מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
Black snake antivenom, Quantity: 18000 U
Seqirus Pty Ltd
Injection, concentrated
Excipient Ingredients: sodium chloride; phenol; water for injections
Intravenous
18 000u X 1
(S4) Prescription Only Medicine
For the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a king brown or mulga snake. Although the antivenom is effective in the management of patients who are bitten by other members of the genus Pseudechis, including the red-bellied or common black snake, Tiger snake antivenom is the preferred treatment.
Visual Identification: Light straw coloured, slightly viscous, transparent solution in a glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2000-07-21
Black Snake Antivenom 1 BLACK SNAKE ANTIVENOM CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING BLACK SNAKE ANTIVENOM? Black Snake Antivenom contains the active ingredient black snake antivenom (equine). Black Snake Antivenom is given to people who become ill from venom after being bitten by a king brown snake or mulga snake . For more information, see Section 1. Why am I using Black Snake Antivenom? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE BEING GIVEN BLACK SNAKE ANTIVENOM? TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before being given Black Snake Antivenom? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Black Snake Antivenom and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS BLACK SNAKE ANTIVENOM GIVEN? • Your doctor will prescribe Black Snake Antivenom if you suffer from the effects of venom from a bite from a king brown snake or mulga snake. • The dose for both adults and children is one vial (18,000 units). The dose can be repeated as necessary. More instructions can be found in Section 4. How is Black Snake Antivenom given? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BEING GIVEN BLACK SNAKE ANTIVENOM? THINGS YOU SHOULD DO • Tell your doctor if you experience any side effects. For more information, see Section 5. What should I know while being given Black Snake Antivenom? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? Common side effects may include: allergic reactions, hives, rash, fever, chills and headache. If you experience the following serious side effects, tell your doctor immediately: • sudden signs of allergy such as rash, itching or hives on the skin, swelling קרא את המסמך השלם
BLACK SNAKE ANTIVENOM (AUST R 74894) PRODUCT INFORMATION Version 7.0 Page 1 of 8 AUSTRALIAN PRODUCT INFORMATION – BLACK SNAKE ANTIVENOM INJECTION 1 NAME OF THE MEDICINE Black snake antivenom (equine) as active ingredient. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BLACK SNAKE ANTIVENOM is prepared from the plasma of horses immunised with the venom of the king brown snake ( _Pseudechis australis_ ) also known as the mulga snake. The king brown snake is a member of the genus _Pseudechis_ , known as black snakes. Each vial contains 18,000 units of antivenom which has been standardised to neutralise _in _ _vitro_ the average yield of venom from the king brown snake. Each 1 mL of the product also contains phenol 2.2 mg, sodium chloride 8 mg and water for injections to 1.0 mL in an aqueous solution. Each vial contains ≤ 170 mg per mL of plasma protein of equine origin. The product volume is potency dependent thus it varies from batch to batch. Please refer to the product volume printed on the carton. 3 PHARMACEUTICAL FORM BLACK SNAKE ANTIVENOM is a concentrated injection (18000U) for intravenous use. It is light straw coloured, slightly viscous, transparent solution in a glass vial. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a king brown or mulga snake. Although the antivenom is effective in the management of patients who are bitten by other members of the genus _Pseudechis_ , including the red-bellied or common black snake, Tiger Snake Antivenom is the preferred treatment (see S ECTION 5.1 – P HARMACODYNAMIC P ROPERTIES ). 4.2 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 it has been established that BLACK SNAKE ANTIVENOM is the appropriate treatment, the contents of one vial (18,000 units) should be administered slowly by intravenous infusion after dilution with Har קרא את המסמך השלם