XEROPRIM Tablet
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
XEROPRIM tablets.
2. Qualitative and quantitative composition
Each tablet contains: Trimethoprim 80 mg Sulphamethoxazole 400 mg Preservative: Nipastat 0,025 % m/m. Sugar free.
3. Pharmaceutical form
White, round flat tablet bisected on one side.
4.1. Therapeutic indications
The treatment of infections of the upper and lower respiratory tract, the urinary tract and the alimentary and genital tract in both sexes, and skin infections caused by sensitive organisms.
4.2. Posology and method of administration
<u>Adults and children older than 12 years:</u> Two tablets every 12 hours for a period of 10 to 14 days.
4.3. Contraindications
XEROPRIM is contraindicated in patients with known sulphonamide or trimethoprirn hypersensitivity or who are suffering from porphyria. It should not be used in patients suffering from liver parenchyma ...
4.4. Special warnings and precautions for use
Erythema multiforme, toxic dermal necrolysis and allergic vasculitis may occur. In patients with renal impairment, reduced or more widely spaced dosage is indicated to avoid accumulation in the blood. ...
4.5. Interaction with other medicinal products and other forms of interaction
Paraldehyde has been reported to increase the acetylation of sulphamethoxazole with subsequent increased risk of crystalluria. Because of the risk of crystalluria, an adequate fluid intake should be maintained. ...
4.6. Pregnancy and lactation
XEROPRIM should not be used during pregnancy and lactation. Use of the substance in premature or new born infants during the first two months of life, is contra-indicated (See CONTRAINDICATIONS).
4.8. Undesirable effects
Haematological changes such as anaemia (including aplastic, haemolytic and nacrocytic), coagulation disorders, granulocytopenia, agranulocytosis, purpura, henoch schöntein purpura; and sulphaermoglobinaemia ...
4.9. Overdose
Nausea, vomiting, cyanosis, heamaturia, oliguria, or anuria and allergic skin reactions (skin rashes, anaphylaxis, etc.). Treatment is supportive and symptomatic.
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 20.2 antimicrobial agents other than antibiotics. XEROPRIM is a combination of trimethoprim and sulphamethoxazole and results in synergistic effects causing a batericidal ...
6.1. List of excipients
Magnesium stearate Microcrystalline cellulose Nipastat Pregelatinised starch Sodium carboxymethyl cellulose Maize σtarch
6.4. Special precautions for storage
Store in a cool dry place at or below 25°C. Protect from light and heat.
6.5. Nature and contents of container
Packed into blisters and patient ready packs of 28s, 56s and 100s and bottles of 20s, 100s and 500s tablets.
7. Marketing authorization holder
Oethmaan Biosims (Pty) Ltd., 14 Komatie Road, Emmarentia, Johannesburg 2195
8. Marketing authorization number(s)
27/20.2/0077
9. Date of first authorization / renewal of the authorization
18 January 2006
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