Volume 19, Number 4—April 2013
Letter
Hepatitis E Virus and Porcine-derived Heparin
Table
Heparin samples tested for hepatitis E virus, porcine circovirus 2, and porcine parvovirus*
Producer, proprietary name/other names, batch or lot no. | Use | Excipient | Concentration | Quantity tested, IU | 95% upper CL, IU−1† |
---|---|---|---|---|---|
Sanofi‡ | |||||
Clexhane/enoxaparin | Injection | H2O | |||
ILA01 | 20 mg/0.2 mL | 6,000 | 0.0006 | ||
34751 | 40 mg/0.4 mL | 4,000 | 0.0009 | ||
OLC56 | 80 mg/0.8 mL | 8,000 | 0.0005 | ||
ILA53 | 60 mg/0.6 mL | 6,000 | 0.0006 | ||
OLC07 | 100 mg/ mL | 10,000 | 0.0004 | ||
12255 |
120 mg/0.8 mL |
12,000 |
0.0003 |
||
Pfizer§ | |||||
Fragmin/dalteparin sodium | Injection | H2O pH adjusted with HCl or NaOH | |||
12339A01 | 5,000 IU/0.2 mL | 15,000 | 0.0002 | ||
12338A01 | 5,000 IU/0.2 mL | 15,000 | 0.0002 | ||
12327B01 | 5,000 IU/0.2 mL | 15,000 | 0.0002 | ||
12257A01 | 5,000 IU/0.2 mL | 15,000 | 0.0002 | ||
12444A01 | 5,000 IU/0.2 mL | 10,000 | 0.0004 | ||
12122C01 | 7,500 IU/0.3 mL | 7,500 | 0.0005 | ||
74774D51 | 10,000 IU/0.4 mL | 10,000 | 0.0004 | ||
74871B51 | 12,500 IU/0.5 mL | 25,000 | 0.0001 | ||
74779G51 | 12,500 IU/0.5 mL | 12,500 | 0.0003 | ||
74871B51 | 12,500 IU/0.5 mL | 12,500 | 0.0003 | ||
74743C52 | 15,000 IU/0.6 mL | 30,000 | 0.0001 | ||
74755A51 | 15,000 IU/0.6 mL | 30,000 | 0.0001 | ||
74832A52 | 15,000 IU/0.6 mL | 15,000 | 0.0002 | ||
74832A01 | 15,000 IU/0.6 mL | 15,000 | 0.0002 | ||
X08580 |
¶ |
¶ |
100,000 IU/4 mL |
100,000 |
0.00004 |
Wockhart# | |||||
Monoparin | Injection | H2O pH adjusted with HCl or NaOH | |||
PK40319 | 1,000 IU/mL | 20,000 | 0.0002 | ||
3090 | 1,000 IU/mL | 10,000 | 0.0004 | ||
Hepsal | Flushing | NaCl, H2O, HCl, and NaOH | |||
5000090 | 10 IU/mL | 120 | 0.03 | ||
91180 | 50 IU/mL | 50 | 0.07 | ||
1069 |
200 IU/mL |
200 |
0.02 |
||
Leo** | |||||
Heparin sodium | Intravenous flushing | Benzyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium citrate, NaCl, and H2O | |||
DD7314 | 100 IU/mL | 200 | 0.02 | ||
CC4338 |
100 IU/mL |
200 |
0.02 |
||
Celgene††, | |||||
Refludan/Lepirudin, 25561611A‡‡ |
Powder used for solution for injection/infusion |
Mannitol, NaOH, and H2O |
12.5 mg/mL |
NA |
NA |
Total quantity tested | NA | NA | NA | 404,270 | 0.000009 |
*NA, not applicable.
†The 95% upper confidence limit of the probability of a virus-positive result per IU was calculated on the basis of the quantity tested for each batch. This was estimated, assuming perfect detection of a Poisson process, by using Fisher exact test. For the pooled result, the upper 95% estimate is ≈1 per 100,000 IU.
‡Sanofi (Guilford, UK).
§Pfizer (Sandwich, UK).
¶Multidose vials used for injection, Excipients: Benzyl alcohol and H2O.
#Wockhart (Wrexham, UK).
**Leo (Buckinghamshire, UK).
††Celgene (Uxbridge, UK).
‡‡Non-porcine–derived anticoagulant alternative.