Fersisi Bacteriophage Annotation
Name of the pharmaceutical product (Patentable): Fersisi Bacteriophage
Composition:
Fersisi bacteriophage is a sterile filtrate of phage lysates to
- Staphylococcus (S. aureus, S. epidermidis) titter no less than 10ml.
- Streptococcus (S. pyogenes, S. sanguis, S. salivarius, S. agalactiae ) titter no less than 10ml.
Inactive ingredients Bacteriological growth medium, standard sodium saline. Chinazolin as a conservator.
Description:
Preparation is a transparent liquid, with yellow, to light brown color.
Pharmacological specifications:
Pharmaco-therapeutical group:
Specific antibacterial solution
Pharmacological actions:
Fersisi Bacteriophage leads to specific lysis of bacteria belonging to Staphylococci and Streptococci.
Prescription:
To be used with curative and prophylaxis aim in pyo-inflammatory and enteric infections caused by the above-mentioned microorganisms.
Indications:
Otolaryngological diseases: inflammation of the middle ear, tonsillitis, laryngitis, rhinitis, tracheitis, bronchitis, pneumonia, pleurisy.
Skin infections: furunculosis, carbunculosis, abscess, deep infiltration and abscessing sycosis.
Surgical diseases: Abscess, wound infections, mastitis, osteomyelitis, phlegmon.
Inflammation of oral cavity: stomatitis, gingivitis, etc.
Eye diseases: bacterial conjunctivitis: Secondary infections with thermal burns.
Urogenital and gynecologic infections: urethritis, cystitis, pyelonephritis, endometritis.
Enteric infections: gastroenterocolitis, cholecystitis, staphylococcal toxic infection, dysbacteriosis.
Pyo- inflammatory disease in children (including newborns) prevention of postoperative periods and hospital infection.
Usage and dosage:
The highest effect is achieved when preparation is used at the onset of the disease and introduced directly to the infection's focus.
FERSISI bacteriophage may be used per os and /or rectum.
- Fersisi bacteriophage is used as a disinfecting agent for locally damaged areas by phage soaked bandage, as well as in liquid form in cavities (wound cavity, abdominal cavity, pleura, abscess cavity, nasal cavity, urinary bladder, uterus, vagina). The preparation can be used orally, and/or by catheter, or enema.
- Phage for local use is applied three times daily, for 3-5 days. The quantity of phage is determined by the size of the damaged area.
- For the treatment of abscesses, pleuritis and arthritis, as well as peritonitis, 50-200ml of bacteriophage is introduces into the cavity every other day.
- In the case of cystitis and pyelonephritis, the phage is administered by catheter and/or orally.
- For the treatment of deep pyoderma, the phage is used intradermally (0.1-0.5ml in 10 injections).
- For conjunctivitis, the bacteriophage is introduced by pipet, 2-3 drops per eye4-6 times a day.
- In the case of neonatal omphalitis and pyoderma, the bacteriophage is applied by a soaked bandage twice daily for 5-7 days.
- For intestinal diseases and dysbacteriosis phage is administered per os/or per rectum. Per rectum Fersis- Bacteriophage is introduced by enema, after stool.
Recommended doses and FERSISI bacteriophage are as follows:
| Age | Per os/Per day | Per rectum/Per day |
| Infants 0-6 months | 5ml 1 times, 30 min before feeding | 10 ml once a day |
| Kids 6-12 months | 5ml 2 times, 30 min before feeding | 10 ml once a day |
| kids 1-3 years | 5ml 3 times, 1 hour before the meal | 20 ml once a day |
| Children 3-8 years | 10ml 2-3 times. 1 hour before the meal | 30 ml once a day |
|
Children older than 8 years, adults |
20ml 2-3 times, 1 hour prior to the meal |
40 ml once a day |
Treatment should continue for 6-10 days.
Before taking FERSISI bacteriophage, it is recommended to take a glass of basic mineral water (or 2-3% solution of baking soda).
Contra-Indications
There are no contraindications ever observed for FERSISI bacteriophage, The use of FERSISI bacteriophage does not exclude concomitant use of antibiotics, or any other medicine.
Side Effects: No side effects have been revealed during the usage of Fersisi bacteriophage.
Special Precautions
Before use, the ampule must be shaken, The liquid must be clear, without sediment.
If the ampoule is damaged, or if the liquid is cloudy, the preparation should not be used.
The preparation should be used immediately after the ampule or flask has been opened. Once opened it should not be saved for later use.
Packaging and Storage Conditions
The preparation is presented in 5 ml ampoules, Storage temperature +2 - +8 C Expiration - 1 Year
Distributed without prescription
Developed by: G. Eliava Institute of bacteriophage, Microbiology and virology.