RIGVIR solution for injection

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

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Disponibil de la:

AS Kevelt

Codul ATC:

L03AX

INN (nume internaţional):

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Dozare:

>10^6 TCID50/ml

Forma farmaceutică:

solution for injection

Unități în pachet:

(1) glass vial 2ml

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2018-01-25

Caracteristicilor produsului

S U MMA R Y O F P R O D U C T CH A RA CT E R I S T I CS
_ _

NAME OF THE MEDICINAL PRODUCT
_ _
RIGVIR solution for injection
_RIGVIR ECHO –7 virus strain _
_ _

QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 2 ml solution for injection contains virus Rigvir titre
≥10
6
TCID
50
/ml
(10
6
– 10
8
TCID
50
/ml).
_ _
ACTIVE SUBSTANCE – Rigvir (ECHO-7 virus strain)
Picornaviridae family, Enterovirus genus, ECHO group, type 7
_ _
LIST OF EXCIPIENTS - Sodium chloride, water for injection.
MEM medium traces: contains minerals, amino acids, vitamins.
_ _

PHARMACEUTICAL FORM
Solution for injection.
One pack contains one vial 6R and contains the a single dose of 2 ml
virus Rigvir solution.
Appearance - frozen solution. Post-thawing the solution is clear,
colourless or with a slightly
pink hue.
_ _

CLINICAL CHARACTERISTICS
_ _
4.1. THERAPEUTIC INDICATIONS
Rigvir
belongs
to
a
group
of
medicines
known
as
immunomodulators;
Rigvir
as
immunomodulator with viral nature with anti-tumour effect is used in
the treatment of
melanoma, local treatment of skin and subcutaneous metastases of
melanoma, for prevention
of relapse and metastasis after radical surgery.
_ _
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
FOR PREVENTION OF RELAPSE AND METASTASIS OF MELANOMA AFTER RADICAL
SURGERY
Post excision of a tumour (when the wound has healed).
_ _
Rigvir course I: for three consecutive days 2 ml are administered
intramuscularly (i.m.) with
respect to regional localization of the tumour to activate the
regional lymph nodes.
_ _
Rigvir course II and III: for three consecutive days 2 ml are
administered every 3-4 weeks.
_ _
Subsequent Rigvir courses: on the first year 2 ml once a month; on the
first half of the second
year every 6 weeks, beginning with the second half of the second year
– every two months.
Comply with the immunostimulation sequence of the regional lymph
nodes.
_ _
_ _
_ _
_ _
_ _
IF THE LYMPH NODES ARE EXTIRPATED, USE 4 INTENSIVE COURSES
Rigvir course I: for three consecutive days 2 ml are administere