VITAMIN B12 DEPOT PANPHARMA 1000 μg injection

Panpharma GmbH

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VITAMIN B12 DEPOT PANPHARMA 1000 μg/ml injection solution. 10X1ml

For use in vitamin B12 deficiency

Active ingredients

  • 1 mg hydroxocobalamin acetate

Excipients

  • Water for injections
  • Acetic acid for pH adjustment
  • Sodium chloride
  • Sodium acetate

VITAMIN B12 depot 1 mg/ml PANPHARMA

Solution for injection for IM, slow IV or SC injection.

Active ingredient: hydroxocobalamin acetate

One ampoule contains:
Hydroxocobalamin acetate 1000 µg, sodium chloride, sodium acetate, acetic acid, water for injections

Vitamin B12 Depot Panpharma 1000 µg/ml injection solution. Active ingredient: hydroxocobalamin acetate. Indications: For vitamin B12 deficiency that cannot be remedied through diet.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vitamin B12 Depot Panpharma 1000 µg/ml injection solution
Active ingredient: hydroxocobalamin acetate

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Vitamin B12 Depot Panpharma must be used as directed.
  • Keep the package leaflet. You may want to read it again later.
  • If you have any further questions, ask your doctor or pharmacist.
  • If your symptoms worsen or do not improve, you should definitely see a doctor.
  • If any of the side effects listed affect you seriously or if you notice side effects not listed in this leaflet, please inform your doctor or pharmacist.


This package leaflet contains:
  1. WHAT IS VITAMIN B12 DEPOTPANPHARMA AND WHAT IS IT USED FOR?
  2. WHAT SHOULD YOU CONSIDER BEFORE USING VITAMIN B12 DEPOT PANPHARMA?
  3. HOW SHOULD VITAMIN B12 DEPOT PANPHARMA BE USE?
  4. WHAT SIDE EFFECTS ARE POSSIBLE?
  5. HOW SHOULD VITAMIN B12 DEPOT PANPHARMA BE STORE?
  6. MORE INFORMATION


1. WHAT IS VITAMIN B12 DEPOTPANPHARMA AND WHAT IS IT USED FOR?

Vitamin B12 Depot Panpharma is a vitamin B12 supplement. Hydroxocobalamin acetate belongs to the group of substances collectively known as ###vitamin B12###. Vitamin B12 Depot Panpharma is used for vitamin B12 deficiency that cannot be corrected through diet.

Vitamin B12 deficiency can manifest itself in the following conditions:
  • Hyperchromic macrocytic megaloblastic anemia (pernicious anemia, Biermer's anemia, Addison's anemia - these are maturation disorders of the red blood cells).
  • Funicular spinal disease (spinal cord damage).


A laboratory-confirmed vitamin B12 deficiency can occur in:
  • Years of deficiencies and malnutrition (e.g. due to 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 needed for the absorption of vitamin B12),
    • Diseases in the final section of the ileum (part of the small intestine), e.g. sprue,
    • Fish tapeworm infestation or
    • Blind&mdash%%%Loop&mdash%%%Syndrome (change in the course of the intestine after gastric surgery).
  • Congenital vitamin B12 transport disorders.


2. WHAT SHOULD YOU CONSIDER BEFORE USING VITAMIN B12 DEPOT PANPHARMA?

Vitamin B12 Depot Panpharma must not be used if you are hypersensitive (allergic) to hydroxocobalamin acetate or any of the other ingredients of the medicine.

When using Vitamin B12 Depot Panpharma with other medicines:
Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription. No interactions are known to date. Due to the instability of vitamin B12, the addition of other medicinal products may result in a loss of effectiveness of the vitamin.

Pregnancy and breastfeeding:
Consult your doctor or pharmacist before taking/using any medicine. The recommended daily vitamin B12 intake during pregnancy and breastfeeding is 4 µg. Experience to date has shown that higher doses do not have any adverse effects on the unborn child. Vitamin B12 is excreted in breast milk.

3. HOW SHOULD VITAMIN B12 DEPOT PANPHARMA BE USED?

Use this medicine according to the dosage recommendations below.

The following dosage recommendations apply unless otherwise prescribed:
At the start of treatment, one ampoule of Vitamin B12 Depot Panpharma (equivalent to 1000 µg hydroxocobalamin acetate) is administered twice a week for the first few weeks after diagnosis. If vitamin B12 absorption impairment in the intestine is proven, 100 µg hydroxocobalamin acetate is then administered once a month.

Method of administration:
Vitamin B12 Depot Panpharma 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 administration:
Vitamin B12 Depot Panpharma is intended for long-term use. Please consult your doctor about this. Please talk to your doctor or pharmacist if you feel that the effect of Vitamin B12 Depot Panpharma is too strong or too weak.

If a larger amount of Vitamin B12 Depot Panpharma has been used:
There are no known cases of poisoning or overdose.

If you stop using Vitamin B12 Depot Panpharma:
If you interrupt treatment, you jeopardize the success of the treatment! If you experience unpleasant side effects, please talk to your doctor about further treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, Vitamin B12 Depot Panpharma can cause side effects, although not everybody gets them.

The following frequency information is used to assess side effects:
Very common: more than 1 in 10 treated patients
Frequently: 1 to 10 patients treated in 100
Occasionally: 1 to 10 patients treated in 1,000
Rarely: 1 to 10 treated patients in 10,000
Very rare: less than 1 in 10,000 treated
Not known: Frequency cannot be estimated based on the available data.


Possible side effects:
Very rarely, skin reactions (acne, eczematous, and urticarial drug reactions) and hypersensitivity reactions (anaphylactic or anaphylactoid reactions) have been observed.

Please inform your doctor or pharmacist if any of the side effects listed affect you seriously, or if you notice side effects not listed in this leaflet.

5. HOW SHOULD VITAMIN B12 DEPOT PANPHARMA BE STORED?

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after ###use by###. The expiry date refers to the last day of that month.

Storage conditions:
Keep the ampoules in the outer carton to protect the contents from light.

Information on shelf life after opening or preparation:
Vitamin B12 Depot Panpharma is for immediate use after opening the ampoules! Any residue remaining in the ampoule must be discarded.

Due to the instability of vitamin B12, the addition of other medicinal products may result in the vitamin becoming less effective. This medicine must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

What Vitamin B12 Depot Panpharma contains:
The active ingredient is hydroxocobalamin acetate. 1 ampoule with 1 ml of solution for injection contains 1000 µg hydroxocobalamin acetate. The other ingredients are: sodium chloride, sodium acetate, acetic acid, water for injections.

What Vitamin B12 Depot Panpharma looks like and contents of the pack:
Original pack with 10 ampoules of 1 ml solution for injection and hospital pack with 100 (10 x 10) ampoules of 1 ml solution for injection.

Pharmaceutical Entrepreneur and Manufacturer:
Panpharma GmbH
Bunsenstraße 4
22946 Trittau

This package leaflet was last revised in March 2025.

Source: Information from the package leaflet . Last
updated: 06/2025
Active ingredient: hydroxocobalamin acetate. Indications: For vitamin B12 deficiency that cannot be corrected through diet.

VITAMIN B12 DEPOT PANPHARMA 1000 μg injection