INTRON A- interferon alfa-2b kit INTRON A- interferon alfa-2b injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

interferon alfa-2b (UNII: 43K1W2T1M6) (interferon alfa-2b - UNII:43K1W2T1M6)

Tilgjengelig fra:

Merck Sharp & Dohme LLC

INN (International Name):

interferon alfa-2b

Sammensetning:

interferon alfa-2b 38 ug in 1 mL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

INTRON® A is indicated for the treatment of patients 18 years of age or older with hairy cell leukemia. INTRON A is indicated as adjuvant to surgical treatment in patients 18 years of age or older with malignant melanoma who are free of disease but at high risk for systemic recurrence, within 56 days of surgery. INTRON A is indicated for the initial treatment of clinically aggressive (see Clinical Pharmacology ) follicular Non-Hodgkin's Lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older. Efficacy of INTRON A therapy in patients with low-grade, low-tumor burden follicular Non-Hodgkin's Lymphoma has not been demonstrated. INTRON A is indicated for intralesional treatment of selected patients 18 years of age or older with condylomata acuminata involving external surfaces of the genital and perianal areas (see DOSAGE AND ADMINISTRATION ). The use of this product in adolescents has not been studied. INTRON A is indicated for the treatment of select

Produkt oppsummering:

INTRON A Powder for Injection, 10 million IU per vial and Diluent for INTRON A (Sterile Water for Injection USP) 5 mL per vial; boxes containing 1 INTRON A vial and 1 vial of INTRON A Diluent (NDC 0085-4350-01). INTRON A Powder for Injection, 18 million IU per vial and Diluent for INTRON A (Sterile Water for Injection USP) 5 mL per vial; boxes containing 1 vial of INTRON A and 1 vial of INTRON A Diluent (NDC 0085-4351-01). INTRON A Powder for Injection, 50 million IU per vial and Diluent for INTRON A (Sterile Water for Injection USP) 5 mL per vial; boxes containing 1 INTRON A vial and 1 vial of INTRON A Diluent (NDC 0085-4352-01). INTRON A Solution for Injection, 18 million IU multidose vial (22.8 million IU per 3.8 mL per vial); boxes containing 1 vial of INTRON A Solution for Injection (NDC 0085-1168-01). INTRON A Solution for Injection, 25 million IU multidose vial (32 million IU per 3.2 mL per vial); boxes containing 1 vial of INTRON A Solution for Injection (NDC 0085-1133-01).

Autorisasjon status:

Biologic Licensing Application

Informasjon til brukeren

INTRON A- INTERFERON ALFA-2B INJECTION, SOLUTION
Merck Sharp & Dohme LLC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 03/2023
MEDICATION GUIDE
INTRON® A (In-tron-aye)
(Interferon alfa-2b, recombinant)
If you are taking INTRON A with REBETOL, also read the Medication
Guide for REBETOL®
(ribavirin) Capsules and Oral Solution.
INTRON A alone is a treatment for certain types of cancers and
hepatitis B virus. INTRON A by itself or
with REBETOL is a treatment for some people infected with hepatitis C
virus.
What is the most important information I should know about INTRON A?
INTRON A can cause serious side effects that may cause death or worsen
certain serious conditions that
you may already have.
Tell your healthcare provider right away if you have any of the
symptoms listed below while taking
INTRON A. If symptoms get worse, or become severe and continue, your
healthcare provider may tell
you to stop taking INTRON A permanently. In many, but not all people,
these symptoms go away after
they stop taking INTRON A.
Heart problems. Some people who take INTRON A may develop heart
problems, including:
•
low blood pressure
•
fast heart rate or abnormal heart
beats
•
trouble breathing or chest pain
•
heart attacks or heart muscle
problems (cardiomyopathy)
Stroke or symptoms of a stroke. Symptoms may include weakness, loss of
coordination, and numbness.
Stroke or symptoms of a stroke may happen in people who have some risk
factors or no known risk
factors for a stroke.
Mental health problems, including suicide. INTRON A may cause you to
develop mood or behavior
problems that may get worse during treatment with INTRON A or after
your last dose, including:
•
irritability (getting upset easily)
•
depression (feeling low, feeling
bad about yourself, or feeling
hopeless)
•
acting aggressive, being angry or
violent
•
thoughts of hurting yourself or
others, or suicide
•
former drug addicts may fall back
into drug addiction or overdose
If you have these sympt

Preparatomtale

INTRON A- INTERFERON ALFA-2B
INTRON A- INTERFERON ALFA-2B INJECTION, SOLUTION
MERCK SHARP & DOHME LLC
----------
INTRON A
INTERFERON ALFA-2B,
RECOMBINANT
FOR INJECTION
PRODUCT INFORMATION
WARNING
ALPHA INTERFERONS, INCLUDING INTRON A, CAUSE OR AGGRAVATE FATAL OR
LIFE-
THREATENING NEUROPSYCHIATRIC, AUTOIMMUNE, ISCHEMIC, AND INFECTIOUS
DISORDERS. PATIENTS SHOULD BE MONITORED CLOSELY WITH PERIODIC CLINICAL
AND
LABORATORY EVALUATIONS. PATIENTS WITH PERSISTENTLY SEVERE OR WORSENING
SIGNS OR SYMPTOMS OF THESE CONDITIONS SHOULD BE WITHDRAWN FROM
THERAPY. IN MANY BUT NOT ALL CASES THESE DISORDERS RESOLVE AFTER
STOPPING INTRON A THERAPY. SEE WARNINGS AND ADVERSE REACTIONS.
DESCRIPTION
INTRON A (Interferon alfa-2b) for intramuscular, subcutaneous,
intralesional, or
intravenous Injection is a purified sterile recombinant interferon
product.
INTRON A recombinant for Injection has been classified as an alpha
interferon and is a
water-soluble protein with a molecular weight of 19,271 daltons
produced by
recombinant DNA techniques. It is obtained from the bacterial
fermentation of a strain of
_Escherichia coli_ bearing a genetically engineered plasmid containing
an interferon alfa-2b
gene from human leukocytes. The fermentation is carried out in a
defined nutrient
medium containing the antibiotic tetracycline hydrochloride at a
concentration of 5 to 10
mg/L; the presence of this antibiotic is not detectable in the final
product. The specific
activity of interferon alfa-2b, recombinant is approximately 2.6 × 10
IU/mg protein as
measured by the HPLC assay.
POWDER FOR INJECTION
VIAL
STRENGTH
MILLION IU
ML
DILUENT
FINAL
CONCENTRATION
AFTER
RECONSTITUTION
MILLION IU/ML
MG INTRON
A PER VIAL
ROUTE OF
ADMINISTRATION
*
†
10
1
10
0.038
IM, SC, IV, IL
18
1
18
0.069
IM, SC, IV
50
1
50
0.192
IM, SC, IV
Prior to administration, the INTRON A Powder for Injection is to be
reconstituted with the
provided Diluent for INTRON A (Sterile Water for Injection USP) (see
DOSAGE AND
ADMINISTRATION). INTRON A Powder for Injection is a white to
cream-c