PHARMACOSUPERVISION

The main priority in the activities of the company «Geolik Farm Marketing Group» is to provide the population with high-quality medicines. In order to make the treatment process more effective and safe, we need to maintain feedback with health professionals, consumers and distributors.

Therefore, if as a result of taking our medicines, you have information about an adverse reaction, the appearance of an unexpected therapeutic effect or the lack of effectiveness of the drug, we ask to inform us about this:

Call us: +38(044)239-2641 and ask a pharmacovigilance specialist;
Fill «Card-message» or «Card-message for medical workers» and send to farmakonadzor@gfmg.ua;
If you have any questions or difficulties in completing the card, please contact an authorized person with pharmacovigilance:
Phone: +38(044)239-2641 /on weekdays during office hours/, or +38(050)383-4905 /24 hours a day/
3. Fill out the online form: for specialists or for consumers

«The control of the safety of medicinal products during their use in Ukraine is regulated by the order of the Ministry of Health of Ukraine dated 27.12.2006 No. 898 "On approval of the procedure for pharmacovigilance for adverse reactions of medicinal products permitted for medical use " with amendments and additions.»

Appendix 6
to the Procedure for the Implementation of Pharmacovigilance
(subparagraph 3 of paragraph 1 of Section IV)

Medical documentation
Form No.137/o

CARD-MESSAGE
about the adverse reaction (hereinafter AR) of the medicinal product (hereinafter MP) and/or lack of effectiveness (hereinafter LE) MP

I.Patient Information

Full name

Number of medical history / outpatient card

Date of Birth

Genderman woman

Weight (kg)

Height (sm)

II.Suspected AR/LE

Suspected AR / Specifying LE

Start date and time AR/LE

End date and time AR/LE

Correction AR/LE

Consequence AR/LE

These manifestations of AR are considered serious (concerns the AR case as a whole)Yes No

If yes, it is noted why AR is considered serious (there are one or more reasons)

death patient
(date of death)
threats to life
hospitalization / prolongation of hospitalization of the patient
long-term incapacity for work
congenital malformations
another important medical evaluation
disability

III.Suspect Information MP

Suspected MP (trade name, dosage form, manufacturer)

Serial number

Indication (if possible according to ICD-10)

Strength of action

Single dose

Multiplicity of admission

Method of administration

Date and time of onset of therapy

Date and time of therapy end

Measures that have been taken against suspect MPs for AR/LE correction

Whether the suspects of the MP were reappliedYes No

If so, indicate whether it was:

Did AR / LE reoccur after re-assignment of the suspect MPYes No

IV.Information about companion MP

(except for MP that were used to correct the consequences of AR/LE)

Associated MP, (trade name, dosage form, manufacturer, serial number)

Indication (if possible according to ICD-10)

Strength of action

Single dose

Multiplicity of admission

Method of administration

Date and time of onset of therapy

Date and time of therapy end

Other important information

V.Information about the notifier

Full name

Specialty

Health care institution

Location

E-mail

Phone

Date

VI.Information about the medical/pharmaceutical specialist

(if not the notifier)

Full name

Specialty

Health care institution

Location

E-mail

Phone

Date

Appendix 2
to the Procedure for the Implementation of Pharmacovigilance
(subparagraph 5 of paragraph 1 of section III)

CARD-MESSAGE
to provide the patient and/or his representative with information on the adverse reaction (hereinafter AR) of the medicinal product (hereinafter MP) and/or lack of effectiveness (hereinafter LE) MP

Patient Information

Second name

First name

Middle name

Address

Phone\Fax

Information about the suspect MP

Tradename

Form of issue

Manufacturer

Suspected MP were assigned to the patient by a doctorYes No

The patient used MP suspects without prescribing a doctorYes No

Description manifestations of AR MP and/or indications of LE MP

Information about the notifier

Second name

First name

Middle name

Address

Phone\Fax

E-mail

Information on the physician, health care institution and place of residence of the patient who has observed AR MP and/or LE MP

Second name

First name

Middle name

Location of the health care institution

Phone\Fax

The name of the health care institution where the attending physician works

Place of patient's residence

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PHARMACOSUPERVISION

I.Patient Information

II.Suspected AR/LE

III.Suspect Information MP

IV.Information about companion MP

V.Information about the notifier

VI.Information about the medical/pharmaceutical specialist

Patient Information

Information about the suspect MP

Information about the notifier

Information on the physician, health care institution and place of residence of the patient who has observed AR MP and/or LE MP