Neiraxin® b

Package leaflet: Information for the user

Neiraxin B, (100 mg/100 mg/1 mg/20 mg)/2 ml, solution for injection
Pyridoxini hydrochloridum, Thiamini hydrochloridum, Cyanocobalaminum, Lidocaini hydrochloridum
Please read carefully all the information in this leaflet before using this 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 nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents of the leaflet

1. What Neiraxin B is and what it is used for
2. Important information before using Neiraxin B
3. How to use Neiraxin B
4. Possible side effects
5. How to store Neiraxin B
6. Contents of the pack and other information

1. What Neiraxin B is and what it is used for

The active substances in Neiraxin B are: pyridoxine hydrochloride (vitamin B₆), thiamine hydrochloride (vitamin B₁), cyanocobalamin (vitamin B₁₂), lidocaine hydrochloride.
Neiraxin B is used in the treatment of haematological and neurological symptoms resulting from chronic deficiency of vitamins B₁, B₆, and B₁₂ in adults and children over 12 years of age.

2. Important information before using Neiraxin B

When not to use Neiraxin B:

• if the patient is allergic to pyridoxine hydrochloride (vitamin B_), thiamine hydrochloride (vitamin B_), cyanocobalamin (vitamin B_), lidocaine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe cardiac conduction disorders or acute decompensated heart failure;
• during pregnancy and breastfeeding.

Due to the presence of benzyl alcohol, this medicine must not be administered to newborns, especially premature infants.
The daily dose of benzyl alcohol must not exceed 90 mg: poisoning and an anaphylactoid reaction may occur in children under 3 years of age.

Warnings and precautions

This medicine should be administered by intramuscular injection (i.m.) only, not intravenously (i.v.). In case of accidental intravenous administration, the patient should be monitored or hospitalized, depending on the severity of symptoms.

Neiraxin B and other medicines

Tell your doctor if you are currently taking, have recently taken, or plan to take any other medicines.

Particular attention should be paid to the following medicines:

• solutions containing sulfites (vitamin B_ degrades in sulfite-containing solutions with acidic pH. Other vitamins may become inactivated in the presence of vitamin B_ degradation products);
• isoniazid, cycloserine – used in the treatment of tuberculosis;
• D-penicillamine – used in the treatment of rheumatoid arthritis;
• epinephrine – used to treat severe allergic reactions (anaphylactic reactions);
• norepinephrine – used in the treatment of shock and low blood pressure;
• sulfonamides – antibiotics also used in the treatment of inflammatory bowel diseases;
• levodopa – used in the treatment of Parkinson's disease.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or nurse before using this medicine.

The safe daily dose of vitamin B_ during pregnancy and breastfeeding is 25 mg. Since this medicine contains 100 mg of vitamin B_ per 2 ml ampoule, it must not be used during pregnancy and breastfeeding.

Driving and operating machinery

This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.

Neiraxin B contains benzyl alcohol, sodium, and potassium

Benzyl alcohol:

• This medicine contains 40 mg of benzyl alcohol in each ampoule, equivalent to 20 mg/ml. Benzyl alcohol may cause allergic reactions.
• Do not administer to premature infants or newborns.
• This medicine may cause poisoning and allergic reactions in infants and children under 3 years of age.
• Consult a doctor or pharmacist if the patient is pregnant, breastfeeding, or has liver or kidney disease, as high amounts of benzyl alcohol may accumulate in the body and cause adverse effects (so-called metabolic acidosis).

Sodium:

• This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

Potassium:

• This medicine contains less than 1 mmol (39 mg) of potassium per dose, meaning the medicine is considered "potassium-free".

3. How to use Neiraxin B

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor.
This medicine should be administered only intramuscularly (i.m.), not intravenously (i.v.). In the event of
accidental intravenous administration, the patient will be monitored or hospitalized, depending on the severity
of symptoms.
Your doctor will determine the appropriate dose and frequency of administration for the patient.
Use in adults and children over 12 years of age
When severe and acute symptoms are present, one injection (2 ml) is usually administered once daily
to achieve high blood concentrations of the active substances. When the acute phase has passed, as well as
in cases of milder symptoms, one injection is given 2–3 times per week.
Elderly patients
Dose adjustment is not required.
Children and adolescents
Neiraxin B, solution for injection, should not be used in children under 12 years of age.
Instructions for opening the ampoule:

1. Turn the ampoule so that the end marked with a coloured dot is on top. If some solution remains
   in the upper part, gently tap with fingers so that the solution flows down to the lower part of the ampoule.
2. To open the ampoule, use both hands; hold the lower part of the ampoule with one hand and
   break off the top part with the other hand by bending in the direction opposite to the coloured dot
   (see figure below).

Accidental overdose of Neiraxin B
This medicine is administered under medical supervision; therefore, it is unlikely that the dose of
Neiraxin B administered would be too high or too low.
If the patient feels that the effect of Neiraxin B is too strong or too weak, consult a doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below are categorized by their frequency of occurrence in the following order:
Rare (may occur in no more than 1 in 1,000 patients)

• Hypersensitivity reactions (e.g., skin rash, respiratory distress, shock, angioedema)
  Benzyl alcohol: hypersensitivity reactions

Very rare (may occur in no more than 1 in 10,000 patients)

• Palpitations (tachycardia)
• Excessive sweating, acne, skin reactions with itching and urticaria

Frequency not known (frequency cannot be estimated from the available data)

• Dizziness, disturbances in consciousness
• Slow heartbeat (bradycardia), cardiac arrhythmias
• Vomiting
• Seizures
• Systemic reactions, including central nervous system stimulation and/or depression (disturbances in balance, nervousness, feeling of impending doom, euphoria, confusion, dizziness, tinnitus, blurred or double vision, vomiting, sensation of cold or heat, numbness) – may occur following rapid administration (accidental intravenous injection, injection into well-perfused tissues), or as a result of overdose.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 helps to provide more information on the safety of this medicine.

5. How to store Neiraxin B

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep in the original packaging to protect from light.
Keep this medicine out of the sight and reach of children.
After opening, the contents should be used immediately.
Do not use this medicine after the expiry date stated on the carton after: expiry (EXP). The expiry date refers to the last day of the specified month.

6. Contents of the pack and other information

What Neiraxin B contains

• The active substances in the medicine are pyridoxine hydrochloride (vitamin B₆), thiamine hydrochloride (vitamin B₁), cyanocobalamin (vitamin B₁₂), and lidocaine hydrochloride.

1 ml of injection solution contains: 50 mg pyridoxine hydrochloride, 50 mg thiamine hydrochloride, 0.5 mg cyanocobalamin, 10 mg lidocaine hydrochloride.
One ampoule (2 ml) contains: 100 mg pyridoxine hydrochloride, 100 mg thiamine hydrochloride, 1 mg cyanocobalamin, 20 mg lidocaine hydrochloride.

• Other components are: benzyl alcohol, pentasodium triphosphate, sodium hydroxide (for pH adjustment), potassium hexacyanoferrate(III), water for injections.

What Neiraxin B looks like and contents of the pack
A clear, red injection solution (injection).
Neiraxin B is supplied in 2 ml amber glass ampoules.
5 ampoules are packed in a PVC blister. 1, 2 or 5 blisters are packed in a cardboard box.
Pack sizes: 5, 10 or 25 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
1057 Rīga
Latvia
Tel.: +371 67083320
E-mail: [email protected]

This medicine is authorised in the European Economic Area countries under the following names:
Estonia Neiratax
Latvia Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml solution for injection
Lithuania Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml injekcinis tirpalas
Czech Republic Neiraxin
Hungary Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml oldatos injekció
Bulgaria Neiraxin B 100 mg/100 mg/1 mg/20 mg/2 ml инжекционен разтвор
Poland Neiraxin B
Slovakia Neiraxin
Romania Neiraxin soluţie injectabilă
Netherlands Neiraxin 100 mg/100 mg/1 mg/20 mg/2 ml oplossing voor injectie