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Oxyglobin

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Summary for the public


What is Oxyglobin?

Oxyglobin contains bovine haemoglobin glutamer-200 (at a strength of 130 mg/ml), which belongs to a class of medicines having an oxygen-carrying action. Oxyglobin is a solution for infusion (drip into a vein).


What is Oxyglobin used for?

Oxyglobin is used to increase the oxygen content of the blood in dogs with anaemia (low red blood cell count). Oxyglobin should be used for at least 24 hours.

Oxyglobin is first warmed to 37°C, then given to the dog as 30 ml per kilogram body weight, administered at a rate of up to 10 ml/kg per hour. The most appropriate dose depends on the severity of the anaemia and how long the dog has been anaemic, as well as the desired duration of the medicine’s effect. Oxyglobin is intended for a single use only. Oxyglobin does not need to be matched to the dog’s blood type. For further information, see the Package Leaflet.


How does Oxyglobin work?

Oxyglobin is a haemoglobin-based oxygen-carrying solution. It contains haemoglobin glutamer-200, which is made from haemoglobin (the protein in red blood cells that carries oxygen around the body) extracted from cows’ blood and diluted in a standard solution (Ringer’s lactate) used to replace blood volume. When Oxyglobin is given to dogs, it increases the amount of haemoglobin in the blood, as well as increasing the volume of blood in the body. This increases the amount of oxygen carried in the blood in the arteries, helping to reduce the symptoms of anaemia.


How has Oxyglobin been studied?

Oxyglobin has been tested in a study of dogs with short or long-term anaemia due to conditions such as blood loss, the abnormal breakdown of red blood cells or low levels of red blood cell production. The study compared the effects of Oxyglobin with no treatment.


What benefit has Oxyglobin shown during the studies?

In the main study in dogs, 95% of the animals treated with Oxyglobin needed no other type of oxygen-carrying treatment after 24 hours, compared with 32% of the dogs that did not receive any treatment. It took longer until additional treatment was needed in dogs treated with Oxyglobin. The medicine also increased levels of haemoglobin in the blood and improved the dogs’ physical condition.

Additional studies supported these results, showing that Oxyglobin can take up, transport and release oxygen in animals other than cows. This oxygen can then be supplied to tissues such as muscle.


What is the risk associated with Oxyglobin?

The side effects seen with Oxyglobin are caused both by the medicine and by the underlying cause of the anaemia. They include discoloration of the skin, mucous membranes (lining of body cavities) and sclera (whites of the eyes), dark faeces and discoloured or turbid (opaque) urine. A common side effect is ‘circulatory overload’ (when the blood fluid leaks out of the blood vessels), which causes tachypnea (rapid breathing), dyspnea (shortness of breath), harsh lung sounds and pulmonary oedema (fluid accumulation in the lungs). Other common side effects are vomiting, loss of appetite and fever. For a full list of all side effects reported with Oxyglobin, see the Package Leaflet.

Oxyglobin should not be used in animals that have received Oxyglobin in the past, or in dogs that are at an increased risk of circulatory overload with conditions such as oliguria or anuria (infrequent or no urination) or advanced heart disease.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

There are no precautions necessary.


Why has Oxyglobin been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Oxyglobin exceed the risks for the provision of oxygen-carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition, and recommended that Oxyglobin be given a marketing authorisation. The benefitrisk balance may be found in module 6 of this EPAR.


Other information about Oxyglobin

The European Commission granted a marketing authorisation valid throughout the European Union for Oxyglobin to Biopure Netherlands B.V. on 14 July 1999. The marketing authorisation was renewed on 14 July 2004. Information on the prescription status of this product may be found on the label of the carton.

Authorisation details
Name: Oxyglobin
EMEA Product number: EMEA/V/C/000045
Active substance: haemoglobin glutamer-200 (bovine)
INN or common name: Haemoglobin glutamer 200
Species: Dogs
ATCvet Code: QB05AA90
Marketing Authorisation Holder: Biopure Netherlands B.V
Revision: 10
Date of issue of Market Authorisation valid throughout the European Union: 29/11/1999
Contact address:
Biopure Netherlands B.V.
Parnassustoren / Locatellikade 1
NL- 1076 AZ Amsterdam
The Netherlands



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE 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
    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.
    2
    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.
    Clinical Pathology
    Chemistry: The presence of Oxyglobin in serum may interfere with colorometric readings and result in
    artifactual increases or decreases in the results of serum chemistry tests depending on the dosage
    administered, the time since infusion, the type of analyzer and the reagents used. (Contact the
    distributor for specific data.)
    Haematology: No interference. Confirm that haemoglobin is measured, not calculated from red blood
    cell number.
    Coagulation: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) can be accurately
    determined using methods that are mechanical, magnetic, and light scattering. Optical methods are not
    reliable for coagulation assays in the presence of Oxyglobin.
    Urinalysis: Sediment examination is accurate. Dipstick measurements (i.e., pH, glucose, ketones, protein)
    are inaccurate while gross discolouration of the urine is present.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    Not applicable.
    4.6 Adverse reactions (frequency and seriousness)
    Adverse events related to Oxyglobin and/or the underlying disease causing anaemia have been observed.
    Undesirable effects include mild to moderate yellow/orange discoloration of the skin,mucous membranes,
    sclera, dark faeces and discoloured or turbid urine due to metabolism and/or excretion of haemoglobin. A
    commonly observed undesirable effect was circulatory overload with associated clinical signs such as
    tachypnea, dyspnea, harsh lung sounds and pulmonary oedema. Adverse effects commonly seen were
    vomiting, a loss of appetite, and fever. Occasionally noted adverse events were diarrhoea, cardiac
    arrhythmias and very rarely nystagmus.
    4.7 Use during pregnancy, lactation or lay
    The safety of Oxyglobin for use in pregnant or lactating bitches has not been determined.
    4.8 Interaction with other medicinal products and other forms of interaction
    None known.
    4.9 Amounts to be administered and administration route
    The recommended dosage of Oxyglobin is 30 ml/kg of body weight administered intravenously at a rate up
    to 10 ml/kg/hr. Oxyglobin is intended for single administration.
    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)
    3
    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
    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.
    Use of Oxyglobin does not require typing or cross–matching of the recipient’s blood.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    Overdosage or an excessive rate of administration (i.e., >10 ml/kg/hr) could result in immediate
    cardiopulmonary effects, in which case infusion of Oxyglobin should be discontinued immediately until
    signs abate. Treatment of circulatory overload may be necessary.
    4.11 Withdrawalperiod(s)
    Not applicable.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Blood substitutes, ATCvet code: QB05AA90
    5.1 Pharmacodynamic properties
    Oxyglobin is a haemoglobin-based oxygen carrying fluid that increases plasma and total haemoglobin
    concentrations and thus increases arterial oxygen content. The plasma half-life is 30-
    40 hours. It is eliminated from the plasma in 5-7 days.
    5.2 Pharmacokinetic particulars
    Metabolism and excretion: Haemoglobin dissociates in plasma and is progressively incorporated in the
    protein pool of the organism. Haeme degrades according to common pathways leading to bilirubin
    and bile pigments. A small amount of unstabilised tetrameric haemoglobin (<5%) may be excreted
    through the kidneys, resulting in transient haemoglobinuria for < 4 hours.
    4
     
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Modified Lactated Ringer’s Solution containing the standard components:
    Water for injection,
    NaCl
    KCl
    CaC12 2H2O
    NaOH
    Sodium lactate
    N-acetyl-l cysteine
    6.2 Incompatibilities
    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.
    6.3 Shelf life
    Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
    Shelf-life after first opening the immediate packaging: 24 hours
    6.4. Specialprecautionsforstorage
    Do not store above 30°C. Do not freeze. Use within 24 hours of removing overwrap.
    6.5 Nature and composition of immediate packaging
    A box with two (2) polyolefin infusion bags (60 ml), each within an overwrap.
    A box with two (2) polyolefin infusion bags (125 ml), each within an overwrap.
    Not all pack sizes may be marketed.
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Biopure Netherlands B.V.
    Parnassustoren / Locatellikade 1
    NL- 1076 AZ Amsterdam
    8.
    MARKETING AUTHORISATION NUMBER
    EU/2/99/015/001-002
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    01.10.2009
    5
    10. DATE OF REVISION OF THE TEXT
    01.10.2009
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA) http://www.emea.europa.eu/ .
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    6
    ANNEX II
    A.
    MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
    BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION REGARDING SUPPLY OR USE
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
    D.
    STATEMENT OF THE MRLs
    7
    A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the biological active substance
    Biopure Corporation
    39 Hurley Street
    Cambridge
    MA 02141
    USA
    Name and address of the manufacturer responsible for batch release
    Dales Pharmaceutical Ltd.
    Snaygill Industrial Estate
    Keighley Road
    Skipton
    North Yorkshire
    BD23 2RW
    United Kingdom
    The printed package leaflet of the medicinal product must state the name and address of the manufacturer
    responsible for the release of the concerned batch.
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D. STATEMENT OF THE MRLs
    Not applicable.
    8
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO
    APPEAR ON THE IMMEDIATE PACKAGE
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Oxyglobin 130 mg/ml Solution for infusion for dogs.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Hemoglobin glutamer-200 (bovine) – 130 mg/ml
    3.
    PHARMACEUTICAL FORM
    Solution for infusion
    4.
    PACKAGE SIZE
    Two single dose bags (60 ml) for intravenous infusion each within an overwrap <outer box>
    Overwrap containing a 60 ml infusion bag <overwrap>
    60 ml infusion bag <infusion bag>
    Two single dose bags (125 ml) for intravenous infusion each within an overwrap <outer box>
    Overwrap containing a 125 ml infusion bag <overwrap>
    125 ml infusion bag <infusion bag>
    5.
    TARGET SPECIES
    Dogs
    6.
    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.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oxyglobin is intended for single intravenous administration by infusion.
    8.
    WITHDRAWAL PERIOD
    Not applicable
    11
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Do not microwave. Do not overheat > 37° C.
    Excessive administration rate (>10 ml/kg/hr) may result in circulatory overload.
    10. EXPIRY DATE
    <EXP {month/year}>
    11. SPECIAL STORAGE CONDITIONS
    Do not store above 30°C. Do not freeze. Use within 24 hours of removing overwrap.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Biopure Netherlands B.V.
    Parnassustoren / Locatellikade 1
    NL- 1076 AZ Amsterdam
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/99/015/001 125ml
    EU/2/99/015/002 60ml
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot> <BN> {number}
    12
     
    B. PACKAGE LEAFLET
    13
    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:
    Biopure Netherlands B.V.
    Parnassustoren / Locatellikade 1
    NL- 1076 AZ Amsterdam
    Manufacturer for the batch release:
    Dales Pharmaceutical Ltd. Snaygill
    Industrial Estate Keighley Road
    Skipton
    North Yorkshire, BD23 2RW
    United Kingdom
    2.
    NAME OF VETERINARY THE 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
    14
    administration. Occasionally noted effects were diarrhoea, discolouration of the skin, cardiac
    arrhythmias and very rarely nystagmus.
    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 anemia 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
    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.
    15
     
    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
    01.10.2009
    Detailed information on this product is available on the website of the European Medicines Agency
    (EMEA) http://www.emea.europa.eu/ .
    15. OTHER INFORMATION
    Clinical Pathology
    Chemistry: The presence of Oxyglobin in serum may interfere with colorometric readings and result in
    artifactual increases or decreases in the results of serum chemistry tests depending on the dosage
    administered, the time since infusion, the type of analyzer and the reagents used. (Contact the
    distributor for specific data.)
    Haematology: No interference. Confirm that haemoglobin is measured, not calculated from red blood
    cell number.
    Coagulation: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) can be
    accurately determined using methods that are mechanical, magnetic, and light scattering. Optical
    methods are not reliable for coagulation assays in the presence of Oxyglobin.
    Urinalysis: Sediment examination is accurate. Dipstick measurements (i.e., pH, glucose, ketones,
    protein) are inaccurate while gross discolouration of the urine is present.
    16
    60 ml infusion bag.
    125 ml infusion bag.
    Not all pack sizes may be marketed.
    17


    Source: European Medicines Agency


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