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Toxicological information

Additional toxicological data

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Administrative data

Endpoint:
additional toxicological information
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Approach to Hyperkalemia
Author:
Lim, S.
Year:
2007
Bibliographic source:
Acta Med Indones-Indones J Intern Med., Vol 39, Number 2, April - June 2007; pp. 99-103.

Materials and methods

Type of study / information:
Cliconical parctice aboute use of Calcium gluconate.
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Treatment of hyperkalemia is dercibed.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): calcium gluconate.

Results and discussion

Applicant's summary and conclusion

Conclusions:
10 mL of 10% Calcium gluconate is used by treatment of severe hyperkalemia.
Executive summary:

"Hyperkalemia is commonly found in hospitalized patients. Given the fact that untreated hyperkalemia is associated with high morbidity and mortality, it is critical to recognize and treat this disorder promptly. Patients at greatest risk for hyperkalemia include those with diabetes or impaired renal function, those with advanced age and those receiving drugs which interfere with renal potassium excretion. Hyperkalemia is likely to become an even more common clinical event, since ACE inhibitors, angiotensin-receptor blockers and aldosterone antagonists are increasingly being used in higher doses and in combination, in the belief that these measures provide additional cardiovascular and renal protection. The urgency of hyperkalemia treatment is dictated by the change in electrocardiogram. Treatment of hyperkalemia includes calcium gluconate, insulin, beta agonists, sodium bicarbonate, cation exchange resin, diuretics and/or dialysis".

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