Diamorphine hydrochloride products: information for supporting intrathecal risk assessment

John Minshull, Deputy Director, London Medicines Information Service, Specialist Pharmacy ServicePublished

Diamorphine products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Licensed for intrathecal use

Products licensed for intrathecal use are the first line option and should be used wherever suitable.

There are currently no known diamorphine products licensed for intrathecal administration.

Not licensed for intrathecal use, limited information available

Products with partial information that are not licensed for intrathecal administration can still sometimes be used. Refer to the advice in our article and complete a risk assessment to enable you to interpret the details below and choose an appropriate product.

Accord

Strength

5 mg ampoule

Excipients

No information

Osmolarity

~24 mOsmol/L

pH

5.0 – 5.9

Endotoxin content

No information

Strength

10 mg ampoule

Excipients

No information

Osmolarity

~45 mOsmol/L

pH

5.2 – 5.5

Endotoxin content

No information

Strength

30 mg ampoule

Excipients

No information

Osmolarity

~118 mOsmol/L

pH

5.0 – 5.2

Endotoxin content

No information

Strength

100 mg ampoule

Excipients

No information

Osmolarity

~185 mOsmol/L

pH

4.2 – 4.4

Endotoxin content

No information

Strength

500 mg ampoule

Excipients

No information

Osmolarity

~575 mOsmol/L

pH

4.6 – 4.8

Endotoxin content

No information

Ennogen

Strength

5 mg ampoule

Excipients

Water for injection (not detectable in the finished product)

Osmolarity

~24 mOsmol/L

pH

5.0 – 5.9

Endotoxin content

No information

Strength

10 mg ampoule

Excipients

Water for injection (not detectable in the finished product)

Osmolarity

~45 mOsmol/L

pH

5.2 – 5.5

Endotoxin content

No information

Strength

30 mg ampoule

Excipients

Water for injection (not detectable in the finished product)

Osmolarity

~118 mOsmol/L

pH

5.0 – 5.2

Endotoxin content

No information

Strength

100 mg ampoule

Excipients

Water for injection (not detectable in the finished product)

Osmolarity

~185 mOsmol/L

pH

4.2 – 4.4

Endotoxin content

No information

Strength

500 mg ampoule

Excipients

Water for injection (not detectable in the finished product)

Osmolarity

~575 mOsmol/L

pH

4.6 – 4.8

Endotoxin content

No information

Wockhardt

Strength

5 mg ampoule

Excipients

Water for injection (not detectable in the finished product)

Osmolarity

~24 mOsmol/L

pH

5.0 – 5.9

Endotoxin content

No information

Strength

10 mg ampoule

Excipients

Water for injection (not detectable in the finished product)

Osmolarity

~45 mOsmol/L

pH

5.2 – 5.5

Endotoxin content

No information

Strength

30 mg ampoule

Excipients

Water for injection (not detectable in the finished product)

Osmolarity

~118 mOsmol/L

pH

5.0 – 5.2

Endotoxin content

No information

Strength

100 mg ampoule

Excipients

Water for injection (not detectable in the finished product)

Osmolarity

~185 mOsmol/L

pH

4.2 – 4.4

Endotoxin content

No information

Strength

500 mg ampoule

Excipients

Water for injection (not detectable in the finished product)

Osmolarity

~575 mOsmol/L

pH

4.6 – 4.8

Endotoxin content

No information

Unlicensed ‘Special’, specified for intrathecal use

Unlicensed medicines that are manufactured in MHRA-licensed Specials Manufacturing Units, at the request of an authorised healthcare professional specifically for intrathecal use.

Preston Pharmaceuticals – Royal Preston Hospital

Strength

500 micrograms in 0.5mL PFS

Queen Alexandra Hospital, Portsmouth

Strength

1mg/mL in 1mL PFS

Royal Hospitals, Belfast – Victoria Pharmaceuticals

Strength

500 micrograms/mL in 1mL PFS

Royal Liverpool Hospitals Foundation Trust

Strength

300 micrograms in 0.3mL PFS

Stepping Hill Hospital – Stockport Pharmaceuticals

Strength

1mg/mL in 1mL PFS

Wirral Hospital aseptic manufacturing unit

Strength

300 micrograms in 0.5mL PFS
500 micrograms in 0.5mL PFS

All our intrathecal product resources

Understand what to consider when giving medicines via the intrathecal route and use our material to help inform your risk assessment

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