Thiogamma solution inf 12mg / ml 50ml vial

$4.76

Thiogamma solution inf 12mg / ml 50ml vial

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Description

Composition
Active substance:
Meglumine salt of thioctic acid – 1167.70 mg (equivalent to 600 mg of thioctic acid) ;.
Excipients:
Macrogol 300 – 4000.00 mg, meglumine, water for injection to 50 ml.
Description:
The clear solution is light yellow or yellowish-green color.
Product form:
Solution for infusion of 12 mg / ml.
50 ml vial, made of brown glass type II, which is closed with a rubber stopper. The plug is fixed with an aluminum cap, on top of which there is a polypropylene gasket. 1 bottle or bottles 10 with outboard housings light shielding by the number of bottles made of polyethylene black cardboard baffles and instructions for use in a cardboard box.
Contraindications
Hypersensitivity to thioctic acid or other ingredients.
Children up to age 18 years.
Pregnancy and breast-feeding.
Before taking this medication, you should consult with your doctor.
Dosage
12 mg / ml
Indications
Diabetic polyneuropathy, alcoholic polyneuropathy.
Interaction with other drugs
Thioctic acid reduces the effectiveness of cisplatin, while taking, and also reacts with metal-containing drugs, iron preparations such as magnesium. Thioctic acid reacts with the molecules of sugars, forming soluble complexes, for example with sodium levulose (fructose). It enhances the anti-inflammatory glucocorticosteroid agents.
Infusion solution of thioctic acid is incompatible with dextrose, Ringer’s solution and solutions of reacting with disulfide and SH – groups. With simultaneous application thioctic acid and insulin or oral hypoglycemic agents their effect can be enhanced. Ethanol and its metabolites weaken the effect of thioctic acid. • If you are already taking other medicines or are going to take them, before taking Tiogamma® medication should consult a physician.
Overdose
Symptoms include nausea, vomiting, headache.
In case of receiving doses of 10 to 40 g of thioctic acid in combination with alcohol intoxication cases were observed until death. Symptoms of acute overdose: psychomotor agitation or dizziness, as a rule, with the subsequent development of generalized seizures and the development of lactic acidosis. cases of hypoglycaemia have also been described, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression, and multiorgan failure.
Treatment is symptomatic. No specific antidote.
pharmachologic effect
Pharmacological group:
Metabolic means.
Pharmacodynamics:
Thioctic acid – endogenous antioxidant (binds free radicals).
The body is formed by oxidative decarboxylation of alpha-ketoksilot. As coenzyme mitochondrial multienzyme complexes involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Thereby reducing the concentration of glucose in blood and increasing in liver glycogen, and reduce insulin resistance. Participates in the regulation of lipid and carbohydrate metabolism, influences the metabolism of cholesterol, improves liver function has a detoxication effect for poisoning by heavy metal salts and other intoxications. Improves trophic neurons. In diabetes thioctic acid reduces the formation of advanced glycation end products, improves endoneurial blood flow, increases glutathione levels to physiological values ​​that results in the improvement of the functional status of peripheral nerve fibers in diabetic polyneuropathy.
Pharmacokinetics:
When the time to reach maximum concentration of intravenous injection – 10 – 11 min, the maximum concentration is about 20 ug / ml. It has the effect of “first pass” through the liver. The formation of metabolites occurs as a result of oxidation of the side chain and conjugation. Total plasma clearance – 10 – 15 ml / min. Thioctic acid and its metabolites are excreted by the kidneys (80 – 90%), in small quantities – unchanged. The half-life of 25 min.
Pregnancy and breast-feeding
Application of pregnancy and lactation is contraindicated.
Conditions of supply of pharmacies
Prescription.
side effects
The incidence of adverse reactions is given in accordance with the WHO classifications:
Very often> 1/10 appointments
Often> 1/100 to
Not often> 1/1000 to
Rarely> 1/10000 to
Very rarely
The frequency is not known can not be established from the available data
Blood disorders and lymphatic system: very rare: petechial hemorrhages in the mucous membranes, skin, thrombocytopenia purpura (purpura), thrombophlebitis;
Disorders of immune system: the frequency is unknown: systemic allergic reactions (up to the development of anaphylactic shock); frequency is unknown: autoimmune insulin syndrome (AIS) patients with diabetes mellitus, which is characterized by frequent hypoglycemia under the presence of autoantibodies to insulin.
Disorders of the nervous system: very rare: change or impaired sense of taste; very rare: convulsions;
Violations by the organ of vision: Very rare: diplopia;
Disorders of the skin and subcutaneous tissue disorders: unknown frequency: allergic reactions – urticaria, pruritus, eczema, rash.
General disorders and administration in place: the frequency is unknown: due to improved glucose uptake may reduce the concentration of glucose in the blood. In this case, you may experience symptoms of hypoglycemia – dizziness, sweating, headache, visual disturbances; very rare: allergic reactions at the injection site – irritation, redness, or swelling; very rarely: in the case of rapid administration may increase intracranial pressure (a feeling of heaviness in the head), difficulty in breathing. These reactions take place on their own.
If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
C Patients with diabetes requires constant monitoring of blood glucose concentration, especially at the initial stage of therapy. In some cases it is necessary to reduce the dose of insulin or oral hypoglycemic agents, in order to avoid hypoglycemia. If you experience symptoms of hypoglycemia (dizziness, sweating, headache, visual disturbances, nausea) should stop treatment immediately. In rare cases, the application Tiogamma® drug in patients with lack of glycemic control and severe general condition can develop serious anaphylactic reactions.
Drinking alcohol during therapy with Tiogamma® reduces the effectiveness of the drug, and is a risk factor for the development and progression of neuropathy.
Patients taking the drug Tiogamma®, should refrain from drinking alcohol.
There are cases of autoimmune insulin syndrome (AIS) during treatment with thioctic acid. The possibility of AIS is defined by the presence of patients alleles HLA-DRB1 * 04: 06 and HLA-DRB1 * 04: 03.
Effects on ability to drive vehicles and operate machinery:
It does not affect the ability to drive a motor vehicle and work with other mechanisms.
Storage conditions
In the dark place at a temperature not exceeding 25 ° C.
Keep out of the reach of children !.
Dosing and Administration
In early drug therapy Tiogamma® infusion solution is administered intravenously at a dose of 600 mg (1 bottle) daily for 2 – 4 weeks. Vial is removed from the box and immediately covered with a sheath attached sunscreen, t. K. Thioctic acid is light sensitive. Infusion produce directly from the vial. Administered slowly, about 1.7 ml / min for 30 min.
You can then continue taking oral forms thioctic acid (Tiogamma®, coated tablets) of 600 mg per day.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

VOERVAG

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