Also, I assume it's not a great concern, but since I am asking the primary question, the first two times I also forgot to shake the bottle when it states to "SHAKE BEFORE USE", hopefully that doesn't prevent another potential problem?

Edit: If you see the "2" referenced next to the +2°C statement, this refers to this:

Clinical data pertaining to reference 2 is unpublished and the confidential property of Novartis. Novartis is providing this information in good faith due to the lack of data of this type in the published literature.

At first I thought this was saying that their reasoning for the +2°C was confidential, but I think it's saying that this finding of +2°C is only referenced in confidential data, but I also assume that this confidential data contains the reason why.

Also, I assume it's not a great concern, but since I am asking the primary question, the first two times I also forgot to shake the bottle when it states to "SHAKE BEFORE USE", hopefully that doesn't prevent another potential problem?

Our dog had a red/bloodshot eye and we were prescribed Maxidex (Dexamethasone) eye drops for our dog.

The first two times we used them they were stored at room temperature (bottle just store below 25c and NOT TO FREEZE); however we then seen our vet on a unrelated incidence and he said we should store them in the fridge.

So we put them in the fridge and used them about 5 more times as she was having one drop twice a day. I was then reading about them online and noted that some documents stated to NOT store them in the fridge (the leaflet we got never mentioned this, just said not to freeze).

I have a temperature gauge in my fridge and I placed it right next to the bottle to see what temp it ended up being stored at, and according to that it got down to about 0c - 1c.

After reading this I stopped giving it to her as her eye was looking better anyway.

Because of this I was curious if now we had given it to her after being in the fridge if it was just going to be ineffective or if it would be harmful in some way, so I emailed the company.

They didn't seem to want to get into specifics but told me that:

The TGA-Approved Consumer Medicine Information1 for Maxidex® eye drops has stated under Storage

Keep Maxidex in a cool dry place where the temperature stays below *25°C.

Do not freeze Maxidex. Do not store Maxidex or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

As previously stated, Maxidex® eye drops can be refrigerated as long as the temperature inside the refrigerator does not drop below +2°C. 2

Storing Maxidex® eye drops outside the registered storage conditions may affect the quality of the product. Novartis can't recommend the use of Maxidex® eye drops stored outside registered storage conditions.

Please speak to your pharmacist or veterinarian if you have any further questions about the storage and use of Maxidex® for your dog.

Novartis recommends the use and store of its products only in accordance with the Consumer Medicines Information (copy available at http://www.novartis.com.au/ products/consumer.shtml or from your pharmacist, doctor or our company).

So all they seemed to want to tell me is that storing them outside these temps may affect the quality of the product; but didn't seem to want to tell me if it would just make the product ineffective or possibly harmful?

Does anyone know how, when doing so, in that it seemingly was stored at 0c - 1c, which is slightly below the stated storage guidelines indicated above would make the product, would affect the product?

Also, I assume it's not a great concern, but since I am asking the primary question, the first two times I also forgot to shake the bottle when it states to "SHAKE BEFORE USE", hopefully that doesn't prevent another potential problem?

Here is the CMI.

Another document I found states to store it between 8c and 27c.

Lastly, here is a full PI.

Our dog had a red/bloodshot eye and we were prescribed Maxidex (dexamethasone) eye drops for our dog.

The first two times we used them they were stored at room temperature (bottle just store below 25°C and NOT TO FREEZE); however, we then seen our vet on a unrelated incidence and he said we should store them in the fridge.

So we put them in the fridge and used them about 5 more times as she was having one drop twice a day. I was then reading about them online and noted that some documents stated to NOT store them in the fridge (the leaflet we got never mentioned this, just said not to freeze).

I have a temperature gauge in my fridge and I placed it right next to the bottle to see what temperature it ended up being stored at, and according to that it got down to about 0°C - 1°C.

After reading this I stopped giving it to her as her eye was looking better anyway.

Because of this I was curious if now we had given it to her after being in the fridge if it was just going to be ineffective or if it would be harmful in some way, so I emailed the company.

They didn't seem to want to get into specifics but told me that:

The TGA-Approved Consumer Medicine Information1 for Maxidex® eye drops has stated under Storage

Keep Maxidex in a cool dry place where the temperature stays below *25°C.

Do not freeze Maxidex. Do not store Maxidex or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

As previously stated, Maxidex® eye drops can be refrigerated as long as the temperature inside the refrigerator does not drop below +2°C. 2

Storing Maxidex® eye drops outside the registered storage conditions may affect the quality of the product. Novartis can't recommend the use of Maxidex® eye drops stored outside registered storage conditions.

Please speak to your pharmacist or veterinarian if you have any further questions about the storage and use of Maxidex® for your dog.

Novartis recommends the use and store of its products only in accordance with the Consumer Medicines Information (copy available at http://www.novartis.com.au/products/consumer.shtml or from your pharmacist, doctor or our company).

So all they seemed to want to tell me is that storing them outside these temperatures may affect the quality of the product; but didn't seem to want to tell me if it would just make the product ineffective or possibly harmful?

Does anyone know how, when doing so, in that it seemingly was stored at 0°C - 1°C, which is slightly below the stated storage guidelines indicated above would make the product, would affect the product?

Also, I assume it's not a great concern, but since I am asking the primary question, the first two times I also forgot to shake the bottle when it states to "SHAKE BEFORE USE", hopefully that doesn't prevent another potential problem?

Here is the CMI.

Another document I found states to store it between 8°C and 27°C.

Lastly, here is a full PI.