Reasons for adding or updating:

• Change to section 6.4 - Special precautions for storage
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 30-Sep-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0Section 6.4: Updated reconstitutioninstructions to reflect use of mix2vial in sealed carton$0Section10: Updated date of revision of text

Reasons for adding or updating:

• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 30-Jul-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

It was noted that the date of revision of text was incorrect.  This has been updated to reflect MHRA Approved SPC to 30/07/2013

Reasons for adding or updating:

• Change to section 4.8 - Undesirable effects - how to report a side effect
• Change to section 6.5 - Nature and contents of container
• Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC: 30-Jun-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.8

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via www.mhra.gov.uk/yellowcard.

6.4     Special precautions for storage

 

Do not store above 25°C.

Do not freeze.

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

For storage conditions after reconstitution of the medicinal product, see section 6.3.

 

6.5     Nature and contents of container

 

One package of Octaplex contains:

- Powder in a vial (type I glass) with a stopper (halobutyl rubber) and a flip off cap (aluminium)

- 20 ml of Water for Injections in a vial (type I or type II glass) with a stopper (halobutyl rubber) and a flip off cap (aluminium)

- 1 transfer set Mix2Vial™.

 

6.6     Instructions for use and handling and disposal

 

Please read all the instructions and follow them carefully!

During the procedure described below, aseptic technique must be maintained!

The product reconstitutes quickly at room temperature.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Reconstituted products should be inspected visually for particulate matter and discoloration prior to administration.

 

After reconstitution the solution must be used immediately.

 

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

 

Instructions for reconstitution:

1.    If necessary, allow the solvent (Water for Injections) and the powder in the closed vials to reach room temperature. This temperature should be maintained during reconstitution.
If a water bath is used for warming, care must be taken to avoid water coming into contact with the rubber stoppers or the caps of the vials. The temperature of the water bath should not exceed 37°C.

2.    Remove the caps from the powder vial and the water vial and clean the rubber stoppers with an alcohol swab.

3.    The Mix2vial™ is depicted in Fig. 1. Place the solvent vial on an even surface and hold it firmly. Take the Mix2Vial™ and turn it upside down. Place the blue part of the Mix2Vial™ on top of the solvent vial and press firmly down until it snaps (Fig. 2+3).

        

 

4.       Place the powder vial on an even surface and hold it firmly. Take the solvent vial with the attached Mix2Vial™ and turn it upside down. Place the transparent part on top of the powder vial and press firmly down until it snaps (Fig. 4). The solvent flows automatically into the powder vial.
5.       With both vials still attached, gently swirl the powder vial until the product is dissolved. Octaplex dissolves quickly at room temperature to a colourless to slightly blue solution. Unscrew the Mix2Vial™ into two parts (Fig. 5).   Dispose the empty solvent vial with the blue part of the Mix2Vial™.

 

 

If the powder fails to dissolve completely or an aggregate is formed, do not use the preparation.

 

Instructions for infusion:

As a precautionary measure, the patients pulse rate should be measured before and during the infusion. If a marked increase in the pulse rate occurs the infusion speed must be reduced or the administration must be interrupted.

1.    Attach a 20 ml syringe to the transparent part of the Mix2Vial™. Turn the vial upside down and draw the solution into the syringe. Once the solution has been transferred, firmly hold the plunger of the syringe (keeping it facing down) and remove the syringe from the Mix2Vial™. Dispose the Mix2Vial™ and the empty vial.

2.    Disinfect the intended injection site with an alcohol swab.

3.    Inject the solution intravenously at a slow speed: Initially 1 ml per minute, not faster than 2 - 3 ml per minute.

 

No blood must flow into the syringe due to the risk of formation of fibrin clots. The Mix2Vial™ is for single use only.

Reasons for adding or updating:

• Change to section 6.3 - Shelf life
• Change to section 10 - Date of revision of the text
• Retired pending re-submission

Date of revision of text on the SPC: 24-Feb-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



At 6.3 Shelf life

Below 2 years Delete the current statement “After reconstitution etc....”

 

has been replaced with:

Chemical and physical in-use stability has been demonstrated for up to 8 hours at +2°C to +25°C.

 

From a microbiological point of view, the product 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 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

 

9 Date of first authorisation/renewal of authorisation

Change  Date of first authorisation: 07.06.2006  to    20/07/2006

 

10. Date of Revision of the Text

24 February 2013

Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC: 01-Oct-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



2.       Qualitative and quantitative composition

 

Octaplex is presented as a powder and solvent for solution for infusion containing human prothrombin complex. Octaplex nominally contains:

 

Name of ingredient	Octaplex Quantity per vial (IU)	Octaplex Quantity after reconstitution with 20 ml of Water for Injections (IU/ml)
Active substances
Human coagulation factor II	280 - 760	14 - 38
Human coagulation factor VII	180 - 480	9 - 24
Human coagulation factor IX	500	25
Human coagulation factor X	360 - 600	18 - 30
Further active ingredients
Protein C	260 - 620	13 - 31
Protein S	240 - 640	12 - 32

Reasons for adding or updating:

• Removal of Black Triangle

Date of revision of text on the SPC: 01-Oct-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Removal of black triangle

Reasons for adding or updating:

• New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): YES