BIOARGININE - PACKAGE LEAFLET - LEAFLETS

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Bioarginine - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: L-arginine

BIOARGININA® 1.66 g / 20 ml oral solution

Bioarginine package inserts are available for pack sizes:

BIOARGININA® 1.66 g / 20 ml oral solution
BIOARGININA® 20g / 500ml solution for infusion

Why is Bioarginine used? What is it for?

Pharmacotherapeutic group

Tonic.

Therapeutic indications

BIOARGININA ® 1,66 g / 20 ml Oral solution is indicated as an adjuvant in oligoasthenospermias and hyposomies. States of fatigue, asthenia.

Contraindications When Bioarginine should not be used

Hypersensitivity to the active substance or to any of the excipients.

Precautions for use What you need to know before taking Bioarginine

No particular precautions are required for the use of the product.

KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN

Interactions Which drugs or foods can modify the effect of Bioarginine

There are no known interactions or incompatibilities.

Warnings It is important to know that:

BIOARGININA ® 1,66 g / 20 ml Oral solution can be used without problems during pregnancy and lactation.

BIOARGININA ® 1,66 g / 20 ml Oral solution does not interfere with the ability to drive and use machines.

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

Unless otherwise prescribed by the doctor:

Oligoastenospermie: at least 3 vials per day.

Hyposomies: 1-2 vials per day.

States of fatigue, asthenia: 1-2 vials per day.

The product should be administered orally and can be suitably diluted with water.

Overdose What to do if you have taken too much Bioarginine

There are no known acute incidents with L-arginine. In case of accidental ingestion of an excessive dose of BIOARGININ ® 1.66 g / 20 ml Oral Solution, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Bioarginine

No undesirable effects were reported.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

It is important to inform the doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.

Expiry and Retention

Do not use the medicine after the expiry date indicated on the package.

The expiry date indicated refers to the product in intact packaging, correctly stored.

After use, do not dispose of the container in the environment.

Composition and pharmaceutical form

Composition

Each vial contains:

Active ingredient: L-arginine 1.66 g.

Excipients: sucrose; citric acid; methyl p-hydroxybenzoate; propyl p-hydroxybenzoate; 96 ° ethyl alcohol; strawberry flavor; purified water.

Pharmaceutical form and content

Oral solution. 20 vials of 20 ml containing 1.66 g of L-arginine.

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 Bioarginine 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 interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the primary packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

BIOARGININE 1,66 G / 20 ML ORAL SOLUTION

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 20 ml vial contains the following active ingredient:

L-arginine 1.66 g.

For excipients, see 6.1.

03.0 PHARMACEUTICAL FORM

Oral solution.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Adjuvant in oligoasthenospermias and hyposomies.

States of fatigue, asthenia.

04.2 Posology and method of administration

Oligoastenospermie: at least 3 vials per day.

Hyposomies: 1-2 vials per day.

States of fatigue, asthenia: 1-2 vials per day.

The product should be administered orally and can be suitably diluted with water.

04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

04.4 Special warnings and appropriate precautions for use

No particular precautions are required when using the product.

Keep this medicine out of the reach and sight of children.

04.5 Interactions with other medicinal products and other forms of interaction

There are no known interactions or incompatibilities.

04.6 Pregnancy and lactation

BIOARGININE 1.66 g / 20 ml Oral solution can be used without problems during pregnancy and lactation.

04.7 Effects on ability to drive and use machines

BIOARGININE 1.66 g / 20 ml Oral solution does not affect the ability to drive or use machines.

04.8 Undesirable effects

There are no clinical side manifestations or undesirable secondary effects.

04.9 Overdose

There have been no reported cases of overdose.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: tonic.

ATC code: A13.

L-arginine is useful in the treatment of seminal dispersions, especially when oligozoospermia and bradycinesis are present. This amino acid is in fact present in high concentration in the nuclei of cells in the process of reproduction and reaches 50% in the nucleus of spermatozoa.

Finally, L-arginine intervenes directly, at the level of the aminergic mechanisms responsible for the release of the GRF (Growth Releasing Factor), thus stimulating the release of GH and the synthesis of brain polyamines.

Bioarginine is therefore indicated, orally, in physiological growth delays in which GH function is normal or subnormal but not abolished.

05.2 Pharmacokinetic properties

L-arginine, for oral administration, is rapidly absorbed in the stomach, electively distributed to the brain, liver and kidney. The maximum plasma concentration is obtained 4 hours after oral administration.

05.3 Preclinical safety data

Non-clinical data reveal no risk for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.