A statistically significant association between polymorphism Msp I and polymorphism Ile/Val was found in both lung cancer patients and healthy controls.

In particular, responses are expected from economic operators on issues within their specific area of interest (e. g. advertising and marketing, labelling…), patient associations and health and consumer protection NGOs.

The committees referred to in Article 56(1) and any working parties and scientific advisory groups established in accordance with that Article shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products, in particular patient organisations and health-care professionals' associations.

We conducted a retrospective study of data on 78,974 Medicare beneficiaries 65 years old or older who were hospitalized with acute myocardial infarction. Patients were categorized according to the hematocrit on admission (5.0 to 24.0 percent, 24.1 to 27.0 percent, 27.1 to 30.0 percent, 30.1 to 33.0 percent, 33.1 to 36.0 percent, 36.1 to 39.0 percent, or 39.1 to 48.0 percent), and data were evaluated to determine whether there was an association between the use of transfusion and 30-day mortality.

this Committee should also include three representatives of patients' associations, designated by the Commission, and three other persons, also designated by the Commission, on a recommendation from the European Agency for the Evaluation of Medicinal Products (hereinafter referred to as 'the Agency");

CPK increases in association with rhabdomyolysis were reported in less than 1 % of patients.

- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,

The educational materials for Healthcare professionals, patients and haemophiliac patients associations should include the following key elements:

Syncope was observed in association with Neupro, but also at a similar rate in patients treated with placebo.

In thalassaemia patients there is an association between liver fibrosis and iron overload and/ or hepatitis C.

In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % of patients (6 % of courses).

Myocardial infarction and cardiac arrest have been observed in association with MabCampath infusion in this patient population.

The proportion of patients who had post-treatment ALT elevations in association with an increase in bilirubin levels was low and similar in patients receiving either lamivudine or placebo.

Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [ NYHA ] functional class III-IV).

In controlled clinical trials, periorbital and/ or eyelid skin darkening in association with the use of TRAVATAN has been reported in 0.4 % of patients.

Patients who experience syncope in association with pulmonary hypertension should avoid any exceptional straining, for example during physical exertion.

Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with Zavesca.

However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.

Heart failure Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV).

In accordance to the results, the association between suicidality risk and paroxetine appears significant only among patients with previous depression but not among patients with previous depression and anxiety or anxiety alone.

Cardiac failure Experience with vildagliptin therapy in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II is limited and therefore vildagliptin should be used cautiously in these patients.

Hypersensitivity reactions Serious hypersensitivity reactions have been reported in association with infusion of RoActemra in approximately 0.3 % of patients (see section 4.8).

3 Cardiac failure Experience with vildagliptin therapy in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II is limited and therefore vildagliptin should be used cautiously in these patients.

* Transient, influenza-like symptoms have been reported in patients receiving intravenous injection of Bonviva 3 mg every 3 months, typically in association with the first dose.

* Transient, influenza-like symptoms have been reported in patients receiving intravenous injection of Bondenza 3 mg every 3 months, typically in association with the first dose.

There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of medicines in non-deformable controlled-release formulations.

Patients with a history of hepatitis B infection should be carefully monitored for signs of active hepatitis B infection when rituximab is used in association with cytotoxic chemotherapy.

8 received placebo throughout the treatment course is shown in Table 3. The proportion of patients who had post-treatment ALT elevations in association with an increase in bilirubin levels was low and similar in patients receiving either lamivudine or placebo.

Bleeding events in association with increases in prothrombin time have been reported, predominantly in the elderly, in patients receiving celecoxib concurrently with warfarin, some of them fatal.

In addition to conventional therapy with diuretics and optional cardiac glycosides, ramipril has been shown to be effective in patients with functional classes II-IV of the New-York Heart Association.

Cardiac failure Experience with vildagliptin therapy in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II is limited and therefore vildagliptin should be used

Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.

In most clinical trials of Avastin, patients with pre-existing CHF of NYHA (New York Heart Association (NYHA) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.

Bleeding events in association with increases in prothrombin time have been reported in arthritis patients (mainly elderly) receiving celecoxib concurrently with warfarin, some of them fatal (see section 4.4).

Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with a relevant medical history.

Cardiac and respiratory reactions, including death due to bronchospasm in patients with asthma, and, rarely, death in association with cardiac failures have been reported following administration of timolol maleate.

Patients taking NRTI treatment in association with ribavirin and interferon alfa-2b or peginterferon alfa-2b may be at increased risk of mitochondrial toxicity, lactic acidosis and hepatic decompensation (see section 4.4).

Respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma and, rarely, death in association with cardiac failure, have been reported following administration of timolol maleate.

Anti-fibrinolytics have been reported to reduce blood loss in association with surgery in haemophilia patients, especially in orthopaedic surgery and surgery in regions rich in fibrinolytic activity, such as the oral cavity.

Patients taking NRTI treatment in association with ribavirin and interferon alfa-2b or peginterferon alfa-2b may be at increased risk of mitochondrial toxicity, lactic 5 acidosis and hepatic decompensation (see section 4.4).

Not recommended combinations: pancreatitis (fatal and nonfatal) and peripheral neuropathy (severe in some cases) have been reported in HIV infected patients receiving stavudine in association with hydroxyurea and didanosine.

Pathological gambling, increased libido and hypersexuality have been reported in Parkinson’ s disease patients treated with dopamine agonists and other dopaminergic treatments such as entacapone in association with levodopa.

To prepare for the gradual replacement of ReFacto with ReFacto AF on the market, the company that makes the medicine will provide educational packs for healthcare workers who will prescribe or use ReFacto AF, for all associations of haemophilia patients in the European Union (EU), for patients receiving ReFacto AF and for laboratories that will monitor patients receiving ReFacto AF.

The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe/ use ReFacto AF, all laboratories that are expected to monitor patients receiving ReFacto AF and all EU Haemophiliac patients associations are provided with Educational packs.

Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing ARICLAIM to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.

Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing CYMBALTA to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.

Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing XERISTAR to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.

Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing duloxetine in patients with increased intraocular pressure, or those at risk of acute narrow- angle glaucoma.

Decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in variations of haemostatic parameters have been reported in patients treated with anticoagulants in association with orlistat (see section 4.4 and 4.5)

Given the high prevalence and natural rate of cataract formation in the older patient population represented in the clinical studies, there was no apparent association between the incidence of lens opacity formation and bexarotene administration.