סודיום כלוריד % 0.9 לעירוי לתוך הוריד BP

ישראל - עברית - Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)

05-03-2020

מרכיב פעיל:
SODIUM CHLORIDE
זמין מ:
TEVA MEDICAL MARKETING LTD.
קוד ATC:
B05XA03
טופס פרצבטיות:
תמיסה לאינפוזיה
הרכב:
SODIUM CHLORIDE 0.9 %W/V
מסלול נתינה (של תרופות):
תוך-ורידי
סוג מרשם:
מרשם נדרש
תוצרת:
BAXTER HEALTHCARE LTD. U.K.
קבוצה תרפויטית:
SODIUM CHLORIDE
איזור תרפויטי:
SODIUM CHLORIDE
סממני תרפויטית:
Treatment of isotonic extracellular dehydration. Treatment of sodium depletion. Vehicle or diluent of compatible drugs for parenteral administration.
מספר אישור:
134 05 31396 00
תאריך אישור:
2014-03-31

מסמכים בשפות אחרות

עלון מידע עלון מידע - אנגלית

17-08-2016

מאפייני מוצר מאפייני מוצר - אנגלית

14-06-2020

ציבור דו ציבור דו"ח הערכה - אנגלית

05-03-2020

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification

Sodium Chloride 0.9% Intravenous Infusion BP

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Sodium Chloride 0.9% Intravenous Infusion BP

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium chloride: 9.0 g/l

Each ml contains 9 mg sodium chloride.

mmol/l:

Na+ : 154

Cl-: 154.

pH: 4.5 -7

For the full list of excipients: see section 6.1

3.

PHARMACEUTICAL FORM

Solution for infusion

Clear solution, free from visible particles.

4.

CLINICAL PARTICULARS

4.1. Therapeutic indications

Sodium Chloride 0.9%

intravenous infusion

is indicated for:

Treatment of isotonic extracellular dehydration

Treatment of sodium depletion

Vehicle or diluent of compatible drugs for parenteral administration.

4.2. Posology and method of administration

Posology

Adults, older people and children:

Doses may be expressed in terms of mEq or mmol of sodium, mass of sodium, or mass of

sodium salt (1 g NaCl = 394 mg, 17.1 mEq or 17.1 mmol of Na and Cl).

The dosage, rate and duration of administration is to be individualized as determined by

several

factors

including

age,

weight,

clinical

condition,

concomitant

treatment

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification

particular the patient's hydration state, clinical and laboratory response to treatment. Fluid

balance and plasma electrolyte concentrations must be monitored during treatment.

Recommended dosage

The recommended dosage for treatment of isotonic extracellular dehydration and sodium

depletion is:

For adults : 500 ml to 3 litres/24h

For babies and children: 20 to 100 ml per 24h and per kg of body weight, depending

of 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 Sodium Chloride 0.9 % is used as a diluent for injectable preparations of other drugs,

the dosage and the infusion rate will also be dictated by the nature and the dose regimen of the

prescribed drug.

Method of administration

The solution is for administration by intravenous infusion through a sterile and non-pyrogenic

administration set, using aseptic technique. The equipment should be primed with the solution

in order to prevent air entering the system.

The product should be inspected visually for particulate matter and discoloration prior to

administration. Do not administer unless solution is clear, free from visible particles and the

seal is intact

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

the solution. Administer immediately following the insertion of infusion set.

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

possible residual air contained in the primary container. 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.

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

For information on incompatibilities and preparation of the product (with additives), please

see sections 6.2 and 6.6.

4.3. Contraindications

The solution is contra-indicated in patient presenting hypernatraemia or hyperchloraemia.

The contra-indications related to the added medicinal product should be considered.

4.4. Special warnings and precautions for use

Fluid balance/renal function

Use in patients with (severe) renal impairment

Sodium Chloride 0.9% should be administered with particular caution to patients with or at

risk of severe renal impairment. In such patients, administration of Sodium Chloride 0.9%

may result in sodium retention.

(See “Use in patients at risk for sodium retention, fluid

overload and oedema” below; for additional considerations.)

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification

Risk of fluid and/or solute overload and electrolyte disturbances

Depending on the volume and rate of infusion, intravenous administration of Sodium

Chloride 0.9% can cause:

Fluid and/or solute overload resulting in overhydration/hypervolemia and, for

example, congested states, including central and peripheral oedema.

Clinically relevant electrolyte disturbances and acid-base imbalance.

In general, the risk of dilutional states (retention of water relative to sodium) is inversely

proportional to the electrolyte concentrations of Sodium Chloride 0.9% and its additions.

Conversely, the risk of solute overload causing congested states (retention of solute relative to

water) is directly proportional to the electrolyte concentrations of Sodium Chloride 0.9% and

its additions.

Special clinical monitoring is required at the beginning of any intravenous infusion. 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.

High volume infusion must be used under specific monitoring in patients with cardiac or

pulmonary failure and in patients with non-osmotic vasopressin release (including SIADH),

due to the risk of hospital-acquired hyponatraemia (see below).

Hyponatraemia

Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress,

infections, burns, and CNS diseases), patients with heart-, liver- and kidney diseases and

patients exposed to vasopressin agonists (see section 4.5) are at particular risk of acute

hyponatraemia upon infusion of hypotonic fluids.

Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema)

characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral

oedema are at particular risk of severe, irreversible and life-threatening brain injury.

Children, women in the fertile age and patients with reduced cerebral compliance (e.g.

meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at particular risk

of the severe and life-threatening brain swelling caused by acute hyponatraemia.

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

Sodium Chloride 0.9% should be used with particular caution, if at all, in patients with or at

risk for:

Hypernatraemia. Rapidly correcting hypernatraemia once adaptation has occurred may

lead to cerebral oedema, potentially resulting in seizures, permanent brain damage, or

death.

Hyperchloraemia

Metabolic acidosis, which may be worsened by prolonged use of this product,

especially in patients with renal impairment.

Hypervolaemia such as congestive heart failure and pulmonary oedema may be

precipitated, particularly in patients with cardiovascular disease.

Iatrogenic hyperchloraemic metabolic acidosis (e.g., during intravenous volume

resuscitation)

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

peripheral), such as patients with

primary hyperaldosteronism,

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification

secondary hyperaldosteronism, associated with, for example,

hypertension,

congestive heart failure,

liver disease (including cirrhosis),

renal disease (including renal artery stenosis, nephrosclerosis) or pre-

eclampsia.

Medications that may increase the risk of sodium and fluid retention, such as corticosteroids

Infusion reactions

Symptoms of unknown aetiology which can appear to be hypersensitivity reactions have been

reported very rarely in association with infusion of Sodium Chloride 0.9 %. These have been

characterized as hypotension, pyrexia, tremor, chills, urticaria, rash and pruritus. Stop the

infusion immediately if signs or symptoms of these reactions develop. Appropriate

therapeutic countermeasures should be instituted as clinically indicated.

Specific patient groups

The consulting physician should be experienced in this product’s use and safety in these

special populations that are especially sensitive to rapid changes in serum sodium levels.

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

serious neurologic complications). See section “Hyponatraemia/hypernatraemia” above.

Paediatric population

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

this population

have impaired

ability to regulate fluids and

electrolytes. Repeated

infusions of sodium chloride should therefore only be given after determination of the serum

sodium level.

Geriatric population

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.

For information on preparation of the product and additives, please see section 6.6.

This medicinal product contains 354 mg sodium per 100 ml, equivalent to 17.7% of the WHO

recommended maximum daily intake of 2 g sodium for an adult.

4.5. Interaction with other medicinal products and other forms of interaction

Drugs leading to an increased vasopressin effect

The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte

free water excretion and may increase the risk of hospital acquired hyponatraemia following

inappropriately balanced treatment with i.v. fluids (see sections 4.4 and 4.8).

Drugs stimulating vasopressin release include: Chlorpropamide, clofibrate,

carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-

N-methamphetamine, ifosfamide, antipsychotics, narcotics

Drugs potentiating vasopressin action include: Chlorpropamide, NSAIDs,

cyclophosphamide

Vasopressin analogues include: Desmopressin, oxytocin, terlipressin

Other medicinal products increasing the risk of hyponatraemia also include diuretics in

general and antiepileptics such as oxcarbazepine.

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification

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

be increased during administration of Sodium Chloride 0.9%. Administration of Sodium

Chloride 0.9% may result in decreased lithium levels.

Corticoids/Steroids and carbenoxolone, are associated with the retention of sodium and water

(with oedema and hypertension). See Section 4.4 Special warnings and precautions for use.

4.6. Fertility, pregnancy and lactation

There are no adequate data from the use of Sodium Chloride 0.9% in pregnant or lactating

women. The physician should carefully consider the potential risks and benefits for each

specific patient before administering Sodium Chloride 0.9%.

Sodium Chloride 0.9% should be administrated with special caution for pregnant women

during labour particularly as to serum-sodium if administered in combination with oxytocin

(see section 4.4, 4.5 and 4.8).

Caution is advised with patients with pre-eclampsia (See Section 4.4. Special warnings and

precautions for use).

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

lactation has to be considered separately.

4.7. Effects on ability to drive and use machines

No studies have been conducted on the influence of Sodium Chloride 0.9% on the ability to

operate an automobile or other heavy machinery.

4.8. Undesirable effects

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

frequency of the adverse drug reactions listed in this section cannot be estimated from the

available data.

System Organ Class

(SOC)

Adverse reactions (Preferred Term)

Frequency

Nervous system disorders

Tremor

Acute hyponatraemic encephalopathy*

Not known

Metabolism and nutrition

disorders

Hospital acquired hyponatraemia*

Not known

Vascular disorders

Hypotension

Not known

Skin and subcutaneous

tissue disorders

Urticaria

Rash

Pruritus

Not known

General disorders and

administration site

conditions:

Infusion site reactions, such as

Infusion site erythema,

Vein irritation, Injection site

streaking, burning sensation,

Local pain or reaction , Infusion

site urticaria

Infection at the site of injection,

Venous thrombosis or phlebitis

Not known

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification

extending from the site of

injection, extravasation and

hypervolemia

Pyrexia

Chills

*Hospital acquired hyponatraemia may cause irreversible brain injury and death, due to

development of acute hyponatraemic encephalopathy, frequency unknown (see sections 4.4,

4.5).

The following adverse reactions have not been reported with this product but may occur:

Hypernatraemia (

e.g.,

when administered to patients with nephrogenic diabetes

insipidus or high nasogastric output)

Hyperchloraemic metabolic acidosis

Hyponatraemia, which may be symptomatic.

Hyponatraemia may occur when normal

free water excretion is impaired

(e.g.,

SIADH or postoperative)

General adverse effects of sodium excess are described in section 4.9 Overdose.

Additives

When Sodium Chloride 0.9% is used as a diluent for injectable preparations of other drugs,

the nature of additives will determine the likelihood of any other undesirable effect.

If an adverse event occurs the patient should be evaluated and appropriate counter measures

be started, if needed the infusion should be stopped. The remaining part of the solution should

be kept for investigation if deemed necessary.

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. Overdose

General adverse effects of sodium excess in the body include nausea, vomiting, diarrhea,

abdominal cramps, thirst, reduced salivation and lacrimation, sweating, fever, tachycardia,

hypertension, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache,

dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions,

coma, and death.

An excessive volume of Sodium Chloride 0.9% may lead to hypernatraemia (which can lead

to CNS manifestations, including seizures, coma, cerebral oedema and death) and sodium

overload (which can lead to central and/or peripheral oedema) and should be treated by an

attending specialised physician.

Excess chloride in the body may cause a loss of bicarbonate with an acidifying effect.

When Sodium Chloride 0.9% is used as a diluent for injectable preparations of other drugs,

the signs and symptoms of over infusion will be related to the nature of the additives being

used. In the event of accidental over infusion, treatment should be discontinued and the

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification

patient should be observed for the appropriate signs and symptoms related to the drug

administered. The relevant and supportive measures should be provided as necessary.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: “Other IV Solution Additives”

ATC code: B05XX

Sodium Chloride 0.9% intravenous infusion is an isotonic solution, with an approximate

osmolarity of 308 mOsm/l.

The pharmacodynamic properties of the solution are those of the sodium and chloride ions in

maintaining the fluid and electrolyte balance. Ions, such as sodium, circulate through the cell

membrane, using various mechanisms of transport, among which is the sodium pump (Na-K-

ATPase). Sodium plays an important role in neurotransmission and cardiac electrophysiology,

and also in its renal metabolism.

5.2. Pharmacokinetic properties

Sodium is predominantly excreted by the kidney, but there is extensive renal reabsorption.

Small amounts of sodium are lost in the faeces and sweat.

5.3. Preclinical safety data

The safety of sodium chloride in animals is not relevant in view of its presence as a normal

component in animal and human plasma.

6. PHARMACEUTICALS PARTICULARS

6.1. List of excipients

Water for Injection.

6.2. Incompatibilities

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

assessed before addition. In the absence of compatibility studies, this solution must not be

mixed with other medicinal products. Those additives known to be incompatible should not

be used.

See section 6.6 for further instructions on the use of the product with additives

6.3. Shelf life

Shelf life as packaged:

The expiry date of the product is indicated on the packaging materials.

In-use shelf life: Additives.

Chemical

physical

stability

additive

Sodium

Chloride

0.9%

Intravenous Infusion in the Viaflo container should be established prior to use.

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification

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

dilution

taken

place

controlled

validated

aseptic

conditions.

used

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

6.4. Special precautions for storage

50 and 100 ml bags: Do not store above 30°C.

250, 500 and 1000 ml bags: No special precautions for storage.

6.5 Nature and contents of container

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

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

2442).

bags

overwrapped

with

protective

plastic

pouch

composed

polyamide/polypropylene.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Please see section 4.2 for information regarding the method of administration.

Before adding a drug, verify it is soluble and stable in water at the pH range of the Sodium

Chloride 0.9% Intravenous Infusion solution. Additives may be introduced before infusion or

during infusion through the injection site.

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

with the Sodium Chloride 0.9% Intravenous Infusion solution by checking for eventual color

change

and/or

eventual

precipitate,

insoluble

complexes

crystals

apparition.

Instructions for Use of the medication to be added must be consulted.

When additive is used, verify isotonicity prior to parenteral administration. Thorough and

careful aseptic mixing of any additive is mandatory. Solutions containing additives should be

used immediately and not stored.

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.

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.

Instructions for use

Opening

Remove the Viaflo container from the overpouch just before use.

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

solution, as sterility may be impaired

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification

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

contains foreign matter, discard the solution.

Preparation for administration

Use sterile material for preparation and administration.

Suspend container from eyelet support.

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.

Attach administration set. Refer to directions of the 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.

Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) 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.

Disinfect medication site.

Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture

resealable medication port and inject.

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.

LICENCE HOLDER AND MANUFACTURER

Licence Holder:

Teva Medical Marketing Ltd.,

Haorgim St. 8, Ashdod.

Manufacturer:

Baxter Healthcare Ltd.,

Thetford, United Kingdom.

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification

8.

REGISTRATION NUMBERS

140.26.30794

134.05.31396

The content of this leaflet was approved by the Ministry of Health in March 2016 and updated

according to the guidelines of the Ministry of Health in March 2020 .

מוצרים דומים

חיפוש התראות הקשורות למוצר זה

צפו בהיסטוריית המסמכים

שתף מידע זה