LifeTide® SW 5
LifeTide® SW 5
is the world’s first and only approved Growth Hormone Releasing
Hormone (“GHRH”) DNA therapy for food animals. The product
is an injectable DNA plasmid encoding for porcine GHRH, and is administered
as a once in a lifetime treatment for use in sows of breeding age
to increase the number of piglets weaned. Licensing studies completed
in Australia demonstrated a significant decrease in perinatal mortality
and morbidity, resulting in an increase in sow productivity and
the number of pigs weaned per sow.
LifeTide® SW 5 was approved in Australia
in January 2008 by the Australian Pesticides and Veterinary Medicines
Authority (APVMA). Further information about this approval is available
Below is the Product Leaflet for LifeTide®
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
LifeTide® SW 5
Injectable Plasmid Encoding Porcine GHRH
Each mL of LifeTide® SW 5 Injectable Plasmid Encoding Porcine
GHRH contains 2.5 mg Synthetic Porcine GHRH-encoding plasmid stabilised
with 1% w/w Poly-L-Glutamate in sterile water.
LifeTide® SW 5 is a once in a lifetime treatment for use in
sows of breeding age to increase the number of piglets weaned. LifeTide®
SW 5 must only be used by, or under the direction of, a registered
In a field study involving 483 treated sows and
gilts and 488 control sows and gilts administration of LifeTide®
SW 5 during pregnancy increased the number of piglets weaned by
at least 1 piglet per sow over three litters.
To maximize the benefit of LifeTide® SW
5 it should only be used in healthy sows and gilts that are well
fed and managed to avoid potentially confounding effects on weaning
rates due to inadequate sow nutrition, ill health or poor hygiene.
MODE OF ACTION
The active constituent in LifeTide® SW 5 is a plasmid sequence
that typically, after intramuscular injection and electroporation,
enters skeletal muscle cells at the injection site and resides within
the muscle cell. Treated muscle cells actively produce growth hormone
releasing hormone (GHRH) at physiological concentrations. The GHRH,
in turn, induces the animal to produce and secrete endogenous growth
hormone under the control of normal physiological feedback mechanisms.
The plasmid is delivered to the target tissue,
usually a large muscle such as the semimembranosus or sternocranialis,
by direct intramuscular injection followed by electroporation. Electroporation
increases the efficiency of uptake of DNA into skeletal muscle cells.
The manufacturer provides the portable electrokinetic device, CELLECTRA®
(VGX™ Animal Health, Inc., The Woodlands, TX, USA). When used
as set by the manufacturer, the CELLECTRA® device will deliver
the appropriate electroporation conditions.
Administration must be conducted with the pig under
short-term, light, general anaesthesia.
DIRECTIONS FOR USE
DO NOT administer any aminoglycoside antibiotic for 7 days after
TO BE USED by, or under the direction of, a veterinary surgeon as
a once in a lifetime treatment in sows under general anaesthesia.
DISCARD UNUSED PRODUCT WITHIN 24 HOURS
OF FIRST BROACHING VIAL
Dosage and administration:
The recommended dose of 2mL LifeTide® SW 5 is injected
intramuscularly prior to electroporation. Sows/gilts must be under
short-term light general anaesthesia during administration and electroporation.
Inject 2mL LifeTide® SW 5 into the muscle
using a 3mL syringe and a 21 gauge, 2.0” needle. Using the
CELLECTRA® device and a five electrode array electroporator
head with the syringe needle inserted through the centre port of
the array, apply electroporation according to the manufacturer’s
Any spilled product should be wiped up with appropriately
diluted bleach and disposed of by incineration.
WITHHOLDING PERIOD: MEAT - NIL
EXPORT SLAUGHTER INTERVAL (ESI): ESI not required
FIRST AID: If poisoning occurs,
contact a doctor or Poisons Information Centre. Phone Australia
SW 5 is available in 10mL PETG multi-dose vials.
STORAGE: Store below -18°C
(Deep freeze). Allow to thaw at room temperature immediately before
injection. Once thawed, unused vials and syringes may be stored
for up to 6 months at 2 to 8°C (Refrigerate). Do not refreeze.
After stopper penetration, product must be used within 24 hours.
DISPOSAL: Dispose of empty syringes
and plastic containers and any unused product by incineration. Rinse
glass vials with bleach and dispose of by wrapping with paper and
putting in garbage.
VGX™ Animal Health, Inc.
2700 Research Forest Drive #180
The Woodlands, TX 77381 USA
Redcap Animal Health Pty Ltd
192A Short Street
Birchgrove NSW 2041 AUSTRALIA
Telephone: (02) 9810 3438
APVMA Approval Number: 59865/0108
1. Data on file
2. Published References
a. Khan, A S.; Brown P A,; Draghia-Akli R. (2005) Current Opinion
in Molecular Therapeutics. 7(4):306-316
b. Khan A S.; Pope M A.; Draghia-Akli R. (2005) DNA and Cell Biology
24 (12) 810-818
c. Brown P A.; Davis W C.; Draghia-Akli R. (2004) Molecular Therapy
10 (4) 644-651
d. Khan A S. et al (2003). Am J. Physiol Endocrinol Metab 285; E224