Prograf

Polyoxyethylene hydrogenated castor oil

Dehydrated alcohol

Tacrolimus is absorbed by PVC plastics. Tubing, syringes and any other equipment used to prepare and administer Prograf 5 mg/ml concentrate for solution for infusion should not contain PVC.

Tacrolimus is unstable under alkaline conditions. Combination of the reconstituted Prograf 5 mg/ml concentrate for solution for infusion with other pharmaceutical products that produce a marked alkaline solution (e.g. aciclovir and ganciclovir) should be avoided.

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, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the dilution has taken place in controlled and validated aseptic conditions.

Tapentadol

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

Each carton contains 10 ampoules.

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 saline solution in polyethylene, polypropylene or glass bottles, but not in PVC containers. Only transparent and colourless solutions should be used.

The concentration of a solution for infusion should be within the range 0.004 - 0.100 mg/ml. The total volume of infusion during a 24-hour period should be in the range 20 - 500 ml.

The diluted solution should not be given as a bolus.

Any unused concentrate in an opened ampoule or unused reconstituted solution should be disposed of immediately in accordance with local requirements to avoid contamination.

Astellas Pharma Ltd.

2000 Hillswood Drive

Chertsey

Surrey

KT16 0RS

United Kingdom

PL 00166/0205

Date of first authorisation: 7 June 1994

Date of last renewal: 27 November 2007

25 June 2015

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain