Ropivacaine products: information for supporting intrathecal risk assessment

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

Ropivacaine 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 ropivacaine 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.

Aspen (Naropin®) infusion

Strength

2mg/mL 100mL or 200mL bags

Excipients

Sodium chloride, hydrochloric acid, sodium hydroxide, water for injection

Osmolarity

No information

pH

No information

Endotoxin content

≤ 0.11 EU/mL

Aspen (Naropin®) injection

Strength

2mg/mL 10mL or 20mL ampoules

Excipients

Sodium chloride, hydrochloric acid, sodium hydroxide, water for injection

Osmolarity

No information

pH

No information

Endotoxin content

≤ 0.11 EU/mL

Strength

7.5mg/mL 10mL or 20mL ampoules

Excipients

Sodium chloride, hydrochloric acid, sodium hydroxide, water for injection

Osmolarity

No information

pH

No information

Endotoxin content

≤ 0.42 EU/mL

Strength

10mg/mL 10mL or 20mL ampoules

Excipients

Sodium chloride, hydrochloric acid, sodium hydroxide, water for injection

Osmolarity

No information

pH

No information

Endotoxin content

≤ 0.56 EU/mL

Altan infusion

Strength

2mg/mL 100mL or 200mL bags

Excipients

Sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

252 – 308 mOsmol/kg

pH

3.8 – 5.8

Endotoxin content

≤ 0.71 EU/mL

Altan injection

Strength

2mg/mL 10mL ampoules

Excipients

Sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

252 – 308 mOsmol/kg

pH

4.5 – 6.0

Endotoxin content

No information

Strength

7.5mg/mL 10mL ampoules

Excipients

Sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

261 – 319 mOsmol/kg

pH

4.5 – 6.0

Endotoxin content

≤ 0.45 EU/mL

Strength

10mg/mL 10mL ampoules

Excipients

Sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

270 – 330 mOsmol/kg

pH

4.5 – 6.0

Endotoxin content

No information

Fresenius injection

Strength

2mg/mL 10mL or 20mL ampoules

Excipients

Sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

255 – 305 mOsmol/kg

pH

4.0 – 6.0

Endotoxin content

≤ 0.094 EU/mL

Strength

10mg/mL 10mL or 20mL ampoules

Excipients

Sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

255 – 305 mOsmol/kg

pH

4.0 – 6.0

Endotoxin content

≤ 0.47 EU/mL

Strength

7.5mg/mL 10mL or 20mL ampoules

Excipients

Sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

255 – 305 mOsmol/kg

pH

4.0 – 6.0

Endotoxin content

≤ 0.35 EU/mL

Sintetica infusion

Strength

2mg/mL in 100mL, 200mL, 250mL or 500mL bags

Excipients

Sodium chloride, sodium hydroxide (for pH adjustment), water for injection

Osmolarity

No information

pH

4.0 – 6.0

Endotoxin content

No information

Sintetica injection

Strength

2mg/mL in 10mL or 20mL ampoules
7.5mg/mL in 10mL or 20mL ampoules
10mg/mL in 10mL or 20mL ampoules

Excipients

Sodium chloride, sodium hydroxide (for pH adjustment), water for injection

Osmolarity

No information

pH

4.0 – 6.0

Endotoxin content

No information

Villerton infusion

Strength

2mg/mL in 100mL, 200mL or 500mL bags

Excipients

Sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

270 – 320 mOsmol/kg

pH

4.0 – 6.0

Endotoxin content

No information

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