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Questionnaire for medical workers
Reporting form to be sent to the pharmacovigilance service for GEROPHARM medicinal products for medical professionals
Confidential if filled in. You can send the form at any stage of its filling in
Page
1/10
Suspect drug:
initial
repeated
Date of initial visit:
Serial number of the repeated report:
Description of the problem
Adverse reaction that can be associated with the administration of the medicinal product
Medicinal product is ineffective
Drug interaction that is not described in the instruction for medical use of a medicinal product
The detection of fake product
Mistakes made during the medical use of the medicinal product
Overdose with the medicinal product
Medicinal product abuse
Incorrect use of the medicinal product
Adverse reaction developed when using medical device
Patient details
Initials:
Date of birth:
Weight:
Height:
Sex:
Male
Female
No. of medical record or outpatient card:
Underlying disease diagnosis:
Comorbidities:
Renal insufficiency:
Yes
No
No information
Hepatic impairment:
Yes
No
No information
Allergy:
Yes
No
No information
What is the allergen:
Smoking:
Yes
No
Used to smoke
Frequency:
Alcohol:
Yes
No
Used to consume
Frequency:
Addictive substances:
Yes
No
Used to consume
Frequency:
Pregnancy:
Yes
No
Frequency:
Information about the case
Please list the symptoms of the adverse reaction and describe it
Adverse reaction started:
Adverse reaction ended:
Outcome of the adverse reaction:
Recovered without sequences
State improved
State unchanged
Recovery with complications
Death
No information
Not applicable
Date of death:
Describe the consequences with an indication of the severity:
Has the administration regime of the suspected medicinal product been changed?
Yes
No
Has the adverse reaction been changed after changing the administration regime of the suspected medicinal product/usage regime of the suspected medical device?
Yes
No
Changes:
The suspected medicinal product was prescribed again:
Yes
No
Has the adverse reaction resumed after the re-prescription of the suspected medicinal product/medical device?
Yes
No
Please describe the adverse reaction:
Has the adverse reaction resumed after the re-prescription of the suspected medicinal product/medical device?
Yes
No
No information
Information about the suspected medicinal product
The adverse reaction is associated with:
medicinal product
with a medical device
Medicinal product (trade name, pharmaceutical form):
Pharmaceutical form, country:
Batch No.:
Expiry date:
Single dose:
Dosage frequency:
Route of administration:
Medicinal product administration began:
Medicinal product administration finished:
Direct indications to prescribe the medicinal product:
Can a sample of the medicinal product be provided for examination (from the same package)?
Yes
No
Have you ever taken the suspected medicinal product before? When? What was the dosage regime? Was it well-tolerated by you?
Add more
Name of medical device:
Brand name:
Manufacturer (name, address):
Date of manufacture, shelf life:
Model:
Lot:
Unique code:
Batch:
Who used the medical device?
Healthcare professional
Person without medical degree/Patient
Other:
Другое:
Is this a disposable medical device that was reconfigured for reuse?
Yes
No
Provide the name and address of the organisation/individual responsible for reconfiguration of the medical device:
Can a sample of the medicinal product be provided for examination (from the same package)?
*
Yes
No
Information about the solvent
If a solvent was used for the administration of the suspected medicinal product, please provide the information about it
Solvent (trade name, pharmaceutical form, concentration):
Pharmaceutical form, country :
Batch No. :
Expiry date:
Administration started:
Administration ended:
Have you ever used this solvent before? When? Was it well-tolerated by you?
Information about the concomitant therapy
Please indicate all the drugs you took simultaneously with the suspected medicinal product and during the 3 months that preceded the beginning of the therapy with the suspected medicinal product.
Medicinal product (trade name, pharmaceutical form):
Pharmaceutical form, country :
Batch No. :
Expiry date :
Single dose :
Dosage frequency :
Route of administration :
Medicinal product administration began :
Medicinal product administration finished :
Direct indications to prescribe the medicinal product:
Add more
Actions taken to correct the adverse reaction
No treatment
Withdrawal of the suspected medicinal product
Date of last admission:
Time of last admission:
The suspected medicinal product dose decrease
Исходный режим:
:
Changes in concomitant therapy
:
:
Drug therapy
Provide the dates of administration and withdrawal, single and daily doses for each of the prescribed medications. If any solvent is used, provide the same information about the solvent
Non-drug therapy (including surgical intervention)
If there is more than one intervention, specify the type, timing, mode, and intensity for each intervention:
Consequences of the adverse reaction
Consequences:
Recovered without sequences
State improved
State unchanged
Recovery with complications
Death
No information
Not applicable
Describe the consequences with an indication of the severity :
Date of death :
Time of death:
Describe the circumstances of death, provide an autopsy report:
Comments:
Information about the person reporting the adverse reaction
Region:
*
Full name:
*
Phone:
*
E-mail:
*
The form is filled out on (date):
Place of work:
*
Institution address:
*
Job title:
Date of sending the form to GEROPHARM Group of Companies:
Additional information
Please provide a detailed description of the adverse reaction:
Please provide additional information about laboratory and instrumental tests, if any deviations are revealed. Do not forget to provide the date of each test:
Please describe the events that could be attributed to the occurrence of this adverse reaction (living conditions, professional harm, stress, etc.):
Please describe the events that could be attributed to the occurrence of this adverse reaction (living conditions, professional harm, stress, etc.):
Please provide any other important information which, in your opinion, can be attributed to the occurrence of this adverse reaction:
Please try to explain with the provision of sufficient evidence the relation of this adverse reaction with the use of the suspected medicinal product:
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You are a health care professional?
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