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The instruction for medical use of Kromoglin® medicine nasal spray the Trade name of Kromoglin® nasal spray the International unlicensed name Kromoglitsiyevaya acid the Dosage form the Spray nasal dosed of 20 mg/ml Structure One ml of solution contains active agent: sodium of the kromoglikat of 20 mg, excipients: dinatrium edetat, sodium hydroxide of 1 M solution, water for injections the Description Transparent, light – yellowish solution Pharmakoterapevticheky group Antiallergenic drugs (excepting corticosteroids). Kromoglitsinovy acid. The ATX R01AC01 code the Pharmacological Pharmacokinetics Later properties of intranasal introduction absorption of drug from mucous membranes is about 8%. With increase in amount of secretion the extent of absorption decreases. Concentration in plasma of 9 ng/ml is reached within 15 minutes. Linking with proteins makes 63-76%. The volume of distribution is 0.13 l/kg. At accidental ingestion, drug is soaked up from digestive tract in the minimum quantity (less than 1%). It is brought out of an organism in not changed view with urine and bile approximately in equal quantities. The pharmacodynamics of Kromoglin® nasal spray blocks receipt of calcium ions in mast cells, preventing that their degranulation and release of mediators of an allergy and inflammation: a histamine, bradykinin, ‘slowly reacting substance’ and other biologically active agents. Indications – prevention and treatment of allergic rhinitis the Route of administration and a dosage to Adults and children are more senior than 6 years it is recommended to accept on 1 dose in each nasal course 4 times a day. It is possible to increase the frequency of introduction to 6 times a day (on 1 dose) or appoint 4 times a day 2 doses. After achievement of therapeutic effect the intervals between doses can be increased. Side effects Sometimes – the passing phenomena of irritation in a nose it is rare – headaches and changes of flavoring feelings – cough and the complicated breath, bleeding from a nose, ulcers of mucous membranes of a nose Very seldom – hoarseness, a laryngeal edema, the Contraindication Quincke’s edema – hypersensitivity to kromoglitsinovy acid or other components of drug – children’s age up to 6 years Medicinal interactions are not described Special instructions For faster effect in 2-3 days prior to use of Kromoglin® nasal spray perhaps to appoint vasoconstrictive drops for a nose. Кромоглин® nasal spray can be applied along with antihistaminic drugs during the short span. At suspicion on allergic reaction to use of Kromoglin® nasal spray it is necessary to avoid repeated uses of drug. Pregnancy and the period of a lactation At long-term use of Kromoglin® nasal spray the teratogenic effect was not observed. Кромоглин® nasal spray gets into maternal milk in very small quantities. Therefore, possibly do not represent risk for babies. Despite this, use of Kromoglin® nasal spray during pregnancy and in the period of a lactation perhaps only after careful weighing by the attending physician of a ratio advantage/risk. Use for children has to be only under observation of adults. Features of influence on ability to run the vehicle or potentially dangerous mechanisms the Overdose does not influence the Form of release and packing On 15 ml is not revealed spill in bottles from white polyethylene of the high density with a capacity of 20 ml, supplied with the portioning device, a tip and with the twisting cover. On 1 bottle together with the instruction for medical use in the state and Russian languages put in a box of cardboard. To Store storage conditions at a temperature not over 25 ºС! To store out of children’s reach! Not to apply a period of storage of 5 years after an expiration date! Prescription status Without prescription Ursapharm Artsnaymittel GmbH Producer, Germany the Owner of the registration certificate ratiopharm GmbH, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of the products (goods) responsible for post-registration observation of safety of medicine of ratiopharm Kazakhstan LLP, Almaty, Al-Farabi Ave., 19, BC Nurly-Tau, 1B, office 603, 604 Phone number, fax (727) 311-09-15, 311-07-34

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