Before starting to take Menopur, check that you have all the parts you need:

1. Menopur bottle (600 IU orange lid / blue lid 1200 IU)

2. Pre-filled mixing syringe(s) (1 syringe in the 600 IU pack / 2 syringes in the 1200 IU - pack)

3. Mixing needle

4. Disinfectant Wipes

5. Disposable syringes for injection (9 syringes in the 600 IU pack / 18 syringes in the 1200 IU - pack)

PAD

1. Menopur bottle

3. Mixing needle

5. Disposable syringes for injection (9 for 600 IU / 18 for 1200 IU)

4. Disinfectant Wipes

2. Pre-filled mixing syringe (1 for 600 IU / 2 for 1200 IU)

Preparations

1. Remove the lid from the Menopur bottle.

Patient instructions for Menopur® 600 IU /1200 IU4. Attach the mixing needle to the mixing syringe.

Mixing

1. Push the needle on the mixing syringe through the middle of the rubber membrane on the Menopur bottle and slowly squirt the liquid down into

the bottle.

Make sure that the needle tip is above the fluid level in the Menopur bottle. Then twist off the first mixing syringe from the needle. Leave the needle in the Menopur 1200 IU bottle.

2. Then remove the mixing syringe with the needle from the Menopur bottle.

Take the second mixing syringe that came in the pack. Carry out step 2 under the heading “Preparations” with this syringe as well. Next, attach the syringe to the mixing needle that is still in thebottle and slowly squirt the liquid down into the bottle.

Note:If you have been prescribed Menopur 600 IU proceed to step 2.

If you have been prescribed Menopur 1200 IU carry on reading below.

MENOPUR

2. Remove the rubber protector from the mixing syringe.

3. Twist off the black protective sleeve from the mixing needle.

5. Remove the needle protector from the mixing needle.

3. Gently swirl the contents of the Menopur bottle around so that the powder dissolves. Do not shake it.

4. The medicine is now ready to use or to store at room temperature (≤ 25˚C) for up to 28 days.

Note that the Menopur bottle contains sufficient medicine for several days’ treatment.

Menopur must be stored in the refrigerator before mixing.

Engelska

Injection

1. Take a disposable syringe for injection and remove the needle protector. Place the Menopur bottle on a flat and solid surface. Push the needle through the middle of the rubber membrane on the Menopur bottle. Press the plunger to the bottom of the syringe.

Note:The Menopur bottle contains sufficient medicine for several days’ treatment. You should therefore only draw out the exact dose prescribed by your doctor.

2. Turn the Menopur bottle and the syringe upside down as shown in the illustration and draw out the desired Menopur dose with reference to the scale on the syringe.

3. Disinfect and inject according to instructions provided by your doctor/nurse.

MENOPUR® 600 IU and 1200 IU - (human menopausal gonadotropin, HMG) powder and solvent for solution for injection Indication: Anovulation, including polycystic ovary syndrome (PCOS) in women who have been unresponsive to treatment with clomifene citrate. Controlled ovarian hyperstimulation to induce the development of multiple follicles for Assisted Reproductive Technologies (ART) including in vitro fertilization / embryo transfer (IVF / ET), "gamete intrafallopian transfer" (GIFT), and intracytoplasmic sperm injection (ICSI). Dosage: Menopur is intended for subcutaneous (SC) or intramuscular (IM) administration after reconstitution with accompanying solvent. NOTE: Menopur 1200 IU must be reconstituted with two pre-filled syringes with solvent before use. The reconstituted solution is intended for repeated injections and may be used for up to 28 days. ATC code: G03GA02. Package sizes: Menopur 600 IU: 1 vial, 1 pre-filled syringe, and 9 disposable syringes. Menopur 1200 IU: 1 vial, 2 pre-filled syringes, and 18 disposable syringes. Rx, Pharmacovigilance system. Marketing Authorization Holder (MAH): Ferring Läkemedel AB, Malmö. For a full summary of product characteristics (SPC 3/12/2010) and pricing information see www.FASS.se.

Use one hand to hold onto the skin on your left or right side. Stick the needle into your skin at an angle of 90˚. Slowly press the plunger all the way in. Once the syringe is empty, pull the needle out.

4. Vary the injection site as instructed by your doctor/nurse.

5. Put any used syringes in a waste container, e.g. an empty milk carton.

6. Any medicine remaining in the Menopur bottle can be kept at room temperature (≤ 25˚C) for up to 28 days.

Ferring Läkemedel AB, Box 4041, 203 11 Malmö, SwedenTel: +46 (0)40 691 69 00, Fax: +46 (0)40 691 69 95, info@ferring.se, www.ferring.se

I M P O R TA N T !

Before mixing:

Menopur must be refrigerated, it can however be stored for a

maximum of 48 hours at room temperature (≤ 25°C), such as during

transport, for example.

After mixing:

Menopur may be stored at room temperature (≤ 25°C) for up to 28

days.