Chlorvescent

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Potassium bicarbonate 384mg;  ; Potassium carbonate 152mg;  ;  ; Potassium chloride 595mg;  ;  

Dostępny od:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Nazwa):

Potassium bicarbonate 384 mg

Forma farmaceutyczna:

Effervescent tablet

Skład:

Active: Potassium bicarbonate 384mg   Potassium carbonate 152mg     Potassium chloride 595mg     Excipient: Acesulfame potassium Aspartame Citric acid Leucine Macrogol 6000 Ribes nigrum Sorbitol

Sztuk w opakowaniu:

Tube, plastic, PP with PE stopper, 30 tablets

Klasa:

Pharmacy only

Typ recepty:

Pharmacy only

Wyprodukowano przez:

Kirsch Pharma GmbH

Wskazania:

The treatment of potassium deficiency (particularly hypochloremic or hypokalemic alkalosis) associated with diuretic and steroid therapy, vomiting and diarrhoea, ulcerative colitis, steatorrhoea, diabetes insipidus and uncontrolled diabetes mellitus, ileostomy or colostomy patients, cirrhosis and dietary insufficiency.

Podsumowanie produktu:

Package - Contents - Shelf Life: Tube, plastic, PP with PE stopper - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Tube, plastic, PP with PE stopper - 60 tablets - 36 months from date of manufacture stored at or below 25°C

Data autoryzacji:

1973-05-17

Charakterystyka produktu

J:\Regulatory Affairs\Regaff\Chlorvescent\+New Zealand\SACN (Updat
data sheet to SPC format) May2019\working
files\Chlorvescent Data Sheet May19 - Clean.doc
NEW ZEALAND DATA SHEET
1.PRODUCT NAME
Chlorvescent Tablets
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorvescent effervescent tablet contains potassium chloride,
potassium bicarbonate
and citric acid, providing 14mmol potassium (548 mg) and 8 mmol
chloride (298 mg) in
the form of an acceptable drink.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
White or white to yellow, round and flat tablets
4.CLINICAL PARTICULARS
4.1 INDICATIONS
Treatment of potassium deficiency (particularly hypochloremic or
hypokalemic
alkalosis) associated with diuretic and steroid therapy, vomiting and
diarrhoea,
ulcerative colitis, steatorrhoea, diabetes insipidus and uncontrolled
diabetes mellitus,
ileostomy or colostomy patients, cirrhosis and dietary insufficiency.
4.2 DOSE AND METHOD OF ADMINISTRATION
1 tablet in half a glass full of water per day is normally sufficient
to correct potassium
and chloride deficiencies. In more severe depletion, up to 4 tablets
(56 mmol
potassium and 32 mmol chloride) can be taken daily in divided doses in
water.
4.3 CONTRAINDICATIONS
Potassium supplements are contraindicated in patients with
hyperkalemia since a
further increase in serum potassium concentration in such patients can
produce
cardiac arrest. Hyperkalemia may complicate any of the following
conditions: chronic
renal impairment, metabolic acidosis such as diabetic acidosis, acute
dehydration,
extensive tissue breakdown as in severe burns or adrenal
insufficiency.
Hypokalemia should not be treated by the concomitant administration of
potassium
salts and a potassium-sparing diuretic (eg. spironolactone or
triamterene) since the
simultaneous administration of these agents can produce severe
hyperkalemia. (see
also section 4.5, Interaction with other medicines and other forms of
interactions)
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is required in cases of