Application Schemes INGARON (injectable)

All indications

 

INGARON®, vials 500,000 IU No.5

Indication

Daily dose

Frequency of administration

Course of therapy

Remarks

  Chronic viral hepatitis B1

500 000 IU

(1 injection)

On the date of administration of interferon alpha

Duration of course - 6 months

In combined therapy

Chronic viral hepatitis C1

500 000 IU

(1 injection)

On the date of administration of interferon alpha

with 1 genotype of chronic hepatitis C duration of course is 3 months.

with non-1genotype of chronic hepatitis C duration of course is 6 months.

In combined therapy

HIV infection2

500 000 IU

(1 injection)

Daily or

every second day

Determined on an individual basis, duration of course is 3 months max.

In combined therapy at the early stage of the disease

Pulmonary tuberculosis3

500 000 IU

(1 injection)

Daily or

every second day

Determined on an individual basis, duration of course is 3 months max.

In combined therapy

Prevention of infectious complications in case of chronic granulomatous disease

500 000 IU

(1 injection)

Daily or

every second day

2 500 000 –

7 500 000 IU

(5‐15 injections)

 

 

Oncological diseases 4, 5

500 000 IU

(1 injection)

Every second day

Determined on an individual basis, depends on chemotherapy regimen

As part of combined therapy as an immunomodulator

Genital herpes virus infection 6

500 000 IU

(1 injection)

Every second day

2 500 000 IU

(5 injections)

Monotherapy

Herpes zoster7

500 000 IU

(1 injection)

Every second day

2 500 000 IU

(5 injections)

Monotherapy

Urogenital clamidiosis8

500 000 IU

(1 injection)

Every second day

2 500 000 IU

(5 injections)

In combined therapy

INGARON®, vials 100,000 IU No.5

Indication

Daily dose

Frequency of administration

Course dose

Remarks

Chronic prostatitis9

100 000 IU

(1 injection)

Every second day

1 000 000 IU

(10 injections)

In combined therapy

Papilloma virus infection10

100 000 IU

(1 injection)

Every second day

500 000 IU

(5 injections)

After cryolysis



INGARON®, vials 100,000 IU No.1, nasal drops - prevention and treatment (as part of combined therapy) of influenza. Prevention and treatment (as part of combined therapy) of H5N1 and H1N1influenza

Pharmacotherapeutic group: antiviral and immunomodulating agent

 

 

 

Notes:

1 Order of the Ministry of Health Care and Social Development of the Russian Federation No.571 dated 21.07.2006 "On approval of standard for medical care for patients with viral hepatitis".

2 Order of the Ministry of Health Care and Social Development of the Russian Federation No.612 dated 17.08.2006 "On approval of standard for medical care for patients with disease induced by human immunodeficiency virus (HIV)".

3 Order of the Ministry of Health Care and Social Development of the Russian Federation No.572 dated 21.07.2006 "On approval of standard for medical care for patients with tuberculosis".

4 Order of the Ministry of Health Care and Social Development of the Russian Federation No.699 dated 09.10.2006 "On approval of standard for medical care for patients with malignant cervical neoplasms (when delivering specialized health care)".

5 Order of the Ministry of Health Care and Social Development of the Russian Federation No.700 dated 09.10.2006 "On approval of standard for medical care for patients with malignant neoplasms of the mammary gland (when delivering specialized health care)"

6 6M.V.Mezentseva, M.R.Rahmatulina, A.A.Gindis, N.V.Kashina Interferon gamma in treatment of genital herpes. Bulletin of dermatology and venerology. 2007, No.14, pages 3-7.

7 V.V. Maleyev, V.A.Shmelyov, A.A.Gindis, M.R.Rakhmatulina Modern approach to therapy of herpes zoster. Infectious Diseases, 2007, vol. 5, No.3, pages 9-12.

8 M.R.Rakhmatulina Clamidiosis and sterility. Woman's Health, 2008, No.3, pages 19-20.

9 D.Y.Pushkar, G.R.Kasian New in treatment of chronic prostatitis: interferon gamma. Pharmateca, 2012, No.4, pages 1-3.

10 M.R.Rakhmatulina New possibilities of combined therapy of anogenital papilloma virus infection. Bulletin of dermatology and venerology, 2011, No.2, pages 79-84.

HIV/AIDS Infection Combined with Tuberculosis
Regimen with interferon alpha-2b and interferon gamma.

As part of combined therapy, course of interferon alpha-2b (ALPHARONA®) in dosage of 3 mln IU and interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously daily. Considering high tolerability of the drugs, course of treatment may be extended up to 3 months (efficiency has been proven in the course of clinical studies performed at the premises of the 5th department of the Saint Petersburg Municipal Tuberculosis Hospital No.2 under the supervision of professor T.V. Sologub, M.D.).

Recommendations. For patients with CD4+ level lower than 350 cells/μl, immunocorrecting therapy with interferons is not recommended. Control of therapy efficiency will be performed considering clinical, bacteriological and X-ray examination.
Chronic Viral Hepatitis B
Combined regimen with interferon alpha-2b + interferon gamma.

Interferon alpha-2b (ALPHARONA®) in dosage of 5 mln IU and interferon gamma (INGARON®) in dosage of 500 thous IU intramuscularly or subcutaneously daily for 6 months (Efficiency has been proven in the course of clinical studies performed in specialized clinic of the State Institution, Scientific and Research Institute of Influenza of the Russian Academy of Medical Sciences, St.Petersburg, under the supervision of E.V. Esaulenko, M.D, and in the infectious diseases department with course of tropical medicine of the State Educational Institution for Higher Vocational Education "Saint Petersburg State Medical Academy named after I.I. Mechnikov of the Ministry of Health" under the supervision of professor T.V. Sologub, M.D).

Recommendations. Monthly measured ALT, AST, bilirubin, hemogram control. Additionally, at least once each 3 months, quantitative PCR for HBV DNA and test for thyroid hormones; advisable, once each 3 months perform test for autoimmune markers (cryoglobulin, АНА, АМА, AGA). Criteria used for evaluation of treatment efficiency are the following: normalization of serum ALT and AST, absence of HBV DNA in blood serum, disappearance of HBeAg (in case of HBeAg- positive hepatitis). In case of pronounced adverse events associated with use of interferons (flu-like syndrome, apparent emotional lability, depression, sharp weight loss), drug dosing regimen may be adjusted under control of the above laboratory indicators: interferon alpha-2b (ALPHARONA®) in dosage of 5 mln IU and interferon gamma (INGARON®) in dosage of 500 thous IU intramuscularly or subcutaneously every second day at least for 6 months (efficiency has been proven in the course of clinical studies performed in specialized clinic of infectious diseases department with course of tropical medicine of the State Educational Institution for Higher Vocational Education "Saint Petersburg State Medical Academy" named after I.I. Mechnikov of the Ministry of Health" under the supervision of professor T.V. Sologub, M.D.).
Chronic Prostatitis
Regimen with Ingaron® in dosage of 100 thous. IU.

As part of combined therapy with interferon gamma (INGARON®) in dosage of 100 thous IU intramuscularly or subcutaneously every second day, in case of protracted treatment - 10 injections (efficiency has been proven in the course of clinical studies performed in the District Urological Department of the Moscow municipal outpatient clinic No.30 under the supervision of Head of the Department, Candidate of Medical Science L.A. Logvinov.).

Recommendations. Main criteria of efficiency of therapy performed is medical evaluation of the patient's condition, results of microscopic evaluation of prostatic fluid and evaluation of quality of life by the patient himself, additional criteria are ultrasound investigation of prostate, urofluometry indicators. In case of insufficient clinical efficiency of the therapy, dosing regimen may be adjusted under control of the above laboratory indicators: interferon gamma (INGARON®) in dosage of 500 thous IU intramuscularly or subcutaneously every second day, course - 10 injections (efficiency has been proven in the course of clinical studies performed in the urological department of the Federal State Institution "Russian Scientific Center of Radiation Therapy of Rosmedtechnologies" under direction of Deputy Director of the Center, professor A.D. Kaprin, M.D.).
Persistent Urinogenital Chlamydiosis
Regimen with interferon gamma.

As part of combined therapy, interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously once a day every second day from the first day of active treatment, the course is 5 injections in total (efficiency has been proven in the course of clinical studies performed in the sexually transmitted infections department of the Federal State Institution "State Scientific Center of Dermatovenerology and Cosmetology of Rosmedtechnologies" under the supervision of associate professor M.R. Rakhmatulina, M.D.).

Recommendations. Criteria of therapy efficiency are disappearance of symptoms and subjective sensations, eradication of the causative microorganism according to PCR and/or direct immunofluorescence.
Herpes Zoster
Regimen with interferon gamma.

In case of monotherapy, interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously once a day every second day, the course is 5 injections in total (efficiency has been proven in the course of clinical studies performed in the sexually transmitted infections department of the Federal State Institution "State Scientific Center of Dermatovenerology and Cosmetology of Rosmedtechnologies" under the supervision of associate professor M.R. Rakhmatulina, M.D.).

Recommendations. Criteria of therapy efficiency are disappearance of symptoms and subjective sensations, eradication of the causative microorganism according to direct immunofluorescence.
Anogenital (Venereal) Warts
Regimen with INGARON® in dosage of 100 thous. IU.

On the day after cryolysis session, interferon gamma (INGARON®) in dosage of 100 thous. IU intramuscularly or subcutaneously as a single dose, then 100 thous. IU every second day. Course of therapy is 5 injections (efficiency has been proven in the course of clinical studies performed in the sexually transmitted infections department of the Federal State Institution "State Scientific Center of Dermatovenerology and Cosmetology of Rosmedtechnologies" under the supervision of associate professor M.R. Rakhmatulina, M.D.).
Genital Herpes Virus Infection
Regimen with interferon gamma.

In case of monotherapy, interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously once a day every second day, the course is 5 injections in total (efficiency has been proven in the course of clinical studies performed in the sexually transmitted infections department of the Federal State Institution "State Scientific Center of Dermatovenerology and Cosmetology of Rosmedtechnologies" under the supervision of associate professor M.R. Rakhmatulina, M.D.).

Recommendations. Criteria of therapy efficiency are disappearance of symptoms and subjective sensations, absence of relapse, eradication of the causative microorganism according to PCR and/or direct immunofluorescence.
Malignant Tumors
Regimen for disseminated skin melanoma.
1st week: interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously daily for 5 days, in case of intradermal metastases, additionally intratumor injection of interferon gamma (INGARON®) in dosage of 250 thous. IU daily for 5 days.

2nd week: chemotherapy + conventional antiemetic therapy.
3rd, 4th and 5th weeks: interferon gamma (INGARON®) in dosage of 500 thous IU intramuscularly or subcutaneously every second day.

Interval between courses is 5 weeks. Start of the next course - daily systemic and intratumor administration of INGARON® (efficiency has been proven in the course of clinical studies performed in the combined treatment methods department of the State Institution "Russian Cancer Research Center named after N.N. Blokhin" of the Russian Academy of Medical Sciences under the supervision of Deputy Director of Research, associate member of the Russian Academy of Sciences, professor M.R. Lichinitser, M.D.).

Recommendations. In case of thrombocytopenia less than 80х103/μl, stop introdiction of interferon gamma (INGARON®) until the number of thrombocytes increases at least up to 100х103/μl.

Regimen for locally advanced and disseminated breast cancer.
1st week: interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously daily for 5 days, in case of intradermal metastases or primary tumor, additionally intratumor administration of interferon gamma (INGARON®) in dosage of 250 thous. IU daily for 5 days.
2nd week: chemotherapy + conventional antiemetic therapy.
3rd - 4th weeks: interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously every second day.

Interval between courses is 3 weeks. Start of the next course - daily systemic and intratumor administration of INGARON® (efficiency has been proven in the course of clinical studies performed in the combined treatment methods department of the State Institution "Russian Cancer Research Center named after N.N. Blokhin" of the Russian Academy of Medical Sciences under the supervision of Deputy Director of Research, associate member of the Russian Academy of Sciences, professor M.R. Lichinitser, M.D.).

Recommendations. In case of locally advanced process, after two or three courses, advice of surgeon is required in order to determine the possibility of surgical treatment. In postoperative period - perform adjuvant chemotherapy and hormonal treatment.

Regimen for squamous cell carcinoma of the cervix.
1st week: interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously every second day (3 injections), additionall intratumor administration of interferon gamma (INGARON®) in dosage of 250 thous. IU daily for 5 days.
2nd week: chemotherapy + conventional antiemetic therapy.

Perform 3 courses, interval between courses is 3 weeks. 3 weeks after the first course of chemoimmunotherapy, surgery shall be performed (efficiency has been proven in the course of clinical studies performed in the combined treatment methods department of the State Institution "Russian Cancer Research Center named after N.N. Blokhin" of the Russian Academy of Medical Sciences under the supervision of Deputy Director of Research, associate member of the Russian Academy of Sciences, professor M.R. Lichinitser, M.D.).

Recommendations. Continuation of treatment will be planned depending on curative effect based on the results of postoperative histological examination. In case surgical treatment is impossible after three courses of chemoimmunotherapy, continue chemoimmunotherapy accoeding to the same regimen up to 6 weeks. In case the tumor is recognized as resectable, surgical treatment will be performed. In case surgical treatment is impossible after 6 courses due to insufficient effect, chemoradiation will be performed.

Regimen for the first line treatment of locally advanced and metastatic kidney cancer.

After surgical resection of the main process, interferon gamma (INGARON®) in dosage of 500 thous. IU intramuscularly or subcutaneously every second day (10 injections), then 10-12 days interval, then course will be repeated according to the same regimen. 3 courses of immunotherapy in total (Efficiency has been proven in the course of clinical studies performed in the oncological and urological center of the Moscow Oncological Clinical Dispensary No.1 under the supervision of Deputy Head Physician for tumor chemotherapy, professor V.I. Borisov, M.D.).

Recommendations. Control of tolerability and hematologic toxicity of the drug.
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