Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium chloride
Disodium edetate
Hydrochloric acid
Water for injection

6.2   Incompatibilities

It is recommended that infusions of naloxone hydrochloride should not be mixed with preparations containing bisulphite, metabisulphite, long-chain or high-molecular-weight anions, or solutions with an alkaline pH. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Shelf-life after first opening
After first opening the medicinal product should be used immediately.
Shelf-life after dilution
Chemical and physical in-use stability has been demonstrated for 30 hours at 25°C.
From a microbiological point of view, the dilutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8oC, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store below 25℃.
Keep the ampoules in the outer carton, in order to protect from light.
6.5   Nature and contents of container

Clear glass ampoules in moulded PVC trays, sealed with a PE foil and packed in a carton box.
Packs of 10 ampoules of 1ml solution are available.

6.6   Special precautions for disposal and other handling

For i.v. infusion naloxone hydrochloride is diluted with sodium chloride 0.9% or glucose 5%. 5 ampoules of naloxone hydrochloride (2 mg) per 500 ml give 4μg/ml.
This medicinal product is for single use only.

Please inspect the medicinal product visually prior to use (also after dilution). Use only clear and colourless solutions practically free from particles.

7.    MARKETING AUTHORISATION HOLDER

A.L.Medi-Market, 3 Hakatif street, Emek Hefer Industrial Park, 3877701 
8.    MARKETING AUTHORISATION NUMBER(S)

177-34-37511-99