ANTIALERZIN 50 mg. 2 ml. 10 ampules
ANTIALERZIN 50 mg. 2 ml. 10 ampules
The injection of Antialerzin is shown in the following cases:
• Symptomatic treatment of allergic reactions of the general type - anaphylactic shock (in addition to therapy with adrenaline), serum sickness, edema Quincke, hypersensitivity reactions to drugs; after insect bites; in urticaria different genesis; in uncomplicated allergic immediate reactions in the use of oral antiallergic agents is impossible or contraindicated;
• sickness - in need of intensive care;
• As an additional tool in preoperativna and postoperative sedapiya in surgery and obstetrics;
• For sedapiya and response of the voltage, and to cause a light sleep, the patient wakes up easily;
4.2. Dosage and method of administration
Parenteral: deep intramuscular or slow intravenous injection. Promethazine intravenously is introduced slowly at not exceeding 25 mg / min, and then diluting to 10 times.
In allergic conditions: the dose is 25 mg and may be repeated after 2 hours
Sedation: apply in a hospital setting and only in adults at a dose of 25-50 mg.
Before and after the operation: 25-50 mg in combination with reduced dosages analgesics and drugs containing atropine.
The maximum single dose is 50 mg, the maximum daily dose is 100 mg. From 5 to 10 godiniPrilaga was intramuscularly in the following single doses: the morning at 0,125 mg / kg weight and evening 0,5 mg / kg, but not more than 6,25 - 12,5 mg.
• Glaucoma, prostatic hypertrophy, bladder outflow obstruction;
• Peptic ulcer and duodenal-pyloric obstruction;
• Bronchial asthma;
• Concurrent use with CNS depressants such as alcohol, barbiturates, tranquilizers because of the risk of deepening the sedation;
• In the range of 14 days after the use of MAO inhibitors;
• Hypersensitivity to promethazine;
• Children under 2 years of age due to the risk of the phenomenon of "sudden infant death" or apnea during sleep;
4.4. Special precautions for use
• If a promethazine injection must be used for the rubber gloves to avoid irritating effects on the skin.
• Use with caution in diabetics and in patients with narrowing of the marrow canal.
• Caution should be used in elderly patients and children due to the risk of increase in adverse reactions to them.
• promethazine not be administered subcutaneously and intraarterially as it causes tissue necrosis and gangrene!
• promethazine potentiate the sedative effects of CNS depressants general anestetili, analgesics, incl. and alcohol.
• Supplied with holinolititsi tricyclic antidepressants, enhances their anticholinergic effects.
• In combination with MAO inhibitors may enhance the vasopressor effects.
4.6. Pregnancy and lactation
Promethazine is used in clinical practice for treatment of nausea and vomiting during pregnancy. Implementation they must be preceded by an accurate assessment of the benefit to the mother against the risk to the fetus.
Antialerzin can be applied in kombinaztsiya other means of labor analgesia.
Not recommended to Antialerzin during lactation ..
4.7. Effects on ability to drive and use machines
Due to its pronounced sedative promethazine should not be appointed to drivers of vehicles and operating machinery.
4.8. Undesirable effects
Nervous system sedative effect, dizziness, nervousness, tremor, fatigue, reduced alertness, impaired coordination, euphoria, insomnia, rarely - deep drowsiness, hallucinations, convulsions. When used in high doses may occur neuroleptic malignant syndrome.
Syrdechno Cardiovascular system: tachycardia, bradycardia, increase or decrease in blood pressure, venous thrombosis.
Digestive system: moderate anesthesia of the mouth, nausea and vomiting, dry mouth, sensory organs: sometimes accommodation disorder, diplopia; Urinary system: in rare cases urinary retention.
Endocrine system: a phenothiazine derivative promethazine may cause galactorrhoea, porphyria and weight gain.
Liver: Possible liver injury with an increase in transaminases; Hematopoiesis: agranulocytosis, expressed as leukopenia;
Allergic reactions: urticaria, dermatitis, bronchospasm, photosensitivity,
Other: for rapid intravenous administration sharp drop in blood pressure and orthostatic collapse and intramuscular administration formation painful infiltrates. In diabetic patients may experience an increase in blood sugar. In childhood can cause agitation associated with anticholinergic effect or phenomenon of "sudden infant death" in infancy.
In high doses may experience drowsiness, reduced alertness, agitation, abnormal movements, difficulty breathing, nightmares, delirium, postural collapse (for rapid intravenous infusion) koma.Lechenieto in these cases is to restore the water-salt balance, respiration, forced diuresis. No specific antidote because koetolechenieto symptomatic.
5.2. Pharmacodynamic properties
The medicinal product is a derivative of phenothiazines. Chemical structure and pharmacological action on the part close to the neuroleptic chlorpromazine. Has expressed antihistamine activity (blocking H1 - receptors) and antiallergic action. Proceed blood-brain barrier and blocks H1 receptors in the CNS as a result of which exhibits the following central effects: sedative, to potentiate the effect of narcotic and non-narcotic analgesics, antispasmodics, sedatives, general and local anesthetics, reduction of body temperature, prevention and relief of emesis , docking of hiccups. As a phenothiazine derivative, has promethazine dopaminolitichno action as a result of eliminating the stress and facilitates the onset of sleep. Turns moderate peripheral and central M-holinolitichnoto and expressed adrenolitichno action.
The therapeutic effect began to show 20 min after drug administration and lasts 4-6, and sometimes 12 h. Metabolised in the liver (dominated processes S-oxidation). Up to 90% is bound to plasma proteins and has a half-life of about 7 hours. Sulphites are dominant metabolites in the urine. Preminavava through the blood-brain and placental barrier
5.3. Preclinical safety data
The results of long term administration of the drug on experimental animals show no mutagenic and carcinogenic effects, and impaired fertility. Test results with standard mutagenicity tests did not show any mutagenic potential.
6. Pharmaceutical particulars
6.1. List of excipients and their amounts
Content in an ampule:
Ascorbic acid 4 mg
Sodium chloride 12 mg
Sodium sulphite anhydrous 2 mg
Sodium metabisulphite 2 mg
6.2. Physico - chemical incompatibilities
He is known
6.3. Expiration date
5 years from date of manufacture.
6.4. Storage Conditions
In original packaging in a dry and dark place at a temperature below 25 ° C.
Do not freeze!
Keep out of reach of children!
6.5. Packaging Data
The product was filled into brown glass ampoules with a capacity of 2 ml. Ten ampoules are placed in rigid PVC blister foil.
One or ten blister placed in an embossed box unilateral pigment coated paperboard. In each box put information on how to use Emery and control number, and where there are markings on the top of the ampoule in the form of a colored dot or ring no avail Emery opening the ampoule.