Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
None.

6.2 Incompatibilities
Bleomycin must not be mixed with solutions of essential amino acids, riboflavin, ascorbic acid, dexamethasone, aminophylline, benzylpenicillin, carbenicillin, cefalotin, cefazoline, diazepam, glutathione, hydrogen peroxide, hydrocortisone sodium succinate, methotrexate, mitomycin, nafcillin, penicillin G, or substances containing sulfhydryl groups, terbutaline, thiols.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 (Special precautions for disposal and other handling).

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
For one-time use only.
Discard any unused solution!

6.4 Special precautions for storage
Store at 2 -8°C. Keep in original package.
Shelf life after reconstitution: 24 hours at 25ºC. Compatible with: Physiological saline.

6.5 Nature and contents of container
Packs with 1 or 10 vials (Type 1 colorless glass with rubber stopper and light green aluminum cap) each containing bleomycin sulphate equivalent to 15 units (USP) 
6.6 Special precautions for disposal and other handling
Safe handling:
The general guidelines for the safe handling of cytotoxic drugs should be followed. Appropriate precautions should be taken to avoid contact with skin, mucous membranes and eyes. In case of contamination, the affected body parts should be rinsed thoroughly with water.
Protective clothing must be worn when handling urine produced up to 72 hours after administration of bleomycin
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Instructions for preparation of the solution for injection/infusion:
Note: To prepare a solution, dissolve the entire contents of one vial (15 units) in the appropriate amount of solvent. Then take the number of units required for treatment from this batch.
Example: Required dose 8.5 units (5 units/m2 BSA = 5 units x 1.7); dissolve the contents of one vial (15 units) in 5 mL solvent; withdraw 2.83 mL (8.5 units) for use.

Intramuscular injection
Dissolve the contents of one vial in 1–5 mL physiological saline.
In case of excessive local reactions, a local anesthetic, e.g., 1.5–2 mL lidocaine HCl 1% may be added to the solution for injection.

Intravenous injection
Dissolve the contents of one vial in 5–10 mL physiological saline.

Intravenous infusion
Dissolve the contents of one vial in 200–1 000 mL physiological saline.

Intraarterial injection
Dissolve the contents of one vial of bleomycin in at least 5 mL physiological saline.

Intraarterial infusion
Dissolve bleomycin in 200–1 000 mL physiological saline. Heparin may be added to prevent thrombosis at the injection site, especially if the infusion is administered over a long period of time.

Subcutaneous injection
Absorption after subcutaneous injection is delayed and may be similar to that associated with slow IV infusion. This method of administration is rarely used. Intradermal injection must be carefully avoided.

Intrapleural instillation
After thoracentesis, bleomycin dissolved in a physiological saline solution is instilled via the puncture cannula or drainage catheter. The cannula or catheter is then removed. To ensure the uniform distribution of bleomycin in the serous cavity, the position of the patient should be changed every 5 minutes for a period of 20 minutes.

Intratumoral injection
Bleomycin is dissolved in physiological saline to a concentration of 1–3 units/mL.