RIGVIR solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

---

Available from:

AS Kevelt

ATC code:

առկա չէ (L03AX)

INN (International Name):

---

Dosage:

>10^6 TCID50/ml

Pharmaceutical form:

solution for injection

Units in package:

(1) glass vial 2ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-12-09

Patient Information leaflet

1 (3)
PACKAGE INSERT: INFORMATION FOR USERS
RIGVIR
solution for injections
_ _
_RIGVIR ECHO –7 virus strain _
BEFORE TAKING THE DRUG, PLEASE READ CAREFULLY THE ENTIRE INSERT AS IT
CONTAINS IMPORTANT
INFORMATION FOR YOU
•
Keep this insert! You may need to reread it later.
•
If you have any questions, please ask your doctor or pharmacist.
•
This drug has been prescribed for you only. Do not give it to others.
It may harm them,
even if they have similar signs of a disease.
•
If you experience any side effects, talk to your doctor or pharmacist.
It also refers to any
possible side effects not listed in this insert. See item 4.
THIS INSERT CONTAINS THE FOLLOWING INFORMATION:
1. What Rigvir is and what it is used for
2. What you need to know prior to taking Rigvir
3. How to take Rigvir
4. Possible side effects
5. How to store Rigvir
6. Content of the package and other information
1.
WHAT RIGVIR IS AND WHAT IT IS USED FOR:
Rigvir belongs to the groups of drugs called immunomodulators
.
Rigvir is a viral immunomodulator with antitumoral effect. Rigvir is
taken:
•
for melanoma treatment, local treatment of cutaneous and subcutaneous
metastases of
melanoma, prevention of relapses and metastases after surgery.
2.
WHAT YOU NEED TO KNOW PRIOR TO TAKING RIGVIR
DO NOT TAKE RIGVIR IN THE FOLLOWING CASES:
•
during radiation therapy and chemotherapy.
•
in case of an acute infection.
Long-term physical load should be restricted after Rigvir injection in
order to avoid inhibition of
body reaction to Rigvir immune stimulating effect.
OTHER DRUGS AND RIGVIR
Tell your doctor about all the drugs you are taking or have recently
taken, including drugs bought
over the counter.
Rigvir is not recommended for use along with other drugs in order to
avoid inhibition of body
reaction to Rigvir immune stimulating effect.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, if you think you may be
pregnant or planning to become
pregnant, please consult your doctor before taking this drug.
There are no data about Rigv

Summary of Product characteristics

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
1.
NAME OF THE MEDICINAL PRODUCT
RIGVIR solution for injection
_RIGVIR ECHO –7 virus strain _
2.
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.
3.
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.
4.
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 administered in
the contralateral site of
lymphadenectomia (for example, if right a