Sodium chloride LSG 20% EIF, 5x10 ml

Instructions for use for Sodium chloride LSG 20% EIF, 5x10 ml

Important notes (compulsory information):

Sodium chloride solution 20% Eifelango infusion solution concentrate. Areas of application: reduced sodium content of the blood (hyponatremia); reduced chloride content of blood (hypochloremia); Hypotone hyperhydration.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Sodium chloride solution 20% Eifelango infusion solution concentrate

Dear user, dear user!
Please read the following useful information because it contains important information about what you should consider when using this medicine. For questions, please contact your doctor or pharmacist.

Cloth or indicator group:
Electrolyte concentrate. 1 ml contains: 3.42 mmol Na + and 3.42 mmol CL-.

Application areas:

• Reduced sodium content of blood (hyponatremia);
• reduced chloride content of blood (hypochloremia);
• hypotone hyperhydration.

Contraindications:
Absolute counterpart: Waxing states (isotons, hypertone hyperhydratation states).
Relative contraindications:

• reduced potassium content of blood (hypocalemia)
• increased sodium content of the blood (hyperremia)
• increased chloride content of blood (hyperchloremia)
• Diseases that provide restrictive sodium supply (e.g., Heart insufficiency, generalized edema, pulmonary edema, hypertension, ecclipsy, heavy renal insufficiency).

Use in pregnancy and lactation:
There are no concerns about an application in pregnancy and lactation.

Precautions for the application:
Checks of electrolyte and liquid status are required.

Interactions with other means:
Interactions are not known yet.

Warnings:
No.

Instruction of dosage and kind of usage:
For the specific correction of existing deficits, the following formula can serve as a gross indication: Na + deficit (mmol) = (Na + - Na + is) x kg body mass x 0.2. (The extracellular volume is calculated from body mass in kilograms x 0.2). Maximum infusion rate: depends on the clinical situation. Maximum daily dose: The maximum daily dose is determined by the liquid and electrolyte requirements. Adults applies a guideline of 3 - 6 mmol sodium / kg body mass, for children from 3 - 5 mmol sodium / kg body mass. The concentrate must not be used undiluted, but only as an additive to infusion solutions.

Notes in the case of overdose:
The symptoms of overdose are:

• Ventilation
• increased sodium and chloride content of the blood (hyperremia, hyperchloremia)
• Hyperosmolarity
• Induction of a azidic substance change.

A too fast administration of a hypertone solution can lead to acute volume load, nausea, vomiting, diarrhea and hypertonic crisis.

Therapy:
Interruption of the supply of the solution, accelerated elimination over the kidneys and a corresponding negative accounting.

Side effects:
Increased sodium and chloride content of the blood. For too fast infusion, especially with concentrated solutions, it may result in acute volume problems as well as to osmotic urinary excretion and diarrhea due to the high electrolyte concentration and the associated osmotic load. Due to the high osmolarity, the highly concentrated solutions can lead to faster and undiluted administration for the venous irritation with subsequent venous warditis and thrombophinebitis.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the BU directlyndesinstitut for drugs and medical devices Dept. Pharmacovigilance Kurt-Georg-Kiesinger Allee 3 53175 Bonn Website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

Notes on the durability of the medicinal product:

• Sodium chloride solution 20% Eifelango may no longer be used after expiry of the expiry date.
• Only use clear solutions in intact containers.
• Opened containers are intended for immediate consumption. Unused content should be discarded.
• Store drug out of reach of children!

Notes on the production of mixed solutions:

• The production of parenteral solutions must be carried out under the in clinic and practice to safeguard the sterility hygienic conditions.
• In the admirement of drugs, the ready-to-use solution for incompatibilities, e.g. Defendants and clarifications to check.
• Solutions with the addition of drugs must not be stored.
• Store drug out of reach of children!

Composition:
Pharmacically effective components: 1000 ml included: sodium chloride 200.0 g. Other ingredients: water for injections, hydrochloric acid for pH adjustment. Titrationacidity to pH 7.4: < 0.3 mmol / l. Theoretical osmolarity: 6844 mosm / l. PH value: 4.5 - 7.0.

Dosage form and content:
Infusion solution concentrate in ampoules to 10 ml. Packs with 5, 10, 50 and 100 ampoules to 10 ml.

Pharmaceutical entrepreneur and manufacturer:
Eifelango - chemical pharmaceutical plant GmbH & Co. KG
Ringener Straße 45
53474 Bad Neuenahr-Ahrweiler
Telephone: 02641/36061
Fax: 02641/34056
E-Mail: [email protected]
Internet: www.eifelango.de

Status of Information: August 2014.

Source: Information of the leaflet
Status: 04/2016