ANKERMANN

B12 ANKERMANN 1000 μg solution for injection Amp.

Important notes (mandatory information)

B12 Ankermann 1000 µg, injection solution. Active ingredient: Cyanocobalamin. Areas of application: Vitamin B12 deficiency that cannot be remedied through nutrition.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

B12 Ankermann 1000 µg, injection solution
Active ingredient: Cyanocobalamin

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, B12 Ankermann 1000 µg must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor in any case.
• If any of the side effects listed here affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

This package leaflet includes

1. WHAT IS B12 ANKERMANN 1000 µG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING B12 ANKERMANN 1000 µG?
3. HOW IS B12 ANKERMANN 1000 µG USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD B12 ANKERMANN 1000 µG BE STORED?
6. FURTHER INFORMATION

1. WHAT IS B,2 ANKERMANN 1000 µG AND WHAT IS IT USED FOR?

B12 Ankermann 1000 µg is a vitamin B12 preparation. Cyanocobalamin belongs to the group of substances that are collectively referred to as "vitamin B12".

Area of application

Vitamin B12 deficiency that cannot be remedied through nutrition.

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

• Hyperchromic macrocytic megaloblastic anemia, (pernicious, Biermer–anemia, Addison–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 the following cases:

• Years of malnutrition and deficiency (e.g. due to a strictly vegetarian diet).
• Malabsorption (insufficient absorption of vitamin B12 in the intestine) due to,
• insufficient production of intrinsic factor (a protein that is produced in the gastric mucosa and is required for the absorption of vitamin B12),
• diseases in the terminal ileum (part of the small intestine), e.g. sprue,
• fish tapeworm infestation or
• blind–loop–syndrome (change in the course of the intestine after stomach surgery).
• Congenital vitamin B12 transport disorders.

2. WHAT SHOULD YOU CONSIDER BEFORE USING B12 ANKERMANN 1000 µg?

B12 Ankermann 1000 µg must not be used if you are hypersensitive (allergic) to cyanocobalamin or any of the other ingredients of B12 Ankermann 1000 µg.

Special care is required when using B12 Ankermann 1000 µ

g

No special precautions are required.

Important information about other ingredients of B12 Ankermann 1000 µ

g

B12 Ankermann 1000 µg contains sodium, but less than 1 mmol (23 mg) sodium per ampoule, i.e. it is virtually "sodium-free".

When using B12 Ankermann 1000 µ

g with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. No interactions are known to date. Due to the instability of vitamin B12, the addition of other medicinal products can lead to a loss of effectiveness of the vitamin.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before using any medicine. The recommended daily intake of vitamin B12 during pregnancy and breastfeeding is 4 µg. According to previous experience, higher doses have no adverse effects on the unborn child. Vitamin B12 is excreted in breast milk.

3. HOW IS B12 ANKERMANN 1000 µg USED?

Always use B12 Ankermann 1000 µg exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: At the beginning of treatment, 1 ml (1 ampoule) of B12 Ankermann 1000 µg is administered once or twice a week for the first two weeks after diagnosis, corresponding to 1000 - 2000 µg cyanocobalamin per week. In the case of a proven vitamin B12 absorption disorder in the intestine, 100 µg cyanocobalamin is then administered once a month.

Type of application

g

B12 Ankermann 1000 µg 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).

Duration of application

g

B12 Ankermann 1000 µg is intended for long-term use. Please consult your doctor about this.

If a larger amount of B12 Ankermann 1000 µ

g is used

Poisoning or overdose symptoms are not known.

If the use of B12 Ankermann 1000 µ

g is forgotten

The double dose should not be used if the previous use was forgotten.

If you stop using B12 Ankermann 1000 µ

g

If you interrupt treatment, you are jeopardizing the success of the treatment!

If you experience any unpleasant side effects, please talk to your doctor about further treatment.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, B12 Ankermann 1000 µg can have side effects, although not everybody gets them.

The following frequency information is used to assess side effects:
Very common g	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Occasionally:	1 to 10 in 1,000 treated persons
Rarely:	1 to 10 in 10,000 treated persons
Very rarely:	less than 1 in 10,000 treated persons
Not known:	Frequency cannot be estimated from the available data.

Possible side effects

Skin reactions (acne as well as eczematous and urticarial drug reactions) and hypersensitivity reactions (anaphylactic or anaphylactoid reactions) have been observed in very rare cases.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package 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, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD B12 ANKERMANN 1000 µg BE STORED?

The expiry date is printed on this package and on the ampoules. Do not use the medicine after this date! Ampoules are for single use only.

Storage conditions

No special temperature conditions are required for storage. Store ampoules in the outer carton to protect the contents from light. Keep this medicine out of the reach of children.

6. FURTHER INFORMATION

What B12 Ankermann 1000 µ

g contains

1 ampoule with 1 ml injection solution

g contains

Active ingredient: Cyanocobalamin 1000 µg. The other ingredients are: Sodium chloride, acetic acid, water for injections.

What B12 Ankermann 1000 µg looks like and contents of the pack

Red and clear injection solution.

Original packs:

• 5 ampoules of 1 ml injection solution.
• 10 ampoules of 1 ml injection solution.

Institutional packs:

• 100 ampoules (10 x 10 ampoules of 1 ml injection solution as a bundle pack).
• 500 ampoules (50 x 10 ampoules of 1 ml injection solution as a bundle pack).

Pharmaceutical entrepreneur and manufacturer

Wörwag Pharma GmbH & Co KG
Calwer Straße 7
71034 Böblingen
Telephone: 07031/6204-0
Telefax: 07031/6204-31
E-mail: info@woerwagpharma.com

Manufacturer

Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestraße 3
34212 Melsungen

This package leaflet was last revised in November 2017.

Source: Information from the package leaflet
Status: 07/2020
Active ingredient: Cyanocobalamin. Areas of application: Vitamin B12 deficiency that cannot be remedied through nutrition.