Staphylococcal Bacteriophage Annotation

STAPHYLOCOCCAL BACTERIOPHAGE

The current preparation is a chromatographically purified phage lysate active against S.aureus bacterial strains.

A necessary condition for use of Staphylococcal bacteriophage is preliminary determinations of phage- susceptibility of bacteria- the causative agent of infections disease. The preparation is used only in case of sensitivity bacteria to the phage 

Therapeutic preparation is directed to use for the treatment of infections caused by staphylococcal such as:

Upper airways, nose, throat, lung, ear (pharyngitis, tonsillitis, tracheitis, bronchitis, Plevritis, pneumonia, inflammation of the middle ear) infectious diseases: 

• Surgical infections ( infectious wound, infected burn, abscess, phlegmon, furuncle, carbuncle, paraproctitis, mastitis, bursitis, osteomyelitis, panaricium);
• Urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis);
• Enteric infections ( gastroenteric colitis, cholecystitis);
• Purulent -  septic infections in the newborn ( omphalitis, pyoderma, conjunctivitis, gastroenteric colitis and others) 
• Other Staphylococcal infections.

The staphylococcal bacteriophage is also used for prophylaxis, for treatment of post-operational and infected wounds, as well as in case of hospital staphylococcal infections, confirmed as an epidemiological indicator.

The preparation might be used by different routes, including orally, for treatment of wounds by drainage and application; rectally; by introduction directly in ear, throat, nose, urinary tract cavities.

Mode of application and doses of Staphylococcal phage preparation during different infectious diseases. 

Staphylococcal bacteriophage preparation is used locally only after appropriate treatment of the source of infection. The duration of phage treatment is 10-20 days. In case of relapse of disease, the course of treatment might be repeated.

• Against purulent-septic infections of upper airways, nose, throat, lung, hear ( pharyngitis, tonsillitis, tracheitis, bronchitis, Plevritis, pneumonia, inflammation of the middle ear), the phage is used 2-3 times a day, using 2-10 ml of preparation by rising, gargling, dropping and plugging (duration of plugging 1 hour).
• For the treatment of furunculosis and carunculous, liquid Staphylococcal Phage is introduced directly in the source of infection, subcutaneously, or infiltrate and around it. The preparation should be injected every day or every other day, based on the severity of the disease, by increasing doses: first injection - 0.5ml. following injections - 1 - 1.5 ml - 2 ml of phage preparation. Duration of treatment includes 3-5 injections. In the case of an infectious abscess, the phage is introduced by injection in the abscess cavity after the evacuation of pus; the volume of the used phage should be less than evacuated pus. In case of an open abscess, a tampon with phage might be used in the cavity.
• 100 ml of phage preparation is used in enteric, pleural, joint and other cavities. Capillary drainage should be left in the cavity for the repeated introduction of phage every other day, in total 3-4 times.
• In the case of lung abscess, the phage is used by trans-thoracal puncture and by catheter in the tracheobronchial system. In the case of emphysema, the preparation could be used for puncture and drainage. One dose includes 10-20ml of phage during phage application by catheter of tracheobronchial system, in case of emphysema the singe dose is from 10ml to 50ml.
• During intestinal problems in newborns, on the initial phase, the first two applications - staphylococcal phage should be diluted twice with cooled boiled water, if there is no side reaction, treatment should be continued by non-diluted phage. In case of sepsis and enterocolitis in newborns, the phage should be applied in the rectum (by catheter) 2-3 times in 24 hours. Bacteriophage can be used orally and by enema.
• Bacteriophage can be applied by application in infected wounds and pyoderma in newborn twice a day (sterile bandage should be soaked in phage and applied on infected/damaged area of skin).

Recommended doses of Staphylococcal bacteriophage are as follows.

Contra-Indications

There are no contraindications ever observed for Staphylococcal phage.

The use of Staphylococcal phage does not exclude concomitant use of other antibacterial remedies.

Overdose: No Data

Influence of pregnancy and lactation: No Data

Packaging and Storage Conditions

Storage temperature +2 - +8 C

Distributed without prescription

Special Precautions

Before use vials must be shaken. The liquid must be clear without sediment.

In the case, the vial is damaged, or if the liquid is cloudy, the preparation should be withdrawn immediately.

The Phage should be taken out from vials aseptically, by a sterile syringe. Opened vials should be stored in the refrigerator at _2 - +8C

Developed by: G. Eliava Institute of bacteriophage, Microbiology and virology.