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IMURAN Tablet (2021)

Αναφορές

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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