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SPC, UK: PROGRAF Hard capsules (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Prograf 0.5 mg hard capsules. Prograf 1 mg hard capsules. Prograf 5 mg hard capsules.

Qualitative and quantitative composition

Prograf 0.5 mg hard capsules: Each capsule contains 0.5 mg of tacrolimus (as monohydrate). Excipient with known effect: 62.85 mg of lactose monohydrate Each capsule contains less than 1 mmol sodium (23 ...

Pharmaceutical form

Prograf 0.5 mg hard capsules: Capsule, hard. Opaque light yellow hard gelatin capsules imprinted in red with 0.5 mg and [f] 607, containing white powder. Prograf 1 mg hard capsules: Capsule, hard. Opaque ...

Therapeutic indications

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

Posology and method of administration

Prograf therapy requires careful monitoring by adequately qualified and equipped personnel. The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians ...

Contraindications

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

Special warnings and precautions for use

Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed. This has led to serious adverse events, ...

Interaction with other medicinal products and other forms of interaction

Metabolic interactions Systemically available tacrolimus is metabolised by hepatic CYP3A4. There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall. Concomitant use of medicinal ...

Fertility, pregnancy and lactation

Pregnancy Human data show that tacrolimus is able to cross the placenta. Limited data from organ transplant recipients show no evidence of an increased risk of adverse effects on the course and outcome ...

Effects on ability to drive and use machines

Tacrolimus may cause visual and neurological disturbances. This effect may be enhanced if Prograf is administered in association with alcohol.

Undesirable effects

The adverse drug reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medications. Many of the adverse ...

Overdose

Experience with overdosage is limited. Several cases of accidental overdosage have been reported; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy, increased ...

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 to be mediated ...

Pharmacokinetic properties

Absorption In man tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract. Following oral administration of Prograf capsules peak concentrations (C<sub>max</sub>) of tacrolimus ...

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 ...

List of excipients

Prograf 0.5 mg hard capsules Capsule content: Hypromellose Croscarmellose sodium Lactose monohydrate Magnesium stearate Capsule shell: Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine Printing ...

Incompatibilities

Tacrolimus is not compatible with PVC. Tubing, syringes and other equipment used to prepare or administer a suspension of Prograf capsule contents should not contain PVC.

Shelf life

Shelf life: 3 years. After opening the aluminium wrapper: 1 year.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Hard capsules should be taken immediately following ...

Nature and contents of container

PVC/PVDC/Aluminium blisters or PVC/PVDC/Aluminium perforated unit-dose blisters. Ten capsules per blister. Two, three, five, six, nine or ten blisters with a desiccant in an aluminium wrapper. Prograf ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, United Kingdom

Marketing authorization number(s)

Prograf 0.5 mg hard capsules: PL 00166/0206 Prograf 1 mg hard capsules: PL 00166/0203 Prograf 5 mg hard capsules: PL 00166/0204

Date of first authorization / renewal of the authorization

Prograf 0.5 mg hard capsules Date of first authorisation: 10 December 1998 Date of last renewal: 27 November 2007 Prograf 1 mg hard capsules Date of first authorisation: 16 February 1996 Date of last renewal: ...

Date of revision of the text

September 2019

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