Pharmaceutical particulars : מידע רוקחי

6)    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Sodium chloride, water for injections.

6.2   Incompatibilities
Not known.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.
6.4   Special precautions for storage
Store in a refrigerator (+2°C to +8°C). Protect from light. Do not use any residual quantity in the vial after the first aspiration.
Unopened, unused vials of CUROSURF that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use.
Do not warm to room temperature and return to refrigerated storage more than once.

6.5   Nature and contents of container
Single-dose vial in clear colourless glass, volume of 5 ml, provided with a chlorobutyl rubber stopper and a plastic and aluminium cap.
One vial of 3 ml 80 mg/ml (240 mg/vial)
One vial of 1.5 ml 80 mg/ml (120 mg/vial)
Two vials of 1.5 ml 80 mg/ml (120 mg/vial)
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
The vial should be warmed to room temperature before use, and gently turned upside down, without shaking, in order to obtain a homogeneous suspension.

The suspension should be withdrawn from the vial using a sterile needle and syringe.
In order to withdraw the suspension, carefully follow the instructions below: 

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1)   Locate the notch (FLIP UP) on the coloured plastic cap
2)   Lift the notch and pull upwards
3)   Pull the plastic cap with the aluminium portion downwards
4)   and 5) Remove the whole ring by pulling off the aluminium wrapper
6)   and 7) Remove the rubber stopper to extract content.

For single use only. Discard any unused portion left in the vial. Do not keep unused portions for later administration.

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

7.    LICENCE HOLDER AND MANUFACTURER

Licence Holder:
Teva Israel Ltd

124 Dvora HaNevi'a St, Tel Aviv 6944020 Israel
Manufacturer:
Chiesi Farmaceutici S.P.A.,
Parma, Italy.