COCARNETIN B12 FLACONCINI OS 10FL 10ML

021852013
12 Items

Energy vials with Cocarnetine and Vitamin B12.

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021852013
12 Items

COCARNETIN B12 FLACONCINI OS 10FL 10ML

Therapeutic indications

Pediatrics: All the states of malnutrition of children, infants and premature babies, growth delays, weight insufficiency, dystrophies, anorexias, weight loss from any cause, post-infectious debilitation. Internal Medicine: Pathological slimming of any etiology, thinness without apparent cause, inappetence, asthenia, convalescence, as an anticatabolic in protracted cortisone therapies and in thyrotoxicosis, in hypoproteinemia of hepatopathies and nephrosis.

Dosage and method of use

Infants and premature babies: a vial per day diluted in water. Children and adolescents: 1-2 vials per day diluted in water. Adults: 2-3 vials per day. Special populations. Elderly patients: No dosage adjustments of CoCarnitin B12 are required in elderly patients. Patients with renal insufficiency: Patients with severe renal impairment should not be treated with the oral administration of high doses of L-Carnitine for prolonged periods as it may induce an accumulation of potentially toxic metabolites, see section 4.4. No data are available for the use of Vitamin B12 in patients with renal insufficiency. Patients with hepatic insufficiency: No data are available in patients with hepatic insufficiency. The characteristics of CoCarnitin B12 may be altered by exposure to light and if it is not used immediately after mixing with liquids or food.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

Adverse reactions from any source (clinical studies, published clinical data for the individual active substances and post-marketing data of CoCarnitin B12) are listed below by MedDRA system organ class. Within each class, adverse reactions are ranked by frequency. Within each frequency class, adverse reactions are ranked in order of decreasing severity. In addition, the corresponding frequency category for each adverse reaction is based on the following convention (CIOMS III): very common (≥1 / 10), common (≥1 / 100, Nervous system disorders. Uncommon: Headache. Gastrointestinal disorders. Uncommon: Abdominal distension, Gastrointestinal pain, Vomiting; Common: Abdominal pain, Diarrhea, Nausea. Cases of seizures have been reported in patients with or without a history of seizure activity who received oral or intravenous L-Carnitine (see section 4.4).Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Chronic oral administration of high doses of L-Carnitine in patients with severe renal insufficiency can induce an accumulation of the potentially toxic metabolites: trimethylamine (TMA) and trimethylamine-N oxide (TMAO). There have been very rare reports of increased INR (International Normalized Ratio) in patients receiving concomitant therapy with L-Carnitine and coumarin drugs. The INR or other suitable coagulation tests - must be checked weekly until the values stabilize and subsequently monthly, in patients taking anticoagulants together with L-Carnitine. Cases of seizures have been reported in patients with or without a history of seizure activity who received oral or intravenous L-Carnitine. In patients with underlying predisposing conditions, treatment with L-Carnitine can trigger seizures. CoCarnitin B12 contains 4.075 g of sorbitol per vial. Sorbitol can cause gastrointestinal upset is have a mild laxative effect. The additive effect of co-administration of sorbitol (or fructose) containing medicinal products and the daily dietary intake of sorbitol (or fructose) must be considered. The content of sorbitol in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. Patients with hereditary fructose intolerance should not be given this medicine. CoCarnitin B12 contains 1.5 g of sucrose per vial. Sucrose can be bad for your teeth. Patients with rare problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. CoCarnitin B12 contains 0.048 g of sodium benzoate per vial. The increase in bilirubin following its detachment from albumin can increase neonatal jaundice which can develop into kernitter (deposits of unconjugated bilirubin in brain tissue). This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially 'sodium-free'. Given the particular lability and photosensitivity of Cobamamide, any solution of the product in liquids or its mixing in other foods must take place immediately before the time of administration. The drug is neither addictive nor addictive. Cobamamide-containing products should not be administered to anemic subjects except on the basis of investigations to establish the exact nature of the anemia.

Pregnancy and breastfeeding

Pregnancy: L-Carnitine crosses the placenta. Carnitine levels in newborns reflect those of the mother. There are no clinical studies available with the administration of vitamin B12 or CoCarnitin B12 in pregnant women. Feeding time: L-Carnitine is the normal component found in breast milk. There are no clinical studies in breastfeeding women with supplements containing L-Carnitine or CoCarnitin B12. Fertility: Clinical fertility studies with L-Carnitine did not report safety concerns. There are no clinical studies on fertility with vitamin B12.

Expiry and retention

Do not store above 25 ° C.

Interactions with other drugs

Oral anticoagulants: Very rare cases of increased INR (International Normalized Ratio) have been reported in patients receiving concomitant therapy with L-Carnitine and coumarin drugs (see section 4.4). INR or other appropriate coagulation tests should be monitored weekly until values stabilize and monthly thereafter in patients taking L-Carnitine together with coumarin drugs (see section 4.4). Other interactions: Concomitant administration of L-Carnitine with drugs that induce hypocarnitinemia due to increased renal carnitine loss (valproic acid, prodrugs containing pivalic acid, cephalosporins, cisplatin, carboplatin and ifosfamide) may reduce the availability of L-Carnitine. There are no known interactions of Vitamin B12 with other drugs.

Overdose

No cases of overdose have been reported.

Active principles

One cap contains: Active principle: Cobamamide 2 mg. A vial contains: Active principle: L-Carnitine internal salt 500 mg. Excipients with known effects: sorbitol solution 70% (E420). 4.075 g, sucrose 1.5 g, sodium benzoate 0.048 (E211) g. For the full list of excipients, see section 6.1.

Excipients

The cap contains: polyethylene glycol 4000, mannitol powder. The vial contains: sorbitol solution 70%, sodium benzoate, black cherry juice, orgeat juice, sucrose, demineralized water to taste

021852013
12 Items

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