JAPROLOX Patch (2019)
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Περιεχόμενα
1. Name of the medicinal product
Japrolox Patch.
2. Qualitative and quantitative composition
Qualitative composition <u>Generic Name:</u> Loxoprofen Sodium Hydrate (JAN) / Loxoprofen (INN) <u>Chemical Name:</u> Monosodium 2-{4-[(2-oxocyclopentyl) methyl]phenyl} propanoate dihydrate <u>Molecular ...
3. Pharmaceutical form
<u>Loxoprofen sodium water-based patch:</u> Patch preparation comprising ointment, uniformly spread over a support with the surface of the ointment covered by a liner. The ointment surface is white to ...
4.1. Therapeutic indications
Loxoprofen sodium patch is indicated for Anti-inflammation and pain relief in Osteoarthritis, Myalgia, Posttraumatic Swelling and Pain.
4.2. Posology and method of administration
Apply to the affected area once daily.
4.3. Contraindications
Loxoprofen sodium patch is contraindicated in the following patients. Patients with a history of hypersensitivity to any ingredients of Loxoprofen sodium patch. Patients with or with a history of aspirin-induced ...
4.4. Special warnings and precautions for use
Careful Administration Loxoprofen sodium patch should be administered with caution in the following patients: Patients with bronchial asthma (as the disease state may be exacerbated.) Clinically Significant ...
4.5. Interaction with other medicinal products and other forms of interaction
Not applicable to both contraindications and precautions for coadministration.
4.6. Pregnancy and lactation
Loxoprofen sodium patch should be administered to women who are or are possibly pregnant only when the anticipated therapeutic benefits are considered to outweigh any potential risk. [The safety of Loxoprofen ...
4.7. Effects on ability to drive and use machines
There is no data available on effects on ability to drive and use machines.
4.8. Undesirable effects
0.5% to <3% <0.5% Incidence unknown <b>Hypersensitivity</b> Pruritus,<br />erythema,<br />contact dermatitis,<br />rash Haemorrhage<br />subcutaneous,<br />skin irritation,<br />pigment precipitation ...
4.9. Overdose
There is no data available on overdose.
5.1. Pharmacodynamic properties
Mechanism of Action After being absorbed transdermally, loxoprofen sodium hydrate is biotransformed into an active metabolite trans-OH form (SRS coordination) to exert its excellent anti-inflammatory and ...
5.2. Pharmacokinetic properties
Plasma Concentration Each of 14 Japanese healthy male adult volunteers was subjected to repeated administration of two Loxoprofen sodium water-based patches on the back once a day for five days, showing ...
5.3. Preclinical safety data
Toxicity test Single dose toxicity test 0, 2 and 4% (0, 28.6 and 57.1 mg/body as anhydride respectively) of Loxoprofen sodium water-based patch (4 5 cm) was percutaneously administered to the trimmed ...
6.1. List of excipients
<u>Loxoprofen sodium water-based patch:</u> Mentha oil, polysorbate 80, titanium oxide, tartaric acid, disodium edetate hydrate, concentrated glycerin, carmellose sodium, talc, dried aluminum hydroxide ...
6.2. Incompatibilities
No applicable data is available.
6.4. Special precautions for storage
24 months.
6.5. Nature and contents of container
A light-protective/moisture-proof.
6.6. Special precautions for disposal and other handling
Japrolox Patch must be stored in light-proof tightly-sealed container. Do not store above 30°C. <u>Expiration date for use:</u> Loxoprofen sodium patch must be used before the expiration date indicated ...
7. Marketing authorization holder
<u>Manufacturer:</u> Lead Chemical Co., Ltd., Hisagane Plant, 327 Hisagane Kamiichi-machi Nakaniikawa-gun, Toyama, Japan <u>Importer and marketing authorization holder:</u> ZUELLIG PHARMA LTD., Bangkok, ...
8. Marketing authorization number(s)
Refer to outer box and immediate label.
10. Date of revision of the text
OCT 2, 2019
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