EXTRANEAL Solution for peritoneal dialysis (2021)
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Περιεχόμενα
1. Name of the medicinal product
EXTRANEAL (Icodextrin 7.5%). Solution for peritoneal dialysis.
2. Qualitative and quantitative composition
A sterile peritoneal dialysis fluid containing Icodextrin at a concentration of 7.5% w/v in an electrolyte solution. Icodextrin 75 g/L Sodium Chloride 5.4 g/L Sodium S-Lactate 4.5 g/L Calcium Chloride ...
3. Pharmaceutical form
Solution for peritoneal dialysis. Extraneal is a sterile, clear, colorless solution.
4.1. Therapeutic indications
Extraneal is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) regimen for the treatment ...
4.2. Posology and method of administration
Posology Extraneal is recommended for use during the longest dwell period, i.e. in CAPD usually overnight and in APD for the long daytime dwell. The mode of therapy, frequency of treatment, exchange volume, ...
4.3. Contraindications
Extraneal should not be used in patients with: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 a known allergy to starch based polymers (e.g. maize starch) ...
4.4. Special warnings and precautions for use
Patients with diabetes mellitus often need additional insulin in order to maintain glycaemic control during Peritoneal Dialysis (PD). Transfer from glucose based PD solution to Extraneal may necessitate ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been conducted with EXTRANEAL. The blood concentrations of dialysable drugs may be reduced by dialysis. Corrective therapy should be instituted if necessary. Blood glucose measurement ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of Extraneal in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Extraneal is not recommended ...
4.7. Effects on ability to drive and use machines
End stage renal disease (ESRD) patients undergoing peritoneal dialysis may experience undesirable effects, which could affect the ability to drive or use machines.
4.8. Undesirable effects
Undesirable effects which occurred in patients treated with Extraneal from the clinical trials and post marketing are listed below. Extraneal associated skin reactions, including rash and pruritus, are ...
4.9. Overdose
No data are available on the effects of overdosage. However, continuous administration of more than one bag of Extraneal in 24 hours would increase plasma levels of carbohydrate metabolites and maltose. ...
5.1. Pharmacodynamic properties
<b>Code ATC:</b> B05DA Icodextrin is a starch-derived glucose polymer which acts as an osmotic agent when administered intraperitoneally for continuous ambulatory peritoneal dialysis. A 7.5% solution is ...
5.2. Pharmacokinetic properties
Carbohydrate polymer levels in blood reach steady state after about 7-10 days when used on a daily basis for overnight dialysis. The polymer is hydrolysed by amylase to smaller fragments which are cleared ...
5.3. Preclinical safety data
Acute toxicity Acute i.v. and i.p. studies in mice and rats have demonstrated no effects at doses up to 2000mg/kg. Subchronic toxicity Twice daily i.p. administration of 20% Icodextrin solution for 28 ...
6.1. List of excipients
Water for injections Sodium hydroxide or Hydrochloric acid q.s. to required pH.
6.2. Incompatibilities
None known. Drug compatibility must be checked before admixture. In addition, the pH and salts of the solution must be taken into account.
6.3. Shelf life
2 years. 12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only). The product, once removed from its overpouch should be used immediately.
6.4. Special precautions for storage
Do not store below 4°C. Do not use unless the solution is clear and the container undamaged.
6.5. Nature and contents of container
Flexible PVC container holding 1.5, 2.0 or 2.5 litres. 1.5 L 8 units per box Single bag Sy II (luer connector) 1.5 L 8 units per box Single bag Sy III (spike connector) 1.5 L 8 units per box Twin bag ...
6.6. Special precautions for disposal and other handling
For details see section 4.2 A range of antibiotics including vancomycin, cephazolin, ampicillin/flucloxacillin, ceftazidime, gentamycin, amphotericin and insulin have shown no evidence of incompatibility ...
7. Marketing authorization holder
Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
8. Marketing authorization number(s)
PL 00116/0266
9. Date of first authorization / renewal of the authorization
06/01/2012
10. Date of revision of the text
19/12/2021
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