Theophylline KI elixir

ประเทศ: อาร์เมเนีย

ภาษา: อังกฤษ

แหล่งที่มา: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

สารออกฤทธิ์:

theophylline, potassium iodide

มีจำหน่ายจาก:

Arpimed LLC

รหัส ATC:

R03DA04, H03CA

INN (ชื่อสากล):

theophylline, potassium iodide

ปริมาณ:

80mg/15ml+ 130mg/15ml

แบบฟอร์มเภสัชกรรม:

elixir

หน่วยในแพ็คเกจ:

100ml and 120ml glass bottle

ประเภทใบสั่งยา:

Prescription

สถานะการอนุญาต:

Registered

วันที่อนุญาต:

2018-04-12

สรุปลักษณะสินค้า

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