IntronA 10 million IU/ml solution for injection or infusion
18 months.
Within its shelf-life, for the purpose of transport, the solution can be kept at or below 25°C for a period up to seven days before use. IntronA can be put back in the refrigerator at any time during this seven-day period. If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
IntronA 25 million IU/2.5ml solution for injection or infusion
2 years.
After first opening the container: Chemical and physical in-use stability has been demonstrated for 28 days at 2°C - 8°C.
From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2°C - 8°C. Other in-use storage times and conditions are the responsibility of the user.
Within its shelf-life, for the purpose of transport, the solution can be kept at or below 25°C for a period up to seven days before use. IntronA can be put back in the refrigerator at any time during this seven-day period. If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
18 September 2017
Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon
Hertfordshire EN11 9BU
United Kingdom
Store in a refrigerator (2°C - 8°C).
Do not freeze.
IntronA 10 million IU/mL solution for injection or infusion
1 mL of solution (corresponding to 10 MIU) is contained in a single dose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene)
IntronA is supplied as:
- Pack of 1 vial.
- Pack of 1 vial, 1 injection syringe of 2 mL, 1 injection needle and 1 cleansing swab
- Pack of 6 vials, 6 injection syringes of 2 mL, 6 injection needles and 6 cleansing swabs
- Pack of 12 vials, 12 injection syringes of 2 mL, 12 injection needles and 12 cleansing swabs
Not all pack sizes may be marketed.
IntronA 25 million IU/2.5mL solution for injection or infusion
2.5 mL of solution (corresponding to 25 MIU) is contained in a multidose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
IntronA is supplied as:
- Pack of 1 vial
- Pack of 1 vial, 6 injection syringes of 1 mL, 6 injection needles and 12 cleansing swabs
- Pack of 1 vial, 6 injection syringes with attached needle and needle protection device of 1 mL and 12 cleansing swabs
- Pack of 1 vial, 6 injection syringes with attached needle of 1 mL and 12 cleansing swabs
- Pack of 2 vials
- Pack of 2 vials, 12 injection syringes of 1 mL, 12 injection needles and 24 cleansing swabs
- Pack of 2 vials, 12 injection syringes with attached needle and needle protection device of 1 mL and 24 cleansing swabs
- Pack of 2 vials, 12 injection syringes with attached needle of 1 mL and 24 cleansing swabs
- Pack of 12 vials
- Pack of 12 vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs
- Pack of 12 vials, 72 injection syringes with attached needle and needle protection device of 1 mL and 144 cleansing swabs
- Pack of 12 vials, 72 injection syringes with attached needle of 1 mL and 144 cleansing swabs
Not all pack sizes may be marketed.
IntronA 10 million IU/ml solution for injection or infusion IntronA 25 million IU/2.5ml solution for injection or infusion |
: : | EU/1/99/127/019-022 EU/1/99/127/027-030; 043-044; 048-053 |
Not all dose forms and strengths are appropriate for some indications. Please make sure to select an appropriate dose form and strength.
IntronA solution for injection or infusion may be injected directly after withdrawal of the appropriate doses from the vial with a sterile injection syringe.
Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “How to self inject IntronAâ€).
Preparation of IntronA for intravenous infusion: The infusion is to be prepared immediately prior to use. Any size vial may be used to measure the required dose; however, final concentration of interferon in sodium chloride solution must be not less than 0.3 million IU/mL. The appropriate dose of IntronA is withdrawn from the vial(s), added to 50 mL of 9 mg/mL (0.9 %) sodium chloride solution for injection in a PVC bag or glass bottle for intravenous use and administered over 20 minutes.
No other medicinal product can be infused concomitantly with IntronA.
As with all parenteral medicinal products, prior to administration inspect IntronA, solution for injection or infusion, visually for particulate matter and discolouration. The solution should be clear and colourless.
IntronA 10 million IU/mL solution for injection or infusion
Any unused medicinal product must be discarded after withdrawal of the dose and in accordance with local requirements.
Date of first authorisation: 9 March 2000
Date of latest renewal: 9 March 2010
