ADOPORT Capsule, hard (2021)

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

Περιεχόμενα

1. Name of the medicinal product

Adoport 0.5 mg Capsules, hard.

2. Qualitative and quantitative composition

Each hard capsule contains 0.5 mg of tacrolimus (as tacrolimus monohydrate). Excipient with known effect: Each hard capsule contains 46.1 mg lactose (as monohydrate). For the full list of excipients, ...

3. Pharmaceutical form

Capsule, hard. Opaque white and ivory hard gelatin capsule containing white to off- white powder. (length: 14.5 mm).

4.1. 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.

4.2. Posology and method of administration

Tacrolimus 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 ...

4.3. Contraindications

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

4.4. 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, ...

4.5. 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 ...

4.6. 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 ...

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.

4.8. 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 ...

4.9. 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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Calcineurin inhibitors ATC code: L04AD02 Mechanism of action and pharmacodynamic effects At the molecular level, the effects of tacrolimus appear to be mediated ...

5.2. Pharmacokinetic properties

Absorption In man tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract. Following oral administration of tacrolimus capsules peak concentrations (Cmax) of tacrolimus ...

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

Capsule contents: Hypromellose (E464) Lactose monohydrate Croscarmellose Sodium (E468) Magnesium stearate (E572) Hard gelatine capsule: Gelatin Titanium dioxide (E171) Sodium laurilsulfate ...

6.2. Incompatibilities

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

6.3. Shelf life

2 years. After opening the bag: 12 months. Do not store above 25°C.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from moisture.

6.5. Nature and contents of container

PVC/PE/PVdC/Aluminium blisters with desiccant in Aluminium bag. Packs of 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 hard capsules. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

8. Marketing authorization number(s)

PL 04416/0939

9. Date of first authorization / renewal of the authorization

31/05/2014

10. Date of revision of the text

08/05/2021

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf