B12 – Hydroxocobalamin 1000mcg/ml (5)

Misc (Generics)

Injectable prescription medicine

Vitamin B12 (hydroxocobalamin) solution for injection

UK Licensed Prescription Only Medicine (Hydroxocobalamin 1mg/ml solution for injection) with Marketing Authorisation held by G.L. Pharma GmbH and distributed in the UK by Kent Pharma UK Ltd.
Manufactured and quality Controlled in accordance with EU/UK Good Manufacturing Practice (GMP) for sterile parenteral medicinal products.
Listed in UK regulatory and medicines information sources (e.g. MHRA documentation, NHS dm+d, BNF) for the treatment and prevention of Vitamin B12 deficiency.
Supplied by Teleta Pharma, an MHRA Accredited, GDP Compliant wholesaler and pharmacy that requires a signed prescription for all POM sales.

UK Licensed Prescription Only Medicine (Hydroxocobalamin 1mg/ml solution for injection) with Marketing Authorisation held by G.L. Pharma GmbH and distributed in the UK by Kent Pharma UK Ltd.
Manufactured and quality Controlled in accordance with EU/UK Good Manufacturing Practice (GMP) for sterile parenteral medicinal products.
Listed in UK regulatory and medicines information sources (e.g. MHRA documentation, NHS dm+d, BNF) for the treatment and prevention of Vitamin B12 deficiency.
Supplied by Teleta Pharma, an MHRA Accredited, GDP Compliant wholesaler and pharmacy that requires a signed prescription for all POM sales.

Vitamin B12 (hydroxocobalamin) solution for injection

Description

B12 – Hydroxocobalamin 1000mcg/ml (5) is a prescription-only injectable form of Vitamin B12 containing 1mg (1000 micrograms) hydroxocobalamin per 1ml glass ampoule. Supplied as a pack of five sterile ampoules, it is used for the treatment and prevention of Vitamin B12 deficiency, including pernicious anaemia and other macrocytic anaemias due to B12 deficiency. By restoring B12 levels, it helps the body produce healthy red blood cells, improving oxygen transport and reducing symptoms such as tiredness and lack of energy. This product is for intramuscular injection by healthcare professionals only and requires a valid prescription.

Bnefits

Provides a potent parenteral form of Vitamin B12 (hydroxocobalamin) for confirmed B12 deficiency.
Longer tissue retention and duration of action than some other B12 forms, allowing less frequent maintenance dosing.
Indicated for pernicious anaemia and other macrocytic anaemias associated with Vitamin B12 deficiency.
Helps correct haematological abnormalities and supports neurological function where deficiency exists.
Single-use, sterile 1ml glass ampoules facilitate accurate dosing and reduce contamination risk.
Prescription-only medicine supplied through licensed UK pharmacies, ensuring regulatory oversight and quality assurance.
Widely used in primary care, hospital, and aesthetic/medical clinic settings under appropriate clinical supervision.

Indications

Addisonian pernicious anaemia.
Prophylaxis and treatment of other macrocytic anaemias associated with Vitamin B12 deficiency.
Vitamin B12 deficiency due to malabsorption, gastrectomy, ileal resection, or certain gastrointestinal diseases.
Vitamin B12 deficiency resulting from strict vegetarian or vegan diets or other dietary insufficiency, where parenteral therapy is indicated.
Prophylaxis of macrocytic anaemia in patients at ongoing risk of B12 deficiency, as determined by a prescriber.

Composition

Each 1ml ampoule contains 1.045 mg hydroxocobalamin acetate equivalent to 1 mg (1000 micrograms) hydroxocobalamin (Vitamin B12).
Sodium chloride.
Sodium hydroxide (for pH adjustment).
Glacial acetic acid.
Water for injections.

Formulation

Red, clear, sterile solution for injection.
Strength: 1mg/ml hydroxocobalamin (as hydroxocobalamin acetate).
Dosage form: Solution for injection in Type I glass ampoules.
Route of administration: Intramuscular injection (other routes only if specified by SmPC and prescriber).
Legal classification (UK): Prescription Only Medicine (POM).

Packaging

Carton containing 5 x 1ml glass ampoules of Hydroxocobalamin 1mg/ml solution for injection.
Each ampoule is intended for single use only; any unused solution must be discarded.
Outer carton and ampoules labelled with product name, strength, batch number, expiry date, storage conditions and Marketing Authorisation details.

Usage

For administration by suitably qualified healthcare professionals only.
Administer by deep intramuscular injection, usually into the upper outer quadrant of the gluteal muscle or another appropriate site, following local clinical guidelines.
The diagnosis of Vitamin B12 deficiency should be confirmed before starting treatment; regular blood monitoring is recommended.
Dosage regimens (initial loading and maintenance) must follow the Summary of Product Characteristics (SmPC) and national guidelines (e.g. BNF) and be tailored by the prescriber to the indication and patient’s clinical status.
Inspect the ampoule before use; the solution should be a clear red liquid free from visible particles. Do not use if discoloured, cloudy, particulate, or if the ampoule is cracked or damaged.
Open the ampoule using aseptic technique and withdraw the required volume into a sterile syringe with an appropriate needle. Ampoules are single-use; discard any remaining solution.
During initial intensive therapy in severe megaloblastic anaemia, monitor plasma potassium and cardiac status due to the risk of hypokalaemia and arrhythmias.
Patients should be advised that treatment duration and injection frequency will be determined by their prescriber and may be lifelong in conditions such as pernicious anaemia.

Contraindications

Known hypersensitivity to hydroxocobalamin, other cobalamins, cobalt, or any of the excipients.
Use with caution in patients with Leber’s hereditary optic neuropathy due to the risk of optic nerve atrophy.
Do not use for treatment of megaloblastic anaemia unless Vitamin B12 deficiency has been confirmed, as other causes (e.g. folate deficiency) require different treatment.
Avoid intravenous administration; the product is intended for intramuscular injection.

Adverse Effects

Injection site reactions including pain, redness, swelling, induration or local irritation.
Hypersensitivity reactions such as rash, pruritus, urticaria, flushing and fever.
Rare severe allergic reactions including bronchospasm, hypotension and anaphylaxis.
Gastrointestinal symptoms including nausea, vomiting or diarrhoea.
Headache, dizziness and a feeling of swelling or general malaise in some patients.
Acneiform or rosacea-like skin eruptions reported with prolonged parenteral use in some cases.
Hypokalaemia and associated cardiac arrhythmias have been reported during intensive treatment of severe megaloblastic anaemia; serum potassium monitoring is recommended.
Thrombocytosis may occur during early treatment of severe anaemia; blood counts should be monitored.

Storage Conditions

Store below 25°C, in accordance with information on the outer carton.
Keep ampoules in the original carton to protect from light.
Do not freeze.
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the carton and ampoule label.
Single use only: discard any opened ampoules or unused solution in accordance with local requirements for disposal of medicinal waste.

Duration

Treatment duration depends on the underlying cause of Vitamin B12 deficiency. In pernicious anaemia and other irreversible causes, hydroxocobalamin therapy is typically lifelong, beginning with a loading course followed by regular maintenance injections (commonly every 2\u20133 months) as per SmPC and national guidance. In reversible deficiency, duration is determined by correction of the cause and restoration of adequate B12 levels.

Onset

Haematological response, such as a reticulocyte rise, may occur within a few days, with anaemia usually improving over several weeks. Symptomatic improvements in fatigue and energy often parallel haematological recovery. Neurological symptoms may take weeks to months to improve and may not fully reverse if deficiency has been longstanding.