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SPC, UK: DEPO-PROVERA Suspension for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Depo-Provera 150 mg/ml.

Qualitative and quantitative composition

Each ml of suspension contains 150 mg medroxyprogesterone acetate. Excipients with known effect: Methylparaben (E218) – 1.35mg Propylparaben (E216) – 0.15mg Sodium chloride – 3.38mg For the full list of ...

Pharmaceutical form

Sterile suspension for injection.

Therapeutic indications

Progestogen: for contraception. Depo-Provera is indicated for long-term female contraception. Each injection prevents ovulation and provides contraception for at least 12 weeks (+/- 5 days). However, it ...

Posology and method of administration

Posology Adults First injection: To provide contraceptive cover in the first cycle of use, an injection of 150 mg i.m. should be given during the first five days of a normal menstrual cycle. If the injection ...

Contraindications

Hypersensitivity to medroxyprogesterone acetate or to any of excipients listed in section 6.1. Depo-Provera should not be used during pregnancy, either for diagnosis or therapy. Depo-Provera is contraindicated ...

Special warnings and precautions for use

Assessment of women prior to starting hormonal contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided ...

Interaction with other medicinal products and other forms of interaction

Aminoglutethimide administered concurrently with Depo-Provera may significantly depress the bioavailability of Depo-Provera. Interactions with other medicinal treatments (including oral anticoagulants) ...

Pregnancy and lactation

Doctors should check that patients are not pregnant before initial injection of Depo-Provera, and also if administration of any subsequent injection is delayed beyond 89 days (12 weeks and five days). ...

Effects on ability to drive and use machines

Depo-Provera may cause headaches and dizziness. Patients should be advised not to drive or operate machinery if affected.

Undesirable effects

The table below provides a listing of adverse drug reactions with frequency based on all-causality data from clinical studies that enrolled more than 4200 women who received DMPA for contraception for ...

Overdose

No positive action is required other than cessation of therapy.

Pharmacodynamic properties

Pharmacotherapeutic group: Progestogens ATC code: G03AC06 Medroxyprogesterone acetate exerts anti-oestrogenic, anti-androgenic and antigonadotrophic effects. Mechanism of action DMPA, when administered ...

Pharmacokinetic properties

Parenteral medroxyprogesterone acetate (MPA) is a long acting progestational steroid. The long duration of action results from its slow absorption from the injection site. Immediately after injection of ...

Preclinical safety data

No data held.

List of excipients

Methylparaben (E218) Macrogol 3350 Polysorbate 80 Propylparaben (E216) Sodium chloride Hydrochloric acid Sodium hydroxide Water for injections

Incompatibilities

Not applicable.

Shelf life

Syringe: 3 years. Vial: 5 years.

Special precautions for storage

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

Nature and contents of container

1 ml suspension for injection in a pre-filled glass syringe with halobutyl rubber plunger stopper and halobutyl rubber tip cap, packed singly. 1 ml suspension for injection in glass vials with halobutyl ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK

Marketing authorization number(s)

PL 00057/0965

Date of first authorization / renewal of the authorization

Date of first authorisation: 27 August 1991 Date of latest renewal: 6 February 1997

Date of revision of the text

08/2019

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