0,9% 5F 5ML

SODIUM CHLORIDE S.A.L.F. 0,9% SOLVENTE FOR PARENTERAL USE

active ingredients

100 ml of solution contain: Active ingredient: sodium chloride 0.9 g mEq/ml: Nana⁺ 0.154 mEq/ml: C^- 0.154 theoretical osmolarity (mOsm/l): 308 pH: 4.5 - 7,0 For the full list of excipients, see paragraph 6.1.

Excellent

Water for injectable preparations.

Therapeutic indications

Equipment of injectable preparations.

Contraindications

Hypernatremia. Pletore hydrosaline. For contraindications, it is also referred to the CPR on the medicinal product that is intended to administer.

Population

Use for solutions, dilutions or temporary suspensions of injectable medicines or other sterile preparations. Choose the volume to be used according to the dilution requirements of the injectable preparation.

Conservation

Store in hermetically closed container. Do not freeze or refrigerate. For conditions of conservation after dilution with the drug to be administered, please refer to paragraph 6.4 of the Summary of the characteristics of the product of the drug that you intend to administer.

Warnings

Sodium salts should be administered with caution in patients with hypertension, heart failure, peripheral or lung edema, reduced kidney function, pre-eclampsia, or other conditions associated with sodium retention (see paragraph 4.5). The solution must be clear, colourless and free of visible particles. Use immediately after opening the container and make sure that the preparation takes place as soon as possible in conditions and according to procedures that take as much as possible the sterility of the solution. Any unused medicinal product must be eliminated.

Interactions

Corticosteroids are associated with sodium and water retention, resulting in edema and hypertension: therefore, it is necessary to use caution in the contemporary administration of sodium salts and corticosteroids (see paragraph 4.4). Although chloride sodium is compatible with a high number of medicines, please refer to the CPR on the medicinal product you intend to administer in order to verify its compatibility.

Effects

The undesirable effects following the administration of chloride sodium are mainly related to disorders of the water and electrolytic balance (hypernatriemia, hyperchloremia, hypervolemia) and problems related to the administration site (infusion infection, pain or local reaction, venous irritation, thrombosis or venous phlebite extending from the infusion site, extravaso). For undesirable effects, we also refer to the CPR regarding the drug you intend to administer.

Overdosing

The administration of excessive doses of chloride sodium solutions can lead, depending on the patient's clinical condition, to hypernatriemia, hyperchloremia and/or hypervolemia. For overdosing, we also refer to the CPR on the medicinal product that is intended to administer.

Although there is no evidence of the effects on the development of the fetus, the medicinal product should only be administered in case of actual need and only after assessing the risk/benefit ratio. The medicine is compatible with breastfeeding. For precautions to be taken in case of pregnancy and breastfeeding, we also refer to the CPR on the medicinal product that is intended to administer.

Source: Farmadati