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SPC, UK: PROGRAF Concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Prograf 5 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

1 ml concentrate for solution for infusion contains 5 mg of tacrolimus. Excipients with known effect: 200 mg of polyoxyethylene hydrogenated castor oil and 638 mg of dehydrated alcohol. For the full list ...

Pharmaceutical form

Concentrate for solution for infusion. The concentrate is a clear colourless solution.

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 in particular polyoxyethylene hydrogenated castor oil or structurally related compounds. ...

Special warnings and precautions for use

During the initial post-transplant period, monitoring of the following parameters should be undertaken on a routine basis: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, ...

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

Not relevant.

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

Polyoxyethylene hydrogenated castor oil Dehydrated alcohol

Incompatibilities

When diluting, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Tacrolimus is absorbed by PVC plastics. Tubing, syringes and any other equipment ...

Shelf life

Shelf life: 2 years. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, ...

Special precautions for storage

Store ampoule in the original package in order to protect from light. Do not store above 25°C. For storage conditions after dilution of the medicinal product, see section 6.3.

Nature and contents of container

1 ml concentrate for solution for infusion in 2 ml, type I Ph. Eur. clear colourless glass ampoules. Each carton contains 10 ampoules.

Special precautions for disposal and other handling

Prograf 5 mg/ml concentrate for solution for infusion must not be injected undiluted. Prograf 5 mg/ml concentrate for solution for infusion should be diluted in 5% w/v glucose solution or physiological ...

Marketing authorization holder

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

Marketing authorization number(s)

PL 00166/0205

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 February 1996 Date of last renewal: 27 November 2007

Date of revision of the text

September 2019

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