Glucose 5% Sodium Chloride 0.45%

Main information

  • Trade name:
  • Glucose 5% Sodium Chloride 0.45% 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:
  • Glucose 5% Sodium Chloride 0.45% Solution for infusion
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Glucose and sodium chloride infusion solution is indicated for replenishing fluid losses, as an energy source and for restoration or maintenance of sodium and chloride ion concentrations. It may be used as a vehicle of medication delivery where intravenous delivery is appropriate and the medicine is compatible with this solution.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 1053
  • Authorization date:
  • 17-05-1991
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

GLUCOSE AND SODIUM CHLORIDE

New Zealand Data Sheet

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GLUCOSE AND SODIUM CHLORIDE

Glucose 2.5% Sodium Chloride 0.45% infusion solution

Glucose 4% Sodium Chloride 0.18% infusion solution

Glucose 5% Sodium Chloride 0.45% infusion solution

Glucose 5% Sodium Chloride 0.9% infusion solution

Composition

Glucose (anhydrous) and Sodium Chloride in Water for Injections BP.

Chemical Structure/Molecular Formula

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

Molecular formulae of glucose and sodium chloride is C

, and NaCl, respectively.

DESCRIPTION

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

granular powder and freely soluble in water. Sodium chloride occurs as a colourless or

white crystal and is freely soluble in water.

Glucose and Sodium Chloride infusion solutions are sterile, nonpyrogenic solutions.

The concentrations of the active ingredients dissolved in a litre of Water for Injection are

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

contain an antimicrobial agent or added buffer, and have a pH of 3.5 - 6.5. They are

iso-osmotic as indicated by their osmolarity shown in Table 1 (see PRESENTATION

AND STORAGE CONDITIONS), except Glucose 5% Sodium Chloride 0.9% and

Glucose 5% Sodium 0.45% which are hypertonic solutions (with osmolarity of

586mOsmol/L and 432mOsmol/L, respectively).

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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 (for conversion to kJ units, see

Table 1 in PRESENTATION AND STORAGE CONDITIONS). 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.

Sodium is the major cation of extracellular fluid and functions principally in the control of

water distribution, fluid and electrolyte balance and osmotic pressure of body fluids.

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

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

characteristic of the cells.

Thus, Glucose and Sodium Chloride infusion solutions have value as a source of

water, electrolytes and energy.

Pharmacokinetics

As Glucose and Sodium Chloride infusion solution is directly administered to the

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

is complete (100%). Excess sodium is predominantly excreted by the kidney, with small

amounts lost in faeces and sweat.

INDICATIONS

Glucose and Sodium Chloride infusion solution is indicated for replenishing fluid

losses, as an energy source and for restoration or maintenance of sodium and chloride

ion concentrations. It may be used as a vehicle of medication delivery where

intravenous delivery is appropriate and the medicine is compatible with this solution.

CONTRAINDICATIONS

Glucose and Sodium Chloride infusion solutions are contraindicated in patients with

the following medical conditions:

know hypersensitivity to the product

known allergy to corn or corn products, because cornstarch is used as raw material

for glucose production

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cardiac failure including congestive heart failure

lactacidosis

uncontrolled diabetes

clinically significant hyperglycaemia

hyperkalaemia

severe impairment of renal function

bloating-ascitic syndrome in cirrhosis

acute ischaemic stroke

patients who have had a head trauma within 24 hours

patients presenting with a clinical state in which there exists oedema with sodium

retention, or with renal, hepatic or cardiac impairment with oedema, hypervolaemia,

hypernatraemia.

Glucose and Sodium Chloride infusion solutions containing ≤ 0.225% sodium chloride

are contraindicated in patients presenting with severe hyponatraemia.

PRECAUTIONS

General

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

Chloride infusion solution preparations has been confirmed in tests with animals

according to the USP biological tests for plastic container, as well as by tissue culture

toxicity studies. Nevertheless, care should be exercised regarding a possible

incompatibility outcomes resulted either from the interaction between the plastic

container or active ingredients and the added therapeutic substances (see also

DOSAGE AND ADMINISTRATION).

When used as a vehicle of intravenous medication delivery, the product information

document of these medicines must be examined to ensure compatibility with Glucose

and Sodium Chloride infusion solution.

In a dilute condition, osmolarity/L is approximately the same with osmolality/kg. As

shown in Table 1 (PRESENTATION AND STORAGE CONDITIONS), Glucose 5%

Sodium Chloride 0.9% and Glucose 5% Sodium 0.45% are hypertonic solutions (with

osmolarity of 586mOsmol/L and 432mOsmol/L, respectively), whilst the other strengths

are isotonic.

The administration of substantially hypertonic solution may lead to a wide variety of

complications. These include crenation (shrinkage) of red blood cells and general

cellular dehydration.

The administration of Glucose and Sodium Chloride infusion solution

n cause fluid

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

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over-hydration, congested states, or pulmonary 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. Thus, caution

must be exercised when administering Glucose and Sodium Chloride infusion solution

to patients with or at risk of:

hypernatraemia

hyperchloraemia

metabolic acidosis

hypervolaemia

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

peripheral), for example: hypertension, heart failure including congestive heart

failure, peripheral or pulmonary oedema, impaired renal function, pre-eclampsia or

other conditions associated with sodium retention.

Similarly, care should be exercised with the administration of these products to patients

receiving corticosteroids or corticotropin, because of a potential sodium and water

retention.

Patients receiving fluid replacement therapy should be monitored as fluid and electrolyte

disturbances such as hyponatraemia and hypokalaemia may occur. Excessive

administration of Glucose and Sodium Chloride infusion solution without addition of

potassium, may result in significant hypokalaemia. Prolonged therapy should be

monitored for changes in fluid balance, electrolyte concentration and acid-base balance.

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

serious neurologic complications). Dosage, rate and duration of administration should

be determined by a physician experienced in intravenous fluid therapy.

Glucose and Sodium Chloride infusion solution should be used with caution in

patients with thiamine deficiency, hypophosphataemia and diabetes mellitus (see

INTERACTIONS WITH OTHER MEDICINES).

Hypersensitivity Reactions

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

Glucose and Sodium Chloride infusion solution (see ADVERSE EFFECTS). If signs

or symptoms of hypersensitivity/infusion reactions develop, stop the infusion

immediately. Appropriate therapeutic countermeasures must be instituted as clinically

indicated.

Hyponatraemia

The infusion of solutions with sodium concentrations < 0.9% may result in

hyponatraemia, which may warrant close clinical monitoring. Hyponatraemia can lead

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to headache, nausea, seizures, lethargy, coma, cerebral oedema, and death, therefore

acute symptomatic hyponatraemic encephalopathy is considered a medical emergency.

The risk of hyponatraemia is increased in children, elderly patients, women,

postoperatively, in patients with psychogenic polydipsia and in patients treated with

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

psychotropic medications).

The risk of developing hyponatraemic encephalopathy is increased, for example, in

paediatric patients, women (in particular, premenopausal women), in patients with

hypoxemia and in patients with underlying central nervous system disease.

The infusion of hypotonic fluids together with the non-osmotic secretion of ADH may

also result in hyponatraemia.

Hypokalemia

The infusion of Glucose and Sodium Chloride infusion solution may result in

hypokalaemia. Glucose and Sodium Chloride infusion solution should be used with

particular caution in patients with or at risk of hypokalaemia, close clinical monitoring

may be warranted in patients with, but not limited to:

metabolic alkalosis

thyrotoxic periodic paralysis, administration of intravenous glucose has been

associated in aggravating hypokalaemia

increased gastrointestinal losses (e.g. diarrhoea, vomiting)

prolonged low potassium diet

primary hyperaldosteronism

medication and treatments that increase the risk of hypokalaemia (e.g. diuretics,

beta-2 agonist, or insulin).

Risk of Hypo-/Hyper-osmolality, Serum Electrolytes & 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 and Sodium Chloride infusion solution can cause:

hypoosmolality

hyperosmolality, osmotic diuresis and dehydration

electrolyte disturbances such as hyponatraemia, hypokalaemia, hypophosphataemia

and hypomagnesaemia

overhydration/hypervolaemia and congested states, including central (e.g.

pulmonary congestion) and peripheral oedema

an increase in serum glucose concentration is associated with an increase in serum

osmolality. Osmotic diuresis associated with hyperglycaemia can result in or

contribute to the development of dehydration and electrolyte losses.

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Clinical evaluation and periodic laboratory determinations may be necessary to monitor

changes to 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.

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, but not limited

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 (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 Glucose and Sodium Chloride infusion solution

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. Early hyperglycaemia has been

associated with poor outcomes in patients with severe traumatic brain injury.

Newborns (See PAEDIATRIC USE).

Prolonged intravenous administration of glucose and associated hyperglycaemia may

result in decreased rates of glucose-stimulated insulin secretion.

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.

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Use in Patients With or at Risk of Severe Renal Impairment

Glucose and Sodium Chloride infusion solution should be administered with particular

caution, to patients with or at risk of (severe) renal impairment. In such patients,

administration of Glucose and Sodium Chloride infusion solution may result in sodium

retention and/or fluid overload.

Blood

Glucose and Sodium Chloride infusion solution 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 plastic 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 (see DOSAGE AND

ADMINISTRATION).

Use in Pregnancy (Category C)

Animal reproduction studies have not been conducted with Glucose and Sodium

Chloride infusion solution. It is also not known whether these dosage forms can cause

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

Intrapartum maternal intravenous glucose infusion may result in foetal hyperglycaemia

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

production.

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

patient before administering Glucose and Sodium Chloride infusion solution.

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.

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Paediatric Use

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

risk of developing hypo- or hyperglycaemia 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, necrotising enterocolitits,

increased oxygen requirements, bronchopulmonary dysplasia, prolonged length of

hospital stay, and death.

Infants and children may have an impaired ability to regulate fluid and electrolytes.

Fluid replacement therapy (including plasma electrolyte concentrations) should be

closely monitored in these populations as fluid and electrolyte disturbances (such as

hyponatraemia and hypokalaemia) may occur.

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

hyponatraemia as well as developing hyponatraemic encephalopathy. For this reason,

intravenous infusions containing ≤0.225% sodium chloride are generally not

recommended for use in children. Hyponatraemia can lead to headache, nausea,

seizures, lethargy, coma, cerebral oedema, and death. Therefore, acute symptomatic

hyponatraemic encephalopathy is considered a medical emergency.

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

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

physician experienced in paediatric intravenous fluid therapy.

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 or concomitant medicines therapy.

Genotoxicity/Carcinogenicity

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

They are basic constituents in all living cells.

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INTERACTIONS WITH OTHER MEDICINES

Glucose and Sodium Chloride infusion solution should not be administered

simultaneously with blood preparation through the same administration set, because of

the possibility of pseudo-agglutination or haemolysis.

If using this solution to administer medicines, the Product Information document(s) of

such medicine(s) must be reviewed to ensure compatibility, including pH and ion

concentrations, with the solution.

Both the glycaemic effects of Glucose and Sodium Chloride infusion solution 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.

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

may be decreased during administration of Glucose and Sodium Chloride infusion

solution and can result in increased lithium levels.

ADVERSE EFFECTS

Adverse effects of sodium salts are attributable to electrolyte imbalances from excess

sodium. Retention of excess sodium in the body can lead to accumulation of

extracellular fluid to maintain normal plasma osmolality, which may result in pulmonary

and peripheral oedema with their consequent effects.

Hypernatraemia rarely occurs with therapeutic doses of sodium chloride, but may occur

after inappropriate intravenous administration of hypertonic saline. The most serious

consequence of this is dehydration of the brain causing somnolence and confusion,

progressing to convulsion, coma and ultimately respiratory failure and death. Other

symptoms include thirst, reduced salivation and lachrymation, fever, tachycardia,

hypertension, headache, dizziness, restlessness, weakness and irritability.

Metabolism and nutrition disorders: hyponatraemia, which could lead to death, have

been reported.

Adverse reactions which may occur because of the solution (e.g. contamination),

additive medicines or the technique of administration include fever response (due to

possible introduction of pyrogens), infection at the site of injection, local pain or reaction,

vein irritation, venous thrombosis or phlebitis extending from the site of injection,

extravasation and hypervolaemia.

Anaphylactic reactions, hypersensitivity and chills have also been reported.

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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. The nature of any additive should be considered

in the event of other undesirable effects.

Post-Marketing Adverse Reactions

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

listed by MedDRA System Organ Class (SOC), then where feasible, by Preferred Term

in order of severity.

IMMUNE SYSTEM DISORDERS: Anaphylactic reaction, Hypersensitivity

METABOLISM AND NUTRITION DISORDERS: Hyponatraemia, Hyperglycaemia

VASCULAR DISORDERS: Phlebitis

SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Rash, Pruritus

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Injection site

reactions including, Infusion site pain, Injection site vesicles, Chills, Pyrexia.

Other Adverse Reactions (Class Reactions)

Other adverse reactions reported with isotonic saline and glucose injection/infusions

include:

hyponatraemia, which may be symptomatic

acidosis hyperchloraemic.

DOSAGE AND ADMINISTRATION

General Directive

To be used only as directed by the physician. The dosage of Glucose and Sodium

Chloride infusion solution is dependent upon the age, weight, clinical condition of the

patient, laboratory determinations and concomitant therapy. For patients with

electrolyte and glucose abnormalities and for paediatric patients, consult a physician

experienced in intravenous fluid therapy. 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.

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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 Glucose and Sodium Chloride infusion solution

unless the solution is clear, colourless and free of particles, and the seals are intact.

Sterile and nonpyrogenic equipment must be used for intravenous administration. The

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

the residual air in the system. Use of an in-line filter is recommended during

administration of all parenteral solutions.

Additives may be introduced before infusion or during infusion through the injection site.

Additives may be incompatible. Check relevant literature for additive, solution and

container compatibility prior to use. Complete information is not available. Those

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

available.

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

Glucose and Sodium Chloride infusion solution and the pH range of Glucose and

Sodium Chloride infusion solution is appropriate.

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

additives, aseptic technique must be used. Mix thoroughly and carefully when additives

have been introduced. After addition, check for a possible colour change and/or the

appearance of precipitates, insoluble complexes or crystals. Do not store solutions

containing additives.

The product should be used once only. Any unused portion should be discarded. Do

not reconnect partially used bags.

The osmolarity of a final admixed solution must be taken into account when peripheral

administration is considered (see Table 1 PRESENTATION AND STORAGE

CONDITIONS for the products’ osmolarity). Hyperosmolar solutions may cause venous

irritation and phlebitis. Thus, any hyperosmolar solutions are recommended to be

administered through a large central vein, for rapid dilution of the hypertonic solution. If

hypertonic solutions are administered peripherally, a large arm vein should be used and,

if possible, the injection site should be altered daily. Rapid infusion in peripheral arm

veins may be harmful.

Directions 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.

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Vented intravenous administration sets with the vent open, or pressurizing 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.

Therefore, vented intravenous administration sets with the vent in the open position

should not be used with flexible containers.

To open

Tear over-wrap down side at slit and remove solution container.

Check solution for limpidity and absence of foreign matter. If solution is not clear or

contains foreign matter, discard the solution. Some opacity of the Viaflex plastic

container 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, use an aseptic method to set up the infusion.

To add medication

Additives may be incompatible. Check the Product Information Document(s) of the

medication(s) prior to their addition to Glucose and Sodium Chloride infusion solution.

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

in use position, re-open the clamp and continue administration.

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OVERDOSAGE

Overdosage with Glucose and Sodium Chloride infusion solution can cause:

hyperglycaemia, adverse effects on water and electrolyte balance, and

corresponding complications. For example, severe hyperglycaemia and severe

dilutional hyponatraemia, and their complications can be fatal

hyponatraemia, which can lead to CNS manifestations (including seizures, coma,

cerebral oedema and death)

hypernatraemia especially in patients with severe renal impairment. Retention of

excess sodium when there is defective renal sodium excretion may result in

pulmonary and peripheral oedema. The most serious effect of hypernatraemia is

dehydration of the brain which causes somnolence and confusion progressing to

convulsions, coma, respiratory failure and death. Other symptoms include thirst,

reduced salivation and lacrimation, fever, tachycardia, headache, dizziness,

restlessness, irritability and weakness

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

Excessive administration of chloride salts may cause a loss of bicarbonate with an

acidifying effect.

Prolonged or rapid administration of large volumes of isotonic solutions may cause

oedema or water intoxication. Prolonged or rapid administration of hypertonic solutions

containing glucose may result in dehydration as a consequence of the induced

hyperglycaemia.

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

Clinically significant overdose of Glucose and Sodium Chloride infusion solution may

therefore constitute a medical emergency. Interventions include discontinuation of

Glucose and Sodium Chloride infusion solution administration, dose reduction,

administration of insulin and other measures as indicated for the specific clinical group.

For information on the management of overdose, contact the Poisons Information

Centre on 131126 (Australia) or 0800 764 766 [0800 POISON] in New Zealand.

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PRESENTATION AND STORAGE CONDITIONS

Glucose and Sodium Chloride infusion solution dosage forms are supplied in Viaflex

plastic bags as shown in Table 1.

Table 1: Glucose and Sodium Chloride infusion solution preparations

Code No.

Product

Osmolarity

α

(mOsmol/L)

TT50-

Pack

S

ize*

(m

L

)

AHB1023

Glucose 2.5% Sodium Chloride 0.45%

Infusion solution, 500mL

[209kJ/500mL]

5535

AHB1253

Glucose 4% Sodium Chloride 0.18%

Infusion solution, 500mL

[334kJ/500mL]

5535/1

AHB1254

Glucose 4% Sodium Chloride 0.18%

Infusion solution, 1000mL

[668kJ/L]

5535/1

1000

AHB6028

Glucose 5% Sodium Chloride 0.45%

Infusion solution, 1000mL

[835kJ/L]

1433/2

1000

AHB1064

Glucose 5% Sodium Chloride 0.9%

Infusion solution, 1000mL

[835kJ/L]

5535/2

1000

Note: Osmolarities

(mOsmol/L) are calculated figures which equate to the approximate Osmolalities

(mOsmol/kg); AHB1064 and AHB6028 are hypertonic solutions as indicated by the osmolarities of

586mOsmol/L and 432mOsmol/L, respectively.

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

* Not all packs are marketed.

Storage

Exposure of the products to heat should be minimised.

Avoid excessive heat. It is recommended that the products be stored at or below 30°C.

MEDICINE CLASSIFICATION

General Sale Medicine.

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NAME AND ADDRESS

Glucose and Sodium Chloride infusion solutions are distributed in New Zealand by:

Baxter Healthcare Ltd

33 Vestey Drive

Mt Wellington

Auckland 1060

Glucose and Sodium Chloride infusion solutions are distributed in Australia by:

Baxter Healthcare Pty Ltd

1 Baxter Drive

Old Toongabbie

NSW 2146

DATE OF PREPARATION

26 October 2015

Based on Australian PI most recent amendment 10 February 2015; and CCSI43720140821 &

CCSI43820140821.

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

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

1-11-2018

Meer regie voor patiënt in medisch dossier GGZ

Meer regie voor patiënt in medisch dossier GGZ

Staatssecretaris Paul Blokhuis (VWS) stelt €45 miljoen beschikbaar voor betere gegevensuitwisseling in de geestelijke gezondheidszorg, meer medicatieveiligheid en betere beschikbaarheid van e-health. Als gegevens gestandaardiseerd worden uitgewisseld kan de patiënt veiliger en makkelijker over zijn gegevens beschikken. Daarmee is de patiënt eigenaar van de gegevens en in staat meer regie te hebben. De patiënt bepaalt welke gegevens hij deelt en welke zorgaanbieder die gegevens krijgt.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

9-10-2018

La FDA aprueba el uso ampliado de Gardasil 9 para incluir a personas de 27 a 45 años de edad

La FDA aprueba el uso ampliado de Gardasil 9 para incluir a personas de 27 a 45 años de edad

La FDA aprueba el uso ampliado de Gardasil 9 para incluir a personas de 27 a 45 años de edad

FDA - U.S. Food and Drug Administration

5-10-2018

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA - U.S. Food and Drug Administration

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

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

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

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

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

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

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

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

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

7-12-2018

Olanzapine Mylan (Mylan S.A.S.)

Olanzapine Mylan (Mylan S.A.S.)

Olanzapine Mylan (Active substance: Olanzapine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7622 of Fri, 07 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/961/T/45

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

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

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

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): 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

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): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

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

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

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

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

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

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

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

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