| In Section 4.2 addition of:
"Renal function declines with age and prior to prescribing this product to elderly patients it should be considered that Calcium Gluconate injection is contraindicated (See section 4.3) for repeated or prolonged administration in patients with impaired renal function. "
In Section 4.3 addition of:
"Aluminium oxide can be leached from ampoule glass by Calcium Gluconate. In order to limit the exposure of patients to aluminium, especially those with impaired renal function and children (less than 18 years of age), hameln pharmaceuticals ltd Calcium Gluconate Injection BP is not intended for use in the preparation of Total Parenteral Nutrition (TPN).
This product should not be used for repeated or prolonged treatment, including as an intravenous infusion, in children (less than 18 years of age) and those with impaired renal function, due to the risk of exposure to aluminium.
Calcium Gluconate Injection must not be co-administered with ceftriaxone in:
· premature newborns up to a corrected age of 41 weeks (weeks of gestation + weeks of life),
· full-term newborns (up to 28 days of age)
because of the risk of precipitation of ceftriaxone- calcium (see section 4.4, 4.8 and 6.2)"
In Section 4.4 addition of:
"Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than newborns, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products. In vitro studies demonstrated that newborns have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups.
In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions, even via different infusion lines or at different infusion sites.
However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation. (see sections 4.3, 4.8, and 6.2)."
In Section 4.8 addition of:
"Rarely, severe, and in some cases fatal, adverse reactions have been reported in preterm and full-term newborns (aged <28 days) who had been treated with intravenous ceftriaxone and calcium.
Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem. The high risk of precipitation in newborns is due to their low blood volume and the longer half life of ceftriaxone compared with adults (see sections 4.3 and 4.4)."
In Section 6.2 addition of:
"Ceftriaxone"
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