When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
SPC Changes
Section 4.3. Contra-indications
Deleted: Calcium chloride injection is contraindicated for injection into tissue (subcutaneous or intramuscular) as it may cause necrosis and sloughing.
Added: Calcium chloride should not be mixed or co-administered with ceftriaxone to any patient irrespective of age, even via different infusion lines at different sites. IV calcium containing solutions should not be administered with ceftriaxone within 48 hours of each other in any patient.
Added: The treatment of asystole and electromechanical dissociation.
Added: Hypersensitivity to any component.
Added:Calcium chloride injection is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur. Great care should be taken to avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, IV administration at that site should be discontinued at once. Local infiltration of the affected area with 1 % procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. Local application of heat may also be helpful.
4.5. Interactions with other Medicaments and other forms of Interaction
Added:Due to the risk of intravascular or pulmonary precipitations in patients, ceftriaxone and calcium-containing solutions, including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites. IV calcium-containing solutions should not be administered with ceftriaxone within 48 hours of each other in any patient.
Added: No data are available on potential interaction between IV calcium chloride and IM ceftriaxone.
Added: Calcium-containing products may decrease the effectiveness of calcium channel blockers.
4.8. Undesirable Effects
Added:Hypertension
Added: Venous thrombosis
Added: Hypercalcemia
4.9. Overdose
Added: Cardiac arrhythmia and cardiac arrest may occur.
10.Date of Revision of the Text
Changed to: July 2009