0.25 mg / ml solution for injection
carboprosttromethamine
What Prostinfenem is and what it is used for
Prostinphenem contains the active substance carboprost.
Prostin phenomena belong to a group of drugs called prostaglandins.
Prostin phenomena are used for:
- to induce abortion.
- treat bleeding that occurs within 24 hours of delivery.
Carboprost contained in Prostinfenem may also be approved for the treatment of other conditions not mentioned in this product information. 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 using Prostinfenem
You should not get Prostinfenem:
- if you are allergic to carboprost or any of the other ingredients of this medicine (listed in section 6).
- if you have a more severe form of urinary tract infection.
- if you have heart, lung, kidney, or liver disease.
Talk to a doctor if you have any of the above conditions.
Warnings and cautions
Tell your doctor if any of the following apply to you to help him or she decide if Prostinfenem is right for you:
- if you have or have had asthma (difficulty breathing)
- if you have high or low blood pressure
- if you have any cardiovascular disease
- if you have any lung, liver, or kidney disease
- if you have visual disturbances or increased pressure in the eye
- if you suffer from anemia, jaundice, diabetes, or epilepsy
- if you have a defect in the uterus (scarring)
If you are not sure if any of the above applies to you, talk to your doctor before taking Prostinfenem.
Other drugs and Prostinfenem
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor especially if you have taken other medicines that stimulate the contraction of the uterus.
Pregnancy, breastfeeding, and fertility
Prostin phenomena should not be used during pregnancy or breastfeeding for purposes other than those mentioned in section 1 above.
Prostinphenem contains benzyl alcohol (see “Prostinphenem contains benzyl alcohol and sodium”).
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
There have been reports of side effects such as dizziness, dizziness, and the need for sleep that can impair the ability to drive and use machines. Patients should therefore refrain from driving until they know that Prostinfenem does not affect their ability to drive and use machines.
Prostin phenom contains benzyl alcohol and sodium
Benzyl alcohol
Prostinphenem contains 9 mg of benzyl alcohol in 1 ml of solution, which corresponds to 9 mg/ml of benzyl alcohol.
Benzyl alcohol can cause allergic reactions.
Large amounts of benzyl alcohol can be stored in the body and cause side effects such as an increased amount of acid in the blood (metabolic acidosis ). Your doctor will take this into account, especially if you have impaired liver or kidney function or if you are pregnant or breastfeeding.
Sodium
This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free’.
How Prostinfenem is given to you
To induce abortion:
Your doctor or nurse will inject the recommended dose into one muscle. Dosage one will be repeated every 2-3 hours. In case of unsatisfactory contraction of the uterus, the doctor will adjust the dose and/or how often you will receive the injections.
To treat bleeding:
Your doctor or nurse will inject the recommended dose into one muscle. One dose is usually enough.
If you have any further questions on the use of this product, ask your doctor or nurse.
If you take more Prostinfenem 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.
The side effects of Prostinfenem are temporary and usually disappear after stopping treatment. The following side effects may occur with this injection:
Very common side effects ( may affect more than 1 user in 10):
- vomiting, diarrhea
- nausea
- 38 ° C fever or higher
Common side effects ( may affect up to 1 in 10 people):
- headache
- redness, hot flashes, chills
- cough
- genital bleeding, placenta or amniotic membranes do not loosen, inflammation and pain in the uterine lining due to infection (endometritis)
Uncommon side effects ( may affect up to 1 in 100 people):
- septic shock (blood poisoning), urinary tract infection
- sleep disturbance, morbid need for sleep ( somnolence ), abnormal mental fatigue ( lethargy )
- dizziness
- muscle movements that affect the posture of the body and head
- general muscle pain, numbness, tingling
- neck brace
- changed taste
- abnormally large sweats
- chest tightness, asthma and general discomfort of not being able to breathe, strained breathing, increased breathing, wheezing, hiccups
- upper abdominal pain, back pain, pelvic pain
- tenderness in the breasts
- blurred vision, eye pain.
- dry mouth
- feeling dizzy
- tinnitus
- fast heartbeat
- high blood pressure, drop in blood pressure
- vomiting blood
- uterine rupture, tearing of the cervix
- injection site pain
Has been reported (occurs in an unknown number of users):
- severe hypersensitivity reaction (such as sudden wheezing, difficulty breathing, swollen eyelids, face or lips, rash or itching (especially if it itches all over the body, swollen tissue )
- poisonous goiter
- anxiety, nervousness.
- fainting (due to a drop in blood pressure)
- palpitation
- bronchospasm, edema of the pharynx, feeling of suffocation, nosebleeds, dry throat, upper respiratory tract infection
- nausea
- rash
- muscle cramps, eyelid cramps
- irregular or profuse menstruation
- chest pain, weakness, thirst
How to store Prostinfenem
Prostin phenomena are stored by healthcare professionals at the hospital or clinic. The storage instructions are as follows if you need to know them:
- Keep this medicine out of the sight and reach of children.
- Store at 2 ° C-8 ° C (in a refrigerator).
- Do not use this medicine after the expiry date which is stated on the bottle 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 carboprost tromethamine. 1 ml contains 0.25 mg carboprost.
- The other ingredients are sodium chloride, benzyl alcohol, ( preservative ), tromethamine, sodium hydroxide / hydrochloric acid ( pH adjustment to pH 7.4), and sterile water (see section 2 “Prostinphenem contains benzyl alcohol and sodium”).
What the medicine looks like and the contents of the pack
Glass ampoule, 1 ml