Hydroxocobalamin (Vitamin B12) 1mg/1ml Ampoules
Misc (Generics)
Injectable prescription medicineVitamin B12 (hydroxocobalamin) solution for injection
Certifications
- UK Marketing Authorisation for Hydroxocobalamin 1mg/ml Solution for Injection held by G.L. Pharma GmbH (PL 21597/0060) 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 medicines references such as the electronic Medicines Compendium (eMC), NHS dm+d and British National Formulary (BNF).
- Supplied by DD Group, a regulated UK medical and dental supplier providing restricted access to prescription medicines only to eligible healthcare customers.
- Subject to ongoing MHRA pharmacovigilance and regulatory oversight for quality, safety and efficacy.
- UK Marketing Authorisation for Hydroxocobalamin 1mg/ml Solution for Injection held by G.L. Pharma GmbH (PL 21597/0060) 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 medicines references such as the electronic Medicines Compendium (eMC), NHS dm+d and British National Formulary (BNF).
- Supplied by DD Group, a regulated UK medical and dental supplier providing restricted access to prescription medicines only to eligible healthcare customers.
- Subject to ongoing MHRA pharmacovigilance and regulatory oversight for quality, safety and efficacy.
Vitamin B12 (hydroxocobalamin) solution for injection
Description
Hydroxocobalamin (Vitamin B12) 1mg/1ml Ampoules is a generic prescription-only injectable form of vitamin B12 containing 1mg hydroxocobalamin per 1ml glass ampoule. Supplied in packs of five sterile ampoules, it is indicated for the treatment and prevention of vitamin B12 deficiency, including pernicious anaemia and other macrocytic anaemias caused by B12 deficiency. The medicine is given by intramuscular injection by healthcare professionals and is widely used in medical, dental and aesthetic practice under appropriate prescription and clinical supervision.
Bnefits
- Provides a potent parenteral form of vitamin B12 (hydroxocobalamin) for confirmed B12 deficiency.
- Longer tissue retention and duration of action than some other injectable B12 forms, allowing less frequent maintenance dosing.
- Indicated for pernicious anaemia and other macrocytic anaemias due to vitamin B12 deficiency.
- Helps restore normal red blood cell production and improve symptoms such as fatigue, pallor and weakness.
- Supports neurological function in patients with B12 deficiency when treated promptly.
- Sterile, single-use glass ampoules support accurate dosing and reduce contamination risk.
- UK-licensed generic medicine supplied through regulated pharmaceutical wholesalers and pharmacies (POM).
Indications
- Addisonian pernicious anaemia.
- Treatment and prevention of other macrocytic anaemias associated with vitamin B12 deficiency.
- Vitamin B12 deficiency due to malabsorption (e.g. following gastrectomy, ileal resection, inflammatory bowel disease).
- Vitamin B12 deficiency caused by dietary insufficiency where parenteral therapy is indicated.
- Prophylaxis of vitamin B12 deficiency in patients at continuous risk, 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 hydroxide 0.5 mg per ml (for pH adjustment).
- Sodium chloride 8 mg per ml.
- Glacial acetic acid (for pH adjustment).
- 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 as specified by product information and prescriber).
- Legal classification (UK): Prescription Only Medicine (POM).
Packaging
- Carton containing 5 x 1ml glass ampoules of Hydroxocobalamin 1mg/1ml solution for injection.
- Each ampoule is intended for single use only; any unused solution must be discarded.
- Pack and ampoules labelled with product name, strength, batch number, expiry date, storage conditions and Marketing Authorisation details.
- DD Group product code: NAH315 (Generic code: HBL001GLP).
Usage
- For administration by suitably qualified healthcare professionals only.
- Confirm vitamin B12 deficiency with appropriate investigations before initiating treatment; ensure regular blood monitoring during therapy as clinically indicated.
- Administer by deep intramuscular injection, usually into the upper outer quadrant of the gluteal muscle or other appropriate site according to local clinical guidelines.
- The dosage regimen (loading and maintenance schedules) must follow the Summary of Product Characteristics (SmPC) and national prescribing guidance (e.g. BNF) and be tailored by the prescriber to the individual patient.
- Inspect each ampoule visually 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 dose into a sterile syringe fitted with an appropriate needle; discard any remaining solution after use (single-use ampoules).
- During initial intensive treatment of severe megaloblastic anaemia, monitor plasma potassium and cardiovascular status due to the risk of hypokalaemia and arrhythmias.
- Advise patients that treatment duration, injection frequency and laboratory monitoring 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.
- History of severe allergic or anaphylactic reaction to injectable vitamin B12 preparations.
- Use with caution in patients with Leber’s hereditary optic neuropathy due to risk of optic nerve atrophy.
- Do not use to treat megaloblastic anaemia unless vitamin B12 deficiency has been confirmed, as other causes (e.g. folate deficiency) require specific management.
- Not for intravenous use; intended route is intramuscular injection unless otherwise specified in product information.
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 disturbances including nausea, vomiting or diarrhoea.
- Headache, dizziness or a feeling of swelling or malaise in some patients.
- Acneiform or rosacea-like skin eruptions reported with prolonged parenteral use.
- During intensive treatment of severe megaloblastic anaemia, hypokalaemia and related cardiac arrhythmias may occur; blood counts and electrolytes should be monitored.
- Thrombocytosis may occur during early treatment of severe anaemia; monitor full blood count as advised in product information.
Storage Conditions
- Store below 25°C or according to the temperature range specified on the carton.
- Keep ampoules in the outer carton in order 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.
- Discard opened ampoules and any unused solution immediately after use in accordance with local requirements for disposal of medicinal waste.
Duration
Varies according to the underlying cause of vitamin B12 deficiency. In pernicious anaemia and other irreversible causes, hydroxocobalamin therapy is typically lifelong, beginning with a loading phase followed by regular maintenance injections at intervals defined by national guidelines and prescriber judgement. In reversible deficiency, treatment continues until stores are replenished and the underlying cause is corrected.
Onset
Haematological improvement (e.g. a rise in reticulocyte count) is usually seen within a few days of starting treatment, with anaemia typically correcting 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 in long-standing deficiency.
