Tractocile 37.5mg5ml solution for infusion vials

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Atosiban acetate

Dostępny od:

Ferring Pharmaceuticals Ltd

Kod ATC:

G02CX01

INN (International Nazwa):

Atosiban acetate

Dawkowanie:

7.5mg/1ml

Forma farmaceutyczna:

Solution for infusion

Droga podania:

Intravenous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 07010300; GTIN: 5015919826813

Ulotka dla pacjenta



= No print
area
= Folding
line
=Perforation
Fiber direction

Pharmacode
75 mm from
top and
bottem.
Drawring
E-MS-3001
Size
180x420mm
2009052820


Title:
Leaflet TRACTOCILE sol inj 7.5mg/ml vial 1x 5ml GB/IE
Document:
Artwork
Code No:
E-2009052820.01
Supersedes:
NA
1
Packaging coordinator
Nathalie Chateau
[phone]
FERRING International Center SA
Ch. de la Vergognausaz 50
1162 St-Prex Switzerland
Ferring item
number
2009052820
E-MS-
number
E-MS-3001
Pharma
code
1829
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:
4314856
Eson Pac Denmark
Hørskætten 26-28
2630 Taastrup
Denmark
Date
2013.06.03
Proof
version
2
Braille
Braille
Perforation
vignette
other
Format
(mm)
180x420
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

Charakterystyka produktu

OBJECT 1
TRACTOCILE 7.5 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 24-Jun-2013 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
Tractocile 37.5 mg/5 ml concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate).
Each ml of solution contains 7.5 mg atosiban.
After dilution, the concentration of atosiban is 0.75 mg/ml.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate).
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 of Tractocile
6.75 mg/0.9 ml, solution for injection
(see Summary of Product Characteristics of thi