Product Summary
| 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:
Albania, Andorra, Australia, Bosnia, Croatia, Herzegovina, Iceland, India,
Kosovo, Jordan, Macedonia, Malta, Montenegro, New Zealand, San Marino, Serbia,
South Korea, Vatican City |
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
| |
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, Hungary, Iceland,
Liechtenstein, Luxembourg, Malta, The Netherlands, Poland, Portugal, Slovakia,
Switzerland
Rest of World:
Argentina, Chile, Colombia, Dominican Republic, Dutch Islands, Hong Kong, Mexico,
Namibia, South Africa, South Korea
• 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, Kuwait, 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.
|
Erwinase®:
Lyophilisate for solution for injection (Erwinia chrysanthemiL-asparaginase; crisantaspase). |
Europe:
Austria, Cyprus2, Czech Republic2, Denmark, Estonia2,
Finland2, France, Germany, Greece, Hungary2, Republic of
Ireland, Latvia2, Lithuania2, The Netherlands, Norway,
Poland2, Portugal, Romania2, Slovakia2,
Slovenia2, Spain2, Sweden, United Kingdom1
Rest of World:
Albania2, Algeria2, Andorra2, Argentina2,
Australia2, Bolivia2, Bosnia2, Brazil2,
Canada, Columbia2, Croatia Ecuador2, Egypt, Herzigovina2,
Hong Kong, Iceland2, India2, Israel2, Kosovo2,
Lebanon, Macedonia2, Malaysia, Mexico2, Montenegro2,
New Zealand2, Palestine2, Paraguay2, Peru2,
Philippines2, Saudi Arabia2, Serbia2, Singapore2,
South Africa2, South Korea, Taiwan2, Thailand, Tunisia2,
Turkey2, Uruguay2, US3
|
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.
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 Only available as part of a treatment IND.
|
Fomepizole:
5 mg/ml concentrate for solution for infusion |
Europe:
Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Iceland, Republic
of Ireland, Latvia, Lithuania, Luxembourg, Norway, Sweden, The Netherlands
Rest of World:
Australia, Brazil, Canada, Iran, Jordan, Kuwait, Lebanon, Malaysia, New
Zealand, Philippines, Russia, Singapore, Saudi Arabia, Turkey, United Arab
Emirates
|
This specific pharmacological antidote is indicated for the treatment of
*ethylene glycol poisoning.
* This compound is commonly used in automotive coolants and 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 yet fully 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
| |
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
| |
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
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 |
