Vitamin B12 Depot RotexMedica Injection Solution, 10x1 ml

Upute za korištenje Vitamin B12 Depot RotexMedica Injection Solution, 10x1 ml

Important notes (compulsory information):

Vitamin B12 Depot Rotexmedica. Active substance: Hydroxocobalaminate acetate. Areas of application: Vitamin B12 deficiency that can not be remedied nutritionally.

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


LEAFLET: INFORMATION FOR THE USER

Vitamin B12 Depot Rotexmedica
1000 μg / ml injection solution
Active substance: Hydroxocobalamine acetate

Read the entire leaflet carefully because it contains important information for you. This medicine is available without prescription. However, in order to achieve the best possible treatment success, Vitamin B12 Depot Rotexmedica must be used properly.

• Lift the package leaflet. You might want to read it again.
• If you have further questions, contact your doctor or pharmacist.
• If your symptoms get worse or no improvement occurs, you must definitely visit a doctor.
• If one of the listed side effects you significantly affect it or notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This leaflet contains:

1. What is Vitamin B12 Depot Rotexmedica and what is it used for?
2. What do you need before using vitamin B12 Note Depot Rotexmedica?
3. How is Vitamin B12 depot-Rotexmedica to apply?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Vitamin B12 Depot Rotexmedica?
6. ADDITIONAL INFORMATION

1. What is Vitamin B12 Depot Rotexmedica and what is it used for?

Vitamin B12 Depot Rotexmedica is a vitamin B12 preparation. Hydroxocobalamine acetate belongs to the group of fabrics, which are summarized as "vitamin B12.

Vitamin B12 Depot Rotexmedica is applied to:
Vitamin B12 deficiency that can not be remedied nutritionally.

Vitamin B12 deficiency can comment in the following diseases:

• Hyperchromic macrocytic megaloblast anemia (Perniciosa, beermer anemia, addison anemia; These are ripening disorders of red blood cells).
• Funicular spinal disease (spinal cord damage).

A laboratory diagnostically secured vitamin B12 deficiency can occur at:

• For years of lack of deficiency and malnutrition (eg by strictly vegetarian food).
• Malabsorption (insufficient recording of vitamin B12 in the intestine) by
  • insufficient production of intrinsic factor (a protein formed in the gastric mucosa and for absorbing vitamin B12 is needed),
  • Diseases in the end portion of the lenum (part of the small intestine), z. B. Sprue,
  • Fish tape web case or
  • Blind-iOop syndrome (change of the intestinal course according to gastrointestinal operation).
• Congenital vitamin B12 transport disturbances.

2. What do you need before using vitamin B12 Note Depot Rotexmedica?

Vitamin B12 Depot Rotexmedica must not be used if it is hypersensitive (allergic) against hydroxocobalamine acetate or any of the other ingredients of the medicine.

When using vitamin B12 depot rotexmedica with other medicines:
Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is non-prescription medicines. So far, no interactions are known.

Due to the instability of vitamin B12, an efficacy of vitamins can occur by admixing other drugs.

Pregnancy and breast feeding period:
Ask before taking / application from all medicines to your doctor or pharmacist for advice. The recommended daily vitamin B12 feed in pregnancy and lactation is 4 μg. According to previous experiences, higher application quantities have no adverse effects on the unborn child. Vitamin BU is eliminated in breast milk.

3. How to use Vitamin B12 Depot Rotexmedica?

Apply this medicine according to the following dosing recommendations. The following dosage recommendations apply unless otherwise prescribed:
At the beginning of the treatment will be in the first weeks after diagnosis 1 ampoule vitamin B12 depot-rotexmedica (corresponding to 1000 μg hydroxocobalaminate acetate) administered twice a week. For proven vitamin BU recording disorder in the intestine, 100 μg of hydroxocobalamin acetate is then administered once a month.

Type of application:
Vitamin B12 Depot Rotexmedica is usually administered intramuscularly (injected in a muscle). But it can also be added slowly intravenously or subcutaneously (sprayed in a vein or under the skin.

Duration of application:
Vitamin B12 Depot Rotexmedica is intended for longer use. Please contact your doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of vitamin B12 depot rotexmedica is too strong or too weak.

If a larger amount of Vitamin B12 Depot Rotexmedica has been applied:
Poisoning or overdose phenomena are unknown.

If you cancel the application of Vitamin B12 Depot Rotexmedica:
When interrupting the treatment, endanger the success of treatment! If you experience unpleasant side effects, please talk to your doctor about further treatment. If you have further questions about the application of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, vitamin B12 can have side effects, which do not have to occur each other.

The assessment of side effects is based on the following frequency information:
Very common: More than 1 treated from 10
Frequently: 1 to 10 treated from 100
Occasionally: 1 to 10 treated from 1,000
Rarely: 1 to 10 treated from 10,000
Very rare: less than 1 treated from 10,000
Unknown: Frequency on the basis of the available data is not estimable

Possible side effects:
Very rarely, skin symptoms (acne as well as eczemate and urticarial drug reactions) and hypersensitivity symptoms (anaphylactic or Anaphylactoid reactions) observed. Please inform your doctor or pharmacist if one of the listed side effects will significantly affect it or notice side effects that are not specified in this document formation.

5. How to keep vitamin B12 Depot Rotexmedica?

Store drug out of reach of children. You may be the medicine after the label and carpenton necti "Usable until" stated expiry date no longer use. The expiry date refers to the last day of the month.

Storage conditions:
Keep the ampoules in the carton to protect the content from light. Note on durability after breaking or preparation:

Vitamin B12 Depot Rotexmedica is determined after the ampoules for immediate application! Possibly remnants remaining in the ampoule are to be discarded! Due to the instability of vitamin B12, an efficacy of vitamins can occur by admixing other drugs. The medicine must not be disposed of in wastewater or budgetary waste. Ask your pharmacist how to dispose of the medicine if you no longer need it. This measure helps protect the environment.

6. Further information

What Vitamin B12 Depot Rotexmedica contains:
The active ingredient is hydroxocobalamine acetate. 1 ampoule with 1 ml injection solution contains 1000 μg hydroxocobalamine acetate.

The other ingredients are:
Sodium chloride, sodium acetate, acetic acid, water for injection purposes.

Like vitamin B12 depot Rotexmedica looks and content of the pack:
Original pack with 10 ampoules to 1 ml injection solution Clinic pack with 100 (10x10) Ampoules to 1 ml injection solution

Pharmaceutical entrepreneur and manufacturer:
ROTEXMEDICA GmbH Arzneimittelwerk
Bunsenstraße 4
22946 Trittau
Tel.: 0 41 54 / 862-0
Fax: 0 41 54 / 862-155

This information information was last revised in July 2013.

Source: Information of the leaflet
Status: 09/2015