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Sandoz initiates voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials
of Methotrexate Injection, USP due to the presence of glass particulates
FOR IMMEDIATE RELEASE - October 27, 2010 - Princeton, New Jersey
- Sandoz Inc. announced
today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and
Parenta brand Methotrexate Injection, USP product (“methotrexate”) to the consumer/user level.
Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all
24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a
limited number of vials in four lots. The flakes are the result of delamination of the glass used to
manufacture the vials of these two dosage presentations.
Due to particle size, there is the potential to develop adverse reactions in areas where the particles lodge.
While it is unlikely, parenteral injection of drug from the affected lots could lead to serious adverse events,
resulting in disability and death. Additionally, neurologic damage could result from intrathecal
administration. Potential adverse events after intravenous administration include local damage to blood
vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result
in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma
formation. Intra-arterial administration could result in damage to blood vessels in the distal extremities or
organs. To date, Sandoz has not received any adverse event reports or product complaints attributable to
particles from any lot of methotrexate, including the lots where flakes have been found.
Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The affected products are only the 50mg/2mL and 250mg/10mL presentations of methotrexate. The product lot numbers, label type and expiration dates are listed below as well as on the Sandoz US website
Sandoz has sent out recall letters to inform all distributors, wholesalers and pharmacies of the voluntary recall. The recall is being conducted with the knowledge of the United States Food and Drug Administration (FDA). Customers and patients should immediately discontinue use of this product and patients should contact their physician or healthcare provider if they experience any problem that might be related to the use of this product. Additionally, as noted in the product’s labeling, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Adverse events related to the use of Sandoz methotrexate product should be reported to Sandoz at 1-800-525-8747 or to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
: use postage-paid FDA form 3500 available at:
Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
Customers and patients can arrange for return and reimbursement through GENCO Pharmaceutical
Services, the returns vendor for Sandoz, by calling the dedicated Methotrexate Recall Hotline of 1-888-
896-4565 or by sending a message to the dedicated Methotrexate Recall Email address of
ators are available 24 hours, seven days per week
to provide assistance.
IMPORTANT SAFETY INFORMATION (PRODUCT LABELING)
Methotrexate should be used only by physicians whose knowledge and experience include the use
of antimetabolite therapy. Because of the possibility of serious toxic reactions (which can be fatal),
Methotrexate should be used only in life-threatening neoplastic diseases, or in patients with
psoriasis or rheumatoid arthritis with severe, recalcitrant, disabling disease which is not
adequately responsive to other forms of therapy.
Deaths have been reported with the use of methotrexate in the treatment of malignancy, psoriasis,
and rheumatoid arthritis.
Patients should be closely monitored for bone marrow, liver, lung and kidney toxicities.
Patients should be informed by their physician of the risks involved and be under a physician’s
care throughout therapy.
The use of methotrexate high dose regimens recommended for osteosarcoma requires meticulous
care. High dose regimens for other neoplastic diseases are investigational and a therapeutic
advantage has not been established. Methotrexate formulations and diluents containing
preservatives must not be used for intrathecal or high dose methotrexate therapy.
1. Methotrexate has been reported to cause fetal death and/or congenital anomalies. Therefore, it
is not recommended for women of childbearing potential unless there is clear medical
evidence that the benefits can be expected to outweigh the considered risks. Pregnant women
with psoriasis or rheumatoid arthritis should not receive methotrexate.
2. Methotrexate elimination is reduced in patients with impaired renal function, ascites, or pleural
effusions. Such patients require especially careful monitoring for toxicity, and require dose
reduction or, in some cases, discontinuation of methotrexate administration.
3. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and
gastrointestinal toxicity have been reported with concomitant administration of methotrexate
(usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs).
4. Methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but generally only after prolonged
use. Acutely, liver enzyme elevations are frequently seen. These are usually transient and
asymptomatic, and also do not appear predictive of subsequent hepatic disease. Liver biopsy
after sustained use often shows histologic changes, and fibrosis and cirrhosis have been
reported; these latter lesions may not be preceded by symptoms or abnormal liver function
tests in the psoriasis population. For this reason, periodic liver biopsies are usually
recommended for psoriatic patients who are under long term treatment. Persistent
abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the
rheumatoid arthritis population.
5. Methotrexate-induced lung disease, including acute or chronic interstitial pneumonitis, is a
potentially dangerous lesion, which may occur acutely at any time during therapy and has
been reported at low doses. It is not always fully reversible and fatalities have been reported.
Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of
treatment and careful investigation.
6. Diarrhea and ulcerative stomatitis require interruption of therapy; otherwise, hemorrhagic
enteritis and death from intestinal perforation may occur.
7. Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur in
patients receiving low-dose methotrexate and, thus, may not require cytotoxic treatment.
Discontinue methotrexate first and, if the lymphoma does not regress, appropriate treatment
should be instituted.
8. Like other cytotoxic drugs, methotrexate may induce "tumor lysis syndrome" in patients with
rapidly growing tumors. Appropriate supportive and pharmacologic measures may prevent or
alleviate this complication.
9. Severe, occasionally fatal, skin reactions have been reported following single or multiple
doses of methotrexate. Reactions have occurred within days of oral, intramuscular,
intravenous, or intrathecal methotrexate administration. Recovery has been reported with
discontinuation of therapy.
10. Potentially fatal opportunistic infections, especially Pneumocystis carinii pneumonia, may
occur with methotrexate therapy.
Pregnant women with psoriasis or rheumatoid arthritis and should be used in the treatment of
neoplastic diseases only when the potential benefit outweighs the risk to the fetus.
Nursing mothers. Patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease or other
Patients with psoriasis or rheumatoid arthritis who have overt or laboratory evidence of
Patients with psoriasis or rheumatoid arthritis who have preexisting blood dyscrasias, such as
bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anemia.
Patients with known hypersensitivity to methotrexate.
The foregoing release contains forward-looking statements that can be identified by terminology such as
“may,” “potential,” “could,” or similar expressions, or by express or implied discussions regarding the recall
of methotrexate injection, or regarding potential future revenues from methotrexate injection. You should
not place undue reliance on these statements. Such forward-looking statements reflect the current views
of the Company regarding future events, and involve known and unknown risks, uncertainties and other
factors that may cause actual results to be materially different from any future results, performance or
achievements expressed or implied by such statements. In particular, management’s expectations could
be affected by, among other things, unexpected regulatory actions or delays or government regulation
generally; uncertainties regarding actual or potential legal proceedings, including, among others, product
liability litigation, government investigations and intellectual property disputes; competition in general;
government, industry and general public pricing pressures; unexpected patent litigation outcomes;
unexpected issues in remedying the metotrexate injection manufacturing process; the impact that the
foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as
recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis
AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results
may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the
information in this press release as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of new information, future events or
otherwise. About Sandoz
Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering
a wide array of high-quality, affordable products that are no longer protected by patents. Sandoz has a
portfolio of about 1000 compounds and sells its products in more than 130 countries. Key product groups
include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines,
cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these
medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In
addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek
(Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria) and Oriel
Therapeutics (US). In 2009, Sandoz employed around 23,000 people worldwide and posted sales of USD
For further information
Sandoz US Communications:
Sandoz Global Communications:
+49 8024 476 2597
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