Vitamin B12 Depot Hevert, 10 ampoules

Vitamin B12 Depot Hevert, solution for injection. Active ingredient: Hydroxocobalamin acetate 1000 µg. Indications: Vitamin B12 deficiency that cannot be corrected by diet.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Vitamin B12 Depot Hevert, solution for injection, vitamin preparation
Active ingredient: Hydroxocobalamin acetate

Indications:
Vitamin B12 deficiency that cannot be corrected by diet.

Vitamin B12 deficiency can manifest itself in the following clinical pictures:

• Hyperchromic macrocytic megaloblastic anemia (pernicious anemia, Biermer anemia, Addison's anemia – these are maturation disorders of red blood cells)
• Funicular spinal disorder (spinal cord damage)

A laboratory-confirmed vitamin B12 deficiency can occur in:

• years of malnutrition and undernourishment (for example, through a strict vegetarian diet),
• Malabsorption (insufficient absorption of vitamin B12 in the intestine)
• due to insufficient production of intrinsic factor (a protein produced in the stomach lining and required for the absorption of vitamin B12),
• Diseases affecting the terminal ileum (part of the small intestine), for example, celiac disease,
• Fish tapeworm infestation or
• Blind loop syndrome (change in the course of the intestine after stomach surgery),
• congenital vitamin B12 transport disorders

Contraindications:

When should you not use Vitamin B12 Depot Hevert?

Vitamin B12 Depot Hevert should not be used if you are intolerant to any of its ingredients.

Precautions for use:

What should you be aware of before using Vitamin B12 Depot Hevert?

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning it is virtually sodium-free.

Pregnancy and breastfeeding:
The recommended daily intake of vitamin B12 during pregnancy and breastfeeding is 4 µg. Based on current experience, higher doses have not had any adverse effects on the unborn child.

Vitamin B12 is excreted into breast milk.

Driving and operating machinery:
No special precautions are necessary.

Interactions with other medicinal products:
No interactions are currently known.

Chemical incompatibilities:
Due to the instability of vitamin B12, the addition of other medicinal products may result in a loss of the vitamin's effectiveness.

Important information regarding certain other ingredients:
Vitamin B12 Depot Hevert contains sodium, but less than 1 mmol (23 mg) sodium per ml.

Dosage instructions, method and duration of use:
The following information applies unless your doctor has prescribed Vitamin B12 Depot Hevert differently.

At the start of treatment, 1 ml of Vitamin B12 Depot Hevert is administered twice a week for the first few weeks after diagnosis (corresponding to 500 µg hydroxocobalamin acetate).

If impaired vitamin B12 absorption in the intestine is confirmed, 100 µg hydroxocobalamin acetate is then administered once a month.

Note:
If only part of the ampoule contents is used, the remaining contents must be discarded.

Method and frequency of use:
Vitamin B12 Depot Hevert is usually administered intramuscularly (injected into a muscle). However, it can also be administered slowly intravenously or subcutaneously (injected into a vein or under the skin).

Duration of use:
Vitamin B12 Depot Hevert is intended for long-term use. Please consult your doctor about this. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Overdose and other application errors:

Use of too large a quantity:
Poisoning or symptoms of overdose are not known.

Use was interrupted or prematurely discontinued:
Interrupting treatment jeopardizes its success! If you experience any unpleasant side effects, please discuss further treatment with your doctor.

Side effects:
In isolated cases, skin reactions (acne, as well as eczematous and urticarial drug reactions) and hypersensitivity reactions (anaphylactic or anaphylactoid reactions) have been observed.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

Storage and shelf life: Do not use this medicine
after the expiry date which is stated on the container and outer carton. Keep out of reach of children! Composition: 1 ampoule of 2 ml contains: Active ingredient: Hydroxocobalamin acetate 1000 µg. Note: Hydroxocobalamin acetate belongs to the group of substances collectively known as vitamin B12. Other ingredients: Water for injections, sodium chloride, sodium acetate/acetic acid (acetate buffer). Dosage form and pack sizes: 5 / 10 / 50 / 100 ampoules of 2 ml solution for injection. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Hevert-Arzneimittel GmbH & Co. KG, In der Weiherwiese 1, D-55569 Nussbaum, Germany , www.hevert.de. This leaflet was last revised in April 2024. Source: Package leaflet information, version: 04/2026

(Apo) Usually ship out within 3-5 business days