Potassium Chloride 20mmol in 0.9% Sodium Chloride (1000mL)

Main information

  • Trade name:
  • Potassium Chloride 20mmol in 0.9% Sodium Chloride (1000mL) Solution for infusion
  • Pharmaceutical form:
  • Solution for infusion
  • Units in package:
  • Bag, Viaflex,, 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 20mmol in 0.9% Sodium Chloride (1000mL) Solution for infusion
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Indicated as a source of water and to restore electrolyte balance as required by the patient's clinical condition, such as hypokalaemia.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 1796
  • Authorization date:
  • 29-09-1980
  • Last update:
  • 09-05-2018

Summary of Product characteristics: dosage,interactions,side effects

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 1 of 14

Baxter Healthcare Ltd

Potassium Chloride and Sodium Chloride (infusion, solution)

Potassium Chloride 10mmol in 0.29% Sodium Chloride (100mL)

Potassium Chloride 20mmol in 0.9% Sodium Chloride (1000mL)

Potassium Chloride 30 mmol in 0.9% Sodium Chloride (1000mL)

Potassium Chloride 40 mmol in 0.9% Sodium Chloride (1000mL)

Potassium Chloride 40 mmol in 0.9% Sodium Chloride (100mL)

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients

Potassium chloride and Sodium chloride.

The strength of the active ingredients and excipients vary with each medicinal product.

Potassium Chloride 10mmol in 0.29% Sodium Chloride (100mL) (Potassium Chloride 10mmol

(7.5g/L) infusion solution, BP in 100mL)

Potassium Chloride 20mmol in 0.9% Sodium Chloride (1000mL) (Potassium Chloride 20mmol

(0.15%) and 0.9% Sodium Chloride infusion solution, BP in 1000mL)

Potassium Chloride 30mmol in 0.9% Sodium Chloride (1000mL) (Potassium Chloride 30mmol

(0.224%) and 0.9% Sodium Chloride infusion solution, BP in 1000mL)

Potassium Chloride 40mmol in 0.9% Sodium Chloride (1000mL) (Potassium Chloride 40mmol

(2.98g/L) infusion solution, BP in 1000mL)

Potassium Chloride 40mmol in 0.9% Sodium Chloride (100mL) (Potassium Chloride 40mmol

(29.8g/L) and 0.9% (9g/L) Sodium Chloride infusion solution, BP in 100mL)

The amounts of potassium chloride and sodium chloride, dissolved in Water for Injection, are also

shown in tabular format in section 6.1.

Hydrochloric acid may be added for pH adjustment. For the full list of

excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Infusion, solution, in VIAFLEX bags.

Potassium Chloride and Sodium Chloride occur as colourless or white crystals and are freely soluble in

water.

Potassium Chloride and Sodium Chloride intravenous infusion solutions are sterile, non‐pyrogenic

solutions. They do not contain an antimicrobial agent or an added buffer and have a pH of

4.0 – 7.0.

The following products are isotonic solutions (see section 6.1):

Potassium Chloride 10mmol in 0.29% Sodium Chloride (100mL)

Potassium Chloride 20mmol in 0.9% Sodium Chloride (1000mL)

The following products are hypertonic solutions (see section 6.1):

Potassium Chloride 30 mmol in 0.9% Sodium Chloride (1000mL)

Potassium Chloride 40 mmol in 0.9% Sodium Chloride (1000mL)

Potassium Chloride 40 mmol in 0.9% Sodium Chloride (100mL)

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 2 of 14

Baxter Healthcare Ltd

4 CLINICAL PARTICULARS

Therapeutic indications

Potassium Chloride and Sodium Chloride infusion solutions are indicated as a source of water and to

restore electrolyte balance as required by the patient’s clinical condition, such as hypokalaemia.

Dose and method of administration

To be used as directed by the physician for intravenous use only. To be used as directed by the

physician for intravenous use only. The choice of the specific Potassium Chloride and Sodium Chloride

infusion solutions formulation, dosage, volume, rate and duration of administration is dependent

upon the age, weight, clinical and biological (acid‐base balance) condition of the patient, concomitant

therapy and laboratory determinations. Additional electrolyte supplementation may be indicated

according to the clinical needs of the patient. Administration should be determined by a physician

experienced in intravenous fluid therapy. A rate‐limiting device such as a rate‐controlled infusion

pump should be used to prevent unintentional bolus doses of solutions containing potassium

chloride. Institutional guidelines for administration of intravenous potassium should be followed.

The Potassium Chloride and Sodium Chloride infusion solutions range have a pH of 4.0 ‐ 7.0 and their

osmolarity are listed in the table in section 6.1. The osmolarity of a final admixed infusion solution

must be taken into account

when peripheral administration is considered. Hyperosmolar solutions

may cause venous irritation and phlebitis. Thus, clinically significant hyperosmolar solutions are

recommended to be administered through a large central vein, for rapid dilution of the hyperosmolar

solution.

Potassium Chloride 40mmol and 0.9% Sodium Chloride in 100mL must be administered via a central

vein

to diminish the risk of causing sclerosis. Be sure the catheter is not in the atrium or ventricle to

avoid localised hyperkalaemia.

The following intravenous potassium infusion solutions should be administered in a large peripheral

or central vein to diminish the risk of causing sclerosis. If infused through a central vein, be sure the

catheter is not in the atrium or ventricle to avoid localised hyperkalaemia.

Potassium Chloride 10mmol and 0.29% Sodium Chloride in 100mL

Potassium Chloride 20mmol and 0.9% Sodium Chloride in 1000mL

Potassium Chloride 30mmol and 0.9% Sodium Chloride in 1000mL

Potassium Chloride 40mmol and 0.9% Sodium Chloride in 1000mL.

Solutions containing potassium should be administered under the following conditions:

The 100mL presentation must be infused over at least 1 hr

Potassium Chloride 40mmol and 0.9% Sodium Chloride in 100mL must be administered via

a central line (see section 4.8)

The maximum time over which infusion may occur is 12 hours for the 100mL product, and

24 hours for the 1000mL presentations.

The recommended administration rate should not exceed 20mmol/hour and not exceed

80mmol for a 24‐hour period (= 6g KCl/24hr).

Paediatric use requires the application of specific institutional protocols

to calculate

appropriate dose rates for individual patients. Do not exceed 3mmol/kg/day.

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

residual air contained in the primary container.

Potassium Chloride and Sodium Chloride infusion solutions are intended for intravenous

administration using sterile

and strict aseptic technique. Parenteral drug products should be

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 3 of 14

Baxter Healthcare Ltd

inspected visually for particulate matter and discolouration prior to administration wherever solution

and container permit (see section 4.4). Do not administer unless solution is clear and seal is intact.

The solutions contain no antimicrobial

agents, and are for single use in only one patient. Unused

portions must be discarded.

The volume in the 1000mL bags will accommodate additives.

The volume in the 100mL bags, will NOT accommodate additives. Do not add supplementary

medication. See section 6.2.

Check for minute leaks by squeezing inner bag

firmly. If leaks are found, discard solution, as sterility

may be impaired.

Additives may be incompatible (see section 6.2). If in the informed judgment of the physician, it is

deemed advisable to introduce additives, use aseptic technique. Add additives to inverted container

(ports uppermost) with a 0.63

─ 0.80mm needle. Squeeze ports and m

ix thoroughly.

Monitoring

Adequate urine flow must be ensured and careful monitoring of electrolyte concentrations and ECG is

essential (see section 4.4).

Paediatric use

These solutions have not been developed for use in children, and age specific paediatric protocols

must be consulted.

The infusion rate and volume depends on the

age, weight, clinical and metabolic conditions of the

patient, concomitant therapy, and should be determined by a physician experienced in paediatric

intravenous fluid therapy. Paediatric use requires the application of specific institutional protocols to

calculate appropriate dose rates for individual patients.

Use in the elderly

When selecting the type of infusion solution and the volume/rate of infusion for a geriatric patient,

consider that geriatric patients are generally more likely to have cardiac, renal, hepatic, and other

diseases and/or concomitant medicinal therapy.

Contraindications

The Potassium Chloride and Sodium Chloride infusion solutions are contraindicated in patients with:

know hypersensitivity to the product or to any

of the excipients listed in section 6.1

documented hyperkalaemia, hyperchloraemia or hypernatraemia

potassium retention

congestive heart failure

severe impairment of renal function

acidosis

haemolysis

Addison’s disease

in conjunction with potassium sparing diuretics

clinical states in which the administration of sodium and

chloride is detrimental.

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 4 of 14

Baxter Healthcare Ltd

Special warnings and precautions for use

Monitoring

Adequate urine flow must be ensured and careful monitoring of plasma potassium and other

electrolyte concentrations is essential.

High dose or high speed infusion must be performed under continuous ECG monitoring.

Hypersensitivity reactions

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

containing potassium chloride and sodium chloride. Stop the infusion immediately if signs or

symptoms of hypersensitivity/infusion reactions develop. Appropriate therapeutic countermeasures

must be instituted as clinically indicated.

Special warnings

To avoid potassium intoxication, Potassium Chloride and Sodium Chloride infusion solutions must not

be infused rapidly. Administration should be carried out under regular and careful surveillance.

Regular monitoring of clinical status, plasma electrolyte concentrations, plasma creatinine levels, BUN

level, acid‐base balance and ECG is essential in patients receiving potassium therapy, particularly

those with cardiac or renal impairment. Adequate urine flow should be ensured and fluid balance

should be monitored.

When infusing Potassium Chloride and Sodium Chloride infusion solutions; care must be taken to

prevent paravenous administration or extravasation because such solutions may be associated with

tissue damage, which may be severe and include vascular, nerve and tendon damage,

leading to

surgical intervention, including amputation. Secondary complications including pulmonary embolism

from thrombophlebitis have been reported as a consequence of tissue damage from potassium

chloride.

Sodium salts should be administered with caution to patients with hypertension, heart failure,

peripheral or pulmonary oedema, impaired renal function, pre‐eclampsia, or other conditions

associated

with sodium retention (see also section 4.5).

Rapid correction of hypernatraemia and hyponatraemia is potentially dangerous (risk of serious

neurologic complications).

In order to reduce risks of thrombophlebitis, it is recommended to change the injection site every

24hrs.

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

potassium chloride into an isotonic sodium chloride renders the Potassium Chloride and Sodium

Chloride infusion solution to be hypertonic (see section 6.5). 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.

Risk of hyperkalaemia

Potassium

salts should be administered with considerable care to patients with cardiac disease or

conditions predisposing to hyperkalaemia and/or associated with increased sensitivity to potassium

such as patients with:

renal impairment or adrenocorticol insufficiency

acute dehydration

extensive tissue injury or burns

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 5 of 14

Baxter Healthcare Ltd

certain cardiac disorders such as congestive heart failure or AV block (especially if they

receive digitalis). In patients under digitalis therapy, regular monitoring of the plasma

potassium level is mandatory

potassium‐aggravated skeletal muscle channelopathies (e.g., hyperkalaemic periodic

paralysis, paramyotonia congenita, and potassium‐aggravated myotonia/paramyotonia).

Potassium Chloride and Sodium Chloride infusion solution should be administered with caution to

patients who are at risk of experiencing hyperosmolality, acidosis, or undergo 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 (see section

4.5). Close monitoring, careful dose selection and adjustment is required particularly in high risk

patients.

Hyperkalaemia can cause cardiac conduction disorders (including complete heart block) and other

cardiac arrhythmias at any time during

infusion. Continuous ECG monitoring is performed to aid in

the detection of cardiac arrhythmias due to a sudden increase in serum potassium concentration

(e.g., when potassium infusion is started) or transient or sustained hyperkalaemia (see sections 4.8

4.9).

Frequently, mild or moderate hyperkalaemia is asymptomatic and may be manifested only by

increased serum potassium concentrations and possibly characteristic ECG changes. However, fatal

arrhythmias can develop at any time during hyperkalaemia. Serum potassium levels are not

necessarily indicative of tissue potassium levels.

Use in patients at risk of sodium retention, fluid overload and oedema

Potassium Chloride and Sodium Chloride infusion solution should be used with particular caution, in

patients with or at risk for:

Hypernatraemia

Hyperchloremia

Metabolic acidosis

Hypervolemia

Conditions that may cause sodium retention, fluid overload and oedema (central and

pheripheral).

Risk of serum electrolytes and water imbalance

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

condition, the intravenous administration of the Potassium Chloride and Sodium Chloride infusion

solution can cause:

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

electrolyte disturbances such as:

hypernatraemia

hyponatraemia

acid‐base imbalance

overhydration / hypervolemia, congested states, including central (e.g., pulmonary

congestion) and peripheral oedema.

The risk of dilution states is inversely proportional to the electrolyte concentrations of the

injections. The risk of solute overload causing congested states with peripheral and

pulmonary oedema is directly proportional to the electrolyte concentrations of the

injections.

Regarding medications that increase the risk of hyponatraemia or sodium and fluid retention, see

section 4.5.

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 6 of 14

Baxter Healthcare Ltd

In patients with diminished renal function, administration of Potassium Chloride and Sodium Chloride

infusion solution may result in sodium or potassium retention. Clinical evaluation and periodic

laboratory determinations may be necessary to monitor changes

in fluid balance, electrolyte

concentration and acid‐base balance during prolonged parenteral therapy or whenever the condition

of the patient or the rate of administration warrants such evaluation.

Hyponatraemia

Potassium Chloride and Sodium Chloride infusion solution should be used with particular caution in

patients with or at risk of hyponatraemia, 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 encelopathy 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.

Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oedema, and death.

Acute symptomatic hyponatraemic encelopathy is considered a medical emergency.

Use in patients at risk of several renal impairment

Potassium Chloride and Sodium Chloride infusion solution should be administered with particular

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

Chloride and Sodium Chloride infusion solution may result in sodium retention, fluid overload, and/or

may predispose to hyperkalaemia.

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.

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.

Paediatric use

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

well as for developing hyponatraemic encephalopathy. The infusion of Potassium Chloride and

Sodium Chloride infusion solution together with the non‐osmotic secretion of ADH may result in

hyponatraemia.

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

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 7 of 14

Baxter Healthcare Ltd

Interaction with other medicines and other forms of interaction

Caution is advised in patients treated with lithium. Renal sodium and lithium clearance may be

increased during administration of Baxter Potassium Chloride and Sodium Chloride IVI and this can

result in decreased lithium levels.

Solutions containing potassium 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

(e.g. potassium sparing diuretics including amiloride, spironolactone and triamterene, ACE inhibitors,

angiotensin

II receptor antagonists, cyclosporin, tacrolimus and medicines that contain potassium

such as potassium salts of penicillin). Administration of potassium in patients treated with such

agents is associated with an increased risk of severe and potentially fatal hyperkalaemia particularly in

the presence of other risk factors for hyperkalaemia.

Potassium Chloride and Sodium

Chloride infusion solution should be used with particular caution in

patients on concomitant medications that may increase the risk of sodium and fluid retention, such as

corticosteroids. Corticosteroids and corticotropin are associated with the retention of sodium and

water, with oedema and hypertension.

Potassium Chloride is not compatible with Mannitol 20%, Sodium Bicarbonate and Colloidal Solutions.

Baxter Potassium Chloride and Sodium Chloride IVI should be administered with caution in patients

on concomitant medications that increase the risk of hyponatraemia such as certain antiepileptic and

psychotropic medications.

The safety of the Viaflex plastic container used to contain Potassium Chloride and Sodium Chloride

infusion solutions has been confirmed in tests in animals according to the USP biological tests for

plastic containers, as well as by tissue culture toxicity studies. Nevertheless, care should be exercised

regarding a possible incompatibility outcome resulting either from the interaction between the plastic

container or active ingredients and the added therapeutic substances (see section 4.2).

The introduction of additives to any solution, regardless of type of container, requires special

attention to ensure that no incompatibilities result. While some incompatibilities are readily

observed, one must be aware that subtle physical, chemical and pharmacological incompatibilities

can occur. The medical literature, data sheet,

package insert and other available sources of

information should be reviewed for thorough understanding of possible incompatibility problems.

Additives known or determined to be incompatible should not be used.

Fertility, pregnancy and lactation

Fertility

Animal reproduction studies have not been conducted Potassium Chloride and Sodium Chloride

infusion solutions.

Pregnancy (Category C)

Animal

reproduction studies have not been conducted Potassium Chloride and Sodium Chloride

infusion solutions. It is not known whether these dosage forms can cause foetal harm when

administered to a pregnant woman or can affect reproduction capacity. There are no adequate data

from the use of Potassium Chloride and Sodium Chloride infusion solutions in pregnant women.

Physicians should carefully consider the potential risks and benefits for each specific patient before

administering Potassium Chloride and Sodium Chloride infusion solutions.

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 8 of 14

Baxter Healthcare Ltd

Lactation

Safety in lactation has not been established. There are no adequate data from the use of Potassium

Chloride and Sodium Chloride infusion solutions in lactating women. Physicians should carefully

consider the potential risks and benefits for each specific patient before administering Potassium

Chloride and Sodium Chloride infusion solutions.

Effects on ability to drive and use machines

There is no information on the effects of Potassium Chloride and Sodium Chloride infusion solutions

on the ability to operate an automobile or other heavy machinery.

Undesirable effects

Adverse reactions to potassium containing solutions include hyperkalaemia, paraesthesia of the

extremities, flaccid paralysis, mental confusion, hypotension, cardiac arrhythmias, heart block, ECG

abnormalities and cardiac arrest.

Adverse reactions which 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 does occur,

discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and

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

Post‐marketing adverse reactions

The following adverse reactions have been reported in the post‐marketing experience, listed by

MedDRA System Organ Class (SOC).

IMMUNE SYSTEM DISORDERS: Hypersensitivity, as manifested by rash and angioedema.

METABOLISM AND NUTRITION DISORDER: Hyperkalaemia, Hyponatraemia, Hypernatraemia, acidosis

hyperchloroemic, fluid overload.

CARDIAC DISORDERS: Cardiac arrest*, asystole*, ventricular fibrillation*, bradycardia (*as

manifestation of rapid intravenous administration and/or of hyperkalaemia).

RESPIRATORY, THORACIC

AND MEDIASTINAL DISORDERS: Dyspnoea.

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Chest pain, chills, infusion site pain,

infusion site irritation, burning sensation.

Other adverse reaction associated with administration of Potassium Chloride and Sodium Chloride

infusion solutions include:

in association with extravasation: skin necrosis, skin ulcer, soft tissue necrosis, muscle

necrosis,

nerve injury, tendon injury and vascular injury

infusion site thrombosis, infusion site phlebitis, infusion site swelling and infusion site

erythema.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continuing monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked

to report any suspected adverse reactions https://nzphv.otago.ac.nz/reporting/

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 9 of 14

Baxter Healthcare Ltd

Overdose

Excessive administration of Potassium Chloride and Sodium Chloride infusion solutions can cause:

Hyponatraemia (which can lead to CNS manifestations including seizures, coma, cerebral

edema and death)

Hypernatraemia, especially in patients

with severe renal impairment

Hyperkalaemia. Potassium overdose can cause potentially fatal hyperkalaemia. The clinical

signs and symptoms of hyperkalaemia include:

disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block,

asystole, ventricular tachycardia, ventricular fibrilliation

hypotension, cold skin, grey pallor and peripheral collapse with fall in blood pressure

muscle weakness up to and including muscular and respiratory paralysis, paraesthesia of

extremities

gastrointestinal symptoms (ilues, nausea, vomiting, abdominal pain)

mental confusion

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

Extremely high serum potassium concentrations (8 – 11mmol/L) may cause death from cardiac

depression, arrhythmias or arrest.

Frequently, mild or moderate hyperkalemia is asymptomatic and may be manifested only by

increased serum potassium concentrations and, possibly, characteristic electrocardiographic changes.

However, fatal arrhythmias can develop at any time.

In addition to arrhythmias and conduction disorders, the ECG shows progressive changes that occur

with increasing potassium levels. Possible changes include: peaking of T waves, loss of P waves and

QRS widening.

The presence of any ECG findings that are suspected to be caused by hyperkalaemia should be

considered a medical emergency.

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

overdose may require immediate medical attention and treatment. Interventions include

discontinuation of Potassium Chloride and Sodium Chloride IVI administration, dose reduction, and

other measures as indicated for the specific clinical constellation. If hyperkalaemia 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.

Lowering of the potassium level should be approached with thorough consideration on adverse

effects that may occur,

in particular with digitalised patients.

A state of hypokalaemia increases the risk of digitalis toxicity. Plasma electrolyte abnormalities

(hypomagnesemia, hypokalaemia and metabolic alkalosis) also contribute to the clinical toxicity even

at normal digoxin plasma level. Thus, caution should be exercised when lowering the potassium level

in a digitalised patient.

For advice on the management of overdose please contact the National Poisons Centre on phone

number: 0800 764 766 [0800 POISON] in New Zealand (or 131126 in Australia).

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 10 of 14

Baxter Healthcare Ltd

5 PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group:

ATC Code:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS, IV SOLUTION

ADDITIVES, ELECTROLYTE SOLUTIONS

B05XA01 (potassium chloride)

B05XA03 (sodium chloride)

Mechanism of Action

Potassium Chloride and Sodium Chloride infusion solutions are mainly intended for the treatment of

potassium depletion. Thus the mode of action of these formulations should be looked at from that

viewpoint.

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

found primarily in muscle cells. It

functions principally in the maintenance of acid‐base balance;

isotonicity and electrodynamic characteristics of the cells.

In contrast, sodium is the major cation of the extracellular fluid (135 – 145mmol/L) and functions

principally in the control of water distribution, fluid and electrolyte balance and osmotic pressure of

body fluids. Na/K‐ATPase

membrane bound enzymes regulate the passage of potassium against a

higher potassium concentration in the cells. Potassium participates in carbohydrate utilisation,

protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction,

particularly in the cardiac muscle.

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. An

increase of chloride concentration may result in a decrease of bicarbonate level, which leads to

plasma acidosis, as shown by the chargeneutrality of the cells by the following equation:

That is:

= CIˉ + HCO

ˉ + [anion gap]ˉ

where pH is related to equation:

pH = pK

H2CO3

+ log [HCO

ˉ]/[H

The anion gap is called "unmeasured anion", thus, Potassium Chloride and Sodium Chloride infusion

solutions have value as a source of water, and electrolytes where the kidney may excrete potassium

up to 80 – 90mmol daily.

Daily requirements of potassium are between 800mg to 1.2g.

Chemical names, structure and CAS

The chemical names are potassium

chloride and sodium chloride, with chemical formulae as KCl and

NaCl, respectively.

Chemical structures of potassium chloride and sodium chloride are KCl and NaCl, respectively.

The CAS numbers are Potassium Chloride 7447‐40‐7 and Sodium Chloride 7647‐14‐5.

Pharmacokinetic properties

As the Potassium Chloride and Sodium Chloride infusion solutions are directly administered to the

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

(100%).

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 11 of 14

Baxter Healthcare Ltd

From vascular system potassium ions first enter the extracellular/interstitial fluid, which then are

pumped into the cells against concentration gradient by the Na/K‐ATPase active transport

mechanism.

The level of potassium in the body is regulated by glomerular filtration and distal tubular secretion.

Potassium excretion is accompanied by sodium and water reabsorption back into systemic circulation.

Thus, the kidney constantly adjusts the sodium and potassium level through this mechanism. The loss

of sodium can be reduced to zero by increasing potassium and hydrogen ion excretion. Hormones,

ADH (antidiuretic hormone) and aldosterone control the kidney function in reabsorption of water and

excretion of potassium, respectively.

The capacity of the kidney to conserve potassium ions is poor, and some urinary excretion of

potassium continues even when there is severe depletion. Some potassium is excreted in the faeces

and small amounts may be excreted in sweat.

Preclinical safety data

Carcinogenicity/mutagenicity

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

6 PHARMACEUTICAL PARTICULARS

List of excipients

Potassium Chloride and Sodium Chloride infusion solutions

Trade Name

Name of the active

components

[Concentrations (%,

mmol/container)]

Name of the excipient

components

[Concentrations (%,

mmol/container)]

Osmolarity

Ф

(mOsmol/L)

Pack size

(mL)

Potassium Chloride

10mmol in 0.29%

Sodium Chloride

(100mL)

Potassium Chloride (7.5g/L)

(0.75%,10)

Sodium Chloride (2.9g/L)

(0.29%, 5)

Water for injection q.s.

300.0 (300)

Potassium Chloride

20mmol in 0.9%

Sodium (1000mL)

Potassium Chloride

(0.15%, 20)

Sodium Chloride (0.9%, 154)

Water for injection q.s.

348.0 (340)

1000

Potassium Chloride

30 mmol in 0.9%

Sodium Chloride

(1000mL)

Potassium Chloride

(0.224%, 30)

Sodium Chloride (0.9%, 154)

368.0 (360)

1000

Potassium Chloride

40mmol in 0.9%

Sodium Chloride

(1000mL)

Potassium Chloride

(29.8g/L) (0.298%,40)

Sodium Chloride (9g/L)

(0.9%, 154)

Hydrochloric acid q.s.

Water for injection q.s.

388.0 (388)

1000

Potassium Chloride

40mmol in 0.9%

Sodium Chloride

(100mL)

Potassium Chloride

(2.98g/L) (0.298%,40)

Sodium Chloride (9g/L)

(0.9%, 154)

Hydrochloric acid q.s.

Water for injection q.s.

1100.0 (1100)

Note: Osmolarity Ф is a calculated figure. In dilute conditions osmolarity/L is approximately the same as

osmolality/kg. The figures in the brackets are osmolality (mOsmol/kg).

*40mmol/100mL is significantly hypertonic.

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 12 of 14

Baxter Healthcare Ltd

Incompatibilities

Additives may be incompatible (see section 4.2). Complete information is not available.

When introducing additives to Potassium Chloride and Sodium Chloride infusion solutions, the

instructions for use of the medication to be added and other relevant literature must be consulted.

Before adding a substance or medication, verify that it is soluble and stable in Potassium Chloride and

Sodium Chloride infusion solutions, and that the pH range of the solution is appropriate.

Only those additives known to be compatible can be added to these infusions. Consult with

pharmacist, if available. If in the informed judgment of the physician, it is deemed advisable to

introduce additives, use aseptic technique. Add additives to inverted container (ports uppermost)

with a 0.63

─ 0.80mm needle. Squeeze ports and mix thoroughly

. After addition, if there is a

discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. In

case of damage, the container should be discarded. Do not store solutions containing additives.

Discard any unused portion. For single use only.

Shelf life

Potassium Chloride 10mmol in 0.29% Sodium Chloride (100mL): 9 months from date of

manufacture.

Potassium Chloride 20mmol in 0.9% Sodium Chloride (1000mL): 24 months from date of

manufacture.

Potassium Chloride 30mmol in 0.9% Sodium Chloride (1000mL): 24 months from date of

manufacture.

Potassium Chloride 40mmol in 0.9% Sodium Chloride (1000mL): 12 months from date of

manufacture.

Potassium Chloride 40mmol in 0.9% Sodium

Chloride (100mL): 24 months from date of

manufacture.

Special precautions for storage

Store at or below 30°C.

Exposure of pharmaceutical products to heat should be minimised. Avoid excessive heat. Do not

freeze.

Nature and contents of container

Potassium Chloride and Sodium Chloride intravenous infusions are supplied in Viaflex plastic

containers as a single unit dose. They are available in various strengths and pack sizes:

Potassium Chloride infusion solutions

Item Code*

Trade Name

TT50‐

Pack size

(mL)

AHB6008

Potassium Chloride 10mmol in 0.29% Sodium Chloride (100mL)

7541

AHB1764

Potassium Chloride 20mmol in 0.9% Sodium Chloride (1000mL)

2184/18

1000

AHB1274

Potassium Chloride 30mmol in 0.9% Sodium Chloride (1000mL)

5538

1000

AHB6034

Potassium Chloride 40mmol in 0.9% Sodium Chloride (1000mL)

7542

1000

AHB6053

Potassium Chloride 40mmol in 0.9% Sodium Chloride (100mL)

7542/1

Note: AHB6053 (40mmol/100mL) is significantly hypertonic.

*Not all packs may be marketed.

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 13 of 14

Baxter Healthcare Ltd

Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MEDICINE SCHEDULE

General Sale Medicine.

8 SPONSOR

Potassium Chloride and Sodium Chloride intravenous infusions 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.

Potassium Chloride and Sodium Chloride intravenous infusions are distributed in Australia by:

Baxter Healthcare Pty Ltd

1 Baxter Drive

Old Toongabbie, NSW 2146.

9 DATE OF FIRST APPROVAL

Date of publication in the New Zealand Gazette of consent to distribute the medicine:

Potassium Chloride 10mmol in 0.29% Sodium Chloride (100mL): 7 June 2012.

Potassium Chloride 20mmol in 0.9% Sodium Chloride (1000mL): 29 September 1980.

Potassium Chloride 30mmol in 0.9% Sodium Chloride (1000mL): 29 September 1980.

Potassium Chloride 40mmol in 0.9% Sodium Chloride (1000mL): 7 June 2012.

Potassium Chloride 40mmol in 0.9% Sodium Chloride (100mL): 23 October 2014.

10 DATE OF REVISION OF THE TEXT

9 January 2018.

SUMMARY TABLE OF CHANGES

Section changed

Summary of new information

Reformatted to SPC format.

Grammatical, spelling, spacing, headings, references to other sections and product

name, corrected and made consistent.

Text moved to align with source document.

Trade names updated.

Consideration of osmolality when determining dosage.

Information regarding additives.

Paediatric use and Use in elderly, updated.

Hypersensitivity reactions precaution included.

Rapid correction of hyper‐ and hypo‐natraemia precaution.

Inclusion of warning in patients at risk of retention, fluid overload and oedema.

Inclusion of risk of serum electrolytes and water imbalances.

Inclusion of warning of hyponatraemia

NEW ZEALAND DATA SHEET

Potassium Chloride and Sodium Chloride Data Sheet 9 January 2018

Page 14 of 14

Baxter Healthcare Ltd

Warning for patients at risk of severe renal impairment

Risk of air embolism added.

Cautions in paediatric use.

Lithium interaction added.

Antiepileptic interaction added.

Sections updated.

Additional metabolism and nutrition disorder adverse effects include.

Additional general disorders and administration site conditions adverse effect

included.

Section updated to include information on excessive administration and fluid

overload.

Pharmacotherapeutic group and ATC code included.

Mechanism of action updated without change to meaning.

Table of excipients included.

Incompatibility updated section.

Footer

Date of revision updated.

Based on Australian PI most recent amendment 23 August 2017, and CCSI 453 2017 0123.

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

Baxter and VIAFLEX are trademarks of Baxter International Inc.

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

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

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

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

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

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

15-3-2018

Duro-K 600 mg potassium chloride tablets

Duro-K 600 mg potassium chloride tablets

Advisory – lead content may exceed regulatory guidelines

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

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


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

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

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

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

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

29-5-2018

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)3397 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety

22-3-2018

Lutetium (<sup>177</sup> Lu) chloride

Lutetium (<sup>177</sup> Lu) chloride

Lutetium (177 Lu) chloride (Active substance: Lutetium (177Lu) chloride) - Centralised - Art 28 - (PSUR - Commission Decision (2018)1902 of Thu, 22 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10391/201706

Europe -DG Health and Food Safety