Pharmacovigilance

The NOVISTEM company today produces two innovative veterinary drugs:

Preparation "Ultracell-Dog" (RC № 77-3-6. 18-4290№PVR-3-6.18/03435, valid until 07.06.2023) is produced in the form of lyophilizate to prepare a solution for intramuscular or subcutaneous injections and is used in the treatment of diseases of the musculo-skeletal system, skin lesions of non-infectious etiology, in the complex therapy of these diseases complicated by infection.

Preparation " Ultracell-horse "(RC № 77-3-6. 18-4291№PVR-3-6.18/03434, valid until 07.06.2023) is produced in the form of lyophilizate to prepare a solution for intramuscular or subcutaneous injections and is used in the treatment of diseases of the musculo-skeletal system, wounds, dry eczema of non-infectious etiology, in the complex therapy of acute and chronic diseases and injuries of the tendon-ligamentous apparatus, as well as in the rehabilitation period after surgical interventions on the musculo-skeletal system.

The quality of the preparations is constantly monitored, each series is accompanied by a data report of analysis, which contains information on the actual values of the quality indicators of the series. The release of the series into civilian circulation is carried out after verification by an authorized person for quality certified by Ministry of Agriculture (Order No. 382 of August 23, 2018 of the Ministry of Agriculture of Russia) after a thorough study of the production processes and quality inspection of this series.

Also, the quality of the preparations is confirmed by declarations of conformity issued by FEDERAL STATE BUDGETARY INSTITUTION «THE RUSSIAN STATE CENTER FOR ANIMAL FEED AND DRUG STANDARDIZATION AND QUALITY», the central inspection institute responsible for the circulation of veterinary medicines, valid until 18.06.2020:

• Declaration no. ROSS RU.SS07D00344 from 27.06.2018- " "Dogstem" preparation
• Declaration no. ROSS RU.SS07D00345 from 27.06.2018- " Horsestem" preparation

The safety of drugs was investigated in the course of their development, contraindications for use were established: hypersensitivity to the components of the drug, autoimmune and oncological diseases. However, in the study there were no cases of hypersensitivity to the components of the drug and other contraindications.

The NOVISTEM company is interested in the consistent quality and safety of products, therefore, it monitors the safety and effectiveness of manufactured products. For this purpose, the "Pharmacovigilance" tab has been posted on the Company's website.

In case of adverse events or negative consequences, as well as in the case of additional effects not specified in the instructions as indications observed when using our drugs in any way, independently or with the participation of a veterinarian, please contact us in any way convenient for you.

We will be grateful for any information provided to identify atypical manifestations or side effects, or lack of effectiveness, as well as to detect additional indications when using medicines of our production.

Before you start filling out a notice of a suspected adverse reaction or lack of efficacy of a drug, we ask you to get familiar with the basic concepts and terms in the field of pharmacovigilance.

• Adverse action (adverse effect) means any unintended effect of the drug that goes beyond its expected therapeutic effect, due to pharmacological properties and manifests itself when used in recommended doses. The lack of therapeutic effect of the drug is also called a adverse effect. The manufacturer should be informed about this.
• Unexpected adverse reaction means an adverse reaction, the nature or severity of which is not consistent with the available information about the drug (with a leaflet / instructions for use of the registered drug).
• Prescribed adverse reaction is an adverse reaction, the nature or severity of which is consistent with the available information on the medicinal product (with a leaflet / instructions for use of the registered drug).
• Serious adverse reaction - any adverse event with the use of the drug (regardless of dose) that leads to death, is life-threatening, requires hospitalization or prolonged hospitalization, leads to disability, or is a congenital anomaly or developmental disability.
• A minor adverse drug reaction is any adverse reaction that does not meet the criteria for a “serious adverse reaction”.
• Lack of effectiveness of the drug - the lack of therapeutic effect of the drug on the course and duration of the disease.
• Interaction reactions - reactions that occur while taking several drugs, which are the result of their mutual influence on the pharmacodynamics and pharmacokinetics of each other.

The information sent by you is strictly confidential and is not subject to disclosure, with the exception of cases established by law.

Please find below the form of the notification for filling and the requirements for its completion.

All fields are required, in case you do not know any information, this should be specified in the corresponding field.

This page serves for feedback from us and does not replace the veterinarian. NOVISTEM Company cannot answer questions related to your pet’s health status. If you have any questions about pet's health, please consult your veterinarian.

Surname, name and patronymic:
Place of work:
Position:
Phone:
E-mail:
Date of receipt of information about adverse reaction by the contact Person:
Date of provision the information on adverse reaction to the RU Holder:
INFORMATION ABOUT THE ANIMAL:
City, RF territorial entity:
Place of detection of adverse reaction (clinic, animal rescue, nursery, farm, etc.):
Description of animal/animals:
Animal type:
Breed / productive line, nickname of the animal:
Weight (kg):
Age:
Gender / physiological status:	Choose the option: Female Male Pregnant Sterilized Lactation Unknown
ОThe grounds of the drug application or initial diagnosis:
Information on detected adverse reaction (filled in by vet):
Information about the drug suspected to cause adverse reaction (hereinafter drug No. 1):
Drug trade name (including the dosage, pharmaceutical form and the product group):
Serial number:
Shelf life:
Was the drug stored according to the instructions?	Choose the option: Yes No Unknown
If not, please specify the reason:
Drug application details:
Dose/frequency of application:
Route of administration:
Injection site:
Who administered the drug:	Choose the option: Veterinarian Vet nursing staff/vet attendant Owner / farmer Other
Duration of treatment:
The treatment plan with the identification of other drugs that have administered to this animal:
Description of the treatment plan with administering of another drug:
Information on each of the drugs (Drug trade name including the dosage, pharmaceutical form and the product group serial number, shelf life; application details: the dose/frequency of application, route of administration, route of administration,injection site):
Who administered the drug:	Choose the option: Veterinarian Vet nursing staff/vet attendant Owner / farmer Other
Adverse reaction description:
Adverse reaction start date:
Date of solution:
Was the drug withdrawal accompanied by the disappearance of an adverse reaction?	Choose the option: Yes No The drug was not discontinued Not applicable
Was there a recurrence of adverse reactions after repeated administration of the drug?	Choose the option: Yes No Not re-administered Not applicable
Taken actions:	Choose the option: Without treatment Suspected drug withdrawal Reducing the dose of suspected drug Withdrawal of concomitant treatment Drug therapy Non-pharmacological treatment (including surgical intervention) Other
Drug therapy of adverse reaction (if ever needed):
Result:	Choose the option: Recovery without consequences Amelioration Condition unchanged Recovery with consequences Death No information Not applicable
Clinical studies conducted for this animal:
Laboratory studies conducted for this animal:
Autopsy results (if conducted):
Efficacy in indications, not provided by the instruction:
Photo of preparation No. 1 (initial and, if available, secondary packagings) *.jpg, not more than 3Mb: