Licensed for intrathecal use
Products licensed for intrathecal use are the first line option and should be used wherever suitable.
Zentiva
Gentamicin Intrathecal
Strength
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.
Advanz (Genticin®)
Strength
Excipients
Water for injection, sulfuric acid
Osmolarity / osmolality
No information
pH
3.0 – 5.5
Endotoxin content
≤ 28.4 IU/mg
Advanz (Cidomycin®)
Strength
Excipients
Sodium chloride, Water for Injections, 2N Sodium Hydroxide (for pH adjustment), 2N Sulphuric Acid (for pH adjustment)
Osmolarity / osmolality
No information
pH
3.0 – 5.5
Endotoxin content
≤ 0.71 IU/mg
B.Braun
Strength
Excipients
Sodium chloride, water for injection
Osmolarity / osmolality
No information
pH
No information
Endotoxin content
No information
Strength
3 mg/mL in 80mL or 120mL bottles
Excipients
Disodium edetate, sodium chloride, water for injection
Osmolarity / osmolality
No information
pH
No information
Endotoxin content
No information
Demo S.A Pharmaceuticals
Marketing authorisation holder Noridem Enterprises Ltd
Strength
20 mg/mL in 2mL ampoules
40 mg/mL in 2mL ampoules
80 mg/mL in 2mL ampoules
Excipients
Disodium edetate, Sodium metabisulfite (E223), sodium hydroxide 1 N (for pH adjustment), sulfuric acid 0.5 M (for pH adjustment), water for injection
Osmolarity / osmolality
80 – 90 mOsmol/kg
pH
3.0 – 5.5
Endotoxin content
< 6.6 EU/ml for a solution with concentration 10mg/ml
Panpharma
Strength
Excipients
Disodium edetate, sodium chloride, sulfuric acid (for pH adjustment), water for injection
Osmolarity / osmolality
No information
pH
3.0 – 5.5
Endotoxin content
No information
Wockhardt
Strength
10 mg/mL in 2mL ampoules
40 mg/mL in 2mL ampoules
Excipients
Sodium metabisulfite (E223), sulfuric acid (10%) or sodium hydroxide (for pH adjustment), water for injection
Osmolarity / osmolality
No information
pH
3.0 – 5.5
Endotoxin content
<0.71 IU/ml
Zentiva
Gentamicin Paediatric
Strength
Excipients
Sodium chloride, 2M sodium hydroxide, 1M sulphuric acid, water for injection
Osmolarity / osmolality
No information
pH
3.0 – 5.5
Endotoxin content
< 0.71 IU/mg
Update history
- Republished
- Republished - Full update to monograph including URLs and data on file. Removed products: Ennogen Gentamicin Paediatric no longer marketed in UK. Hospira discontinued. Cidomycin acquired by Advanz from Sanofi
- Title and URL shortened.
- Published