Vitamin B12 Lichtenstein 1000 µg/ml solution for injection, 10 ampoules

Vitamin B12 Lichtenstein 1,000 µg/ml solution for injection. Active ingredient: Cyanocobalamin. 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 Lichtenstein 1,000 µg/ml solution for injection.
Active ingredient: Cyanocobalamin.

Read all of this leaflet carefully before you start using this medicine because it contains important information. This medicine is available without a prescription. Always use this medicine exactly as described in this leaflet or exactly as your doctor, pharmacist, or nurse has told you.
- Keep the package leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better or if you feel worse, talk to your doctor.

What's in this leaflet:
1. WHAT IS VITAMIN B12 LICHTENSTEIN AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE YOU USE VITAMIN B12 LICHTENSTEIN?
3. HOW TO USE VITAMIN B12 LICHTENSTEIN?
4. POSSIBLE SIDE EFFECTS?
5. HOW TO STORE VITAMIN B12 LICHTENSTEIN?
6. CONTENTS OF THE PACK AND FURTHER INFORMATION

1. WHAT IS VITAMIN B12 LICHTENSTEIN AND WHAT IS IT USED FOR?
Cyanocobalamin belongs to the group of substances collectively known as "Vitamin B12".
Indications:
Vitamin B12 deficiency that cannot be corrected through diet.

Vitamin B12 deficiency can manifest in the following conditions:
- hyperchromic macrocytic megaloblastic anemia (pernicious anemia, Biermer anemia, Addison's anemia – these are maturation disorders of red blood cells),
- subacute combined degeneration of the spinal cord (spinal cord damage).

Laboratory-confirmed vitamin B12 deficiency can occur in cases of:
- years of malnutrition and inadequate nutrition (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 gastric mucosa and required for the absorption of vitamin B12),
- Diseases of the terminal ileum (part of the small intestine), e.g., celiac disease,
- fish tapeworm infestation or
- blind loop syndrome (change in the course of the intestine after stomach surgery),
- congenital vitamin B12 transport disorders.

2. WHAT YOU SHOULD KNOW BEFORE USING VITAMIN B12 LICHTENSTEIN?
Vitamin B12 Lichtenstein must not be used if you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
Please talk to your doctor or pharmacist before using Vitamin B12 Lichtenstein. No special precautions need to be taken.

Using Vitamin B12 Lichtenstein with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. No interactions are currently known.

What chemical incompatibilities can occur?
Due to the instability of vitamin B12, the addition of other drugs can lead to a loss of the vitamin's effectiveness (for infusion solutions, see section 3, "How to use Vitamin B12 Lichtenstein").

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. The recommended daily intake of vitamin B12 during pregnancy and breastfeeding is 4 micrograms. Based on current experience, higher doses have not had any adverse effects on the unborn child. Vitamin B12 is excreted in breast milk.

Driving and using machines:
No special precautions are necessary.

Vitamin B12 Lichtenstein contains sodium compounds.
Vitamin B12 Lichtenstein contains sodium, but less than 1 mmol (23 mg) sodium per ml, i.e., it is essentially "sodium-free".

3. HOW IS VITAMIN B12 LICHTENSTEIN TO BE USED?
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: At the start of treatment, during the first few weeks after diagnosis, one ampoule containing 1 ml of Vitamin B12 Lichtenstein (corresponding to 1000 micrograms of cyanocobalamin) is administered twice a week. If a vitamin B12 malabsorption disorder in the intestine is confirmed, 100 micrograms of cyanocobalamin are then administered once a month.

Method and duration of use:
Vitamin B12 Lichtenstein is usually administered intramuscularly (injected into a muscle). However, it can also be given slowly intravenously or subcutaneously (injected into a vein or under the skin). For infusion, Vitamin B12 Lichtenstein can be mixed with a 0.9% saline solution (0.9% sodium chloride solution for preparing an infusion solution) or a 5% glucose solution. Please note the limited shelf life (see section 5, "How to store Vitamin B12 Lichtenstein"). Vitamin B12 Lichtenstein, solution for injection, can be administered with Fol injekt Lichtenstein, solution for injection, in a 1:1 ratio. Please note the limited shelf life (see section 5, "How to store Vitamin B12 Lichtenstein"). Vitamin B12 Lichtenstein is intended for long-term use. Please consult your doctor about this. Please talk to your doctor if you feel that the effect of Vitamin B12 Lichtenstein is too strong or too weak.

If you have used more Vitamin B12 Lichtenstein than you should:
Poisoning or symptoms of overdose are not known.

If you forget to use Vitamin B12 Lichtenstein:
Do not use a double dose to make up for a missed dose. Please consult your doctor to determine the appropriate dosage.

If you stop using Vitamin B12 Lichtenstein:
Interrupting treatment may jeopardize its success! If you experience any unpleasant side effects, please discuss further treatment with your doctor.

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

4. POSSIBLE SIDE EFFECTS:
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following categories are used to describe the frequency of side effects:

Possible side effects:
In very rare 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the
Federal Institute for Drugs and Medical Devices
, Department of 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.

5. How to store vitamin B12 Lichtenstein:
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and ampoule label after "EXP". The expiry date refers to the last day of the indicated month.

Storage conditions: Store in the original packaging to protect the contents from light.
Note on shelf life after opening or preparation: Vitamin B12 Lichtenstein should not be used after the ampoule has been opened, if the ampoule glass is visibly damaged, or if the injection solution is cloudy.

The injection solution is intended for single use only. Any remaining solution in the ampoule must be discarded. After dilution in 0.9% sodium chloride solution or 5% glucose solution to prepare an infusion solution (store at room temperature in the glass container and away from direct sunlight), the solution must be used within 2 hours. A 1:1 mixture of Vitamin B12 Lichtenstein with Fol injekt Lichtenstein, injection solution, must be used immediately after preparation.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Vitamin B12 Lichtenstein contains:
The active ingredient is cyanocobalamin. One ampoule containing 1 ml of solution for injection contains 1,000 micrograms (1 mg) of cyanocobalamin. The other ingredients are: sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections, and sodium hydroxide for pH adjustment. Vitamin

B12
Lichtenstein is a clear, red solution in amber glass ampoules (OPC ampoules).
Pack sizes: 5 ampoules, each containing 1 ml of solution for injection; 10 ampoules, each containing 1 ml of solution for injection; and 100 (4 x 25) ampoules, each containing 1 ml of solution for injection.

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