bhpardo/ema_en · Datasets at Hugging Face

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WHAT IS ALDARA CREAM AND WHAT IT IS USED FOR
Avastin treatment should be supervised by a doctor who has experience in the use of cancer treatments.
Renal clearance is independent of dose and ranges between 360-471 ml/ min suggesting that entecavir undergoes both glomerular filtration and net tubular secretion.
Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20-28%) and a delay in tmax (approximately 1.75 h) were
In both studies, all patients received a 16/ 16 dose regimen of Busilvex.
Tadalafil at doses of 2 to 100 mg has been evaluated in 16 clinical studies involving 3250 patients, including patients with erectile dysfunction of various severities (mild, moderate, severe), etiologies, ages (range 21-86 years), and ethnicities.
Desloratadine is the primary active metabolite of loratadine.
Nervous system disorders
The most common side effects in patients receiving Avastin with or without chemotherapy (seen in more than 1 patient in 10) are leucopenia (low levels of leucocytes, a type of white blood cell), thrombocytopenia (low levels of platelets in the blood), neutropenia (low levels of neutrophils, a type of white blood cell), peripheral sensory neuropathy (damage to nerves in the extremities, such as the hands and feet), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, asthenia (weakness), fatigue (tiredness), anorexia (loss of appetite), dysgeusia (taste disturbances), headache, eye disorders, dyspnoea (difficulty breathing), epistaxis (nosebleeds), rhinitis (blocked nose), constipation, stomatitis (inflammation of the lining of the mouth), rectal haemorrhage (bleeding from the rectum), exfoliative dermatitis (flaky skin), dry skin, skin discoloration, proteinuria (protein in the urine), pyrexia (fever) and pain.
Adult Moderate renal (40 years) impairment CrCL:
6.
The beginning of storage at room temperature should be recorded on the product carton.
Additionally, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV.
The following are examples of disposable needles that can be used with your BYETTA pen:
However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
Frequency
ABRAXANE
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution have taken place in controlled validated aseptic conditions.
Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.
In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Lactic acidosis Lactic acidosis is a very rare, but serious, metabolic complication that can occur due to metformin accumulation.
STATEMENT OF ACTIVE SUBSTANCE(S)
In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 patients and where the primary end-point was weight gain, significantly less patients had at least 7% weight gain over baseline (i. e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) on aripiprazole (N= 18, or 13% of evaluable patients), compared to olanzapine (N= 45, or 33% of evaluable patients).
EXP
FURTHER INFORMATION
Aclasta is supplied in packs containing one bottle as unit pack or in multi-packs comprising 5 packs, each containing 1 bottle.
CLINICAL PARTICULARS
FURTHER INFORMATION
13 (13)
75 mg
Medicines should not be disposed of via wastewater or household waste.
- medicines which affect the production of blood cells.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicinal products, including ABILIFY, must be discontinued.
Saquinavir: the AUC, Cmin and Cmax of saquinavir were decreased by 19% and 48% and increased by 21%, respectively, when given with amprenavir.
They are in the shape of almonds and have "C 2 ½" marked on one side.
- if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or
Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
I.
General disorders and administration site conditions
During use: do not refrigerate.
Store in the original package in order to protect from moisture.
Avamys is available in pack sizes 30, 60 and 120 sprays.
Injecting Ceplene yourself Your doctor may decide that it would be more convenient for you to inject IL-2 and Ceplene yourself.
EXP.:
Virological response should be frequently monitored in the lamivudine-refractory population and appropriate resistance testing should be performed.
Following intravenous administration, an approximate 25% difference between paediatric and adult patients in the area under the curve from time 0 to infinity (AUC[0-∞]) was observed; however, this difference was less than the 2-fold range in AUC(0-∞) observed for the pediatricpatients.
Uncommon: rash, pruritus
INSTRUCTIONS ON USE
The medicine can only be obtained with a prescription.
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
2.
- if you suffer from kidney problems;
In each trial, the effects were sustained over the 24 hour dosing interval.
Renal impairment The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment.
6.
Changing the site with each injection may help to prevent such skin changes.
weight increase
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) may cause allergic reactions (possibly delayed).
4.
45 Early on, osteoporosis usually has no symptoms.
If it gets too high it can damage your sight.
Vascular disorders
Multiple dosing of mycophenolate mofetil in patients with severe chronic renal impairment has not been studied.
Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Binocrit is not recommended for injection under the skin in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.
The solution should be clear and colourless.
If the patient becomes pregnant or plans to become pregnant while taking Betaferon, she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Malta Helsinn Birex Therapeutics LTD Damastown, Mulhuddart IRL-Dublin 15 Tel: + 353 1 822 54 17
System organ class
Tel.: +421 2 58282010 msd_sk@merck. com
6 (46.2) 3 (50.0)
Interferon beta-1a
NAME OF THE MEDICINAL PRODUCT
9 1.
6.
10.
14 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
41 Special populations
Boehringer-Gasse 5-11 A-1121 Wien Tel: +43 1 80 105-0
The advisability of driving should be considered in these circumstances.
Opportunistic infections:
In this leaflet:
Bristol-Myers Squibb Rue du Docteur André Gilles 28230 Epernon France
5.
8 Based on what is known of other sulphonylureas, hypoglycaemia may be prolonged.
However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported.
Like all medicines, Actraphane can cause side effects, although not everybody gets them.
2% (1%)
CIALIS is a medicine containing the active substance tadalafil.
It is available as 5 mg, 10 mg, 15 mg and 30 mg tablets, as 10 mg, 15 mg and 30 mg orodispersible tablets (tablets that dissolve in the mouth), as an oral solution (1 mg/ ml) and as a solution for injection (7.5 mg/ ml).
България ул.
EU/ 1/ 04/ 285/ 013-020
No interaction studies have been performed.
Dosing of BeneFIX may differ from that of plasma-derived factor IX products.
Blood and the lymphatic system disorders anaemia granulocytopaenia
Common: rapid heart beat Not known: swelling of the hands, ankles or feet
{number}

WHAT IS ALDARA CREAM AND WHAT IT IS USED FOR

Avastin treatment should be supervised by a doctor who has experience in the use of cancer treatments.

Renal clearance is independent of dose and ranges between 360-471 ml/ min suggesting that entecavir undergoes both glomerular filtration and net tubular secretion.

Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20-28%) and a delay in tmax (approximately 1.75 h) were

In both studies, all patients received a 16/ 16 dose regimen of Busilvex.

Tadalafil at doses of 2 to 100 mg has been evaluated in 16 clinical studies involving 3250 patients, including patients with erectile dysfunction of various severities (mild, moderate, severe), etiologies, ages (range 21-86 years), and ethnicities.

Desloratadine is the primary active metabolite of loratadine.

Nervous system disorders

The most common side effects in patients receiving Avastin with or without chemotherapy (seen in more than 1 patient in 10) are leucopenia (low levels of leucocytes, a type of white blood cell), thrombocytopenia (low levels of platelets in the blood), neutropenia (low levels of neutrophils, a type of white blood cell), peripheral sensory neuropathy (damage to nerves in the extremities, such as the hands and feet), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, asthenia (weakness), fatigue (tiredness), anorexia (loss of appetite), dysgeusia (taste disturbances), headache, eye disorders, dyspnoea (difficulty breathing), epistaxis (nosebleeds), rhinitis (blocked nose), constipation, stomatitis (inflammation of the lining of the mouth), rectal haemorrhage (bleeding from the rectum), exfoliative dermatitis (flaky skin), dry skin, skin discoloration, proteinuria (protein in the urine), pyrexia (fever) and pain.

Adult Moderate renal (40 years) impairment CrCL:

6.

The beginning of storage at room temperature should be recorded on the product carton.

Additionally, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV.

The following are examples of disposable needles that can be used with your BYETTA pen:

However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

Frequency

ABRAXANE

If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution have taken place in controlled validated aseptic conditions.

Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.

In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.

35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Lactic acidosis Lactic acidosis is a very rare, but serious, metabolic complication that can occur due to metformin accumulation.

STATEMENT OF ACTIVE SUBSTANCE(S)

In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 patients and where the primary end-point was weight gain, significantly less patients had at least 7% weight gain over baseline (i. e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) on aripiprazole (N= 18, or 13% of evaluable patients), compared to olanzapine (N= 45, or 33% of evaluable patients).

EXP

FURTHER INFORMATION

Aclasta is supplied in packs containing one bottle as unit pack or in multi-packs comprising 5 packs, each containing 1 bottle.

CLINICAL PARTICULARS

FURTHER INFORMATION

13 (13)

75 mg

Medicines should not be disposed of via wastewater or household waste.

- medicines which affect the production of blood cells.

If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicinal products, including ABILIFY, must be discontinued.

Saquinavir: the AUC, Cmin and Cmax of saquinavir were decreased by 19% and 48% and increased by 21%, respectively, when given with amprenavir.

They are in the shape of almonds and have "C 2 ½" marked on one side.

- if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or

Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free.

Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.

I.

General disorders and administration site conditions

During use: do not refrigerate.

Store in the original package in order to protect from moisture.

Avamys is available in pack sizes 30, 60 and 120 sprays.

Injecting Ceplene yourself Your doctor may decide that it would be more convenient for you to inject IL-2 and Ceplene yourself.

EXP.:

Virological response should be frequently monitored in the lamivudine-refractory population and appropriate resistance testing should be performed.

Following intravenous administration, an approximate 25% difference between paediatric and adult patients in the area under the curve from time 0 to infinity (AUC[0-∞]) was observed; however, this difference was less than the 2-fold range in AUC(0-∞) observed for the pediatricpatients.

Uncommon: rash, pruritus

INSTRUCTIONS ON USE

The medicine can only be obtained with a prescription.

Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.

2.

- if you suffer from kidney problems;

In each trial, the effects were sustained over the 24 hour dosing interval.

Renal impairment The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment.

6.

Changing the site with each injection may help to prevent such skin changes.

weight increase

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) may cause allergic reactions (possibly delayed).

4.

45 Early on, osteoporosis usually has no symptoms.

If it gets too high it can damage your sight.

Vascular disorders

Multiple dosing of mycophenolate mofetil in patients with severe chronic renal impairment has not been studied.

Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.

Binocrit is not recommended for injection under the skin in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.

The solution should be clear and colourless.

If the patient becomes pregnant or plans to become pregnant while taking Betaferon, she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).

Malta Helsinn Birex Therapeutics LTD Damastown, Mulhuddart IRL-Dublin 15 Tel: + 353 1 822 54 17

System organ class

Tel.: +421 2 58282010 msd_sk@merck. com

6 (46.2) 3 (50.0)

Interferon beta-1a

NAME OF THE MEDICINAL PRODUCT

9 1.

6.

10.

14 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.

41 Special populations

Boehringer-Gasse 5-11 A-1121 Wien Tel: +43 1 80 105-0

The advisability of driving should be considered in these circumstances.

Opportunistic infections:

In this leaflet:

Bristol-Myers Squibb Rue du Docteur André Gilles 28230 Epernon France

5.

8 Based on what is known of other sulphonylureas, hypoglycaemia may be prolonged.

However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported.

Like all medicines, Actraphane can cause side effects, although not everybody gets them.

2% (1%)

CIALIS is a medicine containing the active substance tadalafil.

It is available as 5 mg, 10 mg, 15 mg and 30 mg tablets, as 10 mg, 15 mg and 30 mg orodispersible tablets (tablets that dissolve in the mouth), as an oral solution (1 mg/ ml) and as a solution for injection (7.5 mg/ ml).

България ул.

EU/ 1/ 04/ 285/ 013-020

No interaction studies have been performed.

Dosing of BeneFIX may differ from that of plasma-derived factor IX products.

Blood and the lymphatic system disorders anaemia granulocytopaenia

Common: rapid heart beat Not known: swelling of the hands, ankles or feet

{number}