Based on the limited amount of available information, in case of an exposure to hydroxycarbamide during pregnancy, a careful follow-up with adequate clinical, biological and ultrasonographic examinations should be considered.

there is no evidence, either clinical or as a result of a laboratory test, of any case of enzootic bovine leukosis in the herd and no such case has been confirmed in the previous two years;

Investigations: patients treated with irbesartan/ hydrochlorothiazide had changes in laboratory test parameters which were rarely clinically significant Common: Uncommon:

post-mortem examinations may be carried on three to four in-contact pigs, particularly if these pigs are showing clinical signs.

Once the clinician has excluded PML (if necessary, by repeating clinical, imaging and/ or laboratory investigations if clinical suspicion remains), dosing of natalizumab may resume.

provides guidelines and minimum requirements on diagnostic procedures, sampling methods and criteria for the evaluation of the results of clinical and post-mortem examinations and laboratory tests for a correct diagnosis of ASF(1);

Field epidemiology expertise, laboratory support, clinical and other essential expertise shall be available as technical assistance for any further investigation within Member States.

Devices other than those which are custom made or intended for clinical investigations considered to meet the essential requirements referred to in Article 3 must bear the EC mark of conformity.

However, these were not evident from clinical trials with Optimark.  Central nervous system disorders In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased.

the competent authority collects information on any zoonotic agents the presence of which has been confirmed in the course of the tests or examinations carried out and on any clinical cases in humans or animals of the zoonoses listed in Annex I, point I;

The manufacturer or his authorized representative established within the Community shall draw up for custom-made devices or for devices intended for clinical investigations the statement comprising the elements stipulated in section 2.

The sentinel piglets shall be placed, in accordance with the requirements of the competent authority, throughout the infected holding and will be examined clinically 28 days after having been placed on the holding, and sampled for serological testing.

Laboratory Test Interactions In clinical trials using VASOVIST, no specific trends were observed that would signify a potential interaction of the medicinal product with laboratory test methods.

Liver function (transaminases, bilirubin and alkaline phosphatase) should be monitored before initiation of treatment and monthly thereafter, or as clinically indicated.

In multifocal patients, the risk for CDMS was independent from MRI findings at baseline, indicating a high risk for CDMS because of the dissemination of the disease based on clinical findings.

The manufacturer may commence the relevant clinical investigations at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary, based on considerations of public health or public order.

Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials.

One of the requirements for a diagnostic agent to be authorised is to demonstrate relevant impact on diagnostic thinking in the clinical context in which the test is to be used, unless such impact can be shown indirectly or historically.

In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times

The written report, signed by the responsible medical specialist, shall comprise a critical evaluation of all the data collected during the clinical investigation.

clinical signs and post-mortem findings consistent with ISA in accordance with the current edition of the OIE Diagnostic manual for aquatic animal diseases, including dead, weak or abnormally behaving fish, signs of anaemia, other post-mortem findings and pathological changes, are observed, and ISAV is detected by one or more of the following methods:

'(h) "placing on the market " means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;

Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the 41st World Medical Assembly in Hong Kong in 1989.

Member States shall ensure that the measures provided for in paragraphs 2 and 3 are applied in the vaccination zone during a period starting not earlier than 30 days from the date of completion of emergency vaccination and terminating with the completion of a clinical and serological survey.

This delay in motor complications with pramipexole should be balanced against a greater improvement in motor function with levodopa (as measured by the mean change in UPDRS-score).

When fish on a farm are suspected of being infected with a list I disease, Member States shall ensure that the official service immediately activates official investigation arrangements to confirm or rule out the presence of the disease, including clinical examination;

In the case of devices intended for clinical investigations, the manufacturer or his authorized representative established in the Community shall, at least 60 days before the commencement of the investigations, submit the statement referred to in Annex 6 to the competent authorities of the Member State in which the investigations are to be conducted.

Due to the risk of bleeding and haematological undesirable effects, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).

In case of pigs to be moved to a slaughterhouse, to a processing plant or to other places to be then killed or slaughtered, in addition to the investigations to be carried out in accordance with point 1, a clinical examination of pigs must be carried out in each subunit in which the pigs to be moved are kept.

no clinical, pathological or serological evidence of Aujeszky's disease has been recorded in the previous 12 months in the holdings located in an area of 5 km surrounding the holding of origin of the pigs;

In laboratory evaluations in clinical trials transient increases in transaminases and gamma- glutamyltransferase have been observed (however associated adverse events have not been reported statistically significantly more frequently with Remeron than with placebo).

30 • Initiation of Volibris is not recommended for patients with clinically significant anaemia. • Patients taking Volibris should have their haemoglobin and/ or haematocrit levels measured regularly. • If tests show a clinically significant decrease in haemoglobin or haematocrit, and other causes have been excluded, consider reducing the dose of Volibris, or stopping treatment.

The presence of Mycobacterium bovis (M. bovis), agent of bovine tuberculosis, in clinical and post-mortem specimens may be demonstrated by examination of stained smears or immunoperoxidase techniques and confirmed by cultivation of the organism on primary isolation medium.

Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/ l) occurred in 2.3 % of Aclasta-treated patients in a large clinical trial compared to 21 % of Aclasta-treated patients in the Paget’ s disease trials.

The patient ’ s electrolyte and glycaemia levels, as well as haematologic, hepatic, renal and coagulation parameter tests must be monitored at least twice weekly, and more frequently for clinically unstable patients during the induction phase and at least weekly during the consolidation phase.

However, in clinical practice, these benign findings do not warrant further evaluation in women with no vaginal bleeding (in accordance with guidelines for postmenopausal women), as the risks of diagnostic uterine procedures in asymptomatic women outweigh any benefits.

If recent mortalities or weak or abnormally behaving fish are observed, but the clinical signs and post-mortem findings are not consistent with ISA, sampling is not obligatory, although such samples as may be required to carry out a differential diagnosis may be taken at the inspector's or veterinarian's discretion.

Member States shall ensure that when pigs show clinical signs suggesting swine vesicular disease or foot-and-mouth disease, differential diagnosis by means of appropriate sampling and laboratory investigations is carried out as quickly as possible, in accordance with the provisions referred to in Chapters IV, VII and VIII of this Manual.

Clinical biochemistry determinations to investigate major toxic effects in tissues and, specifically, effects on kidney and liver, should be performed on blood samples obtained of all animals just prior to or as part of the procedure for killing the animals (apart from those found moribund and/or intercurrently killed).

By way of derogation from Article 60 it may be decided in accordance with the procedure referred to in Article 89(3), to withdraw the restrictions applied in accordance with this Directive after the requirements provided for in Articles 36 and 44 have been met and the clinical and serological survey has been completed and confirmed the absence of foot-and-mouth disease virus infection.

By way of derogation from Article 61 it may be decided in accordance with the procedure referred to in Article 89(3), to withdraw the restrictions applied in accordance with this Directive after the clinical and serological survey provided for in Article 56 and the measures provided for in Article 57 have been completed and confirmed the absence of foot-and-mouth disease virus infection.

• That treatment with Volibris often causes a decrease in haemoglobin and haematocrit o Initiation of Volibris is not recommended for patients with clinically significant anaemia. o Patients taking Volibris should have their haemoglobin and/or haematocrit levels measured regularly. o If tests show a clinically significant decrease in haemoglobin or haematocrit, and other causes have been excluded, consider reducing the dose of Volibris, or stopping treatment.

In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia was higher in the group treated with Cozaar as compared to the placebo group (see section 4.8, 'Hypertension and type 2 diabetes with renal disease - Investigations’ and ‘ Post-marketing experience - Investigations’ Therefore, the plasma concentrations of potassium as well as creatinine clearance values should be closely monitored, especially patients with heart failure and a Creatinine Clearance between 30-50 ml/ min should be closely monitored.

Abnormal Laboratory Findings In the event of an abnormal blood count or liver function test finding, the clinical decision for continuing use or adjusting the dose of Diacomit in conjunction with adjusting the doses of clobazam and valproate needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks (See, section 4.4).

the competent authorities must be satisfied that any possible residual foot-and-mouth disease virus can be detected in the animals intended for restocking either on the base of clinical signs, in the case of bovine or porcine animals, or though laboratory investigations in the case of other species susceptible to foot-and-mouth disease, carried out at the end of the observation period specified in paragraph 1.3;

If clinically significant fluid retention develops during therapy with ambrisentan, with or without associated weight gain, further evaluation should be undertaken to determine the cause, such as ambrisentan or underlying heart failure, and the possible need for specific treatment or discontinuation of ambrisentan therapy.

The applicant has presented a number of publications from the literature in order to discuss the rational for deviation from the ICH Guideline on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ ICH/ 2711/ 99) and the basis of differentiation of 0-14 and 15-28 days instead of the more general definition of neonates as ‘ up to 28 days after birth’, as well as the different dosing regimens used.

4 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Efficib who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.

4 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Janumet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.

4 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Velmetia who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.