MILGAMMA NA 1 ml. 10 ampoules
Milgamma NA is a vitamin product.
Milgamma NA is used to treat vitamin deficiencies proven B1 and Cb, which causes diseases of the nervous system (neurological diseases).
2. BEFORE YOU USE MILGAMMA NA
Do not use Milgamma NA injector:
if you are allergic (hypersensitive) to thiamine hydrochloride or pyridoxine hydrochloride or any of the other ingredients of Milgamma NA injector (see. the other ingredients in t. 6. Further information).
Take special care with Milgamma NA injector
Allergic reactions (hypersensitivity) reactions with shock have been reported very rarely following administration of injectable solutions containing vitamin B1, but are possible (see Adverse effects).
In breathlessness, palpitations (tachycardia), the occurrence of hives (urticaria) or circulatory collapse should immediately get in touch with the doctor.
Observed symptoms of peripheral sensory neuropathy, paresthesia or accompanied by numbness and tingling in hands and feet.
These symptoms can occur after prolonged use of vitamin B6 in daily doses of 50 mg or a shorter dosing gram.
If you observe in your numbness or tingling, contact your doctor. He will check the prescribed dose and, if necessary, to stop taking the drug.
Use of Milgamma NA injector with other medicines:
Please tell your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.
Vitamin B1 (thiamine hydrochloride) reduces its efficacy concomitant antitumor agent 5-fluorouracil (chemotherapy);
Vitamin B1 is excreted primarily in the urine. Therefore, prolonged treatment with the diuretic furosemide may occur deficiency of vitamin B1;
Concomitant use of so-called pyridoxine antagonists, such as hydralazine, isoniazid (INH), cycloserine, D-penicillamine may increase the need for vitamin B6;
Vitamin B6 (pyridoxine hydrochloride) in daily doses of 5 mg or higher doses can reduce the effects of L-dopa (a medicinal product intended to treat Parkinson's disease).
Please note that these data apply to medicinal products whose reception has ended recently.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
During pregnancy and lactation daily vitamin need to be provided through a well balanced diet. Due to the quantity of its active substances, this product is intended solely for the treatment of vitamin deficiency. Therefore, should be used only after careful consideration by the doctor the benefits and risks of use of the product. No studies are available on the application of Milgamma NA injector during pregnancy.
Vitamins B1 and B6 pass into breast milk.
The maximum daily dose pyridoxine hydrochloride during pregnancy and lactation should not exceed 25 mg. The solution for injection contains 50 mg pyridoxine hydrochloride and therefore not be used during pregnancy and lactation.
Driving and using machines c
There is no indication that Milgamma NA injector affect the ability to drive or operate machinery or influences at work, performed with unstable foothold. Therefore, no special precautions.
3. HOW TO USE MILGAMMA NA injector
In case your doctor advises otherwise, the next following dosing information. Please adhere to the instructions for use, otherwise Milgamma NA injector can not exert its therapeutic effect!
In case your doctor advises otherwise, the usual dose is:
Treatment is initiated by injecting 1 ml injection solution (= 1 ampoule) once daily. Further treatment with 1-2 ml of solution for injection (= 1-2 ampoules) weekly.
Method of administration
The injections are given intramuscularly (into the muscle) or intravenously (into a vein).
Duration of treatment
The duration of treatment depends on the type and severity of the disease. Please ask your doctor about it.
Please contact your doctor or pharmacist if you think that the effect of Milgamma NA injector is too strong or too weak.
If you take more dose Milgamma NA injector
In extreme overdose (dose of more than 10 g vitamin B1) was observed paralysis of the nerves (curare-like effect).
Common complaints should be treated by a doctor according to symptoms appeared.
Overdose of vitamin B6 occurs with nerve damage and impaired senses (sensory polyneuropathy).
This may be associated with impaired coordination of muscle movements (ataxia).
Extremely high doses may lead to convulsions.
In overdoses more than 150 mg / kg body weight may be necessary to apply intense emergency medical measures.
If you forget to take Milgamma NA injector
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Milgamma NA injector can cause side effects, although not everybody gets them.
Evaluation of adverse reactions, the following rules for the frequency of their occurrence:
Very common: more than 1 in every 10 patients treated;
Common: less than 1 in 10 but more than 1 in every 100 patients treated;
Uncommon: less than 1 in 100 but more than 1 in 1,000 patients;
Rare: less than 1 in 1000 but more than 1 in every 10,000 patients treated;
Very rare: less than 1 in 10,000 patients, including isolated cases.
Significant side effects or symptoms that need to pay attention and measures to take when they occur to you:
Immune system disorders:
Very rare: Hypersensitivity reactions (sweating, rapid heartbeat / tachycardia / skin reactions with itching / pruritus / and hives / urticaria /) may occur in isolated cases. Shock and circulatory collapse and / or shortness of breath and skin rashes can occur in individual cases (see. "Take special care with Milgamma NA injector").
Nervous system disorders:
Not known: Peripheral sensory neuropathy (nerve disease accompanied by symptoms of numbness and tingling) may occur with prolonged exceeding the daily dose of 50 mg vitamin B6 (see. "Take special care with Milgamma NA injector").
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MILGAMMA NA injector
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the bottle label.
The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Store in the original package in order to protect from light.
6. FURTHER INFORMATION
What Milgamma NA injector
One ampoule of 1 ml solution for injection contains:
thiamin hydrochloride (vitamin B1): 100 mg;
pyridoxine hydrochloride (Vitamin B6) 50 mg.
Other ingredients (excipients):
tartaric acid (Ph. Eur.), water for injections.
5 x 1 ml ampoules
10 x 1 ml ampoules
20 x 1 ml ampoules
He all pack sizes may be marketed.