TRACTOCILE

This brand name is authorized in Nigeria. It is also authorized in Austria, Brazil, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, South Africa, Spain, Turkey, UK.

Active ingredients

The drug TRACTOCILE contains one active pharmaceutical ingredient (API):

1	Atosiban UNII 0P5DNO7CEF - ATOSIBAN ACETATE
	Atosiban is a synthetic peptide which is a competitive antagonist of human oxytocin at receptor level. In human pre-term labour, atosiban at the recommended dosage antagonises uterine contractions and induces uterine quiescence.
	Read more about Atosiban

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
B4-6502	Injection	Tractocile Injection INJ 6.75 mg/0.9 mL 1 x 0.9 mL (in vial)	Solution for Injection Clear, colorless solution without particles 98 RNW-PP-225292 TRACTOCILE INJECTION ATOSIBAN 6.75 mg/ 0.9 ml Atosiban 37.5mg Mannitol 250mg Hydrochloric Acid q.s Water for Injection to 5ml B4-6502 Drugs Imported Products 10.9ml Prescription Only Medicine (POM) 12/29/2021 SWAN MEDICO LIMITED, PLOT B4, PLOT 602, ZUMA MALL, NDOLA SQUARE ZONE 5 ABUJA FCT 80339067 yaksky123@yahoo.com FERRING GmbH, Wittland 11 24109 Kiel Germany , Germany	21/12/2023
B4-6503	Injection	Tractocile Injection (wrong smpc) INJ 37.5 mg/5 mL 1 x 5 mL (in vial)	Concentrate for Solution for Infusion Clear, colorless solution without particles 93 RNW-PP-226179 TRACTOCILE INJECTION ATOSIBAN 37.5 mg/ 5 ml Atosiban 37.5mg/5ml Mannitol 250mg Hydrochloric Acid q.s Water for Injection to 5ml B4-6503 Drugs Imported Products 5ml Prescription Only Medicine (POM) 12/29/2021 SWAN MEDICO LIMITED, PLOT B4, PLOT 602, ZUMA MALL, NDOLA SQUARE ZONE 5 ABUJA FCT 80339067 yaksky123@yahoo.com FERRING GmbH, Wittland 11 24109 Kiel Germany , Germany	21/12/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
Tractocile 7.5 mg/ml Solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
TRACTOCILE Solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
G02CX01	Atosiban	G Genito urinary system and sex hormones → G02 Other gynecologicals → G02C Other gynecologicals → G02CX Other gynecologicals
Discover more medicines within G02CX01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	521401101155316, 521401102151314
EE	Ravimiamet	1196782, 1196793
ES	Centro de información online de medicamentos de la AEMPS	99124001, 99124002
FI	Lääkealan turvallisuus- ja kehittämiskeskus	561555, 561563
FR	Base de données publique des médicaments	61710552, 62476853
GB	Medicines & Healthcare Products Regulatory Agency	47900, 47908
HK	Department of Health Drug Office	48228, 48229
IT	Agenzia del Farmaco	035026018, 035026020
LT	Valstybinė vaistų kontrolės tarnyba	1031314, 1031315
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	549M2001
NG	Registered Drug Product Database	B4-6502, B4-6503
NL	Z-Index G-Standaard	14568101, 14568128
NL	Z-Index G-Standaard, PRK	52582, 52590
PL	Rejestru Produktów Leczniczych	100099395, 100099403
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W53605001, W53606001
TR	İlaç ve Tıbbi Cihaz Kurumu	8697621760103, 8697621770096
ZA	Health Products Regulatory Authority	36/18.9/0335, 36/18.9/0336