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Form for reporting of ADR/Lack of efficacy and quality compaliant

HEALTH PROFESSIONAL/REPORTER

PATIENT DATA

Full Name

InItial letters:

JobTitle

Sex: M F

Office Address

Age: Body weight(kg):

Phone

Pregnancy Gestational age

Date of Recipt of information

Hepatic impairment yes no unknown

Treatment: outpatient inpatient Self-treament

Renal impairment yes no unknown

Report: initial

Allergy (indicate the allergen)

follow up (initial report date)

MEDICINAL PRODUCT NO.1 presumably caused ADR

International Nonproperitey Name TradeMe

Manufacturer Country Batch No.

Indication

Route of administrator

Single dose/daily dose

Start Date of treatment

End Date of treatment

Durg caused the ADR

OTHER DURGS received during last 3 months including those received by patient's own motion Indicate (No) if patient didn't recive other durgs

International Nonproperietary Name(INN)	Trade Name	Route of Administration	Start Date of Treatment	End Date of Treatment	Indication

Description of Case: Start Date of ADR

Did the event resolve after Stoping durg? yes no didn't Stopped not applicable

Did the ADR reappear after reintroduction? yes no didn't Stopped not applicable

Did the patient had recived any of the following during the treatment:omeprazole,esomeprazole,fluoxamine,fluoxetine,moclobemide,voriconazole,fluconazole,ticlopidine,carbamazepine and efavirenz? Yes no Din't have the information

Measures Taken:

Without treatment

Durg therapy

Stopping the suspect durg

Non-durg treatment(including surgery)

Dose reduction of the suspect durg

Other,indicate

Treatment of ADR (if required)

Outcome:

recovery without consequences

death

condition improved

unknown

condition without changes

not applicable

recovery with consequences (specify)...

Criteria for seriousness(specify if applicable):

death

congenital malformations

life-threatening condition

incapacity/ disability

inpatient hospitalization or prolongation of existing hospitalization

not applicable

Relevant additonal information

Data from clinical,laboratory,X-ray investigations,and autopsy,including determinations of durg concentration in the blood/tissues,if there are any and if they are associated with the ADR(please indicate dates).

Concomitant diseases.History data,suspected drug interactions.

For congenital abnormality,specify all other medicinal products taken during pregnancy and the date of last period.Please attach additonal pages if necessary.