STEROFUNDIN Solution for infusion (2018)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

1. Name of the medicinal product

Sterofundin ISO, solution for infusion.

2. Qualitative and quantitative composition

1000 ml Sterofundin ISO solution for infusion contain: Sodium chloride 6.80 g Potassium chloride 0.30 g Magnesium chloride hexahydrate 0.20 g Calcium chloride dihydrate 0.37 g Sodium acetate trihydrate ...

3. Pharmaceutical form

Solution for infusion. A clear, colourless aqueous solution free from visible particles. pH: 5.1-5.9 Theoretical osmolarity: 309 mosm/l.

4.1. Therapeutic indications

Replacement of extracellular fluid losses in the case of isotonic dehydration, where acidosis is present or imminent.

4.2. Posology and method of administration

Posology Adults, the elderly, adolescents and children The dosage depends on the age, weight, clinical and biological conditions of the patient and concomitant therapy. Recommended dosage The recommended ...

4.3. Contraindications

Sterofundin ISO must not be administered in the following situations: Hypervolaemia Severe congestive cardiac failure Renal failure with oliguria or anuria Severe general oedema Hyperkalaemia Hypercalcaemia ...

4.4. Special warnings and precautions for use

High volume infusion must be used under specific monitoring in patients with mild to moderate cardiac or pulmonary failure (for more severe conditions: see Section 4.3). Solutions containing sodium chloride ...

4.5. Interaction with other medicinal products and other forms of interaction

Sodium, potassium, calcium, and magnesium are present in Sterofundin ISO in the same concentrations as in plasma. Hence, the administration of Sterofundin ISO in accordance with the recommended indications ...

4.6. Fertility, pregnancy and lactation

There are no data from the use of Sterofundin ISO in pregnant and lactating women. In the intended indication no risks have to be expected, when volume, electrolyte and acid/base levels are carefully monitored ...

4.7. Effects on ability to drive and use machines

Sterofundin ISO has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Signs of overdose may occur, see section 4.9. Definition of frequency terms used in this section: Rare: ≥1/10,000 to <1/1,000, Not known Frequency cannot be estimated from the available data. Immune ...

4.9. Overdose

Overuse or too fast administration may lead to water and sodium overload with a risk of oedema, particularly when there is a defective renal sodium excretion. In this case extra renal dialysis may be necessary. ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Solutions affecting the electrolyte balance, electrolytes ATC code: B05BB01 This medicinal product is an isotonic electrolyte solution with electrolyte concentrations ...

5.2. Pharmacokinetic properties

Absorption Since the ingredients of Sterofundin ISO are infused intravenously their bioavailability is 100%. Distribution and Elimination Sodium and chloride mainly distribute in the extracellular space, ...

5.3. Preclinical safety data

No preclinical studies have been conducted with Sterofundin ISO. There are no data of relevance to the prescriber additional to those already included elsewhere in the SPC.

6.1. List of excipients

Water for injections Sodium hydroxide (for pH adjustment)

6.2. Incompatibilities

Admixture of the medicinal product with medications containing carbonates, phosphates, sulphates or tartrates may lead to precipitation.

6.3. Shelf life

Shelf life of the medicinal product as packaged for sale: in glass bottles and polyethylene plastic bottles: 3 years in plastic bags: 2 years Shelf life after first opening of the container: From a microbiological ...

6.4. Special precautions for storage

Glass bottles and Polyethylene plastic bottles: Do not refrigerate or freeze. Plastic bags: Do not store above 25°C. Do not refrigerate or freeze.

6.5. Nature and contents of container

The solution for infusion is packed in: type II glass bottles with butyl rubber stoppers containing 250 ml, 500 ml or 1000ml, available in packs of 1 or 10 bottles (250 ml and 500 ml) or of 1 or 6 bottles ...

6.6. Special precautions for disposal and other handling

Only for intravenous use. Single use only. Do not reconnect partially used containers. Unused solution should be discarded. Do not use if container or closure is damaged. Only clear solutions practically ...

7. Marketing authorization holder

B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen, Germany, Phone: +49 5661 71 0, Fax: +49 5661 71 4567

10. Date of revision of the text

February 2018

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf