PastoCys

(Freeze-dried Intravesical BCG)

Freeze-dried Intravesical BCG is a compact powder made up of Pasteur strain 1173P2Mycobacterium bovisBCG that the number of culturable particles after reconstitution with sterile sodium chloride 0.9% is 5-30×108 CFU/vial.

Composition

Each vial consists of:

- Freeze-dried liveMycobacterium bovisBCG Pasteur strain 1173P2:120 mg

- Sodium L-glutamate monohydrate: 75 mg

- Lactose monohydrate: 300 mg

Dosage Form

Freeze-dried powder (creamy color suspension for injection after reconstitution with sterile sodium chloride 0.9%).

Pharmacological Information

- Freeze-dried Intravesical BCG acts as a non-specific immune-potentiator not by a single mechanism but by a variety of actions involving cells of the immune system.

- Freeze-dried Intravesical BCG has a stimulating effect on the macrophage function and activates natural killer (NK) cells and T-lymphocytes.

Dosage & Administration

- Treatment with BCG consists of six consecutive weeks and then a maintenance therapy every three to six months during a period of three years according to physician point of view.

-Normally BCG therapy should be begun immediately after distinction or about 10-14 days after transurethral resection (TUR).

- Primary dilution: Reconstitute each vial with 3 ml of sterile sodium chloride 0.9% by a syringe. To prevent the formation of foam, the suspension should not be shaken vigorously. After one minute the suspension should be mixed by withdrawing it into a syringe and expelling it back into the vial two or three times.

- Preparation of suspension: Solute the vial content with sterile sodium chloride 0.9% to a final volume of 50 ml.

- The suspension should be instilled into the bladder immediately as follows:

- Insert a catheter and drain the bladder completely.

- Connect the syringe containing the suspension to the catheter and instill the suspension.

- Remove the catheter.

- The instilled BCG suspension must remain in the bladder for a period of 2 hours. During this period, the suspension should have sufficient contact with the entire mucosal surface of the bladder.

- For a bed-ridden patient, the position from back to prone and vice versa should be changed every 15 minutes.

- After 2 hours, the patient should void the instilled suspension preferentially in a sitting position.

- Patients should not drink any fluid 4 hours prior to and 2 hours after instillation.

- In case of no medical contraindication, a hyper hydration is recommended to patient two hours after each injection for 48 hours following each instillation.

Notice

Freeze-dried Intravesical BCG should not be used for subcutaneous, intradermal, intramuscular or intravenous.

Indication

Treatment of superficial urothelial bladder carcinoma contains of:

1. Carcinoma in situ (CIS)

2. Ta

3. T1

- Low-grade (I, II): if multifocal and/or recurrent

- High-grade (III)

Warning

-Treatment with BCG should be done in a special hospital under aseptic condition to make the consecutive control possible.

-During and after the treatment period, regular exams including cytological urine exam and cystoscopy should be done and they could be completed by biopsy if it is needed.

-During and before the treatment period, control of the cells situation is recommended.

- In order to protect the partner, the patient is recommended either to refrain from intercourse

within one week after instillation, or to use condom.

- Concurrent administration with viral vaccines is not recommended.

- It is recommended that live vaccines be given 6-8 weeks after and killed vaccine be given 7 days before or 10 days after BCG therapy.

-This product is biologic and should be discarded with safety consideration.

Side Effects

- CNS: Headache, Dizziness.

- Dermatological: Rash.

- Gastrointestinal: Nausea, Vomiting, Anorexia, Weight loss, Abdominal pain, Diarrhea.

- Hepatic: Hepatic granuloma, Hepatitis.

- Hematological: Anemia, Leukopenia.

- Neuromuscular and skeletal: Arthritis, Myalgia.

- Renal: Dysuria, Urinary frequency with pain, Cystitis, Nocturia, Incontinence.

- Respiratory: Pulmonary infection.

- Miscellaneous: Malaise, Fever, Chills, BCG infection disseminated.

- Granulomatous prostatitis.

Contraindications

- Hematuria (Blood in urine)

-  Immune system deficiency

- Active tuberculosis

- Treatment with anti-tuberculosis drugs like Rifampin, Streptomycin, Isoniazid.

- Acute febrile infection; Systemic reaction to BCG; Urinary infection; Positive HIV.

- Radiotherapy.

Pregnancy & Lactation

This drug is not recommended during

pregnancy and lactation.

Precautions

- This drug should be administered under the guidance of a qualified physician.

- Any unused portion should be discarded.

- The parenteral administration of any biological product should be attended by appropriate precautions in case allergic or other untoward reaction occurs.

-Parental drug products should be inspected visually for exogenous particulate matter and discoloration prior administration. Do not use any vials exhibiting exogenous particulate matter or discoloration.

          •        Urine voided for 6 hours after instillation should be disinfected with an equal volume of 5% hypochlorite solution (undiluted household bleach) to stand for 15 minutes before being flushed.

Storage condition & shelf life

          •        Freeze-dried intravesical BCG should be stored at 2-8ºC

(in a refrigerator) and protected from direct sun light.

The expiration date at this condition is 16 months after production.

          •        Keep out of reach of children.

Packaging

Each box contains of 6 small boxes, and each vial contains 120 mg Mycobacterium bovis BCG.