LIPOSOM FORTE - PACKAGE LEAFLET - LEAFLETS

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Liposom Forte - Package Leaflet

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

Active ingredients: Hypothalamic phospholipids

LIPOSOM FORTE 28 mg / 2 ml solution for injection

Indications Why is Liposom Forte used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Other nervous system drugs.

THERAPEUTIC INDICATIONS

Adjuvant in the therapy of cerebral metabolic alterations resulting from neuroendocrine disorders.

Contraindications When Liposom Forte 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 Liposom Forte

The drug does not require special precautions for use.

Interactions Which drugs or foods can modify the effect of Liposom Forte

The administration of the product can be carried out simultaneously with therapy with other drugs, in particular neuroleptics, of which it antagonizes the hyperprolactinemia, tricyclic antidepressants, of which it reduces the latency of action, enhancing their efficacy and cardiological 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.

Dosage and method of use How to use Liposom Forte: Dosage

1 ampoule per day intramuscularly or intravenously, according to medical prescription.

Directions for opening:

position the vial as indicated in figure 1;
apply pressure with your thumb placed over the COLOR DOT.

Overdose What to do if you have taken too much Liposom Forte

No symptoms of overdose have ever been reported at the recommended doses.

Side Effects What are the side effects of Liposom Forte

No undesirable effects definitely related to the drug have been reported.

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.

Other_information "> Other information

Composition

Active ingredient: hypothalamic phospholipids 28 mg.

Excipients: mannitol, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, esters of p-hydroxybenzoic acid, water for injections q.s. to 2 ml.

Pharmaceutical form

Solution for injection for IM use. or i.v.

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.

Further information on Liposom Forte 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 the 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 Incompatibility "- 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 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 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 RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

LIPOSOM FORTE 28 MG / 2 ML SOLUTION FOR INJECTION

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

Active principle

Hypothalamic phospholipids

(Common name of the active ingredient)

A 2ml vial contains:

Hypothalamic phospholipids 28 mg

03.0 PHARMACEUTICAL FORM -

Solution for injection for IM use. or i.v. - 5 ampoules of 2 ml.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Adjuvant in the therapy of cerebral metabolic alterations resulting from neuroendocrine disorders.

04.2 Posology and method of administration -

1 ampoule per day intramuscularly or intravenously 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 -

The administration of the product can be carried out simultaneously with therapy with other drugs, in particular neuroleptics (of which it antagonizes the hyperprolactinemia), tricyclic antidepressants (of which it reduces the latency of action, enhancing their effectiveness) and cardiological drugs.

04.6 Pregnancy and breastfeeding -

LIPOSOM FORTE "28 mg / 2 ml solution for injection" can also be administered during pregnancy and 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 definitely related to the drug have ever been reported.

04.9 Overdose -

No symptoms of overdose have ever been reported at the recommended doses.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Parenteral administration of hypothalamic phospholipids is able to activate hypothalamic metabolism by increasing the turnover of dopamine, the activity of tyrosine hydroxylase and adenyl cyclase, with consequent accumulation of cyclic AMP.

This pharmacological effect is reflected in particular on the functionality of the hypothalamus-pituitary axis.

In the experimental animal it was also observed that hypothalamic phospholipids, by influencing the physico-chemical properties of neuronal membranes, modify the receptorial adaptation of central aminergic neurons to chronic treatment with antidepressants.

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 -

The acute, subacute, chronic toxicity and reproductive function toxicity tests performed on various animal species, the mutagenesis tests and the tolerability tests have shown that the drug is free from toxicity, mutagenic power and is endowed with excellent tolerability.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Mannitol, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, p-hydroxybenzoic acid esters, water for injections.

06.2 Incompatibility "-

To date, no incompatibility phenomena due to the simultaneous administration of LIPOSOM FORTE "28 mg / 2 ml solution for injection" with other drugs are known.