Ferring_ad.qxp 21/4/09 03:12 Page IFC1
When preterm
delivery threatens,
turn to Tractocile.
®
April. 2009
Prescribing Information: Tractocile 7.5mg/ml solution for bolus injection followed by an infusion as before. Undesirable Tractocile
®
7.5 mg/ml solution for injection: EU/1/99/124/001.
injection and Tractocile 7.5mg/ml concentrate for solution effects: Nausea (very common); vomiting, headache, dizziness, Tractocile
®
7.5 mg/ml concentrate for solution for infusion:
for infusion. hot flushes, tachycardia, hypotension, injection site reaction EU/1/99/ 124/002. Marketing Authorisation Holder: Ferring
Please consult the full Summary of Product Characteristics and hyperglycaemia (common); fever, insomnia, pruritus and Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300 Copenhagen
before prescribing. Name of Product: Tractocile
®
7.5 mg/ rash (uncommon) and allergic reaction (one case), rare uterine S, Denmark. Date of preparation Jan. 2009.
ml solution for injection. Each vial contains 6.75 mg atosiban. haemorrhage/uterine atony. Contraindications: Tractocile
®
Tractocile
®
7.5 mg/ml concentrate for solution for infusion. should not be used in the following conditions – gestational 1) Romero, R et al. Am J Obstet Gynecol 2000; 182: 1173- 1183
Each vial contains 37.5 mg atosiban. Indications: Tractocile
®
is age below 24 or over 33 completed weeks; premature rupture
indicated to delay imminent preterm birth in pregnant women with of the membranes >30 weeks of gestation; intrauterine growth
– regular uterine contractions of at least 30 seconds duration, at retardation and abnormal fetal heart rate; antepartum uterine
Adverse events should be reported. Report-
a rate of g744 per 30 minutes; a cervical dilation of 1 to 3 cm haemorrhage requiring immediate delivery; eclampsia and
ing forms and information can be found at
(0-3 for nulliparas) and effacement of g7450%; age g7418 years: a severe preeclampsia requiring delivery; intrauterine fetal death;
gestational age from 24 until 33 completed weeks; a normal fetal suspected intrauterine infection: placenta praevia; abruptio
www.yellowcard.gov.uk. Adverse events
heart rate. Dosage and method of administration: Tractocile
®
placenta; any other conditions of the mother or fetus, in which
should also be reported to Ferring A/S.
is administered intravenously in three successive stages: an continuation of pregnancy is hazardous; known hypersensitivity Email:
medical@ferring.com.
initial bolus dose (6.75 mg), with Tractocile
®
7.5 mg/ml solution to atosiban or any of the excipients. Special warnings and
for injection, immediately followed by a continuous infusion of special precautions for use: In patients in whom premature
Tractocile
®
7.5 mg/ml concentrate for solution for infusion diluted rupture of membranes cannot be excluded, the benefi ts of
to a concentration of 0.75 mg/ml atosiban. An initial infusion delaying delivery should be balanced against the potential risk
rate of 300 µg/min (24 ml/hour) is used for three hours, followed of chorioamnionitis. There is no experience with Tractocile
®
by a lower dose of 100 µg/min (8 ml/hour) for up to 45 hours. treatment in patients with impaired liver or kidney function or in
The duration of the treatment should not exceed 48 hours. patients with an abnormal placental site. There is only limited
The total dose given during a full course of Tractocile
®
therapy experience in the use of Tractocile
®
in multiple pregnancies or
should preferably not exceed 330 mg of the active substance. the gestational age group between 24 and 27 weeks. Experience
Intravenous therapy using the initial bolus injection should be with Tractocile
®
is limited up to 3 retreatments. In intrauterine
started as soon as possible after diagnosis of preterm labour. growth retardation, the decision to continue treatment depends atosiban
Once the bolus has been injected, proceed with the infusion. If on the assessment of fetal maturity. Monitoring of uterine
uterine contractions persist during treatment contractions and fetal heart rate should be considered during
with Tractocile
®
, alternative therapy should treatment. Tractocile
®
may theoretically facilitate uterine
The Tocolytic With Two
be considered. If retreatment with Tractocile
®
relaxation and post-partum bleeding. Legal Classifi cation:
is needed, it should also commence with a POM. Community Marketing Authorisation Number:
Lives In Mind
1
290140 Ferring Tractocile A4 Ad.indd 1 31-03-2009 15:30:45
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84