IMURAN Tablet (2021)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Aspen |
|---|---|
| Διεύθυνση | 12/13 Exchange Place , I.F.S.C., Dublin 1, Ireland |
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Περιεχόμενα
1. Name of the medicinal product
Imuran Tablets 25 mg.
2. Qualitative and quantitative composition
Orange, round, biconvex, film-coated tablets, unscored, branded IM 2 and containing 25 mg Azathioprine BP in each tablet Each tablet contains 25 mg of the active substance azathioprine. <u>Excipient(s) ...
3. Pharmaceutical form
Tablet.
4.1. Therapeutic indications
Azathioprine is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. ...
4.2. Posology and method of administration
Posology <b>Tablets:</b> When the oral route is impractical, azathioprine injection may be administered by the IV route only, however, this route should be discontinued as soon as oral therapy can be tolerated ...
4.3. Contraindications
Hypersensitivity to azathioprine or to any of the excipients listed in section 6.1. Hypersensitivity to 6-mercaptopurine should alert the prescriber to probable hypersensitivity to azathioprine.
4.4. Special warnings and precautions for use
Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts. Therefore, it is recommended that patients do not receive live organism vaccines until at least ...
4.5. Interaction with other medicinal products and other forms of interaction
Food, milk and dairy products The administration of azathioprine with food may decrease systemic exposure slightly but this is unlikely to be of clinical significance (see Section 4.8). Therefore, azathioprine ...
4.6. Fertility, pregnancy and lactation
Fertility The specific effect of azathioprine therapy on human fertility is unknown. Pregnancy Substantial transplacental and transamniotic transmission of azathioprine and its metabolites from the mother ...
4.7. Effects on ability to drive and use machines
There are no data on the effect of azathioprine on driving performance or the ability to operate machinery. A detrimental effect on these activities cannot be predicted from the pharmacology of azathioprine. ...
4.8. Undesirable effects
Summary of the safety profile For this product there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Undesirable effects may vary ...
4.9. Overdose
Symptoms and signs Unexplained infection, ulceration of the throat, bruising and bleeding are the main signs of overdosage with azathioprine and result from bone marrow depression which may be maximal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic and Immunomodulating agents <b>ATC code:</b> L04AX01 Azathioprine is an imidazole derivative of 6-mercaptopurine (6-MP). It is rapidly broken down in vivo ...
5.2. Pharmacokinetic properties
Absorption Azathioprine is well absorbed following oral administration. Although there are no food effect studies with azathioprine, pharmacokinetic studies with 6-mercaptopurine have been conducted that ...
5.3. Preclinical safety data
Teratogenicity Studies in pregnant rats, mice and rabbits using azathioprine in dosages from 5 to 15 mg/kg body weight/day over the period of organogenesis have shown varying degrees of foetal abnormalities. ...
6.1. List of excipients
Lactose Pregelatinised starch Maize starch Stearic acid Magnesium stearate Methylhydroxylpropyl cellulose Polyethylene glycol 400 Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172) ...
6.2. Incompatibilities
None known.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light.
6.5. Nature and contents of container
Blister strips in a pack. Pack sizes: 28, 30, 56, 60 and 100 tablets.
6.6. Special precautions for disposal and other handling
Safe handling Health professionals who handle uncoated azathioprine tablets should follow guidelines for the handling of cytotoxic medicinal products according to prevailing local recommendations and/or ...
7. Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PL 39699/0004
9. Date of first authorization / renewal of the authorization
20 March 1992
10. Date of revision of the text
June 2021
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