Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1.    List of excipients
D-Sorbitol,
lactic acid,
sodium hydroxide (to adjust to pH 3.5),
hydrochloride acid (to adjust to pH 3.5) ,
water for injections.

6.2.    Incompatibilities

None known.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3.    Shelf life

The expiry date of the product is indicated on the packaging materials.
CAMPTO® solution is physically and chemically stable with infusion solutions (0.9% (w/v) sodium chloride solution and 5% (w/v) glucose solution) for up to 28 days when stored in LDPE or PVC 

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containers at 5°C or at 30°C and protected from light. When exposed to light, physico-chemical stability has been demonstrated for up to 3 days.

It is recommended, however, that in order to reduce microbiological hazard, the infusion solutions should be prepared immediately prior to use and infusion commenced as soon as practicable after preparation. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4.    Special precautions for storage

For storage conditions after dilution of the medicinal product, see section 6.3.
- Store below 30°C.
- Store in the original package in order to protect from light.
6.5.    Nature and contents of container

Single amber-coloured medical-grade polypropylene vial closed with halobutyl rubber stopper. Vials contain 40 mg/ 2mL; 100 mg/5 mL or 300 mg/15 mL of solution.

Not all pack sizes may be marketed.

6.6.    Special precautions for disposal and other handling
As with other antineoplastic agents, CAMPTO® must be prepared and handled with caution. The use of glasses, mask and gloves is required.

If CAMPTO® solution or infusion solution should come into contact with the skin, wash immediately and thoroughly with soap and water. If CAMPTO® solution or infusion solution should come into contact with the mucous membranes, wash immediately with water.

Preparation for the intravenous infusion administration:

As with any other injectable medicinal product, the CAMPTO® solution must be prepared aseptically (see section 6.3).
If any precipitate is observed in the vials or after dilution, the product should be discarded according to standard procedures for cytotoxic agents.
Aseptically withdraw the required amount of CAMPTO® solution from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle containing either 0.9% sodium chloride solution or 5% glucose solution. The infusion should then be thoroughly mixed by manual rotation.
Disposal:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
All materials used for dilution and administration should be disposed of according to hospital standard procedures applicable to cytotoxic agents.