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Product Summary
 

Portfolio
Caphosol®
Collatamp®
Erwinase®
Fomepizole®
Kidrolase®
ProstaScint®
Quadramet®
Xenazine®

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Product Availability Description

Caphosol®:
super saturated calcium phosphate mouth rinse

Europe:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Republic of Ireland, Italy, Latvia, Lithuania, Luxembourg, The Netherlands , Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

Rest of World:
Australia, Croatia, Iceland, Hong-Kong, Lebanon

Caphosol is a CE marked Class I Medical device.

Caphosol is indicated for dryness of the mouth and oropharynx (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent.

Caphosol is also indicated as an adjunct to standard oral care in the prevention and treatment of the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.

Further information for Caphosol can be found at www.caphosol.eu

Caphosol®:
super saturated calcium phosphate mouth rinse

US

An FDA-approved medical device, CAPHOSOL is a topical oral agent indicated in the U.S. as an adjunct to standard oral care in treating oral mucositis caused by radiation or high dose chemotherapy.

CAPHOSOL is also indicated for dryness of the mouth (hyposalivation) or dryness of the throat (xerostomia) regardless of the cause or whether the conditions are temporary or permanent.

Full prescribing information for CAPHOSOL can be found at www.caphosol.com

USA - Important Safety Information:
Avoid eating or drinking at least 15 minutes after use. Patients restricted to a low sodium diet should consult their physician before use. In the USA, federal law restricts this device to sale by or on the 0rder of a physician or dentist. Keep out of reach of children.

Collatamp®:
gentamicine impregnated collagen sponge

• Drug
Europe:
Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Iceland, Liechtenstein, Luxembourg, Malta, The Netherlands, Poland, Portugal, Slovakia, Switzerland

Rest of World:
Argentina1, Chile, Colombia, Dominican Republic1, Dutch Islands, Hong Kong1, Mexico, Namibia, South Africa, South Korea1

• Medical Device
Europe:
UK, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Northern Ireland, Norway, Poland, Republic of Ireland, Romania, Slovenia, Spain, Sweden

Rest of World:
Australia, Brazil, Canada, Iran, Jordan, Lebanon, Malaysia, New Zealand, Philippines, Russia, Singapore, Saudi Arabia, Turkey, United Arab Emirates

Collatamp a lyophilized bovine or equine collagen sponge impregnated with the aminoglycoside antibiotic gentamicin, is indicated for local haemostasis of capillary, parenchymatous and seeping haemorrhages in areas with a high risk of infection.

1 available but not registered.

Erwinase®:
Lyophilisate for solution for injection (Erwinia chrysanthemiL-asparaginase; crisantaspase).

Europe:
Austria, Cyprus3, Czech Republic3, Denmark2, Estonia3, France3, Germany2, Greece2, Hungary3, Republic of Ireland, Latvia3, Lithuania3, The Netherlands, Norway2, Poland3, Portugal, Romania3, Slovakia3, Slovenia3, Spain3, Sweden3, United Kingdom1

Rest of World:
Albania3, Algeria3, Andorra3, Argentina3, Australia3, Bolivia3, Bosnia3, Brazil3, Canada, Columbia3, Croatia3, Ecuador3, Egypt2, Herzigovina3, Hong Kong2, Iceland3, India3, Israel3, Kosovo3, Lebanon2, Macedonia3, Malaysia2, Mexico3, Montenegro3, New Zealand2, Palestine3, Paraguay3, Peru3, Philippines3, Saudi Arabia3, Serbia3, South Africa3, South Korea3, Taiwan3, Thailand2, Tunisia3, Turkey3, Uruguay3, US4

Erwinase is used in combination with other anti-neoplastic agents to treat Acute Lymphoblastic Leukemia. It may also be used in other neoplastic conditions where depletion of asparagine might be expected to have a useful effect. Patients receiving treatment with L-asparaginase derived from Escherichia coli, who develop hypersensitivity to that enzyme, may be able to continue treatment with ERWINASE as the enzymes are immunologically distinct. (UK SmPC)

1 Local Marketing Authorisation Holder : the Health Protection Agency

2 Erwinase is not yet fully approved in these countries but upon the request of a physician, Erwinase may be made available to named patients who fulfil a defined criteria.

3 Erwinase is not yet registered in these countries but upon the request of a physician, Erwinase may be made available to named patients who fulfil a defined criteria.

4 Only available as part of a treatment IND.

Fomepizole:
Eusa Pharma®
5 mg/ml concentrate for solution for infusion

Europe:
Austria, Belgium, Bosnia and Herzegovina, Croatia, Czech Republic, Denmark, Finland, Germany, Hungary, Iceland, Republic of Ireland, Kosovo, Luxembourg, Macedonia, Norway, Poland, Serbia, Slovakia, Slovenia, Sweden, Switzerland, The Netherlands

Rest of World:
Turkey

This specific pharmacological antidote is indicated for the treatment of *ethylene glycol poisoning.

* This compound is commonly used in antifreeze.

Kidrolase®: powder for solution for injection
(Escherichia coli L-asparaginase).

Europe:
Austria*, Bulgaria*, Cyprus*, Czech Republic*, Denmark*, Estonia*, Finland*, France, Greece*, Hungary*, Republic of Ireland*, Latvia*, Lithuania*, Norway*, Poland*, Romania*, Slovakia*, Slovenia*, Spain*, Sweden*

Rest of World:
Albania*, Algeria*, Andorra*, Argentina*, Bolivia*, Bosnia*, Canada*, Chile*, Colombia*, Croatia*, Ecuador*, Egypt*, Herzegovina*, Iceland*, Kosovo*, Israel*, Lebanon*, Macedonia*, Morocco*, Montenegro*, Palestine*, Paraguay*, Peru*, Saudi Arabia*, Serbia*, Tunisia*, Turkey*, Uruguay*

KIDROLASE is indicated in the treatment of Acute Lymphoblastic Leukaemia, Leukaemic meningitis and Non-Hodgkin’s lymphoma.

* Kidrolase is not approved in these countries but upon the request of a physician, Kidrolase may be made available to named patients who fulfil a defined criteria

ProstaScint®:
kit for the preparation of Indium In 111 Capromab Pendetide for intravenous use.

US
Singapore

PROSTASCINT is a PSMA-targeting monoclonal antibody-based agent to image the extent and spread of prostate cancer.

Full prescribing information for PROSTASCINT can be found at www.prostascintimaging.com

USA - Important Safety Information:
Patient management should not be based on ProstaScint scan results without appropriate confirmatory studies since in the pivotal trials, there was a high rate of false positive and false negative image interpretations. ProstaScint images should be interpreted only by physicians who have had specific training in ProstaScint® image interpretation. Medications for the treatment of hypersensitivity reactions should be available during administration of this agent.

QuadraMet®:
isotonic solution of samarium-153 lexidronam for intravenous administration.

US

QUADRAMET is a radiopharmaceutical for the treatment of pain in patients whose cancer has spread to the bone.

Full prescribing information for QUADRAMET can be found at
www.quadrametinfo.com

USA - Important Safety Information:
Quadramet causes bone marrow suppression. Before Quadramet is administered, consideration should be given to the patient's current clinical and hematologic status and bone marrow response history to treatment with myelotoxic agents. Because of the unknown potential for additive effects on bone marrow, Quadramet should not be given concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks.

Xenazine®:
25 mg, scored tablets (INN: tetrabenazine)

France

Xenazine was developed by Cambridge Laboratories (UK) and is indicated for the treatment of movement disorders associated with Huntington’s chorea and Hemiballismus.

*Please note that the indication may differ from country to country.

For more information on EUSA Pharma products, please contact EUSA Pharma medical information at : medinfo@EUSAPharma.com

 
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