DEXTROSE 5% AND 0.45% SODIUM CHLORIDE INJECTION

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

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

:ךיראת

411.410.41

תילגנאב רישכת םש

:

Dextrose 5% and Sodium Chloride 0.45% Injection

ושיר רפסמ

ם

:

038 88 22826 00

םושירה לעב םש

:

Teva Medical LTD

ה טורפל דעוימ הז ספוט דבלב תורמחה

תושקובמה תורמחהה

ןולעב קרפ

טסקט

יחכונ

שדח טסקט

Contraindications

Solutions containing dextrose may be contraindicated in

patients with known allergy to corn or corn products

PRECAUTIONS

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.

Drug Interactions

Studies have not been conducted to evaluate additional

drug/drug or drug/food interactions with Dextrose and Sodium

Chloride Injection.

Carcinogenesis, mutagenesis, impairment of fertility

Studies with Dextrose and Sodium Chloride Injection, USP

have not been performed to evaluate carcinogenic potential,

mutagenic potential, or effects on fertility.

Pregnancy: Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not

been conducted with Dextrose and Sodium Chloride Injection,

USP. It is also not known whether Dextrose and Sodium

Chloride Injection, USP can cause fetal harm when

administered to a pregnant woman or can affect reproduction

capacity. Dextrose and Sodium Chloride Injection, USP

should be given to a pregnant woman only if clearly needed.

Labor and Delivery

Studies have not been conducted to evaluate the effects of

Dextrose and Sodium Chloride Injection,

USP on labor and delivery. Caution should be exercised when

administering this drug during labor and delivery.

Nursing Mothers

It is not known whether this drug is excreted in human

milk. Because many drugs are excreted in human milk,

caution should be exercised when Dextrose and Sodium

Chloride Injection is administered to a nursing mother.

Pediatric Use

The use of Dextrose and Sodium Chloride Injection, USP in

pediatric patients is based on clinical practice.

Newborns - especially those born premature and with low

birth weight - are at increased risk of developing hypo - or

hyperglycemia and therefore need close monitoring during

treatment with intravenous glucose solutions to ensure

adequate glycemic control in order to avoid potential long

term adverse effects. Hypoglycemia in the newborn can cause

prolonged seizures, coma and brain damage. Hyperglycemia

has been associated with intraventricular hemorrhage, late

onset bacterial and fungal infection, retinopathy of

prematurity, necrotizing enterocolitis, bronchopulmonary

dysplasia, prolonged length of hospital stay, and death.

Plasma electrolyte concentrations should be closely monitored

in the pediatric population as this population may have

impaired ability to regulate fluids and electrolytes.

The infusion of hypotonic fluids together with the non-

osmotic secretion of ADH may result in hyponatremia in

patients with acute volume depletion. Hyponatremia can lead

to headache, nausea, seizures, lethargy, coma, cerebral

oedema and death, therefore acute symptomatic hyponatremic

encephalopathy is considered a medical emergency (applies to

solutions containing less than 0.9% Sodium Chloride).

Geriatric Use

Clinical studies of Dextrose and Sodium Chloride Injection

did not include sufficient numbers of subjects aged 65 and

over to determine whether they respond differently from

younger subjects. Other reported clinical experience has not

identified differences in the responses between elderly and

younger patients. In general, dose selection for an elderly

patient should be cautious, usually starting at the low end of

the dosing range, reflecting the greater frequency of decreased

hepatic, renal, or cardiac function and of concomitant disease

or other drug therapy.

This drug is known to be substantially excreted by the

kidney, and the risk of toxic reactions to this drug may be

greater in patients with impaired renal function. Because

elderly patients are more likely to have decreased renal

function, care should be taken in dose selection, and it

may be useful to monitor renal function.

ADVERSE

REACTIONS

Hypersensitivity reactions, including anaphylaxis and chills

Hyponatremia

DOSAGE

AND

ADMINISTRATION

As directed by a physician. Dosage is dependent upon the age,

weight, and clinical condition of the patient as well as

laboratory determinations.

Parenteral drug products should be inspected visually for

particulate matter and discoloration prior to administration

whenever solution and container permit. Do not administer

unless solution is clear and seal is intact.

All injections plastic containers are intended for intravenous

administration using sterile equipment.

The dosage and constant infusion rate of intravenous dextrose

must be selected with caution in pediatric patients, particularly

neonates and low weight infants, because of the increased risk

of hyperglycemia/hypoglycemia. 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

pediatric intravenous fluid therapy.

Hyperglycemia and glycosuria may be functions of

rate of administration or metabolic insufficiency.

To minimize these conditions, slow the infusion

rate, monitor blood and urine glucose; if necessary,

administer insulin.

Vitamin B-complex deficiency may occur with dextrose

administration

Additives may be incompatible. Complete information is not

available.

Those additives known to be incompatible should not be used.

Consult with pharmacist, if available. If, in the informed

judgment of the physician, it is deemed advisable to introduce

additives, use aseptic technique. Mix thoroughly when

additives have been introduced. Do not store solutions

containing additives.

ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ 26.1.2017 -ב ודי לע רשואו קדבנ

Dextrose 5% in 0.45%

Sodium Chloride Injection

Solution for Infusion in Non PVC Bags

DESCRIPTION

Dextrose 5% in 0.45% Sodium Chloride Injection is a

sterile, nonpyrogenic solution for fluid and electrolyte

replenishment and caloric supply in single dose

containers for intravenous administration. It contains

no antimicrobial agents. Composition, osmolarity, pH,

ionic concentration and caloric content are shown

in Table 1.

Table 1

Size (mL)

Composition

(g/L)

*Osmolarity

(mOsmol/L) (calc.)

pH nominal (range)

Ionic

Concentration

(mEq/L)

Caloric Content

(kcal/L)

Dextrose

Monohydrate

Sodium

Chloride,

(NaCl)

Sodium

Chloride

Dextrose

0.45%

Sodium

Chloride

Injection

1000

* Normal physiologic osmolarity range is

approximately 280 to 310 mOsmol/L.

The flexible container is a closed system, and air is

prefilled in the container to facilitate drainage. The

container does not require entry of external air during

administration.

The container has two ports: one is the administration

outlet port for attachment of an intravenous

administration set and the other port has a medication

site for addition of supplemental medication (see

DIRECTIONS FOR USE). The primary function of the

overwrap is to protect the container from the physical

environment.

DESCRIPTION Of ThE PRImaRy BagS:

Type and size: Non PVC plastic bag + overpouch;

size: 500 ml and 1000 ml.

Material composition:

- Non PVC plastic film, based on polyethylene,

polyamide, and polypropylene.

- Overpouch

based

co-extruded

blend:

polypropylene/polyamide/polypropylene film.

CLINICaL PhaRmaCOLOgy

Dextrose 5% in 0.45% Sodium Chloride Injection has

value as a source of water, electrolytes, and calories.

It is capable of inducing diuresis depending on the

clinical condition of the patient.

INDICaTIONS aND USagE

Dextrose 5% in 0.45% Sodium Chloride Injection is

indicated to provide electrolytes and calories and as a

source of water for hydration.

CONTRaINDICaTIONS

Solutions containing dextrose may be contraindicated

in patients with known allergy to corn or corn

products.

WaRNINgS

Dextrose 5% in 0.45% Sodium Chloride Injection

should be used with great care, if at all, in patients

with congestive heart failure, severe renal insufficiency,

and in clinical states in which there exists edema with

sodium retention.

Dextrose injections with low electrolyte concentrations

should not be administered simultaneously with blood

through the same administration set because of the

possibility of pseudoagglutination or hemolysis.

The intravenous administration of Dextrose 5% in

0.45% Sodium Chloride Injection can cause fluid and/or

solute overloading resulting in dilution of serum

electrolyte concentrations, overhydration, congested

states, or pulmonary edema. The risk of dilutional states

is inversely proportional to the electrolyte concentrations

of the injections. The risk of solute overload causing

congested states with peripheral and pulmonary edema

is directly proportional to the electrolyte concentrations

of the injections.

Excessive administration of Dextrose 5% in 0.45%

Sodium Chloride Injection may result in significant

hypokalemia.

In patients with diminished renal function, administration

of Dextrose 5% in 0.45% Sodium Chloride Injection

may result in sodium retention.

PRECaUTIONS

general

Do not connect flexible plastic containers of intravenous

solutions in series connections. Such use could result

in air embolism due to residual air being drawn from

one container before administration of the fluid from

a 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.

Dextrose 5% in 0.45% Sodium Chloride Injection

should be used with caution in patients with overt or

subclinical diabetes mellitus.

Administration of hypertonic solutions may cause

venous irritation, including phlebitis. Hyperosmolar

solutions should be administered with caution, if at all,

to patients with hyperosmolar states. See Table 1 in

the DESCRIPTION section for the osmolarities of the

Dextrose and Sodium Chloride Injection solutions.

Laboratory Tests

Clinical evaluation and periodic laboratory determinations

are necessary to monitor changes in fluid balance,

electrolyte concentrations, and acid-base balance during

prolonged parenteral therapy or whenever the condition

of the patient warrants such evaluation.

Drug Interactions

Caution must be exercised in the administration of

Dextrose and Sodium Chloride Injection to patients

receiving corticosteroids or corticotropin.

Studies have not been conducted to evaluate additional

drug/drug or drug/food interactions with Dextrose and

Sodium Chloride Injection.

Carcinogenesis, mutagenesis, Impairment of

fertility

Studies with Dextrose and Sodium Chloride Injection

have not been performed to evaluate carcinogenic

potential, mutagenic potential, or effects on fertility.

Pregnancy: Teratogenic Effects

Pregnancy Category C. Animal reproduction studies

have not been conducted with Dextrose and Sodium

Chloride Injection. It is also not known whether Dextrose

and Sodium Chloride Injection can cause fetal harm

when administered to a pregnant woman or can affect

reproduction capacity. Dextrose and Sodium Chloride

Injection should be given to a pregnant woman only

if clearly needed.

Labor and Delivery

Studies have not been conducted to evaluate the

effects of Dextrose and Sodium Chloride Injection on

labor and delivery. Caution should be exercised when

administering this drug during labor and delivery.

Nursing mothers

It is not known whether this drug is excreted in human

milk. Because many drugs are excreted in human

milk, caution should be exercised when Dextrose

and Sodium Chloride Injection is administered to a

nursing mother.

Pediatric Use

The use of Dextrose and Sodium Chloride Injection, USP

in pediatric patients is based on clinical practice.

Newborns - especially those born premature and with

low birth weight - are at increased risk of developing

hypo- or hyperglycemia and therefore need close

monitoring during treatment with intravenous glucose

solutions to ensure adequate glycemic control in order to

avoid potential long term adverse effects. Hypoglycemia

in the newborn can cause prolonged seizures, coma and

brain damage. Hyperglycemia has been associated with

intraventricular hemorrhage, late onset bacterial and

fungal infection, retinopathy of prematurity, necrotizing

enterocolitis, bronchopulmonary dysplasia, prolonged

length of hospital stay, and death.

Plasma electrolyte concentrations should be closely

monitored in the pediatric population as this population

may have impaired ability to regulate fluids and

electrolytes.

The infusion of hypotonic fluids together with the

non-osmotic secretion of ADH may result in

hyponatremia in patients with acute volume depletion.

Hyponatremia can lead to headache, nausea, seizures,

lethargy, coma, cerebral oedema and death, therefore

acute symptomatic hyponatremic encephalopathy is

considered a medical emergency (applies to solutions

containing less than 0.9% Sodium Chloride).

geriatric Use

Clinical studies of Dextrose and Sodium Chloride

Injection did not include sufficient numbers of subjects

aged 65 and over to determine whether they respond

differently from younger subjects. Other reported clinical

experience has not identified differences in the responses

between elderly and younger patients. In general, dose

selection for an elderly patient should be cautious,

usually starting at the low end of the dosing range,

reflecting the greater frequency of decreased hepatic,

renal, or cardiac function and of concomitant disease

or other drug therapy.

This drug is known to be substantially excreted by the

kidney, and the risk of toxic reactions to this drug may be

greater in patients with impaired renal function. Because

elderly patients are more likely to have decreased renal

function, care should be taken in dose selection, and

it may be useful to monitor renal function.

aDVERSE REaCTIONS

- Hypersensitivity reactions, including anaphylaxis and

chills

- Hyponatremia

Reactions which may occur because of the solution

or the technique of administration include febrile

response, infection at the site of injection, venous

thrombosis or phlebitis extending from the site of

injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the

infusion, evaluate the patient, institute appropriate

therapeutic countermeasures and save the remainder

of the fluid for examination if deemed necessary.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after

authorization of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance

of the medicinal product.

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

DOSagE aND aDmINISTRaTION

As directed by a physician. Dosage is dependent upon

the age, weight, and clinical condition of the patient

as well as laboratory determinations.

Parenteral drug products should be inspected visually

for particulate matter and discoloration prior to

administration whenever solution and container

permit. Do not administer unless solution is clear and

seal is intact.

All injections in plastic containers are intended for

intravenous administration using sterile equipment.

The dosage and constant infusion rate of intravenous

dextrose must be selected with caution in pediatric patients,

particularly neonates and low weight infants, because

of the increased risk of hyperglycemia/hypoglycemia.

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 pediatric intravenous

fluid therapy.

Additives may be incompatible. Complete information

is not available.

Those additives known to be incompatible should not

be used. Consult with pharmacist, if available. If, in

the informed judgment of the physician, it is deemed

advisable to introduce additives, use aseptic technique.

Mix thoroughly when additives have been introduced.

Do not store solutions containing additives.

hOW SUPPLIED

Dextrose 5% in 0.45% Sodium Chloride Injection in

Non PVC plastic container is supplied in 500 ml and

1000 ml bags.

Storage

It is recommended that the product be stored below

25°C.

Shelf life

Unopened product: 24 months

DIRECTIONS

fOR

USE

Of

PLaSTIC

CONTaINER

Do not remove units from overwrap until ready for use.

Use all units promptly when pouch is opened.

To Open

Tear overwrap down side at slit and remove solution

container. Visually inspect the container. If the outlet

port protector is damaged, detached, or not present,

discard container as solution path sterility may be

impaired. Moisture and some opacity of the plastic

due to moisture absorption during the sterilization

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

Caution: Do not use plastic containers in series

connections.

Caution: Use only with a non-vented set or a vented

set with the vent closed.

1. Suspend container from eyelet support.

2. Remove protector from outlet port at bottom of

container.

3. Attach administration set. Refer to complete

directions accompanying set.

To add medication

Additives may be incompatible.

To

add

medication

before

solution

administration

1. Prepare medication site.

2. Using syringe with 19 to 22 gauge needle, puncture

medication port and inject.

3. 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

1. Close clamp on the set.

2. Prepare medication site.

3. Using syringe with 19 to 22 gauge needle, puncture

medication port and inject.

4. Remove container from IV pole and/or turn to an

upright position.

5. Evacuate both ports by squeezing them while

container is in the upright position.

6. Mix solution and medication thoroughly.

7. Return container to in-use position and continue

administration.

REgISTRaTION NUmBER

038.88.22826.00

maNUfaCTURER

Teva Medical Ltd.,

Haorgim Street 8, Ashdod