Milgamma n
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Milgamma N (Milgamma N Injekt)
Thiamini hydrochloridum + Pyridoxini hydrochloridum + Cyanocobalaminum
(50 mg + 50 mg + 0.5 mg)/ml
solution for injection
Milgamma N and Milgamma N Injekt are different brand names of the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet so that you can read it again if necessary.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet:
- What Milgamma N is and what it is used for
- What you need to know before using Milgamma N
- How to use Milgamma N
- Possible side effects
- How to store Milgamma N
- Contents of the pack and other information
1. What Milgamma N is and what it is used for
Milgamma N is a combination of B-group vitamins.
Milgamma N is used in adults in the following conditions:
- neurological disorders of various origins;
- nerve inflammation;
- neuralgia;
- polyneuropathies (e.g. diabetic, alcoholic, etc.);
- muscle pain (myalgia);
- radicular syndrome;
- cervical tension syndrome;
- shoulder pain;
- certain forms of optic neuritis (retrobulbar optic neuritis);
- shingles (herpes zoster);
- facial nerve palsy;
- and as a tonic agent.
2. Important information before using Milgamma N
When not to use Milgamma N:
- if the patient is allergic to thiamine hydrochloride (vitamin B₁), pyridoxine hydrochloride (vitamin B₆), cyanocobalamin (vitamin B₁₂), or any of the other components of this medicine (listed in section 6),
- if there are conduction disturbances or uncontrolled heart failure,
- during pregnancy and breastfeeding,
- in children and adolescents under 18 years of age.
Warnings and precautions
Before starting treatment with Milgamma N, discuss this with your doctor, pharmacist, or
nurse.
Milgamma N is intended exclusively for intramuscular injection (i.m.), not for intravenous
administration (i.v.). Any accidental intravenous injection must be monitored by a physician or
in a hospital setting, depending on the severity of symptoms resulting from it.
This medicine may cause neuropathies if used for longer than six months.
No special precautions are required for elderly patients.
Milgamma N and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken,
or plan to take.
This is particularly important for the following medicines:
- solutions containing sulfites (vitamin B₆ degrades in solutions containing sulfites; other vitamins may be inactivated in the presence of vitamin B₆ degradation products),
- 5-fluorouracil – used in cancer treatment,
- INH (isoniazid) – used in tuberculosis treatment,
- D-penicillamine – used in the treatment of rheumatoid arthritis,
- long-term use of oral contraceptives containing estrogens,
- epinephrine – used in the treatment of severe allergic reactions (anaphylaxis),
- norepinephrine – used in the treatment of depression and low blood pressure,
- sulfonamides – antibiotics also used in the treatment of inflammatory bowel diseases,
- L-dopa – used in the treatment of Parkinson's disease.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
During pregnancy, the recommended daily intake of vitamin B₁ is 1.2 mg (second trimester) to 1.3 mg
(third trimester). The recommended daily intake of vitamin B₆ during pregnancy is 1.9 mg, and of vitamin B₁₂ – 2.6 μg.
The safety of daily doses higher than recommended has not yet been sufficiently studied.
Milgamma N should not be used during pregnancy.
Breastfeeding
During breastfeeding, the recommended daily intake of vitamin B₁ is 1.3 mg, vitamin B₆ – 1.9 mg, and vitamin B₁₂ – 2.6 μg.
The safety of daily doses higher than recommended has not yet been sufficiently studied.
Vitamins B₁, B₆, and B₁₂ pass into breast milk. High doses of vitamin B₆ may inhibit milk secretion.
Milgamma N should not be used during breastfeeding.
Driving and operating machinery
There are no special restrictions.
This medicine contains benzyl alcohol, sodium, and potassium
Benzyl alcohol
Milgamma N contains 40 mg of benzyl alcohol per 2 ml ampoule. Large volumes of benzyl alcohol should be administered with caution and only if necessary, especially in patients with impaired kidney or liver function due to the risk of accumulation and toxicity (metabolic acidosis).
Sodium
Milgamma N contains less than 1 mmol (23 mg) of sodium per 2 ml ampoule, meaning the medicine is considered "sodium-free".
Potassium
Milgamma N contains less than 1 mmol (39 mg) of potassium per 2 ml ampoule, meaning the medicine is considered "potassium-free".
3. How to use Milgamma N
This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
This medicine should be administered by intramuscular injection. Any accidental
intravenous injection must be monitored by a doctor or under hospital conditions, depending on the severity
of symptoms arising from it.
The doctor will determine the appropriate dose and frequency of administration for the patient.
Recommended dose:
In severe and acute painful conditions and to rapidly achieve high blood concentrations:
initial dose is 1 injection (2 ml) per day.
After the acute phase has subsided and in cases of milder symptoms: 1 injection 2–3 times per
week.
There is no need to adjust the dose in elderly patients or in patients with renal insufficiency.
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.
Safety and efficacy have not been established in patients with hepatic impairment. For this
reason, Milgamma N should not be used in patients with severe hepatic impairment.
Weekly monitoring of treatment by a doctor is recommended.
The treatment should be switched to oral administration as quickly as possible.
Use of a higher than recommended dose of Milgamma N
This medicine is administered under medical supervision. It is unlikely that the dose will be too high
or too low; however, if the patient suspects this has occurred, they should inform their doctor or
nurse.
4. Possible adverse reactions
Like all medicines, Milgamma N can cause adverse reactions, although not everyone will experience them.
The adverse reactions are listed below according to their frequency of occurrence:
Very common: may occur in more than 1 in 10 patients
Common: may occur in up to 1 in 10 patients
Uncommon: may occur in up to 1 in 100 patients
Rare: may occur in up to 1 in 1,000 patients
Very rare: may occur in up to 1 in 10,000 patients
Frequency not known: frequency cannot be estimated from the available data
Inform your doctor immediately if any of the following occur:
Rare:
- Allergic reactions (e.g. skin rash, shortness of breath, shock, swelling of the eyes, face, tongue, or throat)
If any of the following adverse reactions occur, consult your doctor as soon as possible:
Very rare:
- Palpitations (tachycardia)
- Excessive sweating, acne, skin reactions with itching and urticaria
Frequency not known:
- Dizziness, drowsiness
- Slowing of the heart rate (bradycardia), heart rhythm disturbances
- Vomiting
- Convulsions
- Systemic reactions (reactions affecting the whole body) may occur following rapid injection (e.g. accidental intravenous administration, injection into tissues with high blood flow) or overdose
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Milgamma N
This medicinal product should be kept out of sight and reach of children.
Store in a refrigerator (2°C – 8°C). Keep in the original packaging. Protect from light.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicinal products 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. Package contents and other information
What Milgamma N contains
2 ml of solution for injection contain:
Active substances:
Thiamine hydrochloride (vitamin B ) 100 mg
Pyridoxine hydrochloride (vitamin B ) 100 mg
Cyanocobalamin (vitamin B ) 1 mg
Excipients:
Benzyl alcohol, lidocaine hydrochloride, sodium hydroxide, potassium hexacyanoferrate(III),
sodium polyphosphate, water for injections.
What Milgamma N looks like and contents of the pack
Packaging contains:
5 ampoules of 2 ml solution for injection;
25 ampoules of 2 ml solution for injection;
100 ampoules of 2 ml solution for injection;
500 ampoules of 2 ml solution for injection.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Wörwag Pharma GmbH & Co.KG
Flugfeld-Allee 24
71034 Böblingen
Germany
Manufacturer:
Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestrasse 3
D-34212 Melsungen
Germany
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Marketing Authorisation Number in Latvia, country of export: 99-0934
Parallel Import Licence Number: 183/16