Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Sucrose
Di-sodium Adipate
Dulbecco’s Modified Eagle Medium (DMEM)
Water for Injection

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 vaccine is indicated on the label and packaging.
The vaccine should be used immediately after opening.

6.4    Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.

Store in the original package, in order to protect from light.

6.5    Nature and contents of container
Oral applicator

1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl) in pack sizes of 1 or 10.

Tube

1.5 ml of oral suspension in a squeezable tube (polyethylene) fitted with a tip seal and a tube cap (polyethylene) in pack sizes of 1, 10 or 50.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling
The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration.

The vaccine is ready to use (no reconstitution or dilution is required).
The vaccine is to be administered orally without mixing with any other vaccines or solutions.

The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


Instructions for administration of the vaccine:
Oral applicator (Syringe)



Oral applicator
Tip-Cap



1. Remove the protective tip cap    2. This vaccine is for oral              3. Do   not inject.
from the oral applicator.           administration only. The child should be seated in a reclining position. Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the oral applicator.
Discard the empty oral applicator and tip cap in approved biological waste containers according to local regulations.


Tube
Please read the instructions for use all the way through before starting to give the vaccine.
A What you need to do before giving Rotarix
•    Check the expiry date.
•    Check the tube has not been damaged nor is already open.
•    Check the liquid is clear and colourless,
without any particles in it.

If you notice anything abnormal, do not use the vaccine.
• This vaccine is given orally ‐ straight from the tube.
• It is ready to use ‐ you do not need to mix it with anything.



B Get the tube ready
1. Pull off the cap
• Keep the cap – you need this to pierce the membrane.
• Hold the tube upright.
2. Repeatedly flick the top of the tube until it is clear of any liquid
• Clear any liquid from the thinnest section of the tube by flicking just below the membrane.



3.Position the cap to open the tube
•  Keep the tube held upright.
•  Hold the side of tube
•  There is a small spike inside the top of the cap ‐ in the centre.
• Turn the cap upside down (180°).



4. To open the tube
• You do not need to twist. Press the cap down to pierce the membrane.
• Then lift off the cap.



C Check the tube has opened correctly
1. Check the membrane has been pierced
• There should be a hole at the top of the tube.
2. What to do if the membrane has not been pierced
• If the membrane has not been pierced return to section B and repeat steps 2, 3 and 4.



D Give the vaccine
•   Once the tube is open check the liquid is clear, without any particles in it.
If you notice anything abnormal, do not use the vaccine.
• Give the vaccine straight away.

1. Position the child to give the vaccine
• Seat the child leaning slightly backwards.

2. Administer the vaccine
• Squeeze the liquid gently into the side of the child’s mouth ‐ towards the inside of their cheek.
• You may need to squeeze the tube a few times to get all of the vaccine out ‐ it is okay if a drop remains in the tip of the tube.


Discard the empty tube and cap in approved biological waste containers according to local regulations.