Pascoe Vitamin B12 depot injectables 1500 µg solution for injection, 10 ampoules

Vitamin B12 Depot Injektopas 1500 µg, solution for injection. Active ingredient: Hydroxocobalamin acetate. 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.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vitamin B12 Depot Injektopas 1500 µg, solution for injection.
Active ingredient: Hydroxocobalamin acetate 1500 µg per ml of solution for injection.

Read the entire package leaflet carefully before you start using this medicine because it contains important information for you.

• Always use this medicine exactly as described in the package leaflet or exactly as your doctor or pharmacist has told you. Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If your symptoms worsen or do not improve, you should definitely see a doctor.

What this leaflet contains:

1. WHAT IS VITAMIN B12 DEPOT INJECTOPAS 1500 µG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING VITAMIN B12 DEPOT INJECTOPAS 1500 µG?
3. HOW IS VITAMIN B12 DEPOT INJECTOPAS 1500 µG TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VITAMIN B12 DEPOT INJECTOPAS 1500 µG BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS VITAMIN B12 DEPOT INJECTOPAS 1500 µG AND WHAT IS IT USED FOR?

Vitamin B12 Depot Injectopas 1500 µg is a vitamin supplement.

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).
• Funicular spinal disease (spinal cord damage).

A laboratory-confirmed vitamin B12 deficiency can occur in:

• Years of malnutrition and undernourishment (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 required for the absorption of vitamin B12),
• Diseases affecting 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 DEPOT INJECTOPAS 1500 µg

Vitamin B12 Depot Injektopas 1500 µg must not be used if: you are allergic to the active substance listed in section 6 or to any of the other ingredients of this medicine.

Warnings and precautions:
Due to the instability of vitamin B12, the vitamin may be less effective if mixed with other drugs.

Using Vitamin B12 Depot Injektopas 1500 µg with other medicines:
No interactions are currently known. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Use of Vitamin B12 Depot Injektopas 1500 µg with food and drink:
No special precautions are necessary.

Pregnancy and breastfeeding:
The recommended daily intake of vitamin B12 during pregnancy and breastfeeding is 4 µg. Based on current experience, higher doses have no adverse effects on the unborn child. Vitamin B12 is excreted into breast milk.

Driving and using machines:
Vitamin B12 Depot Injektopas 1500 µg has no or negligible influence on the ability to drive and use machines. Vitamin B12

Depot Injektopas 1500 µg contains sodium:
Vitamin B12 Depot Injektopas 1500 µg contains sodium; each 1 ml of injection solution contains 9 mg sodium chloride, but less than 1 mmol (23 mg) sodium, i.e., practically sodium-free.

3. HOW TO USE VITAMIN B12 DEPOT INJECTOPAS 1500 µg?

Always use Vitamin B12 Depot Injektopas 1500 µg exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure.
Unless otherwise prescribed: At the start of treatment, 1 ml of Vitamin B12 Depot Injektopas 1500 µg is administered twice a week for the first few weeks after diagnosis (corresponding to 3000 µg hydroxocobalamin acetate). If a vitamin B12 absorption disorder in the intestine is confirmed, 100 µg of cyanocobalamin/hydroxocobalamin/hydroxocobalamin acetate is then administered once a month.

Method of administration:
Vitamin B12 Depot Injektopas 1500 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 use:
Vitamin B12 Depot Injektopas 1500 µg is intended for long-term use. Please consult your doctor about this.

If you have used more Vitamin B12 Depot Injektopas 1500 µg than you should:
Poisoning or symptoms of overdose are not known.

If you forget to use Vitamin B12 Depot Injektopas 1500 µg:
Please contact your doctor to discuss further dosage.

If you stop using Vitamin B12 Depot Injektopas 1500 µg:
Interrupting treatment jeopardizes its success! If you experience unpleasant side effects, please talk to your doctor about further treatment.

4. POSSIBLE SIDE EFFECTS:

Like all medicines, Vitamin B12 Depot Injektopas 1500 µg can cause side effects, although not everybody gets them.

Possible 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 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 DEPOT INJECTOPAS 1500 µG?

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 the container after "EXP". The expiry date refers to the last day of that month.

Storage conditions:
Do not store above 25°C! Keep the ampoules in the outer carton to protect the contents from light.

Note on shelf life after opening or preparation:
Vitamin B12 Depot Injektopas 1500 µg must be used immediately after opening the ampoule. Any unused portion should be discarded.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vitamin B12 Depot Injektopas 1500 µg contains:
The active ingredient is: 1 ampoule with 1 ml of solution for injection contains: Hydroxocobalamin acetate 1500 µg. Note: Hydroxocobalamin acetate belongs to the group of substances collectively known as "vitamin B12". The other ingredients are: Sodium chloride, water for injection.

What Vitamin B12 Depot Injektopas 1500 µg looks like and contents of the pack:
Brown ampoules containing clear, red liquid. Vitamin B12 Depot Injektopas 1500 µg is available in packs of 10 ampoules, each containing 1 ml of solution for injection, and in a hospital pack of 100 ampoules, each containing 1 ml of solution for injection (not intended for dispensing to patients). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
PASCOE pharmazeutische Präparate GmbH, Schiffenberger Weg 55,
D-35394 Giessen, Germany, or for large-volume mailings, postal code D-35383 Giessen, Germany.
Tel.: +49 (0)641/7960-0
Fax: +49 (0)641/7960-109,
e-mail: info@pascoe.de.

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