Injection Guides
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Guidance for Zivafert.
Welcome to the step-by-step guide of how to take your Zivafert injections. This video will explain how to prepare, inject and dispose of your treatment. Please refer to your clinic for the specific dose prescribed to you. Your dose may be adjusted over the course of your treatment. Please refer to your healthcare professional for any questions.
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Patient Information Leaflet
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Frequently Asked Questions
Explore our interactive FAQ section for comprehensive Zivafert injection guidance. This area is designed to provide you with concise yet comprehensive answers regarding the proper usage and administration of Zivafert injections.
Please read your patient information leaflet for full information.
Zivafert PFS contains human chorionic gonadotrophin, a hormone obtained from human urine, belonging to the “gonadotropin” family, which are natural hormones involved in reproduction and fertility.
Zivafert PFS is used:
- To help develop and ripen several follicles (each containing an egg) in women undergoing assisted reproductive technologies (procedure that may help you to become pregnant) such as ‘in vitro fertilisation’ (IVF)
- To help release an egg from the ovary (ovulation induction) in women who cannot produce eggs (‘anovulation’), or women who produce too few eggs (‘oligo-ovulation’)
This medicinal product must be used under the supervision of your doctor unless you are told otherwise by your doctor.
Do not use Zivafert PFS if you:
- are allergic to the human chorionic gonadotropin or any of the other ingredients of this medicine (listed in section 6)
- have untreated diseases involving thyroid, pituitary or adrenal glands
- have ovarian, womb or breast cancer
- have a condition that makes a normal pregnancy impossible, e.g. ovarian failure, absence of a uterus, premature menopause, fallopian tube obstruction, fibroids in the womb or other abnormalities of the reproductive organs
- have recently had unexplained vaginal bleeding
Tell your doctor or pharmacist if you have any of the above because this medicine might not be the right medicine for you.
Warnings and precautions
Before the treatment, your doctor should have checked that your reproductive organs are normal.
Talk to your doctor before taking Zivafert PFS if you suffer from, or have suffered in the past from any of the following conditions:
- abnormalities of the reproductive organs
- long-term disease (such as diabetes, cardiovascular disorders etc.)
- vascular complication (i.e. increased risk of blood clots, previous or family history of blood clots, overweight)
Zivafert PFS is a powder to be dissolved with a liquid (solvent) before use; it is given by injection under the skin (subcutaneously) or into a muscle (intramuscularly). The solution is obtained by combining the solvent with the powder and must be used immediately after preparation.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How Zivafert PFS should be given:
Zivafert PFS is given by injection under your skin (by the subcutaneous route) or into your muscle (intramuscular injection).
Each vial should be used only once and the injection should be used as soon as it is prepared.
The recommended dose of Zivafert PFS is 5000 IU or 10000 IU to be administered 24-48 hours after optimal stimulation of follicular growth is achieved.
After suitable advice and training your doctor may ask you to inject Zivafert PFS yourself.
For the first time, your doctor must:
- have explained how to prepare the right dose of injection
- have shown you how to prepare the solution for injection
- have shown you the possible places where you can inject yourself
- let you practise giving yourself a subcutaneous injection
Before injecting Zivafert PFS yourself, please read the injection guide and watch the video.
Stop using Zivafert PFS and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
- Mild or moderate excessive stimulation of the ovaries (ovarian hyperstimulation syndrome), which manifests as enlargement of the ovaries, ovarian cysts, abdominal pain with vomiting and nausea (see also in section 2. under “Ovarian hyperstimulation syndrome”). This is a common side effect (may affect up to 1 in 10 people)
- Severe excessive stimulation of the ovaries (ovarian hyperstimulation syndrome) characterized by pain in the lower abdomen (pelvis), nausea, vomiting, increase in weight, accumulation of fluids in the abdomen (ascites) or chest (pleural effusion). This event is uncommon (may affect up to 1 in 100 people)
- Ovarian cyst rupture (as a rare consequence of severe OHSS, may affect up to 1 in 1,000 people)
- Formation of clots in the blood vessels (thromboembolic events), as a complication of ovarian hyperstimulation syndrome. This event is rare (may affect up to 1 in 1,000 people)
- Severe generalized allergic reactions which may include: swelling of face, eyes, lip, throat or tongue, breathing difficulties, wheezing, skin rash rare side effect (may affect up to 1 in 1,000 people)
Other side effects
Common side effects: may affect up to 1 in 10 people
- Injection site reaction which may include redness, bruising, swelling, itching or pain at the injection site
- swelling (oedema)
- mood changes
- headache
- painful breast
Uncommon side effects: may affect up to 1 in 100 people
- restlessness (agitation), tiredness
Rare side effects: may affect up to 1 in 1,000 people
- swelling in the deep layers of the skin, often seen with urticaria (hives)
- generalised skin rashes
If you experience any of the rare side effects indicated above, contact your doctor immediately who will assess whether to stop treatment with Zivafert PFS or immediately go to the nearest hospital casualty department.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep the vial and the solvent in prefilled syringe in the outer carton in order to protect from light.
Use immediately after making up the solution.
Do not use this medicine after the expiry date which is stated “after EXP” on the outer carton, the vial and the prefilled syringe of solvent. The expiry date refers to the last day of the month.
Do not use Zivafert PFS if you notice the solution does not look clear (cloudy or with presence of visible particles). After being made up the solution must be clear and colourless.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is: human chorionic gonadotropin.
The excipients in the: vial of powder: lactose monohydrate
The excipients in the:
- vial of powder: lactose monohydrate
- prefilled syringe with solvent (0.9% sodium chloride): water for injections, sodium chloride
Each vial contains: human chorionic gonadotropin 5000 IU, produced from human urine.
What Zivafert PFS looks like and contents of the pack
Zivafert PFS is presented as:
Powder in vial: white to almost white lyophilized powder
Solvent in pre-filled syringe (0.9% sodium chloride): clear and colourless solution
1 pack contains:
- Powder in a vial, sealed with a rubber closure and held in place with a flip-off cap
- 1 ml of solvent in a pre-filled syringe
- 1 long needle for the reconstitution
- 1 short needle for the subcutaneous injection
Multipack containing 2 packs of 5 vial + 5 pre-filled syringes of solvent, as described above.
Manufacturer:
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi - Italy
If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side-effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk.
By reporting side-effects, you can help provide more information on the safety of this medicine.
To report a side effect or product complaint to IBSA Pharma please contact IBSA Pharma Ltd on 01923 233466 and medicalinformation.uk@ibsagroup.com.
▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get.
See Yellow Card | Making medicines and medical devices safer (mhra.gov.uk) for how to report side effects.