Država: Armenija
Jezik: engleski
Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
theophylline, potassium iodide
Arpimed LLC
R03DA04, H03CA
theophylline, potassium iodide
80mg/15ml+ 130mg/15ml
elixir
100ml and 120ml glass bottle
Prescription
Registered
2018-04-12
SUMMARY PRODUCT CHARACTERISTIC (SPC) THEOPHYLLINE KI 80 MG + 130 MG / 15 ML ELIXIR 1. NAME OF THE MEDICINAL PRODUCT – Theophylline KI INTERNATIONAL NON-PROPERTY NAME – Theophylline/Potassium iodide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 15ml of elixir_ _contains: _ACTIVE INGREDIENT:_ theophylline – 80 mg, potassium iodide – 130 mg For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Elixir. A clear orange coloured, orange flavoured elixir. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For excessive tenacious mucus and for relief and/or prevention of symptoms from asthma and reversible bronchospasm associated with chronic bronchitis and emphysema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Effective use of theophylline (i.e., the concentration of drug in the serum associated with optimal benefit and minimal risk of toxicity) is considered to occur when the theophylline concentration is maintained from 10 to 20 mcg/ml. The early studies from which these levels are derived were carried out in patients immediately or shortly after recovery from acute exacerbations of their disease (some hospitalized with status asthmaticus). Although the 20 mcg/ml level remains appropriate as a critical value (above which toxicity is more likely to occur) for safety purposes, additional data are now available which indicate that the serum theophylline concentrations required to produce maximum physiologic benefit may, in fact, fluctuate with the degree of bronchospasm present and are variable. Therefore, the physician should individualize the range appropriate to the patient's requirements, based on both symptomatic response and improvement in pulmonary function. It should be stressed that serum theophylline concentrations maintained at the upper level of the 10 to 20 mcg/ml range may be associated with potential toxicity when factors known to reduce theophylline clearance are operative. If it is not possible to obtain serum level determinations, restrictions of the daily dose (in otherwise hea Pročitajte cijeli dokument