SALAMOL Pressurised inhalation, suspension (2020)
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Περιεχόμενα
1. Name of the medicinal product
Salamol Easi-Breathe CFC-Free Inhaler. 100 micrograms Pressurised Inhalation, suspension.
2. Qualitative and quantitative composition
One metered dose contains salbutamol sulfate equivalent to 100 micrograms salbutamol. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pressurised Inhalation, suspension.
4.1. Therapeutic indications
The symptomatic treatment of asthma and other conditions with associated reversible airways obstruction. For relief of wheezing and shortness of breath, Salamol Easi-Breathe CFC-Free Inhaler should be ...
4.2. Posology and method of administration
Posology For optimum results in most patients Salamol Easi-Breathe CFC-Free Inhaler should be used as required. Adults (including the Elderly) Relief of acute asthma symptoms including bronchospasm One ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Salbutamol inhalation is contraindicated in treatment of threatened abortion or premature labour.
4.4. Special warnings and precautions for use
Salbutamol should be administered cautiously to patients with thyrotoxicosis, coronary insufficiency, hypertrophic obstructive cardiomyopathy, arterial hypertension, known tachyarrhythmias, concomitant ...
4.5. Interaction with other medicinal products and other forms of interaction
Propranolol and other non-cardioselective β-adrenoreceptor blocking agents antagonise the effects of salbutamol, and should not usually be prescribed together. Monoamine oxidase inhibitors, tricyclic antidepressants, ...
4.6. Fertility, pregnancy and lactation
Pregnancy Salamol Easi-Breathe CFC-Free Inhaler during pregnancy should only be used in situations where the expected benefit to the mother is thought to outweigh any risk to the foetus. Salbutamol inhalation ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Based on the MedDRA system organ class and frequencies, adverse events are listed in the table below. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), ...
4.9. Overdose
Overdosage may result in skeletal muscle tremor, tachycardia, tenseness, headache and peripheral vasodilatation. The preferred antidote for overdosage with salbutamol is a cardioselective ß-adrenoceptor ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Selective beta<sub>2</sub> adrenoceptor agonists. <b>ATC Code:</b> R03AC02 Mechanism of action At therapeutic doses salbutamol acts on the β2-adrenoceptors of bronchial ...
5.2. Pharmacokinetic properties
Salamol Easi-Breathe CFC-Free Inhaler has been shown to be therapeutically equivalent to salbutamol metered dose inhaler formulated with chlorofluorocarbon (CFC) propellants. Absorption Salbutamol is readily ...
5.3. Preclinical safety data
Salamol Easi-Breathe CFC-Free Inhaler Toxicological studies in rats and dogs with salbutamol formulated in propellant HFA-134a have shown a comparative safety profile to the current CFC-containing products. ...
6.1. List of excipients
Ethanol, anhydrous Norflurane (Propellant HFA-134a) Salamol Easi-Breathe CFC-Free Inhaler contains a new propellant (HFA-134a) and does not contain any chlorofluorocarbon (CFC) propellants.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
6.5. Nature and contents of container
A pressurised aluminium container with a metering valve and breath-operated actuator. <u>Each pack contains either:</u> Single pack with one Easi-Breathe MDI with 200 metered doses. Twin pack with one ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Norton Healthcare Ltd., T/A IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom
8. Marketing authorization number(s)
PL 00530/0556
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 14 April 2000 Date of latest renewal: 14 April 2010
10. Date of revision of the text
19/06/2020
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