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A.
PREAMBLE: Scorpion Antivenin IP is of equine origin
derived from the plasma of the horses, ponies, mules, etc.,
that have been hyperimmunized against the venom of Red Scorpion(Mesobuthus
tamulus concanesis, Pocock)earlier called as Buthus tamulus.
Serum obtained from plasma contains purified, enzyme refined
and concentrated specific heterologous immunoglobulins.
It is used as a passive immunising agent and affords protection
to the susceptible victims against the sting of Red Scorpion
(Mesobuthus tamulus concanesis, Pocock). 1ml. of the reconstituted
'Scorpion Antivenin IP.' neutralises 1.0 mg. of dried Red
Scorpion (Mesobuthus tamulus concanesis, Pocock) venom.
It also contains 0.25% phenol IP. as preservative. The moisture
content in the lyophilised 'Scorpion Antivenin IP. does
not exceed 1 per cent.
DIRECTIONS FOR USE
A. INDICATIONS: The Scorpion Antivenin IP. is indicated
for all stings caused by Red Scorpion (Mesobuthus tamulus
concanesis, Pocock) venom where patient presents with clinical
signs and symptoms of envenomation.
B. PRECAUTIONS TO BE OBSERVED BEFORE ADMINISTRATION OF
SCORPION ANTIVENIN IP.
1. Elicit history of familiar allergic disorders such as
asthma, eczema, drug allergy from the patient.
2. Whether he had received earlier, injection of serum such
as antitetanus serum, antidiphtheria serum etc.
3. Carry out the sensitivity test on the patient. Inject
subcutaneously 0.1 ml. of the serum diluted 1:10. Observe
the patient for 30 minutes for local or general reactions,
if any. In the absence of adverse reactions, administer
the requisite dose by the chosen route of injection.
4. Keep handy injection Adrenaline (Epinephrine) 1 ml. 1:1000
along with antihistamines and steroids to meet any emergency
arising out of sensitivity reactions.
5. After administering the full dose of serum, the patient
should be kept under observation for atleast 30 minutes.
6. If a patient is found sensitive to the equine antiserum,
you may desensitise him by administering graded dose of
the anitserum at regular and adequate intervals. Before
desensitising the patient the doctor has to decide whether
serotherapy is really needed.
7. In sensitive individuals where the time factor is of
paramount importance, it is advisible to administer Scorpion
Antivenin IP. under the cover of Inj. Adrenaline (Epinephrine)
1ml. (1:1000)i.m. antihistaminics without awaiting the results
of the test dose.
C.
CONTRA-INDICATIONS :
There are no known contraindications for the administration
of Scorpion Anitvenin IP.
D. ADVERSE DRUG REACTIONS: This serum being heterologous
is liable to cause sensitivity reactions in occasional patient.
The immediate reaction is anaphylactic shock (immediate
hypersensitivity) characterised by sweating, pallor , bronchospasm,
laryngospasm, hypotension leading to shock, coma and death.
Treatment consists of prompt administration of Injection
Epinephrine, steroids and antihistamines alongwith ancillary
measures such as endotracheal incubation, oxygen therapy
and treatment of shock. A late serum sickness like syndrome
(delayed hypersensitivity) occurring seven to eight days
after serum administration consists of fever, rashes, lymphaadenopathy,
arthralagias. This is usually self-limiting and does not
require treatment. If the precautions mentioned above are
followed, there is less likelihood of any of these reactions
occurring.
E. RECONSTITUTION OF LYOPHILISED SCORPION ANITVENIN IP.
1. Draw 10 ml. of Sterile Water for Injection IP. in clean,
sterile syringe.
2. Break open the central ring of the seal of the vial and
transfer the contents of the syringe into the vial, shake
well and allow the powder to dissolve completely.
3. Allow it to stand for about a minute to get a crystal
clear solution.
4. The solution is now ready for administration.
5. Froth and undissolved particles, if any, should be left
in the vial. F. GRADING OF ENVENOMATION Envenomation following
a scorpion sting is graded as follows: Grade I: Signs of
peripheral failure with cold and clammy extremities, sweating,
restlessness and hypotension. Grade II: Grade I signs with
sudden onset of tachycardia, gallop rhythm, nausea and vomiting
( suggestive of myocarditis). Grade III:Grade I signs with
neurotoxic manifestations. The Scorpion Antivenin IP. should
be administered at the earliest.
G. ADMINISTRATION: Prior to administering the Scorpion
Antivenin IP, it is obligatory to observe the precautions
and carry out sensitivity test as mentioned at B-3. The
usual mode of administration of Scorpion Antivenin IP is
either by intramuscular or intravenous route. Generally,
10 ml. of the reconstituted Scorpion Antivenin IP is sufficient
for the treatment. However, if the patient continues to
show clinical signs of envenomation for more than 3 hours
or if the signs if aggravate further, 10 ml. of the antiserum
may be administered by the intravenous route. In very rare
cases, further 10 ml. will have to be given.
H. STORAGE:
Being lyophilised the Scorpion Antivenin IP is stable at
room temperature and does not require special storage facilities.
Ideally, it should be stored in a dark place, away from
excessive heat.
I. PRESENTATIONS 10 ml vial box of 1 10 ml vial,
box of 5 10 ml vial , box of 10 10 ml vial, box of 20
An ampoule of Sterile Water for Injection IP 10 ml. accompanies
each vial of Scorpion Antivenin IP. for the purpose of reconstitution
of lyophilised Scorpion Antivenin IP.
J. SOME IMPORTANT DONT'S :
1. Ligature and cryotherapy.
2. Cutting incision and suction.
3. Use of respiratory depressants, diuretics, digitalis,
atropine, corticosteroids and antihistamines.
4. Use of Snake Antivenin.
5. Mixing of Adrenaline (Epinephrine) with lignocaine (for
local anethesia) to relieve pain at the sight of sting.
Emetine Hydrochloride, being protoplasmic poison, its toxic
effects on the myocardium may cause hypotension, tachychardia,
precordial pain, dysponea and ECG abnormalities.
HENCE IT SHOULD BE NEVER BE ADMINISTERED LOCALLY AT THE
SIGHT OF STING TO RELIEVE PAIN.
K. ASSOCIATED THERAPY.: Insuline-glucose therapy
is advised. 0.3 units of regular Insuline/g of glucose and
glucose at the rate of 0.1 g/kg/hr. This glucose insuline
is to be given as continous infusion. Dopamine or dobutamine
drip in 5% glucose (5 to 7 mcg/kg/minute) may also be simultaneously
given to maintain the blood pressure. If the patient presents
with the hypertension during the initial phase of transient
hypertension, give sublingual nifedipine 5 mg in children
and 10 mg in adults.
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