Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride
Sodium meta-bisulfite (E223)
Disodium edetate
Hydrochloric acid (for adjustment of pH)
Water for injections


6.2   Incompatibilities

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.
6.4   Special precautions for storage

The pen must always be kept in the plastic case provided to ensure it is protected.
Store below 25°C. Do not freeze.

6.5   Nature and contents of container
Emerade consists of a pre-filled syringe made of glass with a black chlorobutyl rubber stopper in an auto-injector. Emerade is latex free.

Exposed needle length
Emerade 150 micrograms: 16 mm
Emerade 300 micrograms and Emerade 500 micrograms: 23 mm
Package
Emerade has a plastic box as well as an outer carton boxbox to store the auto-injector in.
Pack sizes: 1 or 2 pre-filled pens.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

It is very important that the patient receives detailed information on how to use Emerade.

For single use only.
The expiry date is indicated on the label and on the outer carton and Emerade should not be used after this date.
Discard and replace the auto-injector after expiry date.
The solution should be checked periodically through the inspection window of the unit by lifting the label to make sure the solution is clear and colourless. Emerade should be discarded and replaced if the solution is discoloured or contains particles.
Emerade should always be carried if at risk of anaphylaxis.

Emerade is designed for easy use and has to be considered as a first aid. Emerade has an opening only at the needle end and none at the opposite end.

Method of administration
The instructions for use must be carefully followed in order to avoid accidental injection.
It is recommended that the patient's family members, carers or teachers are also instructed in the correct use of Emerade.
Emerade should only be used for injection in the outer thigh. The injection occurs when Emerade is pressed into the thigh. This can be done through clothing.



1. The needle shield should be removed



2. Emerade should be placed and pressed against the outer side of the thigh. A click can be heard when the injection goes into the muscle.


3. Emerade should be held against the thigh for about 5 seconds. The injection site should be lightly massaged afterwards.

The patient should be instructed to seek immediate medical help.



The needle in Emerade is protected before, during and after the injection.
When the injection is completed the plunger is visible in the inspection window by lifting the label.
Sometimes a single dose of adrenaline may not be sufficient to completely reverse the effects of a serious allergic reaction. If the symptoms have not improved or have deteriorated within 5-15 minutes after the first injection, either the patient or the person with him should be instructed to give a second injection. For this reason, the patient should be instructed to carry more than one Emerade with him at all times.

Autoinjectors without needles are available for training purposes.