Cobalin H 1000 microgram/ml Injection (B12) Ampoules (5)
Cobalin-H
Prescription-only vitamin B12 injection (POM)
Antianaemic; hydroxocobalamin 1000 microgram/ml solution for intramuscular injection
Certifications
UK MHRA Licensed medicinal product: Cobalin H 1000 microgram/ml Injection, marketing authorisation number PL 20072/0217, marketing authorisation holder Amdipharm UK Limited.
Classified as a Prescription Only Medicine (POM) in the United Kingdom, as per the emc/SmPC listing.
Pharmacotherapeutic classification: Antianaemic preparations – Vitamin B12, ATC code B03BA03, as stated in the SmPC.
UK MHRA Licensed medicinal product: Cobalin H 1000 microgram/ml Injection, marketing authorisation number PL 20072/0217, marketing authorisation holder Amdipharm UK Limited.
Classified as a Prescription Only Medicine (POM) in the United Kingdom, as per the emc/SmPC listing.
Pharmacotherapeutic classification: Antianaemic preparations – Vitamin B12, ATC code B03BA03, as stated in the SmPC.
Product information (SmPC for healthcare professionals and PIL for patients) is approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and published via the electronic medicines compendium (emc).
Description
Cobalin-H 1000 microgram/ml Injection is a branded hydroxocobalamin (vitamin B12) solution for intramuscular injection used in the treatment and prevention of vitamin B12 deficiency states. Each 1 ml clear red solution in a glass ampoule contains 1000 micrograms anhydrous hydroxocobalamin (vitamin B12). According to the UK Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), Cobalin-H is indicated for the treatment of Addisonian pernicious anaemia, the prophylaxis and treatment of other macrocytic anaemias due to vitamin B12 deficiency, and for the treatment of tobacco amblyopia and Leber’s optic atrophy. Vitamin B12 is essential for red blood cell formation, normal neurological function, and folate and carbohydrate metabolism; deficiency can lead to megaloblastic anaemia and neurological damage. Treatment with hydroxocobalamin usually results in rapid haematological improvement and clinical response, while neurological symptoms may improve more slowly. Cobalin-H is a prescription-only medicine and should be administered by intramuscular injection under the direction of an appropriate prescriber, following the licensed dosing schedules in the SmPC.
Bnefits
Treats Addisonian pernicious anaemia associated with impaired vitamin B12 absorption from the stomach by providing parenteral hydroxocobalamin.
Prevents and treats other macrocytic anaemias due to vitamin B12 deficiency, helping to normalise red blood cell morphology and haemoglobin levels.
Used in the treatment of tobacco amblyopia and Leber’s optic atrophy, conditions involving optic nerve damage where vitamin B12 therapy is indicated.
Provides a well-retained depot form of vitamin B12 (hydroxocobalamin) that allows infrequent maintenance dosing (typically every 2–3 months in many deficiency states).
Helps correct clinical manifestations of vitamin B12 deficiency such as megaloblastic anaemia and related symptoms; treatment produces rapid haematological improvement, with neurological symptoms improving more gradually.
Licensed, MHRA-approved medicinal product with an established safety and pharmacodynamic profile documented in official SmPC and PIL.
Product information (SmPC for healthcare professionals and PIL for patients) is approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and published via the electronic medicines compendium (emc).
Teleta Pharma, a distributor of Cobalin H 1000mcg/ml (B12) Ampoules (5), is MHRA accredited, Wholesale Distribution Authorisation (WDA) certified, and Good Distribution Practice (GDP) compliant, supplying prescription medicines and aesthetic products to healthcare professionals.
Teleta Pharma, a distributor of Cobalin H 1000mcg/ml (B12) Ampoules (5), is MHRA accredited, Wholesale Distribution Authorisation (WDA) certified, and Good Distribution Practice (GDP) compliant, supplying prescription medicines and aesthetic products to healthcare professionals.
Antianaemic; hydroxocobalamin 1000 microgram/ml solution for intramuscular injection
Prophylaxis and treatment of other macrocytic anaemias due to vitamin B12 deficiency (for example secondary to gastrectomy, ileal resection, certain malabsorption states, or strict vegetarianism).
Treatment of tobacco amblyopia.
Treatment of Leber’s optic atrophy.
Composition
Active ingredient: Anhydrous hydroxocobalamin 1000 microgram/ml (1 mg/ml) in solution for injection.
Excipients (as listed in the SmPC): sodium dihydrogen orthophosphate, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
The product is a clear red solution supplied in 1 ml Type I glass ampoules; vitamin B12 (hydroxocobalamin) contains cobalt.
Appearance: Clear red solution supplied in clear 1 ml Type I glass ampoules.
Packaging
Supplied as clear 1 ml Type I glass ampoules containing 1000 micrograms hydroxocobalamin solution.
SmPC: Packs (cartons) containing 5 or 10 ampoules of 1 ml each.
Teleta listing: "Cobalin-H 1000mcg/ml (B12) Ampoules (5)" – pack of 5 x 1000 mcg/ml ampoules marketed as a prescription-only product.
Pack and ampoule labelling state the strength (1000 microgram/ml), active ingredient (hydroxocobalamin), and storage/expiry information as per the authorised product labelling.
Usage
Cobalin-H 1000 microgram/ml Injection must be given by intramuscular injection, typically by a doctor, nurse, or other suitably trained healthcare professional.
Before treatment, diagnosis of vitamin B12 deficiency should be confirmed where appropriate; blood counts and vitamin B12/folate status should be monitored during therapy in line with the SmPC and clinical guidelines.
Addisonian pernicious anaemia and other macrocytic anaemias without neurological involvement – initial regimen (SmPC): 250 micrograms to 1000 micrograms intramuscularly on alternate days for one or two weeks, then 250 micrograms weekly until the blood count is normal.
Maintenance for pernicious anaemia and other macrocytic anaemias without neurological involvement: 1000 micrograms intramuscularly every two or three months.
Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement – initial regimen: 1000 micrograms intramuscularly on alternate days for as long as improvement continues.
Maintenance for macrocytic anaemias with neurological involvement: 1000 micrograms intramuscularly every two months.
Prophylaxis of macrocytic anaemias associated with vitamin B12 deficiency (post-gastrectomy, ileal resection, malabsorption states, vegetarianism): 1000 micrograms intramuscularly every two or three months.
Tobacco amblyopia and Leber’s optic atrophy – initial regimen: 1000 micrograms intramuscularly daily for two weeks, then twice weekly as long as improvement is maintained.
Maintenance for tobacco amblyopia and Leber’s optic atrophy: 1000 micrograms intramuscularly every three months or as required.
Dose and schedule for individual patients, including paediatric patients and those with comorbidities, must follow the prescribing clinician’s judgement and the current SmPC/PIL; patients should not self-inject unless specifically trained and authorised.
Patients are advised in the PIL that this medicine is usually given by a healthcare professional; if they have questions about dosing or monitoring, they should discuss them with their doctor, pharmacist, or nurse.
Contraindications
Hypersensitivity to hydroxocobalamin or to any of the excipients listed in the SmPC (sodium dihydrogen orthophosphate, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections).
Cobalin-H Injection should not be used for the treatment of megaloblastic anaemia of pregnancy unless vitamin B12 deficiency has been demonstrated, as stated in the warnings and precautions sections of the SmPC/PIL.
Use is contraindicated in patients with known cobalt allergy, as hydroxocobalamin (vitamin B12) contains cobalt (precaution highlighted in the PIL).
Adverse Effects
Adverse reactions listed in the SmPC are classified with frequency "Not known" (cannot be estimated from the available data) unless otherwise stated.
Blood and lymphatic system disorders: Reactive thrombocytosis can occur during the first weeks of use in megaloblastic anaemia.
Immune system disorders: Hypersensitivity reactions including rash, itching, exanthema; anaphylaxis; antibodies to hydroxocobalamin–transcobalamin II complex have been reported.
Metabolism and nutrition disorders: Initial hypokalaemia (low blood potassium) during early treatment has been reported.
Nervous system disorders: Headache, paraesthesia (pins and needles), tremor.
Cardiac disorders: Arrhythmias secondary to hypokalaemia.
General disorders and administration site conditions: Fever, chills, hot flushes, dizziness, malaise, pain; injection site reactions including injection site pain, erythema, pruritus, induration and swelling.
Skin and subcutaneous tissue disorders: Acneiform (acne-like) and bullous eruptions.
Renal and urinary disorders: Chromaturia (discoloured urine).
The PIL additionally highlights serious allergic reactions (e.g. swelling of lips and face, difficulty breathing, severe rash/redness) and mentions that irregular heartbeat due to hypokalaemia during early treatment has been reported.
Overdose: The SmPC states that treatment is unlikely to be needed in case of overdose; hydroxocobalamin has a wide therapeutic margin.
Storage Conditions
Store below 25°C.
Protect from light.
Keep ampoules in the outer carton until use, to protect from light.
Keep this medicine out of the sight and reach of children.
Do not use the product if the solution is not a clear red liquid or if visible particles are present.
Do not use after the expiry date stated on the ampoule and carton (EXP); the expiry date refers to the last day of that month.
SmPC shelf life: 2 years for the authorised product when stored as recommended.
Duration
For Addisonian pernicious anaemia and other chronic vitamin B12 deficiency states, Cobalin-H therapy is typically long term and often lifelong, with maintenance injections of 1000 micrograms intramuscularly every two to three months (or every two months when there is neurological involvement) once haematological control has been achieved. Initial correction of deficiency may involve daily or alternate-day injections over one to two weeks, then weekly injections until the blood count normalises. In prophylactic settings after gastrectomy, ileal resection, certain malabsorption states, or in strict vegetarians, maintenance injections of 1000 micrograms every two to three months are used for the duration of the risk period. For tobacco amblyopia and Leber\u2019s optic atrophy, initial daily injections for two weeks are followed by twice-weekly injections as long as improvement continues and then 1000 micrograms every three months or as required. Actual duration and frequency of treatment must follow the prescriber\u2019s assessment and current SmPC/PIL guidance.
Onset
The SmPC states that treatment with hydroxocobalamin usually results in rapid haematological improvement and a striking clinical response in vitamin B12 deficiency anaemias, while neurological symptoms respond more slowly. No precise numerical onset time (e.g. hours or days) is specified in the regulatory documents.
