Download MINISTRY OF PUBLIC HEALTH OF THE REPUBLIC OF BELARUS

MINISTRY OF PUBLIC HEALTH OF THE REPUBLIC OF BELARUS
Stamp:
Agreed by
the Ministry of Public Health of the Republic of Belarus
Order of the Ministry of Public Health of the Republic of Belarus
from 20.12.2010 No 1344
committee No 11 from 30.11.2010
INSTRUCTION
(core data sheet for specialists)
for medical application of
RUFERON-Rn
Reg. No.:
Description of the drug
Trade name: Ruferon-Rn
International nonproprietary name: Interferon alfa-2b
General description
Ruferon-Rn is a recombinant interferon drug, which is completely identical to natural
interferon of a human. High activity of the drug allows producing an evident antiviral,
antiproliferative, and immunomodulatory effect. The dosage form of suppositories provides a
simple mode of interferon administration. Ruferon-Rn suppositories are used for the treatment
for a wide range of infectious-inflammatory diseases, caused by antiviral and immune
protection insufficiency.
Ruferon-Rn suppositories are torpedo-shaped homogeneous suppositories of yellowish-white
colour. Irregularity of colour like marble-white is admissible. The presence of a funnelshaped hollow is admissible. The presence of an air rod is admissible.
Ingredients
1 Ruferon-Rn suppository 500000 ME contains human recombinant interferon alfa-2b of
500000 ME activity, ascorbic acid, polysorbate-80, hard fat.
1 Ruferon-Rn suppository 1000000 ME contains human recombinant interferon alfa-2b of
1000000 ME activity, ascorbic acid, polysorbate-80, hard fat.
Dosage form
Suppositories
ATC class: L03A B05
Pharmacotherapeutic class
Immunomodulators.
Interferons.
Pharmacological properties
Pharmacodynamics
Interferon alfa-2b is a high-purified protein, received by means of a recombinant DNA
technology. Biological activity is provided by binding with specific membranous receptors of
cells. As a result differentiation is accelerated, the activity of natural killers and T-lymphocyte
increases. Interferons stimulate phagocytosis, regulate relations between components of
cellular and humoral immunity, production of inflammation mediators, thus bringing the
course of inflammation to normal.
An antiviral effect of interferon alfa-2b is due to a direct inhibitory influence on the main
stages of a viral replication, an increase of effectiveness of infected cells immune destruction.
Pharmacokinetics
The research of pharmacokinetics of recombinant alfa-2 IFN has shown that their rectal
introduction contributes to a longer drug circulation in blood serum, than its intravenous or
intramuscular introduction. The maximum concentration is observed in 2 hours and if the
dose is 1000000 ME IFN amounts to 45 ME IFN/ml, the decrease of concentration is
observed in 12 hours, which requires repeated introduction of the drug.
Indications and usage
Ruferon-Rn is used as a part of a complex therapy for adults while urogenital infection
treatment: clamidiosis, genital herpes, cytomegalovirus infection, ureaplasmosis,
trichomoniasis, papilloma viral infection, bacterial vaginosis, recurrent vaginal candidosis,
mycoplasma.
Dosage and administration
Ruferon-Rn suppositories are administered rectally.
While a complex treatment for chronic infectious-inflammatory diseases of urogenital tract
adults should administer 500000 ME-1000000 ME of Ruferon-Rn once a day for 10 days.
Both people who have sexual relations should be treated.
Adverse reactions
In rare cases allergic reactions like skin rash and itching are possible. They are reversible and
disappear in 72 hours after the drug withdrawal.
Contraindications
Hypersensitivity to interferon alfa-2b or other components of the drug.
Autoimmune hepatitis.
Decompensated disease.
Serious kidneys disorders or creatinine clearance is lower than 50 ml/min.
Overdosage
Overdosage hasn’t been described.
Precautions
Simultaneous use with the drugs inhibiting central nervous system (CNS) should be avoided.
While prescribing Ruferon-Rn to pregnant women, it’s necessary to estimate possible risks
and good in each particular case.
The drug should be prescribed with some precaution to patients with an acute condition of
allergic and autoimmune diseases.
Drug interactions
Ruferon-Rn rectal suppositories are compatible with the majority of drugs, used in the
treatment for the diseases, enumerated in the indications (antibiotics, glucocorticosteroids,
immunosuppressors and so on).
Interferon alfa-2b is able to decrease P-450 cytochrome activity, due to which it can influence
cimetidine, phenytoin, curantyl, theophyllin, diazepam, propranolol, warfarin, and some
cytostatic agents metabolism. As a result a neurotoxic, myelotoxic or cardiotoxic action of the
abovementioned drugs can be increased.
It should be used with special precaution simultaneously with narcotic, hypnotic, and sedative
drugs.
Interferons can influence oxidizing metabolic processes. It should be taken into consideration
while simultaneous use with the drugs which are metabolized by means of oxidization
(including xanthine derivatives – aminophylline and theophyllin). While simultaneous use
with theophyllin it’s necessary to control theophyllin concentration in blood serum and to
change dosage if such a necessity occurs.
Storage conditions
Suppositories should be stored at the temperature of 2°-8°C in a dark dry place. Keep away
from children!
Shelf life is 1 year. Don’t use after the expiration date.
Conditions of sales by pharmacies
Prescription drugs.
Package Description
One blister contains 5 suppositories (interferon alfa-2b 500000 ME or interferon alfa-2b
1000000 ME). Each pack contains two blisters with an instruction for use.
Information about the manufacturer:
ООО (LLC) «Rubikon» Belarus, 210002, Vitebsk, M. Gor’kogo str, 62 B,
tel/fax: +375(212) 34-06-29
Stamp:
Agreed by
the Ministry of Public Health of the Republic of Belarus
Order of the Ministry of Public Health of the Republic of Belarus
The translation of this document from Russian into English is made by Alina Sasnouskaya,
translator.
Настоящий документ переведен с русского языка на английский язык мною,
переводчиком САСНОВСКОЙ АЛИНОЙ ВИКТОРОВНОЙ, достоверность перевода
подтверждаю.