Vitamin b12 wzf

Package leaflet: Information for the patient

VITAMINUM B WZF 100 micrograms/ml, solution for injection
VITAMINUM B WZF 500 micrograms/ml, solution for injection
Cyanocobalaminum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Vitaminum B WZF is and what it is used for
2. Important information before using Vitaminum B WZF
3. How to use Vitaminum B WZF
4. Possible adverse reactions
5. How to store Vitaminum B WZF
6. Contents of the package and other information

1. What Vitaminum B WZF is and what it is used for

Vitaminum B WZF contains cyanocobalamin (vitamin B ), which is essential for body growth. It influences the formation of blood cells and the proper functioning of the nervous system. Vitamin B deficiency may lead to pernicious anaemia and irreversible neurological complications.
This medicine is used:

• in Addison-Biermer pernicious anaemia (a specific type of anaemia caused by vitamin B deficiency);
• in other megaloblastic anaemias due to vitamin B deficiency;
• in vitamin B deficiencies caused by the following conditions:
• complete exclusion of animal-derived products from the diet (strict vegetarianism);
• impaired (congenital or acquired) secretion of intrinsic factor necessary for vitamin B absorption (Castle's factor);
• absence of Castle's factor following gastrectomy (surgical removal of the stomach);
• chronic atrophic gastritis;
• malabsorption syndromes following resection of the ileum, in coeliac disease (gluten intolerance), tropical sprue (also known as psylosis – a gastrointestinal disorder leading to impaired nutrient absorption), or Crohn's disease (inflammatory bowel disease);
• excessive utilization of vitamin B by intestinal bacteria (blind loop syndrome) or parasites (infection with Diphyllobothrium latum);
• in the Schilling test (a test assessing vitamin B absorption).

2. Important information before using Vitaminum B12 WZF

When not to use Vitaminum B12 WZF

• if the patient is allergic to vitamin B12, cobalt, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Vitaminum B12 WZF, discuss this with your doctor or
pharmacist.

• In patients with Leber's disease (visual disturbances due to optic nerve atrophy), the medicine should be used with caution, as cyanocobalamin may accelerate optic nerve atrophy.
• In patients with pernicious anemia (during treatment with high doses of vitamin B12), blood potassium levels may decrease.
• In Addison-Biermer disease, vitamin B12 should be administered regularly for life. A break in administration lasting several months, seemingly justified by good blood test results (morphology), may lead to irreversible damage to the nervous system.
• Vitamin B12 treatment may reveal symptoms of polycythemia vera (intense redness of the face, hands, feet, and oral mucosa).
• Before starting treatment and between the 5th and 7th day of treatment, the following laboratory tests are recommended: serum folic acid concentration, hematocrit, reticulocytes (a marked increase in reticulocyte count—immature red blood cells—is an early sign of effective treatment), and vitamin B12 concentration. During long-term treatment, periodic monitoring of hematological parameters (blood status) and vitamin B12 concentration every 3 to 6 months is recommended.

Vitaminum B12 WZF and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

• Certain antibiotics, methotrexate (used in cancer treatment), or pyrimethamine (used in malaria treatment) may interfere with vitamin B12 serum concentration measurements, leading to false-negative results.
• Impaired absorption of vitamin B12 may occur during treatment with colchicine (used in gout treatment), para-aminosalicylic acid (an antituberculosis drug), or prolonged consumption of large amounts of alcohol for more than 2 weeks.
• Concurrent use of drugs that suppress bone marrow function (e.g., chloramphenicol) may weaken the response to vitamin B12 treatment.
• Folic acid administered in high doses over a prolonged period may reduce vitamin B12 blood concentration.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
No adverse effects have been observed in infants breastfed by women taking recommended doses of vitamin B12.

Driving and operating machinery
This medicine has no influence on the ability to drive vehicles or operate machinery.

Vitaminum B12 WZF contains sodium
Vitaminum B12 WZF 100 micrograms/ml
The medicine contains 3.96 mg of sodium (main component of table salt) per 1 ml ampoule. This corresponds to 0.2% of the maximum recommended daily dietary sodium intake for adults.
Vitaminum B12 WZF 500 micrograms/ml
The medicine contains less than 1 mmol (23 mg) of sodium per 2 ml ampoule, meaning the medicine is considered "sodium-free".

3. How to use Vitaminum B WZF

This medicine should always be used according to the doctor's instructions. If in doubt, consult a
doctor or pharmacist.
The medicine should be administered by intramuscular injection or deep subcutaneous injection.
The medicine must not be administered intravenously. The dosage and method of administration are determined by the doctor.
Detailed dosage instructions, as well as the method of use and preparation of the medicine for administration,
are provided at the end of this leaflet, in the section "Information intended exclusively for medical professionals".
Use of a higher than recommended dose of Vitaminum B WZF
If the patient suspects having received an excessive dose of the medicine, a doctor should be informed immediately.
Cases of overdose are not known.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with this medicine:

• cases of anaphylactic shock (symptoms: circulatory disturbances, drop in blood pressure, swelling of the face, lips, tongue, throat, causing difficulty in breathing or swallowing, urticaria) and deaths following parenteral administration of vitamin B, hypersensitivity (very rare);
• pulmonary edema, congestive heart failure (symptoms: body swelling, fatigue, fluid accumulation in body cavities);
• peripheral vascular thrombosis;
• polycythemia vera;
• itching, rash;
• sensation of bloating, mild transient diarrhoea;
• pain at the site of intramuscular injection.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Vitaminum B12 WZF

Store the ampoules in the outer packaging to protect from light, at a temperature below 25°C. Do not freeze.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule.
The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Vitaminum B12 WZF contains

• The active substance is cyanocobalamin. Each ml of solution contains either 100 or 500 micrograms of cyanocobalamin (vitamin B12).
• Other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections.

What Vitaminum B12 WZF looks like and contents of the pack
Vitaminum B12 WZF is a pink, clear liquid.
Packaging:
Vitaminum B12 WZF 100 micrograms/ml: 10 ampoules of 1 ml in a cardboard box.
Vitaminum B12 WZF 500 micrograms/ml: 5 ampoules of 2 ml in a cardboard box.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Information intended exclusively for healthcare professionals:

VITAMINUM B WZF 100 micrograms/ml, solution for injection
VITAMINUM B WZF 500 micrograms/ml, solution for injection
Cyanocobalaminum

The medicinal product should be administered by intramuscular injection or deep subcutaneous injection.
The product must not be administered intravenously.
Concomitant mixing of vitamin B\textsubscript{12} solution with injectable sodium warfarin is not recommended.
Vitamin C destroys cyanocobalamin in vitro; therefore, simultaneous administration of these vitamins should be avoided.

Instructions for opening the ampoule
Before opening the ampoule, ensure that the entire solution is located in the lower part of the ampoule.
Gently shake the ampoule or tap it with your finger to facilitate the flow of the solution downward.
Each ampoule is marked with a coloured dot (see Figure 1) indicating the score line located beneath it.

• To open the ampoule, hold it vertically with both hands, with the coloured dot facing towards you – see Figure 2. The upper part of the ampoule should be gripped so that the thumb is positioned just above the coloured dot.
• Apply pressure in the direction of the arrow shown in Figure 3.
  Ampoules are intended for single use only and should be opened immediately before use. Any unused portion of the product must be discarded in accordance with applicable regulations.

Figure 1 Figure 2 Figure 3

Dosage
Adults:
Pernicious anemia (Addison-Biermer disease) without neurological symptoms:
250 to 1000 micrograms every other day for 1 to 2 weeks, followed by 250 micrograms once weekly until hematological improvement is achieved. Maintenance dose: 1000 micrograms once monthly.

In cases with neurological complications (so-called subacute combined degeneration of the spinal cord): 1000 micrograms every other day until improvement occurs.

Vitamin B\textsubscript{12} deficiency following gastrectomy or due to malabsorption: 250 to 1000 micrograms once monthly.

Children:
Pernicious anemia (Addison-Biermer disease) without neurological symptoms:
Up to 3 years: 5 to 15 micrograms daily;
3–18 years: 15 to 30 micrograms daily.

Megaloblastic anemia:
Up to 3 years: 5 to 15 micrograms weekly;
3–7 years: 15 to 25 micrograms weekly;
7–18 years: 15 to 30 micrograms weekly.

Anemia with neurological symptoms:
Up to 3 years: 100 to 200 micrograms weekly;
3–7 years: 200 to 500 micrograms weekly;
7–18 years: 500 to 1000 micrograms weekly.

Schilling test
Following oral administration of radiolabelled vitamin B\textsubscript{12}, administer 1000 micrograms of vitamin B\textsubscript{12} intramuscularly as a single dose.