Hartmanns Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hartmann’s Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The product has the following composition:
|
Name |
%w/v |
|
Sodium Chloride BP for Injections |
0.6 |
|
Potassium Chloride BP |
0.04 |
|
Calcium Chloride BP Dihydrate |
0.027 |
|
Sodium Hydroxide BP | |
|
Lactic Acid BP | |
|
Lactic Acid BP and Sodium Hydroxide BP are added as 2M or premade 50% Sodium Lactate Solution equivalent to Sodium Lactate |
0.317 |
3 PHARMACEUTICAL FORM
Intravenous infusion
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Hartmann’s solution is indicated for the treatment of metabolic acidosis and dehydration with acidosis. It may be used to expand extracellular fluids or restore extracellular electrolyte. It may be used in the treatment of diabetic coma.
For intravenous infusion.
4.2 Posology and method of administration
Adults and Children
The rate of administration and volume will depend upon the requirements of the individual patient and the judgement of the physician. A dosage of 300 ml per hour should not be exceeded.
Elderly
Care should be taken in the elderly to avoid circulatory overload, particularly in, patients with cardiac and renal insufficiency.
4.3 Contraindications
Patients with sodium overload. This may occur with myocardial and renal damage but also in the first five or six days after surgery or severe trauma when there may be an inability to excrete unwanted sodium. Hartmann’s solution should not be given to patients with cardiac arrhythmias. Lactate containing solutions are contraindicated in, patients with severe liver disease who are unable to convert lactate to bicarbonate.
4.4 Special warnings and precautions for use
Although Hartmann’s solution provides potassium, this is only enough to maintain the potassium content of extracellular fluid and would be quite inadequate for patients with severe potassium loss. Under these circumstances potassium supplements must be given. Lactate overdose in, patients with heart disease may provoke arrhythmias and heart failure. ECG monitoring is recommended if Hartmann’s solution is administered to such patients use with caution in, patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary oedema and in toxaemia of pregnancy.
The label states: Do not use unless the solution is clear and free from particles.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
4.6 Pregnancy and lactation
The safety of Hartmann’s solution during pregnancy and lactation has not been assessed, but their use during these periods is not considered to constitute a hazard.
Effects on ability to drive and use machines
4.7
Not applicable.
4.8 Undesirable effects
Thrombosis of the chosen vein is always possible with intravenous infusion.
4.9 Overdose
Overdosage may lead to fluid overload and electrolyte imbalance. The use of diuretic may be indicated for the treatment of fluid and electrolyte disturbance.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Potassium chloride, sodium chloride and calcium chloride provide essential ions to maintain the intracellular/extracellular milieu.
Sodium lactate is used as a source of bicarbonate ions, which will correct acid-base balance.
5.2 Pharmacokinetic properties
Sodium lactate is metabolised in the liver to sodium bicarbonate.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
|
Name |
Specification Reference |
%w/v |
|
Water for Injections in bulk BP |
EP |
To 100 |
|
Hydrochloric Acid BP |
EP |
QS |
|
Sodium Hydroxide BP |
BP |
QS |
6.2 Incompatibilities
Incompatible with amikacin, amphotericin B, benzylpenicillin, dobutamine, amiodarone, amsacrine, sodium nitroprusside, tetracyclines, sodium bicarbonate, sodium calcium edetate and sulphadiazine sodium.
6.3 Shelf life
Semi-rigid, cylindrical neutral polythene container with a 'Twist-off seal: 60 months.
Polyethylene bottle with cap and administration/addition points: 36 months.
6.4 Special precautions for storage
Store at 2° to 25°C.
6.5 Nature and contents of container
Sealed semi-rigid, cylindrical neutral polythene container with a 'Twist-off seal at one end and a ring tab at the opposite end
Or
Polyethylene bottle with a cap with an administration point and an addition point (KabiPac).
The container holds 500 or 1000 ml.
6.6 Special precautions for disposal
Do not dilute before use.
Use standard sterile peritoneal dialysis equipment.
MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
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MARKETING AUTHORISATION NUMBER(S)
PL 08828/0045
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/11/1989 / 11/02/2009
DATE OF REVISION OF THE TEXT
03/03/2010
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