Calgel dental gel 10g №1

Name:
Kalgel dental gel (3.3mg + 1mg)/1g in tube.10g in pack №1
Description:
Soft homogeneous yellowish-brown gel with a characteristic odor, free from grains, lumps and foreign particles. The main active substance Cetylpyridinium chloride + lidocaine hydrochloride Release form 10 g in an aluminum tube, varnished from the inside, with a screw-on plastic cap. 1 tube in a cardboard box along with instructions for use. Dosage 3.3mg + 1mg) / 1g Special instructionsKalgel™ does not affect the ability to drive vehicles and work with mechanisms. Pharmacological actionMeans for local anesthesia. Amides. CodeATX: N01BB52. Pharmacodynamics The drug Calgel™ is an analgesic drug used for application to the oral mucosa. At the same time, lidocaine has a local anesthetic effect when applied to the mucous membrane. Cetylpyridinium chloride has antiseptic properties. Pharmacokinetics Absorption Lidocaine is rapidly absorbed from the mucous membrane. Distribution Lidocaine binds to plasma proteins, including α-acid glycoprotein (AKGP). The degree of binding varies and is about 66%. The binding of lidocaine to plasma proteins is somewhat dependent on the concentration of lidocaine and ACGP. Any change in the concentration of ACGP can significantly affect the concentration of lidocaine in the blood plasma. Metabolism Lidocaine is extensively metabolized in the liver. Metabolism in the liver proceeds rapidly, about 90% of the incoming lidocaine undergoes dealkylation with the formation of monoethylglycine xylidide and glycine xylidide. Withdrawal Metabolites of lidocaine are excreted by the kidneys, with less than 10% excreted as unchanged lidocaine. Indications for use Calgel™ is prescribed for teething. Calgel™ helps to quickly relieve the pain of teething and reduces the severity of gum irritation. Calgel™ also has a weak antiseptic effect. Method of application and dosage Method of application For application to the oral mucosa. Adults No relevant data available. Children Calgel™ is intended for children over the age of 3 months. A small amount of gel, approximately 7.5 mm (0.22 g), should be applied to the tip of a clean finger and gently rubbed into the inflamed area of the child’s gums. If necessary, the gel can be applied repeatedly with an interval of 20 minutes, but not more than six times a day. Elderly patients No data available. Patients with impaired renal function No data available. Patients with hepatic impairment No data available. Method of administration and doses For application to the oral mucosa. Adults No relevant data available. Children Calgel™ is intended for children over the age of 3 months. A small amount of gel, approximately 7.5 mm (0.22 g), should be applied to the tip of a clean finger and gently rubbed into the inflamed area of the child’s gums. If necessary, the gel can be applied repeatedly with an interval of 20 minutes, but not more than six times a day. Elderly patients No data available. Patients with impaired renal function No data available. Patients with hepatic impairment No data available. Use in pregnancy and lactation The drug is indicated for use in young children and infants, therefore information on use during pregnancy and lactation is not applicable. Precautions Do not exceed recommended doses. The drug should be kept out of the reach of children. Interaction with other drugs There are no data on the interaction of the drug Calgel™ with other drugs. There are data on the interaction of lidocaine (when administered intravenously) with the following drugs when taken orally: procainamide, phenytoin as monotherapy or in combination with phenobarbital, primidone and carbamazepine, propranolol and non-potassium-sparing diuretics, including bumetanide, furosemide and thiazide. It is unlikely that these drug interactions are related to the use of the drug Calgel™. Contraindications Calgel™ is contraindicated in patients with hypersensitivity to lidocaine hydrochloride and/or cetylpyridinium chloride or any of the excipients. Compound 1 g Active substances: lidocaine hydrochloride 3.3 mg and cetyl pyridinium chloride 1 mg. Excipients: sorbitol non-crystallizing solution 70% (E420), xylitol, ethanol 96%, glycerin, hydroxyethylcellulose, PEG-40 concentrate, hydrogenated castor oil (cremophor RH410), laureth 9, macrogol 300, sodium saccharin, levomenthol, vegetable flavor, caramel ( E150), sodium citrate, citric acid monohydrate, purified water. Overdose Cetylpyridinium Ingestion of cetylpyridinium in large doses can cause gastric upset and depression of the central nervous system. The concentrations at which overdose symptoms were noted were 70 times higher than the concentrations of cetylpyridinium chloride found in this preparation. Lidocaine Systemic toxic effects of local anesthetics (in any form of application) may include effects on the central nervous system and heart. When analyzing post-registration data for this drug, no symptoms of overdose were detected. In case of overdose, discontinue Calgel™ and consult a doctor. Side effects When used in accordance with the instructions, the development of unwanted reactions is unlikely. However, isolated cases of hypersensitivity to lidocaine hydrochloride have been reported in adults and children over 12 years of age after topical injection. The hypersensitivity that arose in these cases was expressed in the form of localized edema, accompanied by a slight difficulty in breathing or a generalized rash. A small amount of chamomile in herbal flavor can cause allergic reactions, which is documented. Hypersensitivity to chamomile, as a rule, manifests itself in the form of difficulty in breathing in individuals predisposed to atopy. Anaphylactic reactions have been reported with herbal tea containing chamomile. Individuals with hypersensitivity may experience a positive skin reaction when using preparations containing chamomile. Adverse reactions are listed below according to organ system classes and frequency of occurrence. The frequency of occurrence was determined as follows: Very often? 1/10 Often ? 1/100 and < 1/10 Uncommon ? 1/1000 and < 1/100 Rarely? 1/10000 and < 1/1000 Very rare < 1/10000 Not known (cannot be estimated from the available data). Immune system disorders Not known: hypersensitivity (including dermatitis). General disorders and disorders at the injection site Not known: reactions at the application site (including erythema). In the event of any adverse reactions, discontinue use of Calgel™ and seek medical advice. Storage conditions At a temperature not exceeding 25 ° C, out of the reach of children. 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