Ovidrel Pen Choriogonadotropin alfa (rch) Consumer Medicine Information

Transcription

1 Ovidrel Pen Choriogonadotropin alfa (rch) Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about Ovidrel. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you using Ovidrel against the benefits it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this information with your medicine. You may want to read it again later. What Ovidrel is used for Ovidrel belongs to a family of hormones known as gonadotrophins, which are involved in the normal control of reproduction. The active substance of Ovidrel is choriogonadotropin alfa that is produced in mammalian cells modified by recombinant DNA technology. Ovidrel is used in women undergoing assisted reproductive techniques such as in vitro fertilisation (IVF). Other medicines are given first to bring about the growth and development of several follicles to produce eggs. Follicles are the structures in your ovaries that contain the egg. Ovidrel is then used to ripen (mature) these follicles. Ovidrel is also used in women who do not produce eggs (anovulation), or who produce too few eggs (oligoovulation). It is used to trigger the release of eggs (ovulation), after other medicines have been used to develop the follicles. Your doctor may prescribe Ovidrel for another reason. Ask your doctor if you have any questions about why Ovidrel has been prescribed for you. Ovidrel is not addictive. This medicine is available only with a doctor's prescription. Before you use Ovidrel When you must not use it Do not use Ovidrel if: you have a history of allergy to choriogonadotropin alfa, or a similar medicine, or any other inactive ingredients (listed at the end of this leaflet). Symptoms of an allergic reaction to Ovidrel may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. Do not take Ovidrel if you have, or have had, any of the following medical conditions: your ovaries are unable to be stimulated to produce eggs (primary ovarian failure or premature menopause) uncontrolled thyroid or adrenal gland disease a tumour of the hypothalamus or pituitary gland ovarian enlargement or one or more large ovarian cysts cancer of your ovaries, uterus (womb) or breasts fibroid tumours in your uterus which would make pregnancy impossible if you have been through menopause Ovidrel should not be used in the elderly or in children. Do not take Ovidrel after the expiry date printed on the pack. Do not take Ovidrel if the packaging is torn or shows signs of tampering. If your medicine has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start using Ovidrel, contact your doctor. Before you start to use it Your doctor will assess you and your partner's infertility. This may include tests for other medical conditions, which may interfere with your ability to become pregnant. If necessary, other medical conditions may be treated before starting infertility treatments and Ovidrel. Tell your doctor if you have or have had any other pre-existing medical conditions. Treatment with Ovidrel may increase your risk of developing a condition OVIDREL PEN 1

2 called ovarian hyperstimulation syndrome (OHSS). This is when the ovaries over react to the hormonal treatment and develop too many follicles. The most common symptom is stomach pain. During stimulation your doctor will monitor your treatment by use of ultrasound and blood tests to measure oestrogen levels. This will help to indicate if you are likely to develop OHSS. If necessary, your doctor will delay or cancel your Ovidrel injection. Compared to natural conception, the frequency of multiple pregnancies and births is increased in patients receiving this treatment. The majority of these are twins. In assisted reproduction techniques, the number of babies is related to the number of embryos replaced. Please discuss with your doctor. There may be a slightly increased risk of birth defects in women using assisted reproductive technologies. This may be due to maternal age, genetic factors, multiple pregnancies or the assisted reproductive technologies. Talk to your doctor about any concerns you may have before undergoing treatment. Tell your doctor if you or your family have or have had increased risk of developing blood clots e.g. stroke, heart attacks. Taking other medicines Tell your doctor if you are taking any other medicines, including any that you buy without prescription from your pharmacy, supermarket or health food shop. Ovidrel may interfere with the results of a blood or urinary hcg (pregnancy) test for up to 10 days. This may lead to a false positive pregnancy test. How Ovidrel is given Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. Treatment with Ovidrel should be started under the supervision of a specialist doctor experienced in fertility treatment. How much to inject The dose of Ovidrel is one pre-filled pen (250 microgram in 0.5 ml) given as a single injection after stimulation of follicle growth by other medicines. Dosage may need to be varied on the instruction of your doctor and you should be confident in your ability to adjust the dose. Please consult your doctor or pharmacist if you are in any doubt. Your doctor will explain exactly when to give the injection. Each pre-filled pen is for single use only. How to inject Ovidrel is given as an injection under the skin (subcutaneously), usually near your stomach. Ovidrel is intended to be injected by yourself or by your partner. Your doctor or nurse will instruct and assist you in learning the procedure and technique of self-injection. Do not attempt self-injection until you are sure of how to do it. Your partner may be trained to give the injection at home. Your doctor or nurse can also give the injection to you. Where to inject Ovidrel is usually given in the stomach area (except around navel and waistline) or the front of your thigh. Do not inject into any areas in which you feel lumps, firm knots, depressions, pain or discolouration. Talk to your doctor if you find anything unusual when injecting. If you forget to inject Ovidrel You should contact your doctor immediately. It is important that Ovidrel is injected on the correct day and at the correct time as instructed by your doctor. You must inform your doctor if your injection was not given when directed. Ask your doctor if you are not sure what to do or have trouble remembering to inject your medicine. If you inject too much Immediately contact your doctor or the Poisons Information Centre (In Australia telephone In New Zealand telephone ) if you are concerned that you have given yourself too much Ovidrel. While you are using Ovidrel Things you must do Tell your doctor if you start taking any new medication while using Ovidrel. Things you must not do Do not give this medicine to anyone else, even if their symptoms seem similar to yours or if they have the same condition as you. Do not use Ovidrel to treat any other complaints unless your doctor says to. Do not stop Ovidrel or change the dose without checking with your doctor. OVIDREL PEN 2

3 Side effects Tell your doctor as soon as possible if you do not feel well while you are taking Ovidrel. Tell your doctor immediately if you experience any of the following: Early signs of ovarian hyperstimulation syndrome (OHSS) which includes severe stomach pain, nausea, vomiting, diarrhoea, shortness of breath and low urine production. Tell your doctor if you notice any of the following and they worry you: Common side effects: injection site soreness/redness headache tiredness nausea/vomiting, abdominal pain rash Uncommon side effects: diarrhoea depression irritability restlessness breast pain severe OHSS mild allergic reaction warning signs of blood clots (such as pain, warmth, redness, numbness or tingling in arm or leg) warning signs of stroke or heart attack Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them. After using Ovidrel Storage Keep this medicine where young children cannot reach it. Ovidrel must be stored at 2 C to 8 C (Refrigerate. Do not freeze) in its original container. Product is for single patient use in one patient only. Contains no antimicrobial preservative. Discard any residue. Disposal After injecting, you should discard the pen even if you have not injected all its contents. Pen and needle should be discarded in an appropriate disposal unit. Product description What it looks like Ovidrel is supplied in a pre-filled pen. Ingredients Active ingredient: choriogonadotropin alfa Inactive Ingredients: mannitol sodium phosphate - monobasic sodium phosphate - dibasic dihydrate phosphoric acid sodium hydroxide poloxamer methionine water for injections Manufacturer/Supplier Ovidrel is supplied in Australia by: Merck Serono Australia Pty Ltd 3-4/25 Frenchs Forest Road Frenchs Forest NSW 2086 Ovidrel is supplied in New Zealand by: Healthcare Logistics 58 Richard Pearse Drive Airport Oaks, Auckland The Australian registration number for: Ovidrel 250 microgram Solution for Injection pre-filled pen is AUST R This leaflet was amended in May A OVIDREL PEN 3

4 HOW TO USE THE OVIDREL PRE-FILLED PEN CONTENTS 1. How to use the Ovidrel pre-filled pen 2. Before you start using your pre-filled pen 3. Getting your pre-filled pen ready for injection 4. Setting the dose How to set the dose to Injecting the dose 6. After the injection Instructions for use 1. How to use the Ovidrel pre-filled pen Before starting to use your pre-filled pen, please read these instructions the whole way through. Only use this pen for yourself, do not let anyone else use it. Inject Ovidrel as your doctor or nurse taught you. This pen is for single use only. 2. Before you start using your pre-filled pen 2.1 Wash your hands It is important that your hands and the things you use to get your pen ready are as clean as possible. 2.2 Find a clean area A good place is a clean table or surface. 2.3 Get together everything you need and lay them out: alcohol swabs the pre-filled pen a needle. Below is a diagram that shows what the pre-filled pen looks like along with the labels of the components: 1. dose setting knob 2. dose display 3. plunger piston 4. reservoir holder 5. threaded needle connector 6. pen cap 7. removable needle 8. inner needle shield 9. outer needle cap 10. peel-off seal tab OVIDREL PEN 4

5 3. Getting your pre-filled pen ready for injection 3.1 Take off the pen cap 3.2 Put on a needle Take the needle - only use the single use needle supplied with the Ovidrel pre-filled pen. Check that the peel-off seal on the outer needle cap is not damaged or loose. CAUTION: If the peel-off seal is damaged or loose, do not use the needle and get another one. Throw away the unused needle with the outer needle cap still on. Ask your pharmacist how to dispose of needles that are no longer required. Pull off the peel-off seal. Hold the outer needle cap firmly. Press the threaded tip of the pen into the outer needle cap and screw the outer needle cap on until it is firmly fixed. Remove the outer needle cap by pulling it gently. Leave the inner needle shield in position. Do not throw away the outer needle cap; you will need it for removing the needle from the pre-filled pen after your injection. 3.3 First remove any large air bubbles Look carefully at the reservoir holder. If you don t notice a large air bubble, the pre-filled pen is ready for use. Please go straight to step 4. Setting the dose to 250. OVIDREL PEN 5

6 An air bubble is large if it fills the tip of the reservoir holder when holding the pre-filled pen with the needle pointing upwards (see picture). If you see a large air bubble inside the reservoir holder you need to remove it. There may be some small air bubbles that stick to the inner wall of the reservoir holder left in the pen. Do not be concerned about small air bubbles; they do not need to be removed. To remove a large air bubble: 1. Gently turn the dose setting knob clockwise until you see a dot ( ) in the dose display. If you pass this position, simply turn the dose setting knob back to the dot ( ). 2. Then take off the inner needle shield and hold the pen with the needle pointing upwards. OVIDREL PEN 6

7 3. Tap the reservoir holder gently with your finger so that any air bubbles rise up towards the needle. With the needle still pointing upwards, slowly press the dose setting knob as far as it will go. 4. A drop of liquid must appear at the tip of the needle; this shows that your pre-filled pen is ready for injection. 5. If you do not see any liquid, you may try a second time (you may do this a maximum of two times) starting from step 1 of section To remove a large air bubble above. 4. Setting the dose to 250 Gently turn the dose setting knob clockwise. The dose display will show a straight line and you have to keep turning until you can read the number 250. Do not push or pull the dose setting button while you turn it. The dose display should read 250, as shown in the figure below. 5. Injecting the dose 5.1 Choose the place to give the injection where your doctor or nurse has told you. 5.2 Clean the skin at the injection site by wiping it with an alcohol swab. 5.3 Check again that the number in the dose display reads 250. If it doesn t, you must adjust it (see step 4. Setting the dose to 250 ) 5.4 Remove carefully the inner needle shield and throw it away, if not already done in step 3.3 First remove any large air bubbles. OVIDREL PEN 7

8 5.5 Inject the dose as you were trained to by your doctor or nurse. Firstly, slowly push the needle into the skin and then secondly press the dose setting knob in as far as it will go, as shown in the picture below. The dose number shown in the dose display will turn back to 0. This shows that the complete dose was delivered. You must keep the needle under the skin with the dose setting knob pressed down for at least 10 seconds. After 10 seconds, keep the dose setting knob pressed down, and take the needle out of your skin. 6. After the injection 6.1 Check that the dose display reads 0 This confirms that the dose has been fully delivered. Do not attempt to inject a second time. In case the dose display doesn t read 0, please contact your doctor or pharmacist. 6.2 Taking off the needle Hold the pre-filled pen firmly by the reservoir holder. Carefully put the outer needle cap onto the needle. OVIDREL PEN 8

9 Then grip the outer needle cap and unscrew the needle. Be careful not to prick yourself with the needle. Now put the pen cap back onto the pen. 6.3 Disposal Use each needle and pen only once. Once you have finished your injection, dispose of the used needle safely, and discard the pen. It is best to put it back into its original package. Medicines should not be disposed of via wastewater or household waste. When the pen is empty, ask your pharmacist how to dispose of it. OVIDREL PEN 9