The most commonly reported presenting signs included facial oedema, vomiting and lethargy. The APVMA notes that products containing this active constituent are often used in conjunction with other products (including vaccines) resulting in a higher number of reports. In most cases it is impossible to attribute the cause of an adverse reaction to a single active constituent. Hence a single report may be classified against multiple active constituents that may have a potential relationship to an adverse experience. The number of reports associated with moxidectin microspheres is low when compared with the number of doses sold in 2013 (less than 1 in 10 000 doses) and therefore no regulatory action is required other than continued monitoring for unexpected or severe reactions. Moxidectin microspheres Canine Number of Reports Probable Possible 116 29 87 Presenting signs (probable and possible) Vomiting (35) Allergy (4) Defaecation (1) Facial oedema (27) Ataxia (4) Epiphora (1) Lethargy (15) Collapse (3) Haemorrhage (1) Injection site reaction (14) Hypersalivation (3) Hypotension (1) Anaphylaxis (11) Cyanosis (2) Malaise (1) Pruritis (11) Erythema (2) Necrosis (1) Anaphylactoid reaction Hepatopathy (2) Panting (1) (10) Inflammation (2) Sarcoma (1) Oedema (9) Tachypnoea (2) Site reaction (swelling) (1) Pyrexia (9) Unconscious (2) Sweating (1) Urticaria (9) Abdominal pain (1) Swelling (local) (1) Anorexia (8) Behavioural change (1) Tachycardia (1) Lump (local) (8) Blood in faeces (1) Tremor (1) Diarrhoea (7) Bradycardia (1) Wheals (1) Pain (6) Conjunctivitis (1) Pale mucous membranes Convulsions (1) (5)
The most commonly reported presenting signs included facial oedema, vomiting and lethargy. The APVMA notes that products containing this active constituent are often used in conjunction with other products (including vaccines) resulting in a higher number of reports. In most cases it is impossible to attribute the cause of an adverse reaction to a single active constituent. Hence a single report may be classified against multiple active constituents that may have a potential relationship to an adverse experience. The number of reports associated with moxidectin microspheres is low when compared with the number of doses sold in 2013 (less than 1 in 10 000 doses) and therefore no regulatory action is required other than continued monitoring for unexpected or severe reactions. Moxidectin microspheres Canine Number of Reports Probable Possible 116 29 87 Presenting signs (probable and possible) Vomiting (35) Facial oedema (27) Lethargy (15) Injection site reaction (14) Anaphylaxis (11) Pruritis (11) Anaphylactoid reaction (10) Oedema (9) Pyrexia (9) Urticaria (9) Anorexia (8) Lump (local) (8) Diarrhoea (7) Pain (6) Pale mucous membranes (5) Allergy (4) Ataxia (4) Collapse (3) Hypersalivation (3) Cyanosis (2) Erythema (2) Hepatopathy (2) Inflammation (2) Tachypnoea (2) Unconscious (2) Abdominal pain (1) Behavioural change (1) Blood in faeces (1) Bradycardia (1) Conjunctivitis (1) Convulsions (1) Defaecation (1) Epiphora (1) Haemorrhage (1) Hypotension (1) Malaise (1) Necrosis (1) Panting (1) Sarcoma (1) Site reaction (swelling) (1) Sweating (1) Swelling (local) (1) Tachycardia (1) Tremor (1) Wheals (1)
adverse-experiences-for-veterinary-medicines-and-agricultural-chemicals-2013.docx