RESONIUM A Powder (2019)

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Περιεχόμενα

1. Name of the medicinal product

Resonium A.

2. Qualitative and quantitative composition

Contains Sodium Polystyrene Sulfonate 99.934% w/w.

3. Pharmaceutical form

Buff coloured powder.

4.1. Therapeutic indications

Resonium A is an ion-exchange resin that is recommended for the treatment of hyperkalaemia associated with anuria or severe oliguria. It is also used to treat hyperkalaemia in patients requiring dialysis ...

4.2. Posology and method of administration

Resonium A is for oral or rectal administration only. The dosage recommendations detailed in this section are a guide only; the precise requirements should be decided on the basis of regular serum electrolyte ...

4.3. Contraindications

In patients with plasma potassium levels below 5mmol/litre. History of hypersensitivity to polystyrene sulfonate resins. Obstructive bowel disease. Resonium A should not be administered <b>orally</b> to ...

4.4. Special warnings and precautions for use

Binding to other orally administered medications Resonium A may bind to orally administered medications, which could decrease their gastrointestinal absorption and efficacy. Avoid co-administration of ...

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

Orally administered medications Resonium A has the potential to bind to other orally administered medications. Binding of Resonium A to other oral medications could cause decrease in their gastrointestinal ...

4.6. Pregnancy and lactation

No data are available regarding the use of polystyrene sulfonate resins in pregnancy and lactation. The administration of Resonium A in pregnancy and during breast feeding therefore is not advised unless, ...

4.7. Effects on ability to drive and use machines

There are no specific warnings.

4.8. Undesirable effects

Metabolism and nutrition disorders In accordance with its pharmacological actions, the resin may give rise to sodium retention, hypokalaemia and hypocalcaemia, and their related clinical manifestations ...

4.9. Overdose

Biochemical disturbances from overdosage may give rise to clinical signs of symptoms of hypokalaemia, including irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia and eventual ...

5.1. Pharmacodynamic properties

Resonium A is a cation exchange resin for the treatment of hyperkalaemia.

5.2. Pharmacokinetic properties

Ion exchange resins with a particle size ranging from 5-10 micrometres (as in Resonium A) are not absorbed from the gastro-intestinal tract and are wholly excreted in the faeces.

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.1. List of excipients

<u>Resonium A also contains:</u> saccharin and vanillin.

6.2. Incompatibilities

There are no specific incompatibilities.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

None stated.

6.5. Nature and contents of container

Supplied in HDPE containers with LDPE tamper evident closures containing 454g Resonium A together with a plastic scoop, which, when filled level, contains approximately 15g.

6.6. Special precautions for disposal and other handling

Refer to 4.2. Posology and method of administration.

7. Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

8. Marketing authorization number(s)

PL 04425/0178

9. Date of first authorization / renewal of the authorization

2 April 2003

10. Date of revision of the text

09/08/2019

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