Potassium Chloride 0.3% W/V Sodium Chloride 0.9% W/V Solution For Infusion.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Potassium Chloride |
3.00g |
Potassium K+ |
40 mmol/litre |
|
Sodium Chloride |
9.00g |
Sodium Na+ |
150 mmol/litre |
|
Chloride Cl' |
190 mmol/litre |
Osmolality approx. 360 mOsm/kg water. For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion
Sterile endotoxin-free solution, colourless to faintly straw coloured without visible particles.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For fluid replacement, and provision of potassium, sodium and chloride electrolytes in the prevention and treatment of hypokalaemia and potassium depletion. Medium for intravenous administration of medicinal products known to be compatible.
4.2 Posology and method of administration
For intravenous infusion under medical supervision.
Single use only.
The pathophysiological response to dehydration, to electrolyte loss and to potassium and sodium chloride infusion will vary with the age of the patient being treated and this should be taken into account during rehydration therapy. The volume of solution needed to replenish deficits varies with age, body weight, complementary treatment and clinical and biochemical status. Rapid infusion may be harmful. The rate of administration should not exceed 30mmol of potassium per hour. Typically 500ml is infused slowly over 2 to 3 hours, but the dose and rate of administration are subject to clinical and laboratory assessment in each case. A recommended maximum dose is 2 - 3 mmol potassium per kg body weight in 24 hours.
4.3 Contraindications
Hyperkalaemia, hypervolaemia and hypernatraemia.
4.4 Special warnings and precautions for use
The solution must be administered with caution to patients with conditions associated with high potassium levels or with conditions of impaired sodium excretion, including renal or adrenocortical insufficiency, cardio-pulmonary disease, peripheral or pulmonary oedema, acute dehydration, acute acidosis, hypertension, cirrhosis of the liver, pre-eclampsia, and cell destruction as in tissue trauma, burn, haemolysis, rhabdomyolysis.
Fluid replacement therapy should be administered with caution to very young and elderly patients who have reduced capacity to compensate for fluctuations in fluid and electrolyte balance.
Repeated measurements of plasma potassium, and serum and/or urinary electrolytes are necessary to monitor treatment and to ascertain whether further infusions are required and to avoid development of hyperkalaemia. Specialist advice and ECG monitoring are necessary in difficult cases. Adequate urine flow must be ensured.
4.5 Interaction with other medicinal products and other forms of interaction
Care should be taken in the concurrent use of drugs containing potassium, potassium-sparing diuretics, and drugs which have the potential for inducing hyperkalaemia, such as spironolactone and triamterene, as well as drugs which promote sodium retention such as ACE inhibitors.
Check compatibility of medicinal products with the solution before admixture and administration.
4.6 Fertility, pregnancy and lactation
Administration of intravenous fluids to pregnant and lactating women requires special consideration of the consequences of possible unwanted effects in relation to the desired therapeutic objective.
4.7 Effects on ability to drive and use machines
Not relevant
4.8 Undesirable effects
General disorders and administration site conditions:
Prolonged intravenous infusion may lead to venous irritation and thrombophlebitis at the infusion site. In the event of adverse reaction, stop infusion immediately.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
For United Kingdom Yellow Card Scheme
Website: www.mhra.gov .uk/yellowcard
For Ireland
HPRA Pharmacovigilance
Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie E-mail: medsafetv@,hpra.ie
4.9 Overdose
Excessive or rapid administration of potassium-containing solutions may cause hyperkalaemia with hypotension, cardiac arrhythmias, heart block, ECG abnormalities and cardiac arrest, mental confusion, and neuromuscular dysfunction such as muscle weakness, paraesthesia and paralysis. Excessive or rapid administration of sodium chloride solution may lead to fluid and electrolyte imbalances such as metabolic acidosis, hypokalaemia, hypervolaemic haemodilution, sodium accumulation and hypernatraemia with resultant dehydration of organs particularly the brain, and oedema, also hypertension, tachycardia, oedema and gastrointestinal effects.
Treatment depends on the individual clinical situation but involves administration of calcium to counteract the effects of hyperkalaemia on cardiac excitability, the use of agents such as insulin or sodium bicarbonate to promote cellular uptake of potassium, and enhanced potassium excretion with exchange resins or dialysis.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group (ATC code): “electrolytes” (B05BB01)
Maco Pharma Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v Solution for infusion is a sterile endotoxin-free solution. Potassium is predominantly an intracellular cation found primarily in skeletal muscle and is essential for nerve conduction, muscle contraction and acid-base regulation. Sodium and chloride contribute to acid-base balance. Sodium is the principal cation in extracellular fluid and is the main osmotic component in control of blood volume. The solution provides important ions in near physiological concentration and allows cellular rehydration and restoration of electrolyte balance. It also serves as an isotonic medium for admixture of medicinal substances for intravenous infusion.
5.2 Pharmacokinetic properties
Potassium is predominantly an intracellular cation found primarily in skeletal muscle with approximately 2% in extracellular fluid. Body content is regulated primarily by renal glomerular filtration and tubular secretion. Normal plasma concentration is 3.5 - 5.0 mmol/litre.
Sodium is principally distributed into extracellular fluid (44%), skeleton (47%) and intracellular fluid (8%). Half life is 11 - 13 days. Excretion is predominantly by renal filtration and reabsorption by the proximal tubule, with a small quantity excreted by faeces, sweat and saliva. The pharmacokinetics of chloride are linked to those of sodium.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber not already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections
6.2 Incompatibilities
Confirm additive compatibility before use. The extent of incompatibility can vary with concentration of additive, the delay between addition of additive and infusion, conditions of storage after addition of additive, and duration of infusion.
6.3 Shelf life
2 years
Use immediately on removal from overwrap.
6.4 Special precautions for storage
Do not store above 25oC. Do not freeze. Store in the original outer container in order to protect from light.
6.5 Nature and contents of container
Macoflex flexible PVC bags containing 500ml or 1000ml solution, individually overwrapped in transparent polypropylene laminate.
Not all pack sizes may be marketed
6.6 Special precautions for disposal of a used medicinal product or waste
materials derived from such medicinal product and other handling of the product
For single use under medical supervision.
Do not use unless the solution is clear and the container undamaged Any unused solution should be disposed of in accordance with local requirements. Do not reconnect partially used bags.
Remove the bag from the plastic overwrapping. Remove the twist-off protector of the infusion site and connect by clamping to the administration set.
Addition of medicinal products : Confirm additive compatibility before addition through the injection port. Clean the injection site using antiseptic solution. Carefully introduce the sterile needle into the sterile chamber in the injection site, attach the needle to the container with the medicinal product, introduce the needle through the second membrane into the bag and inject the medicine. Carefully withdraw the needle. Mix thoroughly with the solution.
Use immediately.
7 MARKETING AUTHORISATION HOLDER
MACO PHARMA (UK) LTD 8th Floor - Regal House 70 London Road Twickenham Middlesex TW1 3QS United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 12580/0012 PA 931/5/1
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12 November 2001/17 December 2002 Date of last renewal: 11 November 2006
10 DATE OF REVISION OF THE TEXT
25/01/2016