1. WHAT VITAMIN B12 IS WHAT IT IS USED FOR
Vitamin B12 solution for injection contains the active substance cyanocobalamin, which belongs to the group of vitamins. It plays an important role in the formation of red blood cells. It is used to treat pernicious and other types of anemia that occur as a result of vitamin B12 deficiency. It is also used to treat other conditions associated with Vitamin B12 deficiency in the body, which can develop with: malnutrition, chronic atrophic gastritis, after surgery to partially or completely remove the stomach, surgery or bowel disease, gastrointestinal intestinal tumors. Vitamin B12 deficiency can also occur in obese vegetarians, as it is not contained in sufficient quantities in foods of plant origin.
2. BEFORE STARTING VITAMIN B12 TREATMENT
Vitamin B12 should not be used in the following cases:
If you are allergic (hypersensitive) to the active substance or excipients in the product;
If you suffer from Leber's disease (hereditary optic nerve atrophy);
If you are pregnant and have megaloblastic anemia that is not due to vitamin B12 deficiency;
If you suffer from thromboembolism;
If you have malignant cancer.
Take special care with Vitamin B12 Treatment
At the beginning of vitamin B12 treatment, the frequency or rhythm of the heart may change in rare cases. If these symptoms occur, consult your doctor.
During vitamin B12 therapy, your doctor may order blood tests to monitor the effect of treatment.
It is possible for the urine to turn red with vitamin B12.
Using other medicines
Please tell your doctor if you are taking birth control pills or are being treated with the antibiotic chloramphenicol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
During pregnancy and lactation Vitamin B12 can be used as prescribed and in doses prescribed by your doctor.
Driving and using machines
Vitamin B12 has no influence on the ability to drive and use machines.
3. HOW TO USE VITAMIN B12
Vitamin B12 is injected intramuscularly by a doctor or other qualified medical staff.
The dosage and frequency of administration are determined by the treating physician according to the degree of vitamin B12 deficiency and the severity of the symptoms.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Vitamin B12 can cause side effects, although not everybody gets them.
Rarely, allergic skin reactions may occur - itching, rash, urticaria. In extremely rare cases, severe allergic reactions (anaphylactic) may occur after injection of vitamin B12. In some cases, fever, chills, hot flushes, fatigue, soreness at the injection site may occur.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
5. STORAGE OF VITAMIN B12
In the original package, in a dark place.
Store below 25 ° C.
Do not freeze!
Keep out of reach of children!
Do not use Vitamin B12 after the expiry date which is stated on the pack.
6. FURTHER INFORMATION
What Vitamin B12 solution for injection contains The
active substance is cyanocobalamin 100, 250, 500 or 1,000 micrograms in 1 ml solution for injection.
The other ingredients are: sodium chloride, sodium acetate trihydrate, glacial acetic acid, water for injections.
What Vitamin B12 looks like and contents of the pack
Vitamin B12 solution for injection is a clear red liquid.
10 ampoules of colorless glass 1 ml in a blister of PVC foil: 1 or 10 blisters, together with a leaflet. The ampoules are opened by pressing the thumb on the mark (point) of the neck above the ampoule.
This leaflet was last approved in May 2008.
The following information is intended for medical or healthcare professionals only.
Dosage and method of administration of Vitamin B12:
The product is administered intramuscularly.
Adults and children
Pernicious and other macrocytic anemias without concomitant neurological symptoms:
Cyanocobalamin is administered at a dose of 250 to 1,000 μg every other day for 1-2 weeks, followed by 250 μg once a week until blood counts return to normal.
Maintenance dose: 1,000 μg once a month.
Pernicious and other macrocytic anemias with concomitant neurological symptoms:
The product is administered in a dose of 1,000 μg every other day until the clinical picture and laboratory parameters are affected.
Prevention of vitamin B12-deficiency anemia due to gastrectomy or malabsorption syndrome:
250 to 1000 μg once a month.
During treatment with vitamin B12, regular monitoring of blood counts is recommended to assess the therapeutic effect