RECIPIENT NAME

HEMATOTOXIC SNAKE ANTIVENIN FOR MALAYAN

PIT VIPER VENOM, GREEN PIT VIPER VENOM,
RUSSELL’S VIPER VENOM

Hematotoxic Snake Antivenin for Malayan Pit Viper

Venom, Green Pit Viper Venom, and Russell’s Viper
Venom: this antivenom can be used for Calloselasma
rhodostoma venom, Trimeresurus albolabris venom,
and Daboia russelli siamensis venom

The Red Cross produces 7 kinds of Monovalent snake

antivenin that separate into 2 major group that are snake
antivenin against the neurotoxic snake (King cobra
antivenin, Cobra antivenin, Banded Krait antivenin and
Malayan Krait antivenin) and hematotoxic snake (Malayan
pit viper antivenin, Green pit viper antivenin and Russell’s
viper antivenin). The polyvalent snake antivenom are also
produced against such 2 group of snake.

Administration

The freeze-dried antivenin must be reconstituted with the

solution supplied (or 10 ml of sterile water for injection)
prior to the administration.

Dosage of hemato polyvalent snake antivenin to

neutralize Malayan Pit Viper venom, Green Pit Viper
venom, and Russell’s Viper venom

The initial dose of this hematotoxic polyvalent snake

antivenin is 30 ml of reconstituted antivenin that should be
given by slow intravenous infusion (approx. 2 ml/min).
Subsequent dose can be given every 6 hours according to
the clinical symptoms.

Contraindication

None, unless the patient is known to be hypersensitive to

constitutions of the product, appropriate precautions must
be taken.

Side effects

Occasionally, transient tenderness at the injection site,

cutaneous reaction and alterations in temperature may
occur. In some cases nausea, vomiting and also circulatory
reactions (e.g. tachycardia, bradycardia, hypotension,
sweating, vertigo) and allergic reactions (e.g. with flush,
urticaria, dyspnea) have been observed, extending in
isolated cases as far as shock. Therefore, the patient
should be monitored for an extended period of
time.Therapeutic measures depend on the nature and

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 severity of side effects. Antihistamines, if necessary
adrenaline, high doses of corticosteroids, volume
replacement, oxygen.

Special precautions

Since the antivenin is prepared from horse serum,

sensitization to heterologous protein may occur in some
individuals. To avoid serious allergic reactions, skin test
should be performed prior to the administration by
injection of 0.02 ml of 1:100 antivenin dilution
intradermally. It should be noted that the skin test may
not predict the anaphylaxis nor delay serum sickness
reactions.

Storage and stability

Keep in tightly closed container and store below 25-degree

Celsius. The product shall have a shelf life of 5 years from
the manufacturing date.

The manufacturing plant of QSMI has developed to meet

the GMP requirement and get the GMP certificated from
Thai FDA since 2003.

RECIPIENT NAME
NEURO POLYVALENT SNAKE ANTIVENIN TO
NEUTRALIZE COBRA AND KING COBRA VENOM,
BANDED KRAIT VENOM, MALAYAN KRAIT VENOM

Neuro Polyvalent Snake Antivenin to Neutralize

Cobra and King Cobra Venom, Banded Krait Venom,
and Malayan Krait Venom: this antivenom can be
used against Ophiophagus Hannah venom, Naja
Kaouthia venom, Bungarus fasciatus venom, and
Bungarus candidus venom

The Red Cross produces 7 kinds of Monovalent snake

antivenin that separate into 2 major group that are snake
antivenin against the neurotoxic snake (King cobra
antivenin, Cobra antivenin, Banded Krait antivenin and
Malayan Krait antivenin) and hematotoxic snake (Malayan
pit viper antivenin, Green pit viper antivenin and Russell’s
viper antivenin). The polyvalent snake antivenom are also
produced against such 2 group of snake.

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 Administration

The freeze-dried antivenin must be reconstituted with the

solution supplied (or 10 ml of sterile water for injection)
prior to the administration.

Dosage of neuro polyvalent snake antivenin to

neutralize Cobra and King Cobra Venom, Banded
Krait Venom, and Malayan Krait Venom

The initial dose of this neuro polyvalent snake antivenin is

50 ml of reconstituted antivenin that should be given by
slow intravenous infusion (approx. 2 ml/min) but the
Cobra antivenin initial dose is 100 ml. Subsequent dose
can be given every 12 hours according to the clinical
symptoms.

Contraindication

None, unless the patient is known to be hypersensitive to

constitutions of the product, appropriate precautions must
be taken.

Side effects

Occasionally, transient tenderness at the injection site,

cutaneous reaction and alterations in temperature may
occur. In some cases nausea, vomiting and also circulatory
reactions (e.g. tachycardia, bradycardia, hypotension,
sweating, vertigo) and allergic reactions (e.g. with flush,
urticaria, dyspnea) have been observed, extending in
isolated cases as far as shock. Therefore, the patient
should be monitored for an extended period of
time.Therapeutic measures depend on the nature and
severity of side effects. Antihistamines, if necessary
adrenaline, high doses of corticosteroids, volume
replacement, oxygen.

Special precautions

In cases of Cobra and Krait bites, respiratory support may

be essential. Since the antivenin is prepared from horse
serum, sensitization to heterologous protein may occur in
some individuals. To avoid serious allergic reactions, skin
test should be performed prior to the administration by
injection of 0.02 ml of 1:100 antivenin dilution
intradermally. It should be noted that the skin test may
not predict the anaphylaxis nor delay serum sickness
reactions.

Storage and stability

Keep in tightly closed container and store below 25-degree

Celsius. The product shall have a shelf life of 5 years from
the manufacturing date.

The manufacturing plant of QSMI has developed to meet

the GMP requirement and get the GMP certificated from

3
 Thai FDA since 2003.

RECIPIENT NAME
BIOSAVE
POLYVALENT ANTI-SNAKE VENOM SERUM
(EQUINE)

Pendahuluan
ABU, yang umumnya beredar di Indonesia, diproduksi oleh
Bio Farma, berasal dari plasma kuda, bersifat
polivalen/trivalen, berupa cairan bening kekuningan,
dipasarkan dengan nama dagang Biosave.
ABU produksi Bio Farma, yang selama ini digunakan di
Indonesia, hanya untuk menetralkan racun ular berbisa,
dari tiga jenis saja.
ABU digunakan sebagai terapi anti venom lini pertama
untuk: 
 Racun ular berbisa, yang bersifat neurotoksik: 
 Naja sputratix, atau ular kobra, atau ular
sendok
 JawaBungarus fasciatus, atau ular welang,
jarang menggigit manusia
 Racun ular berbisa, yang bersifat hemotoksik:
 Calloselasma rhodostoma, atau Agkistrodon
rhodostoma, atau ular tanah, atau juga
dikenal di Malaysia sebagai Malayan pit viper

Indikasi
Indikasi utama Serum Anti Bisa Ular (ABU) semestinya
diberikan kepada pasien, yang dicurigai, atau terbukti
digigit ular berbisa, dan telah menunjukkan satu, atau
lebih tanda klinis manifestasi racun ular, dengan

4
 pemberian dosis sebesar 2 vial, sebagai cairan infus dalam
larutan normal saline.

Dosis
Dosis ideal tidak dapat ditentukan karena belum ada uji
klinis hingga sekarang. Dosis ideal ini berkenaan dengan
jumlah, atau volume racun ular berbisa yang masuk
kedalam tubuh korbannya, dimana pada praktiknya tidak
diketahui secara pasti pada tiap manusia yang digigit ular
berbisa. Karenanya, dosis diberikan secara umum sebesar
2 vial @ 5 mL. Dosis tersebut diberikan sama kepada
orang dewasa, maupun kepada anak, karena sewaktu
menggigit, ular berbisa mengeluarkan racun dalam jumlah
yang sama, baik kepada orang dewasa, atau anak-anak.
Dosis 2 vial ini dimasukkan kedalam larutan fisiologis
sebanyak 5-10 ml larutan isotonik/kgBB atau pada pasien
dewasa dilarutkan dalam 250-500 ml normal salin ataupun
dextrose 5%. Kemudian, ABU diberikan melalui infus
dengan kecepatan konstan selama 1 jam. Apabila pasien
masih mengalami perdarahan yang berlanjut, atau
memburuknya tanda klinis neurotoksik, atau
kardiovaskular, maka dosis dapat diulang dalam waktu 1‒
2 jam setelah dosis awal. Pemberian ini dapat diulang 6
jam kemudian, apabila masih terdapat gangguan koagulasi
darah.
ABU dapat diberikan langsung, secara intravena dengan
injeksi yang sangat perlahan, apabila tidak diencerkan.
Kecepatan pemberian adalah 2 mL/menit. ABU tidak boleh
diberikan secara intramuskular apabila pemberian dapat
dilakukan secara intravena. Apabila terpaksa diberikan
secara intramuskular, misalnya pada keadaan dimana
akses terhadap petugas medis sangat sulit atau akses
intravena tidak memungkinkan, maka ABU tidak boleh
diberikan melalui regio gluteal karena penyerapannya
sangat lambat.
Pada DOEN 2013, tercantum anti bisa ular polivalen II,

5
 khusus digunakan untuk menetralkan racun ular di Papua,
atau Irian Barat. 
ABU diberikan pada situasi dimana pasien dapat dimonitor
secara ketat oleh dokter dan obat-obat untuk menangani
anafilaksis tersedia. Pemberian ABU dihentikan apabila
sudah terdapat resolusi gejala dan koagulasi darah sudah
normal. Selain ABU, anti-tetanus juga diberikan kepada
pasien.

Kontraindikasi
Kontraindikasi Serum Anti Bisa Ular (ABU) jika terdapat
riwayat hipersensitivitas, atau serum sickness dengan
antidot ini, atau riwayat alergi terhadap komponen ABU,
seperti terhadap fenol, sebagai zat aditif. Peringatan
terutama bagi yang pernah mengalami reaksi alergi
terhadap serum anti toksin lainnya, yang berasal dari
plasma kuda, seperti serum anti tetanus, atau serum anti
difteri.
Disamping itu, hindari pemberian ABU secara intra
muskular, atau injeksi sekitar luka gigitan ular berbisa ,
karena pemberian cara ini tidak efektif.  Bioavailabilitas
menjadi buruk, karena komponen ABU berupa molekul
besar dari IgG, atau fragmen-fragmen, diabsorpsi secara
perlahan oleh jaringan limfatik.

Efek Samping
Hal yang harus diperhatikan dalam pemberian Serum Anti
Bisa Ular (ABU) adalah terkait efek samping seperti
reaksi anafilaksis dan serum sickness. Hingga saat ini
belum ada laporan mengenai interaksi obat.  
Pada beberapa kasus, reaksi alergi dapat timbul segera,
dalam beberapa jam, atau dapat bereaksi lambat, yaitu
dalam waktu 5 hari, atau lebih.

Pengawasan Klinis
Pengawasan klinis Serum Anti Bisa Ular (ABU) dilakukan
terhadap tiap pasien yang menerima antidot ini, yang
mesti diobservasi secara ketat selama satu jam, untuk

6
 mengawasi adanya perkembangan reaksi anafilaksis.
Karenanya, epinefrin semestinya disiapkan sebelum
pemberian anti venom ini.
Pengawasan klinis selanjutnya dilakukan untuk mengenali
tanda-tanda dini reaksi alergi tipe lambat. Observasi juga
dilakukan untuk melihat apakah ada perbaikan pada
pasien yang menjalani terapi ABU ini.
Pengawasan klinis juga dilakukan terhadap janin/fetus
pada wanita hamil yang menjalani terapi ABU.

Formulasi
Formulasi Serum Anti Bisa Ular (ABU) produksi Bio Farma
berupa sediaan injeksi berupa vial 5 mL, berasal dari
plasma kuda.

Penggunaan pada Ibu hamil dan menyusui

Pada prinsipnya, penggunaan Serum Anti Bisa Ular (ABU)
pada kehamilan dan wanita menyusui menimbang aspek
manfaat yang melebihi risiko yang dapat terjadi. ABU Bio
Farma ini tidak tercantum dalam kategori FDA dan TGA
untuk penggunaan pada kehamilan dan ibu menyusui,
karena anti venom bisa ular adalah spesifik untuk tiap
negara.
Wanita hamil yang digigit ular berbisa dan bermanifestasi
klinis, dapat berdampak buruk pada janin/fetus, berupa
anoksia, placenta abruptio, kontraksi uterus prematur,
aborsi, hingga kematian janin/fetus.
Ada laporan yang mengatakan bahwa ABU berhasil
mengatasi situasi buruk ibu hamil, yang terkena efek
sistemik racun ular dalam tubuhnya, dan kemudian
melahirkan bayi yang sehat.

7
 RECIPIENT NAME
POLYVALENT SNAKE ANTIVENOM 40.000
UNITS/VIAL
(Australia. PNG)

Composition

POLYVALENT SNAKE ANTIVENOM contains antibodies to

the venom of the following snakes:

King brown or mulga snake (Pseudechis australis),

Mainland tiger snake (Notechis scutatus), Eastern brown
snake (Acanthophis antarcticus), Common death adder
Coastal taipan (Oxyuranus scutellatus).

The antivenom is prepared from the plasma of horses

immunised with the venom of the snakes. The amount of
antivenom has been standardised to neutralise in vitro the
average yield of venom from each snake. The minimum
amount of each antivenom is as follows:

Black snake antivenom 18,000 units, Taipan antivenom

12,000 units, Death adder antivenom 6,000 units, Tiger
snake antivenom 3,000 units, Brown snake antivenom
1,000 units, Total 40,000 units.

Each 1 mL of product also contains 2.2 mg phenol, 8 mg

sodium chloride and water for injections to 1 mL in an
aqueous solution. Each vial contains ≤ 170 mg per mL of
plasma protein of equine origin.

Indication

For the treatment of patients in Papua New Guinea and in

all Australian states except Victoria and Tasmania who
exhibit manifestations of systemic snake envenoming and
the snake has not been definitely identified. In Tasmania,
Tiger Snake Antivenom should be used rather than
polyvalent antivenom whilst in Victoria a combination of
Tiger Snake Antivenom and Brown Snake Antivenom is the
preferred treatment.

POLYVALENT SNAKE ANTIVENOM should not be used when

the snake has been identified, as appropriate monovalent
antivenom provides similar neutralisation of the venom
without introducing the larger amounts of equine protein
present in the polyvalent product.

8
 Dose and Method of Administration

A proportion of people bitten by snakes have symptoms

that are so mild that antivenom is not necessary. When
there is evidence of systemic envenoming and the snake
has not been identified, the contents of one vial (40,000
units) of POLYVALENT SNAKE ANTIVENOM should be
administered slowly by intravenous infusion after dilution
with Hartmann’s Solution or 0.9% w/v sodium chloride.
Once diluted, POLYVALENT SNAKE ANTIVENOM should be
used immediately. Do not store diluted antivenom.

The dose is the same for adults and children.

The antivenom should be diluted 1 in 10, although a

dilution of 1 in 5 may be more appropriate for patients at
risk of fluid overload. Seek expert advice regarding dilution
of antivenom to avoid fluid overload, as required. It should
not be administered by the intramuscular route.

In the past, some authorities have advocated

premedication with 0.25 mL of 1:1,000 adrenaline
subcutaneously and intravenous antihistamine to reduce
the chance of anaphylactic shock, particularly in those
patients who are known to be at risk, but such use is
controversial

Contraindication

There are no absolute contraindications, but the product

should not be used unless there is clear evidence of
systemic envenoming with the potential for serious toxic
effects.

Use in Pregnancy

There is limited but inconclusive information on the safety

of the product in pregnant women. It is advisable to
carefully weigh the risks of untreated envenoming against
the expected benefits and potential risks of antivenom
administration.

Adverse Effects

The following adverse reactions, presented below

according to System Organ Class and frequency, have
been identified during post-approval use of all Seqirus
snake antivenoms. Adverse event frequencies are defined
as follows:

Very common: ≥1/10; common: ≥1/100 and <1/10;

uncommon: ≥1/1000 and <1/100; rare: ≥1/10,000 and

9
 <1/1000; and very rare: <1/10,000.

Immune system disorders

Common: Allergic reactions including anaphylactic shock

and delayed serum sickness

Nervous system disorders

Common: Headache

Gastrointestinal disorders

Uncommon: Abdominal pain, vomiting, nausea and

diarrhoea

Skin and subcutaneous tissue disorders

Common: Urticaria, rash

Musculoskeletal and connective tissue disorders

Uncommon: Myalgia

General disorders and administration site conditions

Common: Pyrexia, chills

Uncommon: Local injection site reactions, chest pain

Reference:
1. Product Leaflet

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