MIONEVRASI - PACKAGE LEAFLET - LEAFLETS

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Mionevrasi - Package Leaflet

Indications Contraindications Precautions for use Interactions Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Vitamin B1, Vitamin B6, Vitamin B12

Mionevrase - powder and solvent for solution for injection

Indications Why is Mionevrasi used? What is it for?

Pharmacotherapeutic group

Multi-vitamin.

Indications

Vitamin deficiency states. B1, B6, B12 and related pathologies, such as: deficient polyneuritis, neuritis under treatment with isoniazid, alcoholic neuropathies.

Supportive therapy in neuritis not related to vitamin deficiency and in trigeminal and sciatic neuralgia.

Contraindications When Mionevrasi should not be used

Hypersensitivity to one or more components of the specialty.

Precautions for use What you need to know before taking Mionevrasi

Injectable preparations containing vitamin B1 or derivatives should be administered with caution in subjects who have a history of previous drug reactions or other allergic diseases (bronchial asthma, urticaria, angioedema, etc.).

There are no particular contraindications for the use of the product during pregnancy or breastfeeding.

Interactions Which drugs or foods can modify the effect of Mionevrasi

Particular caution should be used when the product is prescribed together with levodopa for the treatment of Parkinson's disease.

Dose, Method and Time of Administration How to use Mionevrasi: Posology

1 ampoule per day intramuscularly. In particular cases, this dosage can be increased according to the doctor's judgment.

The duration of treatment must be determined by the doctor.

Overdose What to do if you have taken too much Mionevrasi

No cases of overdose have been reported.

Side Effects What are the side effects of Mionevrasi

Cases of sensitization reactions to vitamin B12, such as skin and subcutaneous rashes, diarrhea and exceptionally anaphylactic manifestations, have been reported rarely.

It is advisable to consult your doctor or pharmacist in case of unwanted effects not mentioned in this leaflet.

Expiry and Retention

Method of conservation

Warning: do not use the medicine after the expiry date indicated on the package

Other information

Composition

1 vial of lyophilisate contains cyanocobalamin (Vit.B12) 1 mg, pyridoxine hydrochloride (Vit.B6) 100 mg, cocarboxylase (Vit.B1) 38.20 mg.

Excipients: aminoacetic acid.

1 ampoule of solvent contains 10 mg lidocaine hydrochloride, water for injections q.s. to ml 3.

Pharmaceutical form and packaging

Powder and solvent for solution for injection. Intramuscular use.

Pack containing 5 vials of lyophilisate + 5 vials of solvent.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Mionevrasi can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

MIONEVRASI

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 vial of lyophilisate contains: cyanocobalamin 1 mg, pyridoxine hydrochloride 100 mg, thiamine diphosphate chloride (cocarboxylase) 38.20 mg.

1 ampoule of solvent contains: 10 mg lidocaine hydrochloride, water for injections q.s. to ml 3.

For excipients, see 6.1.

03.0 PHARMACEUTICAL FORM

Powder and solvent for solution for injection. Intramuscular use.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Deficient states of vitamins B1, B6, B12 and their different clinical forms (deficient polyneuritis, neuritis during treatment with isoniazid, alcoholic neuropathies).

Adjuvant in non-deficient neuritis and neuralgia (of the trigeminal, sciatic).

04.2 Posology and method of administration

One vial a day intramuscularly. In particular cases, this dosage can be increased according to the doctor's judgment.

04.3 Contraindications

Known hypersensitivity to one or more components and to lidocaine.

04.4 Special warnings and appropriate precautions for use

Preparations containing vitamin B1 or derivatives can, particularly parenterally, cause disturbances in those subjects who have had hypersensitization phenomena or morbid manifestations of allergopathies.

Parenteral vitamin B12 can give rise to a haematological response in folate deficient subjects which can lead to a diagnostic error.

04.5 Interactions with other medicinal products and other forms of interaction

Particular caution should be used when the product is prescribed together with levodopa for the treatment of Parkinson's disease, as pyridoxine in high doses can antagonize its therapeutic effect.

04.6 Pregnancy and breastfeeding

No contraindications.

04.7 Effects on ability to drive and use machines

Nobody.

04.8 Undesirable effects

Rare cases of vitamin B12 sensitization reactions with rashes, diarrhea and exceptionally anaphylactic manifestations have been reported.

04.9 Overdose

No cases of overdose have been reported.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vitamin B1, in association with vitamin B6 and vitamin B12

ATC code: A11DB

Mionevrase is a medicinal product characterized by the association of cocarboxylase (vitamin B1), pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12).

The vitamins of the B complex have a favorable action against inflammatory and degenerative diseases and the musculoskeletal system for their intervention in fundamental metabolic processes and for their particular influence on the trophism of nerve and muscle cells. These vitamins are used to eliminate deficiency states, but at high doses they possess much broader pharmacological properties.

Vitamin B1 is also referred to as an antineuritic vitamin. In the phosphorylated form as cocarboxylase it regulates glucose metabolism and therefore finds valid application in acidosic dysmetabolic situations. It also increases muscle and nerve performance.

Pyridoxine hydrochloride (vitamin B6) regulates proteilysis, lipolysis and the splitting of glycides and controls nervous and muscular excitability. Administered in high doses, it induces a rapid improvement of neuralgic and neuritic processes and increases muscle performance. Its neurotropic action it is used, for example, in isoniazid therapy in order to avoid the appearance of neurites.

It also has a characteristic antiemetic action.

Cyanocobalamin (vitamin B12) is well known for its indispensable intervention in hematopoiesis, growth and intermediate metabolism.

Administered in massive dosages, it exerts a particular pharmacodynamic action on neuromuscular trophism, which results in a prompt analgesic effect in states of neuropathy and in a significant increase in muscle performance.