MESASAL Enteric-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
MESASAL Mesalazine enteric-coated tablets.
2. Qualitative and quantitative composition
Each enteric-coated tablet contains 250 mg of mesalazine as the active ingredient. <u>Excipients of known effect:</u> contains 23.9 mg elemental sodium per 250 mg tablet. For the full list of excipients, ...
3. Pharmaceutical form
MESASAL 250 mg enteric-coated tablets are round, biconvex and tan coloured.
4.1. Therapeutic indications
Treatment of acute inflammatory large bowel disease Maintenance therapy of Crohns colitis and ulcerative colitis in patients sensitive to sulfasalazine
4.2. Posology and method of administration
In acute ulcerative colitis, remissions will usually occur within 8 weeks. Adults Treatment of Acute Ulcerative Colitis and Crohns Disease 500 mg (2 250 mg tablets) three times daily, (or as directed ...
4.3. Contraindications
A history of hypersensitivity to mesalazine, other salicylates or any of the excipients in MESASAL Severe renal impairment (glomerular filtration rate <20 mL/min) Pathological tendency to bleeding, or ...
4.4. Special warnings and precautions for use
Caution should be exercised when administering mesalazine to patients with: a history of hypersensitivity to sulfasalazine; although in general, hypersensitivity reactions to mesalazine appear to be less ...
4.5. Interaction with other medicinal products and other forms of interaction
There have been no specific studies on interactions of mesalazine with other drugs that may be co-administered. In common with other salicylates, mesalazine may potentiate the effect of coumarin anticoagulants ...
4.6. Fertility, pregnancy and lactation
Effects on Fertility Decreased sperm count and impaired sperm motility, which may affect male fertility, have been reported with mesalazine. This effect may be reversible when treatment is discontinued ...
4.7. Effects on ability to drive and use machines
The effects of this medicine on a persons ability to drive and use machines were not assessed as part of its registration.
4.8. Undesirable effects
In clinical trials totalling 2,164 patients, adverse reactions related to treatment with mesalazine occurred in 5.3% of patients; these were severe enough to lead to withdrawal in 1.4% of patients. A further ...
4.9. Overdose
Symptoms There is no specific pattern of symptoms following overdose with mesalazine. Possible symptoms may include nausea, vomiting and diarrhoea, and symptoms similar to salicylate overdose. Treatment ...
5.1. Pharmacodynamic properties
Mechanism of Action Mesalazine has been identified as the active component of sulfasalazine in inflammatory bowel disease and is thought to have a topical action. In clinical studies, mesalazine has shown ...
5.2. Pharmacokinetic properties
Healthy Volunteers In fasted, healthy subjects given a single oral dose of mesalazine (500 mg), time to peak plasma concentration was 6.5 hours for mesalazine and 7 hours for acetyl-5-aminosalicylic acid ...
5.3. Preclinical safety data
Genotoxicity No data available. Carcinogenicity No data available.
6.1. List of excipients
The enteric-coated tablets also contain: calcium stearate, colloidal anhydrous silica, glycine, iron oxide red, iron oxide yellow, macrogol 6000, methacrylic acid copolymer, microcrystalline cellulose, ...
6.2. Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
6.3. Shelf life
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
Container type: blister pack (PVC/PVDC/Al). <u>Pack sizes:</u> 100 Some strengths, pack sizes and/or pack types may not be marketed. Australian Register of Therapeutic Goods (ARTG) AUST R 289132 – MESASAL ...
6.6. Special precautions for disposal and other handling
In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.
7. Marketing authorization holder
Viatris Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276
9. Date of first authorization / renewal of the authorization
250 mg: 16/08/2017
10. Date of revision of the text
22/04/2022
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