CALCIUM GLUCONATE Sterile injection (2015)
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Περιεχόμενα
Name of the medicinal product
Calcium Gluconate Injection BP.
Qualitative and quantitative composition
9.5% of Calcium Gluconate in 10ml. Each 1 ml of solution contains 95 mg calcium gluconate, equivalent to 0.22 mmol calcium. Each 10 ml of solution contains 950 mg of calcium gluconate, equivalent to 2.2 ...
Pharmaceutical form
Sterile Injection.
Therapeutic indications
Properties Calcium is an essential body electrolyte. It is necessary for the functional integrity of nerve and muscle and is essential for the muscle contraction, cardiac function and coagulation of the ...
Posology and method of administration
The normal concentration of calcium in plasma is within the range of 2.25-2.75 mmol or 4.5-5.5 mEq per litre. Treatment should be aimed at restoring or maintaining this level. During therapy, serum calcium ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; Patients with severe renal failure; Patients with hypercalcaemia (e.g. in hyperparathyroidism, hypervitaminosis ...
Special warnings and precautions for use
Special warnings Plasma calcium levels and calcium excretion should be monitored when calcium is administered parenterally, especially in children, in chronic renal failure or where there is evidence of ...
Interaction with other medicinal products and other forms of interaction
Cardiac glycosides: The effects of digoxin and other cardiac glycosides may be potentiated by calcium, which may result in serious toxicity. Therefore, intravenous administration of calcium preparations ...
Fertility, pregnancy and lactation
Pregnancy Calcium passes across the placental barrier and its concentration in foetal blood is higher than in maternal blood. Calcium Gluconate Injection BP should not be used during pregnancy unless the ...
Effects on ability to drive and use machines
None.
Undesirable effects
The frequency of undesirable effects listed below is defined using the following convention: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1,000 to <1/100, Rare ≥1/10,000 to <1/1,000, Very rare ...
Overdose
Symptoms Symptoms of hypercalcaemia may include: anorexia, nausea, vomiting, constipation, abdominal pain, polyuria, polydipsia, dehydration, muscle weakness, bone pain, renal calcification, drowsiness, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Solutions affecting the electrolyte balance, electrolytes ATC code: B05BB01 Calcium is the most abundant mineral in the human organism (approx. 1.5% of the entire body weight). ...
Pharmacokinetic properties
Distribution After injection the administered calcium shows the same distribution behaviour as the endogenous calcium. About 45-50% of the total plasma calcium is in the physiologically active ionised ...
Preclinical safety data
No further information other than that which is included in the Summary of Product Characteristics.
List of excipients
Calcium D Saccharate USP Water for Injections Ph. Eur.
Incompatibilities
Calcium salts can form complexes with many drugs, and this may result in a precipitate (See section 4.4). Calcium salts are incompatible with oxidising agents, citrates, soluble carbonates, bicarbonates, ...
Shelf life
Shelf life: 36 months.
Special precautions for storage
Store at less than 25°C.
Nature and contents of container
Type I clear glass ampoule, 10ml. Packed in cardboard cartons to contain 10 ampoules x 10ml.
Special precautions for disposal and other handling
Use as directed by a physician.
Marketing authorization holder
hameln pharmaceuticals ltd, Gloucester, UK
Marketing authorization number(s)
PL 01502/0038
Date of first authorization / renewal of the authorization
12/08/83 –28/11/2000
Date of revision of the text
22/12/2015
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