البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
CETIRIZINE DIHYDROCHLORIDE
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD
R06AE07
SYRUP
CETIRIZINE DIHYDROCHLORIDE 0.1 %W/V
PER OS
Not required
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
CETIRIZINE
CETIRIZINE
Antihistaminic drug for the treatment of allergies for the treatment of seasonal and perennial allergic rhinitis and chronic idiopathic uriticaria in children aged over 2 years and adults.
2023-02-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor’s prescription HISTAZINE SYRUP ACTIVE INGREDIENT Each 5 ml contain: cetirizine dihydrochloride 5 mg Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. Take this medicine according to the instructions in the section about dosage in this leaflet. Consult your pharmacist if you need further information. Talk to a doctor if your symptoms of illness get worse or do not improve after 3 days. 1. WHAT IS THIS MEDICINE INTENDED FOR? This medicine is used to treat seasonal and perennial allergic rhinitis (hay fever) and chronic idiopathic uriticaria (hives) characterized by skin irritation (such as itching, rash). For adults and for children over the age of 2 years. THERAPEUTIC GROUP: antihistamines . BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min); You are sensitive (allergic) to cetirizine dihydrochloride or to any of the other ingredients in this medicine (listed in section 6), to hydroxyzine or to any piperazine derivatives (similar piperazine- group active ingredients of other medicines). SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE YOU START USING HISTAZINE, TELL YOUR DOCTOR IF: You have kidney failure. If necessary, you will take a lower dose of this medicine. Your doctor will determine your new dose. You have problems passing urine (like spinal cord problems or prostate or bladder problems). You have epilepsy or are at risk of getting convulsions. You are scheduled for allergy testing. Ask your doctor if you should stop taking Histazine for several days b اقرأ الوثيقة كاملة
HISTAZINE SYRUP Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Histazine Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg cetirizine dihydrochloride. Excipients with known effect: - one ml of solution contains 400 mg sorbitol - one ml of solution contains 0.34 mg methylparahydroxybenzoate - one ml of solution contains 0.16 mg propylparahydroxybenzoate For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Clear colorless to pale yellow Syrup. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antihistaminic drug for the treatment of allergies. For the treatment of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria in children aged over 2 years and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Children over 6 years old and adults: 10 ml once daily or 5 ml twice daily. Special population _Elderly _ Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. _Renal impairment _ There are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly eliminated via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CL cr ) in ml/min is needed. The CL cr (ml/min) may be estimated from serum creatinine mg/dl) determination using the following formula: Dosing adjustments for adult patients with impaired renal function Group Creatinine clearance (ml/min) Dosage and frequency Normal ≥80 10 mg once daily Mild 50 – 79 10 mg once daily Moderate 30 – 49 5 mg once daily Severe <30 5 mg once every 2 days End-stage renal disease - Patients undergoing dialysis <10 Contraindicated _ Hepatic impairment _ No dose adjustment is needed in patients with solely hepatic impairment. In pa اقرأ الوثيقة كاملة