Summary of Product Characteristics (SmPC) - Sodium Chloride 1.8% intravenous infusion
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 1.8% Intravenous Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride 1.8% Intravenous Infusion has the following composition:
Name Specification
Reference
%w/v
Sodium Chloride EP 1.8
3 PHARMACEUTICAL FORM
Intravenous fluid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Sodium Chloride 1.8% Intravenous Infusion is used in the treatment of acute sodium deficiency and water intoxication.
4.2. Posology and Method of Administration
Adults and Children
The rate of administration and volume infused will depend upon the requirements of the individual patient and the judgement of the physician
Elderly
Care should be taken to avoid circulatory overload, particularly in patients with cardiac and renal insufficiency.
For intravenous infusion.
4.3. Contra-indications
Patients with sodium overload. This may occur with myocardial and renal damage, but it should also be appreciated that in the first five or six days after surgery or severe trauma there may be an inability to excrete unwanted sodium.
4.4. Special Warnings and Precautions for Use
Caution is necessary when considering the use of this solution in patients with cardiac failure, hypertension, impaired renal function and peripheral or pulmonary oedema and toxaemia of pregnancy
The label states: Do not use unless the solution is clear and free from particles.
4.5. Interactions with other Medicaments and other forms of Interaction
No clinically significant interactions known.
4.6. Pregnancy and Lactation
The safety of Sodium Chloride 1.8% Intravenous Infusion during pregnancy and lactation has not been assessed, but its use during these periods is not considered to constitute a hazard.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
Thrombosis of the chosen vein is always a possibility with intravenous infusion. If infusion is protracted then another vein should be selected after 12
- 24 hours.
4.9. Overdose
Overdosage may lead to fluid overload, electrolyte imbalance, in particular hypematraemia.
Treatment should consist of discontinuing the infusion and, if necessary administering a diuretic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Sodium chloride provides a source of sodium and chloride ions to maintain the osmotic tension of the extracellular fluid and tissues.
5.2. Pharmacokinetic Properties
No data available.
5.3. Preclinical Safety Data
N/A
Pharmaceutical Particulars
6.1. List of Excipients
Name Specification Reference %w/v
Water for Injections in bulk EP TO 100 Hydrochloric Acid EP QS
Sodium Hydroxide BP QS
6.2. Incompatibilities
Incompatible with amiodarone, amphotericin B, amsacrine and sodium nitroprusside.
6.3. Shelf Life
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.
The container is overwrapped in polyethylene.
6.6. Instruction for Use/Handling
Do not dilute before use.
Use standard sterile peritoneal dialysis equipment.
7 MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
8. Marketing Authorization Number
PL 08828/0053
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of First Authorisation: 25th April 1989 Date of Renewal of Authorisation: 16th November 1994
10 DATE OF REVISION OF THE TEXT
22/02/2010