Tractocile 6.75mg0.9ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Atosiban acetate

Available from:

Ferring Pharmaceuticals Ltd

ATC code:

G02CX01

INN (International Name):

Atosiban acetate

Dosage:

7.5mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07010300; GTIN: 5015919824109

Patient Information leaflet

= No print
area
= Folding
line
=Perforation
Fiber direction

Pharmacode is
centered
87,5 mm from
the top
Drawring
E-MS-3056
Size
180x500mm


2009052819
Title:
Leaflet TRACTOCILE sol inj 7.5mg/ml vial 1x 0.9ml GB/IE
Document:
Artwork
Code No:
E-2009052819.01
Supersedes:
NA
1
Packaging coordinator
Nathalie Chateau
[phone]
FERRING International Center SA
Ch. de la Vergognausaz 50
1162 St-Prex Switzerland
Ferring item
number
2009052819
E-MS-
number
E-MS-3056
Pharma
code
1828
Comments:
NA
3
M&S country
Country:
All text is according to the National Registration
Documentation.
Printers proof proofread/approved by responsible
regulatory person
Variable Datas
(english
translation)
Line 1 :
Line 2 :
Line 3 :
Name
Date
Signature
2
Supplier
Order number:
4314888
Eson Pac Denmark
Hørskætten 26-28
2630 Taastrup
Denmark
Date
2013.06.03
Proof
version
2
Braille
Braille
Perforation
vignette
other
Format
(mm)
180x500
Colours and Varnish
NA
NA
NA
NA
Black
NA
NA
Comments:
NA
4
Ferring Reviewers
Packaging Support Approval
Date
Comments:
Change / Review log
Version No.
Effective Date
Reason for the Change / Revision
01
New document

Summary of Product characteristics

OBJECT 1
TRACTOCILE 7.5 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 21-Jun-2013 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
Tractocile 6.75 mg/0.9 ml solution for injection
2. Qualitative and quantitative composition
Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection).
Clear, colourless solution without particles.
4. Clinical particulars
4.1 Therapeutic indications
Tractocile is indicated to delay imminent pre-term birth in pregnant
adult women with:
− regular uterine contractions of at least 30 seconds duration at a
rate of ≥ 4 per 30 minutes
− a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and
effacement of ≥ 50%
− a gestational age from 24 until 33 completed weeks
− a normal foetal heart rate
4.2 Posology and method of administration
Posology
Treatment with Tractocile should be initiated and maintained by a
physician experienced in the treatment
of pre-term labour.
Tractocile is administered intravenously in three successive stages:
an initial bolus dose (6.75 mg),
performed with Tractocile 6.75 mg/0.9 ml solution for injection,
immediately followed by a continuous
high dose infusion (loading infusion 300 micrograms/min) of Tractocile
37.5 mg/5 ml concentrate for
solution for infusion during three hours, followed by a lower dose of
Tractocile 37.5 mg/5 ml concentrate
for solution for infusion (subsequent infusion 100 micrograms/min) up
to 45 hours. The duration of the
treatment should not exceed 48 hours. The total dose given during a
full course of Tractocile therapy
should preferably not exceed 330.75 mg of atosiban.
Intravenous therapy using the initial bolus injection should be
started as soon as possible after diagnosis
of pre-term labour. Once the bolus has been injected, proceed with the
infusion (See Summary of Product
Characteristics of Tractocile 37.5 mg/5 ml, concentrate for solution
for infusion). In the case of