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Introna

Marketed in 31 countries across much of Europe and into parts of Latin America, Introna is an internationally distributed brand of interferon alfa-2b, a biologic active ingredient classified within the antitumour, immunostimulant, anti-inflammatory, antiproliferative, and immunomodulating categories. It is a specialist medication, handled in hospital and clinic settings rather than over a general pharmacy counter, and this page is written for travellers, expatriates, and family members trying to understand what the product is and where it can be found.

Interferon alfa-2b is used in the management of chronic viral hepatitis — including chronic hepatitis B — and in certain oncological indications such as forms of leukemia, with use also registered in contexts surrounding chemotherapy and surgery. The structured indication block further down this page lists each registered use as recognised by the regulators of the markets in which Introna is authorised.

Because Introna is registered across a wide European footprint as well as markets such as Chile, the same product is encountered by patients moving between very different healthcare systems. Representative markets where the brand is authorised include Germany, France, Chile, Iceland, and Finland. Brand naming, prescription pathways, and hospital supply arrangements for interferon products vary considerably between countries, and a hospital pharmacist or treating specialist in the destination country is the right person to confirm how the same active ingredient is provided locally.

Other interferon-based and immunomodulating biologics exist internationally under different molecules and brand names, but biologics of this category are not casually substituted. Continuity of therapy, switching between products, and any change in treatment plan should be coordinated with the specialist responsible for the patient's care.

Shelf life

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.

Date of revision of the text

18 September 2017

Marketing authorisation holder

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Special precautions for storage

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Nature and contents of container

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.

Marketing authorisation number(s)

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

Special precautions for disposal and other handling

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 IntronA”).

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/renewal of the authorisation

Date of first authorisation: 9 March 2000

Date of latest renewal: 9 March 2010

Frequently asked questions

What conditions does Introna treat?

Introna is prescribed in the management of certain viral and oncological conditions, including chronic hepatitis B and certain forms of leukemia, and is used in contexts associated with chemotherapy and surgery. As an immunomodulating agent, it is positioned within specialist treatment pathways rather than general practice. The structured indication block below this introduction lists every registered use of Introna in the markets where it is authorised.

Which active substance is in Introna?

Introna contains interferon alfa-2b, a biologic active ingredient classified across several overlapping categories — antitumour, immunostimulant, anti-inflammatory, antiproliferative, and immunomodulating. Interferon alfa-2b is the same molecule whether sold under the Introna brand or under other commercial names internationally; biologics of this kind circulate worldwide under a number of brand identities depending on the manufacturer and the regulatory market.

In how many countries is Introna available?

Introna is registered in 31 countries, with a footprint concentrated in Europe and extending into selected markets further afield. Examples include Germany, France, Chile, Iceland, Hungary, Finland, and Ireland. If your country is not represented on this list, a local pharmacist or hospital specialist can usually confirm whether interferon alfa-2b is available in that market under a different brand name.

Are there other medications with the same active ingredient as Introna?

Interferon alfa-2b is marketed under several brand names in different regional markets, and the broader category of interferon-based and immunomodulating biologics also includes other molecules used in overlapping therapeutic areas. These products are not freely interchangeable and are typically handled through specialist channels. To identify a regional equivalent, search the active ingredient on Pill2Trip or speak with a hospital pharmacist familiar with biologic therapies.

Should I consult a doctor before taking Introna?

Yes. Introna is a prescription biologic used in specialist settings such as hepatology and oncology, and treatment is calibrated closely to the individual patient. Prescription pathways, brand availability, and supply arrangements for interferon products differ meaningfully between countries, which is particularly relevant for patients travelling or relocating. Any decision to start, continue, switch, or pause therapy should sit with the treating specialist rather than be improvised abroad.

Introna

Available in 31 countries