Active ingredients: Phospholipids from the cerebral cortex, Cyanocobalamin
TRICORTIN 1000 12 mg + 1mg / 2 ml solution for injection for intramuscular use
Why is Tricortin used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Psychoanaleptics - other psychostimulants and nootropics - associations.
THERAPEUTIC INDICATIONS
Polyyalgia-neurotic syndromes
Contraindications When Tricortin should not be used
Hypersensitivity to the components of the product and to other closely related substances from a chemical point of view.
Precautions for use What you need to know before taking Tricortin
The drug does not require special precautions for use.
Interactions Which drugs or foods may change the effect of Tricortin
There was no evidence of interactions between TRICORTIN 1000 and other drugs.
Warnings It is important to know that:
The drug can be administered during pregnancy and breastfeeding, under the direct supervision of the doctor. The drug does not interfere with the ability to drive and use machines.
Dose, Method and Time of Administration How to use Tricortin: Posology
1 ampoule per day intramuscularly, according to medical prescription.
Overdose What to do if you have taken too much Tricortin
At the recommended doses, overdosing phenomena have never occurred.
Side Effects What are the side effects of Tricortin
No undesirable effects related to the drug have been reported so far. In any case, inform the attending physician or pharmacist of any undesirable effects not described in this leaflet.
Expiry and Retention
The expiry date indicated on the package refers to the product in intact packaging, correctly stored.
Store at a temperature not exceeding 25 ° C
Warning: do not use the medicine after the expiry date indicated on the package.
Deadline "> Other information
COMPOSITION
Active principle:
- Cerebral cortex phospholipids 12 mg
- Cyanocobalamin 1000 mcg
Excipients: Lidocaine hydrochloride - dibasic sodium phosphate 12H2O - monobasic sodium phosphate 2H2O - esters of p-hydroxybenzoic acid - water for injections q.s. to ml 2
PHARMACEUTICAL FORM
Solution for injection for IM use. 5 ampoules of 2 ml
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 -
TRICORTIN 1000
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Active principles
Cerebral cortex phospholipids
Cyanocobalaminum
(Common name of the active ingredients)
A 2ml vial contains:
Cerebral cortex phospholipids 12 mg
Cyanocobalamin 1000 mcg
03.0 PHARMACEUTICAL FORM -
Solution for injection for IM use. - 5 ampoules of 2 ml
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Hypoxidotic-dysmetabolic states of the CNS:
head trauma - commotional syndromes and post-commotional states - atherosclerotic encephalomyelopathies - vasospastic or toxic headaches - endogenous and exogenous intoxications.
Polyyalgia-neurotic syndromes:
toxic alcoholic polyneuritis - arthritic polyradiculoneuritis - peripheral paralysis of the VII - polyalgic - neurotic states without objective organic basis.
04.2 Posology and method of administration -
1 ampoule per day intramuscularly, according to medical prescription.
04.3 Contraindications -
Hypersensitivity to the components of the product and to other closely related substances from a chemical point of view.
04.4 Special warnings and appropriate precautions for use -
The drug does not require special warnings and precautions for use.
04.5 Interactions with other medicinal products and other forms of interaction -
There was no evidence of interactions between TRICORTIN 1000 and other drugs.
04.6 Pregnancy and breastfeeding -
The drug can be administered during pregnancy and during lactation, under direct medical supervision.
04.7 Effects on ability to drive and use machines -
The drug does not affect the ability to drive and use machines.
04.8 Undesirable effects -
No undesirable effects related to the drug have been reported so far.
04.9 Overdose -
At the recommended doses, overdosing phenomena have never occurred.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Parenteral administration of phospholipids from porcine cerebral cortex (neuromologous phospholipids) is able to activate neuronal metabolism by normalizing membrane enzymatic activities, increase the turnover of neurotransmitters, glucose metabolism and that of endogenous phospholipids.
Cyanocobalamin intervenes as a cofactor in the metabolism of neuronal cells by carrying out a "neurocytotrophic action."
05.2 "Pharmacokinetic properties -
The metabolic fate and stability of doubly labeled phospholipids, administered parenterally, have been studied by evaluating both the total radioactivity found in the brain and the evolution of the ³H / 14C ratio at the cellular level. These studies show that these molecules are stable at the cellular level. blood and which reach the cerebral district intact.
05.3 Preclinical safety data -
Acute toxicity (LD50> 1000 mg / kg in mice and rats), long-term toxicity, reproductive toxicity and mutagenicity studies did not reveal any toxic effects of porcine cerebral cortex phospholipids.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Lidocaine hydrochloride, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, esters of p-hydroxybenzoic acid, water for injections.
06.2 Incompatibility "-
No phenomena of incompatibility of TRICORTIN 1000 with other drugs are known to date.
06.3 Period of validity "-
24 months
06.4 Special precautions for storage -
The drug can be stored under normal environmental conditions.
06.5 Nature of the immediate packaging and contents of the package -
Type I glass amber vials
TRICORTIN 1000 5 ampoules of 2 ml
06.6 Instructions for use and handling -
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07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
FIDIA Farmaceutici S.p.A. - Via Ponte della Fabbrica, 3 / A - 35031 Abano Terme (PD) - Tax Code n 00204260285
08.0 MARKETING AUTHORIZATION NUMBER -
A.I.C. 019941020
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
23.04. 1996
10.0 DATE OF REVISION OF THE TEXT -
May 2001
