Мilgamma N 2 ml. 25 ampules

1. What Milgamma N solution for injection is and what it is used for
Milgamma N Injection is a B-complex vitamin/drug product used in neuropathy.
The active substances are thiamine hydrochloride (Vitamin B1), pyridoxine hydrochloride (Vitamin B6), cyanocobalamin (Vitamin B12), lidocaine hydrochloride

Milgamma N injection solution is used in:

neurological diseases of various origins;
inflammation of the nerves (neuritis);
neurological pains (neuralgias);
polyneuropathies (nerve diseases, for example, diabetic, alcoholic, etc.); muscle pain (myalgia);
disease of the vertebrae of the spine (radicular syndromes); certain forms of inflammation of the optic nerve (retrobulbar neuritis); herpes zoster;
paralysis of the facial nerve (facial paresis) as a tonic (Roborant).
2. What you need to know before you use Milgamma N solution for injection
Do not use Milgamma N solution for injection:
if you are allergic to thiamine hydrochloride (vitamin B1), pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12), lidocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
in severe disturbances of cardiac conduction and acute decompensated heart failure;
if you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before using Milgamma N solution for injection.

This medication should only be injected intramuscularly, not intravenously. If it is accidentally injected into a vein, your condition will be monitored by a doctor and you may need to be admitted to hospital, depending on the severity of the symptoms the injection has caused.

Children
Due to the content of benzyl alcohol, Milgamma N should not be administered to newborn babies and especially to premature babies. A concentration of 90 mg of benzyl alcohol per day should not be exceeded. In children up to 3 years of age, higher concentrations of benzyl alcohol could cause toxic and hypersensitivity reactions (rapidly developing, life-threatening allergic reactions). If necessary, your doctor will give you the necessary instructions.

Other medicines and Milgamma N injection solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pay particular attention to the following:

sulfite solutions (Vitamin Bi is completely degraded under the influence of solutions containing sulfites. Other vitamins can be deactivated in the presence of breakdown products of vitamin B1);
isoniazid (INHA), cycloserine - used in the treatment of tuberculosis;
D-penicillamine - used in the treatment of rheumatoid arthritis,
Epinephrine - used in the treatment of severe allergic reactions (anaphylaxis);
Norepinephrine - used in the treatment of depression and low blood pressure;
Sulfonamides - antibiotics that are used in the treatment of inflammatory bowel diseases;
Levodopa - used in the treatment of Parkinson's disease.
Milgamma N solution for injection with food, drink and alcohol
No special precautions are required.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
With the administration of vitamin B6 during pregnancy in daily doses of up to 25 mg, there are no risks for the mother and the fetus/baby.
This medicine contains 100 mg of vitamin B6/in one ampoule of 2 ml, therefore it should not be used during pregnancy.

Breastfeeding
There is no risk to the mother and fetus/baby when vitamin B6 is administered during breastfeeding in daily doses of up to 25 mg.

This medicine contains 100 mg of vitamin B6 in one ampoule of 2 ml, therefore it should not be used during breastfeeding.

Fertility
Clinical data on the effect of Milgamma N injection solution on fertility are not available.

Driving and using machines
Milgamma N injection solution does not affect the ability to drive and operate machinery.

Milgamma N solution for injection contains benzyl alcohol, potassium and sodium.
This medicine contains 40 mg of benzyl alcohol in each ampoule of 2 ml solution for injection, which are equivalent to 20 mg/ml. May cause allergic reactions.

Benzyl alcohol is associated with a risk of severe side effects, including breathing problems (called "choking syndrome") in young children. Do not use in newborns (up to 4 weeks of age) unless recommended by your doctor.

Do not use for more than one week in young children (under 3 years of age) unless recommended by your doctor or pharmacist.

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding, because large amounts of benzyl alcohol can build up in your body and cause an unwanted reaction (called 'metabolic acidosis').

Ask your doctor or pharmacist for advice if you have
kidney or liver disease, because large amounts of benzyl alcohol can build up in your body and cause an unwanted reaction (called 'metabolic acidosis').

This medicine contains potassium, less than 1 mmol (39 mg) per ampoule of 2 ml, i.e. practically does not contain potassium.

This medicine contains less than 1 mmol sodium (23 mg) per ampoule of 2 ml, i.e. it can be said to be practically sodium-free.
3. How to use Milgamma N solution for injection
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

This medicine should only be injected intramuscularly, not intravenously. If it is accidentally injected into a vein, your condition will be monitored by a doctor and you may need to be admitted to hospital, depending on the severity of the symptoms the injection has caused.

Your doctor will determine the correct dose for you and how often it should be administered. The recommended dose is:

In case of severe and acute painful conditions: initial daily dose - one injection (2 ml) per day.
After the acute phase subsides and with milder symptoms: 2-3 times a week, one injection.
Your doctor may prescribe tablets to take between injections or as follow-up treatment. Up to 3 times a day, 1 coated tablet Milgamma 50 mg/250 micrograms coated tablets or Milgamma 100 100 mg/ 100 mg coated tablets, or 1 capsule Milgamma N 40 mg/ 90 mg/ 250 micrograms soft capsules.

If you have used more than the required dose
This medicine will be given to you under the supervision of a doctor. Although it is unlikely that you will be given too much or too little of this medicine, tell your doctor or nurse if you are not sure.

If you forget to use Milgamma N solution for injection
Do not take a double dose to make up for a missed dose. Continue to follow your doctor's instructions.

If you have stopped using Milgamma N solution for injection
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following side effects:

Rare side effects (may affect up to 1 in 1,000 people):
Allergic reactions (eg skin rash, shortness of breath, shock, swelling of the eyes, face, tongue or throat). In rare cases, benzyl alcohol can cause allergic reactions.
Very rare side effects (may affect up to 1 in 10,000 people):
Palpitations (tachycardia);
Profuse sweating, acne, skin reactions with itching and rashes (urticaria).
Not known (frequency cannot be estimated from the available data):
Dizziness, drowsiness;
Decreased heart rate (bradycardia), irregular heart rhythm;
Vomiting;
Cramps;
Systemic reactions (reactions involving the whole body) are possible with rapid penetration (accidental intravenous administration, injection into highly blood-supplied tissue) or with overdose.
5. How to store Milgamma N solution for injection
Keep out of the reach of children.
Store in the original package in order to protect from light. To be stored in a refrigerator at a temperature of 2 to 8° C!

Do not use this medicine after the expiry date which is stated on the ampoule label and carton after EXP. The expiry date corresponds to the last day of the specified month.

The solution for injection should be administered immediately after opening the ampoule. It is not permissible to store the solution (or part of it) after breaking the integrity of the ampoule, in order to use it for the next injection.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Milgamma N solution for injection contains
The active substances are:
Each ampoule (2 ml) of solution for injection contains: 100 mg thiamine hydrochloride (vitamin B1), 100 mg pyridoxine hydrochloride (vitamin B6), 1 mg cyanocobalamin (vitamin B12) and 20 mg lidocaine hydrochloride.

The other ingredients (excipients) are:
40 mg benzyl alcohol, water for injections, sodium hydroxide (substances to maintain physiological pH), potassium hexacyanoferrate-III and sodium polyphosphate.

What Milgamma N solution for injection looks like and contents of the pack
Red, clear solution in 2 ml OPC brown ampoules, hydrolytic class I, flame-sealed.

Original packages of 5 ampoules of 2 ml injection solution, 10 ampoules of 2 ml injection solution and 25 ampoules of 2 ml injection solution.

 

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