NORSPAN Patch (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

NORSPAN 5mg Patch. NORSPAN 10mg Patch. NORSPAN 20mg Patch.

2. Qualitative and quantitative composition

NORSPAN patch 5: Each square patch releases buprenorphine 5 micrograms per hour over 7 days. The area containing the active substance: 6.25 cm². Total buprenorphine content: 5mg. NORSPAN patch ...

3. Pharmaceutical form

NORSPAN patch is either rectangular (10 micrograms/hr) or square (5 and 20 micrograms/hr) beige coloured matrix patch with rounded corners, marked with the trade name and consisting of a protective liner ...

4.1. Therapeutic indications

Management of moderate to severe pain.

4.2. Posology and method of administration

For application to the skin only (transdermal use) over 7 days. Adults The lowest dose, NORSPAN patch 5 micrograms per hour should be used as the initial dose. Consideration should be given to the previous ...

4.3. Contraindications

NORSPAN patch is contraindicated in patients with known hypersensitivity to buprenorphine or any components of the patch (see Section 6.1), including previous history of application site reactions suggestive ...

4.4. Special warnings and precautions for use

NORSPAN should be used with caution in patients with: Severely impaired respiratory function Sleep apnoea CNS depressants co-administration (see below and section 4.5) Serotonergic agents (see below and ...

4.5. Interaction with other medicinal products and other forms of interaction

Anti-ulcer medication In clinical trial patients there were no apparent effects on NORSPAN patch exposure when used concomitantly with various H2-antagonists or proton pump inhibitors. Benzodiazepines ...

4.6. Fertility, pregnancy and lactation

Pregnancy Buprenorphine has been shown to cross the placenta in humans and has been detected in newborn blood, urine and meconium. Opioid analgesics, including buprenorphine, may cause respiratory depression ...

4.7. Effects on ability to drive and use machines

NORSPAN patch has a major influence on the ability to drive and use machines. Even when used according to instructions, buprenorphine may modify patients' reactions to a varying extent depending on the ...

4.8. Undesirable effects

Adverse reactions that may be associated with NORSPAN patch therapy in clinical use are similar to those observed with other opioid analgesics and tend to reduce with time, with the exception of constipation. ...

4.9. Overdose

The manifestations of buprenorphine overdose are an extension of its pharmacologic actions. Respiratory depression has been absent in some cases of buprenorphine overdose. However, respiratory depression, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics, opioids ATC code: N02AE01 Buprenorphine base (active). CAS Registry Number 52485-79-7. The structural formula is: Buprenorphine is a white or ...

5.2. Pharmacokinetic properties

Each NORSPAN patch provides a steady delivery of buprenorphine for up to seven days. Steady state is achieved by day three following the first application. After removal of a NORSPAN patch buprenorphine ...

5.3. Preclinical safety data

Systemic toxicity and dermal toxicity In single- and repeat-dose toxicity studies in rats, rabbits, guinea pigs, dogs, and minipigs, NORSPAN caused minimal or no adverse systemic events, whereas skin irritation ...

6.1. List of excipients

Inert ingredients: Levulinic acid Oleyl oleate Povidone (PVP) Duro Tak 387-2051 Duro Tak 387-2054 Polyethylene terephthalate (PET)

6.2. Incompatibilities

None known.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

NORSPAN patch is supplied a heat-sealed aluminium/anionic methacrylate laminate pouch. Each carton contains two individually packaged patches.

6.6. Special precautions for disposal and other handling

Disposal after use: When changing the transdermal system, remove the used NORSPAN, fold it over on itself (bringing the adhesive sides together) and dispose of safely, out of the reach of children. ...

7. Marketing authorization holder

Distributed on behalf of Mundipharma New Zealand Limited by: Pharmaco (N.Z.) Ltd, Fisher Crescent, Mt Wellington, Auckland 1060 Ph: (09) 377-3336 Toll Free [Medical Enquiries]: 0800 773 310

9. Date of first authorization / renewal of the authorization

Date of first approval: 16 November 2006

10. Date of revision of the text

19 August 2022

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