For fluid replacement, and provision of potassium, sodium and chloride electrolytes in the prevention and
treatment of hypokalemia and potassium depletion. Medium for intravenous administration of medicinal
products known to be compatible.

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
4 to 6 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.
Fluid balance, serum electrolytes and acid-base balance may need to be monitored before and during
administration, with particular attention to serum sodium in patients with increased non-osmotic
vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients comedicated
with vasopressin agonist drugs, due to the risk of hospital acquired hyponatremia (see sections
4.4, 4.5 and 4.8).
Monitoring of serum sodium is particularly important for hypotonic fluids.
Potassium Chloride 0.6%w/v Sodium Chloride 0.9%w/v Solution for Infusion tonicity: slightly hypertonic.

The infusion rate and volume depend on the age, weight, clinical condition (e.g. burns, surgery, head-injury,
infections), and concomitant therapy should be determined by the consulting physician experienced in
pediatric intravenous fluid therapy (see sections 4.4. and 4.8).

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 edema, acute dehydration, acute acidosis, hypertension,
cirrhosis of the liver, preeclampsia, and cell destruction as in tissue trauma, burns, hemolysis,
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
hyperkalemia. Specialist advice and ECG monitoring are necessary in difficult cases. Adequate urine flow
must be ensured.
High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure,
and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospitalacquired
hyponatremia (see below).
Hyponatremia
Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, postoperative stress, infections,
burns, and CNS diseases), patients with heart-, liver- and kidney diseases and patients exposed to
vasopressin agonists (see section 4.5) are at particular risk of acute hyponatremia upon infusion of
hypotonic fluids.
Acute hyponatremia can lead to acute hyponatremic encephalopathy (cerebral edema) characterized by
headache, nausea, seizures, lethargy and vomiting. Patients with cerebral edema are at particular risk of
severe, irreversible and life-threatening brain injury.
Children, women in the fertile age and patients with reduced cerebral compliance (e.g. meningitis,
intracranial bleeding, cerebral contusion and brain edema) are at particular risk of the severe and lifethreatening
brain swelling caused by acute hyponatremia.

Drugs leading to an increased vasopressin effect
The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water
excretion and may increase the risk of hospital acquired hyponatremia following inappropriately balanced
treatment with I.V. fluids (see sections 4.2, 4.4 and 4.8).
• Drugs stimulating vasopressin release include:

Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-
methylenedioxy-Nmethamphetamine, ifosfamide, antipsychotics, narcotics
• Drugs potentiating vasopressin action include:
Chlorpropamide, NSAIDs, cyclophosphamide
• Vasopressin analogues include:
Desmopressin, oxytocin, vasopressin, terlipressin
Other medicinal products increasing the risk of hyponatremia also include diuretics in general and
antiepileptics such as oxcarbazepine.
Care should be taken in the concurrent use of drugs containing potassium, potassium sparing diuretics, and
drugs which have the potential for inducing hyperkalemia, such as spironolactone and triamterene, as well
as drugs which promote sodium retention such as angiotensin converting enzyme (ACE) inhibitors.
Check compatibility of medicinal products with the solution before admixture and administration.

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.
Potassium Chloride 0.6%w/v Sodium Chloride 0.9%w/v Solution for Infusion should be administrated with
special caution for pregnant women during labor particularly as to serum-sodium if administered in
combination with oxytocin (see sections 4.4, 4.5 and 4.8).

Not relevant

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.
- Hospital acquired hyponatremia*
- Acute hyponatremic encephalopathy*
*Hospital acquired hyponatremia may cause irreversible brain injury and death, due to development of
acute hyponatremic encephalopathy, frequency unknown (see sections 4.2. 4.4, 4.5).
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:
 Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)

Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
 Other GCC States:
Please contact the relevant competent authority.

Excessive or rapid administration of potassium-containing solutions may cause hyperkalemia 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, hypokalemia, hypervolemic hemodilution, sodium accumulation and hypernatremia with resultant
dehydration of organs particularly the brain, and edema, also hypertension, tachycardia, edema and
gastrointestinal effects.
Treatment depends on the individual clinical situation but involves administration of calcium to counteract
the effects of hyperkalemia 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.

Pharmacotherapeutic group (ATC code): “electrolytes” (B05BB01)
Potassium Chloride 0.6%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.

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/liter.
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.

There are no preclinical data of relevance to the prescriber not already included in other sections of the
SPC.

Water for Injections

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.

Do not store above 30oC. Store in the original outer container in order to protect from light.

Flexible NON-PVC bags containing 500ml solution.
Not all pack sizes may be marketed

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 port 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. Remove port protector, 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.