Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Brown snake antivenom, Quantity: 1000 U
Seqirus Pty Ltd
Injection, concentrated
Excipient Ingredients: phenol; sodium chloride; water for injections
Intravenous
1000 x 1
(S4) Prescription Only Medicine
For the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a snake of the genus Pseudonaja. This genus includes the Eastern brown snake, the dugite and the gwardar (Western brown snake).
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
Brown Snake Antivenom 1 BROWN 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 BROWN SNAKE ANTIVENOM? Brown Snake Antivenom contains the active ingredient brown snake antivenom (equine). Brown Snake Antivenom is given to those people who become ill from venom after being bitten by an eastern brown, dugite or gwardar (western brown) snake . For more information, see Section 1. Why am I using Brown Snake Antivenom? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE BEING GIVEN BROWN 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 Brown Snake Antivenom? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Brown 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 BROWN SNAKE ANTIVENOM GIVEN? • Your doctor will prescribe Brown Snake Antivenom if you suffer from the effects of venom from an eastern brown, dugite or gwardar (western brown) snake. • The dose for both adults and children is one vial (1,000 units). The dose can be repeated as necessary. More instructions can be found in Section 4. How is Brown Snake Antivenom given? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BEING GIVEN BROWN 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 Brown 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 ras Aqra d-dokument sħiħ
Brown Snake Antivenom (AUST R 74897) Product Information P a g e 1 | 9 AUSTRALIAN PRODUCT INFORMATION – BROWN SNAKE ANTIVENOM SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE BROWN SNAKE ANTIVENOM (equine) as active ingredient. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BROWN SNAKE ANTIVENOM is prepared from the plasma of horses immunised with the venom of the eastern brown snake (_Pseudonaja textilis_). Each vial contains 1,000 units of antivenom which has been standardised to neutralise _in vitro_ the average yield of venom from the brown snake. The product also contains 2.2 mg phenol, 8 mg sodium chloride and water for injections to 1.0 mL. Each vial contains ≤ 170 mg per mL of plasma protein of equine origin. The product volume is potency dependant thus it varies from batch to batch. Please refer to the product volume printed on the carton. 3 PHARMACEUTICAL FORM BROWN SNAKE ANTIVENOM is a concentrated solution for intravenous injection. It is a 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 snake of the genus _Pseudonaja_. This genus includes the eastern brown snake, the dugite and the gwardar (western brown snake). 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 BROWN SNAKE ANTIVENOM is the appropriate treatment, the contents of one vial (1,000 units) should be administered slowly by intravenous infusion after dilution with Hartmann’s Solution or 0.9% w/v sodium chloride. Once diluted, BROWN 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 Aqra d-dokument sħiħ