Active ingredients: Gemeprost
CERVIDIL 1 mg ova
Why is Cervidil used? What is it for?
This medicinal product is a prostaglandin E1 analogue for gynecological and obstetric use.
It is used to soften and dilate the cervix for gynecological and obstetric needs.
Contraindications When Cervidil should not be used
Do not use CERVIDIL
- if you are allergic to the active substance, to prostaglandins in general or to any of the other ingredients of this medicine (listed in section 6),
- for the induction of labor in the event of a full term or near term birth with a live fetus,
- in case of preeclampsia in hypertensive patients (frequent disease in pregnancy, associated with arterial hypertension and the appearance of proteins in the urine),
- if you have a high risk of bleeding, such as placenta previa (abnormal location of the placenta which may be responsible for severe bleeding during the third trimester of pregnancy) or ectopic pregnancy,
- if you get a fever due to a pelvic infection (infection of the female genital organs) which may get worse with use of the medicine.
Precautions for use What you need to know before taking Cervidil
The medicine must only be administered under medical supervision, in a hospital environment and in conditions that allow immediate treatment of any emergency situations.
- Tell your doctor if you are in any of the following situations as this medicine will need to be used with caution:
- if you suffer from cardiovascular insufficiency,
- if you have an eye disease (glaucoma, intraocular hypertension),
- if you suffer from severe inflammation of the genital system, such as cervicitis (inflammation of the cervix) or vaginitis (inflammation of the vagina),
- if you have previously had uterine surgery or a caesarean section.
- The doctor should be especially careful in patients with multiple births (who have given birth more than once) or with multiple pregnancies, as the uterus may be less resistant and there is a risk that contractions may cause uterine lacerations.
- In the event of an abortion during the second trimester of pregnancy, to avoid uterine ruptures or lacerations of the cervix and excessive bleeding, the doctor must carefully check at each use:
- the state of uterine contractions,
- the degree of softening and dilation of the cervix,
- the volume of blood loss,
- the stage of expulsion of the fetus.
- Since the use of the medicine can cause uterine ruptures or lacerations, the dosage and the modalities of use must be well followed.
- After using Cervidil, the doctor will have to carry out a careful evaluation of the uterine cavity and, if necessary, a revision of the same (curettage). In addition, the doctor will have to verify the absence of uterine ruptures or lacerations.
Children
This medicine is not indicated for the treatment of children.
Interactions Which drugs or foods can modify the effect of Cervidil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor will be especially careful if you are taking an oxytocin or dinoprost medicine at the same time, the effects of which may increase the activity of gemeprost (the active substance in CERVIDIL) on uterine contractility.
Warnings It is important to know that:
Pregnancy and breastfeeding
Cervidil has harmful effects on pregnancy.
Cervidil should not be used while breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Cervidil has no or negligible influence on the ability to drive and use machines.
Dose, Method and Time of Administration How to use Cervidil: Posology
The medicinal product should only be administered under medical supervision in a hospital setting.
This medicine comes in the form of an egg to be placed in the vagina.
In adult women, Cervidil is used:
- For the dilation of the cervix in gynecology, necessary for diagnostic instrumental interventions (biopsy of the endometrium, hysteroscopy), for surgical interventions (curettage) or for the introduction of an intrauterine device (IUD).
Introduce 1 Cervidil egg into the vagina (precisely in the posterior vaginal fornix) 3 hours before surgery. In most of the patients treated, a single Cervidil egg causes adequate dilation of the cervix, which remains stable for at least 6 hours. .
The use of Cervidil allows to replace the traditional mechanical systems for the dilation of the cervix, such as the Hegar probe.
- For dilation of the cervix in obstetrics, necessary in case of fetal death in utero, vesicular mola or induction of labor in the 1st and 2nd trimester of pregnancy.
Introduce 1 egg of Cervidil into the vagina every 3 hours until complete expulsion of the uterine contents, for a maximum of 5 eggs.
Signs and symptoms of the effect of the medicine (bleeding, uterine contractions) occur, in most cases, immediately after the first or second egg is given. If the uterus has not emptied after the introduction of 5 eggs, a similar cycle can be repeated at least 24 hours from the beginning of the previous cycle.
Use in children
Cervidil is not indicated for the treatment of children.
Overdose What to do if you have taken too much Cervidil
Clinical studies conducted to date have not reported any cases of overdose. However, it is recommended not to exceed the recommended dose.
Side Effects What are the side effects of Cervidil
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Your doctor must stop using this product, immediately take all necessary measures to maintain a constant heart, circulatory and respiratory function and carefully monitor your state of health in the event of the following symptoms:
- dyspnoea (difficulty in breathing),
- chest pains,
- sudden drop in blood pressure and coronary spasms (sudden contraction of the arteries of the heart),
- disturbances of the state of consciousness.
The most common side effects are of moderate severity: nausea, vomiting, diarrhea, temperature rise.
Undesirable effects of high severity are represented by shock and myocardial infarction (events arising from spontaneous reports whose frequency is not known), uterine bleeding, uterus rupture and laceration of the cervix (rare side effects).
Very common effects (may affect more than 1 in 10 patients):
- Nausea, vomiting, diarrhea
- Increased body temperature
Common effects (may affect up to 1 in 10 patients):
- Hypertension or arterial hypotension (high or low blood pressure) with palpitations
- Vertigo, headache (headache)
- Itching, rash (skin reactions)
- Low back pain (pain in the lower back)
- Chills, redness of the face
- Painful menstrual cramps
Rare effects (may affect up to 1 in 1,000 patients):
- Hot flashes
- Uterine bleeding, uterus rupture, cervical lacerations
Effects whose frequency is not known (frequency cannot be estimated from the available data):
- Coronary spasms (sudden contraction of the arteries of the heart) and myocardial infarction, cases of shock
- Restlessness
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Italian Medicines Agency, website: www.agenziafarmaco.gov. .it / it / responsible. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Store in a refrigerator (2 ° C - 8 ° C).
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What CERVIDIL contains
The active ingredient is gemeprost. One egg contains 1 mg of gemeprost.
The other ingredients are absolute ethanol, triglycerides of saturated fatty acids.
What CERVIDIL looks like and contents of the pack
This medicine comes in the form of an egg. One box contains 1 egg.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CERVIDIL 1 MG OVULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One egg contains: 1 mg gemeprost.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Fusiform white-yellowish ovules for vaginal use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Softening and dilation of the uterine cervix for gynecological and obstetric needs.
04.2 Posology and method of administration
Dosage
In the adult woman:
to) Dilation of the cervix in gynecology: 1 Cervidil ovum introduced into the posterior fornix 3 hours before instrumental interventions for diagnostic purposes (endometrial biopsy, hysteroscopy) or surgery (revision of the uterine cavity) or for the introduction of I.U.D. The use of Cervidil allows to replace traditional mechanical means (Hegar probes).
In the majority of treated patients, a single Cervidil egg induces adequate cervical dilatation which remains stable for at least 6 hours.
b) Dilation of the cervix in obstetrics: stillborn fetus, vesicular mola, induction of labor in the 1st and 2nd trimester of pregnancy: 1 Cervidil egg every 3 hours until the uterine contents are completely expelled and, in any case, up to a maximum of 5 eggs.
Signs and symptoms of the drug's effect (bleeding, uterine contractions) occur, most of the time, immediately after the first or second egg is given.
If uterine emptying has not occurred after the introduction of 5 ova, the repetition of a cycle similar to the first is allowed, after an interval of at least 24 hours from the beginning of the treatment cycle.
Pediatric population
There is no indication for a specific use of Cervidil in the pediatric population.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Cervidil must not be used for the induction of labor in full term or near term pregnancy with live fetus, in hypertensive gestosis, in conditions with a high haemorrhagic risk (placenta previa, ectopic pregnancy), in case of fever due to infection pelvic area which may get worse with the use of the drug.
04.4 Special warnings and appropriate precautions for use
Cervidil should only be administered under medical supervision, in a hospital setting and preparing to intervene with emergency therapy.
Since uterine ruptures or lacerations may occur with the use of Cervidil, particular attention should be paid to the dosage and method of use.
Cervidil should be used with caution in patients with cardiovascular insufficiency, with ophthalmic diseases (glaucoma, intra-ocular hypertension), with intense inflammation of the genital tract (cervicitis, vaginitis) or who have previously undergone uterine surgery or caesarean section. Particular caution should be used in patients with multiple pregnancies or with multiple pregnancies, as the uterus may be less resistant and there is a risk of uterine laceration caused by induced contractile activity.
To prevent uterine ruptures or lacerations of the cervix and excessive bleeding, which can occur in the case of abortion during the second trimester of pregnancy, it is recommended to carefully check the state of uterine contractions, the degree of softening and dilation of the uterine contractions at each administration. cervix, the volume of blood loss, the degree of expulsion of the fetus.
After recourse to Cervidil, an evaluation of the uterine cavity should be carefully conducted and, if necessary, a revision of the uterine cavity (RCU) carried out. The absence of uterine ruptures or lacerations should also be checked as is the practice in any abortion or birth labor.
04.5 Interactions with other medicinal products and other forms of interaction
Particular caution must be exercised in the simultaneous administration of oxytocin and dinoprost-based drugs, whose effects could enhance the activity of gemeprost on uterine contractility.
04.6 Pregnancy and breastfeeding
Pregnancy
Cervidil has harmful pharmacological effects on pregnancy.
Feeding time
Cervidil should not be used while breastfeeding.
04.7 Effects on ability to drive and use machines
Cervidil has no or negligible influence on the ability to drive and use machines.
04.8 Undesirable effects
The most commonly observed side effects are of modest severity: nausea, vomiting, diarrhea, temperature rise.
The undesirable effects of high severity are represented by shock and myocardial infarction (events arising from spontaneous reports whose frequency is not known), uterine bleeding, uterine rupture and laceration of the uterine cervix (frequency rare).
List of adverse reactions
The adverse reactions listed below are ranked by frequency of occurrence: very common (≥1 / 10), common (≥1 / 100,
Cardiac disorders:
Common frequency: hypertension or arterial hypotension with palpitations.
Frequency not known: coronary spasms and subsequent myocardial infarction, cases of shock.
Nervous system disorders:
Common frequency: dizziness, headache.
Frequency not known: restlessness.
Gastrointestinal disorders:
Very common frequency: nausea, vomiting, diarrhea.
Skin and subcutaneous tissue disorders:
Common frequency: itching and rash.
Musculoskeletal and connective tissue disorders:
Common frequency: low back pain.
General disorders and administration site conditions:
Very common frequency: thermal rise.
Common frequency: chills, flushing of the face.
Rare: hot flashes.
Reproductive system and breast disorders:
Common frequency: cramping pains of the menstrual type.
Rare: uterine bleeding, rupture of the uterus, laceration of the uterine cervix.
In the event that symptoms such as dyspnoea, chest pain, sudden drop in blood pressure and coronary spasms, disturbances of consciousness, the doctor must stop the administration of the product and immediately take all necessary measures to maintain cardiac and circulatory function. and respiratory and follow the patient carefully in the clinical course.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Clinical studies conducted to date do not report cases of overdose. However, it is advisable not to exceed the recommended doses.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: oxytocic drugs, prostaglandins.
ATC code: G02AD03.
Pharmacodynamic effects
Intravaginal doses of 10 mcg / kg of Cervidil administered to rats, on the 20th day of pregnancy, cause uterine contractions; the same effect occurs in pregnant monkeys (50-120 days) with doses of 20 mcg / kg always intravaginally.
Clinical efficacy and safety
The abortive effect of the specialty was studied in rabbits and monkeys; doses of Cervidil proportional to the period of pregnancy, administered intraperitoneally (rabbits) and vaginally (monkeys), resulted in termination of pregnancy in both species. Studies on the ability to dilate the uterine cervix were carried out on pregnant monkeys with positive results at the dose of 1 mg of Cervidil intravaginally.
05.2 Pharmacokinetic properties
By administering to pregnant women 1 ovule of Cervidil of 1 mg, at 3 hour intervals, a peak of 6 ng / mL is detected in the blood after 1 hour from the initial dose and a decrease to about 1/3 of the initial peak after 3 hours. A similar pattern is observed after administration of the second dose.
05.3 Preclinical safety data
Sub-acute toxicity studies were performed on rats by administering up to 2,000 mcg / kg / day of Cervidil subcutaneously and up to 6,250 mcg / kg / day intravaginally for 30 days.
At higher doses the following were found: decrease in spontaneous activity, redness in the extremities in the auricular and perioral area, diarrhea.
In the intravaginally treated group, swelling of the external genitalia, myeloid mitoplasia in the spleen and decreased platelets were noted.
Acute toxicity (LD50 mg / kg) was studied in female mice and rats with the following results for each route of administration:
Female mice: 62.5 by mouth - 32.5 by subcutaneous injection - 29.5 by intravenous injection - 36 by vaginal administration.
Female rats: 60 orally - 24.3 by subcutaneous injection - 28.6 by intravenous injection - 32.5 by vaginal administration.
Chronic toxicity was studied in rats by administering up to 1,000 mcg / kg / day of Cervidil subcutaneously for 26 weeks. At higher doses, vasodilation, diarrhea, polyuria, decreased muscle tone, reduced righting reflex, sedation were noted.
No teratogenic and mutagenic effects were found.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Absolute ethanol, triglycerides of saturated fatty acids.
06.2 Incompatibility
To date, there are no data of incompatibility with other drugs.
06.3 Period of validity
18 months.
06.4 Special precautions for storage
Store in a refrigerator (2 ° C - 8 ° C).
06.5 Nature of the immediate packaging and contents of the package
Opaque white container in P.V.C./Polyethylene laminate with a capacity of 0.9 g containing 1 egg.
Pack of 1 egg.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Merck Serono S.p.A., Via Casilina 125, Rome, Italy
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 026028011
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 30 July 1987
Date of most recent renewal: 1 June 2010
10.0 DATE OF REVISION OF THE TEXT
12/2016
