B12 Hydroxocobalamin 1mg/1ml x 5 Vials

Misc (Generics)

Injectable prescription medicine

Vitamin B12 (hydroxocobalamin) solution for injection

UK Licensed Prescription Only Medicine (Hydroxocobalamin 1mg/ml solution for injection, MA holder Kent Pharma (UK) Ltd or equivalent licensed MA holder depending on brand).
Manufactured in accordance with Good Manufacturing Practice (GMP) for medicinal products.
Subject to MHRA oversight and listed in UK medicines databases and national prescribing references (e.g. BNF, NHS dm+d).
Pack and labelling comply with UK and EU/UK legislation for parenteral prescription medicines, including batch traceability and expiry dating.

UK Licensed Prescription Only Medicine (Hydroxocobalamin 1mg/ml solution for injection, MA holder Kent Pharma (UK) Ltd or equivalent licensed MA holder depending on brand).
Manufactured in accordance with Good Manufacturing Practice (GMP) for medicinal products.
Subject to MHRA oversight and listed in UK medicines databases and national prescribing references (e.g. BNF, NHS dm+d).
Pack and labelling comply with UK and EU/UK legislation for parenteral prescription medicines, including batch traceability and expiry dating.

Vitamin B12 (hydroxocobalamin) solution for injection

Description

B12 Hydroxocobalamin 1mg/1ml x 5 Vials is a prescription-only injectable form of Vitamin B12 containing hydroxocobalamin 1mg per 1ml glass ampoule. Supplied as a pack of five single-use ampoules, it is licensed for the treatment and prevention of Vitamin B12 deficiency, including pernicious anaemia and other macrocytic anaemias due to B12 deficiency. The product is for intramuscular injection by healthcare professionals only and is not available to the general public without a valid prescription.

Bnefits

Provides a potent, injectable form of Vitamin B12 (hydroxocobalamin) for treating and preventing B12 deficiency.
Longer tissue retention and duration of action compared with some other injectable B12 forms, allowing less frequent dosing in maintenance therapy.
Indicated for pernicious anaemia and other macrocytic anaemias associated with Vitamin B12 deficiency.
Helps correct haematological abnormalities (e.g. megaloblastic anaemia) and supports neurological function where deficiency is present.
Sterile, single-use 1ml ampoules support accurate dosing and reduce contamination risk.
Prescription-only medicine supplied via registered UK pharmacies, ensuring quality and regulatory oversight.
Widely used in primary care, hospital, and specialist settings, and in aesthetic/medical clinics under appropriate prescription and medical supervision.

Indications

Treatment of pernicious anaemia.
Treatment of other macrocytic anaemias associated with Vitamin B12 deficiency.
Treatment of Vitamin B12 deficiency arising from malabsorption, dietary deficiency, gastric surgery, or intestinal disease as diagnosed by a clinician.
Prophylaxis and maintenance therapy in patients at risk of recurrent Vitamin B12 deficiency (e.g. following gastrectomy or in chronic malabsorption states), as determined by a prescriber.

Composition

Active substance: Hydroxocobalamin acetate 1.045 mg equivalent to 1 mg hydroxocobalamin (Vitamin B12) per 1 ml.
Sodium chloride.
Glacial acetic acid.
Sodium hydroxide (for pH adjustment, in some presentations).
Water for injections.

Formulation

Sterile, clear red solution for injection.
Concentration: 1 mg/ml hydroxocobalamin (as hydroxocobalamin acetate).
Dosage form: Solution for injection in glass ampoules.
Route of administration: Intramuscular injection (other routes only as specified in the Summary of Product Characteristics and at the prescriber’s discretion).
Legal classification in the UK: Prescription Only Medicine (POM).

Packaging

Carton containing 5 x 1 ml glass ampoules of Hydroxocobalamin 1mg/ml solution for injection.
Each ampoule is intended for single use only and should be discarded after opening.
Pack labelling includes strength, route of administration, batch number and expiry date, along with Marketing Authorisation details.

Usage

For use by healthcare professionals only. Not for self-administration unless specifically trained and authorised under medical supervision.
Administer by deep intramuscular injection, typically into the upper outer quadrant of the gluteal muscle or other appropriate site, following local clinical guidelines.
The dosage regimen (loading and maintenance schedules) must be determined by the prescriber according to the indication, degree of deficiency, and patient factors, following the Summary of Product Characteristics (SmPC) and national guidelines (e.g. BNF).
Before administration, visually inspect the ampoule; the solution should be clear red and free from particulate matter. Do not use if the solution is discoloured, cloudy, or contains particles, or if the ampoule is damaged.
Use aseptic technique when opening the ampoule and drawing up the solution into a sterile syringe.
Any unused solution in an opened ampoule must be discarded; ampoules are single-use only.
Monitor patients as clinically indicated, particularly at the start of therapy and in those with severe deficiency, cardiovascular disease, or neurological involvement.
Patients should be counselled that this is a prescription-only medicine and that treatment duration, dosing schedule and monitoring will be defined by their prescriber.

Contraindications

Known hypersensitivity to hydroxocobalamin, other cobalamins, or any of the excipients.
Patients with a history of severe allergic or anaphylactic reaction to Vitamin B12 injections.
Caution is advised (under specialist supervision) in patients with Leber’s hereditary optic neuropathy, as Vitamin B12 may precipitate optic nerve atrophy.
Do not use for treatment of megaloblastic anaemia unless Vitamin B12 deficiency has been confirmed, as folate deficiency and other causes require different management.

Adverse Effects

Injection site reactions such as pain, redness, swelling or induration.
Systemic hypersensitivity including rash, pruritus, urticaria, flushing or fever.
Rare cases of severe allergic reactions including bronchospasm, hypotension and anaphylaxis.
Gastrointestinal symptoms such as nausea, vomiting or diarrhoea in some patients.
Dizziness, headache or feeling of swelling in the body have been reported.
Acneiform eruptions or rosacea-like cutaneous reactions have been noted rarely with prolonged use.
Laboratory findings may show transient changes in serum potassium or other haematological parameters during intensive treatment of severe anaemia.
Any suspected adverse reactions should be reported via national pharmacovigilance schemes (e.g. MHRA Yellow Card in the UK).

Storage Conditions

Store below 25°C (as stated on the pack or SmPC).
Keep the 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 shown on the carton and ampoule label.
Discard any opened ampoules or unused solution in accordance with local requirements for disposal of medicinal waste.

Duration

Treatment duration varies according to indication and clinical response. In pernicious anaemia and irreversible causes of Vitamin B12 deficiency, therapy is often lifelong with an initial loading phase followed by regular maintenance injections at intervals specified by national guidelines and the prescriber.

Onset

Haematological improvement (e.g. rise in reticulocyte count) is typically observed within a few days of initiation, with correction of anaemia over weeks. Neurological symptoms may take weeks to months to improve and may not fully reverse in long-standing deficiency; onset and extent of effect depend on severity and duration of deficiency and individual patient factors.