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Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use

Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use

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Sodium chloride SALF 0.9% is a sterile isotonic physiological solution in 5 vials of 10 ml , indicated as a solvent for parenteral use in the preparation of injectable preparations . Ideal for diluting injectable drugs and preparing solutions or suspensions for intravenous or intramuscular administration, it guarantees high purity , sterility and excellent tissue compatibility .

NET WEIGHT OF THE PRODUCT

EAN

030684423

MINSAN

030684423

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Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use is an isotonic physiological solution specifically formulated for the preparation of injectable preparations . Each pack contains 5 vials of 10 ml of sterile solution , ideal as a solvent for parenteral use in both hospital and outpatient settings. The product is composed of 0.9% sodium chloride (NaCl), with a concentration of Na+ 0.154 mEq/ml and Cl- 0.154 mEq/ml , guaranteeing an osmolarity of 308 mOsm/l and a pH between 4.5 and 7.0 , optimal parameters for compatibility with human tissues.

This SALF physiological solution is indicated for the dilution of injectable drugs and for the preparation of extemporaneous solutions or suspensions intended for intravenous or intramuscular administration . Thanks to its high purity and sterility , it represents a safe and reliable choice for all injectable preparation needs. The product is classified as an over-the-counter drug and does not require a prescription, making it practical and easily accessible for parenteral use needs in the healthcare sector.

Sodium chloride SALF 0.9% is the ideal solution for those looking for a ready-to-use injectable solution , compliant with the quality and safety standards required for injectable preparations . Its isotonic formulation ensures maximum compatibility with drugs and tissues, making it a universal solvent for multiple clinical applications.


ACTIVE INGREDIENTS

Active ingredients contained in Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use - What is the active ingredient of Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use?

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 full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use - What does Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use contain?

Water for injections.

DIRECTIONS

Therapeutic indications Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use - Why is Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use used? What is it used for?

Preparation of injectable preparations.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use - When should Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use not be used?

Hypernatremia. Hydrosaline plethora. For contraindications, please also refer to the RCP relating to the medicinal product you intend to administer.

DOSAGE

Quantity and method of administration of Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use - How is Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use taken?

Use for extemporaneous solutions, dilutions or suspensions of injectable medications or other sterile preparations. Choose the volume to be used based on the dilution needs of the injectable preparation.

CONSERVATION

Storage Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use - How is Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use stored?

Store in a tightly closed container. Do not freeze or refrigerate. For storage conditions after dilution with the drug to be administered, see paragraph 6.4 of the Summary of Product Characteristics of the drug to be administered.

WARNINGS

Warnings Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use - It is important to know that Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use:

Sodium salts should be administered with caution in patients with hypertension, heart failure, peripheral or pulmonary oedema, impaired renal function, pre-eclampsia, or other conditions associated with sodium retention (see section 4.5). The solution should be clear, colourless and free from visible particles. Use immediately after opening the container and ensure that preparation is carried out as quickly as possible under conditions and according to procedures that preserve the sterility of the solution as much as possible. Any unused medicinal product remaining should be discarded.

INTERACTIONS

Interactions Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use - Which medicines or foods can modify the effect of Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use?

Corticosteroids are associated with sodium and water retention, resulting in oedema and hypertension: therefore, caution should be exercised when sodium salts are administered concomitantly with corticosteroids (see section 4.4). Although sodium chloride is compatible with a large number of medicinal products, please refer to the SPC of the medicinal product you intend to administer to verify compatibility.

SIDE EFFECTS

Like all medicines, Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use can cause side effects - What are the side effects of Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use?

Undesirable effects following the administration of sodium chloride are mainly related to water and electrolyte balance disorders (hypernatremia, hyperchloremia, hypervolemia) and problems related to the site of administration (infection at the infusion site, pain or local reaction, venous irritation, thrombosis or venous phlebitis extending from the infusion site, extravasation). For undesirable effects, please also refer to the RCP relating to the drug you intend to administer.

OVERDOSE

Overdose Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use - What are the risks of Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use in case of overdose?

The administration of excessive doses of sodium chloride solutions may lead, depending on the clinical conditions of the patient, to hypernatremia, hyperchloremia and/or hypervolemia. For overdose, please also refer to the RCP relating to the medicinal product you intend to administer.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use.

Although no effects on fetal development have been observed, the medicine should be administered only if really necessary and only after evaluating the risk/benefit ratio. The medicine is compatible with breastfeeding. For precautions to be taken in case of pregnancy and breastfeeding, please also refer to the RCP relating to the medicine you intend to administer.

DRIVING AND USE OF MACHINERY

Taking Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use before driving or using machines - Does Sodium chloride SALF 0.9% 5×10 ml solvent for parenteral use affect driving or using machines?

The medicinal product does not affect the ability to drive or use machines. For effects on the ability to drive and use machines, please also refer to the RCP of the medicinal product you intend to administer.
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