Suspect drug:

initial

repeated

Please chose "Repeated" if you have already reported about the problem and want to update or supplement the information provided Названиеearlier.

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

Information about the suspected medicinal product

The adverse reaction is associated with:

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

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?

Другое:

Is this a disposable medical device that was reconfigured for reuse?

Yes

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

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:

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):

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 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:

Fields marked with * are obligatory to fill in

Reporting form to be sent to the pharmacovigilance service for GEROPHARM medicinal products for patients

You are a health care professional?