Sodium Chloride 0.9%

Solvent for Parental Use

NAME OF THE MEDICINAL PRODUCT

Sodium chloride SALF 0.9% solvent for parenteral use.

QUALITATIVE AND QUANTITATIVE COMPOSITION

100 ml of solution contain: Active ingredient: sodium chloride 0.9 g mEq / ml: Na + 0.154 mEq / ml: Cl- 0.154 Theoretical osmolarity (mOsm / l): 308 pH: 4.5 - 7.0 For the list full of excipients, see section 6.1. 3.

PHARMACEUTICAL FORM

Solvent for isotonic parenteral use with blood.

CLINICAL INFORMATION

1. Therapeutic indications Preparation of injectable preparations.

2. Posology and method of administration Use for extemporaneous solutions, dilutions or suspensions of injectable medicaments or other sterile preparations. Choose the volume to be used based on the dilution needs of the injectable preparation.

3. Contraindications Hypernatremia. Hydrosaline flask. For contraindications, please refer also to the SmPC relating to the medicinal product you intend to administer.

Special warnings and precautions for use

Sodium salts should be administered with caution in patients with hypertension, heart failure, peripheral or pulmonary edema, impaired renal function, pre-eclampsia, or other conditions associated with sodium retention (see section

The solution should be clear, colorless and free from visible particles. Use immediately after opening the container and make sure that the preparation takes place in the shortest possible time under conditions and according to procedures that preserve the sterility of the solution as much as possible. Any remaining unused medicine should be discarded.

Interactions with other medicinal products and other forms of interaction Corticosteroids are associated with sodium and water retention, resulting in edema and hypertension: therefore, caution should be exercised in concomitant administration of sodium salts and corticosteroids (see section

Although sodium chloride is compatible with a large number of medicines, please refer to the SmPC relating to the medicine you intend to administer, in order to verify its compatibility.

Pregnancy and lactation Although no effects on the development of the fetus have been shown, the medicine should be administered only in case of real need and only after evaluating the risk / benefit ratio. The medicine is compatible with breastfeeding. For the precautions to be taken in the event of pregnancy and breastfeeding, please refer also to the SmPC relating to the medicinal product you intend to administer.

Format: 100ml