Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tacrolimus monohydrate
LEO Pharma
D11HA01
Tacrolimus monohydrate
1mg/1gram
Ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13050300; GTIN: 5390332111181 5390332111198
Daivonex ® range - 10 g, 15 g, 30 g, 60 g Daivobet ® range - 10 g, 15 g, 30 g, 60 g Fucidin ® range - 15 g, 30 g, 60 g Fucicort ® range - 15 g, 30 g, 60 g FRONT OF LEAFLET Creation Date: Revision Date: Sign: Sign: Scale: OMA 24/08/2015 OMA 06/07/2018 Ref. No.: Size: Material: Type: 100% IIE042-03 610 x 350 mm Insert PACKAGING COMPONENT SPECIFICATION LEO Pharma Internal Market Access Industriparken 55 2750 Ballerup Denmark 610x350_105x28_mF_154_AK2_Rev 4 Folded to 105 x 28 mm Comments: IIE042-00 - 13/09/2016 - OMA: New leaflet based on trial 99991530 with new supplier drawing IIE042-01 - 06/11/2017 - JUG: Material number Font and size defind and info added on drawing IIE042-02 - 16/05/2018 - OMA: Updated with drawing from Essentra containing new folding pattern IIE042-03 - 06/07/2018 - OMA: Updated with drawing from Essentra containing new folding pattern and i-mark position Revision info: Used for: IIE042-03 - 610 x 350 mm - page 1 of 2 Only to be used together with CIE093 37 x 32 x 120 mm, CIE094 44 x 32 x 140 mm, CIE095 47 x 38 x 160 mm, 610 mm 350 mm 105 mm 105 mm 105 mm 105 mm 105 mm 85 mm 8 mm 10 26 mm 24 mm 28 mm 28 mm 28 mm 28 mm 28 mm 28 mm 28 mm 28 mm 23 mm 23 mm 20 mm 5 mm 5 mm PACKAGE LEAFLET: INFORMATION FOR THE USER PROTOPIC® 0.1% OINTMENT tacrolimus monohydrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Protopic® is and what it is used for 2. What you need to know before you use Protopic® 3. How to use Protopic® 4. Possible side effects 5. How to store Protopic® 6. Con Lees het volledige document
OBJECT 1 PROTOPIC 0.1% OINTMENT Summary of Product Characteristics Updated 17-Jul-2018 | Leo Laboratories Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Protopic 0.1% ointment 2. Qualitative and quantitative composition 1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%). Excipient with known effect Butylhydroxytoluene (E321) 15 micrograms/g ointment. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Ointment A white to slightly yellowish ointment. 4. Clinical particulars 4.1 Therapeutic indications Protopic 0.1 % ointment is indicated in adults and adolescents (16 years of age and above) Flare treatment _Adults and adolescents (16 years of age and above)_ Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Maintenance treatment Treatment of moderate to severe atopic dermatitis f Lees het volledige document