PROSTIN E2 STERILE SOLUTION 1MG/ML

Active substance: DINOPROSTONE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Prostin E2 Sterile Solution 1 mg/ml.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1 mg dinoprostone.

3.

PHARMACEUTICAL FORM
Colourless, sterile solution, which after appropriate dilution is intended for
intravenous administration to human beings.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
The induction of labour by the intravenous route.

4.2.

Posology and method of administration
Adults: Ampoule contents must be diluted before use and full instructions on
method of dilution and dosage are given on the package insert which should be
consulted prior to initiation of therapy. The following is a guide to dosage:
Dilute with normal saline or 5% dextrose according to the package insert to
produce a 1.5 micrograms/ml solution. The 1.5 micrograms/ml solution is
infused at 0.25 micrograms/minute for 30 minutes and then maintained or
increased. Cases of fetal death in utero may require higher doses. An initial
rate of 0.5 micrograms/minute may be used with stepwise increases, at
intervals of not less than one hour.
Elderly: Not applicable
Children: Not applicable.

4.3.

Contraindications
Prostin E2 Sterile Solution should not be used where the patient is sensitive to
prostaglandins.
Prostin E2 Sterile Solution 1 mg/ml is not recommended in the following
circumstances:
1.

For patients in whom oxytocic drugs are generally contra-indicated or
where prolonged contractions of the uterus are considered
inappropriate such as:
Cases with a history of Caesarean section or major uterine surgery;
Cases where there is cephalopelvic disproportion;
Cases in which fetal malpresentation is present;
Cases where there is clinical suspicion or definite evidence of preexisting fetal distress;
Cases in which there is a history of difficult labour and/or traumatic
delivery;
Grand multiparae with over five previous term pregnancies.

2.

3.

In patients where there is clinical suspicion or definite evidence of
placenta praevia or unexplained vaginal bleeding during this
pregnancy.

4.

4.4

In patients with a past history of, or existing, pelvic inflammatory
disease, unless adequate prior treatment has been instituted.

Patients with active cardiac, pulmonary, renal or hepatic disease.

Special warnings and precautions for use
This product is only available to hospitals and clinics with specialised
obstetric units and should only be used where 24-hour resident
medical cover is provided
Use caution in handling this product to prevent contact with skin.
Wash hands thoroughly with soap and water after administration.
It is advised that Prostin E2 Sterile Solution should not be administered
by the intramyometrial route since there have been reports of a possible
association between this route of administration and cardiac arrest in
severely ill patients.
Caution should be exercised in the administration of Prostin E2 Sterile
Solution 1 mg/ml for the induction of labour in patients with:

(i)
(ii)
(iii)
(iv)
(v)

asthma or a history of asthma;
epilepsy or a history of epilepsy;
glaucoma or raised intra-ocular pressure;
compromised cardiovascular, hepatic, or renal function.
hypertension

As with any oxytocic agent, Prostin E2 Sterile Solution should be used
with caution in patients with compromised (scarred) uteri.
In labour induction, cephalopelvic relationships should be carefully
evaluated before use of Prostin E2 Sterile Solution. During use,
uterine activity, fetal status and the progression of cervical dilation
should be carefully monitored to detect possible evidence of undesired
responses, e.g. hypertonus, sustained uterine contractions, or fetal
distress. In cases where there is a known history of hypertonic uterine
contractility or tetanic uterine contractions, it is recommended that
uterine activity and the state of the fetus (where applicable) should be
continuously monitored throughout labour. The possibility of uterine
rupture should be borne in mind where high-tone uterine contractions
are sustained.
Animal studies lasting several weeks at high doses have shown that
prostaglandins of the E and F series can induce proliferation of bone.
Such effects have also been noted in newborn infants who received
prostaglandin E1 during prolonged treatment. There is no evidence that
short-term administration of prostaglandin E2 can cause similar bone
effects.
Women aged 35 years or older, those with complications during
pregnancy and those with a gestational age over 40 weeks have been
shown to have an increased risk of post-partum disseminated
intravascular coagulation. In addition, these factors may further
increase the risk associated with labour induction (see section 4.8
Undesirable Effects). Therefore, in these women, use of dinoprostone
should be undertaken with caution. Measures should be applied to
detect as soon as possible an evolving fibrinolysis in the immediate
post-partum phase.
4.5.

Interaction with other medicinal products and other forms of interaction
Since it has been found that prostaglandins potentiate the effect of oxytocin, it
is not recommended that these drugs are used together. If used in sequence,
the patient's uterine activity should be carefully monitored.

4.6.

Pregnancy and lactation
Pregnancy Code A

Prostin E2 Sterile Solution 1 mg/ml is only used during pregnancy, to induce
labour.
Prostaglandins are excreted in breast milk. This is not expected to be a hazard
given the circumstances in which the product is used.

4.7.

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
Immune system disorders: Hypersensitivity reactions such as anaphylactoid
reactions and anaphylactic reactions including anaphylactic shock.
Cardiac disorders: Cardiac arrest
Vascular disorders: Hypertension
Gastrointestinal disorders: Diarrhoea, nausea, vomiting
General disorders and administration site conditions: Fever, local tissue
irritation / erythema (injection site)
Immune system disorders: Hypersensitivity reactions such as anaphylactoid
reactions and anaphylactic reactions including anaphylactic shock.
Investigations: Elevated WBC
Musculoskeletal and connective tissue disorders: Back pain

Nervous system disorders: Transient vasovagal symptoms (flushing, shivering,
headache, dizziness)
Pregnancy and puerperium conditions
Maternal-related conditions: uterine hypertonus, uterine rupture, abruptio
placenta, pulmonary amniotic fluid embolism, rapid cervical dilatation
Foetus-related conditions: uterine hypercontractility with/without fetal
bradycardia fetal distress/altered fetal heart rate (FHR)
Neonatal conditions: neonatal distress
Pregnancy and perinatal conditions
Neonatal conditions: neonatal death, stillbirths, low Apgar score
Respiratory, thoracic and mediastinal disorders: Asthma, bronchospasm

Blood and lymphatic system disorders: An increased risk of post-partum
disseminated intravascular coagulation has been described in patients whose
labour was induced by pharmacological means, either with dinoprostone or
oxytocin (see section 4.4 Special Warnings and Special Precautions for
Use). The frequency of this adverse event, however, appears to be rare (<1 per
1,000 labours).

4.9

Overdose
Overdosage may be expressed by uterine hypercontractility and uterine
hypertonus. During use, uterine activity, fetal status and the progression of
cervical dilation should be carefully monitored to detect possible evidence of
undesired responses, e.g. hypertonus, sustained uterine contractions, or fetal
distress. Because of the transient nature of PGE2-induced myometrial
hyperstimulation, non-specific, conservative management was found to be
effective in the vast majority of cases: i.e. maternal position change and
administration of oxygen to the mother. If conservative management is not
effective, ß-adrenergic drugs may be used as a treatment of hyperstimulation
following administration of PGE2 for cervical ripening, in appropriate
patients.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Dinoprostone is a prostaglandin of the E series with actions on smooth muscle.
It induces contraction of uterine muscle at any stage of pregnancy.

5.2.

Pharmacokinetic properties
General characteristics of active substance
Dinoprostone is rapidly metabolised in the body. Intravenous administration
results in very rapid distribution and metabolism, with only 3% of unchanged
drug remaining in the blood after 15 minutes. At least nine prostaglandin E2
metabolites have been identified in human blood and urine.
Characteristics in Patients
No special characteristics. See "Special Warnings and Precautions for use" for
further information.

5.3.

Preclinical safety data
There are no pre-clinical data of relevance which are additional to that already
included in other sections of the SPC.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Dehydrated alcohol.

6.2.

Incompatibilities
None known.

6.3.

Shelf life
24 months.

6.4.

Special precautions for storage
Store in a refrigerator at 4°C. The product after dilution should be stored in a
refrigerator at 4°C and should not be kept for more than 24 hours.

6.5

Nature and contents of container
Ph. Eur. Type I glass ampoule, containing 0.75 ml sterile solution, packed in a
carton.

6.6

Special precautions for disposal
Use caution in handling this product to prevent contact with skin. Wash hands
thoroughly with soap and water after administration.

7

MARKETING AUTHORISATION HOLDER

Pharmacia Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK

8.

MARKETING AUTHORISATION NUMBER(S)
PL: 0032/0020R.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/10/2004

10

DATE OF REVISION OF THE TEXT
14/03/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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