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SPC, UK: AZATHIOPRINE / SANDOZ Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Azathioprine 25 mg film-coated tablets.

Qualitative and quantitative composition

One film-coated tablet contains 25 mg azathioprine. Excipient(s) with known effect: Lactose For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. White to yellowish-white film-coated tablet, biconvex, no score-line.

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. ...

Posology and method of administration

Specialist medical literature should be consulted for guidance as to clinical experience in particular conditions. General When the oral route is impractical, azathioprine injection may be administered ...

Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or the metabolite 6- mercaptopurine. If patients also have a known hypersensitivity to 6-mercaptopurine, the consulting ...

Special warnings and precautions for use

Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts. Therefore, immunisations with live organism vaccines are not recommended (see section 4.5). ...

Interaction with other medicinal products and other forms of interaction

Vaccines The immunosuppressive activity of azathioprine could result in an atypical and potentially deleterious response to live vaccines and so the administration of live vaccines to patients receiving ...

Fertility, pregnancy and lactation

Pregnancy Substantial transplacental and transamniotic transmission of azathioprine and its metabolites from the mother to the foetus have been shown to occur. Azathioprine should not be given to patients ...

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 the drug. ...

Undesirable effects

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 in their incidence depending on ...

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 ...

Pharmacodynamic properties

Therapeutic Group: Antineoplastic and Immunosuppressive agents ATC code: L04AX01 Mode of action Azathioprine is a pro-drug of 6-mercaptopurine (6-MP). 6-MP is inactive but acts as a purine antagonist and ...

Pharmacokinetic properties

Plasma levels of azathioprine and 6-mecaptopurine do not correlate well with the therapeutic efficacy or toxicity of azathioprine. Absorption The absorption of azathioprine is incomplete and variable. ...

Preclinical safety data

Teratogenicity Studies in pregnant rats, mice and rabbits using azathioprine in dosages from 5-15 mg/kg bodyweight/day over the period of organogenesis have shown varying degrees of foetal abnormalities. ...

List of excipients

Core: Lactose monohydrate Maize starch Povidone Colloidal silicon dioxide Magnesium stearate Coating: Hypromellose Microcrystalline cellulose Polyoxyl 8 stearate Talc Colouring agent: titanium dioxide ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

The film-coated tablets are packed in either polypropylene-aluminium blister or PVC/PVDC-aluminium blister in a carton box. The pack contains 20, 28, 30, 50, 90 or 100 film-coated tablets. Not all pack ...

Special precautions for disposal and other handling

There are no risks associated with handling tablets with intact coating. In that case no special safety precautions are necessary. However, cytotoxic agents should be handled in strict accordance with ...

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization number(s)

PL 04416/1247

Date of first authorization / renewal of the authorization

25/10/2002

Date of revision of the text

22/10/2018

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