IntronA 25million units2.5ml solution for injection multidose vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Interferon alfa-2b

Available from:

Merck Sharp & Dohme Ltd

ATC code:

L03AB05

INN (International Name):

Interferon alfa-2b

Dosage:

10mega u/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020400; GTIN: 5012376023229

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
INTRONA
® 25 MILLION IU/2.5 ML SOLUTION FOR INJECTION OR INFUSION
Interferon alfa-2b
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What IntronA
_ _
is and what it is used for
2.
What you need to know before you use IntronA
_ _
3.
How to use IntronA
4.
Possible side effects
5.
How to store IntronA
6.
Contents of the pack and other information
_ _
1.
WHAT INTRONA IS AND WHAT IT IS USED FOR
IntronA (interferon alfa-2b) modifies the response of the body's
immune system to help fight infections
and severe diseases.
IntronA is used in adult patients to treat certain disorders that
affect the blood, bone marrow, lymph
glands, or skin and may extend into the body. Included are hairy cell
leukaemia, chronic myelogenous
leukaemia, multiple myeloma, follicular lymphoma, carcinoid tumour,
and malignant melanoma.
IntronA is also used in adult patients for the treatment of chronic
hepatitis B or C, which are viral
infections of the liver.
IntronA is used in combination with ribavirin in children 3 years of
age and older and adolescents who
have previously untreated chronic hepatitis C.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE INTRONA
DO NOT USE INTRONA
-
if you are allergic to interferon or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have severe heart disease.
-
if you have poor kidney or liver function.
-
if you have advanced decompensated (uncontrolled) liver disease.
-
if you have hepatitis and have been treated recently

Summary of Product characteristics

OBJECT 1
INTRONA 25 MILLION IU/2.5ML SOLUTION FOR
INJECTION OR INFUSION
Summary of Product Characteristics Updated 27-Sep-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
IntronA® 10 million IU/mL solution for injection or infusion
IntronA® 25 million IU/2.5mL solution for injection or infusion
2. Qualitative and quantitative composition
IntronA 10 million IU/mL solution for injection or infusion
One vial of solution for injection or infusion contains 10 million IU
of recombinant interferon alfa-2b
produced in _E. coli_ by recombinant DNA technology, in 1 mL of
solution.
For the full list of excipients, see section 6.1.
IntronA 25 million IU/2.5mL solution for injection or infusion
One vial of solution for injection or infusion contains 25 million IU
of recombinant interferon alfa-2b
produced in _E. coli_ by recombinant DNA technology, in 2.5 ml of
solution.
One mL of solution contains 10 million IU of interferon alfa-2b.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection or infusion.
Clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Chronic hepatitis B
Treatment of adult patients with chronic hepatitis B associated with
evidence of hepatitis B viral
replication (presence of DNA of hepatitis B virus (HBV-DNA) and
hepatitis B antigen (HBeAg), elevated
alanine aminotransferase (ALT) and histologically proven active liver
inflammation and/or fibrosis.
Chronic hepatitis C
Before initiating treatment with IntronA, consideration should be
given to the results from clinical trials
comparing IntronA with pegylated interferon (see section 5.1).
_Adult patients _
IntronA is indicated for the treatment of adult patients with chronic
hepatitis C who have elevated
transaminases without liver decompensation and who are positive for
hepatitis C virus RNA (HCV-RNA)
(see section 4.4).
The best way to use IntronA in this indication is in combination with
ribavirin.
_Children 3 years of age and older and adolescents_
IntronA is indica