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Technical File Or Summary of the Characteristics of The SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dexchlorpheniramine Maleate 5mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Dexchlorpheniramine Maleate contains 5 mg of Dexchlorpheniramine Maleate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear and particle free solution for injection. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Symptomatic treatment of acute urticaria when oral administration is not possible. Dexchlorpheniramine Maleate 5mg/ml solution for injection is indicated in adults and children older of 30 months. 4.2. Posology and method of administration Posology Adults: The dose should be personalised according to the requirements and response of the patient. Elderly patients: Dexchlorpheniramine Maleate 5mg/ml should be used with precaution in elderly patients (See section 4.4). Renal and hepatic impairment: Dexchlorpheniramine Maleate 5mg/ml should be used with precaution (See section 4.4). Paediatric population: The safety and efficacy of Dexchlorpheniramine Maleate 5mg/ml solution for injection in children aged less than 30 months has not yet been established. No data are available. Method of administration 1 The recommended dose is 5 mg (1 ampoule) administered intravenously or intramuscularly. The maximum daily dose is of 20 mg (4 ampoules). In the case of a reaction during a transfusion, do not administer Dexchlorpheniramine Maleate 5mg/ml solution for injection in the transfusion, but apart. 4.3. Contraindications -Hypersensitivity to the active substance, or any of the excipients listed in section 6.1, or to other antihistamines of similar chemical structure. -Children under 30 months of age (See section 4.4). -In patients under treatment with monoamine oxidase inhibitors (MAOI) or the two weeks following the interruption of said treatment. -In patients with risk of closed-angle glaucoma. -In patients with risk of urinary retention related to urethroprostatic disorders. -3rd trimester of pregnancy. 4.4. Special warnings and precautions for use In case of necessity, the use of this medicinal product should not delay the administration of adrenalin. Dexchlorpheniramine should be used with precaution. Elderly patients that presents: -A greater sensitivity to orthostatic hypotension, vertigos and sedation. -Chronic constipation (risk of adynamic ileus). -Eventual prostatic hypertrophy. In the case of severe hepatic and/or renal insufficiency, due to the risk of accumulation. It is unadvisable to have any alcoholic drinks or medicinal products that contain alcohol during the treatment. Paediatric population: May cause excitation in children. 4.5. Interaction with other medicinal products and other forms of interaction Contraindications of concomitant use -Associations with other depressors of the central nervous system (sedative anti- depressants, barbiturates, benzodiazepines, clonidine and similar, hypnotics, morphine derivatives (analgesics and anti-tussives) methadone, neuroleptics, anxiolytics). Increase in central depression. Deterioration in the state of alertness that could make driving and operating machinery dangerous (See section 4.3). -Atropine and other atropinic substances (imipramine anti-depressants, anti-Parkinsons, anti-cholinergics, atropinic anti-spasmodics, disopyramide, phenothiazinic neuroleptics). 2 Addition of atropinic side effects such as urinary retention, constipation and dryness of the mouth (See section 4.3). Concomitant use not recommended Increase in sedation of antihistamine H1 with alcohol. The alteration in alertness could be dangerous when driving or operating machinery. Avoid drinking alcoholic beverages or medicinal products that contain alcohol. (See section 4.4). 4.6. Fertility, pregnancy and lactation Fertility There are no adequate data about the effect of Dexchlorpheniramine to patient fertility (male or female). Pregnancy Dexchlorpheniramine Maleate 5mg/ml solution for injection is contraindicated during 3rd trimester of pregnancy (see section 4.3). During 1st trimester of pregnancy: Studies in animals have not shown any evidence of teratogenicity. In the absence of teratogenic effects in animals, no malformation effects are expected in human beings. In fact, to date, the substances responsible for malformations in human beings have also been found to have teratogenic effects on animals in correctly performed studies carried out on the two species. The results of the epidemiological studies seem to exclude any special malformation effect of chlorpheniramine. During 2nd and 3rd trimesters of pregnancy: Amongst the newborn of mothers treated chronically with high doses of anticholinergic medicinal products, digestive symptoms have been described, although rarely, related to the atropinic properties (abdominal distension, meconium ileus, delay in the expulsion of the meconium, difficulty in initiating alimentation, tachycardia, neurological disorders). Taking into account these data this medicinal product, under normal conditions of use, can be prescribed during the first 2 trimesters of pregnancy. The use should not be considered during the 3rd trimester, except when necessary and limiting it to an occasional use. If this medicinal product is administered towards the end of the pregnancy, it seems reasonable to observe a follow-up period of the neurological and digestive functions of the neonate. Lactation Dexchlorpheniramine have been identified in breastfed newborns/infants of treated women. There is insufficient information on the effects of dexchlorpheniramine in newborns/infants. Dexchlorpheniramine Maleate 5mg/ml solution for injection should not be used during breast-feeding. 3 4.7. Effects on ability to drive and use machines Dexchlorpheniramine Maleate 5mg/ml solution for injection has moderate influence on the ability to drive and use machines. As Dexchlorpheniramine Maleate 5mg/ml solution for injection can cause somnolence, patients should be warned to not carry out mechanical operations that require maximum concentration such as driving or operating equipment, machinery. 4.8. Undesirable effects The pharmacological characteristics of Dexchlorpheniramine cause side effects of variable intensity related or not to the dose. The possible undesirable effects have been reported at the following the system organ class. Nervous system disorders: -Sedation or drowsiness, more pronounced at the start of treatment -Orthostatic hypotension. -Equilibrium disorders, dizziness, reduction in memory or concentration, more frequent in the elderly, -Lack of motor co-ordination, tremor. -Mental confusion, hallucinations. -Very rarely: the effects are of excitation type: agitation, nervousness, insomnia, Skin and subcutaneous tissue disorders: -Rash, eczema, pruritus, purpura, urticaria possible giant. -Oedema, more rarely Quincke’s oedema. Inmune system disorsders: -Anaphylactic shock. Blood and lymphatic system disorders: - Leucopenia, neutropenia. -Thrombocytopenia. -Haemolytic anaemia. General disorders and administration site condictions: -Anticholinergic effects such as dryness of the mucosa, constipation, accommodation disorders, mydriasis, cardiac palpitations, risk of urinary retention. 4.9. Overdose 4 In the case of overdose, urgent treatment should be initiated immediately. Manifestations: The effects of an antihistamine overdose can range from depression of the central nervous system (sedation, apnoea, reduction in mental lucidity, cardiovascular collapse) to stimulation (insomnia, hallucinations, trembling or convulsions) and death. Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision and hypotension. In children, the apparition of symptoms of stimulation is more frequent, as well as anti-cholinergic signs and symptoms (dryness of the mouth, dilated, fixed pupils, flushing, hyperthermia and gastrointestinal symptoms). Treatment: The treatment of the signs and symptoms is symptomatic and supportive. Stimulants should not be used (analeptic agents). Hypotension can be treated with vasopressors. In order to control the convulsions, short term barbiturates can be administered, diazepam or paraldehyde. Hyperpyrexia, especially in children, might require treatment with warm water baths or hypothermic blankets. In the case of apnoea assisted respiration should be applied. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic properties Pharmacotherapeutic group: Antihistamines for systemic use, ATC Code: R06A Dexchlorpheniramine Maleate is an antagonist of the H1 histamine receptors and, therefore, is of clinical value in the treatment of certain allergic manifestations. Mechanism of action Dexchlorpheniramine, like other antihistamines inhibits the H1 receptors in a non- selective way, antagonizing the effects of histamine and competing with it for these receptors. It is indicated in situations as blood allergic reactions, anaphylactic reactions with adrenalin and associated to other measures to control the acute manifestations. 5.2. Pharmacokinetic properties The in vitro and in vivo tests of the antihistamine potential of the optically active isomers of chlorpheniramine show that the predominant activity is in the dextro-isomer, Dexchlorpheniramine. After the oral administration of 4 mg of racemic chlorpheniramine maleate to fasting human volunteers, the blood levels of Dexchlorpheniramine rose rapidly. The peak levels in blood were approximately 7 ng/ml in an average of 3 hours after administration. The half-life of
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