SENSAHIST Film-coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Sensahist.
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg cetirizine dihydrochloride. Contains sugar: Lactose monohydrate.
3. Pharmaceutical form
Film-coated tablet. White, capsule shaped film-coated tablets with break line on one side and M, embossed on the other side.
4.1. Therapeutic indications
Allergic processes responding to a histamine H1 receptor antagonist. Respiratory: Allergic rhinitis, hay fever. Cutaneous: Allergic skin conditions associated with pruritus e.g. urticaria.
4.2. Posology and method of administration
<b>Adults or children 12 years of age or older:</b> One 10 mg tablet daily. <b>Children 6 to 12 years old:</b> 10 mg (one tablet) once daily or 5 mg (half a tablet) twice daily. Special populations At ...
4.3. Contraindications
History of hypersensitivity to cetirizine dihydrochloride or any of the constituents of Sensahist. Hypersensitivity to hydroxyzine or any piperazine derivative. Sensahist is contraindicated in pregnancy ...
4.4. Special warnings and precautions for use
Sensahist lacks significant sedative effects. However, it is advisable to avoid concomitant use with alcohol or other central nervous system depressants during treatment with Sensahist. Information on ...
4.5. Interaction with other medicinal products and other forms of interaction
To date there are no known interactions of Sensahist with other medicines through interactions with medicines metabolised by liver enzymes. Studies with diazepam, glipizide, pseudoephedrine, ketoconazole, ...
4.6. Pregnancy and lactation
Pregnancy Sensahist is contraindicated in pregnancy as safety has not been established (see Contraindications). Lactation Sensahist is contraindicated in lactation since the active ingredient, cetirizine ...
4.7. Effects on ability to drive and use machines
Patients should be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect ...
4.8. Undesirable effects
Sensahist has the following side effects: Blood and the lymphatic system disorder <u>Less frequent:</u> Agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia, sweating. Immune system disorders ...
4.9. Overdose
Drowsiness can be a symptom of overdosage. Overdosage in children may produce agitation, somnolence, pruritus, rash, urinary retention, fatigue, tremor and tachycardia. In the case of massive overdosage, ...
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A.5.7.1 Antihistaminics Cetirizine dihydrochloride, a metabolite of hydroxyzine, is a histamine H1 receptor antagonist.
5.2. Pharmacokinetic properties
Peak blood levels are reached within one hour after oral administration of cetirizine dihydrochloride. Cetirizine dihydrocloride does not undergo extensive first pass metabolism. The terminal half-life ...
6.1. List of excipients
Anhydrous calcium hydrogen phosphate, colloidal anhydrous silica, magnesium stearate, maize starch, povidone (K-30), sodium starch glycolate and coating ingredients (hypromellose (E-5), titanium dioxide, ...
6.4. Special precautions for storage
Store at or below 25°C in original package. Keep tablets in a dry place. Protect from light. Keep out of reach of children.
6.5. Nature and contents of container
Packaged in transparent PVC film and aluminium foil blister strips of 10 tablets. Strips are packed per unit carton to market as 10s or 30s. Not all pack sizes are marketed at any one time.
7. Marketing authorization holder
Oethmaan Biosims (Ply) Ltd, 14 Komatie Road, Emmarentia, Johannesburg, 2195
8. Marketing authorization number(s)
42/5.7.1/0822
9. Date of first authorization / renewal of the authorization
Date of registration: 20 June 2013
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