that are typical of β<sub>2</sub>-adrenergic agonists: headache, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Adrenergics, inhalants; selective β2-adrenoreceptor agonists <b>ATC code:</b> R03AC13 Mechanism of action and pharmacodynamics effects Formoterol is a predominantly selective ...
Pharmacokinetic properties
Absorption As with other substances administered by inhalation, 90% of the inhaled formoterol dose is swallowed and absorbed from the gastrointestinal tract. The pharmacokinetic characteristics of the ...
Preclinical safety data
The effects of formoterol in rats and dogs were largely confined to the cardiovascular system and consisted of known pharmacological manifestations of high β<sub>2</sub>-agonist doses. A somewhat reduced ...
List of excipients
Norflurane Ethanol anhydrous Hydrochloric acid
Incompatibilities
Not applicable.
Shelf life
18 months (see also section 6.4).
Special precautions for storage
<u>Prior to dispensing to the patient:</u> Store in a refrigerator at 2°C to 8°C (for a maximum of 15 months). <u>After dispensing:</u> Do not store above 30°C (for a maximum of 3 months).
Nature and contents of container
1 pressurised, aluminium container fitted with a metering valve, actuator and protective cap, containing a pressurised inhalation solution. Each canister provides 50, 100 or 120 actuations. Not all pack ...
Special precautions for disposal and other handling
For pharmacies Enter the date of dispensing to the patient on the pack. Ensure that there is a period of at least 3 months between the date of dispensing and the expiry date printed on the pack. Any unused ...
Marketing authorization holder
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom
Marketing authorization number(s)
PL 08829/0154
Date of first authorization / renewal of the authorization
20/05/2011
Date of revision of the text
September 2022
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