Advagraf 0.5mg, 1mg, 3mg and 5mg Prolonged-release hard capsules
Following a review by the Commission on Human Medicines (CHM), updated advice on the prescribing and dispensing of oral tacrolimus products has been agreed. This updated advice is that all oral tacrolimus medicines in the UK should be prescribed and dispensed by brand name only.
Table of Contents
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1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
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Go to top of the page1. Name of the medicinal product
Advagraf 0.5 mg prolonged-release hard capsules
Advagraf 1 mg prolonged-release hard capsules
Advagraf 3 mg prolonged-release hard capsules
Advagraf 5 mg prolonged-release hard capsules
Go to top of the page2. Qualitative and quantitative composition
Advagraf 0.5 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as monohydrate).
Excipients with known effect:
Each capsule contains 51.09 mg lactose.
The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).
Advagraf 1 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 1 mg tacrolimus (as monohydrate).
Excipients with known effect:
Each capsule contains 102.17 mg lactose.
The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).
Advagraf 3 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 3 mg tacrolimus (as monohydrate).
Excipients with known effect:
Each capsule contains 306.52 mg lactose.
The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).
Advagraf 5 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 5 mg tacrolimus (as monohydrate).
Excipients with known effect:
Each capsule contains 510.9 mg lactose.
The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).
For the full list of excipients, see section 6.1.
Go to top of the page3. Pharmaceutical form
Advagraf 0.5 mg