PROGRAF Hard capsule (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
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
<u>Prograf 0.5 mg hard capsules:</u> Capsule, hard. Opaque light yellow hard gelatin capsules imprinted in red with 0.5 mg and [f] 607, containing white powder. <u>Prograf 1 mg hard capsules:</u> Capsule, ...
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
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
<u>Prograf 0.5 mg hard capsules:</u> Date of first authorisation: 10 December 1998 Date of last renewal: 27 November 2007 <u>Prograf 1 mg hard capsules:</u> Date of first authorisation: 16 February 1996 ...
Date of revision of the text
September 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
