Hydroxo Vitamin B12 Injection 1mg/1mL 3 ampoules
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Rated 5/5 based on 1 reviews.
Hydroxo Vitamin B12 Injection 1mg/1mL 3 ampoules
- Product type: Medicine — Registered (AUST R)
- Used for: a Schedule 4 injectable vitamin B12 (hydroxocobalamin) used for the treatment of vitamin B12 deficiency under medical supervision
- ARTG listing: AUST R 161606
- Australian sponsor: Aspen Pharmacare Australia Pty Ltd
- Schedule: S4 (Prescription Only)
- Pack size: 3 × 1 mL glass ampoules
- Last reviewed: 29 May 2026
Product specification
| ARTG ID | 161606 |
|---|---|
| Listing / registration number | AUST R 161606 |
| Product type | Medicine — Registered (AUST R) |
| Australian sponsor | Aspen Pharmacare Australia Pty Ltd |
| Dosage form | Solution for injection (ampoule) |
| Route of administration | Intramuscular / Deep subcutaneous (by registered healthcare professional) |
| Pack size | 3 × 1 mL glass ampoules |
| Active ingredients | Hydroxocobalamin chloride 1 mg per 1 mL (1000 micrograms per 1 mL ampoule) |
| Schedule | S4 (Prescription Only) |
| Storage | Store below 30°C in a dry place, away from direct sunlight. Keep out of reach of children. |
About this product
Hydroxo Vitamin B12 Injection 1mg/1mL 3 ampoules is a Schedule 4 injectable vitamin B12 (hydroxocobalamin) used for the treatment of vitamin B12 deficiency under medical supervision. Supplied in Australia by Aspen Pharmacare Australia Pty Ltd. Use it in accordance with the carton instructions and your healthcare professional's advice.
About the active
Vitamin B12 — Hydroxocobalamin
Vitamin B12 is a water-soluble vitamin essential for normal red blood cell formation, neurological function and DNA synthesis. It is not produced by the human body and must be obtained from the diet (animal-derived foods) or via supplementation. Vitamin B12 deficiency leads to megaloblastic anaemia and, if untreated, irreversible neurological injury.
This injection supplies hydroxocobalamin, a pharmaceutical form of vitamin B12 that is well retained in body stores, making it suitable for monthly maintenance dosing once stores are replenished. Each 1 mL ampoule contains 1000 micrograms of hydroxocobalamin chloride.
Indicated for the treatment of vitamin B12 deficiency, including pernicious anaemia, dietary B12 deficiency, and B12 deficiency associated with malabsorption syndromes; for the prevention and treatment of confirmed cyanide poisoning; and for tobacco amblyopia and Leber's optic atrophy.
Safety: Schedule 4 (Prescription Only). Administered by a registered healthcare professional in accordance with the Product Information. Dose and frequency are individualised — typical loading and maintenance schedules are detailed in the PI. Discuss with the prescriber before use during pregnancy or breastfeeding, in Leber's hereditary optic neuropathy, or if you take medicines that affect vitamin B12 absorption (e.g. metformin, long-term proton pump inhibitors).
Indications
The following indications are recorded on this product's ARTG entry:
- Treatment of vitamin B12 deficiency, including pernicious anaemia, dietary B12 deficiency, and B12 deficiency associated with malabsorption syndromes
- Prevention and treatment of confirmed cyanide poisoning
- Tobacco amblyopia and Leber's optic atrophy
Directions for use
Prescription only — administered by a registered healthcare professional in accordance with the Product Information. Dose and frequency are individualised.
Warnings and important information
- Always read the label and follow the directions for use.
- If symptoms persist, talk to your healthcare professional.
- Discuss with your pharmacist or doctor before use during pregnancy or breastfeeding.
- Keep out of reach of children.
- Do not use after the expiry date printed on the pack.
- Stop use and seek advice if any unexpected reaction occurs.
Storage
Store below 30°C in a dry place, away from direct sunlight. Keep the original packaging closed. Keep out of reach of children. Do not use after the expiry date printed on the pack.
Frequently asked questions
What is Hydroxo Vitamin B12 Injection used for?
Hydroxo Vitamin B12 Injection is a Schedule 4 injectable vitamin B12 (hydroxocobalamin) used for the treatment of vitamin B12 deficiency under medical supervision. It is supplied in Australia by Aspen Pharmacare Australia Pty Ltd. Refer to your pharmacist or doctor for advice on whether the product is suitable for you.
How does Hydroxo Vitamin B12 Injection work?
The active in Hydroxo Vitamin B12 Injection is described in detail under 'About the active' above. The mechanism of action is summarised there in plain English.
What are the active ingredients in Hydroxo Vitamin B12 Injection?
Hydroxo Vitamin B12 Injection contains Hydroxocobalamin chloride 1 mg per 1 mL (1000 micrograms per 1 mL ampoule). The full active panel is shown in the Product Specification table above.
How do I take Hydroxo Vitamin B12 Injection?
Prescription only — administered by a registered healthcare professional in accordance with the Product Information. Dose and frequency are individualised.
What are the possible side effects?
Refer to the Consumer Medicine Information leaflet supplied with the pack and to your pharmacist for the full side-effect profile. Stop use and seek advice if any unexpected reaction occurs.
Can I take this with my other prescription medicines?
Several common medicines interact with Hydroxo Vitamin B12 Injection. Bring the pack to your pharmacist and ask them to check it against your current medicines list before starting.
Is this suitable during pregnancy or breastfeeding?
Use during pregnancy or breastfeeding is not recommended without professional advice. Refer to the carton and confirm with your pharmacist or doctor.
What if I miss a scheduled injection?
Hydroxo Vitamin B12 Injection is administered by a registered healthcare professional on the schedule your doctor has prescribed. If you miss an appointment, contact your prescriber to reschedule — do not attempt to make up missed doses by giving extra at the next appointment.
Is this medicine TGA approved?
Yes. Hydroxo Vitamin B12 Injection is a Registered (AUST R) medicine on the Australian Register of Therapeutic Goods, individually evaluated by the TGA for safety, quality and efficacy. The AUST R number is 161606 — you can verify the entry at tga.gov.au/resources/artg/161606.
Where is it manufactured?
Hydroxo Vitamin B12 Injection is supplied in Australia by Aspen Pharmacare Australia Pty Ltd.
This information is general in nature and is not a substitute for professional medical advice. If you have questions about whether Hydroxo Vitamin B12 Injection is right for you, speak with your pharmacist or doctor. For 24-hour health advice in Australia, call Healthdirect on 1800 022 222. For poisoning enquiries, call the Poisons Information Centre on 13 11 26.
Sources
- Australian Register of Therapeutic Goods (ARTG) — entry for this product. tga.gov.au/resources/artg
- Therapeutic Goods Administration — Permissible Indications Determination and Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. tga.gov.au
- Healthdirect Australia — general consumer health information. healthdirect.gov.au
- Manufacturer carton and Consumer Medicine Information (where supplied).
ALWAYS READ THE LABEL ON THE PRODUCT AND FOLLOW THE DIRECTIONS FOR USE UNLESS DIRECTED BY YOUR HEALTHCARE PROFESSIONAL.
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(Product SKU 109909)
| SKU | 109909 |
| Barcode # | 9331134002297 |
| Shipping Cubic | 0.000217000m3 |
| Assembled Length | 0.020m |
| Assembled Height | 0.100m |
| Assembled Width | 0.080m |
Yes
Great Product
24 September 2020I am on regular injections for Pernicious Anaemia. I absolutely love that I can purchase more than one box from David Jones Pharmacy and that they have arrived to me so quickly. This is an amazing product & has helped me a lot over the past few months. Highly recommend for anyone who suffers a deficiency.
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