


Ask a doctor about a prescription for Milgamma N
Milgamma N(Milgamma N Injection)
(50 mg + 50 mg + 0.5 mg)/ml, solution for injection
Thiamine hydrochloride + Pyridoxine hydrochloride + Cyanocobalamin
Milgamma N and Milgamma N Injection are different trade names for the same drug.
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Keep this leaflet, so you can read it again if you need to.
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If you have any doubts, consult your doctor or pharmacist.
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This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
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If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
See section 4.
Milgamma N is a mixture of B vitamins.
Milgamma N is used in adults in the following cases:
Before starting treatment with Milgamma N, discuss it with your doctor, pharmacist, or nurse.
Milgamma N is intended for intramuscular injection (i.m.) only, not for intravenous injections (i.v.). Any accidental intravenous injection must be monitored by a doctor or in a hospital setting, depending on the severity of the resulting symptoms.
This medicine may cause neuropathy if used for more than six months.
There are no special precautions for elderly patients.
Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
This is especially important for the following medicines:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
The recommended daily dose of vitamin B1 is 1.2 mg (second trimester) to 1.3 mg (third trimester). During pregnancy, the recommended daily dose of vitamin B6 is 1.9 mg, and vitamin B12 is 2.6 μg. The safety of doses higher than recommended has not been sufficiently studied. Do not use Milgamma N during pregnancy.
Breastfeeding
The recommended daily dose of vitamin B1 is 1.3 mg, vitamin B6 - 1.9 mg, and vitamin B12 - 2.6 μg during breastfeeding.
The safety of doses higher than recommended has not been sufficiently studied.
Vitamins B1, B6, and B12 pass into breast milk. High doses of vitamin B6 may inhibit milk secretion.
Do not use Milgamma N during breastfeeding.
There are no special restrictions.
Milgamma N contains 40 mg of benzyl alcohol in 1 ampoule of 2 ml. Large volumes of benzyl alcohol should be administered with caution and only when necessary, especially in patients with renal or liver function disorders due to the risk of toxicity accumulation (metabolic acidosis).
Milgamma N contains less than 1 mmol (23 mg) of sodium per 1 ampoule of 2 ml, which means the medicine is considered "sodium-free".
Milgamma N contains less than 1 mmol (39 mg) of potassium per 1 ampoule of 2 ml, which means the medicine is considered "potassium-free".
This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
This medicine is for intramuscular injection only. Any accidental intravenous injection must be monitored by a doctor or in a hospital setting, depending on the severity of the resulting symptoms.
Your doctor will determine the appropriate dose for you and how often to administer it.
The recommended dose is:
In severe and acute pain states and to quickly achieve high blood levels:
the initial dose is 1 injection (2 ml) per day. After the acute phase has subsided and in cases of mild symptoms: 1 injection 2-3 times a week.
There is no need to adjust the dose in elderly patients and patients with renal impairment.
There are insufficient studies on the use of Milgamma N in children and adolescents under 18 years of age. Therefore, Milgamma N should not be used in children and adolescents under 18 years of age. The safety and efficacy of Milgamma N have not been established in patients with liver failure. Therefore, Milgamma N should not be used in patients with severe liver failure.
Treatment should be monitored by a doctor at weekly intervals.
It is recommended to switch to oral administration as soon as possible.
This medicine is administered under medical supervision. It is unlikely that the dose of the medicine will be too high or too low, but if you suspect that this has happened, inform your doctor or nurse.
Like all medicines, Milgamma N can cause side effects, although not everybody gets them.
Side effects are listed by frequency of occurrence:
Very common:may affect more than 1 in 10 people
Common:may affect up to 1 in 10 people
Uncommon:may affect up to 1 in 100 people
Rare:may affect up to 1 in 1,000 people
Very rare:may affect up to 1 in 10,000 people
Frequency not known:frequency cannot be estimated from the available data
Rare:
If you experience any of the following side effects, consult your doctor as soon as possible:
Very rare:
Frequency not known:
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.
Keep the medicine out of sight and reach of children.
Store in a refrigerator (2°C-8°C) in the original packaging. Protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
2 ml of solution for injection contains:
Active substances:
Thiamine hydrochloride (vitamin B1)
100 mg
Pyridoxine hydrochloride (vitamin B6)
100 mg
Cyanocobalamin (vitamin B12)
1 mg
Excipients:
Benzyl alcohol 40 mg, lidocaine hydrochloride 20 mg, sodium hydroxide, potassium hexacyanoferrate (III), sodium polyphosphate, water for injections.
The package contains: 5 ampoules of 2 ml solution for injection.
For more detailed information, contact the marketing authorization holder or the parallel importer.
Wörwag Pharma GmbH & Co.KG
Flugfeld-Allee 24
71034 Böblingen
Germany
Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestrasse 3
D-34212 Melsungen
Germany
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:99-0934
Parallel import authorization number:350/16
Date of leaflet approval: 16.02.2022
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for Milgamma N – subject to medical assessment and local rules.