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STERIFLEX NO 9 RINGERS SOLUTION FOR INJECTION BPC 1959

Active substance(s): CALCIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / CALCIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / CALCIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM CHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Ringers Solution for Injection BPC59, as Steriflex No. 9 or freeflex.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 9 has the following composition:

Name

%w/v

Sodium Chloride BP for Injections

EP

0.86

Potassium Chloride BP

EP

0.03

Calcium Chloride BP Dihydrate

3

Specification
Reference

EP

0.032

PHARMACEUTICAL FORM
Intravenous infusion.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Steriflex No. 9 is used as an intravenous infusion where an isotonic solution is needed
for the treatment of dehydration with salt depletion and where there has been some
loss of intracellular potassium.

4.2

Posology and method of administration
Adults and Children
The volume and rate of infusion 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

Contraindications
Patients with sodium or potassium 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.

4.4

Special warnings and precautions for use
Although this solution contains potassium, the quantity may be inadequate in the
presence of intracellular potassium loss. The solution should not be administered
rapidly or for prolonged periods.
The label states: Do not use unless solution is clear and free from particles.

4.5

Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.

4.6

Fertility, pregnancy and lactation
The safety of this solution during pregnancy and lactation has not been established,
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 vein is always a possibility with intravenous infusion.
Rapid infusion may cause sudden cardiac arrest for circulatory overloading.

4.9

Overdose
Overdosage may lead to fluid overload and electrolyte imbalance. The use of a
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.

5.2

Pharmacokinetic properties
Not applicable

5.3

Preclinical safety data
None

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Water for Injections in bulk BP
Hydrochloric Acid BP
Sodium Hydroxide BP

6.2

Incompatibilities
Incompatible with amikacin, amphotericin B, benzylpenicillin, dobutamine,
amiodarone, amsacrine, sodium nitroprusside, chlopheniramine maleate, tetracyclines
and phosphates.
Because of the nature of the plastic material of the Steriflex bag (PVC) this solution
must not be used as a vehicle for the administration of drugs which, may be sorbed to
the surface of the bag to varying and significant degrees.

6.3

Shelf life
500 & 1000ml PVC Bags - 24 months.
500 & 1000ml Polyolefin Bags - 36 months.

6.4

Special precautions for storage
Store at 2º to 25°C

6.5

Nature and contents of container
a)

A hermetically sealed polythene bag.

b)

A rectangular pouch consisting of polyamide/polythene composite

c)

Polyamide/Polyethylene-Propylene composite laminate welded to polypropylene
ethylene propylene composite, plugged with a polycarbonate plug with either a
bromobutyl (West 448 1/45) or gum (West 7006/45) stopper.

Or

A flexible 500 or 1000ml polyolefine bag sealed in a polyolefine overwrap.

6.6

Special precautions for disposal
Opening the overwrap:
Locate the corner tabs at the end of the bag. Grip the two tabs and pull the two halves
of the overwrap apart, releasing the bag onto a clean surface.
Setting up the solution:
Position the roller clamp of the giving-set to just below the drip chamber and close.
Hold the base of the giving set port firmly and grip the wings of the twist of tab.
Twist to remove the protective cover.
Still holding the base of the giving-set port push the set spike fully into the port to
ensure a leak proof connection.
Prime the set in accordance with the manufacturer’s instructions.

7

MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT

8

MARKETING AUTHORISATION NUMBER(S)
PL 08828/0063

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/05/1989 / 26/02/2009

10

DATE OF REVISION OF THE TEXT
26/09/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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