FLUTIFORM Pressurised inhalation, suspension (2018)
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Περιεχόμενα
1. Name of the medicinal product
Flutiform 50 microgram/5 microgram, 125 microgram/5 microgram and 250 microgram/10 microgram per actuation pressurised inhalation, suspension.
2. Qualitative and quantitative composition
Each metered dose (ex-valve) contains: 50 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 46 ...
3. Pharmaceutical form
Pressurised inhalation, suspension. The canister contains white to off white liquid suspension. The canister is in a white actuator with a grey integrated dose indicator and a light grey mouthpiece cover. ...
4.1. Therapeutic indications
This fixed-dose combination of fluticasone propionate and formoterol fumarate (Flutiform inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid ...
4.2. Posology and method of administration
Posology Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of Flutiform inhaler they are receiving remains optimal ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
The management of asthma should normally follow a stepwise programme and patients' responses should be monitored clinically and by lung function tests. Flutiform inhaler should not be used to treat acute ...
4.5. Interaction with other medicinal products and other forms of interaction
No formal drug interaction studies have been performed with Flutiform inhaler. Flutiform inhaler contains sodium cromoglicate at non-pharmacological levels. Patients should not discontinue any cromoglicate ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are limited data on the use of fluticasone propionate and formoterol fumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose ...
4.7. Effects on ability to drive and use machines
Flutiform inhaler has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Undesirable effects which have been associated with Flutiform inhaler during clinical development are given in the table below, listed by system organ class. The following frequency categories form the ...
4.9. Overdose
There are no data available from clinical trials on overdose with Flutiform inhaler, however, data on overdose with both single drugs are given below: Formoterol fumarate An overdose of formoterol would ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Drugs for obstructive airways adrenergics in combination with corticosteroids or other drugs excl. anticholinergics <b>ATC code:</b> R03AK11 Mechanism of Action and Pharmacodynamic ...
5.2. Pharmacokinetic properties
Fluticasone propionate Absorption Following inhalation, systemic absorption of fluticasone propionate occurs mainly through the lungs and has been shown to be linearly related to dose over the dose range ...
5.3. Preclinical safety data
The toxicity observed in animal studies with formoterol fumarate and fluticasone propionate, given in combination or separately consisted mainly of effects associated with exaggerated pharmacological activity. ...
6.1. List of excipients
Sodium cromoglicate Ethanol anhydrous Apaflurane HFA 227
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 Years. In use shelf – life: 3 months after opening the foil pouch.
6.4. Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. If the inhaler is exposed to freezing conditions then the patient must be advised to allow the inhaler to warm at room temperature for 30 minutes ...
6.5. Nature and contents of container
120 actuations per inhaler. The actuator is white with a grey integrated dose indicator and a light grey mouthpiece cover. The suspension is contained in an aluminium pressurised canister crimped with ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal. For detailed instructions on the use of the medicinal product see section 4.2.
7. Marketing authorization holder
Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, United Kingdom, CB4 0GW
8. Marketing authorization number(s)
PL 16950/0167-0169
9. Date of first authorization / renewal of the authorization
22/08/12
10. Date of revision of the text
26.10.2018
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