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Volume 19, Number 4—April 2013

Letter

Hepatitis E Virus and Porcine-derived Heparin

C. Crossan, L. Scobie, J. Godwin, J.G. Hunter, T. Hawkes, and H.R. DaltonComments to Author 
Author affiliations: Glasgow Caledonian University, Glasgow, Scotland, UK (C. Crossan, L. Scobie, J. Godwin); Royal Cornwall Hospital, Truro, UK (J.G. Hunter, T. Hawkes, H.R. Dalton); University of Exeter Medical School, Truro (H.R. Dalton)

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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.

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