Instructions Nucleo C.M.F. forte lyophilized powder for solution for injection 61 mg ampoule with solvent in ampoules 2 ml No. 3
Composition
active substances: Cytidine-5-disodium monophosphate (CMP disodium salt), uridine-5-trisodium triphosphate (UTP trisodium salt), uridine-5-disodium diphosphate (UDP disodium salt), uridine-5-disodium monophosphate (UMP disodium salt);
1 ampoule with lyophilisate contains cytidine-5-monophosphate disodium salt (CMF disodium salt) 10 mg, uridine-5-triphosphate trisodium salt (UTP trisodium salt), uridine-5-diphosphate disodium salt (UDF disodium salt), uridine-5-monophosphate disodium salt (UMF disodium salt) in total 6 mg (corresponds to 2.660 mg of pure uridine);
excipients: mannitol (E 421);
solvent: water for injection, sodium chloride.
Dosage form
Lyophilisate for solution for injection.
Main physicochemical properties: lyophilized powder in the form of a pastille, white in color, easily soluble.
Pharmacotherapeutic group
Drugs affecting the nervous system. ATX code N07X X.
Pharmacological properties
Pharmacodynamics.
Nucleo C.M.F. Forte contains nucleotides: cytidine monophosphate (CMP), uridine triphosphate (UTP), which are widely used to treat diseases of the central nervous system (CNS).
From a biochemical point of view, the action of these components is as follows:
CMP is involved in the synthesis of a complex of lipids that form the neuronal membrane, mainly sphingomyelin - the main component of the myelin sheath. CMP is also a precursor of nucleic acids (DNA and RNA), which, in turn, are the main elements of cellular metabolism (for example, in protein synthesis).
UTP acts as a coenzyme in the synthesis of glycolipids, neuronal structures, and the myelin sheath, complementing the action of CMP. In addition, UTP acts as a source of energy in the process of muscle contraction.
CMF and UTF participate in the synthesis of phospholipids and glycolipids, which mainly make up the myelin sheath and other nerve structures. This contributes to intensive metabolic activity, which, in turn, contributes to the process of myelin sheath regeneration, regulating demyelination in peripheral nerve injuries. Thus, the combination of CMF and UTF action contributes to the regeneration of the myelin sheath, the correct conduction of nerve excitation and the restoration of muscle trophism.
Pharmacokinetics.
Nucleo C.M.F. Forte contains physiological products present in the body's biological fluids, which makes its study more difficult. And this is the reason why, due to the high radiological load, studies were conducted only on experimental animals using a radioactively labeled product.
The aim of the study was to observe the absorption and pharmacokinetics of UMF, CMF and UTF.
As a result, the same metabolic pathway was found for UMF and UTP, i.e., rapid conversion via uracil into at least one other polar radioactive fraction was found.
The CMF compound was rapidly converted to cytosine, uracil, and at least one other polar radioactive moiety. Cytosine was then primarily converted to uracil. These results reflect that in blood, uracil is metabolized longest in the presence of cytosine, which was restricted from the start of CMF administration.
Indication
Treatment of neuropathies of osteoarticular origin (sciatica, radiculitis), metabolic (alcoholic, diabetic polyneuropathy), infectious origin (shingles) and Bell's palsy.
Facial neuralgia, trigeminal neuralgia, intercostal neuralgia, lumbago.
Contraindication
Allergic reactions to individual components of the drug are known.
Interaction with other medicinal products and other types of interactions
Not installed.
Application features
Nucleo C.M.F. Forte injection, intended for intramuscular administration. Before administration, the solvent must be transferred to the ampoule with the lyophilized powder.
Use during pregnancy or breastfeeding
The use of the drug during pregnancy or breastfeeding is possible if, in the opinion of the doctor, the expected positive effect for the woman outweighs the potential risk to the fetus/child.
Ability to influence reaction speed when driving vehicles or other mechanisms
Nucleo C.M.F. Forte does not affect the ability to drive vehicles and work with complex mechanisms.
Method of administration and doses
Nucleo C.M.F. Forte, injection, is intended for intramuscular administration. Before administration, the solvent must be transferred to the ampoule with the lyophilized powder.
Adults, including elderly patients, are prescribed Nucleo C.M.F. Forte at a dose of 1 injection once a day.
Treatment is continued with the use of Nucleo C.M.F. Forte, capsules.
Children
There is insufficient data for the use of the drug in children.
Overdose
Given the low toxicity of the drug, the likelihood of poisoning is low even if the therapeutic dose is accidentally exceeded.
Adverse reactions
Not described. In individuals with hypersensitivity, allergic reactions are possible, including rashes, itching of the skin, skin hyperemia. In case of adverse reactions due to the use of the drug, consult a doctor.
Expiration date
2 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 30 °C.
Incompatibility.
Not installed.
Packaging
3 ampoules with lyophilized powder and 3 ampoules with solvent in a contoured blister pack.
Vacation category
According to the recipe.
Producer
Ferrer International, S.A., Spain.
Location of the manufacturer and its business address
Legal address
Gran Via Carlos III, 94, 08028 Barcelona, Spain.
Place of production
s/Joan Buscaya, 1-9, 08173 Sant Cugat del Bayes (Barcelona), Spain.
