Asparkam-Farmak - official * instructions for use. Mydocalm injections: instructions for use

INSTRUCTIONS
on the use of a medicinal product for medical use

Registration number:

Tradename.

Asparkam-Farmak.

Group name:

Dosage form.

Compound:

1 ml of solution contains anhydrous magnesium aspartate - 40 mg (3.37 mg magnesium), anhydrous potassium aspartate - 45.2 mg (10.33 mg potassium), aspartic acid - 74 mg, heavy magnesium oxide in terms of 100% substance - 5.59 mg, potassium hydroxide in terms of 100% substance - 14.82 mg;
Excipients: sorbitol - 50 mg, water for injection up to 1 ml.

Description. Clear colorless or slightly yellowish liquid.

Pharmacotherapeutic group.

ATX code: A12CX.

pharmacological properties.

Indications for use.

Contraindications

Carefully.

Use with caution:
during pregnancy (especially the first trimester) and during lactation;
cardiogenic shock (systolic blood pressure less than 90 mm Hg), hypophosphatemia, severe liver failure, metabolic acidosis, risk of edema, chronic renal failure (if regular monitoring of the concentration of Mg2 + in the blood serum is impossible - the risk of cumulation).

Use during pregnancy and during breastfeeding.

Method of application and dose.

It is administered intravenously by drip or using the dosing device "Infusomat" or intravenously by stream (slowly).
Intravenous appoint 10-20 ml once or twice a day for 5 days. Before use, the contents of 1-2 ampoules of 10 ml or 2-4 ampoules of 5 ml are diluted in 100-200 ml of a 5% dextrose (glucose) solution or sterile 0.9% sodium chloride solution and injected drip at a rate of 20-25 drops per minute, or dilute the contents of 1 ampoule of 10 ml or 2 ampoules of 5 ml in 20 ml of 5% dextrose (glucose) solution or sterile 0.9% sodium chloride solution and inject into a vein in a jet at a rate of not more than 5 ml per minute.

Side effect.

Nausea, vomiting, diarrhea, dry mouth, discomfort or burning in the epigastric region (in patients with anacid gastritis or cholecystitis), abdominal pain, ulceration of the mucous membrane of the gastrointestinal tract, bleeding from the organs of the gastrointestinal tract, flatulence, dry mouth ; bradycardia, atrioventricular block, lowering blood pressure, paradoxical reaction (increase in the number of extrasystoles), dyspnea, pruritus, hyperkalemia (nausea, vomiting, diarrhea, paresthesia), hypermagnesemia (flushing of the face, thirst, lowering blood pressure, hyporeflexia, respiratory depression, convulsions).
With injection, nausea and dizziness are occasionally possible, which usually disappear with a decrease in the dose of the drug. Perhaps the development of phlebitis, thrombosis. With rapid intravenous administration - hyperkalemia, hypermagnesemia.
If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, tell your doctor about it.

Overdose.

Interaction with other drugs.

With simultaneous use with potassium-sparing diuretics, ACE inhibitors, beta-blockers, cyclosporine, heparin, non-steroidal anti-inflammatory drugs, the risk of hyperkalemia increases (monitoring of potassium levels in blood serum is necessary).
Asparkam-Farmak reduces sensitivity to cardiac glycosides.
Enhances the negative dromo- and batmotropic effect of antiarrhythmic drugs.
Eliminates hypokalemia caused by glucocorticosteroids and diuretics.
General anesthetics increase the inhibitory effect on the central nervous system; when used simultaneously with atracuronium, decamethonium, succinyl chloride and suxamethonium, neuromuscular blockade may increase.

Special instructions.

Release form:

Storage conditions.

In a place protected from light at a temperature of 15 ° C to 25 ° C. Keep out of the reach of children.

Best before date.

2 years.
Do not use after the expiry date stated on the package.

Leave conditions:

Legal entity in whose name the registration certificate is issued

active substance: L-ornithine-L-aspartate;

1 ml of the drug contains L-ornithine-L-aspartate in terms of 100% substance 500 mg;

excipient: water for injections.

Dosage form. Concentrate for solution for infusion.

Basic physical and chemical properties: clear solution from colorless to light yellow.

Pharmacotherapeutic group.

Drugs used in liver diseases, lipotropic substances. hepatotropic drugs. ATX code A05V A.

Pharmacological properties

Pharmacodynamics.

in vivo The action of L-ornithine-L-aspartate is mediated by the amino acids ornithine and aspartate through two key ammonia detoxification pathways: urea synthesis and glutamine synthesis.

Urea synthesis occurs in periportal hepatocytes, where ornithine acts as an activator of two enzymes: ornithine carbamoyl transferase and carbamoyl phosphate synthetase, as well as a substrate for urea synthesis.

Synthesis of glutamine occurs in perivenous hepatocytes. In particular, under pathological conditions, aspartate and dicarboxylate, including the metabolic products of ornithine, are absorbed into cells and used there to bind ammonia in the form of glutamine.

Glutamate is an amino acid that binds ammonia under both physiological and pathological conditions. The resulting amino acid - glutamine - is not only a non-toxic form for removing ammonia, but also activates an important urea cycle (intracellular glutamine metabolism).

Under physiological conditions, ornithine and aspartate do not limit the synthesis of urea.

Experimental studies on animals have shown that the property of L-ornithine-L-aspartate to reduce the level of ammonia is due to the accelerated synthesis of glutamine. Separate clinical studies have shown this improvement over branched chain amino acids/aromatic amino acids.

Pharmacokinetics.

The half-life of both ornithine and aspartate is short - 0.3-0.4 hours. A small part of aspartate is excreted in the urine unchanged.

clinical characteristics.

Indications

Treatment of concomitant diseases and complications caused by a violation of the detoxification function of the liver (for example, with cirrhosis of the liver) with symptoms of latent or severe hepatic encephalopathy, especially impaired consciousness (precoma, coma).

Contraindications

Hypersensitivity to L-ornithine-L-aspartate or to other components of the drug.

Severe renal insufficiency (creatinine level above 3 mg/100 ml is considered as an approximate value).

Interaction with other drugs and other types of interactions.

Interaction studies have not been conducted. So far, the interactions are unknown.

Application features

Larnamin, concentrate for solution for infusion, should not be injected into an artery.

With the introduction of high doses of the drug Larnamin, it is necessary to control the level of urea in the blood plasma and urine.

In case of impaired liver function, the infusion rate must be adjusted according to the individual condition of the patient in order to prevent nausea and vomiting.

Use during pregnancy or lactation.

Data on the use of the drug Larnamin during pregnancy are not available. Animal studies have not been conducted with Larnamin to investigate its reproductive toxicity. Therefore, the use of Larnamin during pregnancy should be avoided.

However, if treatment with Larnamin during pregnancy is considered essential for health reasons, the physician should carefully weigh the potential risk to the fetus/child against the expected benefit to the mother.

It is not known whether Larnamin passes into breast milk, so the drug should be avoided during breastfeeding.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

Due to the disease, the ability to drive vehicles or operate other mechanisms may deteriorate during treatment with Larnamin, so this type of activity should be avoided during the period of treatment.

Dosage and administration

Apply intravenously.

Usually the dose is up to 4 ampoules (40 ml) per day.

In case of precoma or coma, inject up to 8 ampoules (80 ml) over 24 hours, depending on the severity of the condition.

Before the introduction of the contents of the ampoules, add up to 500 ml of infusion solution, but do not dissolve more than 6 ampoules in 500 ml of infusion solution.

The maximum injection rate of Larnamin is 5 g/h (corresponding to the contents of 1 ampoule).

The course of treatment is determined by the doctor depending on the clinical condition of the patient.

Children.

The experience of use in children is limited, so the drug should not be used in pediatric practice.

Overdose

So far, no signs of intoxication due to an overdose of Larnamin have been observed. Possible increased side effects. In case of overdose, symptomatic treatment is recommended.

Adverse reactions

From the gastrointestinal tract

Very rarely (<1/10000): тошнота.

Rare (> 1/10000,<1/1000): рвота.

In general, these symptoms are short-lived and do not necessarily require discontinuation of the drug. They disappear with a decrease in the dose or rate of administration of the drug.

Allergic reactions are possible.

Best before date

Do not use the drug after the expiration date indicated on the package.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Incompatibility.

Since incompatibility studies have not been conducted, this drug should not be mixed with other medicinal products.

Larnamin can be mixed with common infusion solutions. However, do not dissolve more than 6 ampoules in 500 ml infusion solution.

Package.

10 ml in an ampoule.

5 or 10 ampoules in a pack.

5 ampoules in a blister. 1 or 2 blisters in a pack.

On prescription.

Manufacturer

PJSC Farmak.

Location of the manufacturer and its address of the place of business.

Ukraine, 04080, Kyiv, st. Frunze, 74.

Instructions for the medical use of the drug

Description of the pharmacological action

It inhibits transpeptidase, prevents the formation of peptide bonds and disrupts the later stages of the synthesis of peptidoglycan in the cell wall of a dividing microorganism, causing bacterial lysis.

Indications for use

Infections of the respiratory system, urogenital area, gastrointestinal tract.

Release form

dispersible tablets 125 mg; blister 10.

Pharmacodynamics

Active against gram-positive microorganisms, incl. Staphylococcus spp. (with the exception of strains producing penicillinase), Streptococcus spp. (including Enterococcus spp.), gram-negative microorganisms, incl. Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Bordetella pertussis, some strains of Haemophilus influenzae, Klebsiella pneumoniae, aerobic non-spore-forming bacteria - Listeria monocytogenes. Destroyed by the action of penicillinase, acid-resistant.

Pharmacokinetics

When taken orally, it is well absorbed from the gastrointestinal tract, is not destroyed in the acidic environment of the stomach. With parenteral administration (in / m, in / in), the concentration in the blood exceeds that created by ingestion. T1 / 2 - 2 hours. Distributed in most organs and tissues, found in therapeutic concentrations in pleural, peritoneal and synovial fluids. Poorly penetrates through the BBB, with inflammation of the meninges, the permeability of the BBB increases dramatically. 30% of ampicillin is metabolized in the liver. Excreted mainly with urine (70-80%) and bile, high concentrations of unchanged drug are created in the urine. Ampicillin trihydrate and ampicillin sodium salt do not accumulate with repeated injections.

Contraindications for use

Hypersensitivity.

Side effects

Dyspepsia, stomatitis, allergic reactions.

Dosage and administration

Inside, for adults - 250 and 500 mg every 8 hours. For children weighing up to 20 kg - 12.5-25 mg / kg of body weight every 6 hours or 16.7-33.3 mg / kg of body weight every 8 h; with a body weight of 20 kg and above - the usual dose for adults.

Storage conditions

List B.: In a dry, cool, dark place.

Best before date

Belonging to ATX-classification:

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Instructions for use

Cocarnit instructions for use

Dosage form

Freeze-dried mass of pink color. The reconstituted solution is clear and pink in color.

Compound

Each ampoule of the drug contains:

Active ingredients: triphosadenine disodium trihydrate - 10.0 mg, cocarboxylase - 50.0 mg, cyanocobalamin - 0.5 mg, nicotinamide - 20.0 mg;

Excipients: glycine - 105.875 mg, methyl parahydroxybenzoate - 0.6 mg, propyl parahydroxybenzoate - 0.15 mg.

Each solvent ampoule contains:

Lidocaine hydrochloride - 10 mg, water for injection - up to 2 ml.

Pharmacodynamics

The drug is a rationally selected complex of metabolic substances and vitamins.

Trifosadenine is a derivative of adenosine, stimulates metabolic processes. It has a vasodilatory effect, including on the coronary and cerebral arteries. Improves metabolism and energy supply of tissues. It has hypotensive and antiarrhythmic action. Under the influence of ATP, blood pressure decreases, smooth muscles relax, and the conduction of nerve impulses improves.

Cocarboxylase is a coenzyme formed in the body from thiamine (vitamin B1) supplied from outside. It is part of the carboxylase enzyme, which catalyzes the carboxylation and decarboxylation of α-keto acids. Indirectly promotes the synthesis of nucleic acids, proteins and lipids. Reduces the concentration of lactic and pyruvic acids in the body, promotes the absorption of glucose. Improves the trophism of the nervous tissue.

Cyanocobalamin (vitamin B12) is converted in the body to methylcobalamin and 5-deoxyadenosylcobalamin. Methylcobalamin is involved in the conversion of homocysteine ​​to methionine and S-adenosylmethionine - the key reactions in the metabolism of pyrimidine and purine bases (and, consequently, DNA and RNA). If the vitamin is deficient in this reaction, it can be replaced by methyltetrahydrofolic acid, while the folic reactions of metabolism are disturbed.

5-deoxyadenosylcobalamin serves as a cofactor in the isomerization of L-methylmalonyl-CoA to succinyl-CoA, an important reaction in carbohydrate and lipid metabolism.

Vitamin B12 deficiency leads to impaired proliferation of rapidly dividing cells of the hematopoietic tissue and epithelium, as well as to impaired formation of the myelin sheath of neurons.

Nicotinamide - one of the forms of vitamin PP, is involved in redox processes in the cell, improves carbohydrate and nitrogen metabolism, regulates tissue respiration.

Pharmacokinetics

Trifosadenine

After parenteral administration, it penetrates into the cells of organs, where it is cleaved into adenosine and inorganic phosphate with the release of energy. In the future, the decay products are included in the resynthesis of ATP.

Cocarboxylase

Rapidly absorbed after intramuscular injection. Penetrates into most tissues of the body. undergoes metabolic degradation. Metabolic products are excreted mainly by the kidneys.

cyanocobalamin

In the blood, cyanocobalamin binds to transcobalamins I and II, which transport it to tissues. It is deposited mainly in the liver. Communication with plasma proteins 0 90%. Rapidly and completely absorbed after intramuscular and subcutaneous administration. The maximum concentration after intramuscular injection is reached after 1 hour.

It is excreted from the liver by bile into the intestines and reabsorbed into the blood. The half-life is 500 days. It is excreted with normal kidney function - 7-10% by the kidneys, about 50% - by the intestines. With reduced kidney function - 0-7% by the kidneys, 70-100% - by the intestines. Penetrates through the placental barrier into breast milk.

Nicotinamide

Rapidly distributed to all tissues. Penetrates through the placental barrier and into breast milk. Metabolized in the liver to form nicotinamide-N-methylnicotinamide. Excreted by the kidneys.

The plasma half-life is about 1.3 hours, the stationary volume of distribution is about 60 liters, the total clearance is about 0.6 l / min.

Side effects

The frequency of manifestation of adverse reactions is given in accordance with the WHO classification: very often (more than 1/10); often (less than 1/10, but more than 1/100); infrequently (less than 1/100, but more than 1/1000); rarely (less than 1/1000, but more than 1/10000); very rarely (less than 1/10000), including individual cases; frequency is unknown.

From the immune system: rarely - allergic reactions (skin rash, shortness of breath, anaphylactic shock, Quincke's edema).

From the side of the nervous system: very rarely - dizziness, headache, agitation, confusion.

From the side of the heart: very rarely - tachycardia; in some cases, bradycardia, arrhythmia; frequency unknown - pain in the heart

From the side of the vessels: the frequency is unknown - redness of the skin of the face and upper half of the body with a tingling and burning sensation, "hot flashes".

From the gastrointestinal tract: very rarely - vomiting, diarrhea.

From the side of the skin and subcutaneous tissues: very rarely - increased sweating, acne, itching, urticaria.

On the part of the musculoskeletal and connective tissue: very rarely - convulsions.

General disorders and disorders at the injection site: very rarely - irritation, pain and burning sensation at the injection site, weakness may occur.

If any of these adverse reactions worsen or any other adverse reactions appear that are not indicated in the instructions, you must inform your doctor.

With the development of severe adverse reactions, the drug is canceled.

Selling Features

prescription

Special conditions

If the symptoms of the disease worsen or there is no effect after 9 days, it is necessary to correct the course of treatment.

When using the drug COCARNIT, proper selection of the dose of the hypoglycemic drug and adequate control of the course of diabetes mellitus are necessary.

The color of the prepared solution should be pink.

Do not use the drug if the color of the solution has changed.

The solution must be used immediately after its preparation!

Influence on the ability to drive vehicles, mechanisms

If there are side effects from the central nervous system (dizziness, confusion), it is recommended to refrain from driving vehicles and other mechanisms.

Indications

Symptomatic treatment of diabetic polyneuropathy.

Contraindications

Hypersensitivity to any component of the drug or solvent;

Cardiovascular diseases: acute heart failure, acute myocardial infarction, uncontrolled arterial hypertension, arterial hypotension, severe forms of bradyarrhythmias, II-III degree AV blockade, chronic heart failure (NYHA grade III-IV), cardiogenic shock and other types of shock , QT prolongation syndrome, thromboembolism, hemorrhagic stroke;

Inflammatory lung diseases, chronic obstructive pulmonary disease, bronchial asthma;

Pregnancy, breastfeeding period;

Children's age up to 18 years;

Hypercoagulation (including with acute thrombosis), erythremia, erythrocytosis;

Peptic ulcer of the stomach or duodenum in the acute stage;

Gout;

Hepatitis, cirrhosis of the liver.

The drug should be used with caution in angina pectoris.

Use during pregnancy and during breastfeeding

drug interaction

In patients using hypoglycemic agents of the biguanide group (metformin), due to impaired absorption of cyanocobalamin from the gastrointestinal tract, a decrease in the concentration of cyanocobalamin in the blood may be observed. No drug interactions have been described with other hypoglycemic agents.

Cyanocobalamin is not compatible with ascorbic acid, salts of heavy metals, thiamine bromide, pyridoxine, riboflavin, folic acid. Cyanocobalamin should not be used simultaneously with drugs that increase blood clotting. In addition, the simultaneous use of cyanocobalamin with chloramphenicol should be avoided.

Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium preparations reduce the absorption of cyanocobalamin. With the combined use of preparations containing triphosadenine with dipyridamole, the effect of dipyridamole is enhanced, in particular the vasodilating effect. Dipyridamole enhances the effect of triphosadenine.

Some antagonism appears when the drug is used together with purine derivatives (caffeine, theophylline).

You can not enter simultaneously with cardiac glycosides in large doses, as the risk of adverse reactions from the cardiovascular system increases.

With simultaneous use with xanthinol nicotinate, the effect of the drug is reduced.

Nicotinamide potentiates the action of sedatives, tranquilizers, and antihypertensive drugs.

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