BEROTEC Inhaler (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
BEROTEC 100 HFA.
2. Qualitative and quantitative composition
Each metered dose (puff) provides fenoterol hydrobromide 100 μg. <u>Propellant:</u> 1,1,1,2 – Tetrafluoroethane (HFA 134a). <u>Other excipients:</u> citric acid anhydrous, purified water, ethanol absolute ...
3. Pharmaceutical form
Clear, colourless or almost colourless liquid under pressure in a one-piece stainless steel canister fitted with a metering valve.
4.1. Therapeutic indications
a) Symptomatic treatment of acute asthma attacks. b) Prophylaxis of exercise induced asthma. c) Symptomatic treatment of bronchial asthma and other conditions with reversible airway narrowing e.g. chronic ...
4.2. Posology and method of administration
Acute asthma episodes One puff is sufficient for prompt symptom relief in many cases. In more severe cases, if breathing has not noticeably improved after 5 minutes, a second dose may be taken. If an attack ...
4.3. Contraindications
Hypertrophic obstructive cardiomyopathy, tachyarrythmias. Hypersensitivity to fenoterol hydrobromide or inactive ingredients in the product.
4.4. Special warnings and precautions for use
Special Precautions When using the new formulation of BEROTEC metered dose inhaler for the first time, some patients may notice that the taste is slightly different from that of the CFC-containing formulation. ...
4.5. Interaction with other medicinal products and other forms of interaction
Beta-adrenergics, anticholinergics, and xanthine derivatives (such as theophylline) may enhance the effect of fenoterol. The concurrent administration of other beta-mimetics, systemically available anticholinergics ...
4.6. Pregnancy and lactation
Safety of use in pregnancy and lactation has not been established. Fenoterol may inhibit uterine contractions in pregnancy. Pre-clinical studies have shown that fenoterol is excreted into breast milk. ...
4.8. Undesirable effects
Frequent undesirable side-effects of BEROTEC 100 HFA are fine tremor of skeletal muscles and restlessness, headache, dizziness, tachycardia and palpitations. Nausea, vomiting, sweating, weakness and myalgia/muscle ...
4.9. Overdose
Symptoms The expected symptoms with overdosage are those of excessive beta-adrenergic-stimulation, including exaggeration of the known pharmacologic effects, i.e. any of the symptoms listed under side-effects, ...
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 10.2.1 Bronchodilators Inhalants Pharmacological action Fenoterol hydrobromide is a beta 2 selective bronchodilator with a direct local effect which relaxes the ...
6.4. Special precautions for storage
Store at or below 30°C in a dry place out of the reach of children. Do not force container open.
6.5. Nature and contents of container
Metered aerosol complete with a mouthpiece. Canister of 10 ml, providing 200 metered doses.
6.6. Special precautions for disposal and other handling
Instructions for use/handling The correct administration of the metered aerosol is essential for successful therapy. <b>Depress the valve twice before the apparatus is used for the first time.</b> Before ...
7. Marketing authorization holder
Ingelheim Pharmaceuticals (Pty) Ltd, 407 Pine Avenue, Randburg, South Africa
8. Marketing authorization number(s)
34/10.2.1/0367
10. Date of revision of the text
20 January 2000
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
