Oxmax (previously OC99) 65 mg/ml Solution for Infusion for Dogs

There is no efficacy data available for dogs that have been rehydrated prior to
administration of the product or in cases of normovolaemic anaemia.

Special precautions for use in animals
To be used as single administration.
Avoid food and water for the duration of administration.
The indication for use was established following the concomitant administration
of the product and crystalloid resuscitative fluids (LRS). In the absence of a
critical clinical situation, the product should not be administered to dogs that
have already received fluid therapy to restore circulatory volume.
Due to the plasma expanding properties of the veterinary medicinal product, the
possibility of circulatory overload and pulmonary oedema should be considered
and monitored, especially when administering adjunctive intravenous fluids,
particularly colloidal solutions.
Signs of circulatory overload should be carefully monitored. Rapid blood
volume expansion may be controlled by slowing the rate of administration. If
circulatory overload occurs, cease the infusion immediately, and consider
administering diuretics.
Renal function should be monitored during and after use of the veterinary
medicinal product. If clinical signs of renal impairment such as depression,
reduced food intake, vomiting, polyuria or oliguria are noted, renal function
should be assessed. Results of serum chemistry parameters to evaluate renal
function should be interpreted with care, as the presence of the veterinary
medicinal product at the recommended treatment dose may interfere with the
results for BUN, CREA (Creatinine), BUN/CREA ratio and Urea. These are
likely to be unreliable markers of renal function up to 12 hours (Urea) and up to
4 days (BUN, BUN/CREA ratio and CREA) after administration. Appropriate
treatment should be instigated if impaired renal function is evident. Renal
function can be assessed using tools such as abdominal ultrasound and
urinalysis (specifically urine sediment examination and urine specific gravity
measurement).
In the event of anaphylaxis, clinical signs that include a skin rash, swelling of
the face or extremities, difficulty in breathing and/or vomiting will occur. If
anaphylaxis does occur, treat symptoms immediately as considered
appropriate, for example with adrenaline followed by corticosteroids.

Issued: November 2023
AN: 02049/2023
Clinical pathology
In dogs with pre-existing haemolysis, routine analysis will not be able to
distinguish the veterinary medicinal product from native haemoglobin in the
plasma.
Chemistry and haematology
The presence of the veterinary medicinal product in serum may interfere with
colourimetric readings and result in erroneous increases, or decreases, in the
results of serum chemistry and haematology tests depending on the dose
administered, the time after infusion, the type of analyser and the reagents
used.
Measurement of lactate in canine blood may be affected by the presence of the
veterinary medicinal product. It is advised to interpret the measured lactate
concentration with caution, and to use other parameters in combination with
lactate levels for clinical evaluation of the patient.
Coagulation
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) can be
accurately determined in the presence of the veterinary medicinal product using
methods that are either mechanical, magnetic, or light scattering. Colourimetric
methods may not be reliable for coagulation assays in the presence of the
veterinary medicinal product.
Urinalysis:
Sediment examination and specific gravity measurements are accurate in the
presence of the veterinary medicinal product. Dipstick measurements (e.g. pH,
glucose, ketones, and protein) and gravity measurement using a refractometer,
are likely to be inaccurate if there is visible discolouration of the urine.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
If adverse reactions develop following accidental self-injection, seek medical
advice immediately and show the package leaflet or the label to the physician.
This product contains bovine-derived haemoglobin. There is a risk that immune
mediated reactions (hypersensitivity reactions) may occur in sensitised persons
if repeated accidental self-injection occurs. In case of hypersensitivity reactions,
seek medical advice immediately and show the package leaflet or the label to
the physician. Do not handle or administer the product if a previous
hypersensitivity reaction has occurred.
N-acetyl-L-cysteine is an excipient in this veterinary medicinal product and has
been associated with hypersensitivity reactions in humans following
intravenous infusion. People with known hypersensitivity to N-acetyl-L-cysteine
should take care to avoid accidental self-injection with this veterinary medicinal
product.

Issued: November 2023
AN: 02049/2023
Special precautions for the protection of the environment
Not applicable.
Other precautions
Not applicable.