NULBIA

Administration of Nulbia on genital mucosa, genital skin or leg ulcers should only be performed by a healthcare professional. Posology Adults and adolescents The details of the Indications or Procedures for use, with Dosage and Application Time are provided in Tables 1 and 2.

For further guidance on the appropriate use of the product in such procedures, please refer to Method of administration. Table 1. g. needle insertion and surgical treatment of localized lesions. g. laser hair removal (self- application by patient) Maximum recommended dose: 60 g.

Maximum recommended treated area; 600 cm2 for a minimum of 1 hour, maximum 5 hours1). g. split-skin grafting. 5-2 g / 10 cm2 for 2 to 5 hours1). g. removal of genital warts (condylomata acuminata) and prior to injection of local anaesthetics Approximately 5-10 g of cream for 5-10 minutes1)3)4).

Prior to cervical curettage 10 g of cream should be administered in the lateral vaginal fornices for 10 minutes. Leg ulcer(s) Adults only Mechanical cleansing/debridement Approximately 1-2 g/10 cm2 up to a total of 10 g to the leg ulcer(s)3)5).

Application time: 30-60 minutes 1) After a longer application time anaesthesia decreases. 2) On female genital skin, Nulbia alone applied for 60 or 90 minutes does not provide sufficient anaesthesia for thermocautery or diathermy of genital warts.

2). 4) In adolescents weighing less than 20 kg the maximum dose of Nulbia on genital mucosa should be proportionally reduced. 5) Nulbia has been used for the treatment of leg ulcers up to 15 times over a period of 1-2 months without loss of efficacy or increased number or severity of adverse events.

Paediatric population Table 2 . g. needle insertion and surgical treatment of localized lesions. Approximately 1g/10 cm2 for one hour (see details below) Newborn infants and infants 0-2 months1)2)3) Up to 1 g and 10 cm2 for one hour4) Infants 3-11 months1)2) Up to 2 g and 20 cm2 for one hour5) Toddlers and children 1-5 years Up to 10 g and 100 cm2 for 1-5 hours6) Children 6-11 years Up to 20 g and 200 cm2 for 1-5 hours6) Paediatric patients with atopic dermatitis prior to removal of mollusca Application time: 30 minutes 1) In term newborn infants and infants below 3 months, only one single dose should be applied in any 24 hour period.

8. 4. 4) Application for > 1 hour has not been documented. 5) No clinically significant increase in methaemoglobin levels has been observed after an application time of up to 4 hours on 16 cm2. 6) After longer application times anaesthesia decreases.

Safety and efficacy for the use of Nulbia on genital skin and genital mucosa have not been established in children younger than 12 years. Available paediatric data do not demonstrate adequate efficacy for circumcision. 2). 2) Renal impairment A dose reduction is not necessary among patients with restricted renal function.

Method of administration Cutaneous use The protective membrane of the tube is perforated by applying the cap. 5 cm. , at doses approaching the maximum in newborn infants or if two applications may be required in a 24 hour period), a syringe can be used where 1 mL = 1 g.

A thick layer of Nulbia should be applied to the skin, including genital skin, under an occlusive dressing. For application to larger areas, such as split-skin grafting, an elastic bandage should be applied on top of the occlusive dressing to give an even distribution of cream and protect the area.

In the presence of atopic dermatitis, the application time should be reduced. For procedures related to genital mucosa, no occlusive dressing is required. The procedure should be commenced immediately after removal of the cream. For procedures related to leg ulcers, a thick layer of Nulbia should be applied under an occlusive dressing.

Cleansing should start without delay after removal of the cream.

The Nulbia tube is intended for single use when used on leg ulcers:

The tube with any remaining contents should be discarded after each occasion that a patient has been treated.

Summary of the safety profile The most frequently observed adverse drug reactions (ADRs) are related to administration site conditions (transient local reactions at application site), reported as common. Tabulated list of adverse reactions The incidences of the Adverse Drug Reactions (ADRs) associated with Nulbia therapy is tabulated below.

The table is based on adverse events reported during clinical trials, and/or post-marketing use. Their frequency of Adverse Reactions is listed by MedDRA System Organ Class (SOC) and at the preferred term level. Within each System Organ Class, adverse reactions are listed under frequency categories of: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 3. 9), in newborn infants and infants aged 0 to 12 months. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4 Special warnings and special precautions for use Patients with defective glucose-6-phosphate dehydrogenase, hereditary or idiopathic methaemoglobinaemia are more susceptible to active-substance-induced signs of methaemoglobinaemia.

In glucose-6-phosphate dehydrogenase deficient patients the antidote methylene blue is ineffective at methaemoglobin reduction, and is capable of oxidising haemoglobin itself, and therefore methylene blue therapy cannot be given. Due to insufficient data on absorption Nulbia should not be applied to open wounds (excluding leg ulcers).

2). Care should be taken when applying Nulbia to patients with atopic dermatitis. 1). 8). 8). Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, the eye should immediately be rinsed with water or sodium chloride solution and protected until sensation returns.

When Nulbia is used in children at any site of the body, children should be carefully watched to prevent them from accidental self-administration of Nulbia in their eyes. Nulbia should not be applied to an impaired tympanic membrane.

Tests on laboratory animals have shown that Nulbia has an ototoxic effect when instilled into the middle ear. Animals with an intact tympanic membrane, however, show no abnormality when exposed to Nulbia in the external auditory canal.

, amiodarone) should be carefully monitored and ECG monitoring considered as cardiac effects may be additive. 5 – 2%. For this reason, although one clinical study suggests that the immunization response, as assessed by local wheal formation, is not affected when Nulbia is used prior to BCG vaccination, the results of intracutaneous injections of live vaccines should be monitored.

Nulbia contains castor oil polyoxyl hydrogenated which may cause skin reactions. Paediatric population Studies have been unable to demonstrate the efficacy of Nulbia for heel lancing in newborn infants. In newborn infants/infants younger than 3 months a transient, clinically insignificant increase in methaemoglobin level is commonly observed up to 12 hours after an application of Nulbia within the recommended dosing.

9). Nulbia should not be used - in newborn infants/infants up to 12 months of age receiving concomitant treatment with methaemoglobin-inducing agents. - in pre-term newborn infants with a gestational age less than 37 weeks as they are at risk of developing increased methaemoglobin levels.

Safety and efficacy for the use of Nulbia on genital skin and genital mucosa have not been established in children younger than 12 years. Available paediatric data do not demonstrate adequate efficacy for circumcision.

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