POTASSIUM CHLORIDE Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Potassium Chloride 15% w/v Concentrate for Solution for Infusion.
Qualitative and quantitative composition
Each 10ml contains 15% w/v (1.5g) Potassium Chloride BP.
Pharmaceutical form
Concentrate for Solution for Infusion. Clear, colorless, sterile, aqueous solution for infusion.
Therapeutic indications
For use in patients requiring supplemental potassium therapy.
Posology and method of administration
Route of administration: Intravenous, after dilution. <u>Before administering Sterile Potassium Chloride Concentrate:</u> This solution must be diluted with not less than 50 times its volume of sodium ...
Contraindications
Sterile Potassium Chloride Concentrate should never be used undiluted. Hyperkalaemia (plasma-potassium concentration above 5 mmol/litre). Hyperchloraemia. Impaired renal function with oliguria, anuria ...
Special warnings and precautions for use
<u>Administration (see also section 4.2):</u> Only use with specialist advice. ECG should be used throughout and monitored continuously. High concentrations of potassium cause serious cardiotoxicity, so ...
Interaction with other medicinal products and other forms of interaction
Increased risk of severe hyperkalaemia with the following: ACE-inhibitors. Aliskerin. Angiotensin-II receptor anatagonists. Potassium sparing diuretics such as: amiloride, spironolactone and triamterene ...
Pregnancy and lactation
Potassium chloride should be used during pregnancy or lactation only under the supervision of the prescribing physician if considered essential by the physician.
Effects on ability to drive and use machines
Nil.
Undesirable effects
Excessive intake of potassium may cause hyperkalaemia, with paraesthesia, muscle weakness, paralysis, hypotension, cardiac arrhythmias and cardiac arrest. Pain at the injection site and phlebitis may occur ...
Overdose
Clinical signs and symptoms of potassium overdosage include: Paraesthesia of the extremities, listlessness, mental confusion, weakness or heaviness of the legs, flaccid paralysis, cold skin, grey pallor, ...
Pharmacodynamic properties
Active ion transport by the sodium-potassium ATP ASE carrier maintains a high gradient of potassium across the plasma membrane. Intracellular concentrations of potassium are about 150 mEq per litre while ...
Pharmacokinetic properties
Potassium is an essential dietary constituent and is readily absorbed from the gastro-intestinal tract. Accumulation of potassium by cells occurs via an energy-dependent mechanism that extrudes sodium. ...
Preclinical safety data
No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.
List of excipients
Water for Injections BP
Incompatibilities
Incompatibilities have been reported with dobutamine hydrochloride, amphotericin, amikacin sulphate and fixed oil emulsions.
Shelf life
5 years (60 months).
Special precautions for storage
Keep in outer carton. Do not store above 25°C.
Nature and contents of container
10ml, clear Open point cut (OPC) glass ampoules, glass type 1 Ph.Eur. packed in cardboard cartons to contain 10 10ml ampoules.
Special precautions for disposal and other handling
Warning: Must be diluted before use. Dilute before use with not less than 50 times its volume of Sodium Chloride Injection or another suitable diluent. Discard if cloudy or deposit present. Use as directed ...
Marketing authorization holder
Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 12762/0598
Date of first authorization / renewal of the authorization
1/12/86
Date of revision of the text
February 2019
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