Active ingredients: L-acetylcarnitine
Branigen 500 mg gastro-resistant tablets
Branigen 500 mg granules for oral solution
Branigen 308 mg / ml powder for oral solution
Branigen package inserts are available for pack sizes: - Branigen 500 mg gastro-resistant tablets, Branigen 500 mg granules for oral solution, Branigen 308 mg / ml powder for oral solution
- Branigen 500 mg / 4 ml powder and solvent for solution for injection
Indications Why is Branigen used? What is it for?
Branigen contains the active ingredient L-acetylcarnitine. L-acetylcarnitine has a protective, nourishing and antioxidant action against the cells of the brain, spinal cord and peripheral nerves.
Branigen is indicated for the treatment of lesions of the peripheral nerves (truncular and radicular lesions) due to mechanical causes or inflammatory processes.
Contraindications When Branigen should not be used
Do not use Branigen if you are allergic to L-acetylcarnitine or any of the other ingredients of this medicine.
Precautions for use What you need to know before taking Branigen
Talk to your doctor or pharmacist before using Branigen.
Oral administration does not require special precautions.
Interactions Which drugs or foods can modify the effect of Branigen
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
To date, there are no known interactions when Branigen was used together with other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, particularly in the first trimester of pregnancy, or if you are breastfeeding, your doctor will consider whether the benefits to you clearly outweigh the risks to the fetus / baby before prescribing Branigen.
Driving and using machines
Branigen does not affect the ability to drive or use machines.
Branigen powder for oral solution contains methyl p-hydroxybenzoate and propyl phydroxybenzoate
Methyl p-hydroxybenzoate and propyl p-hydroxybenzoate can cause allergic reactions (possibly delayed).
Dosage and method of use How to use Branigen: Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is 500 mg -1,500 mg per day, divided into 2 or 3 doses according to the doctor's prescription.
How to take Branigen oral solution granules for oral solution
- Dissolve the contents of each sachet in half a glass of water and drink it.
Branigen powder for oral solution.
- To open the bottle, press the cap and, at the same time, rotate it as indicated.
- To prepare the solution add water into the bottle up to the red line on the label (total volume 33 mL).
- Act well.
- With the special syringe you can withdraw a quantity of solution equal to 250 or 500 mg of L-acetylcarnitine. Take the quantity corresponding to the dose prescribed by your doctor.
- Dilute the collected solution in half a glass of water.
- The solution can be stored in the refrigerator for 25 days.
If you forget to take Branigen
Do not take a double dose to make up for a forgotten dose.
If you stop taking Branigen
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Branigen
In case of accidental ingestion of an overdose of Branigen, notify your doctor immediately or go to the nearest hospital.
To date, there have been no reports of accidental ingestion of an overdose of Branigen.
Side Effects What are the side effects of Branigen
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Sporadic cases of mild arousal have been reported, regressing rapidly with dose decrease.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Branigen tablets and granules for oral solution in sachets
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Branigen powder for oral solution
The reconstituted Branigen powder for oral solution can be stored in the refrigerator for 25 days.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other Information
What Branigen contains
Branigen gastro-resistant tablets
- The active ingredient is L-acetylcarnitine. Each tablet contains 590.0 mg L-acetylcarnitine hydrochloride equal to 500 mg of internal salt.
- The other ingredients are polyvinylpyrrolidone, microcrystalline cellulose, magnesium stearate, cellulose acetophthalate, diethylphthalate, dimethicone.
Branigen granules for oral solution
- The active ingredient is L-acetylcarnitine. Each sachet contains 590.0 mg L-acetylcarnitine hydrochloride equal to 500 mg of internal salt.
- The other ingredients are precipitated silica, sodium saccharin, hydroxypropylcellulose, tonic water (1 x 1000), mannitol.
Branigen powder for oral solution
- The active ingredient is L-acetylcarnitine. Each bottle contains 12.0 g L-acetylcarnitine hydrochloride equal to 10.17 g of internal salt.
- The other ingredients are methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, polyvinylpyrrolidone.
Description of what Branigen looks like and contents of the pack
Branigen gastro-resistant tablets
Each pack contains 30 tablets of 500 mg in blisters.
Branigen granules for oral solution in sachets
Each pack contains 20 sachets of 500 mg of powder for oral solution.
Branigen powder for oral solution
Each pack contains 1 bottle of 10.17 g of powder for oral solution.
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.
01.0 NAME OF THE MEDICINAL PRODUCT
BRANIGEN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
500 mg gastro-resistant tablets
One tablet contains:
Active principle
L-acetylcarnitine HCl: 590.0 mg
equal to 500 mg of internal salt
308 mg / ml powder for oral solution
One 12.316g bottle contains:
Active principle
L-acetylcarnitine HCl: 12.00 g
equal to 10.17 g of internal salt
500 mg powder for oral solution
One sachet contains:
Active principle
L-acetylcarnitine HCl: 590.0 mg
equal to 500 mg of internal salt
500 mg / 4 ml powder and solvent for solution for injection
One vial contains:
Active principle
L-acetylcarnitine: 500 mg
One solvent vial contains:
Water p.p.i .: 4 ml
For excipients see 6.1.
03.0 PHARMACEUTICAL FORM
Gastro-resistant tablets, powder for oral solution in bottle, powder for oral solution in sachet, powder and solvent for solution for injection.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Mechanical and inflammatory truncular and radicular lesions of the peripheral nerve.
04.2 Posology and method of administration
0.5 - 1.5 g per day in 2-3 administrations, according to medical prescription.
The injectable form can be administered both intramuscularly and intravenously.
Preparation of the oral solution
Dilute the contents of the bottle with tap water up to the guideline shown on the label.
The reconstituted solution has a volume of 33 ml and can be stored for 25 days in the refrigerator.
Each ml of solution contains 308 mg of L-acetylcarnitine internal salt.
The sachets must be dissolved in half a glass of water.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
The drug presents no risk of addiction or dependence.
The oral administration of BRANIGEN does not require special precautions for use while the intravenous administration must be carried out slowly. In this form of administration, redness with a sensation of heat on the face is possible.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known negative interactions with other drugs.
04.6 Pregnancy and breastfeeding
Although no harmful effects on the fetus have ever been observed in animal studies, in women in the first trimester of pregnancy and during lactation it will be advisable to administer the drug in cases of real need, under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
L-acetylcarnitine does not affect the ability to drive or use machines.
04.8 Undesirable effects
Sporadic cases of mild arousal have been reported which promptly regress with decreasing posology.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: agonist of mitochondrial function, growth and reparative factors (NGF) with antioxidant activity in neurons of the central and peripheral nervous system.
ATC code: N06BX12
L-acetylcarnitine (gamma-trimethyl-beta-acetyl-butyro-betaine) is the natural isomer of a substance present under physiological conditions in various organs including the brain. It is synthesized by reversible acetylation from carnitine at the mitochondrial level through l "Acetyl-L-Carnitine Transferase Enzyme. L-acetylcarnitine, structurally similar to Acetylcholine, plays an indispensable role for the correct cellular and transmitting energy metabolism at the level of the CNS. L-acetylcarnitine, in fact, represents a storage form of acetyl groups that can be associated with the Coenzyme A necessary to trigger the Krebs cycle thus intervening both in the metabolism of fatty acids and carbohydrates. In situations of pathology, L-acetylcarnitine has been shown to be active both as a neuroprotection factor for the cell and its organelles, especially the mitochondrion, and as a trophic factor, for the restoration of cellular integrity.
In particular in the nervous system, both central and peripheral, on the occasion of insult due to hypoxia, aging, toxic (alcohol, MPTP, MAM), resection or crushing of the nerve, diabetes due to aloxan or streptozocin, L-acetylcarnitine has shown an activity of neuroprotection by intervening on the cascade of events that lead to cell death:
- formation of free radicals; accumulation of lipids (from destruction of membranes) responsible for the pathological increase in intramitochondrial calcium;
- reduced activity of mitochondrial respiratory complexes;
- reduced mitochondrial RNA formation due to reduced DNA transcriptase activity.
L-acetylcarnitine also exerts a trophic action on the nervous system, promoting post-lesional recovery through:
- better cellular utilization of NGF (nerve growth factor);
- an increase in the neosynthesis of phospholipids for the construction of membranes;
- an increase in energy production (ATP) without which reparative mechanisms cannot take place.
In the "animal" the neuroprotective and trophic action of L-acetylcarnitine was highlighted with the maintenance and / or recovery of the trophic (number of neurons) and functional situation: better learning, memory, locomotion skills in various models:
- aging;
- hypoxia;
- experimental parkinson;
- microcephaly;
- lesions of the peripheral nerve both on a traumatic and disendocrine basis (diabetes).
In men, controlled clinical studies, even of long duration, have been conducted in various pathologies:
- involutional syndromes on a degenerative basis;
- involutionary syndromes on a vascular basis;
- acute and / or chronic neuropathies on a disendocrine basis (diabetes).
05.2 Pharmacokinetic properties
Intravenous rat blood levels of 333 mg / kg are maximal at 5 min. (5,375 micromol / l) and are reduced in the six hours following administration (106 micromol / l). Orally at a dose of 500 mg / kg the blood peak is reached 4 hours after administration with levels of 40 micromoles / l which remain constant up to 8 hours. The marked L-acetylcarnitine reaches, largely unchanged, numerous tissues between which the cerebral one.
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.
Acute toxicity: in the mouse the LD50 via i.m. is higher than 3,000 mg / kg, by i.p. is higher than 3,600 mg / kg, by i.v. is greater than 1,600 mg / kg, per os is greater than 18,000 mg / kg; in the rat via i.m. is higher than 3,000 mg / kg, by i.p. is 2,748 mg / kg, by i.v. is 1,000 mg / kg, per os is greater than 10,000 mg / kg.
Chronic toxicity: mini-pigs and rabbits treated for 26 weeks with L-acetylcarnitine orally with doses of 250-500 mg / kg / day and by i.m. with doses of 50 mg / kg / day, they did not show significant changes in the course of body weight, blood count, liver function, biochemical blood tests, urinalysis. The macro-microscopic examination of the main organs did not reveal any pathological changes.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
500 mg gastro-resistant tablets:
Polyvinylpyrrolidone, microcrystalline cellulose, magnesium stearate, cellulose acetophthalate, diethylphthalate, dimethicone.
308 mg / ml powder for oral solution:
Methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, polyvinylpyrrolidone.
500 mg powder for oral solution:
Precipitated silica, sodium saccharin, hydroxypropylcellulose, tonic water 1 x 1000, mannitol.
500 mg / 4 ml powder and solvent for solution for injection:
Mannitol.
One solvent vial contains: water for injections.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
Stability is 24 months for gastro-resistant tablets, powder for oral solution in sachets and vials of powder and solvent for injection, 36 months for powder for oral solution in bottle.
06.4 Special precautions for storage
Powder and solvent for solution for injection: store at 2 ° C to 8 ° C in a refrigerator.
The reconstituted solution can be stored for 25 days in the refrigerator.
Tablets - Powder for oral solution in sachets: Store at a temperature not exceeding 25 ° C
06.5 Nature of the immediate packaging and contents of the package
Box of 30 gastro-resistant tablets of 500 mg in blister.
Bottle of powder for oral solution containing 10.17 g of active ingredient.
Box of 20 sachets of 500 mg powder for oral solution.
5 vials of 500 mg powder for injection + 5 solvent ampoules for injectable use.
06.6 Instructions for use and handling
See section 4.2 "Posology and method of administration".
07.0 MARKETING AUTHORIZATION HOLDER
SIGMA-TAU Industrie Farmaceutiche Riunite S.p.A.
Viale Shakespeare, 47 - 00144 Rome
08.0 MARKETING AUTHORIZATION NUMBER
5 vials of 500 mg powder for solution for injection + 5 solvent ampoules - AIC 025368073
30 gastro-resistant tablets of 500 mg - AIC 025368046
Facone powder for oral solution containing 10.17 g of active ingredient - AIC 025368061
20 sachets of powder for oral solution of 500 mg - AIC 025368059
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Authorization:
Gastro-resistant tablets and powder for oral solution in sachets: June 1984
Powder for oral solution in bottle: November 1985
Powder and solvent for solution for injection: March 1993
Renewal:
May 2005
10.0 DATE OF REVISION OF THE TEXT
March 2008
-nelle-carni-di-maiale.jpg)
