Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
haemoglobin glutamer-200 (bovine)
OPK Biotech Netherlands BV
QB05AA10
Haemoglobin glutamer-200 (bovine)
Dogs
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition.,
Revision: 16
Authorised
1999-11-29
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET: OXYGLOBIN 130 MG/ML SOLUTION FOR INFUSION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: OPK Biotech Netherlands BV Herikerbergweg 88 1101CM, Amsterdam The Netherlands Manufacturer for the batch release: Dales Pharmaceutical Ltd. Snaygill Industrial Estate Keighley Road Skipton North Yorkshire, BD23 2RW United Kingdom 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Oxyglobin 130 mg/ml solution for infusion for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Haemoglobin glutamer-200 (bovine) – 130 mg/ml. 4. INDICATION(S) Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours independent of the underlying condition. 5. CONTRAINDICATIONS Do not use in animals previously treated with Oxyglobin. Plasma volume expanders, such as Oxyglobin, are contraindicated in dogs predisposed to circulatory overload with conditions such as oliguria or anuria or advanced cardiac disease (i.e., congestive heart failure) or otherwise severely impaired cardiac function. Oxyglobin is intended for single administration only. 6. ADVERSE REACTIONS During the clinical safety and efficacy study, adverse events were seen which may have been related to Oxyglobin and/or the underlying disease causing anaemia. Side effects which were observed included mild to moderate discolouration of the mucous membranes, sclera, and urine due to metabolism and/or excretion of haemoglobin. Effects commonly seen were vomiting, loss of appetite, fever, and circulatory overload with associated clinical signs such as tachypnea, dyspnea, harsh lung sounds, and pulmonary oedema; circulatory overload was controlled by slowing the rate of administration. Occasionally noted effects were diarrhoea, discolouration of the skin, cardiac 15 arrhythmias and very rarely nystagmus. The frequency of adverse reactions is defined Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Oxyglobin 130 mg/ml solution for infusion for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Haemoglobin glutamer-200 (bovine) – 130 mg/ml EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition. 4.3 CONTRAINDICATIONS Do not use in animals previously treated with Oxyglobin. Plasma volume expanders, such as Oxyglobin, are contraindicated in dogs predisposed to circulatory overload with conditions such as oliguria or anuria or advanced cardiac disease (i.e., congestive heart failure) or otherwise severely impaired cardiac function. Oxyglobin is intended for single administration only. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Concomitant treatment of the cause of the anaemia should be instituted. The animal should not be over-hydrated prior to administration. Due to the plasma expanding properties of Oxyglobin, the possibility of circulatory overload and pulmonary oedema should be considered especially when administering adjunctive intravenous fluids, particularly colloidal solutions. Signs of circulatory overload should be carefully monitored or central venous pressure (CVP) measured (increase in CVP has been recorded in all treated dogs in which it was measured). Circulatory overload may be controlled by slowing the rate of administration. Treatment with Oxyglobin results in a mild decrease in PCV (packed cell volume) immediately post infusion. 3 The safety and efficacy of Oxyglobin have not been evaluated in dogs with thrombocytopenia with active bleeding, oliguria or anuria, or advanced cardiac disease. CLINICAL PATHOLOG Läs hela dokumentet