GLUCOSE 5 % INTRAVENOUS INFUSION BP

לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה

עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור

ןכדועמ( ןכדועמ( ןכדועמ(

.102.50

.102.50

.102.50

ךיראת

.102.30

תילגנאב רישכת םש

םושירה רפסמו

Glucose 5% Intravenous Infusion BP (Viaflo®)

140 24 30797 00 ; 140 24 30797 01; 134 06 31397 00

םושירה לעב םש

Teva Medical (Marketing) Ltd., Haorgim St 8, Ashdod 77100

ה טורפל דעוימ הז ספוט דבלב תורמחה

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

Pharmaceutical

Form

Solution for infusion.

Clear solution, free from visible particles

Solution for infusion.

Clear solution, free from visible particles.

Osmolarity : 278 mOsm/l (approx.)

pH : 3.5 – 6.5

I

ndication

Posology,

dosage &

administration

When additive is used, verify isotonicity prior to

parenteral

administration.

Thorough

careful

aseptic

mixing

additive

mandatory.

Solutions

containing

additives

should

used

immediately and not stored.

Glucose 5% intravenous infusion is an isosmotic solution.

Please see section 3 for the information about the osmolarity

of the solution.

Precautions to be taken before handling or administering the

medicinal product

Parenteral drug products should be inspected visually for

particulate matter and discoloration prior to administration,

whenever solution and container permit.

Electrolyte supplementation may be indicated according to

the clinical needs of the patient.

When introducing additives, the final osmolarity of solutions

need

checked.

Administration

hyperosmolar

solutions

cause

venous

irritation

phlebitis.

Thorough

careful

aseptic

mixing

additive

mandatory. Solutions containing additives should be used

immediately and not stored.

Please see section 4.4 for the risk of air embolism

Contra-

indications

Hypersensitivity to the active substance. See sections 4.4 and

4.8 for corn allergies.

Special

Warnings and

Special

Precautions for

Use

Dilution and other effects on serum electrolytes

Depending on the volume and rate of infusion and depending

on a patient’s underlying clinical condition and capability to

metabolize glucose, intravenous administration of glucose

can cause:

Hyperosmolality, osmotic diuresis and dehydration

Hypoosmolality

Electrolyte disturbances such as

hyponatraemia (see below),

hypokalaemia,

hypophosphataemia,

hypomagnesaemia,

overhydration/hypervolaemia

and,

example,

congested

states,

including

pulmonary congestion and oedema.

The above effects do not only result from the administration

of electrolyte-free fluid but also from glucose administration.

Hyponatraemia

develop

into

acute

hyponatraemic

encephalopathy characterized by headache, nausea, seizures,

lethargy, coma, cerebral oedema, and death.

Children, the elderly, women, postoperative patients, patients

with hypoxia and patients with central nervous system

disease or psychogenic polydipsia are at particular risk for

this complication.

Clinical evaluation and periodic laboratory determinations

necessary

monitor

changes

fluid

balance,

electrolyte

concentrations,

acid-base

balance

during

prolonged parenteral therapy or whenever the condition of

patient

rate

administration

warrants

such

evaluation.

Particular caution is advised in patients at increased risk of

water and electrolyte disturbances that could be aggravated

by increased free water load, hyperglycaemia or possibly

required insulin administration (see below).

Hyperglycaemia

Rapid administration of glucose solutions may produce

substantial

hyperglycemia

hyperosmolar

syndrome.

If hyperglycaemia occurs, rate of infusion should be

adjusted and/or insulin administered

necessary,

provide

parenteral

supplements

potassium.

Intravenous Glucose 5% should be administered with

caution in patients with, for example:

impaired

glucose tolerance (such as in

diabetes

mellitus, renal failure, or in the presence of

sepsis, trauma, or shock),

severe

malnutrition

(risk

precipitating

refeeding syndrome – see below),

thiamine deficiency, e.g., in patients with chronic

alcoholism (risk of severe lactic acidosis due to

impaired oxidative metabolization of pyruvate),

patients

with

ischemic

stroke

severe

traumatic brain injury

Avoid

infusion

within

first

hours

following head trauma. Monitor blood glucose

closely

early

hyperglycaemia

been

associated with poor outcomes in patients with

severe traumatic brain injury.

newborns

Effects on Insulin Secretion

Prolonged

intravenous

administration

glucose

associated hyperglycaemia may result in decreased rates of

glucose-stimulated insulin secretion.

Hypersensitivity Reactions

Hypersensitivity/infusion

reactions,

including

anaphylactic/anaphylactoid

reactions,

have

been

reported

with

Glucose

solutions

(see

section

4.8).

Solutions

containing

glucose

should

used

with

caution, if at all, in patients with known allergy to corn

or corn products. (see section 4.8).

The infusion must be stopped immediately if any signs

or symptoms of a suspected hypersensitivity reaction

develop. Appropriate therapeutic countermeasures must

be instituted as clinically indicated.

Refeeding syndrome

Refeeding severely undernourished patients may result

in the refeeding syndrome that is characterized by the

shift

potassium,

phosphorus,

magnesium

intracellularly

patient

becomes

anabolic.

Thiamine

deficiency

fluid

retention

also

develop.

Careful

monitoring

slowly

increasing

nutrient intakes while avoiding overfeeding can prevent

these complications.

Paediatric population

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 consulting physician

experienced in paediatric intravenous fluid therapy.

In order to avoid potentially fatal over infusion of intravenous

fluids to the neonate, special attention needs to be paid to the

method of administration. When using a syringe pump to

administer intravenous fluids or medicines to neonates, a bag

of fluid should not be left connected to the syringe.

When using an infusion pump all clamps on the intravenous

administration

must

closed

before

removing

administration set from the pump or switching the pump off.

This is required regardless of whether the administration set

has an anti free flow device.

intravenous

infusion

device

administration

equipment must be frequently monitored.

Paediatric hyponatraemia-related issues

Children (including neonates and older children) are at

increased

risk

developing

hypoosmotic

hyponatraemia as well as for developing hyponatraemic

encephalopathy.

Plasma

electrolyte

concentrations

should

closely

monitored in the paediatric population.

Rapid

correction

hypoosmotic

hyponataremia

potentially

dangerous

(risk

serious

neurologic

complications).

Dosage,

rate,

duration

administration

should

determined

physician

experienced in paediatric intravenous fluid therapy.

Geriatric Use

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,

other

diseases

concomitant drug therapy.

Blood

Glucose 5% (an aqueous, i.e., electrolyte-free glucose

solution) should not be administered simultaneously

with, before or after an administration of blood through

the same infusion equipment, because haemolysis and

pseudoagglutination can occur.

Adding other medication or using an incorrect administration

technique might cause the appearance of fever reactions due

to the possible introduction of pyrogens. In case of adverse

reaction, infusion must be stopped immediately.

Risk of Air Embolism

Do not use plastic containers in series connections. Such

use could result in air embolism due to residual air being

drawn from the primary container before the

administration of the fluid from the secondary container

is completed.

Pressurizing 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.

Interaction

with Other

Medicaments

and Other

Forms of Inter-

action

Concomitant administration of catecholamines and

steroids decreases the glucose up-take.

Both the glycaemic effects of Glucose 5% and its effects on

water and electrolyte balance should be taken into account

when

using

Glucose

patients

treated

with

other

substances

that

affect

glycaemic

control,

fluid

and/or

electrolyte balance.

Concomitant administration of catecholamines and steroids

decreases the glucose up-take.

No interaction studies have been performed.

Fertility,

Pregnancy and

Lactation

Glucose solutions are commonly employed during

pregnancy as hydrating fluids and as vehicles for the

administration

other

drugs

(particularly

oxytocin).

There

indications

adverse

effects

progeny by use of Glucose 5% Intravenous Infusion

during pregnancy, labour and lactation.

When a medicinal product is added, the nature of the drug

and its use during pregnancy and lactation have to be

considered separately.

Intrapartum maternal intravenous glucose infusion may result

in foetal insulin production, with an associated risk of foetal

hyperglycaemia and metabolic acidosis as well as rebound

hypoglycaemia in the neonate.

Pregnancy

Glucose solution can be used during pregnancy. However,

caution should be exercised when glucose solution is used

intrapartum.

Fertility

There are no adequate data of the effect of Glucose 5% on

fertility. However, no effect on fertility is expected.

Lactation

There are no adequate data of using Glucose solution during

lactation.

However,

effect

lactation

expected.

Glucose 5% can be used during lactation.

Adverse events

Tabulated list

of adverse

reactions

System Organ

Class

Adverse

reaction

(MedDRA term)

Frequency

General

disorders and

administration

site conditions

Chills*

Pyrexia*

Infusion site

infection

Infusion site

irritation

Extravasation

Local reaction

Pain localised

Not known

Adverse

reactions

associated

with

medicinal product added to the solution; the nature

of the additive will determine the likelihood of any

other undesirable effects.

In case of undesirable effect(s), the infusion must be

discontinued.

Tabulated list

of adverse

reactions

System Organ

Class

Adverse

reaction

(MedDRA term)

Frequency

Skin and

subcutaneous

tissue disorder

Rash

Not known

General

disorders and

administration

site conditions

Chills*

Pyrexia*

Infusion site

infection

Infusion site

irritation for

example

erythema

Extravasation

Local reaction

Pain localised

Not known

Adverse

reactions

associated

with

medicinal

product added to the solution; the nature of the additive will

determine the likelihood of any other undesirable effects.

case

undesirable

effect(s),

infusion

must

discontinued.

Other

adverse

reactions

reported

with

glucose

injection/infusions include:

Hyponatremia, which may be symptomatic

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of

the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal

product

Any suspected adverse events should be reported to

the Ministry of Health according to the National Regulation

by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.

aspx?formType=AdversEffectMedic@moh.gov.il

Overdosage

Prolonged administration or rapid infusion of large

volumes

glucose

solution

cause

hyperosmolarity,

dehydration,

hyperglycaemia,

hyperglycosuria,

osmotic

diuresis

(due

hyperglycaemia). Prolonged administration or rapid

infusion may create a fluid inflation with oedema or

water intoxication (with hyponatremia).

The signs and symptoms of over infusion will be

related to the nature of the additive being used. In

event

accidental

over

infusion,

treatment

should be discontinued and the patient should be

observed for the appropriate signs and symptoms

related

drug

administered.

relevant

symptomatic

supportive

measures

should

provided as necessary.

Prolonged administration or rapid infusion of large volumes

Glucose

cause

hyperosmolarity

hyponatraemia,

dehydration,

hyperglycaemia,

hyperglycosuria,

osmotic

diuresis

(due

hyperglycaemia) and water intoxication and oedema. Severe

hyperglycaemia

hyponatraemia,

fatal

(see

sections 4.4 and 4.8).

In case of suspected overdose, treatment with Glucose 5%

must be stopped immediately. Management of overdose is

symptomatic and supportive, with appropriate monitoring

Pharmaco-

dynamic

Properties

Pharmacotherapeutic group: “Other IV Solution

Additives”

ATC code: B05XX

The pharmacodynamic properties of this solution are

those of glucose, which forms the principal source of

energy in cellular metabolism. Glucose is given as a

source of carbohydrate in parenteral nutrition. The

Glucose 5% solution provides a caloric intake of 200

kcal/l.

Furthermore,

this

glucose

solution

infusion

allows

hydric

supplementation

without

ionic supplementation.

Glucose

intravenous

infusion

isotonic

solution,

with

approximate

osmolarity

278 mOsm/l.

The pharmacodynamics of the additive will depend

on the nature of the drug used.

Pharmacotherapeutic group: “Other IV Solution Additives”

ATC code: B05BA03

The pharmacodynamic properties of this solution are those of

glucose,

which

forms

principal

source

energy

cellular metabolism. Glucose 5% is given as a source of

carbohydrate

parenteral

nutrition.

Glucose

solution provides a caloric intake of 200 kcal/l. Furthermore,

this

glucose

solution

infusion

allows

hydric

supplementation without ionic supplementation.

Glucose 5% is an isosmotic solution, with an approximate

osmolarity of 278 mOsm/l.

The pharmacodynamics of the additive will depend on the

nature of the drug used.

Nature of

contents of

container

Pack sizes:

50 bags of 50 ml per carton

Pack sizes:

50 bags of 50 ml per carton

75 bags of 50 ml per carton

Special

Precautions for

Disposal and

Other

Handling

Advice

Discard after single use.

Discard any unused portion.

Do not reconnect partially used bags.

Do not remove unit from overwrap until

ready for use. The inner bag maintains

the sterility of the product.

Discard after single use.

Discard any unused portion.

Do not store solutions containing additives.

Do not reconnect partially used bags.

Do not remove unit from overwrap until ready for

use. The inner bag maintains the sterility of the

product.

When

introducing

additives

to

Glucose

5%

solution aseptic technique must be used.

Mix the solution thoroughly when additives have

been introduced.

GLUCOSE 5% IV Infusion Viaflo .02.2018 ME

."רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ"

ץרמ :רשואמ ןולע

2017

“This leaflet format has been determined by the Ministry of Health and the content thereof has been

checked and approved.” Date of approval: March 2017.

Glucose 5% Intravenous Infusion BP

(Viaflo® Container)

Summary of Product Characteristics

GLUCOSE 5% IV Infusion Viaflo .02.2018 ME

1.

NAME OF THE MEDICINAL PRODUCT

Glucose 5% Intravenous Infusion BP

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Glucose (as monohydrate): 50.0 g/l

Each ml contains 50 mg glucose (as monohydrate)

Approximately 840 kJ/l (or 200 kcal/l)

For the full list of excipients : see 6.1

3.

PHARMACEUTICAL FORM

Solution for infusion.

Clear solution, free from visible particles.

Osmolarity : 278 mOsm/l (approx.)

pH : 3.5 – 6.5

4.

CLINICAL PARTICULARS

4.1.

T

HERAPEUTIC INDICATIONS

Glucose 5% is indicated for the treatment of carbohydrate and fluid depletion.

Glucose 5% is also used as a vehicle and diluent for compatible medicinal products for parenteral

administration.

4.2.

P

OSOLOGY AND

M

ETHOD OF

A

DMINISTRATION

Posology

Adults, the Elderly and Children :

The concentration and dosage of glucose solution for intravenous use is determined by several factors

including the age, weight, and clinical condition of the patient. Serum-glucose concentrations may

need to be carefully monitored.

The recommended dosage for treatment of carbohydrate and fluid depletion is:

- for adults : 500 ml to 3 litres / 24h

- for babies and children :

- 0-10 kg body weight:

100 ml/kg/24 h.

- 10-20 kg body weight:

1000 ml + 50 ml /kg over 10 kg / 24 h.

- > 20 kg body weight :

1500 ml + 20 ml / kg over 20 kg / 24 h.

The infusion rate depends on the patient's clinical condition.

Infusion

rate

should

exceed

patient’s

glucose

oxidation

capacities

order

avoid

hyperglycaemia.

Therefore,

maximum

dose

ranges

from

5mg/kg/min

adults

10-18

mg/kg/min for babies and children depending on the age and the total body mass.

The recommended dosage when used as a vehicle or diluent ranges from 50 to 250 ml per dose of

medicinal product to be administered.

When Glucose 5% is used as a diluent for injectable preparations of other drugs, the dosage and the

infusion rate will be principally dictated by the nature and the dose regimen of the prescribed drug.

GLUCOSE 5% IV Infusion Viaflo .02.2018 ME

Paediatric population

The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the

patient, concomitant therapy and should be determined by the consulting physician experienced in

paediatric intravenous fluid therapy.

Method of Administration:

The solution is for administration by intravenous infusion (peripheral or central vein).

When the solution is used for dilution and delivery of therapeutic additives for administration by

intravenous infusion, the

direction

with additive therapeutic substances will dictate the

appropriate volumes for each therapy.

Glucose 5% intravenous infusion is an isosmotic solution.

Please see section 3 for the information about the osmolarity of the solution.

Precautions to be taken before handling or administering the medicinal product

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit. Use only if the solution is clear, without

visible particles and the container is undamaged. Administer immediately following the insertion of

infusion set.

The solution should be administered with sterile equipment using aseptic technique. The equipment

should be primed with the solution in order to prevent air entering the system.

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

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

When introducing additives, the final osmolarity of solutions need to be checked. Administration of

hyperosmolar solutions may cause venous irritation and phlebitis. Thorough and careful aseptic

mixing of any additive is mandatory. Solutions containing additives should be used immediately and

not stored.

Please see section 4.4 for the risk of air embolism.

4.3.

C

ONTRA

-

INDICATIONS

The solution is contraindicated in case of uncompensated diabetes, other known glucose intolerances

(such as metabolic stress situations), hyperosmolar coma, hyperglycaemia, hyperlactatemia.

Hypersensitivity to the active substance. See sections 4.4 and 4.8 for corn allergies.

4.4.

S

PECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Dilution and other effects on serum electrolytes

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

condition and capability to metabolize glucose, intravenous administration of glucose can cause:

Hyperosmolality, osmotic diuresis and dehydration

Hypoosmolality

Electrolyte disturbances such as

hyponatraemia (see below),

hypokalaemia,

hypophosphataemia,

GLUCOSE 5% IV Infusion Viaflo .02.2018 ME

hypomagnesaemia,

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

congestion and oedema.

The above effects do not only result from the administration of electrolyte-free fluid but also from

glucose administration.

Hyponatraemia can develop into acute hyponatraemic encephalopathy characterized by headache,

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

Children, the elderly, women, postoperative patients, patients with hypoxia and patients with central

nervous system disease or psychogenic polydipsia are at particular risk for this complication.

Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in

fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or

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

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

could be aggravated by increased free water load, hyperglycaemia

or possibly required insulin

administration (see below).

Hyperglycaemia

Rapid

administration

glucose

solutions

produce

substantial

hyperglycemia

hyperosmolar syndrome.

If hyperglycaemia occurs, rate of infusion should be adjusted and/or insulin administered

If necessary, provide parenteral supplements in potassium.

Intravenous Glucose 5% should be administered with caution in patients with, for example:

impaired glucose tolerance (such as in diabetes mellitus, renal failure, or in the presence of

sepsis, trauma, or shock),

severe malnutrition (risk of precipitating a refeeding syndrome – see below),

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

due to impaired oxidative metabolization of pyruvate),

patients with ischemic stroke or severe traumatic brain injury

Avoid infusion within the first 24 hours following head trauma. Monitor blood glucose

closely as early hyperglycaemia has been associated with poor outcomes in patients with

severe traumatic brain injury.

newborns

Effects on Insulin Secretion

Prolonged

intravenous

administration

glucose

associated

hyperglycaemia

result

decreased rates of glucose-stimulated insulin secretion.

Hypersensitivity Reactions

Hypersensitivity/infusion reactions, including anaphylactic/anaphylactoid reactions, have been

reported with Glucose solutions (see section 4.8). Solutions containing glucose should be used

with caution, if at all, in patients with known allergy to corn or corn products. (see section 4.8).

infusion

must

stopped

immediately

signs

symptoms

suspected

hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as

clinically indicated.

Refeeding syndrome

Refeeding

severely

undernourished

patients

result

refeeding

syndrome

that

characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient

becomes anabolic. Thiamine deficiency and fluid retention may also develop. Careful monitoring

GLUCOSE 5% IV Infusion Viaflo .02.2018 ME

slowly

increasing

nutrient

intakes

while

avoiding

overfeeding

prevent

these

complications.

Paediatric population

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 consulting physician experienced in

paediatric intravenous fluid therapy.

In order to avoid potentially fatal over infusion of intravenous fluids to the neonate, special attention

needs

paid

method of

administration. When

using

syringe pump to

administer

intravenous fluids or medicines to neonates, a bag of fluid should not be left connected to the syringe.

When using an infusion pump all clamps on the intravenous administration set must be closed before

removing the administration set from the pump or switching the pump off. This is required regardless

of whether the administration set has an anti free flow device.

The intravenous infusion device and administration equipment must be frequently monitored.

Paediatric glycaemia-related issues

Newborns – 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 newborn can cause prolonged seizures, coma and cerebral

injury. Hyperglycaemia has been associated with intraventricular haemorrhage, late onset bacterial and

fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia,

prolonged length of hospital stay, and death.

Paediatric hyponatraemia-related issues

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

hyponatraemia as well as for developing hyponatraemic encephalopathy.

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

Rapid

correction

hypoosmotic

hyponataremia

potentially

dangerous

(risk

serious

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

physician experienced in paediatric intravenous fluid therapy.

Geriatric Use

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 drug therapy.

Blood

Glucose 5% (an aqueous, i.e., electrolyte-free glucose solution) should not be administered

simultaneously

with,

before

after

an administration

of blood through the same infusion

equipment, because haemolysis and pseudoagglutination can occur.

Adding other medication or using an incorrect administration technique might cause the appearance of

fever reactions due to the possible introduction of pyrogens. In case of adverse reaction, infusion must

be stopped immediately.

GLUCOSE 5% IV Infusion Viaflo .02.2018 ME

Risk of Air Embolism

Do not use plastic containers in series connections. Such use could result in air embolism due to

residual air being drawn from the primary container before the administration of the fluid from the

secondary container is completed.

Pressurizing 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.

4.5.

I

NTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION

Both the glycaemic effects of Glucose 5% and its effects on water and electrolyte balance should be

taken into account when using Glucose 5% in patients treated with other substances that affect

glycaemic control, or fluid and/or electrolyte balance.

Concomitant administration of catecholamines and steroids decreases the glucose up-take.

No interaction studies have been performed.

4.6.

F

ERTILITY

,

PREGNANCY AND LACTATION

When a medicinal product is added, the nature of the drug and its use during pregnancy and lactation

have to be considered separately.

Intrapartum maternal intravenous glucose infusion may result in foetal insulin production, with an

associated risk of foetal hyperglycaemia and metabolic acidosis as well as rebound hypoglycaemia in

the neonate.

Pregnancy

Glucose solution can be used during pregnancy. However, caution should be exercised when glucose

solution is used intrapartum.

Fertility

There are no adequate data of the effect of Glucose 5% on fertility. However, no effect on fertility is

expected.

Lactation

There are no adequate data of using Glucose solution during lactation. However, no effect on lactation

is expected. Glucose 5% can be used during lactation.

4.7.

E

FFECTS ON THE ABILITY TO DRIVE AND USE MACHINES

None known.

4.8.

U

NDESIRABLE EFFECTS

Undesirable effects which occurred in patients treated with Glucose 5% from the post-marketing

experience are tabulated below.

The adverse drug reactions listed in this section are given following the recommended frequency

convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100);

GLUCOSE 5% IV Infusion Viaflo .02.2018 ME

rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the

available data).

Tabulated list of adverse reactions

System Organ Class

Adverse reaction (MedDRA term)

Frequency

Immune system disorders

Anaphylactic reaction*

Hypersensitivity*

Not known

Metabolism and nutrition

disorders

Electrolyte imbalance

Hypokalaemia

Hypomagnesaemia

Hypophosphatemia

Hyperglycaemia

Dehydration

Hypervolaemia

Not known

Skin and subcutaneous

tissue disorders

Rash

Not known

Vascular disorders

Venous thrombosis

Phlebitis

Not known

Renal and urinary disorders

Polyuria

Not known

General disorders and

administration site

conditions

Chills*

Pyrexia*

Infusion site infection

Infusion

site

irritation

example

erythema

Extravasation

Local reaction

Pain localised

Not known

*Potential manifestation in patients with allergy to corn, see section 4.4

Other adverse reactions reported with glucose injection/infusions include:

Hyponatremia, which may be symptomatic

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product

Any suspected

adverse events should be reported to the Ministry of Health according to the National Regulation by

using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il.

4.9.

O

VERDOSE

Prolonged

administration

rapid

infusion

large

volumes

Glucose

cause

hyperosmolarity and hyponatraemia, dehydration, hyperglycaemia, hyperglycosuria, osmotic diuresis

(due

to the hyperglycaemia) and

water

intoxication

oedema.

Severe

hyperglycaemia

hyponatraemia, may be fatal (see sections 4.4 and 4.8).

In case of suspected overdose, treatment with Glucose 5% must be stopped immediately. Management

of overdose is symptomatic and supportive, with appropriate monitoring.

GLUCOSE 5% IV Infusion Viaflo .02.2018 ME

5.

PHARMACOLOGICAL PROPERTIES

5.1.

P

HARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: “Other IV Solution Additives”

ATC code: B05BA03

The pharmacodynamic properties of this solution are those of glucose, which forms the principal

source of energy in cellular metabolism. Glucose 5% is given as a source of carbohydrate in parenteral

nutrition. The Glucose 5% solution provides a caloric intake of 200 kcal/l. Furthermore, this glucose

solution for infusion allows hydric supplementation without ionic supplementation.

Glucose 5% is a isosmotic solution, with an approximate osmolarity of 278 mOsm/l.

The pharmacodynamics of the additive will depend on the nature of the drug used.

5.2.

P

HARMACOKINETIC PROPERTIES

Glucose is metabolized via pyruvic or lactic acid to carbon dioxide and water with the release of

energy.

The pharmacokinetics of the additive will depend on the nature of the drug used.

5.3.

P

RECLINICAL SAFETY DATA

The safety of glucose in animals is not relevant in view of its presence as a normal component in

animal and human plasma.

The safety of the additive should be considered separately.

6.

PHARMACEUTICALS PARTICULARS

6.1.

L

IST OF EXCIPIENTS

Water for Injections.

6.2.

I

NCOMPATIBILITIES

As with all parenteral solutions compatibility of the additives with the solution must be assessed

before addition.

It is the responsibility of the physician to judge the incompatibility of an additive medication

with the Glucose 5% solution by checking for eventual color change and/or eventual precipitate,

insoluble complexes or crystals apparition. The Instructions for Use of the medication to be

added must be consulted.

Before adding a drug, verify if it is soluble and stable in water at the pH of Glucose 5%.

When a compatible medication is added to the Glucose5%, the solution must be administered

immediately.

Those additives known to be incompatible should not be used.

6.3

IN USE SHELF LIFE

In-use shelf life: Additives.

Chemical and physical stability of any additive at the pH of Glucose 5% in the Viaflo container

should be established prior to use.

GLUCOSE 5% IV Infusion Viaflo .02.2018 ME

From a microbiological point of view, the diluted product must be used immediately unless

dilution has taken place in controlled and validated aseptic conditions. If not used immediately,

in-use storage times and conditions are the responsibility of the user.

6.4

SPECIAL PRECAUTIONS FOR STORAGE

50 mL, 100 mL bags: Do not store above 30

250 mL, 500 mL, 1000 mL bags: This medicinal product does not require any special storage

conditions.

6.5

NATURE

AND

CONTENTS

OF

CONTAINERS

Bag sizes: 50, 100, 250, 500 or 1000mL .

The bags known as Viaflo are composed of polyolefin/polyamide co-extruded plastic (PL-

2442).

bags

overwrapped

with

protective

plastic

pouch

composed

polyamide/polypropylene.

Outer carton contents:

50 bags of 50 ml per carton

75 bags of 50 ml per carton

50 bags of 100 ml per carton

60 bags of 100 ml per carton

30 bags of 250 ml per carton

20 bags of 500 ml per carton

10 bags of 1000 ml per carton

Not all pack size may be marketed.

6.6

S

PECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

Discard after single use.

Discard any unused portion.

Do not store solutions containing additives.

Do not reconnect partially used bags.

Do not remove unit from overwrap until ready for use. The inner bag maintains the

sterility of the product.

When introducing additives to Glucose 5% solution aseptic technique must be used.

Mix the solution thoroughly when additives have been introduced.

1. Opening

Remove the Viaflo container from the overpouch just before use.

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

solution, as sterility may be impaired.

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

contains foreign matters, discard the solution.

Preparation for administration

Use sterile material for preparation and administration.

Suspend container from eyelet support.

GLUCOSE 5% IV Infusion Viaflo .02.2018 ME

b. Remove plastic protector from outlet port at bottom of container:

grip the small wing on the neck of the port with one hand,

grip the large wing on the cap with the other hand and twist,

the cap will pop off.

Use an aseptic method to set up the infusion

d. Attach administration set. Refer to complete directions accompanying set for connection,

priming of the set and administration of the solution.

Techniques for injection of additive medications

Warning: Additives may be incompatible.

To add medication before administration

Disinfect medication site.

b. Using

syringe

with

gauge

(1.10mm)

gauge

(0.70

needle,

puncture

resealable medication port and inject.

Mix solution and medication thoroughly. For high-density medication such as potassium

chloride, tap the ports gently while ports are upright and mix.

Caution: Do not store bags containing added medications.

To add medication during administration

Close clamp on the set.

b. Disinfect medication site.

Using syringe with 19

gauge

(1.10mm) to 22 gauge (0.70

mm) needle, puncture

resealable medication port and inject.

d. Remove container from IV pole and/or turn to an upright position.

Evacuate both ports by tapping gently while the container is in an upright position.

Mix solution and medication thoroughly.

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

7.

REGISTRATION NUMBERS

140 24 30797 00

140 24 30797 01

134 06 31397 00

8.

MANUFACTURER

Baxter Healthcare Ltd.

Thetford, United Kingdom.

9.

LICENCE HOLDER

Teva Medical Marketing Ltd.,

Haorgim St 8, Ashdod 77100.

The content of this leaflet was approved by the Ministry of Health in March 2017 and updated

according to the guidelines of the Ministry of Health in February 2018.