Hydroxocobalamin Solution for Injection 1mg/1ml 5 Ampoules

Misc (Generics)

Injectable prescription medicine

Vitamin B12 (hydroxocobalamin) solution for injection

UK Licensed Prescription Only Medicine (Hydroxocobalamin 1mg/ml solution for injection; Marketing Authorisation held by Kent Pharma (UK) Ltd or equivalent UK MA holder).
Manufactured according to European and UK Good Manufacturing Practice (GMP) standards for parenteral medicinal products.
Listed in UK medicines databases such as the electronic Medicines Compendium (eMC), NHS dm+d and British National Formulary (BNF).
Pack and labelling compliant with UK regulatory requirements, including batch traceability and clear storage/expiry information.
Subject to ongoing MHRA pharmacovigilance and quality monitoring.

UK Licensed Prescription Only Medicine (Hydroxocobalamin 1mg/ml solution for injection; Marketing Authorisation held by Kent Pharma (UK) Ltd or equivalent UK MA holder).
Manufactured according to European and UK Good Manufacturing Practice (GMP) standards for parenteral medicinal products.
Listed in UK medicines databases such as the electronic Medicines Compendium (eMC), NHS dm+d and British National Formulary (BNF).
Pack and labelling compliant with UK regulatory requirements, including batch traceability and clear storage/expiry information.
Subject to ongoing MHRA pharmacovigilance and quality monitoring.

Vitamin B12 (hydroxocobalamin) solution for injection

Description

Hydroxocobalamin Solution for Injection 1mg/1ml 5 Ampoules is a prescription-only injectable form of Vitamin B12 containing 1mg hydroxocobalamin (as hydroxocobalamin acetate) per 1ml ampoule. Supplied as a pack of five sterile, single-use glass ampoules, it is indicated for the treatment and prevention of Vitamin B12 deficiency, including pernicious anaemia and other macrocytic anaemias due to B12 deficiency. The product is administered by intramuscular injection by healthcare professionals and is commonly used in medical and aesthetic practice under appropriate prescription and clinical supervision.

Bnefits

Provides a potent parenteral form of Vitamin B12 (hydroxocobalamin) for the treatment and prevention of B12 deficiency.
Longer tissue retention and duration of action compared with some other injectable B12 forms, allowing extended dosing intervals during maintenance therapy.
Indicated for pernicious anaemia and other macrocytic anaemias caused by Vitamin B12 deficiency.
Helps correct haematological abnormalities such as megaloblastic anaemia and supports neurological function where deficiency is present.
Sterile, unit-dose 1ml ampoules allow accurate dosing and minimise contamination risk.
Prescription-only medicine supplied via licensed UK pharmacies, ensuring quality, traceability and regulatory oversight.
Widely used in primary care, hospital and specialist aesthetic/medical clinics where Vitamin B12 injections are prescribed.

Indications

Treatment of pernicious anaemia.
Treatment of other macrocytic anaemias associated with Vitamin B12 deficiency.
Treatment of Vitamin B12 deficiency due to 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, in chronic malabsorption states or certain restrictive diets) as determined by a prescriber.

Composition

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

Formulation

Sterile, red, clear 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, e.g. deep subcutaneous, only as specified in the Summary of Product Characteristics and under prescriber direction).
Legal classification in the UK: Prescription Only Medicine (POM).

Packaging

Carton containing 5 x 1 ml Type I glass ampoules of Hydroxocobalamin 1mg/ml solution for injection.
Each ampoule is intended for single use only and any unused solution must be discarded.
Pack labelling includes product name, strength, batch number, expiry date, storage instructions and Marketing Authorisation details.

Usage

For administration by healthcare professionals only. Not for self-administration unless a patient has been specifically trained and authorised under medical supervision.
Administer by deep intramuscular injection, typically into the upper outer quadrant of the gluteal muscle or other suitable site, according to local clinical guidelines and the Summary of Product Characteristics.
Dosage regimens (loading and maintenance) must be determined by the prescriber based on indication, severity of deficiency, and patient factors, following national guidance (e.g. BNF) and the official product information.
Before use, visually inspect the ampoule; the solution should be a clear red solution free from visible particles. Do not use if discoloured, cloudy, contains particulate matter, or if the ampoule is damaged.
Open the ampoule using aseptic technique and withdraw the required volume into a sterile syringe fitted with an appropriate needle.
Ampoules are single-use; discard any remaining solution after the dose has been drawn up.
Monitoring of blood parameters (e.g. full blood count, reticulocytes, serum B12, potassium) should be performed as clinically indicated, particularly during initial intensive treatment.
Patients should be advised that this is a prescription-only medicine and that dosing frequency, duration of treatment and any monitoring will be directed by their prescriber.

Contraindications

Hypersensitivity to hydroxocobalamin, other cobalamins, or any of the excipients.
History of severe allergic or anaphylactic reaction to injectable Vitamin B12 preparations.
Caution (under specialist supervision) in patients with Leber’s hereditary optic neuropathy, as Vitamin B12 may precipitate 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 different management.
Use with care in patients with early optic nerve disease or those at risk of hypokalaemia during rapid correction of severe anaemia.

Adverse Effects

Injection site reactions (pain, redness, swelling, induration).
Hypersensitivity reactions including rash, pruritus, urticaria, flushing or fever.
Rare severe allergic reactions such as bronchospasm, hypotension or anaphylaxis.
Gastrointestinal symptoms including nausea, vomiting or diarrhoea in some patients.
Headache, dizziness or a feeling of swelling may occur rarely.
Acneiform or rosacea-like skin eruptions have been reported with prolonged use.
During intensive treatment of severe megaloblastic anaemia, hypokalaemia and cardiac arrhythmias have been reported; electrolyte monitoring is recommended.
Any suspected adverse reactions should be reported through national pharmacovigilance systems (e.g. MHRA Yellow Card in the UK).

Storage Conditions

Store below 25°C or as stated on the outer carton.
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 after the expiry date printed on the carton and ampoule label.
Discard any opened ampoule or unused solution immediately after use in accordance with local requirements for disposal of medicinal waste.

Duration

Treatment duration depends on the cause and severity of Vitamin B12 deficiency. In pernicious anaemia and other irreversible causes of deficiency, therapy is usually lifelong, beginning with an intensive loading phase followed by regular maintenance injections at intervals defined by national guidelines and clinical judgement.

Onset

Haematological response typically begins within days, with an increase in reticulocyte count, and correction of anaemia usually achieved over several weeks. Neurological improvement may take weeks to months and may be incomplete in long-standing deficiency; onset and extent of benefit depend on how severe and longstanding the deficiency is and on individual patient factors.