Document: Natriumklorid Meda solution for infusion ENG SmPC change

• Natriumklorid Meda solution for infusion SmPC
• Natriumklorid Meda solution for infusion ENG SmPC

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summary of the product characteristics

Natriumklorid Meda 9 mg/ml solution for infusion

1000 ml solution for infusion contains 9 g sodium chloride.

Electrolyte content per litre: Na⁺ 154 mmol, Cl^- 154 mmol.

For a full list of excipients, see section 6.1.

Solution for infusion

Clear, colourless sterile water solution.

Osmolarity: approx. 290 mOsm/l

pH: 4.5-7.0

For the treatment of:

• isotonic extracellular dehydration

• hypovolaemia

Is also used as:

For intravenous use.

Individual dosage is dependent on the age, body weight and clinical condition of the patient. The product is administered at the rate required by the clinical condition. 1 g of sodium chloride corresponds to 17 mmol of sodium.

Overhydration

Decompensated cardiac insufficiency

Hypernatraemia, hyperchloraemia

Caution should be exercised in patients with impaired cardiac function, severely impaired renal function, hypokalaemia, hyperkalaemia, and in clinical conditions associated with oedema and sodium retention, such as cirrhosis of the liver. Dependent on the condition of the patient and the dosage, frequent monitoring of serum electrolyte levels and fluid and acid-base balance may be required.

Premature or term infants may retain an excess of sodium due to immature renal function. In premature or term infants repeated infusions of sodium chloride should therefore only be given after determination of the serum sodium levels.

None known.

Can be used during pregnancy and lactation.

Not applicable.

Excessive administration of sodium may lead to hypernatraemia, peripheral oedema and pulmonary oedema.

Thrombophlebitis.

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.*

Sodium retention can be treated with a suitable injectable diuretic.

Pharmacotherapeutic group: Electrolytes.

ATC code: B05B B01

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Water for injections.

Can be used as a diluent for medicinal products administered intravenously, where it is recommended.

100 ml: 1 year

250 ml: 18 months

500 ml, 1000 ml, 2000 ml, 2500 ml: 2 years.

From a microbiological point of view, the product should be used immediately after first opening or following reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C unless opening has taken place in controlled and validated aseptic conditions.

No special precautions for storage.

Soft plastic container (Propyflex) with an inner layer consisting of ethylene-vinyl acetate in an overpouch consisting of polypropylene/nylon/ethylene-vinyl acetate.

24 x 100 ml, 15 x 250 ml, 12 x 500 ml, 9 x 1 000 ml, 4 x 2 000 ml, 4 x 2500 ml, 40 x 2 000 ml, 40 x 2500 ml, 240 x 2000 ml and 160 x 2500 ml.

Not all package sizes may be marketed.

The product should be handled with care. This applies in particular to the large volume pack sizes. The product should not be used if there is appearance of leaking or obviously damaged parts of the container.

Any unused solution should be discarded.

Meda AB

Box 906

SE-170 09 Solna

Sweden

15465

1999-11-19/2009-11-19

2016-09-22