Isotonic Nacl solution 0.9% Eifel fango, 5x50 ml

Instructions for use: Isotonic sodium chloride solution 0.9% Eifel fango, solution for infusion

Dear user, dear user!Please read the following leaflet carefully because it contains important information about what you should pay attention to when using this medicine.No prescription is required for this product.If you have any questions, please contact your doctor or pharmacist.

Substance or indication group

Electrolyte solution.1 ml contains: 0.154 mmol Cl-, 0.154 mmol Na+.

Areas of application

Fluid and electrolyte replacement in hypochloremic alkalosis;chloride losses;short-term intravascular volume replacement;hypotonic dehydration;isotonic dehydration.

Contraindications

Absolute contraindication: states of overhydration (hyperhydration).Relative contraindications: decreased potassium content in the blood (hypokalemia), increased sodium content in the blood (hypernatremia), increased chloride content in the blood (hyperchloremia), diseases that require restrictive sodium intake (e.g. heart failure, generalized edema, pulmonary edema, high blood pressure, eclampsia, severe renal insufficiency).

Use during pregnancy and breastfeeding

There are no concerns about use during pregnancy and breastfeeding.

Precautions for use

Electrolyte and fluid status checks are required.

Interactions with other agents

None are known so far.

Warnings

None.

Dosage instructions, type and duration of application

For intravenous infusion.The dosage usually depends on the fluid and electrolyte requirements (40 ml/kg body mass/day or 2 mmol sodium/kg body mass/day).The following guidelines apply: Maximum infusion rate: Depends on the clinical situation.Maximum daily dose: The maximum daily dose is determined by fluid and electrolyte requirements.For adults a value of 3-6 mmol sodium/kg body mass applies, for children it is 3-5 mmol sodium/kg body mass.In the case of hypertonic dehydration, an infusion rate that is too fast should be avoided (Caution: increase in plasma osmolarity and plasma sodium concentration).

If you have any questions about use, please contact your doctor or pharmacist.

Advice in case of overdose

The symptoms of an overdose are: overhydration, increased sodium and chloride content of the blood (hypernatremia, hyperchloremia), hyperosmolarity, induction of an acidotic metabolic state.

Therapy for overdose

Interruption of the supply of the solution, accelerated elimination via the kidneys and a reduced supply of the corresponding electrolytes.

Side effects

Increased sodium and chloride content in the blood (hypernatremia, hyperchloremia).

Reporting of side effects

If you notice any side effects, contact your doctor or pharmacist.This also applies to side effects that are not listed in this leaflet.

Information on the shelf life of the drug

You must not use the medicine after the expiry date stated on the carton and bottle label.Only use clear solutions in undamaged containers!Use solution immediately after opening!Discard remaining stock!

Composition

Medicinally active ingredients: 1000 ml contains sodium chloride 9.00 g.Other ingredients: Water for injections, hydrochloric acid for pH adjustment.Titration acidity up to pH 7.4: <0.1 mmol/l.Theoretical osmolarity: 309 mOsm/l.pH value: 4.5 - 7.0.

Dosage form and contents

Infusion solution in injection bottles of 50 and 100 ml;Packs of 1, 5, 10 and 20 bottles.

Pharmaceutical entrepreneur and manufacturer

Eifelfango Chemisch Pharmazeutisches Werk GmbH & Co. KG, Ringener Straße 45, 53474 Bad Neuenahr-Ahrweiler.

This leaflet was last revised in November 2015.