Cervidil

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Dinoprostone 10mg;  

Disponible des:

Pharmaco (NZ) Ltd

Designació comuna internacional (DCI):

Dinoprostone 10 mg

Dosis:

10 mg

formulario farmacéutico:

Pessary

Composición:

Active: Dinoprostone 10mg   Excipient: Hydrogel Texturised polyester yarn retrieval system

Unidades en paquete:

Sachet, laminate, Al/Polyethylene x 1 pessary, 1 pessary

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Kyowa Pharma Chemical Co. Ltd.

indicaciones terapéuticas:

Cervical ripening in patients, at or near term, who have favourable induction features and in whom there is a medical or obstetrical indication for induction of labour.

Resumen del producto:

Package - Contents - Shelf Life: Sachet, laminate, Al/Polyethylene - 1 pessaries - 36 months from date of manufacture stored below -20°C (Deep freeze). (stability data to -15°C only) - Sachet, laminate, Al/Polyethylene - 5 pessaries - 36 months from date of manufacture stored below -20°C (Deep freeze). (stability data to -15°C only)

Data d'autorització:

2000-10-11

Informació per a l'usuari

CERVIDIL®
1
CERVIDIL®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or midwife.
1.
WHY AM I BEING GIVEN CERVIDIL?
CERVIDIL can be used to prepare the birth canal in women who require,
and have favourable features for, induction of labour
after 37 weeks of pregnancy have been completed. It helps the part of
the birth canal, known as the cervix, to soften and open
to allow the baby through. It contains the active ingredient
dinoprostone.
There can be several reasons why you might need treatment with
CERVIDIL. Ask your doctor if you would like to know more.
For more information, see Section 1. Why am I being given CERVIDIL?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE I AM GIVEN CERVIDIL?
CERVIDIL SHOULD NOT BE USED IF YOU HAVE EVER HAD AN ALLERGIC REACTION
TO DINOPROSTONE, URETHANE, OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THE CMI.
There are several circumstances in which CERVIDIL should not be used
or when it should only be used with additional caution.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR TAKE
ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before I am
given CERVIDIL?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CERVIDIL and affect how it works.
This includes aspirin and other NSAIDs.
Refer to Section 3. What if I am taking other medicines?
in the full CMI for more information.
YOU MUST NOT BE GIVEN CERVIDIL IF YOU ARE BEING GIVEN, OR WILL BE
GIVEN WITHIN THE NEXT 30 MINUTES, OTHER MEDICINES TO MAKE
YOUR WOMB CONTRACT OR BRING ON (INDUCE) LABOUR, E.G. OXYTOCIN.
4.
HOW WILL I BE GIVEN CERVIDIL?
•
CERVIDIL MUST ONLY BE USED IN A HOSPITAL SETTING BY HEALTHCARE
PROFESSIONALS TRAINED IN THE CARE OF WOMEN AND BABIES
DURING PREGNANCY AND CHILDBIRTH. Facilities for continuous monitoring
of you and your baby must be available.
•
When you are lying down, your doctor or midwife will place one p

Fitxa tècnica

NEW ZEALAND DATA SHEET
CERVIDIL – CERVIDIL004
October 2021
Page 1 of 12
CERVIDIL® 10MG PESSARY
Dinoprostone (Prostaglandin E
2
)
1 PRODUCT NAME
CERVIDIL® 10mg PESSARY
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary (vaginal insert) contains 10 mg of dinoprostone
(prostaglandin E
2
) and releases a mean
dose of approximately 0.3 mg dinoprostone per hour over 24 hours. The
dinoprostone is dispersed
throughout a matrix consisting of 241 mg of hexanetriol/macrogol
8000/isocyanate cross-linked
hydrogel copolymer, which is a semi-transparent, beige coloured, flat
rectangular pessary (vaginal
insert) measuring 29 mm by 9.5 mm and 0.8 mm in thickness. The pessary
(vaginal insert) and its
retrieval system, made of polyester yarn, are non-toxic and, when
placed in a moist environment,
absorb water, swell, and release dinoprostone.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
CERVIDIL® is a thin, flat, polymeric pessary (vaginal insert) which
is rectangular in shape with
rounded corners. The pessary (vaginal insert) is contained within the
pouch of an off-white knitted
polyester retrieval system designed to aid retrieval at the end of the
dosing interval.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cervical ripening in patients, at or near term, who have favourable
induction features and in
whom there is a medical or obstetrical indication for induction of
labour.
4.2
DOSE AND METHOD OF ADMINISTRATION
CERVIDIL® is used as a single dosage in a single application.
Cervidil should only be administered by
qualified
healthcare
personnel
in
hospitals
and
clinics
with
obstetric
units
with
facilities
for
continuous fetal and uterine monitoring.
After insertion, uterine activity and fetal condition must be
carefully and regularly monitored.
_ _
_PAEDIATRIC POPULATION _
The safety and efficacy of CERVIDIL® in pregnant woman aged less than
18 years has not been
established. No data are available.
_ _
_ADMINISTRATION _
CERVIDIL® should be removed from the freezer immediately prior to the
ins