Medicines
Update of 04/03/2024
*VITAMIN B12 HORUS PHARMA®
cyanocobalamin
Forms and presentations
Eye drops in solution at 0,5 ‰ (clear, pink): Bottle of 5 ml.Eye drops in solution at 0,2 mg/0,4 ml (clear, pink): Single-dose containers of 0,4 ml, box of 20.
Composition
| Eye drops at 0,5 ‰: | p bottle |
| Cyanocobalamin or vitamin B12
|
2,5 mg |
| Eye drops at 0,2 mg/0,4 ml: | single-dose p |
| Cyanocobalamin or vitamin B12
|
0,2 mg |
Indications
Adjunctive treatment of corneal healing disorders.Dosage and administration
Instil 1 drop of eye drops into the eye or eyes to be treated, 3 to 4 times a day, depending on the eye disorders.
- Paediatric population:
- No data are available.
Topical use. For ocular instillation.
Wash hands thoroughly before proceeding with instillation.
Turn the cap to open the bottle or the single-dose container.
Instil into the conjunctival sac of the affected eye, looking upwards, and gently pulling the lower eyelid downwards.
Avoid contact of the tip with the eye or eyelids.
- Single-dose container:
- Each single-dose container contains a sufficient quantity of eye drops to treat both eyes.
- Discard the single-dose container after use. Do not keep it for later use.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section Composition.Warnings and precautions
Do not inject, do not swallow.
To avoid contamination, do not let the tip of the bottle or the single-dose container come into contact with the eye or any other surface.
Due to the coloring of the eye drops Vitamine B12 Horus Pharma, wearing contact lenses is not recommended throughout the duration of treatment.
In case of concomitant treatment with another eye drops, wait 15 minutes between each instillation.
- Vial:
- Recap the bottle after use.
Interactions
The efficacy of eye drops may be affected by the simultaneous instillation of another eye drop.
Fertility, pregnancy and breastfeeding
For Vitamine B12 Horus Pharma, eye drops in solution, there are no data on the use of this medicine in pregnant or breastfeeding women.
Consequently, the use of Vitamine B12 Horus Pharma, eye drops in solution, should be undertaken with caution in pregnant or breastfeeding women.
Driving and using machines
Vision may be blurred for a few minutes after instillation. In this case, the patient should be advised not to drive or use machines until normal vision is restored.Adverse effects
Adverse effects are classified by system organ class and listed below as: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10 000, < 1/1000); very rare (< 1/10 000); frequency not known (cannot be estimated from the available data).
The following adverse effects have been reported after use of Vitamine B12 Horus Pharma, eye drops in solution, with a frequency not known (cannot be estimated from the available data):
- Immune system disorders:
- Possibility of allergic reactions, as with all other eye drops.
- Eye disorders:
- A transient discomfort (stinging, eye burning) may be felt after instillation of the eye drops.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.
Overdose
No cases of overdose have been reported.
Pharmacodynamics
Pharmacotherapeutic class: Other ophthalmological medicines (ATC code: S01XA).
Eye drops for wound-healing purposes.
Pharmacokinetics
No controlled pharmacokinetic study has been performed in animals or in humans.
Preclinical safety
Non-clinical data from conventional safety pharmacology and repeated-dose toxicity studies did not reveal any particular risk for humans.
Storage conditions
- Shelf life before opening:
- 2 years.
- Bottle: store at a temperature not exceeding 25 °C.
- Single-dose container: no special precautions for storage.
- After opening:
- Bottle: use within 30 days.
- Single-dose container: the product must be used immediately. Discard the single-dose container after use. Do not store it for later use.
HANDLING/DISPOSAL INSTRUCTIONS
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) | 3400931134374 (1961/97, SmPC rev 11.10.2013) vial. |
| 3400936729872 (2004, SmPC rev 24.03.2020) single-dose. |
| Not reimbursed by Social Security. |
HORUS PHARMA
22, Allée Camille-Muffat
INEDI 5. 06200 Nice
Tel: 04 93 19 54 03. Fax: 04 93 19 54 09
https://www.horus-pharma.com
Source: VIDAL · Updated on 11/11/2026. This information does not replace advice from a healthcare professional.