According to the World Health Organization (WHO), Pharmacovigilance is defined as the science and activities related to the detection, evaluation, understanding and prevention of adverse events or any other safety related situations with the products.

Responsibility for ensuring safety in the use of medicines belongs to everyone: industries, regulatory agencies, health professionals and patients. Therefore, when you become aware of an adverse event by a patient under treatment with a Cellera Farma drug, we advise you to contact us using the form below, or contact our team of pharmacists by phone:

0800 17 7003

Monday through Friday
From 8:30 a.m. to 4:00 p.m.
(except on holidays)

Adverse Event

According to ANVISA (RDC 04/09), an adverse event is any medical occurrence, which may occur during treatment with a medicine, but that doesn’t necessarily have a causal relationship to that treatment

Therefore, an adverse event is considered:

Suspected adverse drug reactions;

Reaction to a drug that is harmful and unintentional and that occurs at doses normally used in humans for prophylaxis, diagnosis, therapy of the disease or for the modification of physiological functions.

Adverse events due to deviations from the quality of medications;

Any unfavorable medical occurrence that may occur during treatment with a drug associated with a technical claim involving such drug (e.g. changes in color, odor, taste).

Adverse events resulting from the unapproved use of medicines;

Use not described in the lable (“off label”): It encompasses the use in situations other than the recommended in the package insert of a drug registered with Anvisa. It may include differences in indication, age range / weight, dose, frenquency, presentation or route of administration.

Drug interactions;
Pharmacological, toxicological, clinical or laboratory response caused by combining the drug with other drugs.
Therapeutic ineffectiveness, total or partial;
It is the exposure to a product that does not result in the desired therapeutic effect as the indication approved in the package insert.
Drug-related intoxication;
Harmful response resulting from the intentional or unintentional use of a drug in doses higher than those usually used for prophylaxis, diagnosis, treatment or for the medication of physiological functions.
Overuse of drugs;
Intentional overuse of one or more drugs that may be persistent or sporadic, accompanied by harmful physical or psychological effects.
Drug errors, potential and real;
Any preventable event that may cause or lead to inappropriate use of medicines or harm to a patient while the medication is under the control of healthcare professionals, patients or consumers. This event may be related to professional practice, health products, procedures and systems, including prescription, verbal guidance, labeling, packaging and nomenclature of processed and handled products, dispensing, distribution, administration, education, monitoring and use.
Exposure via parent;
It is the exposure of a fetus / baby / child to a medication via the parent (during conception) or the mother (during conception, pregnancy, delivery or breastfeeding).The cases of exposure by parent should be reported with or without reaction
Overdosage.
Administration of the product at a dosage higher than the maximum dose recommended in the package insert, whether or not the patient is suspected of having an adverse reaction.

Important notice: We do not issue any medical opinion regarding health matters, which should be done by doctor of confidence









Patient details

Name or initials*:

Age*:
Weight*:
Height:

City:
State:

Sex: FemaleMaleIgnored

Pregnancy?* YesNo
Diabetes?* YesNo
Renal problems?* YesNo
Alcoholism?* YesNo
Hypertension?* YesNo
Heart Problems?* YesNo
Liver problems?* YesNo
Smoking?* YesNo
Previous allergic reaction to the drug? YesNo

Rapporteur Data (person responsible for reporting; the patient may also be the rapporteur)

Name*:

Phone*:
Healthcare professional?* YesNo

What is the specialty?
Registration number with the council

Email

Your report relates to which of the adverse events listed below?*

Suspected adverse drug reactionsAdverse events due to drug quality deviationsSuspected inneficacyAbuseMisuse / Incorrect or improper useExposure via parentOff-label useDrug interactionsDrug-related intoxication

Attention!

To properly review your complaint, we ask that the following fields be filled with as much information as possible.

Data on the Cellera Farma drug

Drug name?* (please specify the complete presentation of the medicine)

Drug batch number?*

What dose was ingested, also specifying the frequency and route of administration?*

What is the indication?

What is the starting date of the treatment?* (Preferably, inform the day/month/ year. In case it is impossible to specify the day, please inform at least the month/year)

Is the patient undergoing treatment? YesNo

Was the drug prescribed / indicated by a healthcare professional? YesNo

Adverse Event

What adverse effects were presented?*

When did the event start?* (Preferably, inform the day/month/ year. In case it is impossible to specify the day, please inform at least the month/year)

Does the patient use other drugs? If yes, please specify the name, indication, presentation and treatment period.*

What is the resolution of the event? Does it continue? Did it improve? Was there a need to take any other drug to reverse the event presented? Please specify.*

In your opinion, is the adverse effect related to the use of the drug?*

Have any laboratory tests been performed? If yes, please inform the type of test and the results.

I authorize the contact of a Pharmacovigilance professional if additional information is necessary