ZIPZOC Impregnated dressing (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Zipzoc 20%, Impregnated Dressing.
2. Qualitative and quantitative composition
20% Zinc Oxide. Each stocking (80 cm x 7 cm) contains about 41.5g of ointment. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Impregnated dressing. Zipzoc is a sterile rayon stocking impregnated with an ointment containing Zinc Oxide.
4.1. Therapeutic indications
To be used as an aid in the treatment of chronic venous leg ulcers. Where chronic venous insufficiency exists the stocking can be used as a primary contact layer under compression bandaging or hosiery. ...
4.2. Posology and method of administration
Posology Zipzoc should be applied to cover the lower leg from the base of the toes to below the knee. All folds should be smoothed out. In the case of excessive calf size care should be taken to apply ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Arterial leg ulcers.
4.4. Special warnings and precautions for use
If the outer bandage is inappropriate or the stocking is not changed with sufficient frequency it can cause the stocking to dry out.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
There is no evidence to suggest Zipzoc should not be used during pregnancy or lactation.
4.7. Effects on ability to drive and use machines
It is unlikely to have an effect.
4.8. Undesirable effects
General disorders and administration site conditions <u>Very rare:</u> Application site pain <u>Very rare:</u> Oedema Skin and subcutaneous tissue disorders <u>Very rare:</u> Application site folliculitis ...
4.9. Overdose
None known.
5.1. Pharmacodynamic properties
<b>ATC-code:</b> D09AB01 The stocking consists of tubular rayon gauze impregnated with zinc oxide Ph Eur 20% in an ointment base. Zinc oxide has a soothing and protective effect. Zipzoc has no effect on ...
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Nothing relevant to add to the prescribing information.
6.1. List of excipients
<u>Ointment base consists of:</u> Liquid paraffin White soft paraffin
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
Polyethylene aluminium foil laminated pouches, each pouch containing a single stocking. The outer carton will contain 1, 4 or 10 pouches. Each pouch contains a tubular rayon gauze stocking impregnated ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
Evolan Pharma AB, PO Box 120, 182 12 Danderyd, Sweden
8. Marketing authorization number(s)
PA2262/001/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 13 July 1998 Date of last renewal: 01 October 2006
10. Date of revision of the text
November 2020
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