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Colecalciferol (Vitamin D) 300,000iu/ml (2 vials)

Colecalciferol (Vitamin D) 300,000iu/ml (2 vials)

Dibase

Prescription-only high-dose vitamin D3 medicine (POM; imported unlicensed in the UK)
  • Authorised medicinal product in Italy: DIBASE 300,000 IU/ml soluzione iniettabile holds Italian marketing authorisation numbers 036635024 (pack of 1 ampoule) and 036635035 (pack of 2 ampoules) as listed in the Abiogen Pharma SmPC.
  • Classified pharmacologically as vitamin D and analogues (ATC code A11CC05) in the DIBASE SmPC.
  • Used in the UK as an unlicensed imported medicine; NHS and UK formulary documents state that colecalciferol 300,000 IU/ml injection used via imports does not have a UK marketing authorisation and is supplied through specialist importers.
  • Manufactured in accordance with European Union and Italian medicinal product quality, safety and efficacy standards, with SmPC approved by the Italian medicines agency (AIFA).
  • Supplied in the UK by Aestheticsrx Pharma Ltd, a GPhC Registered pharmacy (Reg No. 9012430), which is subject to UK pharmacy regulatory standards and inspection.
Systemic vitamin D; colecalciferol (vitamin D3) high-strength injectable solution

Description

Colecalciferol (Vitamin D) 300,000iu/ml (2 vials) is a high-strength injectable vitamin D3 (colecalciferol) preparation equivalent to DIBASE 300,000 IU/ml solution for injection. Each 1 ml amber glass ampoule contains 7.5 mg colecalciferol (vitamin D3), corresponding to 300,000 IU, dissolved in refined olive oil for injectable use. The product is intended for the treatment and prevention of clinically confirmed vitamin D deficiency in adults, particularly where high-dose therapy is required, such as in severe deficiency, malabsorption states, or where adherence to daily oral supplementation is problematic. It is supplied by Aestheticsrx Pharma as a pack of two sterile vials for use by qualified healthcare professionals under medical supervision, typically administered by intramuscular injection to restore vitamin D stores before maintenance therapy with lower-dose vitamin D products. The formulation is manufactured to pharmaceutical standards and authorised in Italy; in the UK it is used as an unlicensed imported medicine.

Bnefits

  • Provides a very high-dose 300,000 IU (7.5 mg) of colecalciferol (vitamin D3) in a single 1 ml ampoule to correct severe vitamin D deficiency.
  • Supports normal bone, teeth and muscle health by helping regulate calcium and phosphate homeostasis.
  • Allows rapid repletion of vitamin D stores under medical supervision, which can be useful in patients with very low baseline vitamin D levels.
  • Injectable intramuscular formulation can be used in patients with malabsorption syndromes or poor adherence to daily oral vitamin D supplements.
  • Supplied as a pack of two ampoules to provide flexibility in dosing and stock management in clinical and aesthetic practice settings.
  • Manufactured by Abiogen Pharma S.p.A. as DIBASE 300,000 IU/ml solution for injection with formal marketing authorisation in Italy.
  • Sterile, oil-based solution (refined olive oil for injectable use) in amber glass ampoules designed to preserve stability and protect from light.

Indications

  • Treatment of clinically confirmed vitamin D deficiency in adults, as stated in the DIBASE 300,000 IU/ml solution for injection SmPC.
  • Restoration of vitamin D stores in adults where high-dose parenteral therapy is indicated, such as in malabsorption syndromes where oral vitamin D absorption is impaired.
  • High-dose vitamin D repletion in adults with very low serum 25-hydroxy-vitamin D (25(OH)D) levels, followed by maintenance therapy with lower-dose vitamin D preparations.
  • Use within specialist or supervised protocols for patients who cannot reliably adhere to daily oral supplementation regimens.
  • In aesthetic and wellness clinic settings, use as part of medically supervised injectable vitamin supplementation programmes to correct laboratory-confirmed deficiency.

Composition

  • Active ingredient: colecalciferol (vitamin D3) 7.5 mg per 1 ml ampoule, equivalent to 300,000 IU.
  • Each ampoule of DIBASE 300,000 IU/ml solution for injection contains: colecalciferol (vitamina D3) 7.5 mg (300,000 IU).
  • Excipient: refined olive oil for injectable use (olio di oliva raffinato per uso iniettabile).
  • No other excipients are listed in section 6.1 of the DIBASE 100,000 IU/ml and 300,000 IU/ml solution for injection SmPC.
  • Pharmacotherapeutic group: Vitamin D and analogues; ATC code A11CC05 (colecalciferol).

Formulation

  • Pharmaceutical form: solution for injection.
  • Appearance: clear, transparent, colourless to yellow-greenish oil-based solution (as described in the DIBASE SmPC).
  • Concentration: 300,000 IU/ml (7.5 mg colecalciferol per 1 ml ampoule).
  • Route of administration: intramuscular injection only, for use by healthcare professionals.
  • Vehicle: refined olive oil for injectable use.
  • High-dose, single-ampoule formulation intended for rapid repletion of vitamin D stores in adults under specialist supervision.

Packaging

  • Pack supplied by Aestheticsrx Pharma: two sterile vials (ampoules) of Colecalciferol (Vitamin D) 300,000iu/ml.
  • According to the DIBASE SmPC, the 300,000 IU/ml solution for injection is supplied in amber glass ampoules, with pack sizes including 1 ampoule or 2 ampoules per outer carton.
  • Ampoules are provided with a pre-scored (prerottura) ring to facilitate opening following the instructions in the SmPC.
  • Outer packaging is designed to protect the ampoules from light and includes concentration, batch number and expiry date to support clinical documentation and inventory control.

Usage

  • Product is intended strictly for administration by trained healthcare professionals; dosing must follow a prescriber’s directions and local vitamin D deficiency guidelines.
  • Per the DIBASE 300,000 IU/ml solution for injection SmPC, therapy by intramuscular injection is indicated particularly in cases of malabsorption syndromes.
  • Treatment of vitamin D deficiency should be based on clinical assessment and/or laboratory confirmation of deficiency (serum 25-hydroxy-vitamin D).
  • The SmPC advises that, during the treatment phase, a cumulative dose of 300,000 IU is generally not exceeded unless otherwise directed by the physician.
  • For DIBASE 300,000 IU/ml, a typical regimen described in the SmPC is 1 ampoule (300,000 IU) administered intramuscularly for the treatment of deficiency in adults, with the exact regimen and any repeats determined by the prescriber.
  • Subsequent maintenance therapy with lower-dose vitamin D preparations should follow if the risk of deficiency persists, at an appropriate daily or weekly dose selected by the clinician.
  • Serum calcium and 25(OH)D levels should be monitored in prolonged high-dose therapy or in at-risk patients (e.g. renal impairment, sarcoidosis, hyperparathyroidism).
  • The SmPC specifies that the ampoules must be opened carefully using the pre-scored ring and appropriate finger protection, and the contents administered intramuscularly only.
  • Patients receiving this product should be counselled about the symptoms of hypercalcaemia (e.g. nausea, vomiting, thirst, polyuria, constipation) and instructed to seek medical advice if these occur.

Contraindications

  • Hypersensitivity to colecalciferol (vitamin D3) or to any excipient listed in section 6.1 of the SmPC (refined olive oil for injectable use).
  • Hypercalcaemia.
  • Hypercalciuria.
  • Calcium-containing kidney stones (nephrolithiasis) or nephrocalcinosis.
  • Severe renal impairment (glomerular filtration rate < 30 ml/min/1.73 m²), where colecalciferol is not normally metabolised and alternative forms of vitamin D are recommended.
  • Hypervitaminosis D.
  • Use at these high doses is not recommended in pregnancy or during breastfeeding due to lack of clinical data, as specified in the DIBASE SmPC.

Adverse Effects

  • Adverse reactions reported with vitamin D and listed in the DIBASE 100,000 IU/ml and 300,000 IU/ml solution for injection SmPC include the following, with frequencies categorised as uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known:
  • Immune system disorders: hypersensitivity reactions (frequency not specified).
  • Metabolism and nutrition disorders: hypercalcaemia, hypercalciuria; reduced appetite, increased thirst (polydipsia).
  • Psychiatric disorders: somnolence, confusion state.
  • Nervous system disorders: headache, dizziness (vertigo).
  • Gastrointestinal disorders: abdominal pain, nausea, diarrhoea, vomiting, constipation, flatulence, dry mouth, dysgeusia.
  • Skin and subcutaneous tissue disorders: rash, pruritus, urticaria.
  • Renal and urinary disorders: polyuria, nephrocalcinosis, renal insufficiency.
  • Cardiac disorders: cardiac arrhythmias (in the context of hypercalcaemia).
  • General disorders and administration site conditions: asthenia (fatigue).
  • Overdose: chronic or acute overdose can cause marked hypercalcaemia and hypercalciuria with symptoms such as nausea, vomiting, thirst, polydipsia, polyuria, constipation and dehydration; prolonged hypercalcaemia can lead to vascular and organ calcification. Treatment includes stopping colecalciferol, rehydration and appropriate medical management as described in the SmPC.

Storage Conditions

  • According to section 6.4 of the DIBASE solution for injection SmPC, the product should be stored at a temperature not exceeding 30°C.
  • Store in the original package to protect the ampoules from light.
  • Do not freeze.
  • Shelf life: 3 years (as stated in section 6.3 of the SmPC).
  • Ampoules should be stored and handled in accordance with local regulations for injectable medicinal products, ensuring that expired or damaged ampoules are not used.

Duration

According to the DIBASE solution for injection SmPC, vitamin D deficiency treatment with high-dose injectable colecalciferol aims to restore vitamin D stores with a cumulative dose generally not exceeding 300,000 IU during the treatment phase, usually delivered as a single 300,000 IU intramuscular injection (1 ampoule of 300,000 IU/ml) in adults, with the exact regimen and any repetition of dosing determined by the physician based on severity of deficiency, patient response and follow-up 25(OH)D levels. After repletion, ongoing maintenance therapy with lower-dose vitamin D preparations is recommended if deficiency risk persists; the duration and maintenance dosing schedule are set by the prescriber and are not rigidly specified in the DIBASE SmPC.

Onset

Not publicly listed (no specific quantified onset-of-action time for serum 25(OH)D normalisation or clinical benefit is provided in the DIBASE 300,000 IU/ml solution for injection SmPC or the seller\u2019s product documentation).

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