1 mg and 2 mg vaginal gel
dinoprostone
What Minprostin is and what it is used for
Minprostin contains the active substance dinoprostone. Dinoprostone belongs to a group of medicines called prostaglandins. Dinoprostone softens the cervix and opens it so that childbirth can take place. It also triggers contractions which help the baby to come out of the womb.
Minprostin is used to initiate labor during or near the end of pregnancy. There can be several reasons why you want to start labor. Ask your doctor if you want to know more.
Dinoprost contained in Minprostin may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you receive Minprostin
Minprostin is not given:
- if you are allergic to prostaglandins , dinoprostone or any of the other ingredients of this medicine (listed in section 6).
- if the placenta blocks the cervix
- if the size of the fetal head can lead to problems during childbirth
- if the position of the fetus in the womb does not allow vaginal delivery
- if you have been through more than 6 completed pregnancies
- if you have previously had surgery on your uterus, including a caesarean section
- at crowded pelvis
- if the fetus shows signs of not feeling well
- if there is a reason why you should be delivered by caesarean section
- if you have or have had any unexplained vaginal bleeding during your current pregnancy
Warnings and cautions
Talk to your doctor before receiving Minprostin:
- if the amniotic fluid has passed
- if you have previously undergone childbirth that has been complicated and / or traumatic, eg:
- with too strong, too dense or too prolonged pains,
- where the labor has been delayed
- where labor has been extended.
- if you are expecting more than one child
- if you have glaucoma ( glaucoma , an eye disease)
- if you have elevated eye pressure
- if you get spinal anesthesia (epidural anesthesia)
- if you have or have had asthma
- if you have any cardiovascular disease
- if you have impaired kidney or liver function
- if you are 35 years or older and you have a pregnancy complication in the form of diabetes , high blood pressure , hypothyroidism ( hypothyroidism ) or if the duration of pregnancy has exceeded 41 weeks because there is an increased risk of developing disseminated intravascular coagulation ( DIC ), a unusual condition that affects blood coagulation .
If you are not sure if any of the above applies to you, talk to your doctor before taking Minprostin.
Other medicines and Minprostin
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Oxytocin (used, among other things, to initiate labor) should not be used until 6 hours after the last dose of Minprostin as it may cause the pain to be too strong, too dense, or too prolonged.
Pregnancy and breastfeeding
Minprostin is used to initiate labor during or near the end of pregnancy. Minprostin should not be used during other stages of pregnancy
Driving and using machines
Not relevant as Minprostin is only given during childbirth.
How to use Minprostin
Minprostin will be given to you by trained staff at a hospital or clinic that has access to equipment for monitoring you and your child.
Your doctor or midwife will administer 1 mg of dinoprost in the posterior fornix (next to the cervix) of the vagina. Dosage one can be repeated with an additional dose of 1 mg or 2 mg after 6 hours if needed.
The fetal heart function and your pain will be monitored using CTG (cardiotocography) 30 minutes before and at least 1 hour after receiving Minprostin.
If you have any further questions on the use of this product, ask your doctor or nurse.
If you get more Minprostin than you should
Because this medicine is given by a doctor or nurse, it is unlikely that you will receive too much.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects ( may affect up to 1 in 10 people):
- Abdominal pain
- Hyperstimulated uterus (when the pains are too strong, too dense or too prolonged)
Uncommon side effects ( may affect up to 1 in 100 people):
- Nausea, vomiting, diarrhea
- Feeling of warmth in the vagina
Rare side effects ( may affect up to 1 in 1,000 people):
- Fever, back pain, hypersensitivity reaction .
- Effects on fetal heart function as a sign of stress (isolated cases of fetal death have been reported in association with dinoprostone treatment).
- Uterine rupture
- Disseminated intravascular coagulation (an unusual condition affecting blood coagulation )
Has been reported (occurs in an unknown number of users)
- Hypersensitivity reactions (eg anaphylactic reactions, anaphylactic shock , anaphylactoid reaction).
- Fetal death, stillbirth and death of the newborn, especially after the onset of serious side effects such as uterine rupture.
How to store Minprostin
- Keep this medicine out of the sight and reach of children.
- Store in a refrigerator (2 ° C-8 ° C).
- Do not use this medicine after the expiry date which is stated on the carton and single-dose syringe after EXP. The expiration date is the last day of the specified month.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is dinoprostone. Each single-dose syringe contains 1 mg and 2 mg dinoprostone, respectively, in 2.5 mg gel .
- The other ingredients are: anhydrous colloidal silica, glycerol triacetate.
What the medicine looks like and contents of the pack
Minprostin vaginal gel is a clear gel.
Single-dose syringe, 2.5 ml
Marketing Authorization Holder and Manufacturer
Pfizer AB
191 90 Sollentuna
Tel: 08-550 520 00
Email: eumedinfo@pfizer.com