Potassium chloride 30mmol in 5% Glucose

Main information

  • Trade name:
  • Potassium chloride 30mmol in 5% Glucose 30 mmol/L Solution for infusion
  • Dosage:
  • 30 mmol/L
  • Pharmaceutical form:
  • Solution for infusion
  • Units in package:
  • Bag, plastic, 1000 mL
  • Class:
  • General sale
  • Prescription type:
  • General sale
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Baxter Healthcare Pty Ltd

Documents

Localization

  • Available in:
  • Potassium chloride 30mmol in 5% Glucose 30 mmol/L Solution for infusion
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Potassium chloride and Glucose IV infusion is indicated for replenishing fluid losses, as an energy source and for restoration or maintenance of potassium and chloride ion concentrations. This is also an alternative route of administration for patients who are unable to take potassium orally or if hypokalaemia is severe. It may be used as a vehicle of drug delivery where intravenous delivery is appropriate and the drug is compatible with this solution.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 7247
  • Authorization date:
  • 29-09-1980
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

POTASSIUM CHLORIDE, 5% GLUCOSE

New Zealand Data Sheet

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POTASSIUM CHLORIDE 20MMOL IN 5% GLUCOSE

Potassium Chloride 20mmol (0.15%) in 5% Glucose infusion solution, BP

POTASSIUM CHLORIDE 30MMOL IN 5% GLUCOSE

Potassium Chloride 30mmol (0.224%) in 5% Glucose infusion solution, BP

Composition

The active ingredients are glucose and potassium chloride .

Chemical Structure/Molecular Formulae

The chemical name of glucose is D-(+) glucopyranose.

Molecular formulae of glucose and potassium chloride are: C

and KCl, respectively.

The chemical structure of glucose is:

DESCRIPTION

Glucose is a monosaccharide, having physical characteristics as a white crystal or granular

powder and freely soluble in water. Potassium chloride occurs as a colourless or white

crystal, which is freely soluble in water.

Potassium Chloride 20mmol (0.15%) in 5% Glucose infusion solution and

Potassium Chloride 30mmol (0.224%) in 5% Glucose infusion solution [Potassium

Chloride and Glucose intravenous infusions] are sterile, non-pyrogenic solutions. The

concentrations of the active ingredients, dissolved in one litre of Water for Injections, are

shown in Table 1 (see PRESENTATION AND STORAGE CONDITIONS). They do not

contain an antimicrobial agent or an added buffer and have a pH of 3.5 – 6.5. Their

osmolarities are in the upper level of the isotonic range as listed in Table 1 (see

PRESENTATION AND STORAGE CONDITIONS).

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PHARMACOLOGY

Mechanism of Action

Glucose is readily metabolised into carbon dioxide and water, with a release of energy. As

such, an administration of a glucose solution either by oral or parenteral route provides

water for body hydration as well as energy (see Table 1 PRESENTATION AND STORAGE

CONDITIONS for conversion to kJ units). In addition it may reduce catabolic loss of

nitrogen from the body and aid in prevention of depletion of liver glycogen. That is, in the

absence of glucose, amino acids undergo deamination followed by oxidation in order to

release energy.

Potassium is the major cation of intracellular fluid (approximately 160mmol/L of intracellular

water) and it controls the body fluid composition and electrolyte balance; 98% of the total

body potassium is intracellular.

In the extracellular fluids (interstitial and vascular compartments) sodium ions predominate

whilst potassium ions are generally low ranging from 3.5 to 5.0mmol/L. A membrane bound

enzyme, sodium-potassium activated ATPase (Na/K-ATPase), actively pumps sodium ions

out of the cells and potassium ions into the cells through a gate-mechanism against a

concentration gradient in order to maintain a homeostasis of electrolytes of the cells.

Potassium participates in carbohydrate utilization, protein synthesis, and is critical in the

regulation of nerve conduction and muscle contraction, particularly in the heart.

Chloride, the major extracellular anion, closely follows the physiological disposition of

sodium cation in maintenance of acid-base balance, isotonicity and electrodynamic

characteristics of the cells. Thus, Potassium Chloride and Glucose intravenous infusion

has value as a source of water, electrolytes and energy (835kJ/L); see Table 1

(PRESENTATION AND STORAGE CONDITIONS) for the strength of the solution.

Pharmacokinetics

Potassium Chloride and Glucose intravenous infusion is directly administered to the

systemic circulation by infusion; the bioavailability (absorption) of the active components is

complete (100%). After its distribution into extracellular compartments, these ions are

actively pumped into the cells by action of Na/K-ATPase. Glucose, insulin and oxygen

facilitate the movement of potassium into the cells. Thus, in insulin-deficient diabetic

patients, the tolerance of potassium load is impaired.

Under normal conditions, the kidney primarily excretes the excess of potassium, if any, with

only a small amount appearing in the faeces. The capacity of the kidney to conserve

potassium ions is poor, and a deficiency of these ions will develop rapidly if intake drops

significantly. In the kidney, it is secreted in the distal tubules, where the sodium-potassium

exchange takes place. A small amount of potassium is lost in sweat.

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INDICATIONS

Potassium Chloride 20mmol (0.15%) in 5% Glucose infusion solution or

Potassium Chloride 30mmol (0.224%) in 5% Glucose infusion solution [Potassium

Chloride and Glucose intravenous infusion] is indicated for replenishing fluid losses, as an

energy source and for restoration or maintenance of potassium and chloride ion

concentrations. This is also an alternative route of administration for the patients who are

unable to take potassium orally or if hypokalaemia is severe. It may be used as a vehicle of

drug delivery where intravenous delivery is appropriate and the drug is compatible with this

solution.

CONTRAINDICATIONS

Although the level of potassium ions in Potassium Chloride and Glucose intravenous

infusion is relatively low, administration of this product is contraindicated:

in patients who have known hypersensitivity to the product

in patients suffering from renal impairment with oliguria, anuria or azotemia;

untreated chronic adrenocortical insufficiency (Addison’s disease); hyperadrenalism

associated with adrenogenital syndrome; extensive tissue breakdown such as in

severe burns; hyperkalaemia of any form; clinically significant hyperglycaemia.

Potassium is contraindicated in patients having a disease associated with abnormality of AV

conduction in the heart, because an increased potassium level (hyperkalaemia) may

worsen the degree of this heart block syndrome.

Cornstarch is the raw material for the production of glucose. Therefore, for patients known

to have an allergy to corn, or corn products, Potassium Chloride and Glucose intravenous

infusion is contraindicated.

PRECAUTIONS

Potassium Chloride 20mmol (0.15%) in 5% Glucose infusion solution and

Potassium Chloride 30mmol (0.224%) in 5% Glucose infusion solution [Potassium

Chloride and Glucose intravenous infusion] are available in Viaflex bags. The safety of the

Viaflex plastic bag has been confirmed in tests with animals according to the USP biological

tests for plastic containers, as well as by tissue culture toxicity studies. Nevertheless, care

should be exercised regarding possible incompatibility outcomes resulting either from the

interaction between the plastic container or active ingredients and the added therapeutic

substances (see also DOSAGE AND ADMINISTRATION).

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The introduction of additives to any parenteral solution, regardless of the type of container,

requires special attention so that it will not be adversely affected by an incompatibility

problem. While some incompatibilities are readily observed, one must be aware that subtle

physical, chemical and pharmacological incompatibilities can occur. The product

information of those added medicines must be examined thoroughly to ensure compatibility

with Potassium Chloride and Glucose intravenous Infusion.

Do not administer Potassium Chloride and Glucose intravenous infusions unless clear,

colourless and free of particles (see DOSAGE AND ADMINISTRATION), and the seals are

intact.

Under a dilute condition, osmolarity/L is approximately the same as osmolality/kg. The

osmolarity of Potassium Chloride and Glucose intravenous infusions is listed in Table 1

(see PRESENTATION AND STORAGE CONDITIONS). Administration of substantially

hypertonic solutions may lead to a wide variety of complications, such as crenation

(shrinkage) of red blood cells and general cellular dehydration.

Administration should be carried out under regular and careful surveillance. Regular

monitoring of clinical status, plasma electrolyte concentrations, and ECG is essential in

patients receiving potassium therapy, particularly those with pre-existing imbalances and

those with hepatic, cardiac or renal impairment. Plasma potassium levels may not be

directly related to tissue levels.

Due to the risk of pseudo-agglutination precipitated by its glucose content, Potassium

Chloride and Glucose intravenous infusion must not be added to, or administered

simultaneously through, the same tubing with citrate anticoagulated/preserved blood (see

INTERATIONS WITH OTHER MEDICINES).

The intravenous administration of Potassium Chloride and Glucose intravenous infusion

can cause fluid and/or solute overloading resulting in dilution of the serum electrolyte

concentrations, over-hydration, congested states, or pulmonary oedema. The risk of

dilution states is inversely proportional to the electrolyte concentrations of the injections.

Whilst the risk of solute overload causing congested states with peripheral and pulmonary

oedema is directly proportional to the electrolyte concentrations of the injections.

Potassium Chloride and Glucose intravenous infusion should be used with caution in

patients with overt or subclinical diabetes mellitus (see INTERACTIONS WITH OTHER

MEDICINES) as they contain glucose.

Hypersensitivity reactions

Hypersensitivity/infusion reactions, including anaphylaxis, have been reported with other

potassium chloride and glucose intravenous products (see ADVERSE EFFECTS). Stop the

infusion immediately if signs or symptoms of hypersensitivity/infusion reactions develop.

Appropriate therapeutic countermeasures must be instituted as clinically indicated.

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Risk of hyperkalaemia

Hyperkalaemia is the most common and serious hazard of potassium treatments. Since an

exact measurement of potassium deficiency is not usually possible, potassium supplements

should be administered slowly and with caution, especially in patients with cardiac disease

including congestive heart failure, conditions predisposing to hyperkalaemia such as renal

dysfunction, hepatic insufficiency and those that are digitalised.

Potassium Chloride and Glucose intravenous infusion should be administered with caution,

if at all, to patients with conditions predisposing to hyperkalaemia and/or associated with

increased sensitivity to potassium, such as patients with:

severe renal impairment

acute dehydration

extensive tissue injury or burns

certain cardiac disorders such as congestive heart failure or atrioventricular (AV)

block (especially if they receive digitalis)

potassium-aggravated skeletal muscle channelopathies (e.g., Hyperkalaemic

periodic paralysis, paramyotonia congenita, and potassium-aggravated

myotonia/paramyotonia)

Thus, the presence of adequate renal function must be confirmed and frequent observation

of clinical status of the patient and periodic ECGs and/or determinations of serum

concentrations should be made.

Potassium Chloride and Glucose intravenous infusion should be administered with caution

to patients who are at risk of experiencing hyperosmolality, acidosis, or undergoing

correction of alkalosis (conditions associated with a shift of potassium from intracellular to

extracellular space) and patients treated concurrently or recently with agents or products

that can cause hyperkalaemia or increase the risk of hyperkalaemia (see INTERACTIONS

WITH OTHER MEDICINES).

Other groups of patients in whom Potassium Chloride and Glucose intravenous infusion

should be used with caution include patients with cardiac arrhythmia. Arrhythmias can

develop at any time during hyperkalaemia. Frequently, mild or moderate hyperkalaemia is

asymptomatic and may be manifested only by increased serum potassium concentrations

and, possibly, characteristic ECG changes.

Use in patients at risk of severe renal impairment

Potassium Chloride and Glucose intravenous infusion should be administered with

particular caution, to patients at risk of severe renal impairment. In such patients,

administration of Potassium Chloride and Glucose intravenous infusion may result in or

predispose to hyperkalaemia and/or fluid overload.

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Hyperglycaemia

Rapid administration of glucose solutions may produce substantial hyperglycaemia and

hyperosmolar syndrome. In order to avoid hyperglycaemia, the infusion rate should not

exceed the patient’s ability to utilise glucose. To reduce the risk of hyperglycaemia-

associated complications, the infusion rate must be adjusted and/or insulin administered if

blood glucose levels exceed levels considered acceptable for the individual patient.

Intravenous glucose should be administered with caution in patients with, for example:

impaired glucose tolerance (such as in diabetes mellitus, renal impairment, or in the

presence of sepsis, trauma, or shock),

severe malnutrition (risk of precipitating a refeeding syndrome),

thiamine deficiency, e.g., in patients with chronic alcoholism (risk of severe lactic

acidosis due to impaired oxidative metabolism of pyruvate),

water and electrolyte disturbances that could be aggravated by increased glucose

and/or free water load.

Other groups of patients in whom Potassium Chloride and Glucose intravenous infusion

should be used with caution include:

patients with ischaemic stroke. Hyperglycaemia has been implicated in increasing

cerebral ischaemic brain damage and impairing recovery after acute ischaemic

strokes.

patients with severe traumatic brain injury (in particular during the first 24 hours

following the trauma). Early hyperglycaemia has been associated with poor

outcomes in patients with severe traumatic brain injury.

Newborns.

Prolonged intravenous administration of glucose and associated hyperglycaemia may result

in decreased rates of glucose-stimulated insulin secretion.

Risk of hypo- and hyperosmolality, serum electrolytes and water imbalance

Depending on the volume and rate of infusion and depending on a patient’s underlying

clinical condition and capability to metabolise glucose, intravenous administration of

glucose can cause:

hypoosmolality

hyperosmolality, osmotic diuresis and dehydration

electrolyte disturbances such as,

hyponatraemia,

hypophosphataemia,

hypomagnesaemia,

acid-base imbalance

overhydration/hypervolaemia and, for example, congested states, including central

(e.g., pulmonary congestion) and peripheral edema. Particular caution should be

taken in patients with conditions that may cause sodium retention, fluid overload, and

edema (central and peripheral).

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hyponatraemia and a decrease in extracellular sodium concentrations related to

hyperglycaemia causing a transcellular shift of water. Infusion of Potassium Chloride

and Glucose solution corresponds to the increasing body’s load of free water,

possibly leading to hypoosmotic hyponatraemia.

Clinical evaluation and periodic laboratory determinations may be necessary to monitor

changes in fluid balance, electrolyte concentrations, and acid-base balance during

prolonged parenteral therapy or whenever the condition of the patient or the rate of

administration warrants such evaluation.

Particular caution is advised in patients at increased risk of and from water and electrolyte

disturbances that could be aggravated by increased free water load.

Hyponatraemia

The use of Potassium Chloride and Glucose intravenous infusion may result in

hyponatraemia. Close clinical monitoring may be warranted. Hyponatraemia can lead to

headache, nausea, seizures, lethargy, coma, cerebral oedema, and death. Acute

symptomatic hyponatraemic encephalopathy is considered a medical emergency.

The risk of hyponatraemia is increased, for example:

in children

in elderly patients

in women

postoperatively

in persons with psychogenic polydipsia

in patients treated with medications that increase the risk of hyponatraemia (such as

certain antiepileptic and psychotropic medications).

The risk for developing hyponatraemic encephalopathy is increased, for example:

in paediatric patients (≤16 years of age)

in women (in particular, premenopausal women)

in patients with hypoxemia

in patients with underlying central nervous system disease

Hypokalaemia

The infusion of solutions with Potassium Chloride and Glucose may result in hypokalaemia.

Hypokalaemia can lead to arrhythmias, muscle weakness, paralysis, heart block, and

rhabdomyolysis.

Potassium Chloride and Glucose intravenous infusion should be used with particular

caution, warranting close clinical monitoring, for example:

in patients with metabolic alkalosis,

in patients with thyrotoxic or hypokalaemic periodic paralysis,

in patients with increased gastrointestinal losses (e.g.diarrhoea, vomiting)

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in patients on prolonged low potassium diet (e.g. undernourished or cachectic

patients)

in patients with primary hyperaldosteronism,

in patients treated with medications that increase the risk of hypokalaemia (e.g.

hydrochlorothiazide, loop diuretics, beta-2 agonists, or insulin).

Refeeding syndrome

Refeeding severely undernourished patients may result in the refeeding syndrome that is

characterised by the shift of potassium, phosphorus, and magnesium intracellularly as the

patient becomes anabolic. Thiamine deficiency and fluid retention may also develop.

Careful monitoring and slowly increasing nutrient intake while avoiding overfeeding can

prevent these complications.

Use in patients at risk of severe renal impairment

Potassium Chloride Glucose intravenous infusion should be administered with particular

caution, to patients at risk of severe renal impairment. In such patients, administration of

Potassium Chloride and Glucose intravenous infusion may result in fluid overload and/or

may predispose to hyperkalaemia.

Blood

Potassium Chloride and Glucose intravenous infusion should not be administered

simultaneously with blood through the same administration set because of the possibility of

pseudoagglutination or haemolysis.

Risk of air embolism

Do not connect flexible plastic containers in series in order to avoid air embolism due to

possible residual air contained in the primary container.

Pressurising intravenous solutions contained in flexible containers to increase flow rates

can result in air embolism if the residual air in the container is not fully evacuated prior to

administration.

Use of a vented intravenous administration set with the vent in the open position could

result in air embolism. Vented intravenous administration sets with the vent in the open

position should not be used with flexible plastic containers.

Use in pregnancy

Category C

Animal reproduction studies have not been conducted with Potassium Chloride and

Glucose intravenous infusion. It is also not known whether this product can cause foetal

harm when administered to a pregnant woman or can affect reproduction capacity.

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Intrapartum maternal intravenous glucose infusion may result in foetal hyperglycaemia and

metabolic acidosis as well as rebound neonatal hypoglycaemia due to foetal insulin

production (See PRECAUTIONS/PAEDIATRIC USE). Potassium Chloride and Glucose

intravenous infusion should be given to pregnant women only if clearly needed after careful

consideration of the potential risks and benefits.

Use in lactation

Safety in lactation has not been established. Use this product in a nursing woman only

when it is clearly needed and the potential benefits outweigh the potential risks to the baby.

Paediatric use

Neonates, especially those born premature and with low birth weight, are at increased risk

of developing hypo- or hyperglycemia and therefore need close monitoring during treatment

with intravenous glucose solutions to ensure adequate glycaemic control in order to avoid

potential long term adverse effects. Hypoglycaemia in the neonate can cause prolonged

seizures, coma and brain damage. Hyperglycaemia has been associated with cerebral

injury, including intraventricular haemorrhage, late onset bacterial and fungal infection,

retinopathy of prematurity, necrotizing enterocolitits, bronchopulmonary dysplasia,

increased oxygen requirements, prolonged length of hospital stay, and death.

Children (including neonates and older children) are at increased risk of developing

hyponatraemia as well as developing hyponatraemic encephalopathy. The infusion of

hypotonic fluids together with the non-osmotic secretion of ADH may result in

hyponatraemia. Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma,

cerebral oedema, and death; therefore, acute symptomatic hyponatraemic encephalopathy

is considered a medical emergency.

Plasma electrolyte concentrations should be closely monitored in the paediatric population.

Rapid correction of hyponatraemia is potentially dangerous (risk of serious neurologic

complications). Dosage, rate, volume and duration of administration should be determined

by a physician experienced in paediatric intravenous fluid therapy.

Use in the elderly

In general, the type of infusion solution, the volume/rate of infusion and dose selection for

an elderly patient should be cautious, usually starting at the low end of the dose range,

reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of

concomitant disease or drug therapy.

Genotoxicity/Carcinogenicity

The active ingredients, glucose and potassium chloride, are not carcinogenic or mutagenic.

They are basic nutrients in all living cells.

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INTERACTIONS WITH OTHER MEDICINES

Potassium Chloride 20mmol (0.15%) in 5% Glucose infusion solution or

Potassium Chloride 30mmol (0.224%) in 5% Glucose infusion solution [Potassium

Chloride and Glucose intravenous infusion] should not be administered simultaneously with

blood preparations through the same administration set, because of the possibility of

pseudo-agglutination or haemolysis.

Potassium Chloride and Glucose intravenous infusion should be used with caution in

patients treated concurrently or recently with agents or products that can cause

hyperkalaemia or increase the risk of hyperkalaemia. Administration of potassium in

patients treated with such agents is associated with an increased risk of severe and

potentially fatal hyperkalaemia, in particular in the presence of other risk factors for

hyperkalaemia. These products should not be administered concomitantly with potassium

sparing diuretics (such as amiloride, spironolactone, triamterene), angiotensin converting

enzyme (ACE) inhibitors or angiotensin 2 receptor antagonists (A2RAs). Simultaneous

administration of these medicines or potassium supplements with Potassium Chloride and

Glucose intravenous infusions can result in severe hyperkalaemia.

Potassium Chloride and Glucose intravenous infusion should also be used with caution in

patients treated with corticosteroids, cyclosporin, tacrolimus and medicines that contain

potassium.

If using this solution to administer medicines, the product information document(s) of such

medicine(s) must be reviewed to ensure compatibility with the solution.

Concurrent use of these products with insulin will decrease serum potassium. Use of these

infusions may necessitate review of a patient’s oral hypoglycaemic or insulin requirements,

so close monitoring of serum glucose levels is also required.

Both the glycaemic effects of Potassium and Glucose intravenous infusion and its effects on

water and electrolyte balance should be taken into account when using these products in

patients treated with other substances that affect glycaemic control, or fluid and/or

electrolyte balance.

Potassium Chloride and Glucose intravenous infusion should be used with caution in

patients treated with medications that can increase the risk of hyponatraemia, or sodium

and fluid retention, such as corticosteroids.

ADVERSE EFFECTS

Adverse reactions may occur because of the solution or the technique of administration,

including fever response, infection at the site of injection, venous thrombosis or phlebitis

extending from the site of injection, extravasation and hypervolemia. If an adverse reaction

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does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic

countermeasures and save the remainder of the fluid for examination if deemed necessary.

Physiologically, an excessive administration of any potassium preparation may result in

symptoms of hyperkalaemia. This is particularly manifested in patients with renal

impairment. The clinical signs and symptoms of potassium intoxication include paresthesia

of the extremities, weakness or heaviness of the legs, cardiac arrhythmias, heart block,

cardiac arrest and mental confusion. Intravenous infusion of potassium at rates exceeding

20mmol/hour, or concentrations of potassium exceeding 40mmol/L or less in the case of

renal impairment, may lead to a dangerous level of hyperkalaemia. Potassium serum levels

of greater than 6mmol/L commonly manifest cardiac arrhythmias.

Symptoms and signs of potassium intoxication include:

Cardiovascular

Fall in blood pressure, cardiac depression, arrhythmias, heart block and cardiac arrest.

Hyperkalaemia is usually asymptomatic but may exhibit the following ECG abnormalities:

disappearance of the P wave, prolongation of the QT interval, widening and slurring of the

QRS complex, changes of the ST segment and tall peaked T waves.

Other

Listlessness, mental confusion, paraesthesia of the extremities, muscle weakness,

heaviness of the legs, paralysis.

Anaphylactic reactions, hypersensitivity, pyrexia and chills have also been reported for

similar solutions containing glucose.

Post-marketing

The following adverse reactions have been reported in the post-marketing experience.

General Disorders and Administration Site Conditions: Infusion site rash, Infusion

site pain

Other reactions (Class reactions)

Other adverse reactions reported with potassium chloride and glucose intravenous

injections/infusions include:

Immune System Disorders: anaphylactic reaction / hypersensitivity

Metabolism and Nutrition Disorders: hyperkalaemia, hypokalaemia

General Disorders and Administration Site Conditions: infusion site reactions,

including Infusion site vesicles, Infusion site pruritus, Infusion site phlebitis, Chills,

Pyrexia

Cardiac Disorders: Cardiac arrest (as a manifestation of hyperkalaemia)

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DOSAGE AND ADMINISTRATION

To be used as directed by the physician. The choice of specific Potassium Chloride and

Glucose concentrations, dosage, volume, rate and duration of administration depends on

the age, weight, concomitant treatments, and clinical condition of the patient as well as

laboratory determinations, and administration should be determined by a physician

experienced in intravenous fluid therapy.

Parenteral medicinal products should be inspected visually for particulate matter and

discolouration prior to administration whenever solution and container permit (see

PRECAUTIONS). Do not administer unless solution is clear, colourless and free of

particles and the seals are intact.

Electrolyte supplementation may be indicated according to the clinical needs of the patient.

A gradual increase of flow rate should be considered when starting administration of

glucose-containing products.

Hyperosmolar solutions may cause venous irritation and phlebitis. Thus, any hyperosmolar

solutions are recommended to be administered through a large central vein, for thorough

and rapid dilution of the hyperosmolar solution. See PRESENTATION AND STORAGE

CONDITIONS for information on the products’ osmolality.

Except in the presence of severe renal impairment, hyperkalaemia is not likely to occur from

slow intravenous administration of a dilute solution of potassium chloride. However,

hyperkalaemia may result from rapid intravenous administration of potassium chloride.

Generally, the concentration of potassium in an intravenous fluid should not exceed

40mmol/L and the rate of administration should not exceed potassium 20mmol/hour (see

Table 1 PRESENTATION AND STORAGE CONDITIONS for comparison).

Potassium Chloride and Glucose intravenous infusion is intended for intravenous

administration using sterile and non-pyrogenic equipment. They are a pre-mixed potassium

chloride in isotonic glucose solution, which are readily available for restoration of potassium,

such as in the treatment of hyperkalaemia.

The equipment should be primed with the solution in order to prevent air embolism due to

residual air in the system. Additives may be introduced before infusion or during infusion

through the injection site. Additives may be incompatible. Check additive compatibility with

both the solution and container prior to use. Complete information is not available. Those

additives known to be incompatible should not be used. Consult with a pharmacist, if

available.

If in the informed judgment of the physician, it is deemed advisable to introduce additives,

use aseptic technique. Mix thoroughly and carefully when additives have been introduced.

After addition, if there is a colour change and/or the appearance of precipitates, insoluble

complexes or crystals, do not use. Do not store solutions containing additives.

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The product should be used once only. Any unused portion should be discarded. Do not

reconnect partially used bags.

Direction for use of Viaflex plastic container

Do not remove unit from over-wrap until ready for use. The inner bag maintains the sterility

of the product. Do not use plastic containers in series connections. Such use could result

in embolism due to residual air being drawn from the primary container before

administration of the fluid from the secondary container is completed. Vented intravenous

administration sets with the vent open, or pressurising intravenous solutions contained in

flexible plastic containers to increase flow rate can result in air embolism if the residual air in

the container is not fully evacuated prior to administration.

To Open

Tear over wrap down side at slit and remove solution container. Some opacity of the plastic

due to moisture absorption during the sterilisation process may be observed. This is normal

and does not affect the solution quality or safety. The opacity will diminish gradually.

Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution

as sterility may be impaired.

If supplemental medication is desired, follow directions below.

Preparation for Administration

(1) Suspend container from eyelet support.

(2) Remove plastic protector from outlet port at the bottom of container.

(3) Attach administration set.

To add medication

Additives may be incompatible. Before adding a substance or medication, verify that it is

soluble and/or stable in Potassium Chloride and Glucose intravenous infusion and that the

pH range of Potassium Chloride and Glucose intravenous infusion is appropriate. The

product information document(s) of the medication(s), the instructions for use of the

medication(s) to be added and other relevant literature must be consulted prior to their

addition to Potassium Chloride and Glucose intravenous infusion.

To add medication before solution administration

Prepare medication site. Using syringe with 19 to 22-gauge needle, puncture resealable

medication port and inject. Mix solution and medication thoroughly. For high-density

medication such as potassium chloride, squeeze ports while ports are upright and mix

thoroughly.

To add medication during solution administration

Close clamp on the set. Prepare medication site. Using syringe with 19 to 22-gauge

needle, puncture resealable medication port and inject. Remove container from IV pole

and/or turn to upright position. Evacuate both ports by squeezing them while container is in

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the upright position. Mix solution and medication thoroughly. Return container to in-use

position, re-open the clamp and continue administration.

After addition, if there is a color change and/or the appearance of precipitates, insoluble

complexes or crystals, do not use. Do not store solutions containing additives.

OVERDOSAGE

Symptoms

There is no overdose experience with Potassium Chloride and Glucose intravenous infusion

preparations. However, excessive administration or impaired excretion of potassium may

lead to:

hyperglycaemia, adverse effects on water and electrolyte balance, and

corresponding complications. For example, severe hyperglycaemia, severe dilutional

hyponatraemia, hyponatraemia (which can lead to CNS manifestations including

seizures, coma, cerebral oedema) and their complications, can be fatal,

fluid overload (which can lead to central and/or peripheral oedema)

a development of potentially fatal hyperkalaemia. It is usually asymptomatic and

may be manifested only by an increased serum potassium concentration and

characteristic ECG changes (peaking of T waves, depression of the ST segment,

disappearance of P wave, prolongation of the QT interval, and widened QRS

complex). Extremely high serum potassium concentrations (8 ─ 11mmol/L) may

cause death from cardiac depression, arrhythmia or arrest (see ADVERSE

EFFECTS).

However, the correlation between potassium levels and ECG changes is not precise, and

whether or at which potassium level certain ECG signs develop depends on factors such as

patient sensitivity, the presence of other electrolytes disorders, and the rapidity of the

development of hyperkalaemia. Manifestations of hyperkalaemia may also include:

disturbances in cardiac conduction and arrhythimias, including bradycardia, heart

block, asystole, ventricular tachycardia, ventricular fibrillation

hypotension

muscle weakness up to and including muscular and respiratory paralysis,

paresthesia of extremities

gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain).

When assessing an overdose, any additives in the solution must also be considered.

Clinically significant overdose of Potassium Chloride and Glucose intravenous infusion may,

therefore, constitute a medical emergency.

POTASSIUM CHLORIDE, 5% GLUCOSE

New Zealand Data Sheet

NZ Data Sheet 20 July 2016

Page 15 of 17

Baxter

Treatment

No specific antidotes to this preparation are known. Should overdose occur, interventions

include discontinuation of solution administration, dose reduction, administration of insulin

and other measures as indicated for the specific clinical constellation.

If hyperkalemia is present or suspected, discontinue the infusion immediately and institute

close ECG, laboratory and other monitoring and, as necessary, corrective therapy to reduce

serum potassium levels. Treatment of hyperkalaemia depends on its severity. It must be

kept in mind that rapid lowering of serum potassium concentrations in digitalised patients

can cause cardiac toxicity.

Clinically, only the intravascular potassium concentration causes the cardiac disorders.

Therefore, infusion of the potassium chloride solution and other exogenous sources of

potassium, such as potassium-rich containing foods or medications causing potassium

retention (potassium-sparing diuretic) must be discontinued immediately. In patients with

severe hyperkalaemia, measures which facilitate the shift of potassium ions from the

vascular to the intracellular space, should be initiated. It can be achieved by administration

of sodium bicarbonate, glucose/insulin, or calcium gluconate infusions.

In patients with serum potassium concentrations greater than 6.5mmol/L, intravenous

infusion of 40 ─ 160mmol of sodium bicarbonate over a 5 minute period has been

recommended. This dose may be repeated every 15 minutes if ECG abnormalities persist.

This treatment results in a temporary alkalosis and lowers serum potassium levels by

0.6mmol/L for every 0.1 increase of the pH.

Glucose/insulin infusion is another treatment for an overdose episode with potassium

chloride medications. It consists of 300 ─ 500mL of 10 ─ 25% Glucose Intravenous

Infusion containing 5 ─10IU Insulin per 20g of glucose infused over a 1 hour period.

Patients whose ECGs show the absence of P waves or a broad QRS complex and who are

not receiving cardiac glucosides should immediately be given intravenously 0.5 ─ 1.0g

(5 ─ 10mL of a 10% solution) of calcium gluconate or another calcium salt over a 2 minute

period (with continuous ECG monitoring) to antagonize the cardiac toxic effects of

potassium. If ECG abnormalities persist, repeated doses of calcium salt may be given,

allowing 1 ─ 2 minutes between doses.

When the ECG approaches normal, efforts should be directed toward removal of excess

potassium from the body. This is a choice of treatment, when the removal of the potassium

should be initiated as soon as possible. This is accomplished by administration of sodium

polystyrene sulphonate resin orally or rectally, where sodium is exchanged with potassium

in the gastrointestinal tract. One gram of resin will remove 1mmol of potassium, but at the

same time it will add 2 ─ 3mmol of sodium, which may lead to a sodium overload. To

overcome the constipating effect by the resin, it is formulated in sorbitol solution (20%).

POTASSIUM CHLORIDE, 5% GLUCOSE

New Zealand Data Sheet

NZ Data Sheet 20 July 2016

Page 16 of 17

Baxter

The initial dose of 30 ─ 60g of resin in 120 ─ 240mL of 20% sorbitol has been

recommended. It can be repeated every 1 ─ 2 hours.

As a last resort, haemodialysis or peritoneal dialysis can be used to remove potassium from

the body, in particular, patients with renal impairment. The infusion of furosemide (high

ceiling diuretics) with substantial amounts of sodium chloride and bland solution will excrete

potassium at the distal tubules of the renal system by sodium exchange mechanism into the

urine.

In the event of overdosage, in New Zealand please contact the National Poisons

Information Centre (telephone 0800 POISON or 0800 764 766), or in Australia the Poison

Information Centre (telephone 13 11 26).

PRESENTATION AND STORAGE CONDITIONS

Potassium Chloride 20mmol (0.15%) in 5% Glucose infusion solution and

Potassium Chloride 30mmol (0.224%) in 5% Glucose infusion solution [Potassium

Chloride and Glucose intravenous infusions] preparations are supplied in Viaflex plastic

bags as a single unit dose. They are available in several strengths as shown in the

following table.

Table 1: Potassium Chloride 20mmol (0.15%) in 5% Glucose and

Potassium Chloride 30mmol (0.224%) in 5% Glucose

intravenous infusion solution preparations

Code No.

Name of the active components

energy (kJ)]

Osmolarity Ф

(mOsmol/L)

TT50-

Pack Size*

(mL)

AHB1134

Potassium Chloride 0.15% (20mmol/L)

and Glucose 5%

(278mmol/L) [835 kJ/L]

317.0 (318.0)

5539

1000

AHB1174

Potassium Chloride 0.224% (30mmol/L)

and Glucose 5%

(278mmol/L) [835 kJ/L]

340.0 (338.0)

5539/1

1000

Note:

Osmolarity Ф is a calculated figure, whilst figures in the bracket are approximately Osmolality (mOsmol/kg).

1 gram of glucose provides 16.7 kiloJoules (kJ) of energy.

*Not all packs may be marketed.

POTASSIUM CHLORIDE, 5% GLUCOSE

New Zealand Data Sheet

NZ Data Sheet 20 July 2016

Page 17 of 17

Baxter

Storage

Exposure of pharmaceutical products to heat should be minimised. Avoid excessive heat.

It is recommended that the product should be stored below 30°C.

MEDICINE CLASSIFICATION

General Sale Medicine.

NAME AND ADDRESS

Potassium Chloride 20mmol (0.15%) in 5% Glucose infusion solution and

Potassium Chloride 30mmol (0.224%) in 5% Glucose infusion solution are distributed in New

Zealand by:

Baxter Healthcare Ltd

33 Vestey Drive

Mt Wellington

Auckland 1060.

Baxter Healthcare Ltd

PO Box 14 062

Panmure

Auckland 1741

Phone (09) 574 2400.

Distributed in Australia by:

Baxter Healthcare Pty Ltd

1 Baxter Drive

Old Toongabbie, NSW 2146.

DATE OF PREPARATION

20 July 2016.

Based on Australian PI amended 11 July 2016; and CCSI44820151113.

Please refer to the Medsafe website (www.medsafe.govt.nz) for most recent data sheet.

BAXTER and VIAFLEX are trademarks of Baxter International Inc.

12-1-2019

Safety evaluation of the food enzyme glucose isomerase from Streptomyces murinus (strain NZYM‐GA)

Safety evaluation of the food enzyme glucose isomerase from Streptomyces murinus (strain NZYM‐GA)

Published on: Fri, 11 Jan 2019 The food enzyme is a glucose isomerase (d‐xylose aldose‐ketose‐isomerase; EC 5.3.1.5) produced with a non‐genetically modified Streptomyces murinus strain NZYM‐GA by Novozymes A/S. The glucose isomerase is intended only to be used in an immobilised form in glucose isomerisation for the production of high fructose syrups. Residual amounts of total organic solids are removed by the purification steps applied during the production of high fructose syrups using the immobilised...

Europe - EFSA - European Food Safety Authority EFSA Journal

3-1-2019

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

FDA - U.S. Food and Drug Administration

20-12-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinog...

FDA - U.S. Food and Drug Administration

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

30-11-2018

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of  blood glucose monitors to empower patients with diabetes with reliable  tools to manage their health. Read more:  https://go.usa.gov/xPMyA   #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

FDA - U.S. Food and Drug Administration

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,potassium hydrogen carbonate (ADV7103), decision type: , therapeutic area: , PIP number: P/0214/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,potassium hydrogen carbonate (ADV7103), decision type: , therapeutic area: , PIP number: P/0214/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,potassium hydrogen carbonate (ADV7103), decision type: , therapeutic area: , PIP number: P/0214/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

6-11-2018

November is #DiabetesAwarenessMonth  #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes

November is #DiabetesAwarenessMonth #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes

November is #DiabetesAwarenessMonth #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes: https://go.usa.gov/xPdK4 

FDA - U.S. Food and Drug Administration

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

27-7-2018

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)5047 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/03

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety