MODIGRAF Granules for oral suspension (2019)

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Περιεχόμενα

1. Name of the medicinal product

Modigraf 0.2 mg granules for oral suspension. Modigraf 1 mg granules for oral suspension.

2. Qualitative and quantitative composition

Modigraf 0.2 mg granules for oral suspension Each sachet contains 0.2 mg tacrolimus (as monohydrate). Excipient with known effect: Each sachet contains 94.7 mg lactose (as monohydrate). Each sachet ...

3. Pharmaceutical form

Granules for oral suspension. White granules.

4.1. Therapeutic indications

Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal ...

4.2. Posology and method of administration

This medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. Modigraf ...

4.3. Contraindications

Hypersensitivity to tacrolimus or to any of the excipients listed in section 6.1. Hypersensitivity to other macrolides.

4.4. Special warnings and precautions for use

There are no safety data available on the use of Modigraf granules following a temporary switch from Prograf or Advagraf in critically ill patients. Modigraf should not be switched with Advagraf as a clinically ...

4.5. Interaction with other medicinal products and other forms of interaction

Systemically available tacrolimus is metabolised by hepatic CYP3A4. There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall. Concomitant use of substances known to inhibit ...

4.6. Fertility, pregnancy and lactation

Pregnancy Human data show that tacrolimus crosses the placenta. Limited data from organ transplant recipients show no evidence of an increased risk of adverse reactions on the course and outcome of pregnancy ...

4.7. Effects on ability to drive and use machines

Tacrolimus may cause visual and neurological disturbances. This effect may be enhanced if tacrolimus is administered in association with alcohol. No studies on the effects of tacrolimus (Modigraf) on the ...

4.8. Undesirable effects

Summary of the safety profile The adverse reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medicinal ...

4.9. Overdose

Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, calcineurin inhibitors ATC code: L04AD02 Mechanism of action and pharmacodynamic effects At the molecular level, the effects of tacrolimus appear ...

5.2. Pharmacokinetic properties

Absorption In man, tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract. Available tacrolimus is generally rapidly absorbed. Modigraf granules are an immediate-release ...

5.3. Preclinical safety data

The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons. In rats, tacrolimus caused toxic effects to the nervous system and the eyes. Reversible ...

6.1. List of excipients

Lactose monohydrate Hypromellose (E464) Croscarmellose sodium (E468)

6.2. Incompatibilities

Tacrolimus is not compatible with PVC (polyvinylchloride) plastics. Materials used to prepare and administer the suspension, e.g. drinking vessels, cups, or tubing, must not contain PVC.

6.3. Shelf life

3 years. After preparation, the suspension should be administered immediately.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Sachets consisting of layers of polyethylene terephtalate (PET), aluminium (Al) and polyethylene (PE). Pack size: carton box containing 50 sachets.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands

8. Marketing authorization number(s)

Modigraf 0.2 mg granules for oral suspension: EU/1/09/523/001 Modigraf 1 mg granules for oral suspension: EU/1/09/523/002

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 15 May 2009 Date of latest renewal: 17 Feb 2014

10. Date of revision of the text

23 September 2019

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