QVAR MDI Pressurised inhalation, solution (2019)
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Περιεχόμενα
1. Name of the medicinal product
Qvar 50 Aerosol 50 micrograms per actuation pressurised inhalation solution.
2. Qualitative and quantitative composition
Beclometasone Dipropionate 50 micrograms per metered (ex-valve) dose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pressurised inhalation, solution. A colourless solution in a pressurised aluminium canister fitted with a metering valve and an actuator. Qvar contains a propellant, which does not contain any chlorofluorocarbons ...
4.1. Therapeutic indications
Qvar is indicated in children aged 5 and over, adolescents and adults for the prophylactic management of mild, moderate or severe asthma.
4.2. Posology and method of administration
Posology NOTE: The recommended total daily dose of Qvar is lower than that for current beclometasone dipropionate containing products and should be adjusted to the needs of the individual patient. It is ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Patients should be properly instructed on the use of the inhaler to ensure that the drug reaches the target areas within the lungs. To be effective, Qvar must be used by patients on a regular basis, even ...
4.5. Interaction with other medicinal products and other forms of interaction
Qvar contains a small amount of ethanol. There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole. Beclometasone is less dependent on CYP3A ...
4.6. Pregnancy and lactation
The potential risk of this product for humans is unknown. Qvar There is no experience of this product in pregnancy and lactation in humans, therefore the product should only be used if the expected benefits ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely. As with other inhalation therapy, paradoxical bronchospasm may occur after ...
4.9. Overdose
Acute overdosage is unlikely to cause problems. The only harmful effect that follows inhalation of large amounts of the drug over a short time period is suppression of HPA axis function. Specific emergency ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Glucocorticoids ATC Code: R03BA01 Beclometasone dipropionate is a pro-drug with weak glucocorticoid receptor binding affinity. It is extensively hydrolysed via esterase enzymes ...
5.2. Pharmacokinetic properties
The pharmacokinetic profile of Qvar shows that the peak serum concentration for total- beclometasone (BOH) (total of any beclometasone OH and beclometasone dipropionate or monopropionate hydrolysed to ...
5.3. Preclinical safety data
In animal studies, propellant HFA-134a has been shown to have no significant pharmacological effects other than at very high exposure concentrations, then narcosis and a relatively weak cardiac sensitising ...
6.1. List of excipients
Propellant HFA-134a (Norflurane) Ethanol
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Shelf life: 3 years.
6.4. Special precautions for storage
Do not store above 25°C. Protect from frost and direct sunlight. The canister contains a pressurised liquid. Do not expose to temperatures higher that 50°C. Do not pierce the canister.
6.5. Nature and contents of container
Pressurised aluminium canister closed with a metering valve containing either 100 or 200 actuations. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
8. Marketing authorization number(s)
PL 00289/1371
9. Date of first authorization / renewal of the authorization
2<sup>nd</sup> November 2009
10. Date of revision of the text
20/11/2019
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