Oxyglobin
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
20-10-2020
Vara einkenni
(SPC)
20-10-2020
Opinber matsskýrsla
(PAR)
19-03-2012
Virkt innihaldsefni:
haemoglobin glutamer-200 (bovine)
Fáanlegur frá:
OPK Biotech Netherlands BV
ATC númer:
QB05AA10
INN (Alþjóðlegt nafn):
Haemoglobin glutamer-200 (bovine)
Meðferðarhópur:
Dogs
Lækningarsvæði:
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Ábendingar:
Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition.,
Vörulýsing:
Revision: 16
Leyfisstaða:
Authorised
Leyfisdagur:
1999-11-29
Upplýsingar fylgiseðill
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
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Vara einkenni
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
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