Oxyglobin - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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 arrhythmias and very rarely nystagmus.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated )

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

The recommended dosage of Oxyglobin is 30 ml/kg of body weight administered intravenously at a rate up to 10 ml/kg/hr. In certain clinical situations, a dosage of 15–30 ml/kg may be appropriate. The optimum dosage is based upon the degree and chronicity of the anaemia and the desired duration of the effect. (See Table A Pharmacokinetic Parameters)

Table A: Pharmacokinetic Parameters at Multiple Dose Levels after a Single Infusion of

Oxyglobin

Dose (ml/kg)	Immediate post infusion plasma concentration* (g/dl)	Duration hours): Oxyglobin levels over 1 g/dL	Cleared from plasma (days)
15	2.0–2.5	23–39	4–6
21	3.4–4.3	66–70	5–7
30	3.6–4.8	74–82	5–9

* range based on mean ± SD

range based on estimated mean value with bounds of a 95 % prediction interval

range based on 5 terminal half-lives

• 9. ADVICE ON CORRECT ADMINISTRATION

Remove overwrap prior to use. Use within 24 hours. Oxyglobin should be administered using aseptic technique via a standard intravenous infusion set and catheter. As with any intravenous fluid administration, Oxyglobin should be warmed to 37 °C prior to administration. Do not microwave. Do not overheat.

Do not administer with other fluids or medicinal products concurrently via the same infusion set. Do not add medications or other solutions to the bag. Do not combine the contents of more than one bag.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

Do not store above 30 °C. Do not freeze. Use within 24 hours of removing overwrap. Do not use after the expiry date stated on the label.

• 12. SPECIAL WARNING(S)

Do not use in animals previously treated with Oxyglobin.

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 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. If CVP increases to a clinically unacceptable level and/or if signs of circulatory overload are observed, the infusion of Oxyglobin should be temporarily discontinued and re-instituted at a slower rate when signs abate and/or CVP decreases.

Treatment with Oxyglobin results in a mild decrease in PCV (packed cell volume) immediately post infusion.

The safety and efficacy of Oxyglobin have not been evaluated in dogs with, thrombocytopenia with active bleeding, oliguria or anuria, or advanced cardiac disease.

The safety of Oxyglobin for use in pregnant or lactating bitches has not been determined. The use in such animals is not recommended.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR

WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION