Drugs Index
Medical Conditions:
- Medical Conditions G
- Medical Conditions I
- Medical Conditions P
- Medical Conditions C
- Medical Conditions N
- Medical Conditions T
- Medical Conditions E
- Medical Conditions D
- Medical Conditions F
- Medical Conditions H
- Medical Conditions M
- Medical Conditions B
- Medical Conditions U
- Medical Conditions O
- Medical Conditions S
- Medical Conditions A
- Medical Conditions R
- Medical Conditions L
- Medical Conditions W
- Medical Conditions V
- Medical Conditions K
- Medical Conditions J
- Medical Conditions X
Drug Classes
- Drug Classes A
- Drug Classes M
- Drug Classes H
- Drug Classes C
- Drug Classes B
- Drug Classes U
- Drug Classes T
- Drug Classes O
- Drug Classes I
- Drug Classes N
- Drug Classes V
- Drug Classes E
- Drug Classes G
- Drug Classes P
- Drug Classes L
- Drug Classes Q
- Drug Classes F
- Drug Classes S
- Drug Classes D
- Drug Classes R
- Drug Classes 5
- Drug Classes K
Drugs Information:
Drugs List
1. Name Of The Medicinal Product
ZOMORPH capsules 10mg, 30mg, 60mg, 100mg, 200mg
2. Qualitative And Quantitative Composition
• Morphine sulphate BP 10mg
• Morphine sulphate BP 30mg
• Morphine sulphate BP 60mg
• Morphine sulphate BP 100mg
• Morphine sulphate BP 200mg
3. Pharmaceutical Form
Sustained-release capsules.
4. Clinical Particulars
4.1 Therapeutic Indications
Severe chronic pain and/or pain resistant to other analgesics, in particular pain associated with cancer.
4.2 Posology And Method Of Administration
Route of administration : orally.
As directed by a medical practitioner.
Recommended dosage
Adults: Recommended dosage is one capsule twice daily, at 12-hourly intervals.
Elderly: As with all narcotics, a reduction in dosage may be advisable in the elderly, as appropriate.
Children: Not recommended.
The capsules should not be chewed and should normally be swallowed whole.
The dosage varies according to the severity of pain and the previous analgesic treatments received by the patient.
If the pain persists, or if the patient develops tolerance to morphine, the dosage may be increased by prescribing the 10mg, 30mg, 60mg, 100mg and 200mg capsules in various combinations or alone to obtain the desired relief.
Patients previously treated with immediate-release oral morphine should receive the same daily dose of sustained-release capsules, but in two di
1. Name Of The Medicinal Product
Zyomet Gel
2. Qualitative And Quantitative Composition
Metronidazole 0.75% w/w
3. Pharmaceutical Form
Gel for cutaneous use
4. Clinical Particulars
4.1 Therapeutic Indications
Zyomet Gel is indicated for the treatment of acute inflammatory exacebations of acne rosacea
4.2 Posology And Method Of Administration
Adults: Apply to the affected skin of the face in a thin film twice a day for eight to nine weeks. Thereafter, further applications may be necessary depending on the severity of the condition.
Use in the elderly: As detailed for adults.
Use in Children: Not recommended
4.3 Contraindications
Patients with known hypersensitivity to any of the ingredients should not use the product.
4.4 Special Warnings And Precautions For Use
If a reaction suggesting local irritation occurs patients should be directed to use the medication less frequently, discontinue use temporarily or discontinue use until further instructions. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. Exposure of treated sites to ultraviolet or strong sunlight should be avoided during use of metronidazole. Unnecessary and prolonged use of this medication should be avoided.
Zyomet Gel has been reported to cause lacrimation of the eyes, thereforeavoid contact with eyes; if eye contact does occur the gel should be washed out carefully with water. Avoid drinking alcohol while using Zyomet Gel.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
There is evidence to suggest that systemic absorption of
1. Name Of The Medicinal Product
Zovirax Tablets BP 800mg
2. Qualitative And Quantitative Composition
Aciclovir 800mg BP
3. Pharmaceutical Form
Dispersible film coated tablet
4. Clinical Particulars
4.1 Therapeutic Indications
Zovirax tablets 800 mg are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections (excluding neonatal HSV and severe HSV infections in immunocompromised children).
4.2 Posology And Method Of Administration
Dosage in adults:
Treatment of varicella and herpes zoster infections: 800 mg Zovirax should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days.
In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing.
Dosing should begin as early as possible after the start of an infection: Treatment of herpes zoster yields better results if initiated as soon as possible after the onset of the rash. Treatment of chickenpox in immunocompetent patients should begin within 24 hours after the onset of the rash.
Dosage in children:
Treatment of varicella infections:
6 years and over: 800 mg Zovirax four times daily.
Treatment should continue for five days.
No specific data are available on the treatment of herpes zoster infections in immunocompetent children.
1. Name Of The Medicinal Product
Zantac 75 Relief
2. Qualitative And Quantitative Composition
Quantities per tablet
Active Ingredient:
Ranitidine Hydrochloride 84mg
(equivalent to ranitidine 75mg)
3. Pharmaceutical Form
Tablet.
4. Clinical Particulars
4.1 Therapeutic Indications
Symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity.
4.2 Posology And Method Of Administration
Route of Administration
Oral
Dosage
Adults (Including The Elderly) and children 16 years of age and older:
Swallow one Zantac 75 Relief tablet whole, with a drink of water, as soon as you have symptoms. If symptoms persist for more than one hour or return, take another tablet. Do not take more than two tablets in 24 hours.
Do not take the tablets for more than 6 days without the advice of a pharmacist or doctor.
Children under 16 years
Not recommended for children under 16 years of age.
4.3 Contraindications
Ranitidine is contraindicated for people known to be hypersensitive to the drug or any of the ingredients of Zantac 75 Relief tablets.
4.4 Special Warnings And Precautions For Use
Treatment with a histamine H2-antagonist such as Zantac 75 Relief may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition.
Zovirax Double Strength Suspension
aciclovir
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1 What Zovirax is and what it is used for
- 2 Before you take Zovirax
- 3 How to take Zovirax
- 4 Possible side effects
- 5 How to store Zovirax
- 6 Further information
What Zovirax is and what it is used for
Zovirax Double Strength Suspension (called ‘Zovirax’ in this leaflet) contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.
Zovirax can be used to:
- treat chickenpox and shingles
- treat cold sores and genital herpes
- stop these problems returning after you have had them
- stop these problems in people whose immune systems work less well, which means their bodies are less able to fight infections.
Before you take Zovirax
Do not use Zovirax if:
- you are allergic (hypersensitive) to aciclovir or valaciclovir or any of the
1. Name Of The Medicinal Product
ZIBOR
2. Qualitative And Quantitative Composition
Bemiparin sodium: 2500 IU (anti Factor Xa*) per 0.2 ml pre-filled syringe (equivalent to 12500 IU (antiFactor Xa*) per millilitre solution for injection)
Potency is described in International anti-Factor Xa activity units (IU) of the 1st International Low Molecular Weight Heparin Reference Standard
For excipients, see 6.1
3. Pharmaceutical Form
Solution for injection in pre-filled syringe.
(Colourless or slightly yellowish, clear solution, free of visible particles)
4. Clinical Particulars
4.1 Therapeutic Indications
Prevention of thromboembolic disease in patients undergoing general surgery.
Prevention of clotting in the extracorporeal circuit during haemodialysis.
4.2 Posology And Method Of Administration
| WARNING: The different low molecular weight heparins are not necessarily equivalent. Therefore compliance with the dosage regimen and the specific method of use for each of these medicinal products is required. |
Adults:
General surgery with moderate risk of venous thromboembolism:
On the day of the surgical procedure, 2,500 IU anti-Xa is to be administered by subcutaneous route (sc), 2 hours before or 6 hours after surgery. On subsequent days, 2,500 IU anti-Xa sc is to be administered every 24 hours.
Prophylactic treatment must be followed in accordance with the physician's opinion during the period of risk or until the patient is mobilised. As a general rule, it is considered necessary to maintai
ZANAFLEX 2mg tablets
ZANAFLEX 4mg tablets
(Tizanidine)
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What ZANAFLEX is and what it is used for.
- 2. Before you use ZANAFLEX.
- 3. How to use ZANAFLEX.
- 4. Possible side effects.
- 5. How to store ZANAFLEX.
- 6. Further information.
What Zanaflex Is And What It Is Used For
The name of this medicine is ZANAFLEX. The active ingredient is tizanidine hydrochloride which belongs to a group of medicines called muscle relaxants.
ZANAFLEX is used to relax muscles which have become stiff due to multiple sclerosis or other diseases affecting the spinal cord.
Before You Take Zanaflex
Do not take ZANAFLEX if you:
- Are allergic (hypersensitive) to tizanidine hydrochloride or any of the other ingredients in ZANAFLEX.
- Have liver problems.
- Are taking a medicine called fluvoxamine or ciprofloxa
1. Name Of The Medicinal Product
ZORAC 0.1%, gel
2. Qualitative And Quantitative Composition
Active substance:
Tazarotene ......................................................... 0.1 g
Excipients with a well known effect:
Butylhydroxyanisole............................................ 0.05 g
Butylhydroxytoluene............................................ 0.05 g
For 100 g of gel
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Gel.
Colourless to light yellow, translucent to homogeneous cloudy gel.
4. Clinical Particulars
4.1 Therapeutic Indications
For the topical treatment of mild to moderate plaque psoriasis involving up to 10% body surface area.
4.2 Posology And Method Of Administration
Zorac gel is available in two concentrations.
To initiate a treatment with Zorac, it is advisable to start with Zorac 0.05% in order to evaluate the skin response and tolerance before progressing to Zorac 0.1% if necessary.
Treatment with the lower concentration gel is associated with a somewhat lower incidence of local adverse events (see sections 4.8 Undesirable effects and 5. Pharmacological Properties).
Treatment with the higher concentration gel gives a faster and numerically higher response rate. The physician should choose the concentration to be used based on clinical circumstances and the principle of using the least concentration of drug to achieve the desired effect.
Individual variations with respect to efficacy and tolerability are possible. It is thus advisable for patients to consult their physician on a weekly basis when initiating therapy.
1. Name Of The Medicinal Product
Zydol SR 50 mg prolonged-release tablets
2. Qualitative And Quantitative Composition
Active substance: tramadol hydrochloride
Zydol SR 50 mg prolonged-release tablets
1 prolonged-release tablet contains 50 mg tramadol hydrochloride.
Excipient: Each prolonged-release tablet contains 2.5 mg lactose monohydrate (see section 4.4).
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Prolonged-release tablets
round, biconvex, film-coated tablets, marked with the manufacturer's logo on one side,
- 50 mg tablet: pale yellow coloured, marked T0 on the other side
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of moderate to severe pain.
4.2 Posology And Method Of Administration
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient.
Unless otherwise prescribed, Zydol SR should be administered as follows:
Adults and adolescents above the age of 12 years:
The usual initial dose is 50-100 mg tramadol hydrochloride twice daily, morning and evening. If pain relief is insufficient, the dose may be titrated upwards to 150 mg or 200 mg tramadol hydrochloride twice daily.
The tablets are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals.
The lowest analgesically effective dose should generally be selected. Daily doses of 400 mg active substance should not be exceeded, except in special clinical circumstances.
Zydol SR should under no circumstances be administered for longer than absolutely
1. Name Of The Medicinal Product
Zantac Injection 50 mg/2ml
2. Qualitative And Quantitative Composition
Ranitidine Hydrochloride HSE 56.0 mg/2ml equivalent to Ranitidine 50.0 mg/2ml.
3. Pharmaceutical Form
Injection (Aqueous solution)
A clear colourless to pale yellow liquid, practically free from particles.
4. Clinical Particulars
4.1 Therapeutic Indications
Adults:
Zantac Injection is indicated for the treatment of duodenal ulcer, benign gastric ulcer, post - operative ulcer, reflux oesophagitis, Zollinger - Ellison Syndrome and the following conditions where reduction of gastric secretion and acid output is desirable:
The prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients, the prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's Syndrome), particularly obstetric patients during labour. For appropriate cases, Zantac tablets are also available.
Children (6 months to 18 years):
Zantac Injection is indicated for the short term treatment of peptic ulcer and the treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.
4.2 Posology And Method Of Administration
(See Section 5.2 Pharmacokinetic Properties – Special patient Populations)
Adults (including elderly) / Adolescents (12 years and over)
Zantac Injection may be given either as a slow (over 2 minutes) intravenous injection up to a maximum of
zumenon 2mg
film-coated tablets
What you should know about Zumenon
Please read this leaflet before you take your medicine, and keep it safe because you may want to read it again. If you have any questions or are not sure about anything, ask your doctor or a pharmacist.
What is in Zumenon?
Zumenon belongs to a group of medicines known as Hormone Replacement Therapy or HRT.
Each tablet contains 2 mg estradiol. The tablets are brick-red coloured and can be recognised by the following markings: 'a letter S above a triangle’ on one side and ‘379’ on the other. The estradiol in the tablets is made from plant materials. The tablets also contain: lactose, talc, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate, macrogol 400, titanium dioxide (E171) and red, black and yellow iron oxides (E172).
Zumenon is available as a three month (84 tablets) calendar pack, which is marked with the days of the week to help you remember to take your tablets.
The marketing authorisation holder is
Zumenon is made by
Zestril 2.5 mg Tablets
Zestril 5 mg Tablets
Zestril 10 mg Tablets
Zestril 20 mg Tablets
lisinopril
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Zestril is and what it is used for
- 2. Before you take Zestril
- 3. How to take Zestril
- 4. Possible side effects
- 5. How to store Zestril
- 6. Further information
What Zestril is and what it is used for
Zestril contains a medicine called lisinopril. This belongs to a group of medicines called ACE inhibitors.
Zestril can be used for the following conditions:
- To treat high blood pressure (hypertension).
- To treat heart failure.
- If you have recently had a heart attack (myocardial infarction).
- To treat kidney problems caused by Type II diabetes in people with high blood pressure.
Zestril works by making your blood vessels widen. This helps to lower your blood pressure. It also makes
ZoviraxSuspension
aciclovir
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1 What Zovirax is and what it is used for
- 2 Before you take Zovirax
- 3 How to take Zovirax
- 4 Possible side effects
- 5 How to store Zovirax
- 6 Further information
What Zovirax is and what it is used for
Zovirax Suspension (called ‘Zovirax’ in this leaflet) contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.
Zovirax can be used to:
- treat chickenpox and shingles
- treat cold sores and genital herpes
- stop these problems returning after you have had them
- stop these problems in people whose immune systems work less well, which means their bodies are less able to fight infections.
Before you take Zovirax
Do not use Zovirax if:
- you are allergic (hypersensitive) to aciclovir or valaciclovir or any of the other ingr
Zolvera 40mg/5ml Oral Solution
Verapamil Hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
- 1. What is Zolvera and what is it used for
- 2. Before you take Zolvera
- 3. How to take Zolvera
- 4. Possible side effects
- 5. How to store Zolvera
- 6. Further information
What Zolvera is and what it is used for
The name of your medicine is Zolvera. It contains verapamil hydrochloride. This belongs to a group of medicines called calcium channel blockers. The heart muscle and the muscle in your blood vessel walls need calcium to contract and tighten.
Zolvera stops calcium from getting into these muscles. This
- relaxes your heart and blood vessels
- makes your heart pump out less blood every time it beats
- slows down your heart rate (pulse)
Zolvera can be used to:
- treat high blood pressure (hypertension)
- treat chest pain (angina)
- treat heart rhythm problems such as heart flutter (supraventricular tachycardia).
Before you take Zolvera
1. Name Of The Medicinal Product
Zemplar 1 microgram capsules, soft
Zemplar 2 micrograms capsules, soft
Zemplar 4 micrograms capsules, soft
2. Qualitative And Quantitative Composition
Each capsule, soft contains
|
Paricalcitol |
Excipients (Ethanol) |
|
|
Zemplar 1 microgram |
1 microgram |
0.71 mg |
|
Zemplar 2 micrograms |
2 micrograms |
1.42 mg |
|
Zemplar 4 micrograms |
4 micrograms |
1.42 mg |
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Capsule, soft
1 microgram capsule: oval, gray soft capsule imprinted with
2 micrograms capsule: oval, orange-brown soft capsule imprinted with
4 micrograms capsule: oval, gold soft capsule imprinted with
4. Clinical Part
1. Name Of The Medicinal Product
Zeffix 5 mg/ml oral solution
2. Qualitative And Quantitative Composition
Each ml of the oral solution contains 5 mg lamivudine
Excipients:
Sucrose 20 % (4 g/20 ml)
Methyl parahydroxybenzoate (E218) 1.5 mg/ml
Propyl parahydroxybenzoate (E216) 0.18 mg/ml
For a full list of excipients see section 6.1.
3. Pharmaceutical Form
Oral solution
Clear, colourless to pale yellow in colour.
4. Clinical Particulars
4.1 Therapeutic Indications
Zeffix is indicated for the treatment of chronic hepatitis B in adults with:
• compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and/or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).
• decompensated liver disease in combination with a second agent, without cross-resistance to lamivudine (see section 4.2).
4.2 Posology And Method Of Administration
Posology
Therapy with Zeffix should be initiated by a physician experienced in the management of chronic hepatitis B.
Adults: the recommended dosage of Zeffix is 100 mg once daily.
In patients with decompensated liver disease, lamivudine should always be used in combination with a second agent, without cross-resistance to lamivudine, to reduce the risk of resistance and to achieve rapid viral suppression.
Duration of treatme
1. Name Of The Medicinal Product
ZYDOL XL 200 mg tablets.
2. Qualitative And Quantitative Composition
Tablets containing tramadol hydrochloride 200 mg.
For excipients, see 6.1
3. Pharmaceutical Form
Prolonged release, white, film coated tablets, marked T 200.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of moderate to severe pain.
4.2 Posology And Method Of Administration
ZYDOL XL tablets should be taken at 24-hourly intervals and must be swallowed whole and not chewed.
As with all analgesic drugs, the dose of tramadol should be adjusted according to the severity of the pain and the clinical response of the individual patient. The correct dosage for any individual patient is that which controls the pain with no or tolerable side effects for a full 24 hours. Patients transferring from immediate release tramadol preparations should have their total daily dose calculated, and start on the nearest dose in the ZYDOL XL range. It is recommended that patients are slowly titrated to higher doses to minimise transient side effects. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported. (See Section 4.4 Special Warnings and Precautions for Use).A total daily dose of 400 mg should not be exceeded except in special clinical circumstances.
Adults and children over 12 years: The usual initial dose is one 150 mg tablet daily. If pain relief is not achieved, the dosage should be titrated upwards until pain relief is achieved.
Elderly and patients with renal or hepatic impairment: Dosing as for adults. The elimination half-life of tramadol may be prolonged in patients over 75 years. A startin
1. Name Of The Medicinal Product
Zarontin Syrup 250mg/ 5ml
2. Qualitative And Quantitative Composition
.
Each 5 ml syrup contains: Ethosuximide 250 mg.
3. Pharmaceutical Form
Syrup
4. Clinical Particulars
4.1 Therapeutic Indications
Primarily useful in absence seizures. When generalised tonic clonic seizures (grand mal) and other forms of epilepsy co-exist with absence seizures, Zarontin may be administered in combination with other antiepileptic drugs.
4.2 Posology And Method Of Administration
For oral use.
Adults, the Elderly and Children over 6 Years:
Start with a small dose - 500mg (2 x 5ml) daily with increments of 250mg every five to seven days until control is achieved with 1000 - 1500 mg daily. Occasionally 2000 mg in divided doses may be necessary.
Children aged 0-6 years:
Begin with a daily dose of 250 mg (5ml) and increase the dose gradually by small increments every few days until control is achieved. The optimal dose in most children is 20mg/kg/day. The maximum dose should be 1000 mg.
Effective plasma levels of ethosuximide normally lie between 40 and 100 mcg per ml, but the clinical response should be the criteria for the regulation of the dosage. The half-life of ethosuximide in the plasma is more than 24 hours but the daily dose if large is more comfortably divided between morning and evening.
Older children and adults will normally take Ethosuximide in capsule form.
Currently available clinical trial data regarding the use of ethosuximide in the paediatric population are described in section 5.1
4.3 Contraindications
Hypersensitivity to succinimide
Zanidip 10 mg film-coated tablets
Zanidip 20 mg film-coated tablets
lercanidipine hydrochloride
Please read this leaflet before taking your medicine and keep it in a safe place just in case you require it again. This leaflet contains only the most essential information on your medicine. If you have any other questions about your medicine or if you are unsure about anything, ask your doctor or your pharmacist.
Zanidip 10 mg: 1 tablet contains 10 mg of lercandipine hydrochloride, which is equivalent to 9.4 mg of lercanidipine.
Zanidip 20 mg: 1 tablet contains 20 mg of lercanidipine hydrochloride, which is equivalent to 18.8 mg of lercanidipine.
The following inactive ingredients are also included in Zanidip tablets, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K30, magnesium stearate, hypromellose, talc, titanium dioxide (E171), macrogol 6000, and ferric oxide (E172).
Zanidip is available in blister packs of 7, 14, 28, 35, 42, 50, 56, 98, 100 tablets*.
Lercanidipine belongs to a group of medicines called calcium channel blockers (of the dihydropyridine group) which are used to treat high blood pressure.
Marketing Authorisation Holder and Manufacturer of the product: Manufactured for
Recordati PharmaceuticalsIsis House
43 Station Rd
Henley on Thames
OXON
RG9 1AT
Tel: 01491 576336
by the Marketing Authorisation holder
1. Name Of The Medicinal Product
Zutectra
2. Qualitative And Quantitative Composition
One pre-filled syringe of 1 ml contains Human hepatitis B immunoglobulin 500 IU.
Human protein 150 mg/ml of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml.
Distribution of IgG subclasses:
IgG1: 59 %
IgG2: 35 %
IgG3: 3 %
IgG4: 3 %
IgA content max. 6 mg/ml.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection in pre-filled syringe.
The solution is clear and pale yellow or light brown.
4. Clinical Particulars
4.1 Therapeutic Indications
Prevention of hepatitis B virus (HBV) re-infection in HBV-DNA negative patients
Zutectra is indicated in adults only.
The concomitant use of adequate virostatic agents should be considered, if appropriate, as standard of hepatitis B re-infection prophylaxis.
4.2 Posology And Method Of Administration
Posology
In HBV-DNA negative adults
- patients with bodyweight < 75 kg: 500 IU (1 ml)/week
- patients with bodyweight
Prior to the initiation of subcutaneous treatment with Zutectra, anti-HBs serum levels should be stabilised with an adequate intravenous hepatitis B immunoglobulin to levels at or above 300
Patients must be monitored for serum anti-HBs antibody levels regularly.
There is no relevant indication for use of Zutectra in children.
Method of administration