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SPC, UK: CRINONE Vaginal gel (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Crinone 8% w/w Progesterone Vaginal Gel.

Qualitative and quantitative composition

Active Ingredient:   mg/dose %w/w Progesterone 90 8.0 Excipient with known effect: Contains Sorbic acid 0.08% w/w (0.9mg/1.125 g dose). For the full list of excipients, see section 6.1.

Pharmaceutical form

Vaginal gel.

Therapeutic indications

Treatment of infertility due to inadequate luteal phase. For use during in-vitro fertilisation, where infertility is mainly due to tubal, idiopathic or endometriosis linked sterility associated with normal ...

Posology and method of administration

Posology Intravaginal application. Treatment of infertility due to inadequate luteal phase One application (1.125g 8% gel) every day, starting after documented ovulation or arbitrarily on the 18th – 21st ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Undiagnosed vaginal bleeding Known or suspected progesterone-sensitive malignant tumours Porphyria Thrombophlebitis, ...

Special warnings and precautions for use

The pre-treatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear. Cautious use in severe hepatic insufficiency. In cases of breakthrough ...

Interaction with other medicinal products and other forms of interaction

Crinone is not recommended for use concurrently with other vaginal preparations. Although there is evidence of interaction between oral progestogens and CYP3A4 inducers, resulting in a decrease of serum ...

Pregnancy and lactation

Pregnancy In case of corpus luteum deficiency, Crinone can be used during the first month of pregnancy. Breast-feeding Do not use during lactation.

Effects on ability to drive and use machines

Drivers and users of machines are warned that risk of somnolence may occur.

Undesirable effects

The adverse reactions reported below are classified according to frequency of occurrence as follows: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to ...

Overdose

Not applicable.

Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones ATC code: G03DA04 The pharmacological particulars of the product are those of the naturally occurring progesterone with induction of a full secretory endometrium. ...

Pharmacokinetic properties

The progesterone vaginal gel is based on a polycarbophil delivery system which attaches to the vaginal mucosa and provides a prolonged release of progesterone for at least three days.

Preclinical safety data

In rabbits, Crinone was an eye irritant categorised class IV (minimal effects clearing in less than 24 hours), but not a dermal irritant. A moderate vaginal irritation was found in rabbits after application ...

List of excipients

Glycerin Light Paraffin Hydrogenated Palm Oil Glyceride Carbopol 974P Sorbic acid Polycarbophil Sodium hydroxide Purified water

Incompatibilities

No incompatibilities were found with the usual contraceptive devices.

Shelf life

Shelf life: 36 months.

Special precautions for storage

Store below 25°C.

Nature and contents of container

A single use, one piece, white polyethylene applicator with a twist-off top, designed for intravaginal application. Each applicator contains 1.45g of gel and delivers 1.125g of gel. Each one is wrapped ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK

Marketing authorization number(s)

PL 11648/0261

Date of first authorization / renewal of the authorization

Date of first authorisation: 1st March 2013 Date of latest renewal: 26th June 2004

Date of revision of the text

08/2019

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