OVESTIN Vaginal cream (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Ovestin 1 mg cream.

Qualitative and quantitative composition

1mg estriol in 1g cream. For a full list of excipients, see section 6.1.

Pharmaceutical form

Vaginal cream. Homogeneous, smooth, white to nearly white mass of creamy consistency.

Therapeutic indications

Treatment of vaginal oestrogen deficiency symptoms: Treatment of symptoms of vaginal atrophy due to oestrogen deficiency in postmenopausal women. As pre-surgery therapy for vaginal operations and during ...

Posology and method of administration

Ovestin cream is an estrogen-only product for intravaginal use. Adults and Elderly Treatment of atrophic vaginitis: 1 application per day for the first weeks (maximally 4 weeks), followed by a gradual ...

Contraindications

Known, past or suspected breast cancer; Known or suspected estrogen-dependent malignant tumours (e.g endometrial cancer); Undiagnosed genital bleeding; Untreated endometrial hyperplasia; Previous or current ...

Special warnings and precautions for use

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken ...

Interaction with other medicinal products and other forms of interaction

Due to the vaginal administration and minimal systemic absorption, it is unlikely that any clinically relevant drug interactions will occur with Ovestin. However interactions with other locally applied ...

Pregnancy and lactation

Ovestin is not indicated during pregnancy. If pregnancy occurs during medication with Ovestin treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to ...

Effects on ability to drive and use machines

As far as is known Ovestin has no effect on alertness and concentration.

Undesirable effects

The following adverse reactions, associated with estrogen treatment may occur during estriol therapy or overdose: Nausea and vomiting, breast tenderness or pain in the breasts, vaginal bleeding or spotting ...

Overdose

The acute toxicity of estriol in animals is very low. Symptoms that may occur in the case of an acute oral overdosage are nausea, vomiting and possibly withdrawal bleeding in females. No specific antidote ...

Pharmacodynamic properties

Pharmacotherapeutic group: natural and semisynthetic estrogens ATC code: G03CA04 Mechanism of action Ovestin contains the natural female hormone estriol. Unlike other estrogens, estriol is short acting. ...

Pharmacokinetic properties

Absorption After administration of Ovestin Cream, estriol is also absorbed from the vagina into the general circulation, shown by a sharp rise in plasma estriol, followed by a gradual decline. Distribution ...

Preclinical safety data

No particulars.

List of excipients

Octyldodecanol Cetyl palmitate Glycerin Cetyl alcohol Stearyl alcohol Polysorbate 60 Sorbitan stearate Chlorhexidine dihydrochloride Lactic acid Sodium hydroxide to pH 4 Purified water

Incompatibilities

None stated.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 25°C. Do not freeze.

Nature and contents of container

15g Collapsible aluminium tube with styrene acrylonitrile (copolymer) applicator.

Special precautions for disposal and other handling

Please see Section 4.2.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization number(s)

PL 39699/0058

Date of first authorization / renewal of the authorization

20 August 1982/ 16 December 1999

Date of revision of the text

12/03/2019

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