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Calcium Gluconate 10%/10ml Ampoule (10)

Calcium Gluconate 10%/10ml Ampoule (10)

Calcium Gluconate

IM/IV Vitamins & Electrolytes
  • Prescription Only Medicine (POM) in the UK, with marketing authorisation (e.g. Calcium Gluconate 10% solution for injection/infusion BP, hameln pharma ltd; MA numbers such as PL 17589/0012 for comparable UK products).
  • Manufactured in compliance with Good Manufacturing Practice (GMP) for sterile injectable medicinal products.
  • Product characteristics and safety information aligned with the UK Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for Calcium Gluconate 10% solution for injection/infusion BP.
  • Supplied by Aesthetics RX Pharma to healthcare professionals as part of IM/IV and emergency medicine ranges, in line with UK medicines distribution regulations.
Injectable calcium replacement (10% solution for injection/infusion)

Description

Calcium Gluconate 10%/10ml Ampoules are a prescription-only, sterile injectable preparation used to provide rapid calcium supplementation in acute and controlled clinical settings. Each 10 ml glass ampoule contains a clear, colourless 10% w/v solution of calcium gluconate, equivalent to 950 mg of calcium gluconate (2.12 mmol calcium) plus calcium derived from calcium saccharate for a total calcium content of 2.23 mmol per ampoule. The product is indicated for the treatment of acute symptomatic hypocalcaemia, for cardioprotection in severe hyperkalaemia and cardiac arrest due to hyperkalaemia, and for hypocalcaemia associated with fluoride or lead poisoning. In aesthetic and wellness practice it is stocked as an emergency medicine to correct significant calcium disturbances under medical supervision. Each pack contains ten 10 ml ampoules, manufactured to high pharmaceutical standards to ensure purity, sterility and batch-to-batch consistency.

Bnefits

  • Provides rapid intravenous calcium replacement in acute symptomatic hypocalcaemia when oral therapy is insufficient or impossible.
  • Acts as a cardioprotective agent in severe hyperkalaemia and cardiac arrest due to hyperkalaemia by stabilising cardiac cell membranes.
  • Useful in the management of hypocalcaemia associated with fluoride or lead poisoning as part of specialist toxicology protocols.
  • Well-established safety and efficacy profile with extensive clinical experience in emergency, critical care and general hospital practice.
  • Standardised 10% solution with known elemental calcium content (2.23 mmol per 10 ml ampoule) enables predictable dosing under medical supervision.
  • Sterile, clear solution in sealed glass ampoules reduces contamination risk and supports safe administration when used correctly.
  • Pack of ten ampoules provides a convenient stock level for clinics, GP surgeries, pharmacies, emergency trolleys, crash carts and aesthetic practices that maintain emergency medicines.
  • Compatible with slow intravenous injection or dilution for infusion in accordance with the Summary of Product Characteristics and local protocols.

Indications

  • Acute symptomatic hypocalcaemia requiring rapid correction under hospital or specialist supervision.
  • Fluoride (e.g. hydrofluoric acid) or lead poisoning-induced hypocalcaemia, as part of specialist toxicology management.
  • Acute severe hyperkalaemia (with or without ECG changes) as an emergency cardioprotective treatment while definitive potassium-lowering measures are instituted.
  • Cardiac arrest caused by severe hyperkalaemia, where calcium gluconate is used to stabilise myocardial excitability.
  • Use as an injectable calcium source in patients with documented calcium deficiency when parenteral administration is clinically indicated and oral supplementation is unsuitable or insufficient.
  • In aesthetic and wellness environments, maintained as an emergency medicine for the management of severe hypocalcaemia or related electrolyte disturbances, strictly under the direction of a qualified prescriber.

Composition

  • Active substance: Calcium gluconate 10% w/v.
  • Each 1 ml of solution contains 95 mg calcium gluconate, equivalent to 0.21 mmol calcium.
  • Each 10 ml ampoule contains 950 mg calcium gluconate, equivalent to 2.12 mmol calcium.
  • Excipients with known effect: Calcium D-saccharate (providing an additional 0.11 mmol calcium per 10 ml), bringing the total calcium content to 0.22 mmol/ml (2.23 mmol/10 ml).
  • Other excipients: Water for injections.
  • Pharmaceutical form: Clear, colourless solution for injection/infusion, free from visible particles; pH approximately 6.0–7.0; osmolality approximately 270–310 mOsmol/kg.

Formulation

  • Concentration: 10% w/v solution for injection/infusion (100 mg calcium gluconate per ml).
  • Presentation: Sterile, non-pyrogenic, aqueous solution intended for slow intravenous injection and/or dilution for intravenous infusion.
  • Legal status (UK): Prescription Only Medicine (POM).

Packaging

  • Primary packaging: 10 ml clear glass ampoules containing Calcium Gluconate 10% solution for injection/infusion.
  • Each carton contains 10 ampoules (10 x 10 ml).
  • Ampoules are individually sealed to maintain sterility until use and are clearly labelled with product name, strength, batch number and expiry date.
  • Supplied in outer cartons designed to protect from light and facilitate organised storage in clinical environments.

Usage

  • For parenteral use only under the supervision of a suitably qualified healthcare professional familiar with intravenous calcium administration.
  • Administer by slow intravenous injection or by intravenous infusion after appropriate dilution with compatible fluids (e.g. sodium chloride 0.9% or glucose 5%), in accordance with the Summary of Product Characteristics and local institutional guidelines.
  • Continuous ECG and serum calcium monitoring are recommended during and after administration, particularly in patients with cardiac disease, renal impairment or severe electrolyte disturbances.
  • Ensure secure intravenous access; extravasation can cause severe local tissue injury including tissue necrosis. The injection site should be observed carefully throughout administration.
  • The patient should normally be in the supine position during administration to reduce the risk of hypotension and circulatory compromise.
  • Dosage, rate of administration and the need for repeat doses must be individually determined by the prescriber based on the clinical situation (e.g. acute hypocalcaemia, hyperkalaemia, cardiac arrest) and current guidelines; self-administration by patients is not appropriate.
  • Calcium Gluconate 10% solution must not be mixed in the same line with solutions known to be incompatible (e.g. sodium bicarbonate solutions or those containing phosphate) due to the risk of precipitation; use a dedicated line or follow compatibility guidance.
  • After use, any remaining solution, opened ampoules and consumables should be disposed of as clinical/ pharmaceutical waste according to local regulations.

Contraindications

  • Known hypersensitivity to calcium gluconate or to any of the excipients (including calcium D-saccharate).
  • Hypercalcaemia of any cause (e.g. hyperparathyroidism, hypervitaminosis D, certain malignancies with bone resorption, sarcoidosis, milk-alkali syndrome).
  • Hypercalciuria (persistently high urinary calcium excretion).
  • Severe renal impairment where repeated or prolonged administration would risk aluminium accumulation and hypercalcaemia, unless urgently required for short-term life-saving treatment under close monitoring.
  • Use in patients receiving cardiac glycosides (e.g. digoxin) except in exceptional life-threatening circumstances (severe hypocalcaemia or hyperkalaemia) where no safer alternative exists and intensive cardiac monitoring is available.
  • Concomitant use with ceftriaxone in premature neonates and full-term newborns up to 28 days of age due to the risk of precipitation of ceftriaxone-calcium complexes.
  • Use in Total Parenteral Nutrition (TPN) solutions prepared with glass ampoule products due to the risk of aluminium exposure, particularly in children and patients with renal impairment.
  • Repeated or prolonged treatment in children under 18 years of age because of aluminium exposure risk from glass ampoules.

Adverse Effects

  • Local reactions at the injection site such as pain, erythema, burning, irritation or tenderness; extravasation may cause severe soft-tissue calcification, skin necrosis and sloughing.
  • Cardiovascular effects, particularly if administered too rapidly, including bradycardia, arrhythmias, hypotension, vasodilation, hot flushes, circulatory collapse and, rarely, cardiac arrest.
  • Systemic effects associated with hypercalcaemia if excessive doses are given, including nausea, vomiting, constipation, abdominal pain, polyuria, polydipsia, muscle weakness, confusion and bone pain.
  • Flushing, sensation of heat and sweating during or shortly after injection.
  • In patients receiving interacting medicines (e.g. cardiac glycosides, ceftriaxone), serious complications may occur if contraindications and interaction warnings are not strictly followed.
  • In cases of repeated or prolonged treatment in susceptible populations (e.g. children, patients with renal impairment), potential aluminium accumulation with neurodevelopmental and bone toxicity has been reported in the wider literature; such use is specifically discouraged in the product information.

Storage Conditions

  • Store at a temperature below 25°C.
  • Keep ampoules in the outer carton to protect from light.
  • Do not freeze.
  • Keep out of the sight and reach of children.
  • Do not use the solution if it shows discolouration, precipitation or visible particles, or if the ampoule is cracked or damaged.
  • Do not use after the expiry date printed on the carton and ampoule label.

Duration

Short-term, acute parenteral treatment only; repeated or prolonged use is generally avoided, especially in children and patients with impaired renal function, due to the risk of aluminium exposure and hypercalcaemia. Duration is determined by clinical response and specialist guidance.

Onset

Intravenous calcium gluconate typically has an onset of action within approximately 3 minutes, with a duration of action of around 30\u201360 minutes; additional doses may be required depending on the underlying indication and patient response.

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