SOLTEL Pressurised inhalation, suspension (2021)
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Περιεχόμενα
Name of the medicinal product
Soltel CFC-free Inhaler 25 micrograms per actuation pressurised inhalation, suspension.
Qualitative and quantitative composition
Each metered dose (ex-valve) contains 25 micrograms salmeterol (as xinafoate). This is equivalent to a delivered dose (ex-actuator) of 21 micrograms salmeterol (as xinafoate). Excipient with known effect: ...
Pharmaceutical form
Pressurised inhalation, suspension. Pressurised aluminium canister containing a white suspension sealed with a metering valve, with a mid-green polypropylene actuator and a pale green polypropylene dust ...
Therapeutic indications
Asthma Soltel CFC-free Inhaler is indicated for the regular symptomatic add-on treatment of reversible airways obstruction in patients with asthma, including those with nocturnal asthma, who are inadequately ...
Posology and method of administration
Posology Asthma Adults and adolescents over 12 years of age Two actuations of 25 micrograms salmeterol twice daily. In asthma patients with more severe airways obstruction up to four inhalations of salmeterol ...
Contraindications
Hypersensitivity to salmeterol xinafoate or to any of the excipients listed in see section 6.1. Excipients Soltel CFC-free Inhaler 25 micrograms contains soya lecithin and is contraindicated in patients ...
Special warnings and precautions for use
The management of asthma should normally follow a stepwise programme and patient response should be monitored clinically and by lung function tests. Salmeterol should not be used (and is not sufficient) ...
Interaction with other medicinal products and other forms of interaction
Beta adrenergic blockers may weaken or antagonise the effect of salmeterol. Both non-selective and selective β blockers should be avoided in patients with asthma unless there are compelling reasons for ...
Pregnancy and lactation
Pregnancy There are limited data (between 300 to 1000 pregnancy outcomes) from the use of salmeterol in pregnant women indicating no malformative or feto/neonatal toxicity. Animal studies do not indicate ...
Effects on ability to drive and use machines
Based on the pharmacodynamic profile of salmeterol and reported adverse effects there is no or negligible influence of salmeterol on the ability to drive and use machines.
Undesirable effects
Adverse effects are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) ...
Overdose
Symptoms The signs and symptoms of a salmeterol overdose are those typical of β<sub>2</sub>-adrenergic stimulation including dizziness, increases in systolic blood pressure, tremor, headache and tachycardia. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Selective β<sub>2</sub> adrenoceptor agonists <b>ATC code:</b> R03AC12 Salmeterol is a selective long-acting (12 hour) β<sub>2</sub> adrenoceptor agonist with a long side ...
Pharmacokinetic properties
Salmeterol acts locally in the lung and previous studies have suggested that plasma levels are not necessarily an indication of therapeutic effects. In addition there are only limited data available on ...
Preclinical safety data
The only findings in animal studies with relevance for clinical use were the effects associated with exaggerated pharmacological activity. In reproduction and developmental toxicity studies with salmeterol ...
List of excipients
Anhydrous ethanol Soya lecithin (E322) Norflurane (HFA 134a), a hydrofluoroalkane (non-chlorofluorocarbon) propellant. This product does not contain any chlorofluorocarbon propellants.
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Store below 30°C. Do not freeze. The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not puncture, break or burn even when apparently empty.
Nature and contents of container
Pressurised aluminium canister containing a white suspension sealed with a metering valve, with a mid-green polypropylene actuator and a pale green polypropylene dust cap. Each canister provides 120 actuations, ...
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom
Marketing authorization number(s)
PLGB 36390/0361
Date of first authorization / renewal of the authorization
04/11/2011
Date of revision of the text
06/08/2021
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