CLIPPER Gastro-resistant prolonged-release tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Clipper 5 mg gastro-resistant prolonged-release tablets.
2. Qualitative and quantitative composition
Each tablet contains 5 mg of beclometasone dipropionate. <u>Excipient with known effect:</u> lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant prolonged-release tablets. Each ivory white, coated tablet is round and convex.
4.1. Therapeutic indications
The tablets are indicated for the treatment of mild or moderate ulcerative colitis in active phase, as add-on therapy to 5-ASA containing drugs in patients who are non-responders to 5-ASA therapy in active ...
4.2. Posology and method of administration
Posology Dosage Recommendations Adults One Clipper 5 mg tablet a day to be taken in the morning before or after a light breakfast. Therapy cycles of not more than four weeks are recommended. Elderly No ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Tubercular, local mycotic and viral infections.
4.4. Special warnings and precautions for use
As there are no data in patients with severe hepatic impairment, treatment with Clipper in these patients is not recommended. There are no data in patients with hepatic or renal insufficiency, so these ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. As beclometasone dipropionate undergoes a very rapid metabolism via esterases enzymes without involvement of cytochrome P450, it is less dependent on CYP3A metabolism ...
4.6. Pregnancy and lactation
Pregnancy Data on a large number of exposed pregnancies indicate no adverse effects of 1 mg per day beclometasone dipropionate (after inhalation), on pregnancy or on the health of the newborn child. To ...
4.7. Effects on ability to drive and use machines
Clipper has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, ...
4.9. Overdose
No cases of overdose have so far been reported. However, in case of acute or chronic intake exceeding the therapeutic dose, the following measures should be taken: <u>Acute:</u> Ingestion of the drug in ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Corticosteroids for local use <b>ATC Code:</b> A07EA07 Mechanism of action and pharmacodynamic effects Clipper tablets contain beclometasone dipropionate (BDP), a pro-drug ...
5.2. Pharmacokinetic properties
Beclometasone dipropionate (BDP) is very rapidly hydrolysed to its active metabolite (B-17-MP), via esterase enzymes found mostly in liver and lung tissues. In human serum and intestinal juices, B-17-MP ...
5.3. Preclinical safety data
Chronic toxicity studies with beclometasone dipropionate resulted in dose dependent effects typical of glucocorticoids. Beclometasone dipropionate is non-genotoxic and no evidence of carcinogenicity was ...
6.1. List of excipients
<u>In Tablet Core:</u> Lactose monohydrate Hypromellose (E.464) Microcrystalline cellulose Maize starch Magnesium stearate <u>In Tablet Coat:</u> Macrogol 4000 Methacrylic acid-methyl methacrylate copolymer ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
PVC/PVDC/Al/PVDC blister. Packs of 10 or 30 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom
8. Marketing authorization number(s)
PL 08829/0153
9. Date of first authorization / renewal of the authorization
7<sup>th</sup> January 2005
10. Date of revision of the text
May 2019
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