HEMOSOL B0 Solution for haemodialysis / haemofiltration (2022)
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Περιεχόμενα
1. Name of the medicinal product
Hemosol B0 solution for haemodialysis/haemofiltration.
2. Qualitative and quantitative composition
Hemosol B0 consists of a two compartment PVC bag containing the electrolyte solution in the small compartment (compartment A) and the buffer solution in the large compartment (compartment B). BEFORE RECONSTITUTION ...
3. Pharmaceutical form
Solution for haemodialysis/haemofiltration. Clear and colourless reconstituted solution. Theoretical Osmolarity: 287 mOsm/l
4.1. Therapeutic indications
As substitution solution in continuous haemofiltration and haemodiafiltration and as dialysis solution in continuous haemodialysis for acute renal failure in adult and children of all ages.
4.2. Posology and method of administration
Posology The rate at which Hemosol B0 is administered depends on the blood concentration of electrolytes, acid-base balance, fluid balance and overall clinical condition of the patient. The volume of replacement ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Warnings The substitution solution Hemosol B0 is potassium-free. The serum potassium concentration must be monitored before and during hemofiltration and/or hemodialysis. The electrolyte solution <b>must ...
4.5. Interaction with other medicinal products and other forms of interaction
The blood concentration of filterable/dialysable drugs may be reduced during treatment. Corresponding corrective therapy should be instituted if necessary to establish the desired blood concentrations ...
4.6. Fertility, pregnancy and lactation
Pregnancy and breastfeeding No effects during pregnancy or on the breast-fed newborn/infant are anticipated. There is no report on Hemosol B0 during pregnancy or lactation but literature on renal replacement ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
The following undesirable effects are reported from post-marketing experience. The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies: ...
4.9. Overdose
Overdose with Hemosol B0 substitution fluid should not occur if the procedure is carried out correctly and the fluid balance, electrolyte and acid-base balance of the patient are carefully monitored. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Hemofiltrates <b>ATC code:</b> B05ZB Pharmacodynamic effects Hemosol B0 is pharmacologically inactive. The sodium, calcium, magnesium and chloride ions are present at ...
5.2. Pharmacokinetic properties
Not relevant. The active ingredients are pharmacologically inactive and are present at concentrations similar to physiological plasma levels.
5.3. Preclinical safety data
Not relevant. The active ingredients are pharmacologically inactive and are present at concentrations similar to physiological plasma levels.
6.1. List of excipients
In the small compartment A: Water for injections In the large compartment B: Water for injections, Carbon dioxide
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. It is the responsibility of the physician to judge the incompatibility of an additive medication ...
6.3. Shelf life
1 year as packaged for sale. Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 22°C. From a microbiological point of view, once opened (i.e. connected ...
6.4. Special precautions for storage
Do not store below +4°C. For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5. Nature and contents of container
The container made in Polyvinyl chloride (PVC) is a two-compartment bag. The 5000 ml bag is comprised of a small compartment (250 ml) and a large compartment (4750 ml). The two compartments are separated ...
6.6. Special precautions for disposal and other handling
The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after breaking the frangible pin immediately before use to obtain the reconstituted solution. A patient ...
7. Marketing authorization holder
Baxter Holding B.V., Kobaltweg 49, 3542CE Utrecht, Netherlands
8. Marketing authorization number(s)
PA2299/051/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation:11 June 1999 Date of last renewal: 15 October 2014
10. Date of revision of the text
December 2020
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