POLYVALENT SNAKEBITE ANTISERUM

Država: Južnoafrička Republika

Jezik: engleski

Izvor: South African Health Products Regulatory Authority (SAHPRA)

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Preuzimanje Uputa o lijeku (PIL)
11-06-2024
Preuzimanje Svojstava lijeka (SPC)
11-06-2024

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Uputa o lijeku

                                POLYVALENT SNAKEBITE ANTISERUM
THE SOUTH AFRICAN INSTITUTE FOR MEDICAL RESEARCH
SERUM AND VACCINE DEPARTMENT, RIETFONTEIN.
Modderfontein Road, Edenvale, Transvaal · P O Box 1038, Johannesburg, 2000 · Telegrams “Bacteria”
PROPRIETARY NAME
(and dosage form):
POLYVALENT SNAKEBITE ANTISERUM
DESCRIPTIVE NAME:
POLYVALENT SNAKE BITE ANTISERUM 
(ANTIVENOM) (REFINED EQUINE SERUM GLOBULINS).
REGISTRATION NO.:
T517 (Act 101 1965)
PHARMACOLOGICAL CLASSIFICATION:
A30.2 ANTIBODIES
SCHEDULING STATUS:
S1
COMPOSITION:
Pepsin-refined immunoglobulins, prepared from the serum of horses that have been hyper-immunised with snake venoms.
The venoms of the following snakes are used as antigens in the preparation of Polyvalent Antivenom:–Bitis arietans
(puff adder), B. gabonica (Gaboon adder), Hemachatus haemachatus (rinkhals), Dendroaspis angusticeps (green mamba),
D. jamesoni (Jameson's mamba), O. polylepis (black mamba) Naja nivea (Cape cobra), N. melanoleuca (forest cobra), N.
haje (Egyptian cobra), N. mossambica (black-necked cobra). Contains 0,3% Cresol as preservative.
It conforms to the potency requirements laid down in the South African Therapeutic Substances Regulations.
IDENTIFICATION:
A light yellowish to light brown clear liquid.
PHARMACOLOGICAL ACTION:
Neutralises the venom of specific snakes.
INDICATIONS:
For the treatment of snake bite as follows:-
Polyvalent Antivenom (Bitis, Dendroaspis, Hemachatus, Naja).
This serum is effective against the venoms of the rinkhals, the mambas and all the cobras and vipers likely to cause
serious accidents in Southern and Central Africa. Serum treatment is usually not required for bites by the night adders
(Causus).
The serum is ineffective, AND SHOULD NOT BE USED in the treatment of bites caused by the berg adder (Bitis atropos),
the horned adders (Bitis cornuta, B.
                                
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Svojstava lijeka

                                GUIDELINES FOR THE MANAGEMENT OF SNAKEBITE VENOM
CYTOTOXIC
NEUROTOXIC
MIXED CYTOTOXIC AND NEUROTOXIC
HAEMOTOXIC
SNAKE SPECIES
Puff adder, Gaboon adder, spitting cobras (Mozambique,
black-necked, black, zebra), Stiletto snakes (Bibron’s and
Congo), night adders, horned and many horned adders,
lowland swamp viper.
Black and green mamba, non-spitting
cobras (snouted, Cape, forest, Anchieta’s)
Rinkhals, berg adder, Peringuey’s adder, desert
mountain adder, garter snakes, shield-nose
snake
Boomslang, vine snake (eastern
and savanna)
DOMINANT CLINICAL
PRESENTATION OF
VICTIM
Painful progressive swelling (PPS)
Bleeding may occur in puff adder bites
(thrombocytopenia) and Gaboon adder bites
(consumption coagulopathy)
Progressive weakness (PW)
PPS occurs in non-spitting cobra bites
Combined PPS and PW
Bleeding (B)
FIRST AID
* Suction or nil.
* Suction or nil.
Non-spitting cobras : pressure
immobilisation or arterial tourniquet.
Mambas : arterial tourniquet. Polyvalent
antivenom for the triad of perioral
paraesthesia, excessive salivation or
metallic taste and sweating OR difficulty
in breathing. Artificial respiration may be
necessary
* Suction or nil.
* Suction or nil.
TAKE THE PATIENT TO HOSPITAL OR NEAREST MEDICAL HELP
SUPPORTIVE
TREATMENT
Intravenous fluids
Elevate bitten limb **
Analgesia
Oxygen by mask or ventilation. Protect
the airway.
See cytotoxic and neurotoxic
Blood or blood component
therapy
ANTIVENOM MAY BE
NECESSARY FOR
THREAT TO LIMB OR
LIFE ***
Puff adder, spitting cobras, Gaboon adder
All species
Rinkhals
Boomslang
ANTIVENOM TYPE
Polyvalent
Polyvalent
Polyvalent
Boomslang monospecific
SUGGESTED DOSE BY
INTRAVENOUS
INJECTION
50ml : puff adder and spitting cobras
200ml : Gaboon adder
80ml (40 – 200ml)
Small doses may lead to a recurrence of
symptoms.
50ml
10 – 20ml
PERCENTAGE BITES
ANTIVENOM
INDICATED IN
< 10%
50 – 70%
< 10%
80 -100%
*
SUCTION IS OF MINIMAL BENEFIT BUT REASSURING TO THE PATIENT
**
SOME AUTHORITIES PREFER KEEPING THE BITTEN LIMB AT HEART LEVEL.
*** POLYVALENT ANTIVENOM IS EFFECTI
                                
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