Milgamma - instructions for use, doses, side effects, contraindications

Excipients: benzyl alcohol 40.0 mg, sodium polyphosphate 20 mg, potassium hexacyanoferrate 0.20 mg, sodium hydroxide 12.0 mg, water for injection up to 2 ml.

Description:

Transparent solution of red color with a characteristic odor.

Pharmacotherapeutic group:Vitamins of group B + other.

ATX: & nbsp

A.11.E.X B group vitamins in combination with other drugs

Pharmacodynamics:

Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and motor apparatus. Promotes increased blood flow and improves the functioning of the nervous system.

Thiamine plays a key role in the metabolism of carbohydrates, as well as in the Krebs cycle with subsequent participation in the synthesis of TPP (thiamine pyrophosphate) and ATP (adenosine triphosphate).

Pyridoxine is involved in protein metabolism, and in part, in the metabolism of carbohydrates and fats. The physiological function of both vitamins is the potentiation of each other's action, manifested in a positive effect on the nervous, neuromuscular and cardiovascular systems. With a deficiency of vitamin B₆ widespread deficit conditions quickly stop after the administration of these vitamins.

Cyanocobalamin is involved in the synthesis of the myelin sheath, stimulates hemopoiesis, reduces pain associated with peripheral nervous system damage, stimulates nucleic acid metabolism through the activation of folic acid.

Lidocaine is a local anesthetic that causes all kinds of local anesthesia: terminal, infiltration, and conductive.

Pharmacokinetics:

After intramuscular injection thiamine is rapidly absorbed from the injection site and enters the blood (484 ng / ml after 15 minutes on the first day of dosing at 50 mg) and is distributed unevenly in the body with a content of 15% in leukocytes, 75% in erythrocytes and 10% in plasma. In connection with the lack of significant vitamin stores in the body, it must enter the body daily. Thiamine penetrates the blood-brain and placental barriers and is found in breast milk. Thiamine is excreted in the urine in the alpha phase after 0.15 hours, in the beta phase after 1 hour and in the terminal phase within 2 days. The main metabolites are: thiaminic acid, pyramine and some unknown metabolites. Of all vitamins thiamine remains in the body in the smallest amount. The adult body contains about 30 mg of thiamine in the form of 80 % thiamine pyrophosphate, 10% thiamine triphosphate, and the balance in the form of thiamine monophosphate.

After intramuscular injection pyridoxine quickly absorbed into the bloodstream and distributed in the body, performing the role of coenzyme after phosphorylation of the CH group₂OH in the 5th position. About 80% of the vitamin binds to blood plasma proteins. Pyridoxine is distributed throughout the body and crosses the placenta and is found in breast milk, is deposited in the liver and oxidized to 4-pyridoxic acid, which is excreted in the urine, maximum 2-5 hours after absorption. The human body contains 40-150 mg of vitamin B₆ and its daily elimination rate is about 1.7 - 3.6 mg with a replacement rate of 2.2 - 2.4%.

Indications:

As a pathogenetic and symptomatic agent in the complex therapy of diseases and syndromes of the nervous system of various origins: neuralgia, neuritis, facial nerve paresis, retrobulbar neuritis, ganglionitis (including shingles), plexopathy, neuropathy, polyneuropathy (diabetic, alcoholic, etc.) nocturnal muscular spasms, especially in older age groups, neurological manifestations of spinal osteochondrosis: radiculopathy, lumboeishalgia, muscular-tonic syndromes.

Contraindications:

The period of pregnancy and breastfeeding (see section "Application during pregnancy and during breast-feeding").

Childhood.

Decompensated heart failure.

Increased individual sensitivity to the components of the drug.

Pregnancy and lactation:

The use of the drug is contraindicated during pregnancy and breastfeeding (see section "Contraindications").

Dosing and Administration:

Injections are performed intramuscularly.

In cases of severe pain in order to quickly achieve a high level of the drug in the blood, it is advisable to start treatment with 2.0 ml daily for 5-10 days. In the future, after the abatement of the pain syndrome and with mild forms of the disease, then either the therapy with the oral dosage form (for example, the preparation Milgamma® compositum) or for rarer injections (2-3 times a week for 2-3 weeks) with the possible continuation of therapy with the oral dosage form (eg, Milgamma® composite).

Weekly monitoring of therapy by the doctor is recommended.

The transition to therapy with oral dosage form (for example, Milgamma® compositum) is recommended in the shortest possible time.

Side effects:

The incidence of adverse adverse reactions is given in accordance with the WHO classification:

Very Frequent	more than 1 in 10 treated
Frequent	less than 1 in 10, but more than 1 in 100 treated
Infrequent	less than 1 in 100, but more than 1 in 1,000 treated
Rare	less than 1 in 1000, but more than 1 in 10,000 undergoing treatment
Very rare	less than 1 in 10,000, including individual cases

* In some cases - the symptoms manifest with an unknown frequency;

From the immune system:

rare: allergic reactions (skin rash, shortness of breath, anaphylactic shock, Quincke's edema);

from the nervous system:

in some cases: dizziness, confusion;

from the cardiovascular system:

very rare: tachycardia;

in some cases: bradycardia, arrhythmia;

from the gastrointestinal tract:

in some cases: vomiting;

from the skin and subcutaneous tissues:

very rare: increased sweating, acne, pruritus, urticaria;

from the osteomuscular and connective tissue:

in some cases: convulsions;

general disorders and disorders at the site of administration:

in some cases: irritation may occur at the injection site; Systemic reactions are possible with rapid administration or overdose.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:Treatment of an overdose consists in the abolition of the drug and symptomatic therapy.

Interaction:

Thiamin completely dissolves in solutions containing sulfites. And as a consequence, thiamine decay products inactivate the actions of other vitamins.

Thiamin is incompatible with oxidizing and reducing compounds, including: iodides, carbonates, acetates, tannic acid, iron ammonium citrate, phenobarbital, riboflavin, benzylpenicillin, dextrose, disulfites, etc. Copper accelerates the destruction of thiamine; Besides, thiamine Loses its effectiveness with increasing pH (more than 3).

Therapeutic doses of pyridoxine weaken the effect of levodopa (the antiparkinsonian action of levodopa is reduced) with simultaneous admission. There is also interaction with cycloserine, penicillamine, isoniazid.

When parenteral application of lidocaine in the case of additional use of norepinephrine and epinephrine may increase the side effect on the heart. The interaction with sulfonamides is also observed.

Cyanocobalamin is incompatible with salts of heavy metals. Riboflavin also has a destructive effect, especially with simultaneous exposure to light; nicotinamide accelerates photolysis, while antioxidants have an inhibitory effect.

Special instructions:

In case of accidental intravenous injection, the patient should be observed by the doctor or should be hospitalized depending on the severity of the symptoms.

Effect on the ability to drive transp. cf. and fur:

Information about caution regarding the use of the drug by drivers of vehicles and persons working with potentially dangerous mechanisms is not available.

Form release / dosage:

Solution for intramuscular injection.

Packaging:

To 2 ml in the ampoule of brown light-protective hydrolytic glass type I, a white dot is applied to the ampoule with paint.

5 ampoules per tray of PVC with dividers.

On 1,2,5 pallets from PVC (on 5 ampoules in the pallet) place in a cardboard pack together with the instruction on application.

When packaged by LLC "Ellara", Russia:

5 ampoules per tray of polyvinylchloride (PVC) film with separators.

For 1,2,5 pallets of PVC (5 ampoules per pallet) are placed together with instructions for use in a pack of cardboard for consumer packaging.

Storage conditions:

Store in a dark place at a temperature of 2 to 8 ° C. Do not freeze!

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N012551 / 02

Date of registration:26.09.2011 / 18.01.2018

Expiration Date:Unlimited

The owner of the registration certificate:Wörwag Pharma GmbH & Co. KG. KGWörwag Pharma GmbH & Co. KG. KG Germany

Manufacturer: & nbsp

Solupharm Pharmazeutische Erzeugnisse, GmbH Germany

Representation: & nbspVEVWAG PHARMA GmbH & Co. KG VEVWAG PHARMA GmbH & Co. KG Germany

Information update date: & nbsp09.06.2018

Illustrated instructions

Instructions

Milgamma® (Milgamma®)