Applied and Environmental Microbiology,
September 1999, p. 4255-4260, Vol. 65, No. 9
0099-2240/99/$04.00+0
Bacterial
Spores Survive Treatment with Commercial Sterilants and
Disinfectants
Jose-Luis Sagripanti*
and Aylin Bonifacino
Molecular Biology Branch (HFZ-113), Division of
Life Sciences, Office of Science and Technology, Center for Devices
and Radiological Health, Food and Drug Administration, Rockville,
Maryland
ABSTRACT
This study compared the activity of commercial liquid sterilants
and disinfectants on Bacillus subtilis spores deposited on
three types of devices made of noncorrodible, corrodible, or
polymeric material. Products like Renalin, Exspor,
Wavicide-01, Cidexplus, and cupric ascorbate were tested
under conditions specified for liquid sterilization.
These products, at the shorter times indicated for
disinfection, and popular disinfectants, like Clorox, Cavicide,
and Lysol were also studied. Data obtained with a sensitive
and quantitative test suggest that commercial liquid
sterilants and disinfectants are less effective on
contaminated surfaces than generally
acknowledged.
TEXT
Different reports agree that 5 to 10% (1.75 to 3.5 million) of
the 35 million patients annually admitted to hospitals in the United
States acquire an infection during hospitalization (5,
6,
22). More than 850,000 of these
have been estimated to be implant- and device-related infections (2).
Abundant data linking the transmission of various diseases
(including AIDS, tuberculosis, and Creutzfeldt-Jakob disease, as
well as hospital epidemics of infections with Pseudomonas, Serratia,
and Bacillus species) to medical devices suggest that the
effectiveness of disinfection and sterilization practices has been
overestimated (21).
The capacity to kill bacterial spores determines how a commercial
product will be marketed. Disinfectants are not expected to kill all
bacterial spores and are used to decontaminate devices that
ordinarily do not penetrate tissues or that touch only intact skin (3,
16,
25). Sterilants are expected to
kill all microorganisms, including bacterial spores, and are used to
treat devices that penetrate tissue or present a high risk if unsterile. Viable spores still attached to various materials could
remain undetected by current sporicidal tests (1),
resulting in overestimation of the sporicidal activity of
sterilizing agents (4,
7,
11,
12,
14,
15). The goal of this study was to
compare the sporicidal activities of commercial liquid sterilants
under manufacturer-specified conditions by using a sensitive method
able to quantitatively account for the survival of all spores on
contaminated carrier devices.
Selection of carrier devices. The device to which
spores are attached might alter the sporicidal activity of some
germicidal agents (19).
Therefore, the criteria used to select the carrier devices that we
tested were based on the following practical considerations: (i)
diverse material composition, (ii) geometry representative of
medical devices, (iii) similar spore load capacities, (iv) size
amenable to microtesting, and (v) cost. Miniature stainless steel
machine screws (no. 0/80, pan head, 1.5 mm in diameter, and 12.5 mm
long) were purchased at a local hardware store (Home Depot,
Rockville, Md.) or from Thompson & Cooke (Bladensburg, Md.). Dental
burs (FG 557) made of carbon steel were manufactured by Midwest
Dental Products Corporation (Des Plaines, Ill.). Medical-grade
silicone rubber tubing, 3.1-mm outer diameter and 1.5-mm inner
diameter (Silastic; catalog no. 602-285), was manufactured by Dow
Corning Corporation Medical Products (Midland, Mich.) and used in
12.5-mm-long sections. All devices were cleaned prior to use by
washing with detergent, rinsing three times with distilled water,
washing once in acetone, and rinsing again in distilled water before
sterilization by autoclaving. The devices were immersed 5 mm deep in
spore-loading suspensions. This procedure contaminated areas of
20, 40, and 78 mm2 on dental burs, screws, and tubing, respectively.
Likely due to differences in geometry and materials, the test
described below loaded similar numbers of spores onto the three
devices in spite of the different immersed areas. The miniature
stainless steel screws and small sections of medical-grade silicone
rubber tubing were small enough to fit our microtest format and
inexpensive (costing 6 and 3 cents each, respectively). Easy
availability of tubing, burs, and screws made custom manufacturing
of carriers unnecessary. Their low cost allowed these carriers to be
used only once and then discarded, thus preventing spore carryover
and the need to wash and sterilize the carriers between tests.
Direct measurement of spores loaded onto carriers.
Spores of Bacillus subtilis subsp. globigii (Spordex) were purchased
from AMSCO American Sterilizer Co. (Erie, Pa.) with a reported D
value for dry-heat killing at 160°C of 2.2 min and a D value for
ethylene oxide killing (600 mg/liter at 54°C) of 3.5 min,
respectively. The number of spores loaded onto carriers was
determined by using radioactively labeled spores. A method that
produces dry-heat-resistant spores in synthetic medium (8,
13,
23) was modified in our laboratory
so that it would result in maximum incorporation of radiolabeled
precursor as previously described (19).
A rapidly growing culture (106 bacteria in 5 ml) was inoculated into
300 ml of synthetic sporulating medium in which methionine was
replaced with radioactive L-[methyl-14C]methionine (0.33 Ci/ml;
NEC165H; 50 mCi/mmol; New England Nuclear, Boston, Mass.). After
5 days of incubation at 32°C in a shaker operating at 140 rpm,
cultures were chilled in ice and spores were pelleted by
centrifugation for 30 min at 900 × g in a Beckman TJ-R refrigerated
centrifuge. After five cycles of centrifugation and resuspension in
new Luria-Bertani (LB) broth, the radioactivity in the supernatant
was reduced to less than 2% of the radioactivity in the pellet
containing the spores. Samples from each batch of spores
radioactively labeled and concentrated in our laboratory or
nonradiolabeled spores obtained commercially (Spordex) were
microscopically examined and exposed to acid for confirmation of
spore morphology and chemical resistance as previously described (18).
No vegetative cells (rods) were observed during the counting of
1,000 radioactively labeled or nonlabeled spores. Spores were
exposed for various time periods to either deionized,
glass-distilled, autoclave-sterile water (controls) or hydrochloric
acid (2.5 N). After exposure they were neutralized with ice-cold LB
broth (Advanced Biotechnology IC, Columbia, Md.) and titrated onto
broth-agar (LB broth [Miller-Difco, Detroit, Mich.], 1.5% Agar
Select [Gibco-BRL, Paisley, Scotland]) plates 100 mm in diameter.
Typical spore survival in hydrochloric acid for 5 and 10 min was
100 and 88%, respectively.
Spores labeled with [14C]methionine were diluted in LB broth, and
identical aliquots were either titrated for viability or counted for
radioactivity. The specific activity of each spore preparation was
obtained from the slope of the regression line of spore number (as
determined by titration) versus incorporated 14C label (measured by
scintillation counting). We transferred various devices to Eppendorf
polypropylene tubes (1.5 ml) containing 50 µl of 14C-labeled spores
at different concentrations. Each device was immersed in a separate
spore-loading suspension for 30 min. The devices were then removed
from the loading suspension with forceps and dried for 10 min under
vacuum (Speed Vac; Savant, Farmingdale, N.Y.). Each 50-µl suspension
was used once and then discharged.
The spore load on each device was estimated by immersing the
loaded devices in scintillation liquid, measuring radioactivity, and
multiplying this value by the specific activity of the preparation.
One large batch with a specific activity of 1.7 × 103 ± 0.3 × 103
spores per cpm was used for final calibration of all devices. The
number of spores attached to no. 0/80 stainless steel screws
(ranging from 6.0 × 106 to 6.5 × 106) was comparable to that loaded
into medical-grade silicone rubber tubing (3.8 × 106) immersed in a
spore suspension with a similar spore concentration (1.7 × 109/ml).
The increase in the number of spores loaded onto the stainless steel
screws or silicone rubber tubing was approximately linear with
increasing concentrations of the loading suspension in the range of
107 to 1010 spores/ml. This contaminating procedure loaded, on
average, 3 spores per 1,000 spores/ml of the loading suspension.
Sterilants and disinfectants. Cidexplus (3.4%
glutaraldehyde, pH 8.0; Johnson and Johnson Medical Inc., Arlington,
Tex.) was activated as specified and used full strength at 21°C over
a period of either 10 h, for sterilization, or 20 min, as indicated
for high-level disinfection. Exspor (Alcide Corp., Redmond, Wash.),
containing 1.52% sodium chlorite, was activated daily before
experiments by mixing 1 part base concentrate, 4 parts water, and
1 part activator (yielding a pH between 2.3 and 2.7). The label
prescribes the treatment of medical items with an Exspor-activated
solution for 10 h to achieve sterilization and for 1 to 3 min for
killing of Mycobacterium sp. and other bacteria, pathogenic fungi,
and viruses on hard surfaces. Renalin (Renal Systems Division of
Minntech Corp., Minneapolis, Minn.), a mixture of 20.0% hydrogen
peroxide and 4.0% peroxyacetic acid, was used as recommended for
sterilization at a dilution of 1:5 (final dilution; pH 1.8) in
sterile, deionized, and glass-distilled water for an 11-h exposure.
Wavicide-01 (2% glutaraldehyde; Wave Energy Systems, Wayne, N.J.)
was used full strength for 10 h at 21°C as a sterilant or at a 1:4
dilution for 10 min (at room temperature [21°C]), as specified for
killing of vegetative bacteria and viruses. Clorox (5.25% sodium
hypochlorite, manufactured by The Clorox Company, Oakland, Calif.)
was used at a 1:21 dilution, as recommended for disinfection. Lysol
I.C. (7.24% o-benzyl-p-chlorophenol and 2.23% o-phenylphenol;
National Laboratories, Montvale, N.J.) was used at the 1:128
dilution specified for use in hospitals, nursing homes, dental
offices, and other institutional facilities as a germicidal,
tuberculocidal, pseudomonacidal, staphylococcidal, fungicidal, and
virucidal compound. Cavicide (15.30% isopropanol and 0.25%
diisobutyl phenoxyethoxyethyl dimethyl benzyl ammonium chloride;
Micro Aseptic Products, Inc., Palatine, Ill.) was used full
strength, as specified for disinfection of noncritical medical
instruments. Cupric chloride (CuCl2 · 2H2O; Mallinckrodt Specialty
Chemicals, Paris, Ky.), L-ascorbic acid, and (30% wt/vol) hydrogen
peroxide (both from Aldrich Chemical, Milwaukee, Wis.) were used in
a mixture (0.5% cupric ions [as cupric chloride]-0.1% ascorbic
acid-0.003% hydrogen peroxide, pH 2.9).
Hepatitis C Survives Treatment with Commercial Sterilants and
Disinfectants
http://www.safetec.com/sanizide.php3
2001
SAFETEC SANIZIDE PLUSTM
Germicidal Solution SaniZide PlusTM is a
ready-to-use, hospital grade, hard surface disinfectant/deodorizer.
Our Quaternary Ammonium, alcohol free formulation is non-flammable
making SaniZide PlusTM safe to ship, as well as, non-corrosive.
Choosing SaniZide PlusTM helps you to comply with the OSHA
Bloodborne Pathogens Standard, which requires the use of an
"appropriate disinfectant" that is tuberculocidal and virucidal
against HIV-1 and HBV. For use on: glass, porcelain, ceramic, metal,
polyethylene, polypropylene, vinyl, polyester, rubber, bakelite, and
many more hard surfaces. For use in: industrial, institutional,
commercial, medical and residential facilities, equipment and
vehicles. EPA Registered. Now effective against Hepatitis C Virus
(HCV)!
* Alcohol-free formula
* Kills HBV, HIV, HCV and TB
* Ready-to-use hospital grade disinfectant
* Virucidal, Tuberculocidal, Fungicidal, Bactericidal
* Controls mold and mildew
* EPA registered
* Neutralizes odors and freshens in one step
* Helps you comply with the OSHA Bloodborne Pathogens standard
Vaccins et vaccination dans le monde, n°5,
November 1997, p.2. WHO journal, pp. 2-4: "We must act now and take
advantage of the new mass vaccination campaigns that are soon to be
launched, to improve injection safety. If we fail, we will not only
have a catastrophe on our hands, but we will have missed a golden
opportunity to resolve this problem". The problem of dangerous
injections had already been raised at the Yamoussoukro meeting in
1994, which in turn followed those of Bamako in 1974, Dakar in 1981,
Niamey in 1987. Cf. Marchés tropicaux, n°628, 1 April 1994, p.628
2001
Read down to the 'Warnings' it's still not 100%
HEPATITIS B IMMUNE GLOBULIN (HUMAN)Rx
NABI-HB™ (Nabi)
Solvent/Detergent Treated and Filtered
DESCRIPTION
Hepatitis B Immune Globulin (Human), Nabi-HB™,
is a sterile solution of immunoglobulin (5 ± 1% protein) containing
antibodies to hepatitis B surface antigen (anti-HBs). It is prepared
from plasma donated by individuals with high titers of anti-HBs. The
plasma is processed using a modified Cohn 6 / Oncley 9 cold-alcohol
fractionation process 1,2 with two added viral reduction steps
described below. Nabi-HB™ is formulated in 0.075 M sodium chloride,
0.15 M glycine, and 0.01% polysorbate 80, at pH 6.2. The product is
supplied as a nonturbid sterile liquid in single dose vials and
appears as clear to opalescent. It contains no preservative and is
intended for single use by the intramuscular route only.
The manufacturing steps for Nabi-HB™ are
designed to reduce the risk of transmission of viral disease. The
solvent/detergent treatment step, using tri- n -butyl phosphate and
Triton® X-100, is effective in inactivating known enveloped viruses
such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human
immunodeficiency virus (HIV) 3 . Virus filtration, using a Planova®
35 nm Virus Filter, is effective in reducing some known enveloped
and non-enveloped viruses 4 . The inactivation and reduction of
known enveloped and non-enveloped model viruses were validated in
laboratory studies as summarized in the following table:
Product potency is expressed in international
units (IU) by comparison to the World Health Organization (WHO)
standard. Each milliliter (mL) of product contains greater than 312
IU anti-HBs. The potency of each milliliter of Nabi-HB™ exceeds the
potency of anti-HBs in a U.S. reference hepatitis B immune globulin
(FDA). The U.S. reference has been tested by Nabi® against the WHO
standard and found to be equal to 208 IU/mL.
CLINICAL PHARMACOLOGY
Hepatitis B Immune Globulin (Human) products
provide passive immunization for individuals exposed to the
hepatitis B virus as evidenced by a reduction in the attack rate of
hepatitis B following use 6-9 .
Clinical studies 10,11 conducted prior to 1983
with hepatitis B immune globulins similar to Nabi-HB™ indicate the
advantage of simultaneous administration of hepatitis B vaccine and
Hepatitis B Immune Globulin (Human). The Centers for Disease Control
and Prevention Advisory Committee on Immunization Practices (ACIP)
advises that the combination prophylaxis be provided in certain
instances of exposure based upon the increased efficacy found with
that regimen in neonates 12 . Cases of hepatitis B are rarely seen
following exposure to HBV in persons with preexisting anti-HBs.
However, no prospective studies have been performed on the efficacy
of concurrent hepatitis B vaccine and Hepatitis B Immune Globulin
(Human) administration following parenteral exposure, mucous
membrane contact, or oral ingestion in adults.
Infants born to HBsAg-positive mothers are at
risk of being infected with HBV and becoming chronic carriers 13 .
The risk is especially great if the mother is also HBeAg-positive 14
. Studies conducted with hepatitis B immune globulins similar to
Nabi-HB™ indicated that for an infant with perinatal exposure to an
HBsAg-positive and HBeAg-positive mother, a regimen combining one
dose of Hepatitis B Immune Globulin (Human) at birth with the
hepatitis B vaccine series started soon after birth is 85-98%
effective in preventing development of the HBV carrier state 15-17 .
Regimens involving either multiple doses of Hepatitis B Immune
Globulin (Human) alone or the vaccine series alone have a 70-90%
efficacy, while a single dose of Hepatitis B Immune Globulin (Human)
alone has 50% efficacy 18 .
Since infants have close contact with primary
caregivers and they have a higher risk of becoming HBV carriers
after acute HBV infection, prophylaxis of an infant less than 12
months of age with Hepatitis B Immune Globulin (Human) and hepatitis
B vaccine is indicated if the mother or primary caregiver has acute
HBV infection 19 .
Sexual partners of HBsAg-positive persons are
at increased risk of acquiring HBV infection. A single dose of
Hepatitis B Immune Globulin (Human) is 75% effective if administered
within two weeks of the last sexual exposure to a person with acute
hepatitis B 19 .
Pharmacokinetics
Pharmacokinetics trials 20 of Nabi-HB™,
Hepatitis B Immune Globulin (Human), given intramuscularly to 50
healthy volunteers demonstrated pharmacokinetic parameters similar
to those reported by Scheiermann and Kuwert 21 . The half-life for
Nabi-HB™ was 23.1 ± 5.5 days. The clearance rate was 0.35 ± 0.12
L/day and the volume of distribution was 11.2 ± 3.4 L.
Maximum concentration of Nabi-HB™ was reached
in 6.5 ± 4.3 days. The maximum concentration of anti-HBs and the
area under the time-concentration curve achieved by Nabi-HB™ were
bioequivalent to that of another licensed Hepatitis B Immune
Globulin (Human) when compared in the same pharmacokinetics trial.
Comparability of pharmacokinetics between Nabi-HB™ and a
commercially available hepatitis B immunoglobulin indicate that
similar efficacy of Nabi-HB™ should be inferred.
INDICATIONS AND USAGE
Nabi-HB™, Hepatitis B Immune Globulin (Human),
is indicated for treatment of acute exposure to blood containing
HBsAg, perinatal exposure of infants born to HBsAg-positive mothers,
sexual exposure to HBsAg-positive persons and household exposure to
persons with acute HBV infection in the following settings:
- Acute Exposure to Blood Containing HBsAg
Following either parenteral exposure (needlestick, bite,
sharps), direct mucous membrane contact (accidental splash), or
oral ingestion (pipetting accident), involving HBsAg-positive
materials such as blood, plasma, or serum.
- Perinatal Exposure of Infants Born to
HBsAg-positive Mothers
Infants born to mothers positive for HBsAg with or without HBeAg
12 .
- Sexual Exposure to HBsAg-positive Persons
Sexual partners of HBsAg-positive persons.
- Household Exposure to Persons with Acute
HBV Infection
Infants less than 12 months old whose mother or primary
caregiver is positive for HBsAg. Other household contacts with
an identifiable blood exposure to the index patient.
Nabi-HB™ is indicated for intramuscular use
only.
CONTRAINDICATIONS
Individuals known to have had an anaphylactic
or severe systemic reaction to human globulin should not receive
Nabi-HB™, Hepatitis B Immune Globulin (Human), or any other human
immune globulin. Nabi-HB™ contains less than 100 micrograms per mL
IgA. Individuals who are deficient in IgA may have the potential to
develop IgA antibodies and have an anaphylactoid reaction. The
physician must weigh the potential benefit of treatment with
Nabi-HB™ against the potential for hypersensitivity reactions.
WARNINGS
In patients who have severe thrombocytopenia
or any coagulation disorder that would contraindicate intramuscular
injections, Nabi-HB™, Hepatitis B Immune Globulin (Human), should be
given only if the expected benefits outweigh the potential risks.
Nabi-HB™ is made from human plasma. Products
made from human plasma may contain infectious agents, e.g., viruses,
and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The
risk that such products can transmit an infectious agent has been
reduced by screening plasma donors for prior exposure to certain
viruses, by testing for the presence of certain current viral
infections, and by inactivating and/or reducing certain viruses. The
Nabi-HB™ manufacturing process includes a solvent/detergent
treatment step (using tri- n -butyl phosphate and Triton® X-100)
that is effective in inactivating known enveloped viruses such as
HBV, HCV, and HIV. Nabi-HB™ is filtered using a Planova® 35 nm Virus
Filter that is effective in reducing the levels of some enveloped
and non-enveloped viruses. These two processes are designed to
increase product safety. Despite these measures, such products can
still potentially transmit disease. There is also the possibility
that unknown infectious agents may be present in such products. ALL
infections thought by a physician possibly to have been transmitted
by this product should be reported by the physician or other health
care provider to Nabi at 1-800-458-4244. The physician should
discuss the risks and benefits of this product with the patient.
PRECAUTIONS
General
Nabi-HB™, Hepatitis B Immune Globulin (Human),
must be administered only intramuscularly for post-exposure
prophylaxis. The preferred sites for intramuscular injections are
the anterolateral aspect of the upper thigh and the deltoid muscle.
If the buttock is used due to the volume to be injected, the central
region should be avoided; only the upper, outer quadrant should be
used, and the needle should be directed anterior (i.e., not inferior
or perpendicular to the skin) to minimize the possibility of
involvement with the sciatic nerve 22 .
The 50 healthy volunteers who received Nabi-HB
in pharmacokinetic studies were followed for 84 days for possible
development of anti-HCV antibodies. No subject seroconverted.
Drug Interactions
Vaccination with live virus vaccines should be
deferred until approximately three months after administration of
Nabi-HB™, Hepatitis B Immune Globulin (Human). It may be necessary
to revaccinate persons who received Nabi-HB™ shortly after live
virus vaccination.
There are no available data on concomitant use
of Nabi-HB™ and other drugs; therefore, Nabi-HB™ should not be mixed
with other drugs.
Pregnancy Category C
Animal reproduction studies have not been
conducted with Nabi-HB™. It is also not known whether Nabi-HB™ can
cause fetal harm when administered to a pregnant woman or can affect
a woman's ability to conceive. Nabi-HB™ should be given to a
pregnant woman only if clearly indicated.
Nursing Mothers
It is not known whether this drug is excreted
in human milk. Because many drugs are excreted in human milk,
caution should be exercised when Nabi-HB™ is administered to a
nursing mother.
Pediatric Use
Safety and effectiveness in the pediatric
population have not been established for Nabi-HB™. However, the
safety and effectiveness of similar hepatitis B immune globulins
have been demonstrated in infants and children 12 .
Geriatric Use
Clinical studies of Nabi-HB™ did not include
sufficient numbers of subjects aged 65 and over to determine whether
they respond differently than younger subjects. Other reported
clinical experience has not identified differences in responses
between the elderly and younger patients.
ADVERSE REACTIONS
Fifty male and female volunteers received
Nabi-HB™, Hepatitis B Immune Globulin (Human), intramuscularly in
pharmacokinetics trials 20 . The number of patients with reactions
related to the administration of Nabi-HB™ included local reactions
such as erythema 6 (12%) and ache 2 (4%) at the injection site, as
well as systemic reactions such as headache 7 (14%), myalgia 5
(10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%). The
majority (92%) of reactions were reported as mild. The following
adverse events were reported in the pharmacokinetics trials and were
considered probably related to Nabi-HB™: elevated alkaline
phosphatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%),
elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1
(2%). All adverse events were mild in intensity. There were no
serious adverse events.
No anaphylactic reactions with Nabi-HB™ have
been reported. However, these reactions, although rare, have been
reported following the injection of human immune globulins 23 .
OVERDOSAGE
Although no data are available, clinical
experience reported with other human immune globulins suggests that
the only manifestations of overdose with Nabi-HB™, Hepatitis B
Immune Globulin (Human), would be pain and tenderness at the
injection site.
DOSAGE AND ADMINISTRATION
This product is for intramuscular use only.
The use of this product by the intravenous route is not indicated.
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration.
It is important to use a separate vial,
sterile syringe, and needle for each individual patient, in order to
prevent transmission of infectious agents from one person to
another. Any vial of Nabi-HB™, Hepatitis B Immune Globulin (Human)
that has been entered should be used promptly. Do not reuse or save
for future use. This product contains no preservative; therefore,
partially used vials should be discarded immediately.
Hepatitis B Immune Globulin (Human) may be
administered at the same time (but at a different site), or up to
one month preceding hepatitis B vaccination without impairing the
active immune response to hepatitis B vaccine 11 .
- Acute Exposure to Blood Containing HBsAg
Table 2 summarizes prophylaxis for percutaneous (needlestick,
bite, sharps), ocular, or mucous membrane exposure to blood
according to the source of exposure and vaccination status of
the exposed person. For greatest effectiveness, passive
prophylaxis with Hepatitis B Immune Globulin (Human) should be
given as soon as possible after exposure, as its value after
seven days following exposure is unclear 12 . An injection of
0.06 mL/kg of body weight should be administered intramuscularly
as soon as possible after exposure and within 24 hours, if
possible. Consult the hepatitis B vaccine package insert for
dosage information regarding the vaccine.
For persons who refuse hepatitis B vaccine or are known
non-responders to vaccine, a second dose of Hepatitis B Immune
Globulin (Human) should be given one month after the first dose
12
- Prophylaxis of Infants Born to Mothers
who are Positive for HBsAg with or without HBeAg
Table 3 contains the recommended schedule of hepatitis B
prophylaxis for infants born to mothers that are either known to
be positive for HBsAg or have not been screened. Infants born to
mothers known to be HBsAg-positive should receive 0.5 mL
Hepatitis B Immune Globulin (Human) after physiologic
stabilization of the infant and preferably within 12 hours of
birth. The hepatitis B vaccine series should be initiated
simultaneously, if not contraindicated, with the first dose of
the vaccine given concurrently with the Hepatitis B Immune
Globulin (Human), but at a different site. Subsequent doses of
the vaccine should be administered in accordance with the
recommendations of the manufacturer.
Women admitted for delivery, who were not screened for HBsAg
during the prenatal period, should be tested. While test results
are pending, the newborn infant should receive hepatitis B
vaccine within 12 hours of birth (see manufacturers'
recommendations for dose). If the mother is later found to be
HBsAg-positive, the infant should receive 0.5 mL Hepatitis B
Immune Globulin (Human) as soon as possible and within seven
days of birth; however, the efficacy of Hepatitis B Immune
Globulin (Human) administered after 48 hours of age is not known
10,19 . Testing for HBsAg and anti-HBs is recommended at 12-15
months of age. If HBsAg is not detectable and anti-HBs is
present, the child has been protected 12 .
- Sexual Exposure to HBsAg-positive Persons
All susceptible persons whose sexual partners have acute
hepatitis B infection should receive a single dose of Hepatitis
B Immune Globulin (Human) (0.06 mL/kg) and should begin the
hepatitis B vaccine series, if not contraindicated, within 14
days of the last sexual contact or if sexual contact with the
infected person will continue. Administering the vaccine with
Hepatitis B Immune Globulin (Human) may improve the efficacy of
post exposure treatment. The vaccine has the added advantage of
conferring long-lasting protection 19 .
- Household Exposure to Persons with Acute
HBV Infection
Prophylaxis of an infant less than 12 months of age with 0.5 mL
Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is
indicated if the mother or primary caregiver has acute HBV
infection. Prophylaxis of other household contacts of persons
with acute HBV infection is not indicated unless they had an
identifiable blood exposure to the index patient, such as by
sharing toothbrushes or razors. Such exposures should be treated
like sexual exposures. If the index patient becomes an HBV
carrier, all household contacts should receive hepatitis B
vaccine 19 .
HOW SUPPLIED
Nabi-HB™, Hepatitis B Immune Globulin (Human),
is supplied as:
| NDC Number
|
Contents
|
| 59730-4202-1
|
a carton
containing a 1 mL dose in a single-use vial (>312 IU)
and package insert |
| 59730-4203-1
|
a carton
containing a 5 mL dose in a single-use vial (>1560
IU) and package insert |
|
STORAGE
Refrigerate between 2 to 8 °C (36 to 46 °F).
Do not freeze. Do not use after expiration date. Use within 6 hours
after the vial has been entered.
REFERENCES
- Cohn E.J., Strong W.L., Mulford D.J.,
Ashworth J.N., Melin M., Taylor H.L. Preparation and Properties
of Serum and Plasma Proteins IV. A system for the separation
into fractions of the protein and lipoprotein components of
biological tissues and fluids. J Am Chem Soc 1946, 68: 459-475.
- Oncley J.L, Melin M, Richert D.A, Cameron
J. W, Gross P.M. The separation of antibodies, issogglutinins,
prothrombin, plasminogen and b1-lipoproteins into sub-fractions
of human plasma. J Am Chem Soc 1949, 71:541-550.
- Horowitz B: Investigations into the
application of tri( n -butyl)phosphate/detergent mixtures to
blood derivatives. Morgenthaler J (ed): Virus Inactivation in
Plasma Products, Curr Stud Hematol Blood Transfus 1989;
56:83-96.
- Burnouf T: Value of virus filtration as
method for improving the safety of plasma products. Vox Sang
1996; 70:235-236.
- Unpublished data on file, Viral
Validation Study Reports, Nabi.
- Grady GF, and Lee VA: Hepatitis B immune
globulin - prevention of hepatitis from accidental exposure
among medical personnel. N Engl J Med 1975; 293:1067-1070.
- Seeff LB, et al. : Type B hepatitis after
needle-stick exposure: Prevention with hepatitis B immune
globulin. Ann Int Med 1978; 88:285-293.
- Krugman S, and Giles JP: Viral hepatitis,
type B (MS-2-strain). Further observations on natural history
and prevention. N Engl J Med 1973; 288:755-760.
- Hoofnagle JH, et al. : Passive - active
immunity from hepatitis B immune globulin. Ann Int Med 1979;
91:813-818.
- Beasley RP, et al. : Efficacy of
hepatitis B immune globulin for prevention of perinatal
transmission of the hepatitis B virus carrier state: Final
report of a randomized double-blind, placebo - controlled trial.
Hepatology 1983; 3:135-141.
- Szmuness W, et al. : Passive active
immunisation against hepatitis B: Immunogenicity studies in
adult Americans. Lancet 1981; 1:575-577.
- Centers for Disease Control:
Recommendations for protection against viral hepatitis.
Recommendations of the Immunization Practices Advisory Committee
(ACIP). MMWR 1985; 34(22):313-335.
- Shiraki Y, et al. : Hepatitis B surface
antigen and chronic hepatitis in infants born to asymptomatic
carrier mothers. Am J Dis Child 1977; 131:644-647.
- Beasley RP, et al. : The e antigen and
vertical transmission of hepatitis B surface antigen. Am J
Epidemiol 1977; 105:94-98.
- Wong VCW, et al. : Prevention of the
HBsAg carrier state in newborn infants of mothers who are
chronic carriers of HBsAg and HBeAg by administration of
hepatitis B vaccine and hepatitis B immunoglobulin: Double-blind
randomized placebo-controlled study. Lancet 1984; 1:921-926.
- Poovorawan Y, et al. : Long term
hepatitis B vaccine in infants born to hepatitis B e antigen
positive mothers. Archives of Diseases in Childhood 1997;
77:F47-F51.
- Stevens CE, et al. : Perinatal Hepatitis
B virus transmission in the United States: Prevention by
passive-active immunization. JAMA 1985; 253:1740-1745.
- Jhaveri R, et al. : High titer multiple
dose therapy with HBIG in newborn infants of HBsAg positive
mothers. J Pediatr 1980; 97:305-308.
- Centers for Disease Control: Hepatitis B
virus: A comprehensive strategy for eliminating transmission in
the United States through universal childhood vaccination.
Recommendations of the Immunization Practices Advisory Committee
(ACIP). MMWR 1991; 40(13):1-25.
- Data on file, Nabi®
- Scheiermann N, Kuwert EK: Uptake and
elimination of hepatitis B immunoglobulins after intramuscular
application in man. Develop Biol Standard 1983; 54:347.
- Centers for Disease Control: General
recommendations on immunization. Recommendations of the Advisory
Committee on Immunization Practices (ACIP). MMWR 1994; 43:1-38.
- Ellis EF, Henney CS: Adverse reactions
following administration of human gamma globulin. J Allerg 1969;
43:45-54.
Manufactured by:
Nabi®
Boca Raton, FL 33487
U.S. License No. 1022
November 2001
3-440-1118
July 29, 2004
http://www.prweb.com/news/20040729/index.htm
NEW
- Hepatitis C disinfectant just introduced in the Salon industry,
could mean the end of O'L BLUE!
SaniGuard an emerging leader in infection control products has
introduced a complete line of sanitization products for the beauty
and barber industry's including SaniGuard PRO™ the Industry’s First
Hospital Grade Disinfectant with a Hepatitis C Efficacy Claim and 4
patent pending color choices.
For salon and spa owners, providing services to their clients in
clean and safe surroundings has to be their number one priority.
Until now the choices have been limited with no real advances with
sanitization in the beauty & barber industry. To help achieve a
healthy environment, SaniGuard®, an emerging leader in the medical
and health field, has introduced a new cutting edge professional
line of salon sanitization products, SaniGuard Professional Salon
Products.
The SaniGuard Professional Salon Products line encompasses seven
products with their first product release and includes many firsts
in the salon and spa industry, such as the first Hepatitis C
efficacy claim and patent-pending colored disinfectants for salon
tools and implements.
The SaniGuard Professional Salon Products line includes:
•SaniGuard PRO™ Concentrated Hospital Grade Disinfectant - The
beauty and barber industry’s first EPA-registered hospital grade
disinfectant with a Hepatitis C efficacy claim. SaniGuard PRO comes
in four patent-pending colors (green, purple, red & yellow) and is
virucidal, fungicidal, bactericidal and has been tested on and
proven effective against TB, HIV 1 & 2, Hepatitis B & C, Herpes 1 &
2, Staph, Strep & over 50 other leading infection concerns including
MSRA strains. It also does not contain dangerous phenols like other
TB approved products in the beauty industry.
•SaniGuard Barrier Skin Cream™ - The most advanced barrier skin
cream introduced to date. When applied it dries quickly without any
sticky residue and will provide temporary protection for 3-4 hours
repelling everything from chemicals and dyes to perm solutions and
water. In many applications it is making latex or vinyl gloves a
thing of the past.
•SaniGuard Dry Sanitizing Surface Spray™ - The world's first dry on
contact spray sanitizer and deodorizer. Due to it's dry on contact
properties, it safely sanitizes surfaces that ordinary wet products
damage. Electronics, rubber, plastic, fabrics even paper, without
damage!
•SaniGuard Total Release Fogger™ - The World's first disposable room
fogger. It enables the user to quickly sanitize entire rooms in just
minutes with the same "kill on contact" power of the conventional
SaniGuard sprays. Each fogger treats up to 625 sq. ft. in one
application.
•SaniGuard PRO™ Salon Disinfectant and Manicure Jar - Modern
designed options for more efficent brush and tool disinfecting.
SaniGuard's trademark square jar is quickly becoming the industries
top choice nationwide.
•SaniGuard PRO Brush & Comb Tub™ - A one gallon plastic tub for
large scale disinfecting, hair removal or sanitary storage of combs
and brushes. SaniGuard Tubs provide an attractive design for any
station and easy function for maintaining a sanitary service area.
“From SaniGuard PRO – the first high powered Hepatitis C rated
liquid tool disinfectant with color options, to the industries first
Total Release Fogger for effectively treating entire rooms in just
minutes to the most advanced Barrier Skin Cream that the industry
has seen to date, SaniGuard is your source for superior salon and
spa sanitization essentials that are priced right,” says David
Harried, V.P. of Marketing. “SaniGuard Professional Salon Products
help to protect your customers and your employees, while making it
easier to meet tough state regulations. It's time to say so long to
the outdated old blue formula and replace it with advanced
protection."
For more information on how SaniGuard Professional Salon Products
can help you achieve the ultimate in clean for your salon or spa,
please contact David Harried at 608.347.9003,
sales@saniguardpro.com or visit us
online at
http://saniguardpro.com.
All Press Releases for July 29, 2004
|
Home