MULTIBIC Solution for haemodialysis/haemofiltration (2017)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

multiBic potassium-free solution for haemodialysis/haemofiltration. multiBic 2 mmol/l potassium solution for haemodialysis/haemofiltration. multiBic 3 mmol/l potassium solution for haemodialysis/haemofiltration. ...

2. Qualitative and quantitative composition

multiBic potassium-free/2/3/4 mmol/l potassium is provided in a two-compartment bag with 4750 ml of an alkaline hydrogen carbonate solution in one compartment and 250 ml of an acidic electrolyte, glucose ...

3. Pharmaceutical form

Solution for haemodialysis/haemofiltration. The ready-to-use solution is clear and colourless. Theoretical osmolarity: multiBic potassium-free 292 mOsm/l multiBic 2 mmol/l potassium 296 mOsm/l multiBic ...

4.1. Therapeutic indications

multiBic potassium-free/2/3/4 mmol/l potassium is indicated for intravenous use as substitution solution in haemofiltration and haemodiafiltration, and as dialysis solution in haemodialysis and haemodiafiltration. ...

4.2. Posology and method of administration

Continuous renal replacement therapy including the prescription of this medicinal product should be performed under the direction of a physician with experience in these treatments. Posology In acute kidney ...

4.3. Contraindications

Solution related contraindications multiBic potassium-free/2/3 mmol/l potassium: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Hypokalaemia Metabolic alkalosis ...

4.4. Special warnings and precautions for use

Use only after mixing of the two solutions. multiBic potassium-free/2/3/4 mmol/l potassium should be warmed prior to use with appropriate equipment to approximately body temperature and must not be used ...

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

No interaction studies have been performed. The correct dose of multiBic potassium-free/2/3/4 mmol/l potassium and strict monitoring of clinical chemistry parameters and vital signs will avoid risks related ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of multiBic potassium-free/2/3/4 mmol/l potassium in pregnant women. Animal studies are insufficient with respect to reproductive toxicity ...

4.7. Effects on ability to drive and use machines

Not relevant.

4.8. Undesirable effects

Adverse reactions may result from the treatment mode itself or may be induced by this medicinal product: Gastrointestinal disorders - nausea, vomiting Vascular disorders - hypertension, hypotension ...

4.9. Overdose

After use of recommended doses no reports of emergency situations have arisen; moreover, the administration of this medicinal product can be discontinued at any time. If fluid balance is not accurately ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Haemofiltrates ATC code: B05ZB Mechanism of action Basic principles of haemodialysis, haemofiltration and haemodiafiltration: During haemofiltration water and solutes ...

5.2. Pharmacokinetic properties

This medicinal product must only be administered intravenously or used as haemodialysis solution. Distribution / Biotransformation / Elimination The distribution of electrolytes and bicarbonate is regulated ...

5.3. Preclinical safety data

There are no preclinical data of relevance to the prescriber.

6.1. List of excipients

Small compartment: Water for injections Hydrochloric acid 25% Large compartment: Water for injections Carbon dioxide Sodium dihydrogen phosphate dihydrate

6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3. Shelf life

2 years. Storage conditions after mixing of the two compartments (ready-to-use solution): Chemical and physical in-use stability of the ready-to-use solution has been demonstrated for 48 hours at 30°C. ...

6.4. Special precautions for storage

Do not store below +4°C.

6.5. Nature and contents of container

Double chamber bag with 4750 ml (alkaline hydrogen carbonate solution) + 250 ml (acidic electrolyte, glucose solution) = 5000 ml (ready-to-use solution). The foil used for the bag is made of polyethylene-terephthalate, ...

6.6. Special precautions for disposal and other handling

Do not use unless the ready-to-use solution is clear and colourless and the bag and connectors are undamaged. For single use only. Any unused solution must be discarded. Must be used by means of metering ...

7. Marketing authorization holder

Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany

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