TRACTOCILE 6.75 mg/0.9 mlsolution for injection

TRACTOCILE contains atosiban. TRACTOCILE can be used to delay the premature birth of your baby. TRACTOCILE is used in pregnant adult women, from week 24 to week 33 of the pregnancy.

TRACTOCILE works by making the contractions in your womb (uterus) less strong. It also makes the contractions happen less often. It does this by blocking the effect of a natural hormone in your body called ?oxytocin? which causes your womb (uterus) to contract.

Do not use TRACTOCILE:

• If you are allergic (hypersensitive) to atosiban or any of the other ingredients of TRACTOCILE (listed in Section 6).
• If you are less than 24 weeks pregnant.
• If you are more than 33 weeks pregnant.
• If your waters have broken (premature rupture of your membranes) and you have completed 30 weeks of your pregnancy or more.
• If your unborn baby (foetus) has an abnormal heart rate.
• If you have bleeding from your vagina and your doctor wants your unborn baby to be delivered straight away.
• If you have something called ?severe pre-eclampsia? and your doctor wants your unborn baby to be delivered straight away. Severe pre-eclampsia is when you have very high blood pressure, fluid retention and/or protein in your urine.
• If you have something called ?eclampsia? which is similar to ?severe pre-eclampsia? but you would also have fits (convulsions). This will mean your unborn baby needs to be delivered straight away.
• If your unborn baby has died.
• If you have or could have an infection of your womb (uterus).
• If your placenta is covering the birth canal.
• If your placenta is detaching from the wall of your womb.
• If you or your unborn baby have any other conditions where it would be dangerous to continue with your pregnancy. Do not use TRACTOCILE if any of the above apply to you. If you are not sure, talk to your doctor, midwife or pharmacist before you are given TRACTOCILE.

Take special care with TRACTOCILE:

Check with your doctor, midwife or pharmacist before you are given TRACTOCILE:

• If you think your waters might have broken (premature rupture of your membranes).
• If you have kidney or liver problems.
• If you are between 24 and 27 weeks pregnant.
• If you are pregnant with more than one baby.
• If your contractions start again, treatment with TRACTOCILE can be repeated up to three more times.
• If your unborn baby is small for the time of your pregnancy.
• Your womb may be less able to contract after your baby has been born. This may cause bleeding.. If any of the above apply to you (or you are not sure), talk to your doctor, midwife or pharmacist before you are given TRACTOCILE.

Taking other medicines:

Please tell your doctor, midwife or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

TRACTOCILE will be given to you in a hospital by a doctor, nurse or midwife. They will decide how much you need. They will also make sure the solution is clear and free from particles.

TRACTOCILE will be given into a vein (intravenously) in three stages:

• The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute.
• Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.
• Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to 45 hours, or until your contractions have stopped. Treatment should last no longer than 48 hours in total. Further treatment with TRACTOCILE can be used if your contractions start again. Treatment with TRACTOCILE can be repeated up to three more times. During treatment with TRACTOCILE, your contractions and your unborn baby?s heart rate may be monitored. It is recommended that no more than three re-treatments should be used during a pregnancy.

Like all medicines, TRACTOCILE can cause side effects, although not everybody gets them. The side effects seen in the mother are generally of a mild severity. There are no known side effects on the unborn or new-born baby.

The following side effects may happen with this medicine:
Very common (affects more than 1 in 10 people)

• Feeling sick (nausea).

Common (affects less than 1 in 10 people)

• Headache.
• Feeling dizzy.
• Hot flushes.
• Being sick (vomiting).
• Fast heart beat.
• Low blood pressure. Signs may include feeling dizzy or light-headed.
• A reaction at the site where the injection was given.
• High blood sugar.

Uncommon (affects less than 1 in 100 people)

• High temperature (fever).
• Difficulty sleeping (insomnia).
• Itching.
• Rash.

Rare (affects less than 1 in 1,000 people)

• Your womb may be less able to contract after your baby has been born. This may cause bleeding.
• Allergic reactions.

If any of the side effects gets serious, or if you notice these or any other side effects not listed in this leaflet, please tell your doctor, midwife or pharmacist.

• Keep out of the reach and sight of children.
• Do not use TRACTOCILE after the expiry date which is stated on the label EXP {MM/YYYY}. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C - 8°C).
• Store in the original package in order to protect from light.
• Once the vial has been opened, the product must be used straight away.
• Do not use TRACTOCILE if you notice particulate matter and discoloration prior to administration.

What TRACTOCILE contains

• The active substance is atosiban.
• Each vial of TRACTOCILE 6.75 mg/0.9 ml solution for injection contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.
• The other ingredients are mannitol, hydrochloric acid and water for injections.

What TRACTOCILE looks like and contents of the pack

TRACTOCILE 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles. One pack contains one vial containing 0.9 ml solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
2300 København S
Denmark

Manufacturers:
Ferring AB

Limhamnsvägen 108

20061 Limhamn

Sweden

Ferring GmbH

Wittland 11

24109 Kiel

Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien NV Ferring SA Hopmarkt 9 b.3 B-9300 AALST TélTel 32-53729200 LuxembourgLuxemburg NV Ferring SA Hopmarkt 9 b.3 B-9300 AALST BELGIQUEBELGIEN Tél 32-53729200

Magyarország Ferring Hungary Pharmaceuticals Trading Ltd H-1138 Budapest Váci út. 140. Tel. 36 1 236 3800 .. . 16 BG-1612 . 359 2 895 21 10

eská republika FERRING Pharmaceuticals CZ s.r.o. K Rybníku 475 CZ-252 42 Jesenice u Prahy tel. 420 241 041 111 Malta E.J. Busuttil Ltd. Niche, Flat 1, Triq ix-Xorrox, MT-BKara BKR 1633, Tel. 356 21447184 356 21445885

Danmark Ferring Lægemidler AS Kay Fiskers Plads 11 DK-2300 Copenhagen S Tlf 45 88 16 88 17 Nederland Ferring BV Postbus 184 NL-2130 AD HOOFDDORP Tel 31-235680300

Deutschland Ferring Arzneimittel GmbH Postfach 2142 Fabrikstraße 7 D-24103 KIEL Tel 49-43158520 Norge Ferring Legemidler AS Nydalsveien 36 B Postboks 4445 Nydalen N-0403 Oslo Tlf 47 22 02 08 80

Eesti MEDA Pharma SIA Narva mnt. 11 D EE-10151 Tallinn Tel. 372 62 61 025 Österreich Ferring Arzneimittel Ges.m.b.H Vienna Twin Towers Turm West, 10. OG Wienerbergstrasse 11 A-1100 Wien Tel 43 1 60808-0

FERRING 3, GR-151 25, . 30 210 6843449 Polska Ferring Pharmaceuticals SA Spóka Akcyjna Przedstawicielstwo w Polsce ul. Bonifraterska 17 PL-00 203 Warszawa Tel 48 22 246 06 80

España Ferring S.A.U C Gobelas n 11 E-28023 Madrid Tel 34- 917994780 Portugal FERRING PORTUGUESA Produtos Farmacêuticos, Sociedade Unipessoal, LDA Rua Alexandre Herculano Edifício 1- Piso 6P-2795-240 Linda-a-Velha Tel 351 219405190

France FERRING S.A.S. 7, rue Jean-Baptiste Clément F-94250 GENTILLY Tél 33-149089123 România Ferring Pharmaceuticals SA Reprezentana în România Str. Coriolan Brediceanu nr. 10, City Business Centre, cldirea B, et. 1 Timioara 30011 RO Tel 40 356 113 270

Ísland Vistor hf. Hörgatún 2 IS-210 Garðabær Tel 354 535 7000 Slovenija PharmaSwiss Wolfova 1 SI-1000 Ljubljana Tel 386 1 23 64 700

Slovenská republika Ferring Pharmaceuticals SA organizaná zloka Slovakia BC Aruba, Galvaniho 7D SK-821 04 Bratislava tel 421 2 5441 1847 Ireland Ferring Ireland Ltd United Drug House Magna Drive Magna Business Park Citywest Road IRL-Dublin 24 Tel 353-14637355

Italia Ferring S.p.A. Via Senigallia 182 I-20161 MILANO Tel 39-02 6400011 SuomiFinland Ferring Lääkkeet Oy PL 23 FIN-02241 Espoo PuhTel 358-207 401440

. POTAMITIS MEDICARE LTD . . 62 CY-2059 , 357 22583333 Sverige Ferring Läkemedel AB Box 4041 SE-203 11 Malmö Tel 46 40 691 69 00

Latvij MEDA Pharma SIA O. Vciea iela 13 Rga LV-1004 Tlr. 371 7 805 140 United Kingdom Ferring Pharmaceuticals Ltd The Courtyard Waterside Drive LANGLEY Berks SL3 6EZ UK Tel 44-1753214800

Lietuva
MEDA Pharma SIA
134 Veiveriu g.,
LT-46325, Kaunas
Tel.: +370 37330509

This leaflet was last approved on {date}

INSTRUCTION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended for medical or healthcare professionals only: (See also section 3)

Instructions for use

Before using TRACTOCILE, the solution should be examined to ensure it is clear and free from particles.

TRACTOCILE is given intravenously in three successive stages:

• The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
• A continuous infusion at a rate of 24 ml/hour is given for 3 hours.
• A continuous infusion at a rate of 8 ml/hour is given for up to 45 hours, or until the contractions of the uterus have subsided.

The total duration of the treatment should be no more than 48 hours. Further treatment cycles of TRACTOCILE can be used should contractions recur. It is recommended that no more than three retreatments should be used during a pregnancy.

Preparation of the intravenous infusion

The intravenous infusion is prepared by diluting TRACTOCILE 37.5 mg/5 ml, concentrate for solution for infusion in sodium chloride 9 mg/ml (0.9%) solution for injection, Ringer's lactate solution or 5% w/v glucose solution. This is done by removing 10 ml of solution from a 100 ml infusion bagand replacing it with 10 ml TRACTOCILE 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml. If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.

TRACTOCILE should not be mixed with other medicinal products in the infusion bag.