LACTATED RINGER'S INJECTION (HARTMANN'S SOLUTION)

Israel - English - Ministry of Health

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Active ingredient:
CALCIUM CHLORIDE; LACTIC ACID AS SODIUM; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Available from:
TEVA MEDICAL MARKETING LTD.
ATC code:
B05BB02
Pharmaceutical form:
SOLUTION FOR INJECTION
Composition:
SODIUM CHLORIDE 6 G/L; POTASSIUM CHLORIDE 0.3 G/L; CALCIUM CHLORIDE 0.2 G/L; LACTIC ACID AS SODIUM 3.1 G/L
Administration route:
I.V
Prescription type:
Required
Manufactured by:
TEVA MEDICAL LTD, ISRAEL
Therapeutic group:
ELECTROLYTES WITH CARBOHYDRATES
Therapeutic area:
ELECTROLYTES WITH CARBOHYDRATES
Therapeutic indications:
As a supply of water, for administration of electrolytes or calories, or as an alkalinizing agent.
Authorization number:
025 29 20064 00
Authorization date:
2011-10-31

"

ע עבקנ הז ןולע טמרופ

"

רשואו קדבנ ונכותו תואירבה דרשמ י

."

רשואמ ןולע

7/5/2013

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

checked and approved.” Date of approval: 7/5/2013

Lactated Ringer's Injection (Hartmann’s Solution)

Solution for Injection .

In Non PVC Bags

Description

Lactated Ringer's Injection (Hartmann’s Solution) Solution for Injection is sterile,

nonpyrogenic solutions for fluid and electrolytes replenishment and/or caloric supply

in single dose bags for intravenous administration. It contains no antimicrobial agents.

The composition, osmolarity, and pH values are shown in Table 1.

Table 1

Composition, Osmolarity, and Approximate pH Values

Lactated Ringer's Injection (Hartmann’s

Solution) Solution for Injection

* Normal physiologic isotonicity range is approximately 280-310 mOsm/L.

Administration of substantially hypotonic solutions may cause hemolysis, and administration

of substantially hypertonic solutions may cause vein damage.

**Approx. pH values are USP for applicable solutions, corporate specification for non-USP solutions.

Approximate ionic concentrations (mEq/L) and calories per liter are shown in Table 2.

Table 2

Approximate Ionic Concentrations (mEq/L) and Calories per liter

Ionic Concentration (mEq/L)

Lactated Ringer's Injection (Hartmann’s

Solution) Solution for Injection

LACTATED RINGER’S INJECTION (Hartmann’s Solution) SOLUTION FOR INJECTION

IN NON PVC BAGS 8 5. 2013, RH

LACTATED RINGER’S INJECTION (Hartmann’s Solution) SOLUTION FOR INJECTION

IN NON PVC BAGS 8 5. 2013, RH

Description of the Primary Bags:

Type and size: Non PVC plastic bag +overpouch; size: 1000 ml.

Material composition:

- Non PVC plastic film, based on polyethylene, polyamide, and polypropylene.

- Overpouch based on co-extruded blend: polypropylene/polyamide/polypropylene

film.

Clinical Pharmacology

As a source of water, electrolytes, and/or calories and capable of inducing diuresis

depending on the clinical condition of the patient.

For caloric value of the solution see Table 2.

Solutions which are di-electrolytic or polyelectrolytic have value in maintaining or

replenishing electrolytes. See also Table 2 for ionic concentrations.

Solutions containing lactate ion produce a metabolic alkalinizing effect. Lactate ions

are metabolized in the liver to glycogen, and ultimately to carbon dioxide and water,

which requires the consumption of hydrogen cations.

Indications

As a supply of water, for administration of electrolytes and/or calories, or as an

alkalizing agent.

Contraindications

None known.

Warnings

General

Note: Dispensing without Doctor's prescription is prohibited.

The administration of Intravenous Injections 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

potassium-free

solutions

result

significant

hypokalemia.

In patients with diminished renal function, administration of solutions containing

sodium or potassium ions may result in sodium or potassium retention.

Administration by central venous catheter should be used only by those familiar with

this technique and its complications.

For Solutions Containing Sodium Ions

Solutions containing sodium ions 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. In patients with diminished renal function,

administration of Sodium Chloride Injections may result in sodium retention.

For Solutions Containing Potassium Ions

Solutions containing potassium ions should be used with great care, if at all, in

patients with hyperkalemia, severe renal failure, and in conditions in which potassium

retention is present.

LACTATED RINGER’S INJECTION (Hartmann’s Solution) SOLUTION FOR INJECTION

IN NON PVC BAGS 8 5. 2013, RH

For Solutions Containing Lactate Ions

Solutions containing lactate ions (especially Sodium Lactate Injection) should be used

with great care, if at all, in patients with metabolic or respiratory alkalosis (excessive

administration of Lactated Ringer’s Injection may result in metabolic alkalosis). The

administration of lactate ions should be done with great care, in those conditions in

which there is an increased level or an impaired utilization of lactate ions, such as

severe hepatic insufficiency.

Lactated Ringer's Injection is not for use in the treatment of lactic acidosis.

For Solutions Containing Calcium Ions

Solutions containing calcium ions should not be administered simultaneously through

the same administration set as blood because of the likelihood of coagulation.

Use in Pregnancy

Animal reproduction studies have not been conducted. It is also not known whether

these solutions can cause fetal harm when administered to a pregnant woman, or can

affect reproduction capacity. Therefore, these solutions should be given to a pregnant

woman only if clearly needed.

Use in Pediatrics- for Lactated Ringer’s Solution

Safety and effectiveness of Lactated Ringer’s Injection in pediatric patients have not

been

established

adequate

well

controlled

trials;

however,

electrolyte solutions in the pediatric population is referenced in the medical literature.

The warnings, precautions and adverse reactions identified in the label copy should

be observed in the pediatric population.

Use in Geriatrics - for Lactated Ringer’s Solution

Clinical studies of Lactated Ringer’s 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

responses between the 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 drug therapy.

Adverse Reactions

General

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.

Nausea, fever, and flushing of the skin have occurred.

If an adverse reaction does occur, the infusions should be discontinued, the patient

evaluated, appropriate therapeutic countermeasures instituted, and the remainder of

the fluid saved for examination if deemed necessary.

For Lactated Ringer’s Solution

Allergic

reactions

anaphylactoid

symptoms

such

localized

generalized

urticaria and pruritis; periorbital, facial, and/or laryngeal edema; coughing, sneezing,

and/or difficulty with breathing have been reported during administration of Lactated

Ringer’s Injection. The reporting frequency of these signs and symptoms is higher in

women during pregnancy.

LACTATED RINGER’S INJECTION (Hartmann’s Solution) SOLUTION FOR INJECTION

IN NON PVC BAGS 8 5. 2013, RH

Precautions

General

Do not administer unless the solution is clear and the seal is intact.

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.

Caution should be exercised in the administration of parenteral fluids, especially those

containing dextrose, sodium ions, to patients receiving corticosteroids or corticotropin.

Caution should be exercised in the administration of these injections to the very young

and to elderly patients.

Administer

that

extravasation

does

occur.

thrombosis

occurs

during

administration, stop injection and correct.

Dosage and Administration

Note: Do not administer unless solution is clear and seal is intact.

Parenteral drug products should be inspected visually for particulate matter and

discoloration prior to administration whenever solution and container permit. Use of a

final filter is recommended during administration of all parenteral solutions, where

possible.

The dosage is usually dependent upon the age, weight and clinical condition of the

patient, as well as laboratory determinations. All injections in plastic bags are intended

intravenous

administration

using

sterile

equipment.

recommended

that

intravenous administration apparatus be replaced at least once every 24 hours.

Additives may be incompatible Complete information is not available. Those additives

known to be incompatible should not be used. A pharmacist should be consulted, if

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

introduce additives, aseptic technique should be used. Thorough mixing should be

performed when additives have been introduced. Solutions containing additives must

not be stored.

Directions for Use of Plastic Bags

Warning : Do not use plastic bags in series connections. Such use could result in air

embolism due to residual air being drawn from the primary bag before administration

of the fluid from the secondary bag is completed.

To Open

Do not remove units from overwrap until ready for use. Use all units promptly

when pouch is opened.

The overwrap is a moisture barrier. The inner bag maintains the sterility of the

product.

Tear pouch down side at slit and remove solution bag. Check for minute leaks by

squeezing inner bag firmly. If leaks are found, discard solution as sterility may be

impaired.

supplemental

medication

desired,

follow

directions

below

before

preparing for administration.

LACTATED RINGER’S INJECTION (Hartmann’s Solution) SOLUTION FOR INJECTION

IN NON PVC BAGS 8 5. 2013, RH

Preparation for Administration

1. Suspend bag from eyelet support.

2. Remove plastic protector from outlet port at bottom of bag.

3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication Before Solution Administration

Warning: Additives may be incompatible.

1. Prepare medication site.

2. Using syringe with 19-22 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 19-22 gauge needle, puncture resealable medication port

and inject.

4. Remove bag from IV pole and/or turn to an upright position.

5. Evacuate both ports by squeezing them while bag is in the upright position.

6. Mix solution and medication thoroughly.

7. Return bag to in use position and continue administration.

Overdosage

In the event of fluid or solute overload during parenteral fluids, reevaluate the patient’s

condition and institute appropriate corrective treatment.

Storage

Avoid storage at excessive heat. It is recommended that the product be stored below

Registration Numbers

025 29 20064 00

Presentation

1000 ml bags

Manufacturer

Teva Medical Ltd.,

Haorgim Street 8, Ashdod 77100

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